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\b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {INTRODUCTION
\par }\pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b\fs24 
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\fs24 \tab }{\fs24 Ice cream-making machines, Advil, a horror movie entitled \'93Return of the Living Dead,\'94 hair regrowth formula\emdash 
these commodities seem to have little in common, but in the world of litigation they share a dubious distinction.  Each has been the subject of a lawsuit under Section 43(a) of the Lanham Act, the federal false advertising statute.}{\cs17\fs24\super 
\chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See}{ }{\i Nikkal Industries, Ltd. v. Salton, Inc.}{
, 735 F. Supp. 1227, 15 U.S.P.Q.2d 1444 (S.D.N.Y. 1990); }{\i McNeilab, Inc. v. American Home Products Corp.}{, 848 F.2d 34, 6 U.S.P.Q.2d 2007 (2d Cir. 1988); }{\i Dawn Associates et al. v. Link et al.}{
, 203 U.S.P.Q. (BNA) 831 (N.D.Ill., East. Div. 1978); }{\i Upjohn Co. v. Riahom Corp.}{, 641 F. Supp. 1209, 1 U.S.P.Q.2d 1433 (D. Del. 1986).  The Lanham Act is codified as 15 U.S.C. \'a7 1051 et seq. (2000); \'a7 43(a) is 15 U.S.C. \'a7 1125(a) (2000).  
}}}{\fs24   Since the passage of the Lanham Act in 1946, manufacturers in myriad industries have invoked the statute, to enjoin their competitors from making false or
 misleading representations in advertisements or commercial promotions and to seek damages for economic injury they have suffered as a result of these misrepresentations.
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\fs24 In recent years, many of the most complex and high profile false advertising lawsuits
 have involved the advertising and promotion of prescription drugs.  The Food and Drug Administration (\'93FDA\'94
) lifted its moratorium on direct-to-consumer advertisements for prescription drugs in 1985.  Television and radio advertisements for prescription d
rugs were still rare, however, because FDA required manufacturers to provide a brief summary of side effects in their ads, and it was difficult for advertisers to include such a summary in broadcast advertisements.  In 1997, FDA revised its guidelines.  T
he new guidelines required television and radio advertisements to provide information about the major risks associated with featured drugs and ways for consumers to learn more about the drugs, but dropped the brief summary requirement.}{\cs17\fs24\super 
\chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Prescription Drugs and the Cost of Advertising Them}{, at }
{\field\flddirty{\*\fldinst { HYPERLINK "http://www.therubins.com/geninfo/advertise.htm" }{{\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000002f00000068007400740070003a002f002f007700770077002e0074006800650072007500620069006e0073002e0063006f006d002f00670065006e0069006e0066006f002f006100640076006500720074006900730065002e00680074006d000000e0c9ea79
f9bace118c8200aa004ba90b5e00000068007400740070003a002f002f007700770077002e0074006800650072007500620069006e0073002e0063006f006d002f00670065006e0069006e0066006f002f006100640076006500720074006900730065002e00680074006d000000}}}{\fldrslt {\cs21 
http://www.therubins.com/geninfo/advertise.htm}}}{.  FDA still requires advertisers to include a brief summary of side effects in print advertisements.}}}{\fs24   Since 1997, pharmac
eutical companies have inundated television stations and radio broadcasts with advertisements for prescription drugs.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See id.}{  (\'93The amount spent on consumer advertising rose from $1.3 billion in 1998 to $1.8 billion in 1999.\'94).}}}{\fs24\cf5   }{\fs24 
Manufacturers of competing prescription drugs, over-the-counter (\'93OTC\'94) drugs, generic drugs, cosmetics, dietary supplements, and drugs 
not approved for sale in the United States began to wage comparative advertising campaigns.  Their attempts to capitalize on the consumer demand created by the public\rquote 
s heightened awareness of the availability of treatments for a wide range of medical problems have led to numerous Lanham Act lawsuits. 
\par As the number of false advertising lawsuits filed by pharmaceutical companies has increased, litigants have used Section 43(a) of the Lanham Act not only to promote fairness in commerce, the law\rquote s original intent,}{\cs17\fs24\super \chftn 
{\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ For years many courts did not view consumer protect
ion as a purpose of the Lanham Act.  }{\i See, e.g.}{,}{\i  Colligan v. Activities Club of N.Y., Ltd., }{442 F.2d 686, 692 (2d Cir. 1971) (concluding that Congress\rquote  purpose in enacting \'a7
43(a) was to create a special and limited unfair competition remedy, not to protect consumers).  Today courts understand consumer protection to be an important goal of the statute.  }{\i See, e.g.}{, }{\i CBS, Inc. v. Springboard Int. Records}{
, 429 F. Supp. 563, 563 (S.D.N.Y. 1976); }{\i Yameta Co. v. Capitol Records, Inc.}{, 279 F. Supp. 582, 587 (S.D.N.Y. 1968), rev\rquote d on other grounds, 393 F.2d 91 (2d Cir. 1968).}}}{\fs24 
 but also to attempt to self-regulate the drug/cosmetic/dietary supplement industry.  Drug makers whose products are subject to strict regulation by FDA can invoke the statute to prevent companies whose products face less intense FDA scrutiny from cl
aiming that these unregulated products have the same effects on the human body as drugs which have undergone lengthy and rigorous testing.  Such Lanham Act cases have the important benefit of protecting consumers from harm that could result from their rel
iance on misinformation in commercial advertising.  
\par While Section 43(a) of the Lanham Act has the potential to become an extremely useful tool to ensure competitive fairness and consumer safety in the pharmaceutical industry, recent cases show that numerou
s obstacles prevent Lanham Act plaintiffs from prevailing in their lawsuits.  In this Paper, I will examine how the procedural requirements of false advertising law and substantive FDA doctrines combine to hinder drug manufacturer-plaintiffs\rquote 
 chances for success in Lanham Act claims.  I will advocate greater clarification of the evidentiary standards and standing requirements for Lanham Act claims and suggest reforms for FDA\rquote 
s regulations regarding manufacturers of generic drugs and foreign manufacturers whose drugs are not approved for use in the United States.  I will describe the elements necessary for a successful claim under the Lanham Act using the recent case of }{
\i\fs24 Zeneca, Inc. v. Eli Lilly & Co.}{\fs24 , 1999 U.S. Dist. LEXIS 10852 (S.D.N.Y. July 19, 1999) as an example.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ 1999 U.S. Dist. LEXIS 10852 (S.D.N.Y. 1999).}}}{\fs24 
  Finally, I will explore alternatives to private litigation for false advertising cases, including trademark infringement litigation, lawsuits initiated by FDA and the Federal Trade Commission (\'93FTC\'94), and suits by state attorneys general.  
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\fs24 
\par {\pntext\pard\plain\s1 \b \hich\af0\dbch\af0\loch\f0 I.\tab}}\pard\plain \s1\ql \fi-720\li720\ri0\sl480\slmult1\keepn\widctlpar\jclisttab\tx720{\*\pn \pnlvlbody\ilvl0\ls1\pnrnot0\pnucrm\pnstart1\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls1\outlinelevel0\adjustright\rin0\lin720\itap0 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {The Lanham Act and the Federal Food, Drug, and Cosmetic Act
\par }\pard\plain \s2\ql \fi720\li0\ri0\sl480\slmult1\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel1\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
To understand how manufacturers of drugs subject to FDA approval use the Lanham Act to police the promotional claims of manufacturers whose products are not subject to FDA approval, it is necessary to know which products are subject to FDA\rquote 
s jurisdiction and which promotional activities are subject to Section 43(a) of the Lanham Act.  
\par }\pard\plain \s3\ql \li0\ri0\keepn\widctlpar\aspalpha\aspnum\faauto\outlinelevel2\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\tab The Federal Food, Drug, and Cosmetic Act (\'93FD&C Act\'94) defines \'93drugs\'94
 as 
\par }\pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
\par {\listtext\pard\plain\fs20 \hich\af0\dbch\af0\loch\f0 (A)\tab}}\pard \ql \fi-360\li1800\ri0\widctlpar\jclisttab\tx1800\aspalpha\aspnum\faauto\ls2\adjustright\rin0\lin1800\itap0 {articles recognized in the official United States Pharmacopoeia, official

\par }\pard \ql \li1440\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin1440\itap0 { Homeopathic Pharmacopoeia of the United States, or official National Formulary,
\par or any supplement to any of them; and (B) articles intended for use in the diagnosis,
\par cure, mitigation, treatment, or prevention of disease in man or other animals; and (C)
\par }\pard \ql \fi720\li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {articles (other than food) intended to affect the structure or any function of the 
\par }\pard \ql \li1440\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin1440\itap0 {body of man or other animals; and (D) articles intended for use as a component of any 
\par article specified in clause (A), (B), or (C).}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{
 21 U.S.C.S. \'a7 321 (2000).}}}{
\par 
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\fs24 A su
bstance which meets this broad FD&C Act definition of a drug is subject to numerous FDA regulations.  The manufacturer of a new drug must obtain FDA approval of a new drug application (\'93NDA\'94) prior to marketing.}{\cs17\fs24\super \chftn {\footnote 
\pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ 21 U.S.C.S. \'a7 355 (2000).}}}{\fs24   As part of the NDA, the manufacturer must 
provide FDA with information about the composition of the drug and the manufacturing process, provide FDA with samples of the drug, produce studies which prove that the drug is safe and effective to treat the medical problem for which patients will use th
e drug, and secure a patent for the drug and/or resolve any potential patent conflicts.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i Id}{.}}}{\fs24   (Some drugs are exempt from these premarket approval requirements because they were on the market prior to FDA\rquote 
s institution of these requirements; these drugs are still subject to other FDA regulations.)}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{  21 U.S.C.S. \'a7 321p (2000).}}}{\fs24   Producers of all drugs must adhere to FDA\rquote s packaging and labeling requirements}{\cs17\fs24\super \chftn {\footnote 
\pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ 21 U.S.C.S. \'a7 352 (2000).}}}{\fs24 
 and receive approval from FDA for changes in the manufacturing process of the drug.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ 21 U.S.C.S. \'a7 356a (2000).}}}{\fs24   Drug companies must provide FDA with information about the drugs they produce and allow inspection of their manufacturing facilities.}{
\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ 21 U.S.C.S. \'a7 360 (2000).}}}{\fs24 
  A company seeking to market a drug for an additional use than the one for which the drug was originally approved must submit research proving the drug\rquote s safety and efficacy for the new use similar to that required of a new drug.}{
\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ 21 U.S.C.S. \'a7 360aaa-3 (2000).}}}{\fs24   

\par Finally, manufacturers of an article classified as a prescription drug face stringent regulations on the information they can include in advertisements.  These regulations include restrictions 
on comparative claims, recommendations that consumers use the drug for unapproved uses, the use of statistics, and research results.}{\cs17\fs24\super  \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ 21 C.F.R. \'a7 202.1 (2001).}}}{\fs24 
  These regulations also compel manufacturers to provide information about side effects the drug may cause, including the 
occurrence of side effects in particular classes of patients likely to use the drug, and give specific guidelines for the presentation of information about side effects in an advertising spread.}{\cs17\fs24\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i Id.}}}{\fs24   Compliance with these regulations limits the promotional cl
aims that drug manufacturers can make in comparison with manufacturers of foods, cosmetics, or dietary supplements.  While manufacturers of articles not classified as prescription drugs must still comply with the advertising standards of the Lanham Act, t
h
ey have much more flexibility in terms of the uses they can recommend for their products and the way they can present research findings.  Additionally, unlike manufacturers of drugs, they have no duty to report information about side effects that may dete
r
 consumers from purchasing their products.  The greater freedom that makers of non-prescription-drug substances have in advertising their products allows them to make promotional therapeutic claims that makers of drugs cannot.  Drug makers therefore turn 
to the Lanham Act to remedy this disparity. 
\par Adherence to FDA\rquote s advertising and other regulations costs pharmaceutical companies enormous financial, human, and time resources.  It is estimated that the approval of a new drug in the United States today takes
 seven to thirteen years and costs between $30 million and $50 million.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs17\super \chftn }{ }{\i See}{\scaps  Peter B. Hutt & Richard A. Merrill, Food and Drug Law: Cases and Materials }{514 (2d ed. 1991).}}}{\fs24 
  Once a manufacturer overcomes the colossal hurdle of FDA approval, the status of its product as a drug subjects it to all the ongoing regulations mentioned above.  While the FD&C Act
 also regulates foods, cosmetics, and medical devices, the regulations for these entities do not create the substantial barriers to entry in their respective markets as the premarket approval and marketing regulations for new drugs do.  Consequently, when
 analyzing the drug/cosmetic/dietary supplement marketplace, competitors can be divided into two categories: manufacturers of substances subject to FDA regulation as drugs and manufacturers of substances not subject to FDA regulation as drugs.  
\par }\pard \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab }{\fs24 Claims bro
ught under the Lanham Act by pharmaceutical companies thus fall into three categories.  First, there are claims brought by manufacturers of substances classified as drugs against manufacturers of other substances classified as drugs.  For example, in }{
\i\fs24 McNeilab, Inc. v. American Home Products Corp}{\fs24 .,}{ }{\fs24 848 F.2d 34 (2d Cir. 1988), McNeilab, the maker of Tylenol, sued American Home Products (\'93AHP\'94
), the maker of Advil, for commercials claiming that Advil caused stomach upset no more frequently than Tylenol.  McNeilab won the suit by producing evidence refuting AHP\rquote s claims that Advil was as safe as Tylenol.  Cases like }{\i\fs24 McNeilab }{
\fs24 are the false advertising lawsuits with which most people are most familiar.  In such cases, FDA regulation affects both manufacturers equa
lly; because neither drug requires a prescription, neither manufacturer is subject to FDA regulation of its advertising.  Plaintiffs in these cases do not invoke the Lanham Act to police the drug market to ensure that products not subject to FDA regulatio
n
 do not gain a competitive advantage over those that are.  Rather, these plaintiffs file false advertising claims simply to correct what they perceive as false or misleading comparisons between two products, and in this sense, their claims are no differen
t than those filed by Lanham Act plaintiffs in any industry.
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\fs24 
Second, there are claims brought by manufacturers of substances which are considered drugs, but which are not subject to FDA premarket approval, against manufacturers of other substances classified similarly.  Examples include }{\i\fs24 
Ethex Corporation v. Warner Chilcott, Inc.}{\fs24 , and }{\i\fs24 Florida Breckenridge, Inc. v. Solvay Pharmaceuticals, Inc.}{\fs24 , 1998 U.S. Dist. LEXIS 14742, *, (S.D. Fl. 1998).}{\i\fs24   }{\fs24 In }{\i\fs24 Ethex,}{\fs24 
 the manufacturer of a pre-natal vitamin sought a declaratory judgment that its product was a generic version of a vitamin. Although both substances required a doctor\rquote s prescription, neither was subject to FDA\rquote 
s premarket and branding approval because the vitamins had been on the market before such approval was required.}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See}{ Robert C. Scheinfeld, }{\i False Advertising of Allegedly \'93Generic\'94 Drugs}{, }{\scaps Law.com Briefing Papers}{, }{\i at}{
 http://www10.law.com/papers/cgi-bin/ljx_abstract.cgi?memo_id=13760&topic_code=Intellectual. }}}{\fs24   The }{\i\fs24 Florida Breckenridge}{\fs24 
 plaintiff, the maker of a generic prescription hormonal replacement therapy drug, also sought a declaratory judgment against the maker of similar drug who had neglected to obtain FDA approval.}{\cs17\fs24\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Florida Breckenridge v. Solvay Pharmaceuticals, Inc.}{
, 174 F.3d 1227, 1230 (11th Cir. 1999).}}}{\fs24   
\par In cases of the second type like }{\i\fs24 Ethex}{\fs24  and }{\i\fs24 Florida Breckenridge}{\fs24 , the classification of an article as a drug does not subject the substance to FDA\rquote 
s premarket and branding approval requirements.  Instead, in these cases, the plaintiffs\rquote  drugs\rquote  }{\i\fs24 lack }{\fs24 of FDA regulation hinders their 
ability to compete in the marketplace, because manufacturers who claim to produce a generic equivalent face differing standards depending on whether the drug they imitate is subject to FDA regulation.  Plaintiffs in such cases do not use the Lanham Act in
 
an attempt to ensure promotional opportunities equal to those of competitors subject to less scrutiny than they are.  Rather, they attempt to ensure equal treatment to their competitors who benefit from FDA regulation, because this regulation raises the b
ar for generic manufacturers seeking entry to their markets.  
\par Finally, there are cases in which the manufacturer of a substance classified by FDA as a drug and subject to FDA\rquote s testing and branding requirements sues the manufacturer of a product not classi
fied by FDA as a drug, or a product classified by the FDA as a drug for another use and subject to FDA\rquote 
s testing and branding requirements only for the use for which it has been approved.  These cases include claims by manufacturers of FDA-regulated drugs 
against manufacturers of cosmetics, dietary supplements, drugs not approved for sale in the United States, and drugs being marketed for uses for which they have not received FDA approval.  In these cases, as in the second type of cases, a successful claim
 will result not only in the enjoinment of the defendants\rquote  specific behavior, but also in drug manufacturers\rquote  enhanced ability to compete in the marketplace despite the regulatory restrictions they face.   
\par The status of a Lanham Act party\rquote s product as a dr
ug under the FD&C Act is most relevant, therefore, in the second and third types of cases.  These cases include those in which a drug manufacturer attempts to enjoin the maker of a generic version of its product from claiming equivalence to the pioneer dr
ug and those in which a drug manufacturer attempts to enjoin the maker of a non-drug from claiming it is equally effective to the drug.  
\par Since it is clear that these types of plaintiff pharmaceutical companies}{\cs17\fs24\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 
{\cs17\super \chftn }{ By \'93plaintiff companies,\'94 I refer to those companies which desire to end behavior by a competitor which they believe constitutes false and misleading advertising.  In some cases, such as }{\i Ethex}{ and }{\i 
Florida Breckenridge}{, those companies are in fact defendants, because the party alleging acting in violation of the Lanham Act has filed suit for a declaratory judgment.}}}{\fs24  have the most to gain by relying on Section 4
3(a) of the Lanham Act to achieve equal opportunity in the marketplace, the next step is to determine the types of behavior these companies can prohibit under the statute.  The false advertising provision of the Lanham Act provides a remedy for parties in
jured by the false or misleading representations of their competitors in commercial advertising or promotion.  Specifically, the provision reads:
\par {\listtext\pard\plain\fs20 \hich\af0\dbch\af0\loch\f0 (1)\tab}}\pard \ql \fi-360\li1800\ri0\widctlpar\jclisttab\tx1800\aspalpha\aspnum\faauto\ls3\adjustright\rin0\lin1800\itap0 {
Any person who, on or in connection with any goods or services, or any container
\par }\pard \ql \li1440\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin1440\itap0 {for goods, uses in commerce any word, term, name, symbol, or device, or any
\par combination thereof, or any false designation of origin, false or misleading 
\par description of fact, or false or misleading representation of fact, which \endash 
\par {\listtext\pard\plain\fs20 \hich\af0\dbch\af0\loch\f0 (A)\tab}}\pard \ql \fi-360\li1800\ri0\widctlpar\jclisttab\tx1800\aspalpha\aspnum\faauto\ls4\adjustright\rin0\lin1800\itap0 {is likely to cause confusion, or to cause mistake, or to
 deceive as to the affiliation,
\par }\pard \ql \li1440\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin1440\itap0 {connection, or association of such person with another person, or as to the 
\par origin, sponsorship, or approval of his or her goods, services, or commercial
\par activities by another person, or
\par {\listtext\pard\plain\fs20 \hich\af0\dbch\af0\loch\f0 (B)\tab}}\pard \ql \fi-360\li1800\ri0\widctlpar\jclisttab\tx1800\aspalpha\aspnum\faauto\ls4\adjustright\rin0\lin1800\itap0 {in commercial advertising or promoti
on, misrepresents the nature, characteristics,
\par }\pard \ql \li1440\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin1440\itap0 {qualities, or geographic origin of his or her or another person\rquote s goods, services, or
\par commercial activities,
\par shall be liable in a civil action by any person who believes that he or she is or is 
\par likely to be damaged by such act.}{\cs17\fs24\super  \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ 15 U.S.C.S. 
\'a7 1125(a) (2000).}}}{\fs24 
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\fs24 
\par }\pard\plain \s20\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\tab 
Accordingly, the following elements are necessary to prove violation of the Lanham Act: 1) the defendant\rquote s behavior must occur in a commercial context, 2) the defendant must convey false or misleading information, and 3) the plainti
ff must be able to show that the defendant\rquote 
s illegal promotional activity caused or is likely to cause it harm.   A defendant can convey false or misleading information, the second element of a violation, in two ways.  First, as described in (1)(A), a defe
ndant can attempt to confuse consumers by trying to \'93pass off\'94 its product as the plaintiff\rquote s, by trying to \'93reverse pass off\'94 the plaintiff\rquote 
s products as its own, or by imitating the trade dress (the image and appearance) the plaintiff uses to distinguish
 its product in its own trade dress.  Second, as described in (1)(B), a defendant can make misleading statements about either its own product or the plaintiff\rquote s product.
\par }\pard\plain \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\fs24 
Lanham Act cases involving pharmaceuticals have qualities which can make proof of each
 of these three elements difficult.  The commercial contexts in which prescription drugs are promoted, for example, can involve presentations by sales representatives to doctors in addition to traditional promotional activities such as newspaper and telev
ision advertisements, as this Paper will discuss in Section II.B.  Additionally, the definition of \'93false or misleading\'94
 is  unclear in comparative advertisements involving drugs.  Claims that a non-drug will have the same effects on the body that a drug does might be considered \'93false or misleading\'94
 since only those substances classified as drugs affect the structure or any function of the body or diseases present in the body, according to the FD& C Act definition.  Yet courts have permitted the manufacture
rs of non-drugs to advertise their products as having a cosmetic effect on the body similar to the chemical effect produced by a drug.}{\cs17\fs24\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Ortho Pharmaceutical Corp. v. Cosprophar, Inc., }{
32 F.3d 690, 696-7 (2d Cir. 1994) (maker of anti-aging cosmetic cream may promote product as effective for diminishing signs of photoaging, including wrinkles).}}}{\fs24    
\par }\pard\plain \s20\ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
Third, a prevailing plaintiff in a Lanham Act claim must show not only that the defendant created a false or misleadi
ng advertisement, but also that injury resulted.  The plaintiff must show four elements to prove injury.  First, consumers must be likely to see the defendant\rquote s advertisement.  Second, consumers must be likely to believe the defendant\rquote 
s claims.  The second step does not place a great burden on plaintiffs, because proof that consumers have actually been deceived is not required.}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See}{ Ivan L. Preston & Jef I. Richards, }{\i 
Consumer Miscomprehension and Deceptive Advertising: A Response to Professor Craswell}{, 68 }{\scaps B.U. L. Rev. }{431, 431 n.7 (\'93In fact, the act
ual FTC standard involves only the potential for creating a false belief, which means deceptive capacity rather than actual deception.\'94). }}}{  Conversely, proof that the defendant\rquote 
s promotional claims are false is irrelevant if reasonable consumers are unlikely to believe them.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See id.}{ at 431 (\'93For example, a weight-loss ad might state that consumers will \lquote lose 15 pounds in 5 days.\rquote   Consumers might understand the advertiser
\rquote s promise, yet their prior personal experience and knowledge of similar weight-loss products could render them skeptical of that promise.  If they disbelieve the claim and so reject the product, neither they nor the advertiser\rquote 
s competitors will be harmed by the ad.\'94). }}}{  Third, consumers\rquote  belief or likely belief of the defendant\rquote s claim must be material, i.e., it must \'93have a significant propensity to effect a consumer\rquote s purchase decision.\'94}{
\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i Toro Co. v. Textron}{,}{\i  Inc.}{
, 499 F. Supp. 241, 253 (D. Del. 1980).}}}{  Fourth, consumers\rquote  belief of the defendant\rquote s claim must cause or be like
ly to cause direct, demonstrable harm to the plaintiff.   This harm can occur because consumers choose or will likely choose to buy the defendant\rquote s product rather than the plaintiff\rquote 
s, or because the defendant made derogatory statements which may cause consumers not to buy the plaintiff\rquote s product, regardless of whether they buy the product manufactured by the defendant.  For example, AHP\rquote s claims in }{\i McNeilab}{
 that Advil was equal in safety to Tylenol might have caused some users who tried Advil and suffered 
stomach upset to avoid purchasing Tylenol, out of an incorrect assumption that Tylenol would cause them stomach upset, too.  Substitution of Advil for Tylenol was not the only possible harm that AHP\rquote s commercials caused McNeilab.
\par A plaintiff pharmaceutical
 company that successfully litigates a claim under Section 43(a) has several remedies available, and it can affect a substantial change in the marketplace by asserting them.  Most plaintiffs will request a permanent injunction prohibiting the defendant fr
om continuing to make the claims which have been deemed false or misleading.  In cases involving drugs and other articles ingested or applied to consumers\rquote 
 bodies, such injunctions may be of critical importance from the viewpoint of consumer safety as well as the viewpoint of the plaintiff\rquote 
s economic injury.  When the plaintiff has suffered actual, not merely likely, damage, it may demand that the defendant commence a corrective advertising campaign.  Again, this remedy may serve important public safety goal
s in addition to helping the plaintiff restore its competitive position in the marketplace.  Plaintiffs can also obtain damages if they can prove actual rather than likely economic injury.  
\par These options make the Lanham Act a powerful tool for private parties to force their competitors to comply with FDA standards and to protect consumers\rquote 
 welfare.  They also underscore the need for reforms that make it easier for plaintiffs to bring Lanham Act lawsuits.  Reform is necessary because most Lanham Act plainti
ffs seek injunctive relief rather than damages, so defendants do not face a substantial financial risk.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\super 26}{\i  See}{ Steven A. Zalesin, }{\i Defending Consumer Class Actions for False Advertising}{, }{\scaps IP on Trial}{, }{\scaps Patterson, Belknap, Webb & Tyler.Legal Resources}{, }{\i at }{
http://www.pbwt.com/Resources/index.html}{\cf5 .  }{Plaintiffs\rquote 
 preference for injunctive relief rather than damages is presumably due to the fact that any estimate of damages is likely to be speculative, because Section 43(a) provides a cause of action as soon as a defendant creates a }{\i likelihood}{
 of confusion, when no actual confusion may have yet occurred, resulting in }{\i likely}{ harm to the plaintiff, when no actual harm may yet have occurred.}}}{
  Because the risk of financial loss does not deter potential defendants from violating the Lanham Act, the risk to plaintiffs of losing such suits shou
ld be lowered, to ensure that plaintiffs have the necessary incentive to police the behavior of competitors whose lack of risk creates a moral hazard.
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {
\par {\pntext\pard\plain\s20 \b \hich\af0\dbch\af0\loch\f0 II.\tab}}\pard \s20\ql \fi-720\li720\ri0\widctlpar\jclisttab\tx720{\*\pn \pnlvlbody\ilvl0\ls1\pnrnot0\pnucrm\pnstart1\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls1\adjustright\rin0\lin720\itap0 {\b Evidentiary Obstacles Pharmaceutical Companies Face in Establishing the Elements Required for a Lanham Act Claim
\par }\pard \s20\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b 
\par }\pard \s20\ql \li720\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {Drug manufacturers\rquote  compliance with the FDA regulations described above and 
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar\tx720\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {promotional practices unique to the pharmaceutical industry can complicate plaintiffs\rquote 
 efforts to establish the elements required in a Lanham Act claim.  This Section wi
ll examine two unique complications pharmaceutical companies face in false advertising lawsuits and determine whether these complications are effective deterrents of frivolous litigation or areas in which  legislative reform is necessary.
\par \tab First, Section 43(a) requires that plaintiffs show that consumers were aware of the defendant\rquote 
s promotional claims, believed them, and relied on them in a material way.  Plaintiffs in Section 43(a) cases typically establish this requirement by producing carefully crafted 
survey evidence, but the types of promotional activities customary in the pharmaceutical industry can hurt plaintiffs\rquote  efforts to create admissible consumer surveys.  A second evidentiary obstacle arises from drug manufacturers\rquote 
 extensive use of sales repr
esentatives who meet physicians face-to-face to promote specific drugs.  These sales representatives are engaged in the commercial advertising activities subject to Section 43(a).  Yet it is difficult for the plaintiff in such a lawsuit to prove that the 
defendant has made false or misleading representations, because of the lack of tangible evidence when the alleged representations are oral claims made by sales reps to doctors.  
\par \tab 
\par {\pntext\pard\plain\s20 \b\i \hich\af0\dbch\af0\loch\f0 A.\tab}}\pard \s20\ql \fi-720\li1440\ri0\widctlpar\jclisttab\tx1440{\*\pn \pnlvlbody\ilvl0\ls5\pnrnot0\pnucltr\pnstart1\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls5\adjustright\rin0\lin1440\itap0 {\b\i The Difficulty of Admitting Consumer and Doctor Surveys as Evidence of the  False or Misleading Advertising of Drugs
\par }\pard \s20\ql \li720\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {
\par 
\par }\pard \s20\ql \fi720\li0\ri0\sl480\slmult1\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {
Plaintiffs in false advertising lawsuits typically establish that consumers are likely to see, believe, and make purchasing decisions based on the defendant\rquote s promotional claims through the use of consumer surveys
.  Proving that consumers saw an ad and that it conveyed the implied message to them is relatively simple.  Courts usually require at least fifteen percent of survey respondents to perceive the claim the ad attempts to make for sufficient proof to exist t
hat the allegedly false or misleading claims have reached the target audience.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See }{Andrew D. Schau,}{\i  What To Do When Your Competitor\rquote s Advertising Is False or Misleading}{, }{\scaps 
False Advertising, Patterson, Belknap, Webb & Tyler.Legal Resources}{, }{\i at }{http://www.pbwt.com/ Resources/index.html.}}}{
  Proving that consumers relied on the ad, and that their reliance caused or is likely to cause harm to the plaintiff, is more difficult.  Plaintiffs have successfully demonstrated the effect of the defendant\rquote 
s advertisements with consumer surveys indicating that some consumers thought they could substitute the defendant\rquote s product for the plaintiff\rquote s product.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn 
\pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See,}{ }{\i e.g.}{,}{\i  Johnson & Johnson v. Carter-Wallace, Inc.,}{
 631 F.2d 186, 191 (2d Cir. 1980), cited in}{\i  Ortho Pharmaceutical, }{32 F.3d at 695.}}}{  
\par Three legal hurdles limit the use of survey evidence.  First, for consumer surveys to be relevant to the claim, they must establish a causal link between the defendant\rquote s advertisements and the damage claimed by the plaintiff.}{\cs17\super \chftn 
{\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Ortho Pharmaceutical}{
, 32 F.3d at 696.}}}{  The design of a survey is extremely important in establishing this link.  Surveys are not relevan
t to a Lanham Act claim if they do not specifically ask consumers if they were misled in a way that persuaded them to purchase the defendant\rquote s products rather than the plaintiff\rquote 
s, with the plaintiff consequently losing sales to the defendant.  Thus, plaintiffs must carefully design their surveys so that responses reveal not only consumers\rquote  awareness of the plaintiff\rquote s and defendant\rquote 
s products, but also whether consumers believe they could use the defendant\rquote s product instead of the plaintiff\rquote s product because of false or misleading claims made by the defendant.  Courts have excluded plaintiffs\rquote 
 surveys as irrelevant when they did not provide insight into specific consumer behavior.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See id.}{ at 696-7.}}}{
\par Second, a plaintiff that designs its survey to ask the appropriate questions
 must also administer it according to guidelines established by false advertising case law, for the survey to be admissible.  These guidelines permit admission of a survey if it is:
\par }\pard \s20\ql \fi720\li720\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\fs20  fairly and scientifically conducted by qualified experts and impartial interviewers,
\par  if the study drew responses from a sample of a relevant portion of potential customers,
\par  if the questions upon which the results relied do not appear to be misleading or biased,
\par  and if the recordation of responses was handled in a completely unbiased manner.}{\cs17\fs20\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i Gilbert/Robinson, Inc. v. Carrie Beverage-Missouri, Inc.}{, 758 F. Supp. 512, 524 (E.D. Mo. 1991), aff\rquote d in part, rev\rquote 
d in part on other grounds, 989 F.2d 985 (1993), reh\rquote g denied 1993 U.S. App. LEXIS 11,700 (8th Cir. 1993)(en banc).}}}{\fs20 
\par 
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {Surveys that fail to meet these guidelines may be excluded as hearsay under Federal Rule of Evidence (\'93FRE
\'94) 801,}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }
{\scaps Fed. R. Evid}{. 801.}}}{ but a survey that meets them is likely to be admitted under the \'93business records\'94 exception of FRE 803(6).}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0
\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\scaps Fed. R. Evid.}{ 803(6).}}}{  A survey can fail to meet the \'93business records\'94
 guidelines if, for example, an employee of the plaintiff\rquote s firm has summarized the survey data into a marketing report.  In such an instance, uncertainty arises as to whether \'93the recordation of responses was handled in
 a completely unbiased manner,\'94 because the employee has the opportunity to present the survey data in the light most favorable to the firm.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec 
}\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Ortho Pharmaceutical Corp. v. Cosprophar, Inc.}{
, 828 F. Supp. 1114, 1119-1120 (S.D.N.Y. 1993) (rejecting a summary report of a survey about physicians\rquote  use of plaintiff\rquote s drug written by plaintiff\rquote s market research manager). }}}{  
\par \tab While the first two limitations on the admissibility of surveys apply equally to drug-industry and non-drug-industry plaintiffs, the third limitation is specific to the drug industry.  This restriction affects plaintiffs\rquote 
 surveys of physicians, rather than drug consumers.  Because the false advertising statute covers oral statements made by sales representatives to doctors, plaintiffs have attempted to prove that their adversaries\rquote 
 representative have made false or misleading statements by surveying doctors about their conversations with sales reps.  These surveys do not poll \'93a sample of a relevant portion of potential customers,\'94
 so they do not technically meet the guidelines for properly conducted Lanham Act surveys.  
\par }\pard \s20\ql \fi720\li0\ri0\sl480\slmult1\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {For example, in }{\i Schering Corp. v. Pfizer Inc.}{
, 1999 WL 144921 (S.D.N.Y. March 16, 1999), Schering, the maker of the antihistamine Claritin, tried t
o admit doctor surveys to prove that sales reps for Pfizer, the maker of competing antihistamine Zyrtec, were making false claims that Zyrtec was non-sedating.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn 
\pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See}{ }{\i Schering Corp. v. Pfizer Inc.}{
, 1999 WL 144921 (S.D.N.Y. March 16, 1999). }}}{  The trial court excluded these surveys because they did not meet the admissibility standards for Lanham Act surveys.  The trial court rejected arguments that the surveys met the \'93state of mind\'94
 exception to the hearsay rule, found in FRE 803(3) and that the surveys were admissible under the \'93residual hearsay exception,\'94 found in FRE 807.  The circuit court reversed and admitted the surveys,}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Schering Corp. v. Pfizer Inc.}{
, 189 F.3d 218 (2d Cir. 1999).}}}{ and this action has been interpreted as a sign that courts are willing to apply the survey guidelines liberally in Lanham Act cases involving drugs.}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See}{ Harold P. Weinberge
r and Jonathan M. Wagner, }{\i On the False Advertising Battlefront; Fiercest Lanham Act Conflicts Waged by Large Pharmaceutical Companies Over Reps\rquote  Oral Claims}{, }{\scaps N.Y. Law J., }{July 24, 2000, (Supplement: Intellectual Property)}{\cf5  }
{at S3.}}}{
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab Given these three problems with admissibility of survey evid
ence, a few simple procedural reforms could clarify and increase the types of surveys admissible in Lanham Act litigation.  These reforms would prevent plaintiffs from investing valuable resources in the creation of surveys only to have them excluded from
 
evidence, as has happened in numerous Lanham Act cases.  First, the legislature could codify the required elements for consumer surveys in Lanham Act proceedings in the Federal Rules of Evidence.  Although case law already provides guidelines, uniform nat
i
onal admissibility standards would reduce the instances in which plaintiffs design or administer their surveys incorrectly.  A second option, which is more feasible because it requires less Congressional action, is for the legislature to revise the curren
t
 guidelines to admit surveys of non-customers (i.e., doctors) who are the target audience of the allegedly false or misleading representations in cases involving drug manufacturers.  The Second Circuit has relaxed the Lanham Act standards to allow such su
rveys in }{\i Schering}{, but no federal law currently compels other courts to take this lenient approach.  
\par 
\par {\pntext\pard\plain\s20 \b\i \hich\af0\dbch\af0\loch\f0 B.\tab}}\pard \s20\ql \fi-720\li1440\ri0\widctlpar\jclisttab\tx1440{\*\pn \pnlvlbody\ilvl0\ls5\pnrnot0\pnucltr\pnstart1\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls5\adjustright\rin0\lin1440\itap0 {\b\i The Difficulty of Admitting Sales Representatives\rquote  Call Notes as Evidence of the False or Misleading Advertising of Drugs
\par }\pard \s20\ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\b\i 
\par }\pard \s20\ql \li720\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {The evidentiary challenges a plaintiff faces when the defendant\rquote s promotional 
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {
activities occur in the form of oral statements made by sales representatives to doctors do not apply to surveys alone.  Recently, Zeneca, the manufacturer of tamoxifen, the only drug approved by FDA for redu
cing breast cancer risk in high-risk women, sued Eli Lilly, the manufacturer of Evista, a drug approved for osteoporosis prevention.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See}{ }{\i Zeneca, Inc. v. Eli Lilly & Co.,}{ 1999 U.S. Dist. LEXIS 10852 (S.D.N.Y. July 19, 1999).}}}{  Zeneca alleged that members of Eli Lilly\rquote 
s one-thousand-person sales force were telling doctors that Evista had also been proven to reduce the risk of breast cancer and that it was a safer drug than tamoxifen, which can increase patients\rquote  risk of uterine cancer.}{\cs17\super \chftn 
{\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See id.}{ at *1-*2, *18, *23.}}}{  Zeneca\rquote 
s lawsuit thus exemplifies self-regulatory use of the Lanham Act by a company that must adhere to FDA reg
ulations to stop the behavior of a company whose products have not received FDA approval for the use for which it has promoted them.  To prove its allegations, Zeneca introduced Eli Lilly reps\rquote  \'93call notes,\'94
 written notes prepared by reps shortly after they met with physicians in which they summarized the visits.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See id}{. at *24.}}}{  The court admitted the call notes under FRE 803(6)\rquote s \'93business records\'94
 exception to the hearsay rule, and the call notes became the key means by which Zeneca proved its claims.
\par \tab The court\rquote s admission of Eli Lilly\rquote s reps\rquote  call notes as evidence, despite Eli Lilly\rquote s hearsay objection,}{\i  }{is analogous to its admission of Schering\rquote 
s physician survey despite Lanham Act case law which explicitly allows only consumer surveys.  Although it is likely that future courts would also permit plaintiffs to introduce defendant drug companies\rquote  reps\rquote 
 call notes into evidence, legislative action similar to that advocated in Part II.A. for surveys could ensure that courts do not exclude this potentially valuable source of evidence.  Courts can also encourage plaintiffs to submit defendants\rquote 
 call notes as evidence, in case surveys they submit are excluded.
\par 
\par {\pntext\pard\plain\s20 \b \hich\af0\dbch\af0\loch\f0 III.\tab}}\pard \s20\ql \fi-720\li720\ri0\widctlpar\jclisttab\tx720{\*\pn \pnlvlbody\ilvl0\ls1\pnrnot0\pnucrm\pnstart1\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls1\adjustright\rin0\lin720\itap0 {\b Obstacles Plaintiffs Face in Establishing Standing in Lanham Act Claims Involving Pharmaceuticals
\par }\pard \s20\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b 
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar\tx720\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\tab Plaintiffs in Section 43(a) claims in the drug/cosmetic/dietary supplement field face two hurdles related to the statute\rquote 
s standing element, which requires plaintiffs to show that they have suffered or are likely to suffer actual harm due to the defendant\rquote s impropriety.  
One of these obstacles affects plaintiff consumers, rather than plaintiff manufacturers.  A deluge of direct-to-consumer advertisements in the mass media by drug manufacturers followed the repeal of FDA\rquote 
s moratorium on prescription drug advertising and the
 softening of its restrictions on the content of  such ads.  These ads have raised the possibility of class action lawsuits by consumers who allege that false or misleading advertisements caused them to purchase products based on misinformation or incompl
ete information.  The difficulty of proving actual harm presents a major impediment to these lawsuits.  The second obstacle hinders manufacturers\rquote  efforts to prevail in Lanham Act claims.  A plaintiff can show that a defendant\rquote 
s activities have caused or are likely to cause it harm most convincingly if both parties compete in the same market.  Whether FDA has approved either the plaintiff\rquote s or defendant\rquote 
s article as a drug, and whether it has classified either as prescription or OTC,  will heavily influence a court\rquote 
s finding of whether the plaintiff and the defendant compete in the same market.  Consequently, it is more difficult for a plaintiff to establish standing if  FDA categorizes its product differently than the defendant\rquote s product.
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {
\par {\listtext\pard\plain\s20 \b\i \hich\af0\dbch\af0\loch\f0 A.\tab}}\pard \s20\ql \fi-360\li1080\ri0\widctlpar\jclisttab\tx1080\aspalpha\aspnum\faauto\ls6\adjustright\rin0\lin1080\itap0 {\b\i        The Difficu
lty of Establishing Standing for Consumer Plaintiffs in False  
\par }\pard \s20\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\i                         Advertising Cases
\par }\pard \s20\ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\b\i 
\par }\pard \s20\ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {Section 43(a) plaintiffs must overcome significant hurdles to establishing standing in addition to the evidentiary hurdles they face.  The FD&C Act d
oes not provide a private right of action,}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See}{, 
}{\i e.g.}{, }{\i Florida ex. rel. Broward Cty. v. Eli Lilly & Co.}{, 329 F. Supp. 364, 365 (S.D. Fla. 1971).}}}{
 but the Lanham Act does.  Consequently, consumers who cannot police pharmaceutical companies by means of FD&C claims have tried to police them with false advertising lawsuits.  Consumers who have no interest in i
nfluencing the behavior of pharmaceutical companies have another incentive to initiate class action lawsuits \emdash  the potential of a large damage reward which refunds the price all consumers have paid for a falsely or misleadingly advertised good.}{
\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See}{ Zalesin, }{\i supra }{note 26.  }}}{
  Consumers
 have not been able to persuade courts to certify class action false advertising claims, however, because it is impossible for them to meet the standing element of the Lanham Act.  For an entire class of consumers to have standing, every member of the cla
ss must be able to show that he or she saw the advertisement at issue, believed the ad, used information from the ad in his or her purchasing decision, then suffered harm when the product failed to work as the ad claimed.  
\par Four recent attempts by consumers to file class action lawsuits under Section 43(a) failed due to the class\rquote s inability to establish standing, according to an attorney who represented the defendants in each of them.}{\cs17\super \chftn {\footnote 
\pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See id.}}}{
  Consumer witnesses in these cases forgot whether viewing ads had influenced their decisions to purchase the defendants\rquote  products, confused the defendants\rquote  products with fictitious products, and purchased the defendants\rquote 
 products for reasons other than the promotional claims at issue.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs17\super \chftn }{ }{\i See id}{.}}}{  In one case, a consumer-advocate plaintiff purchased suntan lotion, the label on which claimed it would create the appearance of healthy tanned skin, for the sole purpose of bringing a lawsuit to protest FDA
\rquote s permission of non-protective suntan oils in the skin care market.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs17\super \chftn }{ }{\i See Archer v. Schering-Plough Corp.}{, slip op. No. 60333/97 (N.Y. Sup. Ct., Apr. 28, 1998), cited in}{\i  id.}}}{  The court dismissed the case due to the lack of harm suffered by the plaintiff.  Despite the plaintiff\rquote 
s lack of standing, this case offers a good illustration of the use of the Lanham Act to challenge promotional claims made about a non-drug which might be considered in th
e same market as a drug.  Tanning oils are cosmetics whose manufacturers do not face FDA\rquote s strict drug regulatory standards; sunscreens which prevent sunburn and skin cancer are over-the-counter drugs subject to regulation as such.}{\cs17\super 
\chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See}{ Peter Barton Hutt, }{\i 
Reconciling the Legal, Medical, and Cosmetic Chemist Approach to the Definition of a \'93Cosmetic,\'94 }{\scaps 3 CTFA Cosmetic J., }{No. 3 (1971) (distinguishing tanning oil cosmetics from sunscreen prevention drugs).}}}{
\par The challenge that stan
ding presents to consumer plaintiffs in Lanham Act cases is one obstacle which should remain in effect, because it serves several important public policy objectives.  First, just as allowing both FDA and private parties to bring claims under the FD&C Act 
m
ight create overlapping lawsuits and subject defendants to liability to multiple parties, allowing both competitors and consumers to bring false advertising claims might result in similar confusion about the parties entitled to relief and the form that re
lief should take.   Second, by enjoining consumers from filing class actions for false advertising, courts avoid clogging their dockets with lawsuits brought by opportunistic plaintiffs who seek a windfall resulting from a corporation\rquote 
s irresponsible marketing decision.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{
 Consumers can file class action lawsuits based on violations of  tort and contract law against manufacturers they cannot sue under the Lanham Act.  Because tort and contract law require plaintiffs to show more than a }{\i likelihood}{ of confusion and a 
}{\i likelihood }{of injury to establish standing, however, consumers are less likely to bring tort and contract class action lawsuits than they would be to bring false advertising lawsuits, if the Lanham Act permitted such suits.}}}{
  Finally, there is little risk that by prohibiting these lawsuits, courts may allow the public to suffer as a result of their reliance on misinformation in advertisements.  If consumers are concerned about potentially harmful drug advertisem
ents, they can alert FDA.  If FDA fails to act, consumers can publicize the problem in the media to exert pressure on FDA or the company responsible for the advertisements.
\par }\pard \s20\ql \fi-720\li1440\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin1440\itap0 {\b\i B.\tab The Difficulty of Establishing Standing for Manufacturer Plaintiffs Whose Products FDA Classifies Differently than the Defendants\rquote 
 Products
\par }\pard \s20\ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {
\par The second obstacle to lawsuits in the drug/cosmetic/dietary supplement industry created by the Lanham Act\rquote s standing requirements affects the more typical plaintiffs in these lawsuits, drug manu
facturers.  A plaintiff manufacturer has a greater chance of convincing a court that it has suffered or is likely to suffer harm by losing sales to the defendant if the plaintiff can show that it operates in the same market as the defendant.  FDA affects 
the parties\rquote  positions in a particular market when it makes decisions about the classifications of either the plaintiff\rquote s or the defendant\rquote 
s product.  These decisions can involve issues such as whether products will be deemed drugs, whether substances class
ified as drugs will sold by prescription or over-the- counter, or whether FDA will approve drugs for uses other than the ones for which they originally gained approval.
\par Two recent cases illustrate how FDA\rquote s classifications of the products at issue or uncertainty as to how FDA will classify them can derail false advertising suits regarding FDA-regulated substances.  In the first case, }{\i 
Pharmacia & Upjohn Co. v. Generation Health}{, }{\i Inc.}{, 1998 U.S. Dist. LEXIS 21534 (May 18, 1998), plaintiff Pharmacia & Upjohn (\'93P&U\'94
), sold a prescription cholesterol drug, Colestid.  Defendant Generation Health (dba as Pharmanex) manufactured a product called Cholestin, which it marketed for the treatment of hypercholesterolemia.  Because Cholestin was a dietary supplement rather
 than a drug, Pharmanex was able to sell it over-the-counter without receiving FDA\rquote 
s permission.  P&U had invested substantial resources toward obtaining FDA approval for over-the-counter sales of Colestid.  P&U viewed the presence of Cholestin in the OTC 
cholesterol treatment market as a serious threat to the financial success of Colestid if Colestid were in fact to receive FDA approval for OTC sales.  P&U sued Pharmanex, claiming that Cholestin was in fact an unapproved drug rather than a supplement and 
that by promoting the substance as a supplement Pharmanex falsely advertised it.  
\par During the interim between P&U\rquote s filing of the lawsuit and the trial, however, FDA appeared increasingly unlikely to grant OTC status to Colestid, and more likely to classify Cholestin as a drug rather than a dietary supplement.}{\cs17\super 
\chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Pharmacia & Upjohn}{
, 1998 U.S. Dist. LEXIS 21534 at *8, *9 n.2.}}}{  This uncertainty about the status of both Colestid and Cholestin motivated P&U to move to dismiss its own lawsuit.  The United States District Court for the Western District of Michigan granted P&U\rquote 
s
 motion.  P&U obviously based its decision to drop its claims against Pharmanex on its preference that FDA, rather than itself, invest the time and money necessary to remove Cholestin from the OTC market, and on its uncertainty that Colestid would ever ga
i
n the OTC status that would place it in the same market as Cholestin.  FDA did later designate Cholestin as an unapproved drug which could not be sold in the United States, and banned the importation of Chinese red yeast rice, which Pharmanex used to manu
facture Cholestin.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See }{Marlys J. Mason, }{\i 
Drugs or Dietary Supplements: FDA\rquote s Enforcement of DSHEA}{, }{\scaps J. Pub. Pol\rquote y & Marketing, }{Fall 1998,}{\cf5  }{at 296.}}}{  In response, Pharmanex sued FDA.}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Pharmanex, Inc. v. Shalala}{, 35 F.Supp.2d 1341 (D. Utah 1998), rev\rquote 
d, 221 F.3d 1151 (10th Cir. 2000).}}}{  The District Court for the District of Utah held Cholestin to be a dietary supplement, but on appeal, the Tenth Circuit reversed and remanded.}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Pharmanex, Inc. v. Shalala}{, 221 F.3d 1151 (10th Cir. 2000).}}}{
  On remand, the District Court held that FDA\rquote s prior determination was correct and should not be set aside:  Pharmanex was actually manufacturing lovastatin, an article approved as a drug subsequent to Pharmanex\rquote 
s selling of it, and marketing its lovastatin as the dietary supplement Cholestin.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Pharmanex, Inc. v. Shalala}{, 2001 U.S. Dist. LEXIS 4598 (D. Utah, Mar. 30, 2001).}}}{ 
\par  While P&U\rquote s dec
ision to withdraw the lawsuit seems prudent, this decision came after P&U, Pharmanex, and the court had invested substantial time and financial resources into this lawsuit.  The dismissal left Pharmanex fearful of future liability to P&U, \'93
totally exposed to a continuing risk of crippling injunctive and monetary relief which [P&U], even now, asserts that it is entitled to inflict on Pharmanex.\'94}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ Brief in Opposition to Plaintiff\rquote s Motion to Dismiss, at 5-6, in }{\i Pharmacia & Upjohn}{
, 1998 U.S. Dist. LEXIS 21534, at *10-*11.}}}{  Additionally, FDA, Pharmanex, and two other courts later invested more time and economic resources to resolve the same issue that was at the core of P&U\rquote 
s initial lawsuit.  The Cholestin controversy is thus a clear example of the inefficiencies that can result when pharmaceutical companies must wait for FDA action while they are trying to litigate a claim.
\par Alternative strategies to P&U\rquote 
s lawsuit would not have prevented the loss of the valuable resources of all the parties involved and the lingering vulnerability to liability to P&U that Pharmanex felt after the dismissal of the case.  First, as the court itself sugg
ested, Pharmanex could have initiated its own lawsuit against P&U for a declaratory judgment,}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Pharmacia & Upjohn}{, 1998 U.S. Dist. LEXIS 21534, at *15.}}}{
 as it later did against FDA.  While this solution would provide Pharmanex with the certainty it desired, it would not address the wasted resources resulting from
 this litigation.  Second, P&U could have waited at least until FDA decided whether to allow OTC sales of Colestid before initiating this lawsuit.  This solution would have prevented the wasting of the parties\rquote 
 resources, but it would have been risky.  It 
is possible that FDA could have never taken any action with regard to Colestid.  It is also possible that P&U might have incurred the substantial risk of spending the money necessary to get OTC status for Colestid, only to learn through a later court ruli
ng that it could not prevent OTC sales of Cholestin, a ruling that would seriously damage its potential revenues.  
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\i \tab }{One possible solution to this dilemma caused when parties find themselves simultaneously at the mercy of FDA and the court system is for FDA
 to expedite the approval process for products that are the subjects of litigation.  This solution may be unrealistic, given FDA\rquote 
s limited resources and its need to prioritize its review of drugs according to their potential to have an impact on public health.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See }{\scaps Hutt & Merrill, }{\i supra }{note 16, at 529-31 (describing FDA\rquote s prior
itization process for approval of new drugs, which bases priority on factors such as how effective the drug appears to be and whether other drugs or therapies already exist to treat the disease the drug treats). }}}{
  If it were possible, though, an expedited review of drugs at the center of lawsuits might encourage plaintiffs to bring Lanham Act lawsuits which enhance consumer safety.
\par \tab }{\i Pharmacia & Upjohn}{ is an unusual case because both parties, the plaintiff dru
g manufacturer and the defendant non-drug manufacturer, were uncertain as to how FDA would classify their products and whether they would ever compete in the same market.  In cases in which the FDA status of the products at issue is not at stake, however,
 FDA\rquote s classifications may still influence a court\rquote s decision about whether the plaintiff\rquote s products are in competition with defendant\rquote s and, consequently, whether the defendant\rquote 
s promotional activities have or are likely to cause the harm to the plaintiff necessary to establish standing.  
\par }\pard \s20\ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {In }{\i Ortho Pharmaceutical Corp. v. Cosprophar, Inc.}{
, 32 F. 3d (2d Cir. 1994), plaintiff Ortho lost the case largely because of its inability to show that consumers perceived its drug tretinoin, sold under the name Retin-A, as a possible substitute for the defendant\rquote 
s Anti-Age cosmetics line, after a district court finding that the two products were not in direct competition.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Ortho Pharmaceutical, }{32 F.3d at 690.}}}{  FDA had approved Retin-A as a prescription drug effective for the treatment of acne.  Shortly there
after, researchers discovered that tretinoin was also effective to treat photodamaged skin, skin which is wrinkled, sallow, and irregularly pigmented as a result of sun exposure.  Although FDA regulations prevented Ortho from promoting Retin-A as an anti-
aging drug until the drug had won approval for this use, doctors could prescribe Retin-A to treat photodamaged skin.  At the time Ortho initiated its lawsuit, approximately 45% of its Retin-A sales were to consumers seeking therapy for photoaging.}{
\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See id.}{ at 692.}}}{  The pub
licity created by the research findings that tretinoin might reverse the signs of photoaging led Cosprophar to develop its Anti-Age line containing retinol, a chemical similar to tretinoin but classified as a cosmetic by FDA.  
\par Ortho sued under the Lanham Act when Cosprophar began to market its skin creams with advertisements stating that they contained a chemical which \'93belongs to the same family\'94 as tretinoin but that \'93
retinol is used as a cosmetic, whereas transretinoic acid is used as a drug and can cause reddening and irritation.\'94}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i Id}{. at 693.}}}{  Ortho claimed that Cosprophar\rquote 
s advertisements misleadingly compared the effects of Retin-A with those of the Anti-Age cosmetics, and that Ortho would likely suffer harm when consumers bought Cosprophar\rquote s products rather tha
n Retin-A, or refused to buy Retin-A because they did not like Cosprophar\rquote s products.  Ortho faced a strict standard to establish standing, however, because of the District Court\rquote 
s finding that Retin-A and the Anti-Age cosmetics did not compete in the same market.  The District Court held, \'93Ortho and Cosprophar are not in direct competition given the nature of their products: one is a drug requiring a doctor\rquote 
s prescription, the other is a cosmetic available in a pharmacy.\'94}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs17\super \chftn }{ }{\i See Ortho Pharmaceutical}{,}{\i  }{828 F. Supp. at 1124.}}}{  Because FDA had classified their
 products differently, and because the products were sold through different channels as a result, the court deemed Ortho and Cosprophar not to be direct competitors.  Because the Circuit Court \'93
require[d] a more substantial showing [of harm] where the plaintiff\rquote s products are not obviously in competition with the defendant\rquote s products,\'94
 Ortho was held to a higher level of scrutiny and could not produce the requisite evidence of harm.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Ortho Pharmaceutical}{, 32 F.3d at 694.}}}{  
\par Ortho would not necessarily have prevailed in this case even if the District Court had found that Retin-A and Cosprophar\rquote 
s cosmetics were in direct competition.  Similarly, had Ortho introduced evidence such as a consumer survey, which showed that buyers perceived the Anti-Age cosmetics as a substitute for Retin-A, Ortho might have won despite the District Court\rquote 
s finding that the products did not compete in the same market.  Nevertheless, Ortho would have had better odds of winning its lawsuit if the products at issue were not subject to FDA regulations which categorized them 
differently.  Ortho did not lose the case solely because FDA designated Retin-A as a drug and the Anti-Age products as cosmetics, but Retin-A\rquote s drug status hurt Ortho\rquote s case.
\par Manufacturers like Ortho should not be at a disadvantage when they attempt to rid
 their industry of manufacturers who engage in potentially false or misleading advertising of similar, if not exactly the same, products, simply because the products they make are subject to strict regulations by a government agency.  In industries with f
e
wer regulations than the drug/cosmetic/dietary supplement industry, no sharp line divides product categories.  There is no presumption, therefore, that a plaintiff is free from harm simply because its products fall on one side of this line and the defenda
nt\rquote s products fall on the other side.  
\par The existence of this presumption in the drug/cosmetic/dietary supplement industry seems both incorrect and contrary to public policy.  First, the notion that prescription drugs are not in direct competition with food
s, cosmetics, or dietary supplements is questionable for three reasons.  First, as one scholar has noted, consumer confusion between drugs and non-drugs is on the rise in the dietary supplement industry.  This confusion results at least in part from the 1
994 Dietary Supplement Health and Education Act (\'93DSHEA\'94),}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super 
\chftn }{ 1994 Dietary Supplement Health and Education Act, Pub. L. No. 103-417, 108 Stat. 4325.}}}{
 which categorizes dietary supplements as food but exempts them from the nutrition labeling required on other foods by the Nutrition Labeling Education Act of 1990 (\'93NLEA\'94).}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ Nutrition Labeling Education Act of 1990, Pub. L. No. 101-535, 104 Stat. 2353 (amended 1993). }}}{
  Consequently, \'93DSHEA allows greater freedom in the labeling, product testing, and marketing of supplements.  As a result of this Act, the ability to distinguish between supplements and drugs is becoming more difficult.\'94}{\cs17\super \chftn 
{\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ Mason, }{\i supra}{ note 48.}}}{
 Second, consumers may blur their distinctions between dru
gs and non-drugs based on the fact that FDA often changes the status of products over time.  Many drugs that were once available only by prescription are now sold over-the-counter.  Since consumers can now purchase the ibuprofen for which they once needed
 
a prescription over-the-counter, they might not perceive a difference in the therapeutic effectiveness of substances they obtain from a doctor and substances they buy off pharmacy shelves.  Third, direct-to-consumer advertising of prescription drugs means
 that consumers receive information about drugs from the same sources from which they receive information about foods, cosmetics, dietary supplements, and OTC drugs \endash 
 advertisements in newspapers and magazines, on the radio, and on television.  It is easy t
o see how consumers who see an ad for Retin-A alongside an ad for Anti-Age lotion, or an ad for Colestid next to an ad for Cholestin, might think that the products are interchangeable, even though the products themselves are not sold side-by-side on the d
rugstore shelf.
\par The second problem with courts\rquote  presumption that drugs and non-drugs do not directly compete is that drug manufacturers have to meet a higher standard to prove harm in Lanham Act claims, and as a result this presumption may deter drug manufa
cturers from bringing lawsuits against non-drug manufacturers.  Because these lawsuits may protect consumers from the harm they may suffer if they use a drug, cosmetic, or supplement based on misinformation, deterring these lawsuits may adversely affect p
ublic safety.  
\par One suggestion for reform in the standing requirements drug manufacturer plaintiffs must meet, therefore, is to prohibit courts from using products\rquote  FDA status and the places in which they are purchased in their determinations of whether tho
se products compete.  It is true that prescription drugs are not displayed next to cosmetics on pharmacy shelves.  Nonetheless, the distinctions between drugs and non-drugs are eroding and courts need to keep this fact in mind when evaluating plaintiffs
\rquote  attempts to establish standing.
\par }{\cf5 
\par {\pntext\pard\plain\s20 \b \hich\af0\dbch\af0\loch\f0 IV.\tab}}\pard \s20\ql \fi-720\li720\ri0\widctlpar\jclisttab\tx720{\*\pn \pnlvlbody\ilvl0\ls1\pnrnot0\pnucrm\pnstart1\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls1\adjustright\rin0\lin720\itap0 {\b Obstacles Pharmaceutical Companies Face in Establishing Lanham Act Claims Against Foreign Manufacturers
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b 
\par }\pard \s20\ql \li720\ri0\sl480\slmult1\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {In addition to using the Lanham Act as a vehicle to regulate the behavior of 
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {manufacturers of cosmetics and supplement
s which enjoy comparatively relaxed FDA scrutiny of their labeling, product testing, and marketing activities, drug manufacturers have attempted to use the law of false advertising to regulate the behavior of foreign manufacturers who import drugs into th
e United States.  These attempts, however, are likely to fail.  As two recent cases, }{\i Syntex, Inc. v. Interpharm, Inc.}{, 1993 U.S. Dist. LEXIS 10716 (N.D. Ga. June 7, 1993) and }{\i Eli Lilly & Co. v. Roussel Corp.}{
, 23 F.Supp.2d 460 (D. N.J. 1998) show, courts frequently consider lawsuits against foreign manufacturers to be attempts by private parties to halt the importation of drugs that do not comply with FDA standards, an action only FDA can undertake.}{
\cs17\super  }{ The filing of these lawsuits nonetheless suggests that problems exist with FDA\rquote 
s enforcement of policies related to the importation and promotion of drugs manufactured outside the United States.  Courts should permit and encourage private companies to police foreign manufacturers through these lawsuits if private 
parties can do so more swiftly than FDA.
\par \tab The }{\i Syntex}{ plaintiff tried to use Section 43(a) to prevent a foreign defendant from importing naproxen, a prescription anti-inflammatory drug used for the treatment of osteoarthritis and rheumatoid arthritis.}{\cs17\super \chftn {\footnote 
\pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See}{ }{\i Naproxen Sodium, }{\scaps 
RxList Monographs, }{at http://www.rxlist.com/cgi/generic/naproxsod_ids.htm.}}}{  The
 defendant did not have FDA approval to sell naproxen in the United States.  Syntex had previously tried to stop Interpharm with a lawsuit under Section 43(b) of the Lanham Act, which prohibits the importation of mislabeled goods.  The District Court for 
t
he Northern District of Georgia found in favor of the defendants, however, because unlike Section 43(a), Section 43(b) does not provide a private right of action.  Only FDA can halt the importation of products not in compliance with the FD&C Act, the Cour
t held.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{
\i See Syntex}{, 1993 U.S. Dist. LEXIS 10716, at *3, n.3.}}}{
  Syntex amended its complaint and filed under Section 43(a).  Syntex claimed that Interpharm made representations that it was an international pharmacy and that its business was legitimate, and that these representations were misleading because it 
was trying to sell unapproved drugs in the United States.  While the District Court acknowledged that the plaintiffs might succeed on a Section 43(a) claim, FDA had already stopped the importation of Interpharm\rquote s products at Syntex\rquote s urging.

\par \tab }{\i Syntex}{ can be
 interpreted in two ways.  Some observers might take the cynical view that the case illustrates private parties trying to overstretch the boundaries of Section 43(a) so that they can bring claims that only FDA has the authority to bring.  Syntex\rquote 
s dispute with Interpharm did not really center on Interpharm\rquote 
s promotional activities, these observers would argue; Syntex was just looking for a way to rid the market of a competitor whose products were not authorized for sale in the United States.  Others might s
ee the case as an illustration of the frustration felt by private parties when FDA fails or is slow to curb the behavior of drug manufacturers in violation of the FD&C Act.  These observers would argue that FDA\rquote 
s inactivity forced Syntex to bring the lawsuit because the company saw no other way to stop Interpharm and that private parties should not bear the burden of policing their competitors.  
\par }\pard \s20\ql \fi720\li0\ri0\sl480\slmult1\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {
Regardless of which of these interpretations is correct, the result of this litigation is beneficial to consumer
s and lawsuits like this one are exactly the kind of Lanham Act claims we want to encourage.  While Syntex may have crafted its complaint creatively to find a way to sue Interpharm, Syntex nevertheless spent its own resources to try to enjoin behavior tha
t may have been harmful to public safety as well as its revenues.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ It can be argued tha
t consumers still pay the costs of regulating the drug/cosmetic/dietary supplement marketplace even if private companies initiate actions rather than the government, because private companies will pass the costs of  policing the market through to consumer
s by increasing the price of their drugs.  This Paper assumes that even if no cost savings exist, private companies are still better police of the market: they have a greater incentive than the government to monitor their competitors\rquote 
 behavior closely, and they are more likely to take action against their competitors than FDA, which must oversee the practices of thousands of manufacturers.}}}{  While FDA might have been slow to respond to Syntex\rquote 
s complaints, FDA did force Interpharm to halt its shipments of naproxen and naproxen sodium to the United States.  FDA regulates a vast 
number of foods, drugs, cosmetics, and medical devices, and the sheer magnitude of its authority means that the agency will inevitably be slow to respond to manufacturers\rquote 
 complaints at times.  When private companies are willing to self-regulate their industries in partnership with FDA, the combined effort results in improved public safety.
\par Eli Lilly met the same jurisdictional roadblock that Syntex did when Lilly sued an Italian supplier and the French and American drug manufacturers which purchased from that supplier under the Lanham Act in 1998.}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Roussel}{,}{\i  }{23 F.Supp.2d 460.}}}{
  Eli Lilly has sold the antibiotic cefaclor in the United States since 1979.  Opos, an Italian chemical company, manufactured bulk cefaclor which could be used to produce a generic version of Eli Lilly\rquote s drug.  O
pos filed an Abbreviated Antibiotic Drug Application (\'93AADA\'94
), which FDA approved in April 1995, so that it could sell its bulk cefaclor to American drug manufacturers who could then market a generic alternative to the Eli Lilly antibiotic.  Once it receiv
ed FDA approval, Opos began to sell cefaclor to a North American company and its French subsidiaries described collectively in the litigation as the \'93Roussel defendants,\'94
 and to the American companies American Home Products, Zenith Goldline Pharmaceuticals, and the Rugby Group.  Shortly after Opos\rquote s AADA was approved, however, FDA received complaints about adverse reactions to cefaclor produced with Opos\rquote 
s chemicals.  In 1996, FDA inspected Opos\rquote s manufacturing facilities and found that Opos was not manufac
turing cefaclor according to the process it had described in its AADA.  Opos halted its shipments of cefaclor to its American customers in October 1996.  In December, FDA sent Opos a letter stating that its AADA had contained \'93
false and misleading statements.\'94 
\par  In April 1997, Eli Lilly brought suit in the U.S. District Court for the District of New Jersey under Section 43(a) of the Lanham Act, among other claims, alleging that Opos obtained FDA approval of its generic cefaclor by making false and misleadin
g claims, and that Opos\rquote s customers falsely promoted its cefaclor through their implications that the drug was manufactured at an FDA-approved facility.  The District Court dismissed Eli Lilly\rquote 
s false advertising claims because the defendants had not }{\i advertised}{ their products as having \'93proper FDA approval.\'94}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }
\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See id.}{ at 478.}}}{
  Eli Lilly did not claim that the defendants misrepresented their products; rather, it alleged that the defendants obtained FDA approval by misrepresenting their manufacturing process.  If this allegat
ion were true, the Court found, it would constitute a violation of the FD&C Act rather than the Lanham Act.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }
\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See id. }{at 479-80.}}}{
  Since the FD&C Act does not allow a private right of action, Eli Lilly could not sue Opos and its customers for fraudulently obtaining FDA approval \endash  only FDA could sue the defendants for that action. 
\par In making this decision, the }{\i Roussel }{court relied heavily on a Fourth Circuit decision, }{\i Mylan Labs., Inc. v. Matkari}{, 7 F.3d 1130 (4th Cir. 1993), which had a very similar fact pattern to }{\i Roussel}{.   M
ylan Laboratories, like Eli Lilly, had argued that the defendant\rquote 
s act of placing a drug into the market was an implied misrepresentation to consumers that the drug met FDA standards, since consumers would assume that the manufacturer had obtained FDA approval legitimately and not through fraudulent misrepresentations.
}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i 
See Mylan Labs.}{, 7 F.3d at 1137-38.}}}{  The defendant therefore falsely advertised its product by omission, when it failed to inform consumers that its drug did not in fact adhere to FDA standards.  The Fourth Circuit disagreed t
hat the Lanham Act allows a cause of action for representations about FDA approval made by omission.  It \'93distinguished a failure to disclose non-approval from affirmative statements of [FDA] approval, finding that \lquote 
an affirmative misrepresentation that a product has \lquote FDA approval\rquote  is actionable under the Lanham Act as opposed to a failure to disclose non-approval).\rquote \'94}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn 
\pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i Roussel}{, 23 F.Supp.2d at 477, n.27, citing}{\i  Mylan}{ }{\i Labs}{
., 7 F.3d at 1139.}}}{  In other words, a Section 43(a) plaintiff can only sue for affirmative misrepresentations, not for implied misrepresentations.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0
\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Braintree Lab., Inc. v. Nephro-Tech, Inc., et al.}{, 1997 U.S. Dist. LEXIS 2372, }{\b *}{
18-*19 (D. Kan. Feb. 26, 1997) (\'93It is clear that a plaintiff may not maintain a Lanham Act claim alleging
 only that the defendant has failed to disclose that the FDA has not approved its product. Affirmative misrepresentations, however, are generally actionable under the Lanham Act, even if the product is regulated by the FDA. Most obviously, a false stateme
nt of FDA approval is actionable.\'94).}}}{
\par   As a result, Eli Lilly, like Syntex, was frustrated in its attempt to use the Lanham Act to regulate the practices of a foreign competitor selling drugs in the United States.  In both }{\i Roussel}{ and }{\i Syntex}{, the plaintiffs\rquote 
 primary motivations for filing the lawsuits w
ere to block competitors that did not adhere to FDA standards from taking sales away from them.  Had the lawsuits succeeded, the plaintiffs would have accomplished more than simply this goal, however, because verdicts in their favor would have also result
ed in the removal of potentially unsafe drugs from the market.  In both of these cases, this socially beneficial secondary result occurred anyway, due to FDA\rquote s intervention.  Nonetheless, FDA\rquote 
s exclusive authority to police manufacturers who import non-FDA-approved drugs or who fraudulently obtain FDA approval stifled Eli Lilly\rquote s and Syntex\rquote s attempts to engage in socially beneficial litigation.  
\par These cases therefore raise the question: how can we encourage private drug manufacturers to police their competitors who fail to adhere to FDA\rquote 
s standards while we continue to grant FDA exclusive authority to halt the importation and sales of substandard drugs?  One possibility is to continue to allow only FDA to bring claims under the FD&C Act, but for courts to a
llow plaintiffs to bring Section 43(a) cases for false advertising by implied misrepresentations as well as explicit ones.  
\par Section 43(a) can be expanded to apply to implied representations in two ways.  Currently, the statute applies only to \'93[A]ny person who \'85
 uses in commerce any word, term, name, symbol, or device, or any combination thereof, or any false designation of origin, false or misleading description of fact \'85\'94.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn 
\pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ 15 U.S.C. \'a7 1125(a) (2000).  
\par }}}{  The type of violation alleged by Syntex, Eli Lilly, and Mylan Laboratories, was the last one, a \'93false or misleading description\'94 of the fact that the defendants\rquote 
 products were manufactured according the standards necessary for FDA approval.  The first possibility, then, would be simply to amend the statute to add the phrase \'93by affirmative representation or material omission\'94 after \'93
false or misleading description of fact.\'94  To expand the statute\rquote s coverage without amending it, courts could interpret the placement of a drug into the market as a kind of tacit \'93description\'94 that the product is an }{\i FDA-approved}{
 drug. While these solutions would provide American plaintiffs with a claim against foreign defendants, they might be viewed as overly broad, in effect creating a private cause of action to enforce the FD&C Act and contradicting the Act\rquote 
s purpose.  The second solution is the better one, because it would only expand the reach of the Lanham Act in the drug arena, so courts would not be flooded with false-advertising-by-omissions cases in every industry.  
\par A clear justification exists for this broad interpretation of what constitutes a \'93description\'94
 in the area of drugs but not in other industries.  The stringent regulations on the packaging, labeling, marketing, and even selling (in the case of prescription drugs) of drugs result in consumers\rquote 
 inference that substances sold in the manner in which FDA-approved drugs are sold are in fact FDA-approved drugs, and that as FDA-approved drugs, they meet FDA standards of safety and effectiveness.   In other words, a consumer would not necessarily
 assume that a pair of vinyl shoes displayed in a department store alongside leather shoes are leather, simply because they are next to leather shoes, because department stores often carry shoes manufactured from a variety of materials.  A consumer who pu
r
chases a bottle of pain-reliever tablets displayed in a drug store alongside aspirin and ibuprofen is more likely to infer that the tablets are FDA-approved simply because they are next to FDA-approved drugs, because pharmacies do not knowingly sell drugs
 
unregulated by FDA.  If the tablets also have a package insert similar to the inserts found in the packages of FDA-approved drugs, and if the label lists their active ingredients, the consumer will be especially likely to assume that the tablets are FDA-a
pproved, because a manufacturer not subject to FDA\rquote s authority would not likely follow FDA\rquote 
s packaging and labeling specifications.  Once the consumer believes that the tablets are FDA-approved, her logical inference is that the manufacturer obtained FDA approval honestly rather than fraudulently.  
\par Because FDA\rquote s extensive regulation of the packaging, labeling, and marketing of drugs signals to consumers that products that meet these regulations are FDA-approved, products that meet these regulations but do not meet FDA\rquote 
s standards implicitly signal a false message to consumers.  In the drug industry, unlike other industries, it is therefore possible for manufacturers to present their products in a false or misleadingly way through omissions as well as affirma
tive representations.  If courts extended their interpretation of Section 43(a)\rquote 
s coverage to include implied false or misleading descriptions of drugs, and articles in other highly regulated industries if necessary, they could solve the problem faced by p
laintiffs like Mylan, Eli Lilly, and Syntex (if a court had had to rule on Syntex\rquote s Section 43(a) claim).  They could allow FDA-compliant manufacturers to police non-FDA-compliant foreign manufacturers without enlarging the statute\rquote 
s scope so greatly that they exceed their judicial authority, and without allowing private parties to usurp FDA\rquote s authority.  
\par As the American economy becomes more and more global, the value of allowing private parties to sue foreign manufacturers who falsely obtain FDA approval 
or who falsely assert that they have obtained FDA approval will increase.  Last year, Congress passed the Medicine Equity and Drug Safety Act of 2000, which allows American pharmacies and prescription-drug wholesalers to import drugs from other countries 
so they can make them available to consumers at a lower cost.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ Pub. L. No. 106-387, \'a7 1(a), 114 Stat. 1549A-35 (2000).}}}{
  American consumers are also finding ways to buy the drugs they need directly from foreign manufacturers, motivated in part by the fact that imported drugs are often cheaper than American drugs 
and in part by new technologies like the Internet, which give Americans greater access to foreign merchants.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }
\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See}{ Mason Essif, }{\i Prescription Drugs Are Crossing Borders to Buyers,}{ }{\scaps CNN.com/Health}{
, Mar. 12, 2001, at }{\field\flddirty{\*\fldinst { HYPERLINK "http://www.cnn.com/2001/HEALTH/03/12/prescription" }{{\*\datafield 
00d0c9ea79f9bace118c8200aa004ba90b02000000170000003200000068007400740070003a002f002f007700770077002e0063006e006e002e0063006f006d002f0032003000300031002f004800450041004c00540048002f00300033002f00310032002f0070007200650073006300720069007000740069006f006e00
0000e0c9ea79f9bace118c8200aa004ba90b6400000068007400740070003a002f002f007700770077002e0063006e006e002e0063006f006d002f0032003000300031002f004800450041004c00540048002f00300033002f00310032002f0070007200650073006300720069007000740069006f006e000000}}
}{\fldrslt {\cs21 http://www.cnn.com/2001/HEALTH/03/12/prescription}}}{.drugs/index.html (featuring American consumer who saved 33% prescription drugs costs by purchasing asthma and high blood pressure drugs from thecanadiandrugstore.co
m; when FDA learned of the transactions, it sent the consumer a warning letter and held his next shipment of drugs at the Canadian border). }}}{
  While FDA can seize those foreign drugs mailed directly to consumers in the United States that it can locate, it is virtually impossible for FDA 
to police the enormous number of online drug sales transactions involving foreign manufacturers.  As of June 2000, FDA was aware of 346 websites through which consumers could purchase prescription drugs; numerous additional sites FDA has not yet located p
robably exist.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn 
}{ }{\i See}{ Marc J. Scheineson, }{\i Ready to Regulate, FDA Goes Online; Agency Has Dropped Hands-Off Approach to Web Pharmacies}{, }{\scaps Legal Times, }{June 19, 2000, at 25.}}}{\cf5   }{
If the courts relaxed the requirements of Section 43(a) to allow private companies to bring suit against foreign competitors whose drugs do not meet FDA standards for safety and effectiveness, private parties could significantly assist FDA\rquote 
s efforts in this area.
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {
\par {\pntext\pard\plain\s20 \b \hich\af0\dbch\af0\loch\f0 V.\tab}}\pard \s20\ql \fi-720\li720\ri0\widctlpar\jclisttab\tx720{\*\pn \pnlvlbody\ilvl0\ls1\pnrnot0\pnucrm\pnstart1\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls1\adjustright\rin0\lin720\itap0 {\b Obstacles Pharmaceutical Companies Face in Establishing Lanham Act Claims Against Manufacturers of Generic Drugs
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b 
\par }\pard \s20\ql \li720\ri0\sl480\slmult1\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {The issue of FDA approval complicates plaintiffs\rquote  attempts to sue generic drug
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 { manufacturers for false advertising i
n a slightly different way than it affects the other kinds of drug suits.  In the cases involving imported drugs, cosmetics, and dietary supplements, plaintiffs who are subject to stringent FDA regulation sue to force competitors who are subject to less o
r no FDA regulation out of their markets.  In cases involving manufacturers of generic drugs, the manufacturers who feel disadvantaged in the marketplace are those whose drugs are }{\i not}{
 subject to FDA approval.  Their disadvantage arises from the fact that FD
A has stringent standards which a drug must meet to be considered an acceptable generic substitute for a pioneer drug that is FDA-regulated, but looser standards apply to drugs not subject to FDA regulation.  Thus, a generic manufacturer can make promotio
nal claims that its product is a generic substitute for a pioneer drug without violating the Lanham Act, even if the generic drug does not meet the FDA requirements.  
\par \tab The specific difference in the standards that generic drugs must meet is that generic substitutions for FDA-approved drugs must be \'93bioequivalent\'94 while substitutions for non-FDA-regulated drugs must only meet the lower threshold of \'93
chemical equivalence,\'94 also called \'93pharmaceutical equivalence.\'94  Bioequivalent drugs are those whose \'93rate an
d extent of absorption do not show a significant difference when administered at the same molar does of the therapeutic moiety under similar experimental conditions, either single dose or multiple dose.\'94}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ 21 C.F.R. }{\f39 \'a7}{ 320.1 (2001).}}}{
  Simply put, bioequivalent drugs are those which ha
ve the same active ingredients as the pioneer drug and whose active ingredients are absorbed into the body at the same rate and to the same extent as the active ingredients of the pioneer drug.  Chemically or pharmaceutically equivalent drugs \'93
contain identical amounts of the identical active ingredient\'85 in identical dosage forms, but [do] not necessarily [contain] the same inactive ingredients.\'94}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn 
\pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ 21. C.F.R. \'a7 320.1 (2001).}}}{
  In other words, although a chemically equivalent drug contains the same active ingredients in the same dosage 
as a pioneer drug, its active ingredients may be absorbed into the body at a different rate or to a different extent than the active ingredients of the pioneer drug.
\par \tab Because generic alternatives to pioneer drugs not regulated by FDA must only meet the sta
ndard of chemical equivalence, manufacturers of these pioneer drugs have lost on their Lanham Act claims against manufacturers of chemically equivalent articles who promote them as generic drugs.  For example, in 1998 Florida Breckenridge, the manufacture
r of a line of generic hormonal replacement therapy drugs for menopausal women called MENOGEN, sued Solvay Pharmaceuticals, the manufacturer of the pioneer drug line called Estratest, for a declaratory judgment that it could market its drugs as \'93
generic equivalents\'94 to Solvay\rquote s.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Florida Breckenridge}{, 1998 U.S. Dist. LEXIS 14742 at *9-*10.}}}{  Solvay\rquote 
s Estratest drugs are sold by prescription but Solvay had never been approved by FDA,  having had several new drug applications rejected by FDA.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0
\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Florida Breckenridge v. Solvay Pharmaceuticals}{, 174 F.3d 1227, 1230 (11th Cir. 1999).  On Solvay\rquote 
s appeal, the Eleventh Circuit determined that Estratest was on the market illegally and that MENOGEN, as a generic version of an illegal drug, was also on the market illegally.  Solvay ultimately withdrew its appeal.}}}{
  While the MENOGEN and Estratest drugs contained the same active ingredients i
n the same dosages, the MENOGEN drugs broke down in the body in three minutes and were fully absorbed into the bloodstream in just fifteen minutes, while the Estratest drugs took 48 minutes to break down in the body and 120 minutes to be fully absorbed in
to the bloodstream.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super 
\chftn }{ }{\i See Florida Breckenridge}{, 1998 U.S. Dist. LEXIS 14742 at *5, *7.}}}{  The generic MENOGEN line of drugs was therefore chemically equivalent but not bioequivalent to the Estratest drugs.  
\par }\pard \s20\ql \fi720\li0\ri0\sl480\slmult1\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {Thus, as the }{\i Breckenridge}{ court stated, \'93Whether Breckenridge\rquote 
s claims of generic equivalence are literally false hinges upon an issue of first impression: what the term \lquote generic equivalent\rquote  means in the context of a non-FDA regulated drug.\'94  The court answered this question: \'93
It means chemical equivalence.\'94}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 
{\cs17\super \chftn }{ }{\i See id.}{ at *31.}}}{ The court reasoned that Breckenridge\rquote s customers were sophisti
cated buyers who knew that the Estratest line was not regulated by FDA, thus they knew that it was not necessary for Breckenridge to establish bioequivalence for the MENOGEN drugs.  Breckenridge was not promoting its products in a false or misleading way 
when it told potential customers that the drugs were the generic equivalent of Solvay\rquote 
s despite their lack of bioequivalence.  Had the Estratest drugs been subject to FDA regulation, the case would have had the opposite outcome.   Unlike most Lanham Act cases in which a drug\rquote s status as FDA-regulated impedes its maker\rquote 
s success in its lawsuit, in this case it was a drug\rquote s unregulated status which lost its maker\rquote s case.
\par Whether the outcome of }{\i Florida Breckenridge }{was correct is debatable.  Solvay appealed to 
the Eleventh Circuit, but withdrew its appeal when it became obvious that it did not have a legal justification for its failure to obtain FDA approval.  Nonetheless, FDA filed an Amicus Curiae brief to the Eleventh Circuit, urging the court to adopt a bio
equivalence standard for non-FDA-regulated drugs.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Florida Breckenridge}{, 174 F.3d 1227, at 1231.}}}{
  FDA argued that the differences in the rate or extent of absorption of the active ingredients which prevent the generic drug from obtaining bioequivalent status can alter the therapeutic effectiveness of a
 drug, so that a patient who ingests the chemically equivalent generic drug may unknowingly cause harm to his body.  On the other hand, it is hard to see why a manufacturer like Solvay, who fails to comply with the burdens of FDA regulation, deserves to r
eap the benefits of FDA protection.  
\par While both the district and circuit courts felt that the outcome of }{\i Florida Breckenridge}{ was appropriate due to Solvay\rquote s unscrupulous behavior, the same outcome is inappropriate for cases involving those drugs that are 
unregulated by FDA for valid reasons.  Amendments to the FD&C Act in 1938 and 1962 exempted from FDA regulation those drugs invented prior to FDA\rquote s institution of its premarket approval and branding requirements.}{\cs17\super \chftn {\footnote 
\pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{
 The 1938 Amendment grandfathering drugs marketed prior to 1938 is codified in the FD&C Act as 21 U.S.C.S. \'a7 321p(1) (2001).  The 1962 Amendment grandfathering drugs marketed between 1938 and 1962, Pub. L. No. 87-781, Title 1, \'a7
 107, 76 Stat. 788, is not codified as part of the FD&C Act.}}}{  In litigation in which a drug has been legally exempt from FDA regulation due to its grandfathered status, the outcome has been the same}{\i  }{\endash 
 a maker of a generic drug can market its drug as the \'93generic equivalent\'94 of the pioneer drug as long as the generic drug meets the threshold of chemical equi
valence, even if it is not bioequivalent.  This situation occurred, for example, when a generic manufacturer of pre-natal vitamins classified as a prescription drug, began to market them as the \'93generic equivalent\'94
 to the pioneer drug.  The generic drugs contained the same active ingredients as the pioneer drug but different inactive ingredients, so they were chemically equivalent but not bioequivalent.}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See}{ Scheinfeld, }{\i supra }{note 17.}}}{  

\par There are several ways to prevent manufacturers from being able to market non-bioequivalent drugs as g
eneric substitutes of non-FDA-regulated drugs.  First, FDA can police these manufacturers.  FDA has already sent informal warning letters to some of these manufacturers, threatening to sue them under the FD&C Act.}{\cs17\super \chftn {\footnote 
\pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See id.}{ }}}{  Given FDA\rquote 
s limited financial and human resources, however, many manufacturers of non-bioequivalent generic drugs would likely escape FDA detection, so this option is not the best solution.}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{
 The fact that Solvay sold its unapproved hormone replacement therapy drugs for thirty years without FDA taking action against it illustrates FDA\rquote s inability to enforce the FD&C Act against a countless number of violators.}}}{  
\par A second option would require all fifty states to adopt FDA\rquote s \'93Orange Book\'94 as their reference manual for generic drug substitutions.  The \'93Orange Book\'94
 is an FDA publication listing all the generic drugs which FDA has rated bioequivalent to pioneer drugs.  Over half of the states currently require pharmacists to rely on the Orange Book before making drug substitutions.}{\cs17\super \chftn {\footnote 
\pard\plain \s16\ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See }{Scheinfeld, }{\i supra}{
 note 17.}}}{  In these states, it is already illegal, for example, for pharmacists to substitute chemically equivalent pre-natal vitamins for the pioneer vitamins.  If all fifty states were to adopt the Orange Book as their reference standard for drug su
bstitutions, Lanham Act lawsuits against generic versions of non-FDA-regulated drugs would be unnecessary.  Since pharmacists could not substitute these drugs anyway, manufacturers would have no incentive to market them to doctors or consumers.  As a resu
l
t, the inability of manufacturers of non-FDA-regulated pioneer drugs to prevail in Lanham Act claims against generic manufacturers would be irrelevant.  This solution is feasible, yet somewhat problematic because it places the burden of compliance on phar
macists rather than drug manufacturers, even though it is drug manufacturers who are engaging in the practice it seeks to eradicate.  
\par Finally, a third alternative would be for Congress to amend the federal regulations to establish a standard of bioequivale
nce for all generic drugs, regardless of whether they are substitutes for FDA-approved or exempt drugs.  This option is probably the best solution, since it establishes a uniform national standard with the passage of a single law, rather than requiring ea
c
h of the states that does not currently use the Orange Book to pass a law adopting the Orange Book standards.  A combination of this option and the first two would also work.  Adopting all three enforcement methods would spread the burden of policing gene
ric drug manufacturers between FDA, pharmacists, and private companies, and provide the greatest protection of consumer safety.  
\par {\pntext\pard\plain\s20 \b \hich\af0\dbch\af0\loch\f0 VI.\tab}}\pard \s20\ql \fi-720\li720\ri0\widctlpar\jclisttab\tx720{\*\pn \pnlvlbody\ilvl0\ls1\pnrnot0\pnucrm\pnstart1\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls1\adjustright\rin0\lin720\itap0 {\b How Pharmaceutical Companies Can Succeed as Plaintiffs in Section 43(a) Lawsuits 
\par }\pard \s20\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {
\par }\pard \s20\ql \li720\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {So far, this Paper has examined the challenges drug manufacturers face in their 
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {
attempts to use the Lanham Act to police their competitors who endanger public safety, either by violating FDA regulations or because they are not subject to FDA scrutiny.  With these challenges in mind and with the cas
e law indicating such a low likelihood of success for plaintiffs, a drug company contemplating the initiation of a false advertising lawsuit must wonder whether such a lawsuit  makes sense.  Such a potential plaintiff must keep in mind that the Lanham Act
 can be an extremely effective way for a drug company to halt a competitor\rquote 
s illegal behavior, but it must also assess its odds of prevailing.  A plaintiff will have optimal odds for winning a Lanham Act claim when: 1) the plaintiff possesses convincing, ad
missible evidence; 2) FDA acts in cooperation with the plaintiff; 3) the plaintiff\rquote s and defendant\rquote s products exist in a rapidly changing market; and 4) the defendant\rquote s product poses a grave threat to public safety.   
\par }\pard \s20\ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {    }{\i Zeneca, Inc. v. Eli Lilly & Co.}{, 
a case discussed in Section II.B. for its evidentiary rulings, is a good example of a false advertising lawsuit in which all four of these conditions favoring the plaintiff were present, so the plaintiff was able to prevail.  To recap, in }{\i Zeneca}{
 the maker 
of tamoxifen, the only drug approved by FDA for the reduction of the risk of breast cancer in healthy women with a high risk of developing the disease, sued the maker of raloxifene (marketed under the brand name Evista), a drug approved for use in osteopo
rosis prevention, for promoting Evista as effective in reducing patients\rquote  risk of breast cancer.  All four of the conditions mentioned above were present, which explains at least in part why Zeneca succeeded on its Section 43(a) claim.
\par First, as discussed in Section II.B., Zeneca bolstered its case by introducing several types of evidence to prove that Eli Lilly had promoted Evista as a breast cancer prevention drug.  Zeneca\rquote 
s evidence included hundreds of call notes recorded by Eli Lilly sales representativ
es shortly after they met with doctors to promote Evista, instructions Eli Lilly executives had given the representatives about how to pitch Evista, and surveys of doctors who had discussed Evista with Eli Lilly representatives.  By introducing a variety 
o
f different kinds of evidence, Zeneca decreased its reliance on any one particular kind of evidence.  This strategy was wise considering the number of surveys courts deem inadmissible in Lanham Act cases, either because they are hearsay or because they do
 not establish the necessary link between the defendant\rquote 
s behavior and the harm the plaintiff alleges.  By including evidence other than survey evidence, and by carefully crafting its survey evidence, Zeneca was able to prove that Eli Lilly had in fact made the false claims that it alleged.}{\b 
\par }\pard \s20\ql \li720\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {Additionally, the fact that FDA had also taken actions to enjoin Eli Lilly from 
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {promoting Evista as effective for reducing the risk of breast cancer strengthened Zeneca\rquote s case.  Eli Lilly began to examine Evista\rquote s potent
ial as breast cancer prevention drug when its \'93Multiple Outcomes of Raloxifene Evaluation\'94 (\'93MORE\'94) study, testing Evista\rquote 
s effectiveness in treating osteoporosis, showed that a lower percentage of women taking the drug developed breast cancer than women taking the placebo.}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Zeneca}{, 1999 U.S. Dist. LEXIS 10852, at *31, n.5.}}}{
  Because the purpose of the MORE study was to evaluate Evista as an osteoporosis prevention drug, rather than a breast cancer prevention drug, FDA did not accept the MORE study as convincing evidence that Evista reduced the risk of breast cancer.}{
\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See id. }{at *52.}}}{
  Consequently, while FDA permitted Eli Lilly to change the Evista label to include the MORE study\rquote s results, the Agency also required it to include a statement indicating,  \'93The effectiveness of raloxifene in reducing the risk of breast cancer 
has not yet been established.\'94}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See id.}{
 at *33.}}}{  Several times after FDA approved the label change, FDA met with representatives from Eli Lilly, and each time FDA insisted that Eli Lilly could not market Evista as a breast cancer prevention drug.}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See id.}{ at *57-*62.}}}{  This series of interact
ions between Eli Lilly and FDA regarding the status of Evista showed Eli Lilly\rquote s clear desire to sell Evista as a breast cancer prevention drug and its persistence in seeking FDA approval to market it as such, which made Zeneca\rquote 
s allegations of Eli Lilly\rquote s illegal behavior much more believable.  In this case, as in}{\cf5  }{cases like }{\i Syntex }{and }{\i Pharmanex}{
, the fact that FDA was working to stop the same behavior the plaintiff sought to enjoin surely enhanced the court\rquote s opinion that the plaintiff\rquote s claims had merit.
\par \tab The third factor that increased Zeneca\rquote 
s likelihood of success on its Section 43(a) claim was the newness of the market into which the plaintiff and defendant placed their products.  Tamoxifen was the first drug approved anywhere in the world for reduction in the risk of breast cancer.}{
\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See id. }{at *112.}}}{
  At the time that Eli Lilly began to promote Evista as a breast cancer reduction drug, Tamoxifen was the only drug approved for this use.  With tamoxifen, Zeneca created a new market, the breast cancer prevention drug marke
t, a market so new that it was impossible to predict its potential growth.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs17\super \chftn }{ }{\i See id. }{at *17-*18 (quoting Zeneca\rquote s Business Manager for Oncology as saying, \'93[N]obody has ever had a drug in the area of prevention. . . . there [was] no . . . market for risk reduction or prevention,\'94
 and concluding from these statements that \'93Zeneca thus had to create the market from scratch.\'94).}}}{  The newness of the market in which tamoxifen and Evista competed persuaded the court to rule in Zeneca\rquote 
s favor, because it is obvious that an entrant in a developing market will steal a share of that market from its competitor if its competitor currently has a monopoly on that market.}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See id. }{at *110 (\'93
[A]ny sale of Evista for breast cancer prevention or risk reduction is a lost sale of Zeneca\rquote s . . .\'94).}}}{
  It was much easier for Zeneca to show that Eli Lilly caused it economic harm that it would be for any one seller in a well-established market with 
many competitors to show that a new entrant had stolen a substantial share of its sales.  While a Lanham Act plaintiff could successfully prove that the defendant has caused it economic harm even in a market saturated with numerous competitors, it is easi
er for a plaintiff to show harm in a smaller market.
\par \tab Finally, as the }{\i Zeneca }{court noted, a court is more likely to weigh evidence in the plaintiff\rquote s favor if the alleged behavior of the defendant poses a serious threat to public safety.  Eli Lilly was promoting the drug at issue in }{\i 
Zeneca}{ as effective at reducing patients\rquote  risk of a frequently fatal disease.  Eli Lilly\rquote s own witnesses in the case conceded that \'93it could be dangerous if a physician prescribes a drug erroneously believing that the drug could 
prevent cancer.\'94}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i Id}{. at *119.}}}{
  The court acknowledged that it ruled in favor of Zeneca not only because Zeneca had suffered or was likely to suffer economic harm, but also because the public interest required that it enjoin Eli Lilly\rquote s activities.  While Zeneca still 
had to prove all the elements of a Lanham Act violation, the court was more likely to look favorably at Zeneca\rquote s arguments than, say, the court in }{\i Ortho Pharmaceutical v. Cosprophar}{, 32 F. 3d 690, 696-7 (2d Cir. 1994), in which the defendant
\rquote s controversial promotional claims related to an anti-wrinkle skin cream.  
\par \tab As }{\i Zeneca}{ illustrates, a variety of factors influence a plaintiff drug manufacturer\rquote s chances of succeeding in a Section 43(a) lawsuit.  These factors include the evidentiary and standing requirements inherent in the Lanham Act and FDA
\rquote s exclusive authority to set and enforce standards for foreign and generic drug manufacturers, as well as the volume of evidence the plaintiff can introduce, FDA\rquote s relationship with the defendant, the structure of
 the market in which the products at issue compete, and the life-saving potential of the drugs involved.  Before suing a competitor for false advertising, a drug manufacturer must assess how each of these factors affects its likelihood of success.
\par  
\par }\pard \s20\ql \fi-720\li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\b VII.\tab When the Obstacles Are Insurmountable: Pharmaceutical Companies\rquote  Alternatives to Lanham Act Lawsuits 
\par }\pard \s20\ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {
\par }\pard \s20\ql \li720\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {Several legal options are available to drug manufacturers who determine they are 
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {unlikely to prevail in false advertising lawsuits but who desire to stop
 their competitors from falsely or misleadingly promoting their products.  In some cases, manufacturers can file trademark infringement or dilution lawsuits. Alternatively, private companies can pressure FDA, FTC, or state attorneys general to file suit a
g
ainst their competitors.  Both private-sector and government plaintiffs have succeeded in using these strategies to rid the market of substances which were potentially unsafe because their manufacturers marketed them with deceptive or incomplete informati
on.  
\par \tab   
\par \tab }{\b\i A.  \tab Private Action
\par }\pard \s20\ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {
The first option, suing under trademark law, is available only when the plaintiff owns a protectable trademark.  If the defendant uses a mark which consumers are likely to confuse with the plaintiff\rquote s in an attempt to capitali
ze on the goodwill associated with the plaintiff\rquote s mark by leading consumers to believe the defendant\rquote s product is similar to or affiliated with the plaintiff\rquote s product, the plaintiff has a claim of trademark infringement.}{
\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ 15 U.S.C.S. \'a7 1125(a) (2000).}}}{  If the plaintiff
\rquote s mark is famous, it can also sue under the federal trademark dilution statute, which can occur either when consumers associate the defendant\rquote s inferior product with the plaintiff\rquote 
s superior product, or when consumers see the plaintiff\rquote s mark so often or on so many products that the mark loses its ability to be a unique identifier of the plaintiff\rquote s product.}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ 15 U.S.C.S. \'a7
 1125(c) (2000).  State anti-dilution statutes also exist, which do not require the plaintiff\rquote s mark to be famous for the plaintiff to have a cause of action.}}}{
  For example, in a recent case decided by the Court of Appeals for the Seventh Circuit, }{\i Eli Lilly & Co. v. Natural Answers, Inc.}{, 233 F.3d 456 (7th Cir. 2000), Eli 
Lilly, the manufacturer of the FDA-approved prescription antidepressant Prozac, relied on trademark law to enjoin a small company selling an herbal supplement called Herbrozac over the Internet.  Eli Lilly succeeded on an infringement claim by showing tha
t the defendant\rquote s Herbrozac mark was similar to the plaintiff\rquote 
s Prozac mark, and that Natural Answers marketed Herbrozac as having mood-altering effects similar to those of Prozac.  Eli Lilly also succeeded on a dilution claim, by merely showing that the Pr
ozac mark had achieved enough recognition to deem it famous and the Herbrozac mark was similar.  The Court of Appeals reasoned that the mere likelihood of dilution was adequate to satisfy the statute. 
\par  Of course, in order for a drug manufacturer to sue th
e maker of a non-FDA-regulated substance for trademark infringement, the plaintiff must have trademark rights over the name and appearance of its product, and the defendant must have chosen a mark which bears enough similarity to the plaintiff\rquote 
s mark to make consumer confusion likely.  To prevail on a federal trademark dilution claim, the plaintiff\rquote s mark must also be famous.  The vast majority of FDA-approved drugs do not have the brand recognition of Prozac,}{\cs17\super \chftn 
{\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Natural Answers, Inc.}{, 233 F.3d at 459, n.1 (\'93In 1999 }{\i 
Fortune}{ magazine name [Prozac] one of the top six \lquote health and grooming\rquote  products of the 20}{\super th}{ Century. . . The other five were Gillette disposable safety razors, Band-Aids, Penicillin, tampons, and birth control pills.\'94). }}}{
 so their manufacturers cannot sue for trademark dilution.  Additionally, because many cosmetic and dietary supplement manufacturers are savvy enough about trademark law to avoid choosing a mark for their product which may infringe on an existing drug
\rquote s mark, trademark infringement suits do not always 
provide a means for drug manufacturers to police their competitors.  Even in instances when infringement or dilution has occurred, a drug manufacturer might not regard bringing a trademark claim as more desirable than bringing a false advertising claim, b
e
cause it still forces the manufacturer to incur the expenses inherent in litigation and the risk of investing time and resources in a lawsuit in  which it may be unsuccessful.  Nevertheless, trademark law provides one avenue for drug manufacturers who wis
h to curtail the promotional activities of manufacturers of products not subject to FDA\rquote s regulations.
\par 
\par }{\b\i B. \tab Government Action
\par }{The first government body drug manufacturers should contact when they believe their competitors may be making false or misleading r
epresentations about their products is FDA,  the only agency with jurisdiction to sue manufacturers under the FD&C Act.  In many of the cases discussed in this Paper, FDA was pursuing some action against the defendant company at the time of the plaintiff
\rquote s
 lawsuit.  FDA banned the importation of the Chinese red yeast rice Pharmanex used to manufacture its Cholestrin supplement at the same time P&U sued Pharmanex; FDA forced Interpharm to stop importing drugs after Syntex commenced a Lanham Act suit against
 
it; FDA met with Eli Lilly executives several times to discuss their marketing of Evista for the reduction of breast cancer risk and gave them specific instructions on how to label and advertise the drug.  Indeed, in most of these controversies, it was ul
t
imately FDA that forced the defendant to change its promotional practices or to stop selling its product altogether, rather than the plaintiff.  Since FDA has more authority to change the behavior of a drug/cosmetic/dietary supplement manufacturer than a 
private litigant, one option for private parties is to refrain from initiating lawsuits altogether and instead to petition FDA to take action against the defendants.  
\par Because FDA has the daunting task of enforcing FD&C Act standards for so many different t
ypes of products, however, a drug manufacturer that relies on FDA to enforce its regulations against its competitors is likely to experience either frustration at the length of time it takes for FDA to act or disappointment if FDA fails to act at all.}{
\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ It has been estimated that 
more than 25 cents of every dollar U.S. consumers spend goes toward products regulated by FDA.  }{\i See }{\scaps Hutt & Merrill, }{\i supra }{note 16, at v.}}}{  Wi
se companies will pressure FDA to take action against their competitors before investing their own resources in private lawsuits, but they will prepare to litigate if FDA does not respond to their complaints quickly enough to prevent them from incurring e
c
onomic harm and to avoid possible health hazards to consumers.  When companies do eventually file suit, the media attention created by their lawsuits may prompt FDA to hasten its own enforcement activities against the defendants.  In such instances, even 
if it is FDA action rather than their lawsuits which stops the defendants\rquote 
 behavior, the result will be the outcome the plaintiff drug manufacturers sought.  As this Paper has suggested, maximum consumer safety results from the combination of FDA working in
 partnership with private parties to discover violations of the Lanham and FD&C Acts and to punish their perpetrators.
\par Another alternative for drug manufacturers who doubt they can prove the necessary elements of a false advertising claim is to urge FTC to
 take action against their competitors under the Federal Trade Commission Act. The FTC Act specifically prohibits the dissemination of  \'93any false advertisement\'85for the purpose of inducing\'85
the purchase of foods, drugs, devices, services, or cosmetics\'85\'94.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\cs17\super \chftn }{ 15 U.S.C.S. \'a752 (2001).}}}{  While FD&C Act authorizes FDA to regulate the advertisement of prescription drugs,}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ 21 C.F.R. \'a7 202.1 (2001).}}}{
 FTC alone can evaluate advertising claims made for over-the counter drugs, dietary supplements, foods, and cosmetics.  If a pharmaceutical company decides to petition the government to enjoin a competitor\rquote 
s behavior, therefore, rather than filing a private lawsuit, and FDA cannot find the authority to exert jurisdiction over the competitor by means of the FD&C Act, the complainant company must seek the assistance of FTC rather than FDA.  
\par Finally, in some instances state attorneys general have taken action against manufacturers of products they considered to pose a threat to public safety, suing those manufacturers and seeking a ban on the sale of their products in their resp
ective states without prodding from private industry.  In 1997, for example, the state attorneys general of Arizona, California, Illinois, Minnesota, Pennsylvania, Texas, and Wisconsin individually sued Global World Media Corporation (\'93GWMC\'94
) a manufacturer of \'93herbal ecstasy,\'94 a dietary supplement containing the herb ephedra, under state laws prohibiting deceptive trade practices.}{\cs17\super  \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See }{Mason, }{\i supra }{note 48.}}}{
  GWMC promoted herbal ecstasy as a natural stimulant which could increase consumers\rquote  energy, elevate their moods, enhance their sexual experiences, and induce feelings of euphoria.}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See }{Meg Jones, }{\i Herbal Stimulant Stirs Up Lawsuits}{, }{\scaps Milwaukee J. Sentinel, }
{Oct. 16, 1997, at 1.}}}{  While small doses of ephedra can be effective as a decongestant, herbal ecstasy combined ephedra and caffeine, and  doctors warned that this combination could trigger heart attacks or strokes.}{\cs17\super \chftn {\footnote 
\pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See id.}}}{  At 
the time these states filed suit, FDA and FTC had already reached agreements with GWMC regarding the promotional claims it could make about the supplement.}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See }{Global World Media Corp., 62 Fed. Reg. 41,965 (FTC 1997).}}}{
  Fifteen Americans had nonetheless died after ingesting ephedra-based supplements, so the states sought to eliminate herbal ecstasy from their markets altogether.  
\par While all of these cases did not proceed to verdicts, the results indicate that state-initiated lawsuits can be an effective tool to rid the marketplace of unsafe or falsely advertised products.}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{
 It is likely that states will increase their use of these lawsuits to force companies to end deceptive product promotion tactics, given states\rquote 
 success in lawsuits against the tobacco industry, which resulted in tobacco companies being compelled to disclose the health risks posed by cigarettes.  }{\i See, e.g.}{, Andrew Edgecliffe-Johnson, }{\i History May Haunt Big Tobacco}{, }{\scaps 
Fin. Times}{, Sept. 24, 1999, at 4 (\'93[T]here is one important}{\f28  }{legacy from the}{\f28  }{states\rquote  suits: the settlement forced tobacco companies to }{\cs23 disclose}{
 internal industry documents dating back several decades.  These have become vital weapons for those pursuing other litigation against the industry\'85\'94).}}}{
  Texas, for example, won a $3.1 million judgment against GWMC and another ephedra-based supplement manufacturer, Tantric Corporation, and a permanent injunction.  The injunction prohibited the companies from making representations about herbal ecstas
y unsubstantiated by scientific research and required the companies to disclose that heart attacks, strokes, seizures, and death can result from taking the supplement in large doses.}{\cs17\super \chftn {\footnote \pard\plain 
\s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ }{\i See Texas Obtains $3.1 Million Judgment}{, }{\scaps Consumer Protection Rep.,}{
 Jan. 1999, at 14.  The judgment also required GWMC and Tantric to pay over $1 million in civil penalties, consumer restitution, and investigation-related costs. }}}{  With such sizable potential awards, if just a few states file suit agai
nst a company engaging in deceptive product promotions, their efforts will be enough to devastate the company financially and eliminate it from the market.  Lawsuits by state attorneys general can therefore be an effective method for state governments to 
fill in enforcement gaps created by limitations on FDA\rquote s and FTC\rquote s authority.}{\cs17\super \chftn {\footnote \pard\plain \s16\ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 
\fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\cs17\super \chftn }{ Around the time that the seven states commenced their suits against GWMC, FDA did take action to regulate the amount of ephedra available in supplements.  }{\i See}{
 Dietary Supplements Containing Ephedrine Aklaloids, 62 Fed. Reg. 30,678 (HHS, PHS, FDA 1997).}}}{
\par Because the specific violations alleged in each claim against a drug/cosmetic/dietary supplement manufacturer vary, these alternatives to Lanham Act litigation will not be availa
ble to every complainant drug manufacturer.  Additionally, the gravity of the harm caused by an individual defendant\rquote 
s behavior will influence the level of interest federal agencies and state governments will have in pursuing action against a particular pa
rty.  Private-sector trademark lawsuits, and lawsuits filed by FDA, FTC, or individual states can still be effective means to punish rogue manufacturers when a company cannot afford a false advertising lawsuit or when its case is weak.  
\par 
\par }\pard \s20\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b CONCLUSION
\par }{\tab The n
umber of Section 43(a) lawsuits filed by manufacturers of FDA-regulated drugs has increased in recent years.  Because the FD&C Act does not provide for a private right of action, companies that must comply with numerous FDA regulations have attempted to u
s
e the law of false advertising to force competitors that escape these regulations to adhere to the same standards when they market their products. When companies prevail in these cases, their lawsuits result in increased consumer safety in addition to the
 restoration of an even playing field in the marketing of drugs.  The private companies that litigate these lawsuits alleviate some of FDA\rquote 
s enormous burden of  policing the entire drug/cosmetic/dietary supplement industry and allow  FDA to focus on other i
ssues.  These benefits of increased public safety and decreased work for FDA make these cases a desirable way for drug companies to police their competitors.  Yet in almost all of these cases, the plaintiff manufacturers lose.
\par \tab The reasons why drug compani
es typically lose their Lanham Act lawsuits vary.  The Lanham Act requires that plaintiffs prove several elements: that the defendant made a false or misleading promotional claim, that consumers knew about the claim and that it influenced their purchasing
 
decisions, and that the plaintiff suffered or is likely to suffer harm as result.  Proof of these elements can be especially difficult for pharmaceutical companies, since a large percentage of their marketing activities involve face-to-face visits by sale
s representatives to doctors.  The role of doctors as intermediaries between buyers and sellers of drugs and the ephemeral nature of face-to-face promotional visits hinder plaintiffs\rquote 
 chances of obtaining admissible evidence.  In addition to problems relati
ng to the admissibility of evidence, drug manufacturers have also encountered problems establishing standing, when FDA has classified their products in a different category than the defendants\rquote  products and courts have held that the defendants
\rquote  actions consequently have not affected the plaintiffs\rquote 
 markets.  Drug manufacturers have also been frustrated in their suits against foreign  manufacturers and manufacturers of generic drugs under Section 43(a), when courts have suspected these claims were really att
empts by private companies to enforce the FD&C Act indirectly.
\par \tab Several legislative and judicial reforms could help to alleviate these obstacles which hinder drug companies\rquote  ability to win Lanham Act lawsuits.  First, there are ways to eliminate  the setba
cks plaintiffs have faced when trying to admit evidence establishing the Lanham Act elements.  Because consumers do not access prescription drugs directly from manufacturers but must go through a physician-middleman, courts should amend the case-law guide
l
ine which requires surveys in Lanham Act cases to poll consumers to permit surveys which poll physicians when prescription drugs are at issue.  Courts should also amend these evidentiary guidelines to permit the admission of call notes of sales representa
tives\rquote 
 visits to physicians and to ensure that records of such visits are not excluded as hearsay.  Additionally, the legislature should codify these survey guidelines into the Federal Rules of Evidence so that potential Lanham Act litigants in all jurisdic
tions have a clear, uniform sense of the form their consumer survey evidence must take.  
\par \tab Second, both FDA and the courts could reduce the likelihood of plaintiffs losing their cases simply because the plaintiff\rquote s product is a drug and the defendant\rquote s is 
not, especially as the distinction between drugs and non-drugs continues to blur.  FDA should expedite its evaluation of substances which are the subjects of litigation whenever possible, and the courts should refrain from using a product\rquote 
s FDA classification as the most important determinant of whether two products are in competition.  Third, courts can facilitate private companies\rquote 
 attempts to rid the markets of foreign drugs that have not received FDA approval.  Because American consumers presume that al
l drugs sold in the United States have received FDA approval, courts should interpret the act of placing a drug into the United States market as a tacit \'93false or misleading\'94
 description that the drug has earned that approval, and permit Lanham Act lawsuits against foreign manufacturers importing non-approved drugs in the United States.  Finally, Congress could facilitate plaintiffs\rquote 
 attempts to police manufacturers of generic drugs that do not meet a standard of bioequivalence by eliminating the loophole t
hat currently allows the marketing of non-bioequivalent versions of drugs not subject to FDA approval because they were on the market prior to FDA\rquote s institution of premarket approval standards.  
\par \tab With these reforms in place, and with the cooperation not only of FDA but also of FTC and state governments, pharmaceutical companies subject to FDA\rquote 
s most demanding drug regulations would be more likely to win Lanham Act lawsuits against companies who are subject to less or no FDA scrutiny, or who have simply man
aged to escape it.  With increased odds of success, pharmaceutical companies would likely bring more of these lawsuits.  Although consumers may pay for the increase in  litigation if manufacturers raise the price of their drugs, fewer of their tax dollars
 
would go to government-sponsored enforcement of the Lanham and FD&C Acts, and private companies would likely be more efficient in their spending than government agencies.  More importantly, because private companies feel the direct effects of their compet
itors\rquote 
 unfair promotional practices, they are likely to be more scrupulous police of their industries than large government agencies which must monitor thousands of different companies in a plethora of industries.  By enacting legislative and judicial refor
ms which encourage pharmaceutical companies to bring Lanham Act cases, therefore, we can decrease the number of  businesses promoting their products in unethical and unsafe ways, and increase the safety of all American consumers.
\par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\fs24 \tab 
\par }\pard\plain \s20\ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\par }\pard\plain \s16\ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\tab }{\fs24 
\par }\pard\plain \ql \li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\fs24 \tab 
\par }\pard \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\page 
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\par }\pard \qc \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\b\scaps\fs24 
\par \'93The Lanham Act and the FD&C Act: Shaping the Law of False Advertising into a Tool for Drug Manufacturers to Self-Regulate Their Industry and Protect Consumers\'94
\par }\pard\plain \s24\qc \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 \b\scaps\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {
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\par \tab \tab \tab                      }{\b0\scaps0 Jessica Turko
\par }\pard \s24\ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\b0\scaps0 \tab \tab   \tab \tab \tab \tab \tab  Food & Drug Law/
\par }\pard \s24\ql \fi720\li5040\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin5040\itap0 {\b0\scaps0  Written Work Requirement
\par }\pard \s24\ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\b0\scaps0 \tab \tab \tab \tab \tab \tab \tab  Professor Peter Barton Hutt
\par \tab \tab \tab \tab \tab \tab \tab  May 1, 2001
\par \sect }\sectd \marglsxn1440\linex0\endnhere\titlepg\sectdefaultcl \pard\plain \s15\qc \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {TABLE OF CONTENTS
\par }\pard\plain \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b\fs24 
\par 
\par INTRODUCTION}{\fs24 \'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85.1
\par 
\par }{\b\fs24 I.  \tab The Lanham Act and the Federal Food, Drug, and Cosmetic Act}{\fs24 \'85\'85\'85\'85\'85\'85...\'853
\par 
\par {\pntext\pard\plain\b \hich\af0\dbch\af0\loch\f0 II.\tab}}\pard \ql \fi-720\li720\ri0\widctlpar\jclisttab\tx720{\*\pn \pnlvlbody\ilvl0\ls7\pnrnot0\pnucrm\pnstart2\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls7\adjustright\rin0\lin720\itap0 {\b\fs24 Evidentiary Obstacles Pharmaceutical Companies Face in Establishing the
\par }\pard \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\b\fs24 Elements Required for a Lanham Act Claim}{\fs24 \'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'8512
\par }{\b\fs24 
\par {\pntext\pard\plain\b\i \hich\af0\dbch\af0\loch\f0 A.\tab}}\pard \ql \fi-720\li2160\ri0\widctlpar\jclisttab\tx2160{\*\pn \pnlvlbody\ilvl0\ls8\pnrnot0\pnucltr\pnstart1\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls8\adjustright\rin0\lin2160\itap0 {\b\i\fs24 The Difficulty of Admitting Consumer and Doctor Surveys as 
\par }\pard \ql \li2160\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin2160\itap0 {\b\i\fs24 Evidence of the False or Misleading Advertising of Drugs}{\fs24 \'85\'85...\'85\'85.13
\par }\pard \ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\i\fs24 
\par {\pntext\pard\plain\b\i \hich\af0\dbch\af0\loch\f0 B.\tab}}\pard \ql \fi-720\li2160\ri0\widctlpar\jclisttab\tx2160{\*\pn \pnlvlbody\ilvl0\ls8\pnrnot0\pnucltr\pnstart1\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls8\adjustright\rin0\lin2160\itap0 {\b\i\fs24 The Difficulty of Admitting Sales Representatives\rquote  Call Notes as
\par }\pard \ql \li2160\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin2160\itap0 {\b\i\fs24 Evidence of the False or Misleading Advertising of Drugs}{\fs24 \'85\'85\'85\'85\'8516
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\i\fs24 
\par {\pntext\pard\plain\s1 \b \hich\af0\dbch\af0\loch\f0 III.\tab}}\pard\plain \s1\ql \fi-720\li720\ri0\sl480\slmult1\keepn\widctlpar\jclisttab\tx720{\*\pn \pnlvlbody\ilvl0\ls7\pnrnot0\pnucrm\pnstart2\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls7\outlinelevel0\adjustright\rin0\lin720\itap0 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {Obstacles Plaintiffs Face in Establishing Standing in Lanham Act Claims
\par }\pard\plain \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b\fs24 Involving Pharmaceuticals}{\fs24 \'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85
\'85\'85.\'85\'85\'85\'85\'85.18
\par }{\b\fs24 
\par {\pntext\pard\plain\b\i \hich\af0\dbch\af0\loch\f0 A.\tab}}\pard \ql \fi-720\li2160\ri0\widctlpar\jclisttab\tx2160{\*\pn \pnlvlbody\ilvl0\ls9\pnrnot0\pnucltr\pnstart1\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls9\adjustright\rin0\lin2160\itap0 {\b\i\fs24 The Difficulty of Establishing Standing for Consumer Plaintiffs
\par }\pard \ql \li2160\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin2160\itap0 {\b\i\fs24 In False Advertising Cases}{\fs24 \'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85...\'8518
\par }\pard \ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\i\fs24 
\par {\pntext\pard\plain\b\i \hich\af0\dbch\af0\loch\f0 B.\tab}}\pard \ql \fi-720\li2160\ri0\widctlpar\jclisttab\tx2160{\*\pn \pnlvlbody\ilvl0\ls9\pnrnot0\pnucltr\pnstart1\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls9\adjustright\rin0\lin2160\itap0 {\b\i\fs24 The Difficulty of Establishing Standing for Manufacturer
\par }\pard \ql \li2160\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin2160\itap0 {\b\i\fs24 Plaintiffs Whose Products FDA Classifies Differently than the
\par Defendants\rquote  Products}{\fs24 \'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'8521
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\i\fs24 
\par {\pntext\pard\plain\s1 \b \hich\af0\dbch\af0\loch\f0 IV.\tab}}\pard\plain \s1\ql \fi-720\li720\ri0\sl480\slmult1\keepn\widctlpar\jclisttab\tx720{\*\pn \pnlvlbody\ilvl0\ls7\pnrnot0\pnucrm\pnstart2\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls7\outlinelevel0\adjustright\rin0\lin720\itap0 \b\fs24\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {Obstacles Pharmaceutical Companies Face in Establishing Lanham Act Claims
\par }\pard\plain \ql \li720\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 \fs20\lang1033\langfe1033\cgrid\langnp1033\langfenp1033 {\b\fs24 Against Foreign Manufacturers}{\fs24 \'85\'85\'85\'85
\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85...\'85\'85\'85..28
\par }\pard \ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\fs24 
\par {\pntext\pard\plain\b \hich\af0\dbch\af0\loch\f0 V.\tab}}\pard \ql \fi-720\li720\ri0\widctlpar\jclisttab\tx720{\*\pn \pnlvlbody\ilvl0\ls7\pnrnot0\pnucrm\pnstart2\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls7\adjustright\rin0\lin720\itap0 {\b\fs24 Obstacles Pharmaceutical Companies Face in Establishing Lanham Act Claims
\par }\pard \ql \li720\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\b\fs24 Against Manufacturers of Generic Drugs}{\fs24 \'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85.36

\par }\pard \ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\fs24 
\par {\pntext\pard\plain\b \hich\af0\dbch\af0\loch\f0 VI.\tab}}\pard \ql \fi-720\li720\ri0\widctlpar\jclisttab\tx720{\*\pn \pnlvlbody\ilvl0\ls7\pnrnot0\pnucrm\pnstart2\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls7\adjustright\rin0\lin720\itap0 {\b\fs24 How Pharmaceutical Companies Can Succeed as Plaintiffs in Section 43(a)
\par }\pard \ql \li720\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\b\fs24 Lawsuits}{\fs24 \'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85
\'85\'85\'85\'85\'85\'8542
\par }\pard \ql \li0\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\b\fs24 
\par {\pntext\pard\plain\b \hich\af0\dbch\af0\loch\f0 VII.\tab}}\pard \ql \fi-720\li720\ri0\widctlpar\jclisttab\tx720{\*\pn \pnlvlbody\ilvl0\ls7\pnrnot0\pnucrm\pnstart2\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls7\adjustright\rin0\lin720\itap0 {\b\fs24 When the Obstacles Are Insurmountable: Pharmaceutical Companies\rquote 
\par }\pard \ql \li720\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin720\itap0 {\b\fs24 Alternatives to Lanham Act Lawsuits}{\fs24 \'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85....46
\par }{\b\fs24 
\par {\pntext\pard\plain\b\i \hich\af0\dbch\af0\loch\f0 A.\tab}}\pard \ql \fi-720\li2160\ri0\widctlpar\jclisttab\tx2160{\*\pn \pnlvlbody\ilvl0\ls10\pnrnot0\pnucltr\pnb1\pni1\pnstart1\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls10\adjustright\rin0\lin2160\itap0 {\b\i\fs24 Private Action}{\fs24 \'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'8546
\par }\pard \ql \li1440\ri0\widctlpar{\*\pn \pnlvlcont\ilvl0\ls0\pnrnot0\pndec }\aspalpha\aspnum\faauto\adjustright\rin0\lin1440\itap0 {\b\i\fs24 
\par {\pntext\pard\plain\b\i \hich\af0\dbch\af0\loch\f0 B.\tab}}\pard \ql \fi-720\li2160\ri0\widctlpar\jclisttab\tx2160{\*\pn \pnlvlbody\ilvl0\ls10\pnrnot0\pnucltr\pnb1\pni1\pnstart1\pnindent360\pnsp120\pnhang{\pntxta .}}
\aspalpha\aspnum\faauto\ls10\adjustright\rin0\lin2160\itap0 {\b\i\fs24 Government Action}{\fs24 \'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85...\'8548
\par }\pard \ql \li0\ri0\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\fs24 
\par }{\b\fs24 CONCLUSION}{\fs24 \'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'85\'8552
\par }\pard \ql \fi720\li0\ri0\sl480\slmult1\widctlpar\aspalpha\aspnum\faauto\adjustright\rin0\lin0\itap0 {\fs24 
\par }}