Title: Vaccines
Author: Amy Wilkie Litty
Last saved by: Chad and Sarah Ludington
Company: Harvard Law School

The Vaccine Additive Thimerosal: Causation and Compensation for Children with Autism

Amy W. Ray
J.D. Candidate, Harvard Law School
May 2003

Food and Drug Law 
Course Paper and Third Year Written Work Requirement
Supervised by Professor Peter Barton Hutt

I. 	Introduction

Thousands of parents believe their children’s autism is linked to the vaccine additive thimerosal.  The parents of Joseph Alexander Counter (“JAC”) happily witnessed his normal development after his birth in 1996.  At twenty months, he had some vocabulary and had achieved all developmental milestones for a toddler his age.  Then he lost all of his language skills and could communicate solely through screaming.  A doctor diagnosed him with autism as well as having high levels of mercury exposure.  Knowing they had been careful not to expose their son to any heavy metals, Joseph and Theresa Counter began researching websites, which led them to a theory.  JAC had received all of his scheduled vaccinations since birth, and those vaccines contained a preservative called thimerasol, which is 49.6 percent mercury by weight.  In the first civil case of its kind, JAC’s parents sued vaccine and thimerosal makers in May 2001, charging that his autism was caused by mercury exposure.  

The authentic tale is relayed by plaintiffs’ attorney Andrew Waters of Dallas’ Waters & Krause in Margaret Cronin Fisk, Suits Over Mercury-Containing Vaccines May Be Down for the Count, National Law Journal, Nov. 27, 2002.

Counter v. American Home Products, No. 15285 BH01 (Brazo Co., Tex. Dist. Ct. 2001).

.   .   .   .   .
Although now vital to our public health, vaccines have been the focus of much controversy since the first widespread use of Edward Jenner’s smallpox vaccine in 1798.  Two hundred years later, the dangers of vaccines are recognized and injuries are compensated under no-fault federal statutes such as the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”).   However, a recent legislative attempt to amend the Vaccine Injury Compensation Program (“VICP” or “Compensation Program”) added to existing strong criticism of the Compensation Program from parents of autistic children.  

See Peter Barton Hutt & Richard A. Merrill, Food and Drug Law, Cases and Materials 660 (2d ed. 1991)[hereinafter “Hutt & Merrill”].

Pub. L. No. 99-660, 100 Stat. 3756 (1986) (codified at 42 U.S.C. §§ 300aa-1 to 33 (1986)); Title XXI of the Public Health Service Act, 42).

The National Vaccine Injury Compensation Program (“VICP”) makes up Part 2 of the National Childhood Vaccine Injury Act of 1986.

Many families similarly situated to JAC’s parents opted to pursue claims in state and federal courts due to the unreceptive stance the Federal Court of Claims has taken in individual VICP thimerosal proceedings.  A rider to the Homeland Security Act, passed by Congress in late 2002, exempted manufacturer Eli Lilly and Co. from liability for the additive.  The relevant amendment redefined vaccine ingredients to include anything listed within the vaccine’s product license application or product label.  Thus, the parents’ claims against thimerosal would automatically become a claim against the vaccine, thereby funneling the cases back into the administrative Compensation Program.  

Pub. L. 107-296, § 1716 (2002). Clarification of Definition of Vaccine: 

Section 2133 of the Public Health Service Act (42 U.S.C. 300aa-33) is amended by adding at the end the following:
(7) The term `vaccine' means any preparation or suspension, including but not limited to a preparation or suspension containing an attenuated or inactive microorganism or subunit thereof or toxin, developed or administered to produce or enhance the body's immune response to a disease or diseases and includes all components and ingredients listed in the vaccines's [sic] product license application and product label. 
(emphasis added).

In early 2003, congressional leaders removed the provision.  However, concerns underlying the “get out of jail free card” remain, especially given the proliferation of thimerosal tort lawsuits.  This Paper explores the complex thimerosal debate.  Part II briefly sets out the history of vaccine manufacturers in the last half of the twentieth century culminating with the passage of the Vaccine Act; it also posits frequent criticisms of the VICP.  Part III discusses the theorized thimerosal-autism link and recounts failures and minor successes of parents of autistic children in various tribunals in the past year.  The innovative evidentiary solution offered by the Court of Federal Claims, the Omnibus Autism Proceeding, is the focus of Part IV.  Lastly, Part V concludes with implications of the thimerosal dispute, including an analysis of relevant provisions in the proposed National Vaccine Injury Compensation Program Improvement Act of 2003.    

H.R. 248, 108th Cong. (January 8, 2003).  The bill has been referred to the Committee on Energy and Commerce.  It would “strike unrelated provisions concerning changes to the National Vaccine Injury Compensation Program and liability for vaccine manufacturers” by deleting § 1716.

See Fisk, supra note 1.

See Jonathan Groner, Vaccine Bill Becomes Big Headache, Legal Times, March 10, 2003.  Parents have filed more than 1,800 lawsuits in trial courts and in the VICP.  Id.

II. 	Liability for Vaccine Manufacture in the United States
	
In the United States, vaccines have had dramatic effects on human health.  The decrease in morbidity rates throughout the course of the twentieth century for diseases such as smallpox (100%), diphtheria (100%), pertussis (95.7%), tetanus (97.4%), paralytic poliomyelitis (100%), measles (100%), mumps (99.6%), rubella (99.3%) and congenital rubella (99.4%) are awe-inspiring.  Indeed, they may be the single most effective means of health intervention and disease prevention.

See Elizabeth C. Scott, The National Childhood Vaccine Injury Act Turns Vaccine, 56 Food Drug L.J. 351, 351 (2001), citing Achievements in Public Health, 1990-1999 Impact of Vaccines Universally Recommended for Children--United States, 1990-1998, 48 Morbidity & Mortality Wkly. Rep. 243 (1999), available at www.cdc.gov/mmwr/preview/mmwrhtml/00056803.htm.

Id.

See H.R. Rep. No. 99-908, at 4 (1986), reprinted in 1986 U.S.C.C.A.N. 6344, 6345 ("Vaccination of children against deadly, disabling, but preventable infectious diseases has been one of the most spectacularly effective public health initiatives this country has ever undertaken.").

	As is well known, along with their prevention powers, vaccines can also bring swelling, iatrogenic complications, or even death.  These adverse reactions are unforeseeable for the majority of children who experience them.  

See Elizabeth A. Breen, Note, A One Shot Deal: The National Childhood Vaccine Injury Act, 41 Wm. & Mary L. Rev. 309 (1999).

See H.R. Rep. No. 99-908, supra note 12, reprinted in 1986 U.S.C.C.A.N., at 6345–47.

	Given the substantial benefits of a vaccinated society, individual parents deciding to vaccinate their children should be careful not to overestimate the risk of adverse effects.  While over 100 million doses of vaccines are given each year to children in the United States, immunizations caused less than 100 deaths in 1997.  For purposes of this Paper, the scarcity of nonfatal reactions is also important to note.  

Stacey Schultz, Immunization Roulette: Parents Who Don't Vaccinate Play a Risky Game, U.S. News & World Rep., Nov. 23, 1998, at 65.

Id.

See id.  Among childhood vaccinations, DPT injections have the greatest risk of nonfatal injury, as there is a 1/100,000 chance of permanent brain damage.  Breen, supra note 13, at 314.  This is relevant to thimerosal claims, as the additive was commonly found in increasing quantities in DPT vaccine in the 1990s as the vaccination schedule changed to add the newer HIB flu vaccine and hepatitis B.  See Fisk, supra note 1.

A. 	Pre-NCVIA Litigation

	Parents of children injured by vaccines at first countered with tort suits and experienced uncertain and inconsistent recoveries in the common law courts.  The House Committee on Energy and Commerce summarized plaintiffs' glum chances of recovery in 1986: 

See Theodore H. Davis, Jr. & Catherine B. Bowman, No-Fault Compensation for Unavoidable Injuries: Evaluating the National Childhood Vaccine Injury Compensation Program, 16 U. Dayton L. Rev. 277, 297 (1991).  See also Scott , supra note 10, at 354.

[F]or the relatively few who are injured by vaccines--through no fault of their own--the opportunities for redress and restitution are limited, time- consuming, expensive, and often unanswered. Currently, vaccine-injured persons can seek recovery for their damages only through the civil tort system or through a settlement arrangement with the vaccine manufacturer. Over time, neither approach has proven satisfactory. Lawsuits and settlement negotiations can take months and even years to complete. Transactions costs--including attorneys' fees and court payments--are high. And in the end, no recovery may be available. Yet futures have been destroyed and mounting expenses must be met.

H.R. Rep. No. 99-908, supra note 12, reprinted in 1986 U.S.C.C.A.N., at 6347.  On plaintiffs' perils under traditional state tort law regimes in general, see J. O'Connell & B. Kelly, The Blame Game 126-27 (1986).

The system was a nightmare, as many victims deserving compensation were denied recovery because they could not prove that someone or something was at fault, and many others received a mere fraction of what they deserved because they wanted to avoid the financial strain of years of delayed settlement.

O'Connell & Kelly, supra note 19, at 126-27.

Despite these hurdles, plaintiffs in 1985 continued to file over 100 new cases and requested damages of over $3.5 billion.   Manufacturers grappling with damages and defense costs took the initiative to demand a better solution.  

Subcommittee on Health and the Env. of the House Comm. on Energy and Commerce, 99th Cong., 2d Sess., Childhood Immunization 103-06 (Comm.Print 1986). [hereinafter Childhood Immunization]

Id.

B. 	Manufacturers Respond and Prompt Congress to Act 

	Manufacturers’ first response to the few large judgments was to raise prices dramatically.  At the same time, insurance companies became increasingly demanding as to what expensive but limited policies they would provide to drug companies.  One important consideration for manufacturers was that vaccine sales accounted for a relatively small portion of manufacturers’ overall sales due to the limited market for vaccines yet seemed to expose them to unlimited liability.  This lack of adequate protection against liability was no secret to Congress when it wrote that the "withdrawal of even a single manufacturer would present the very real possibility of vaccine shortages, and, in turn, increasing numbers of unimmunized children, and, perhaps, a resurgence in preventable diseases."  Things were so bad in 1985 that the federal Centers for Disease Control and Prevention (“CDC”) asked doctors to stretch the supply of DPT by delaying giving the booster shots to children.  

See Lisa J. Steel, Note, National Childhood Vaccine Injury Compensation Program: Is This the Best We Can Do for Our Children?, 63 Geo. Wash. L. Rev. 144, 145 (1994).  In four years (1982-1986), the price of a dose of DPT rose 300% from ten cents $3.00. Okianer C. Dark, Is the National Childhood Vaccine Injury Act of 1986 the Solution for the DTP Controversy?, 19 U. Tol. L. Rev. 799, 808–10 (1988) (citing Nancy Blodgett, Remedy For Vaccination Harms?, A.B.A. J., Sept. 1, 1987, at 25, 25).

Insurance companies also played a major role in convincing drug companies to demand that Congress revamp the liability structure in the swine flu vaccination program.  See Thomas Baines, Liability for Vaccine Related Injuries: Public Health Considerations and Some Reflections on the Swine Flu Experience, 21 St. Louis University Law Journal 44 (1977), reprinted in Hutt & Merrill, supra note 3,  at 716.  However, at the time, the low liability limits they demanded were surprising given the paucity of litigation: out of 70 million doses of flu vaccine in a five year period, only there were only 20 claims against manufacturers.  Id. at 717.

See Childhood Immunization, supra note 21, at 72.

See H.R. Rep. No. 99-908, supra note 12, reprinted in 1986 U.S.C.C.A.N. at 6348.

See Steve Seidenberg, The National Law Journal, Dec. 30, 2002.

C. 	The National Childhood Vaccine Injury Act of 1986

To assuage the product liability dilemma, Congress passed the Vaccine Act, one of the most successful public health enactments to balance product safety and product availability.  The Act does not merely reform tort doctrine.  Instead, it both limits tort law principles while at the same time providing an alternative compensatory program funded by an excise tax garnered from sales of covered vaccines.  

The tax and fund provisions can be found in the Internal Revenue Code, 26. U.S.C. §§ 4131, 9510.  The fee is 75 cents per dose.

There are two parts to the Act.  The first part is the National Vaccine Program, which concentrates on the perfection of vaccines, minimizing and monitoring adverse effects of vaccines, and supporting the Department of Health and Human Services in ways that improve immunization programs in the United States.  The second part of the Vaccine Act establishes the Compensation Program, with the goal of applying a federal no-fault system awarding persons suffering from vaccine-related injuries quickly, easily, and with certainty and generosity. 

42 U.S.C §§ 300aa-1 to -6; see also H.R. Rep. No. 99-908, supra note 12, reprinted in 1986 U.S.C.C.A.N. at 6344.

42 U.S.C. §§ 300aa-10 to -34; see also H.R. Rep. No. 99-908, supra note 12, reprinted in 1986 U.S.C.C.A.N. at 6344.

The Compensation Program shelters vaccine manufacturers from strict design defect liability consistent with Restatement (Second) of Torts section 402A, comment k.  It also adopts the learned intermediary doctrine, allowing manufacturers to fulfill their duty to warn by providing information to the treating physician rather than directly to the vaccinee.  Finally, it creates a presumption that manufacturer warnings that comply with the Food and Drug Administration (“FDA”) standards are adequate, thereby preventing a state court’s independent assessment of the warnings' sufficiency. 

42 U.S.C. § 300aa-22(b)(1) (providing that the manufacturer of a vaccine shall not be liable for any vaccine-related injury or death caused by unavoidable side effects so long as the manufacturer properly prepared and labeled the vaccine with proper warnings).

See Restatement (Second) of Torts 402A cmt. k (1965) (commenting that manufacturers of products that are unavoidably unsafe, such as prescription drugs, shall not be held strictly liable for injuries relating to their product, as long as the item is manufactured properly and contains adequate warnings). The policy justification for this absence of strict liability comes from the realization that while these products can never be totally safe, they are a desirable product that benefits the health and well-being of society. See id.

The duty to warn was established in the landmark product liability cases Reyes v. Wyeth Laboratories, Inc., 498 F.2d 1264 (5th Cir. 1974), and Davis v. Wyeth Lab., 399 F.2d 121 (9th Cir. 1968) (in tort suit by a polio vaccine recipient, manufacturer had a duty to warn based on its extensive involvement in the administration of the vaccination program.).

42 U.S.C. § 300aa-22(c) (stating that no manufacturer shall be liable in civil actions for failing to directly warn the injured recipient).

Id. at § 300aa-22(b)(2).  But see id. at § 300aa-22(b)(2)(B) (allowing plaintiff to rebut this presumption by showing that manufacturer failed to exhibit due care); § 300aa-23(d)(2) (allowing rebuttal of presumption by plaintiff’s showing that the manufacturer engaged in fraud).

	In late 2002, Congress attempted to amend the Vaccine Act to include in the definition of “vaccines” all “components and ingredients” listed in the product license application or product label of the vaccine.   The wisdom of the policies behind this Homeland Security Act provision and its implications for parents’ overall trust of the Compensation Program will be explored in Part V. 

See supra Part I.

III. 	The Vaccine Injury Compensation Program (VICP)

In the Vaccine Injury Compensation Program, Congress sought to create a more equitable and efficient remedy than the pre-VICP civil tort system.  It has been administered by the Federal Court of Claims for 15 years and by most accounts is an improved solution for families suffering form rare side effects of childhood vaccines.  However, it is not universally lauded and has drawn criticism from practitioners and scholars alike.  This section summarizes VICP procedures and addresses common criticisms.  Part IV outlines why thimerosal claimants have had particular difficulty recovering VICP remedies.  

See H.R. Rep. No. 99-908, supra note 12, reprinted in U.S.C.C.A.N. at 6345-46.

A.	Administrating the VICP

There are several important initial procedural requirements of which prospective vaccine claimants should be aware.  The Office of Special Masters (“OSM”) of the United States Court of Federal Claims acts as the trier of law and fact.  Rules of procedure under the Vaccine Act are less formal than traditional rules.  Most important, any plaintiff anticipating filing a lawsuit should know that lawsuits stating injuries arising from a vaccine cannot be filed against the manufacturer or administrator of a vaccine until a claim is filed and decided under the Act.  

42 U.S.C. § 300aa-12(d)(3)(A).

42 U.S.C. § 300aa-12(d)(3)(A)–(E).  The Vaccine Act directs the Court of Federal Claims to promulgate rules that "provide for a less-adversarial, expeditious, and informal proceeding for the resolution of petitions." 42 U.S.C. § 300aa-12(d)(2)(A).  The Rules can be accessed easily in on the website of United States Court of Federal Claims, available at http://www.uscfc.uscourts.gov/OSM/Vaccine%20Rules.pdf.

42 U.S.C. § 300aa-11(a)(2)(A). This provision applies to injuries arising after the Act’s effective date of October 1, 1988, and since the thimerosal causation theory is relatively new, this Paper will focus on post-1988 procedures.  The Act also creates an ethical obligation for any attorney who is counseling a vaccine-injured person to inform that person of the possibility of compensation under the Act.  42 U.S.C. § 300aa-10(b).

If the injured claimant properly passes this first hurdle of bypassing trial courts, she files a petition under the Act with the Court of Federal Claims.^,  The Court of Federal Claims will then assign the petition to a special master. Using a preponderance of the evidence standard, the special master uses his discretion to decide whether the petition demonstrates that the allegedly injured vaccinee (1) suffered or aggravated any illness, disability, or injury due to the vaccination (or contracted polio from another person who received an oral polio vaccine); and (2) has died or suffered an injury or illness for more than 6 months, resulting in unreimbursable expenses in excess of 

42 U.S.C. §§ 300aa-11(a)(1), -12(a).

The Court of Federal Claims was formerly known as the United States Claims Court.

42 U.S.C. § 300aa-12(c).

$ 1,000. 

42 U.S.C. §§ 300aa-11(c), -13(a).

There is additional documentation that must be submitted along with a petition.  The claimant must submit medical records establishing that the vaccine caused the injury alleged. The 1989 amendments also set a minimum documentation requirement that includes: maternal prenatal and delivery records, newborn hospital records, vaccination records, pre- and post-injury doctor or clinic records, all post-injury in-patient and out-patient records, and if available a death certificate and autopsy results.  The claimant is given the opportunity to explain any failure to produce any of the required records to the special master.  

42 U.S.C. § 300aa-11(c)(2).

Id. as amended in 1989.

42 U.S.C. § 300aa-11(c)(3).

A claimant has two methods to use in demonstrating an injury by a preponderance of the evidence.  The claimant’s first option is to show that she suffered an injury on the Vaccine Injury Table.  The Table is a useful tool that sets forth injuries the Act presumes are caused by a vaccine; the injury must occur within the time period stated in the Table.  Meeting this Table-driven requirement shifts the burden to the Department of Health and Human Services (“HHS”), who is the respondent in all cases under the Act.  The HHS representative then attempts to show, also by a preponderance of the evidence, that the injury is due to a factor unrelated to the vaccine.  The government can meet its burden only by identifying a particular factor that caused the injury.  It is not sufficient for the government to assert that the injury is due to an unknown or unexplainable factor.   

See 42 U.S.C. § 300aa-14(a).

See 42 U.S.C. §§ 300aa-11(c)(1)(C)(i), –13(a)(1); Gamache v. Secretary of Dep't of Health & Human Servs., 27 Fed. Cl. 639, 640 (1993).  Included in the Table are injuries from the diphtheria, tetanus, pertussis, measles, mumps, rubella, and polio vaccines.

42 U.S.C. § 300aa-13(a)(1); see Dileo v. Secretary of Dep't of Health & Human Servs., 23 Cl. Ct. 796, 798 (1991).

Id.

42 U.S.C. § 300aa-13(a)(1).

42 U.S.C. § 300aa-13(a)(2).

Although the easier path guides the petitioner to attempt to establish an injury within the guidelines set by the Table, if she has sustained an injury that is not listed on the Table or has sustained an injury on the Table but not within the required time limitations, the possibility exists that her injury remains compensable under the Vaccine Act.  However, using this second method of recovery destroys the presumption that the vaccine caused the petitioner’s injury, and she will be required to meet the burden of showing, again by a preponderance of the evidence, causation between the vaccine and her injury.  

A study by the General Accounting Office (“GAO”) stated that, through 1999, claimants with on-table injuries won 35% of the time while those with off-table injuries won only 13% of their claims.

See 42 U.S.C. §§ 300aa-11(c)(1)(C)(ii), -13(a)(1); Gamache, 27 Fed. Cl. at 640.

42 U.S.C. §§ 300aa-13(a)(1); see Gamache, 27 Fed. Cl. at 640.

The petitioner will need to show additional evidence to establish causation outside the listings in the Table.  A House Report describes the scope of this evidence: "Simple similarity to conditions or time periods listed in the Table is not sufficient evidence of causation. . . ."  Thus, in addition to the minimum documentation required to file the claim, the petitioner must present evidence such as a scientific study or expert medical testimony to support her claim under this second method. 

See H.R. Rep. No. 99-908, supra note 12, reprinted in U.S.C.C.A.N. at 6356.

Id.

See 42 U.S.C. § 300aa-13(a)(1). "The special master or court may not make such a finding based on the claims of a petitioner alone, unsubstantiated by medical records or by medical opinion." Id.

Succeeding under either of the two methods entails persuading the special master that a vaccine caused the petitioner’s injury, and she is then entitled to the specific compensation available under the Act.  The death of a vaccinee entitles the successful claimant to $250, 000.  If the successful claimant was injured, but not killed, she receives compensation for future and past unreimbursable expenses incurred as a result of the vaccine injury, and in addition to medical care, this includes "rehabilitation, developmental evaluation, special education, vocational training and placement, case management services, counseling, emotional or behavioral therapy, residential and custodial care and service expenses, special equipment, related travel expenses, and facilities determined to be reasonably necessary."  The successful claimant may also receive actual and anticipated lost earnings, pain and suffering not exceeding $250,000, as well as reasonable attorneys’ fees and costs.  It bears mention that attorneys’ fees and costs will be paid to successful and unsuccessful petitioners alike, so long as the attorney both brings the case in good faith and charges fees in a reasonable basis. http://www.lexis.com/research/retrieve?_m=6b471edca29773a7b3766ebcfea34129&docnum=15&_fmtstr=FULL&_startdoc=11&wchp=dGLbVlz-lSlbt&_md5=7985356d485f9630270c885e1c607c36 - n141#n141 No punitive damages may be awarded.

42 U.S.C. § 300aa-13(a)(1).

42 U.S.C. §300aa-15(a)(2).  This amount has not increased since the Act’s original enactment.

42 U.S.C. § 300aa-15(a)(1)(A)(iii).

42 U.S.C. §§ 300aa-15(a)(3) to (4), (e).

42 U.S.C. § 300aa-15(e)(1).

As mentioned previously, the source of money for post-1988 cases is a Vaccine Injury Compensation Trust Fund supported by excise taxes on the sale of vaccines.  Thus, the source of funding for the Compensation Program contributes to the fund to the extent that manufacturers sell vaccines.

26 U.S.C. § 9510(b) (Internal Revenue Code); 42 U.S.C. § 300aa-15(i)(2).

Finally, after the special master has decided in an administrative proceeding under the Act, if the dissatisfied petitioner elects to pursue her case in a state civil court, the Act limits her available arguments against the manufacturer.  Her civil court argument may not allege manufacturer responsibility for any unavoidable injury, direct manufacture failure to warn the vaccinee of dangers of the vaccine, or that the manufacture did not provide proper warnings and instructions with the vaccine. 

42 U.S.C. § 300aa-22(b).

42 U.S.C. § 300aa-22(b)(1).

42 U.S.C. § 300aa-22(c).  See also Randall B. Keiser, Deja Vu All Over Again? The National Childhood Vaccine Injury Compensation Act of 1986, 47 Food & Drug L.J. 15, 17 (1992).

42 U.S.C. § 300aa-11(a)(1), -12(a).

B.	Criticisms of the VICP

Since its inception, many scholars have criticized and offered solutions for improving the Vaccine Compensation Program.  Due to the quantity of such responses, only a survey is provided here. 
One common criticism is the amount of time it takes for a petition to result in a decision by a special master.  Earlier implementation of the VICP was satisfactorily expeditious to most claimants.  This was because the Vaccine Act limited the issues special masters considered for compensation, leading to the average VICP case lasting less than one year.  If the Secretary, as defendant, conceded compensability of the injury, recovery was even faster.  In comparison, litigants opting out of the VICP in favor of trial or settlement with manufacturers faced an average 6 to 8 year wait for compensation. 

See, e.g., Scott, supra note 10, at 358.

See Mary Beth Neraas, Comment, The National Childhood Vaccine Injury Act of 1986: A Solution to the Vaccine Liability Crisis?, 63 Wash. L. Rev. 149, 164-65 (1988).

See Denis J. Hauptly & Mary Mason, The National Childhood Vaccine Injury Act, 37 Fed. B. News & J. 452 (1990), cited in Scott, supra note 10, at 358.

See Nerass, supra note 71.

Then, as more pre-Vaccine Act cases reached Special Masters, the system faced a severe backlog of cases.  Some of these cases, in which the alleged injuries occurred prior to 1988, did not have a compensation determination until ten years later.  A 1998 investigation revealed that the pace of case resolution slowed further as the 1990s progressed.  The effect of delay on the families themselves was stressful not only due to mounting uncompensated medical costs but also the time and care their seriously-injured children required.  According to the 1998 study, almost 60 families that had received a favorable ruling had already waited from 3 to 5 years without seeing any compensation from the program.    

See generally Steel, supra note 23.

See id. at 124.

See John Hanchette & Sunny Kaplan, National Vaccine Compensation Program for Children Draws Fire, Gannett News Service, Aug. 11, 1998, available at 1998 WL 5632365, cited in Scott, supra note 10, at 358.

Id. at 19.

Id.

Although the Program provides compensation for all attorneys presenting good faith claims, recent experience has led lawyers to flee the compensation system.  The main concern of attorneys willing to handle the cases is that the hourly rates are relatively low; they are pegged to the fees of attorneys having similar legal experience in the same geographic area.  Payment is not made until the claim is fully adjudicated, and even then the attorney must take the additional steps of filing a fee petition, waiting for the government’s response to the fee petition, and then appearing before a special master solely for the purpose of fee approval.  This process can take years.  Cliff Shoemaker, who has 20 years of experience in representing plaintiffs in vaccine cases commented on his experience: “I have $2 million in fees that are outstanding in the program.  Not too many people can afford to defer their fees too long.”  While it might be argued that a few years is not an unreasonable wait period, the existing fee structure necessitates amendment.  One concession from HHS has been its willingness in some cases to provide payment of interim costs to attorneys who otherwise have to wait years to recover their outlay in obtaining expert witness testimony. 

See, e.g., Seidenberg, supra note 27.  Seidenberg interviewed Michael Hugo, who once represented 25% of vaccine compensation claims in the United States and helped craft the program.  Said Hugo, “The lawyers that work in this program on a regular basis, you can probably count them on your hands. . . . Attorneys who have participated once in the program will not go back.”  Id.

See id.  Hugo, now a practicing lawyer in Boston who has rejoined the program due to many claimants’ expressed inability to find representation, elucidated on the going rates: “You won’t get more than $250 per hour. . . . Most lawyers get between $150 and $175 per hour.  Moreover, federal law forbids attorneys from receiving payments from any other source for their work in the program.”  Id.

See id.

Id.

Id. quoting John L. Euler, a deputy director in the Department of Justice Civil Division.

A more basic critique of the system is that an adversarial nature that has come to dominate VICP proceedings.  Participants bemoan the increased tensions between government and petitioners’ attorneys which has arisen despite a specific statutory mandate to the contrary.    As described by Elizabeth C. Scott, “the system that was designed originally to be a form of alternative dispute resolution has become contentious and even stingy in nature, pitting government attorney against petitioner in a way that makes the program a mere ‘microcosm of the system it had hoped to replace.’”  Not only did the parties maintain their traditional litigious roles.  The Court of Federal Claims had promulgated rules that were more formal than necessary which "virtually foreclosed any opportunity for petitioners or respondents to proceed without litigators at their sides."   Some petitioners withheld or sought to exclude evidence, while at the same time lawyers for the government increasingly adopted aggressive and technical arguments inconsistent with the simple no-fault compensatory goal of the system.  

42 U.S.C. § 300aa-12(d)(2)(A).  See supra note 39.

Scott, supra note 10, at 362, quoting Laura Mazzuca, Shot Through With Problems--A Partial Success, Vaccine Injury Fund Faces Case Logjam, Funding Shortfalls, Bus. Ins., Aug. 24, 1992, available at 1992 WL 9479842.  Scott elaborates further: 

The legislative history of the NCVIA suggests that Congress envisioned a short, informal process, and not an "exhausting and extremely adversarial process of nickel-and-dime arguments," as one family complained.  Instead, the Department of Justice assigned 17 full-time lawyers, all of whom are veteran litigators, to defend the claims, and the proceedings have turned into "combative mini-trials"  where the credibility of petitioners' expert witnesses is attacked and, even after the decision to compensate is made, the government lawyers fight over minutia like the future cost of diapers in a certain state. Interested parties on both sides of the table have argued that the system has become too adversarial. One physician, testifying at the 1999 hearings, expressed concern that petitioner's attorneys contribute to the adversarial nature of the program, and that a pseudo-science of "vaccine-ology" has arisen. Both of the players in this program, the government and the petitioners, stand to gain from a system that looks less like an adversarial system and more like a peaceful way to resolve disputes. The adversarial nature of the program undoubtedly contributes to the cost and reduces the efficiency of the program, but more importantly, it detracts from the fairness of the program by upsetting the balance between petitioner and government (and therefore society). Ironically, when the fund is at its biggest surplus yet, the government is guarding its "coffers" more and more as families of injured children go uncompensated. 

Scott at 362 (citations omitted).

See Kristine M. Severyn, Jacobson v. Massachusetts: Impact on Informed Consent and Vaccine Policy, 5 J. Pharmacy & Law 249, 266 (1995).  Severyn cites the discussion in a 1992 paper by California attorney Andrew W. Dodd: 

“[W]hat has occurred . . . is that Program participants have 'traded' Department of Justice counsel in place and stead of pharmaceutical industry defense counsel, the attorneys they would have faced in traditional litigation. . . . [But he believes that the Program has been a success by] . . . the diversion of traditional civil litigation from pharmaceutical firms, and a very few doctors, into a system of adversarial litigation involving the United States Government as a defendant.”  

Id. (citations omitted).

See H.R. Rep. No. 101-247 (1989), reprinted in 1989 U.S.C.C.A.N. 1906, 2236.

See id.  But see Seidenberg, supra note 27, quoting DOJ attorney John L. Euler (“If the secretary of HHS thinks that a particular condition is not caused by a vaccine, it is our job to defend that position”).  Euler also denies that DOJ has fought more vigorously, noting that the number of attorneys working on the program (20) has remained stable for the past ten years.  Id.

A 1989 House Report acknowledged that pursuing VICP claims was much more difficult than the drafter originally intended, and recommended that the compensatory procedures are meant to "be informal, flexible, and expeditious."  Little changed in the 1990s as parents faced increasing disillusionment with the Compensation Program.  

See Steel, supra note 23, at 159–160.

Perhaps the most widely-criticized feature of the Program is its statute of limitations.  The Vaccine Act prevents the filing of a petition "if the first symptom or manifestation of onset or of the significant aggravation of such injury occurred more that thirty-six months after the date of the administration of the vaccine."  This means that for a parent to file a petition, she must be aware of a potential link between her child’s injury and the vaccine.  Perhaps in today’s world of easily-accessible electronic information this is a somewhat acceptable assumption, but many parents find that by the time they are aware of recovery under the Vaccine Act, the 3-year statute of limitations has run, thus allowing a court to deny their claim.  By contrast, all 50 states have laws that toll their statues of limitation until a child reaches the age of majority. 

42 U.S.C. § 300aa-16(a)(2).

A Google search for “autism” returned over 1 million results, yet the main page of one of the first five results discussed the mercury-thimerosal-autism link: http://www.autism.com/ari/contents.html.  Also note that JAC’s parents, the family described in the introduction to this paper, learned about this theory from the Internet while researching his disease.

See, e.g., Stevens v. Secretary of the Dep't. of Health & Human Services, 31 Fed. Cl. 12 (1994).

In the 2002 case Dickey v. Connaught Laboratories, an Illinois Appellate Court held, as a matter of first impression, that the mother’s failure to timely file a federal petition for compensation under Vaccine Act barred any subsequent state civil action.  Gina Dickey had waited only 11 days past the 3-year deadline before filing her daughter’s petition with the Court of Claims, and, upon dismissal of that petition, attempted a state-court action to no avail.  While agreeing with the majority that the Vaccine Act’s statute of limitations does not preempt state law, the Dissent thought the Dickeys had “substantively complied with the act” by pressing the issue to final judgment.^,  

777 N.E.2d 974 (Ill. App. 3d. 2002).

Id. at 975–76.

Id. at 979–80.  Judge Breslin’s dissent cited conflicting law from the Supreme Court of Mississippi.  See Cook v. Children's Medical Group, 756 So.2d 734 (2000) (determining that if a petition under the Vaccine Act is dismissed as being time-barred in the Court of Claims, a plaintiff should be allowed to bring suit under state law).

See generally, Andrew Harris, Federal Vaccine Act Kills Suit, The National Law Journal, Aug. 16, 2002. The article quotes the Dickey family’s lawyer, Darlene D. Soderberg of Rockford, Illinois, as saying: “We complied not with the letter of the law, but with the meaning of the law” and that “[a]n incompetent minor should be allowed more time to have her case heard in state court.”  Id.  Even though the Vaccine Act expressly says that it does not preempt state law, interpreting its 3-year deadline to also bar state claims effectively preempts such claims.

Recent proposed changes to the Vaccine Act include a provision for increasing the statute of limitations to 6 years.  All parties involved seem to agree that this amendment would “catch virtually all the valid and meritorious claims.” 

H.R. 3741, 107th Cong. (Feb. 13, 2002).  Sec. 7 proposed extending the statute of limitations to 6 years as part of the National Vaccine Injury Compensation Program Improvement Act of 2002.  Representative Burton reintroduced the 2003 Improvement Act to the House in the 108th Congress.  H.R. 1349 (March 15, 2003).  The latest bill was referred to the Subcommittee on Health on March 24, 2003.

Seidenberg, supra note 27, quoting John L. Euler.

III.	Thimerosal Claimants 

A. 	Growing Concern 

Since 1940, thimerosal, a water-soluble compound containing mercury, has been added to vaccines.  It effectively prevents contamination and bacteria growth.  Its use increased in the 1990s when the vaccine schedule added HIB flu vaccine and the hepatitis B vaccine to the traditional DTP vaccine.   While it varied by manufacturer, many of the 1990s vaccine doses contained thimerosal; thus, with the increased vaccinations came increased exposure to mercury.  Another factor adding to the increased use of thimerosal was the manufacturers’ reliance on multidose vials, as these required higher concentrations of preservations to prevent contamination. 

See Fisk, supra note 1 (quoting Kathleen Daily of Portland, Oregon’s Williams Dailey O’Leary Craine & Love).

See id.

The first suspicion of a link between autism and thimerosal came in 1997.  In that year, a rider to the Food and Drug Administration Modernization Act of 1997 required the FDA to create a list of drugs and foods with mercury-containing compounds.  A June 1999 FDA report indicated that “infants who received thimerosal-containing vaccines at several visits may be exposed to more mercury than recommended by federal guidelines for total mercury exposure.”  A month after the FDA released its report, the American Academy of Pediatrics issued to its members an announcement stating a preference for thimerosal-free vaccines.  Parents and parent-activists took notice.  

Pub. L. No. 105-115, 111 Stat. 2296 at 2376-2377 (1997).  The provision reads as follows: 

§ 413. Food and Drug Administration Study of Mercury Compounds in Drugs and Food. 

(a) List and Analysis.--The Secretary of Health and Human Services shall, acting through the Food and Drug Administration-- 

   (1) compile a list of drugs and foods that contain intentionally introduced mercury compounds, and 

   (2) provide a quantitative and qualitative analysis of the mercury compounds in the list under paragraph (1).The Secretary shall compile the list required by paragraph (1) within 2 years after the date of enactment of the Food and Drug Administration Modernization Act of 1997 and shall provide the analysis required by paragraph (2) within 2 years after such date of enactment. 
….
(c) Study of Mercury Sales.-- 

   (1) Study.-- The Secretary of Health and Human Services, acting through the Food and Drug Administration and subject to appropriations, shall conduct, or shall contract with the Institute of Medicine of the National Academy of Sciences to conduct, a study of the effect on humans of the use of elemental, organic, or inorganic mercury when offered for sale as a drug or dietary supplement. Such study shall, among other things, evaluate-- 

     (A) the scope of mercury use as a drug or dietary supplement; and 

     (B) the adverse effects on health of children and other sensitive populations resulting from exposure to, or ingestion or inhalation of, mercury when so used.

FDA, Mercury Compounds in Drugs and Foods (Nov. 1999), available at at http://www.fda.gov/cder/ fdama/mercuryreport.htm (discussing drugs and biologics that contain intentionally introduced mercury compounds).  While there was no recall, when the FDA asked vaccine manufacturers to reduce the mercury content in vaccines, the companies complied.

CDC, Thimerosal in Vaccines: A Joint Statement of the American Academy of Pediatrics and the Public Health Service. MMWR 48:563-5 (July 8, 1999).

The possible connection between vaccines and the tremendous increase in autoimmune diseases is increasingly the focus of serious scientific study.  Autism rates have risen significantly. In the state of California, the autism rate has increased 210% from 1987 to 1998.  Congressional testimony from scientists and parents alike has invigorated the debate over whether mercury causes autism in vaccinated children.  Representative Dan Burton, Chairman of the House of Representatives Government Reform Committee, has taken a keep interest in the debate, as his own grandson experienced symptoms of autism shortly after receiving a routine litany of immunizations.

See Michael E. Horwin, Comment, Ensuring Safe, Effective and Necessary Vaccines for Children, 37 Cal. W. L. Rev. 321, 330–31. To date, no study by the CDC or the Institute of Medicine has found a causal link.

California Health and Human Services Agency, Department of Developmental Services, Changes in the Population of Persons with Autism and Pervasive Developmental Disorders in California's Developmental Services System: 1987 through 1998, March 1, 1999, at 7.  According to one of the plaintiffs’ lawyers, the national autism rate was once 1/10,000 births, but now it is 40/10,000; in some areas such as California and New Jersey, it is up to 1/150 births.  See Fisk, supra note 1 (quoting Michael Gallagher).

See, e.g., Autism: Present Challenges, Future Needs - Why the Increased Rates? Before the Government Reform Committee of the House of Representatives, 106th Cong. (April 6, 2000).

See id. Statement of Dan Burton available at 2000 WL 426109 (F.D.C.H.).  Rep. Burton shared the story of his grandson, Christian: 

I don't have to read a letter to experience the heartbreak. I see it in my own family.  My grandson   Christian was born healthy.  He was beautiful and tall.  We were already planning his NBA career.He was outgoing and talkative.  He enjoyed company and going places. Then, his mother took himfor his routine immunizations and all of that changed.  He was given what so many children were given - DTP, OPV, Haemophilus, Hepatitis B, and MMR all at one office visit.  That night Christian had a slight fever and he slept long periods of time.  When he was awake he would scream a horrible high-pitched scream.  He would scream for hours.  He began dragging his head on the furniture and banging it repeatedly.  Over the week-and-a-half after the vaccinations, Christian would stare into space and act like he was deaf.  He would hit himself and others, which was something he had never done.  He would shake his head from side to side as fast as he could.  He lost all language.  

However, Rep. Burton voted for the Homeland Security Act, including the vaccine rider.  One of his aides was quoted as saying, “He voted for the bill as a whole . . . He was unaware at the time of the provision.  He didn’t read the whole bill.”  See Fisk, supra note 1.

The causation issue is hotly contested.  The industry’s point of view is that there is no scientific data to support a connection between thimerosal and autism.  The manufacturers view the many lawsuits filed in 2002 as attempts to circumvent the Vaccine Program, and see the thimerosal claims as particularly improper.  Parents disagree, as they have watched their babies develop normally and then suddenly exhibit signs of autism.  One mother of a boy diagnosed with pervasive developmental disorder, a form of autism, had her son’s hair tested; the results showed a mercury level four times greater than the EPA’s action level for mercury toxicity.  Although scientists have not yet found the link between the mercury-based chemical and the rapidly rising rate of childhood autism, they still continue to study the thimerosal question intensively. 

See, e.g., CBER, Thimerosal in Vaccines (2001), available at  http://www.fda.gov/cber/vaccine/ thimerosal.htm.  In December 2002, the House Reform Committee revisited the link between vaccines and autism.  See Verbatim Transcript of House of Representatives Government Reform Committee Hearing, Dec. 10, 2002 available at 2002 WL 31772845 (F.D.C.H.).  Rep. Henry Waxman told Rep. Burton that Burton had “been well intentioned in [his] efforts and genuine in [his] convictions, but often [his] theories have just been wrong.”  Id.  At the same time, Rep. Waxman denounced the liability exemption in the Homeland Security Bill, reporting that it had been “cherry picked from a list of recommendations made by an expert panel that oversees the vaccine injury compensation program” and that other measures recommended by the panel such as “increasing the death benefit, doubling the statute of limitations for the program, and allowing the program to pay for family counseling” had been left out of the Bill entirely.

See Fisk, supra note 1, quoting Len Lavenda, spokesperson for Aventis.

Id.

Id. (describing the implications of a mercury level of 4.8 ppm in 8-year-old Will Redwood’s hair).  Lyn Redwood, Will’s mother, proceeded to found Safe Minds.  The group’s February 2001 Freedom of Information Act Request asked for all CDC research regarding mercury in vaccines.  A possible “smoking gun” was unearthed: CDC research initially showed that children exposed to 62.5 mcgs of mercury in vaccines in the first 3 months were 2.48 times more likely to develop autism.  The reason the report never emerged was that the epidemiological study was altered to add more children, bringing the correlation down to 1.69 times.  Id. (citing conversation with Elizabeth Prit of Chicago’s Ross & Hardies).

B. 	Thimerosal Proceedings in the Federal Court of Claims 

The peculiar difficulty with thimerosal claims is that the symptoms rarely happen immediately after vaccination.  Instead, petitioners argue, the cumulative doses function as an autism-inducing time bomb in the child.  Neither the Federal Court of Claims nor the Federal Circuit has been receptive to this argument, leading to mass dissatisfaction among thimerosal claimants in vaccine court proceedings.  
	The Federal Circuit held in Brice v. Secretary of HHS that equitable tolling is inapplicable in Vaccine Act cases.   Further, the Federal Circuit stated in Brice that "[W]e note that the statute of limitations here begins to run upon the first symptom or manifestation of the onset of injury, even if the petitioner reasonably would not have known at that time that the vaccine had caused an injury."  Thus, there is little, if any, room for cases that are “filed . . . after the expiration of 36 months after the date of the . . . first symptom . . . of such injury. . . .”  Policies frequently cited for this hostility to equitable tolling are conformance with "the limitations period is part of a detailed statutory scheme which includes other strict deadlines" and emphasis in the Act on “the importance of quick resolution of claims.”  Since the Brice decision, petitioners have proffered to the vaccine court creative arguments to overcome the effect of its strict language.  

240 F.3d 1367, 1370 (Fed.Cir. 2001), cert. denied sub nom. Brice v. Thompson, 122 S.Ct. 614 (2001) (“a statute of limitations is a condition on the waiver of sovereign immunity by the United States," and courts should be "careful not to interpret [a waiver] in a manner that would extend the waiver beyond that which Congress intended"(citations omitted)).

240 F.3d at 1373.

42 U.S.C. § 300aa-16(a)(2).

240 F.3d at 1373.

Id.

For example, in Vessels ex rel. Vessels v. Secretary of Dept. of Health and Human Services, the claimants alleged that their son Joshua Vessels suffered developmental delays and autism due to the cumulative administration of vaccines.  Joshua was born on March 3, 1997, and he began receiving vaccines at the age of two month (May 1997).  His medical records showed that, at the age of 14 months (May 1998), he had symptoms of autism including: loss of eye contact, withdrawn behavior, lack of responsiveness, and inability to react to pain.  His symptoms had to banging behavior and speech delay at 18 months (September 1998).  His parents filed their Vaccine Program petition on March 11, 2002, at which time Joshua was 5 years old.  The Vessels’s first theory challenging the stringent Brice requirement was that the statute of limitations should not start running until October 20, 1999, the day when Joshua was formally diagnosed with a developmental disorder.  In other words, until a condition is known, parents cannot determine that a child has manifested a symptom of the condition.  The special master denied equitable tolling on this argument, reasoning that the Vaccine Act requires only the occurrence of a symptom and does not require that a symptom be "defined" in order for the statute of limitations to start to run in a causation-in-fact (i.e. “off the Table”) case.  The family’s second theory that the statute of limitations could not have run because medical and scientific evidence had yet to confirm a link between autism and thimerosal was resoundingly rejected as well: “This is a breathtaking statement because it means that the statute of limitations can never run as long as there is a dispute among the medical profession over whether someone indeed has a vaccine injury.”  

2002 WL 31441210 (Fed. Cl.  Sep. 3, 2002).

2002 WL 31441210 at *5.

	A similar decision came to Destiny Lemire’s family in Lemire ex rel. Lemire v. Secretary of Dept. of Health and Human Services.  The petitioners asserted that they needed to wait until Destiny received her first MMR on January 26, 1999, in order to recognize a symptom that would trigger a claim under the Vaccine Act since "the cumulative effect of the thimerosal contained in the vaccines . . .  was incomplete up until that point."  The court responded by noting that the MMR vaccination does not contain thimerosal.   The remainder of the opinion is nearly a carbon copy of the discussion in Vessels.    

2002 WL 31441209 (Fed.Cl. Sep. 25, 2002).

Id. at *3.

For this proposition, the court cited the Institute of Medicine, Immunization Safety Review. Thimerosal-Containing Vaccines and Neurodevelopmental Disorders, at 27 (2001) ("[i]nactivated polio vaccine (IPV) and live viral vaccines, such as measles-mumps-rubella (MMR), varicella, and oral polio vaccine (OPV) do not contain, and have never contained, thimerosal (AAP, 1999; FDA, 2001)”).

Less than a month later, the opinion in Leroy v. Secretary of Dept. of Health and Human Services sent shudders though parents participating in thimerosal-related vaccine court claims.  Nicholas Leroy’s parents argued adamantly that that their claim reached beyond the scope of the Vaccine Act because their son suffers from mercury poisoning in the vaccine’s thimerosal preservative and not from any condition associated with the therapeutic components of the vaccines.  The issue was whether the Court of Claims would retain jurisdiction over the case.  Lawyers representing HHS argued that compensation has been granted to vaccinees for injuries sustained from a vaccine preservative, that thimerosal is neither an adulterant nor a contaminant under the Vaccine Act, and that the petitioners' legal position would lead to a "multiplicity of litigation"  in conflict with the Program's legislative purpose.  Applying canons of statutory interpretation as well as dictionary definitions of the terms "adulterant" and "contaminant," the court held that a preservative is an intentional ingredient, rather than an adulterant or contaminant, and, thus, the Leroy’s claims were outside of the Vaccine Act.   Policy considerations supporting the holding included the fact that the Vaccine Act contemplates streamlined litigation that first proceeds through the VICP, that the Act’s legislative history supports the same conclusion, and that there was evidence from the scientific community showing strong support for considering thimerosal a vaccine component or constituent.

2002 WL 31730680 (Fed. Cl. Oct. 11, 2002).

Grant v. Secretary of HHS, 956 F.2d 1144 (Fed. Cir. 1992).

In an illustrative display of the Court of Claims hostility to thimerosal-induced autism claims, the court rejected all of petitioner’s “creative” arguments.  2002 WL 31730680 at *12 (“Petitioners' creative argument that thimerosal’s limited role as an FDA-approved preservative nonetheless renders it not part of the vaccine is just that, creative. As with much of petitioners' arguments, no support is given and none can be found.”).

2002 WL 31730680 at *9–10.  The Vaccine Act's purpose is to ensure the vaccine safety and supply and reduce civil litigation, all while providing compensation to injured vaccinees.  Id. at *9.

The important ramifications of this decision has not been lost on subsequent Federal Court of Claims decisions or federal district courts hearing actions premised on thimerosal injury to vaccinees. 

See Stewart ex rel. Stewart v. Secretary of Health and Human Services, 2002 WL 31965743 (Fed. Cl. Dec. 30, 2002)(discussed below in Part IV addressing the Omnibus Autism Proceeding).

See Wax v. Aventis Pasteur Inc., 240 F. Supp. 2d 191, 196 (E.D.N.Y. 2002); Shadie v. Aventis Pasteur, Inc., 2003 U.S. Dist. LEXIS 4954 *8 n.2 (M.D. Pa. Mar. 31, 2003); Oxendine v. Merck & Co., 236 F. Supp. 2d 517, 521 (D. Md. 2002).

	The most recent vaccine court opinion addressing the thimerosal debate is Setnes v. Secretary of Health and Human Services.  To support the claims of A.J. Setnes and his parents that the thimerosal in the multiple vaccinations AJ received caused his autism spectrum disorder, they supplemented their petition with a medical expert report describing the frequency and mercury content of the immunizations.  However, their petition was filed seven months too late.  The court, using the same language and arguments found in Vessel and Lemire, rejected equitable tolling arguments and dismissed the Setnes petition.

2003 WL 431591 (Fed. Cl. Jan 31, 2003).

C. 	Thimerosal Tort Suit Litigation 

The Vaccine Act's alterations of state tort law were not intended to have a large impact on vaccine litigation because the bulk of vaccine injury claims were meant to be resolved within the statutory framework animating the VICP.  As Vessel, Lemire, Leroy, and Setnes demonstrate, the arguments of thimerosal petitioners were not making much headway within the administrative Compensation Program.  Not surprisingly, former asbestos and other plaintiff’s lawyers quickly an opportunity exists in autism cases.   

See generally Daniel A Cantor, Striking a Balance Between Product Liability and Product Safety: Lessons from the Vaccine Act, 44 Am. U.L. Rev. 1853 (1995), for an examination of the Act’s alterations to the civil tort system.

	In spite of the availability of the Compensation Program, dozens of lawsuits, including putative class actions, had already been filed in state courts as of late 2002.   Some plaintiffs made the determination that individual lawsuits are a better way to pursue personal injury claims than class actions.  As early as March 2002, at least three coalitions of plaintiffs’ lawyers had been established to pool resources and share information in order to litigate the thimerosal claims.  In some states, plaintiffs’ attorneys advertised on television and in print ads to find prospective clients in families with autistic children almost most attorneys had no problem attracting prospective plaintiffs.  

See Fisk, supra note 1.  As of Nov. 11, 2002, none of the suits had gone to trial, and the Homeland Security rider has delayed further the start of any trial.

See id.  As described by plaintiffs’ attorney Michael Gallagher of Houston’s Gallagher, Lewis, Downey & Kim, a “war chest” is being established as “it will take millions of dollars to litigate these cases.”  Id.  According to JAC’s lawyer, Andrew Waters, his firm is part of a separate coalition, the Mercury Vaccine Alliance, of about 35 firms working together nationally.

See id.

The plaintiffs all claim that exposure to mercury in vaccines caused autism or other neurological defects in children.  Much as in Leroy, plaintiffs’ attorneys attempt to describe thimerosal as a contaminant, and they argue that the unsafe contaminant, especially when derived from a known toxin, merits claims that do not fall within the Vaccine Act.  If accepted, their theory would take their lawsuits out of the Federal Court of Claims and put them into state courts, thus skirting the current stringent statute of limitations and capped damages in the Vaccine Compensation Program.  They would also then be free to use the full panoply of tort theories including: strict liability, breach of express warranty, breach of implied warranty, intentional infliction of emotional distress, fraud, claims for medical expenses, and negligence in manufacture, marketing, and/or sale of mercury-containing products.  As compensation, plaintiffs want both medical monitoring and recovery for their children’s injuries.  It goes without saying that the jury appeal in these cases would be unparalleled. 

Not all autistic children are potential plaintiffs.  If a child is born with autism, she would not be able to make these arguments.  A “regressive” or traceable vaccine-induced effect is required.  With this in mind, some plaintiffs’ lawyers estimate that the potential number of plaintiffs is still quite large—perhaps ^1/_3 to ^1/_2 of autistic children born in the 1990s can trace their neurological defects to mercury exposure.  See id. (quoting Andrew Waters).

See Fisk, supra note 1.

Of course, while in effect, the vaccine rider to the Homeland Security Act would eliminate this possibility.

See Julie Kay, National Lawyer Network Gears up for Mercury Litigation, Miami Daily Business Review, April 29, 2002; see also Shannon P. Duffy, Vaccination Suit is State Court Case, The Legal Intelligencer, Aug. 20, 2002

	Defendants in the mass tort suits include the vaccine makers American Home Products Corp., Aventis Pasteur Inc., Merck & Co., Wyeth-Ayerst Laboratories, and GlaxoSmithKline, as well as the producers of thimerosal, including Uriah Corp. and Emerck.  Defendants could also include pediatricians who administered the vaccines.  Chief on some plaintiffs’ lists is Eli Lilly & Co, the company that invented thimerosal and promoted its use as a preservative.  The defendants, and primarily Eli Lilly, have argued that as a vaccine component, thimerosal ought to be included in the existing vaccine program.  Eli Lilly accuses plaintiffs lawyers of taking advantage of a loophole in the statute that was unintended by Congress and believes that characterizing thimerosal as an additive rather than an actual vaccine draws too fine a line.   

See id.  Miami lawyer Louis Robes has named as a defendant Dr. Federico Martinez, the pediatrician of Justin Edoo, a five-year-old boy who first exhibited symptoms of autism six months after his last vaccination.  See id.  Robes’s tactics may not be representative of the plaintiff class, however, as he has also named Florida Power & Light as a defendant for exacerbating Justin’s condition when it released mercury-containing emissions into the air.  See id.

See Fisk, supra note 1 (citing Andrew Waters).

With or without a specially-crafted amendment.

Thus far, the litigation has been highly complex and the results have been  inconsistent.  The remainder of this section comprises a summary of key rulings from the past year.

For a general discussion of preemption doctrine in relation to the Vaccine Act see Cantor, supra note 129.

At least two courts have dealt severe blows to plaintiffs’ claims by ruling that the Vaccine Act creates a preemptive 3-year statute of limitations even for state law tort actions.  Both courts ruled that the law allows suits on vaccines administered after October 1, 1988, only if the claims were first decided under the program.  The Vaccine Act made no exceptions, according to the courts.  For claims governed by holding, if the claim cannot be heard under the vaccine program because the 3-year statute of limitations has expired, a tort suit can never be brought.    

Strauss v. American Home Products Corp., 208 F. Supp. 2d 711 (S.D. Texas 2002); McDonald v. Lederle Technologies, 341 N.J. Super 369 (N.J. Super. Ct. App. Div. 2001).

See also Dickey v. Connaught Laboratories, supra Part II.

Going one step beyond having a state civil court hear their claims, thimerosal plaintiffs’ attorneys have thus far unsuccessfully attempted to gain access to federal district courts.  Soon after defense lawyers removed one thimerosal case to federal court, a Senior U.S. District judge in the Eastern District of Pennsylvania requested sua sponte briefs on the question of jurisdiction.  The federal court then ruled that the Vaccine Act does not create federal question jurisdiction.  Senior U.S. Judge Norma L. Shapiro also rejected defendants’ arguments that the plaintiffs had added “sham” Pennsylvania defendants for purposes of defeating diversity jurisdiction.  The court also held that the defendants’ fraudulent joinder argument did nothing more than identify a legal issue.  

See Duffy, supra note 136.

Cheskiewicz v. Aventis Pasteur Inc. 2002 U.S. Dist. LEXIS 15339 (E.D. Pa.).

The plaintiffs in Garcia v. Aventis Pasteur, Inc. were also remanded to state court.  In Garcia, the plaintiffs’ main argument was that the Vaccine Act completely preempted state court jurisdiction.  The federal district court for the District of Oregon disagreed, holding that: (1) preemption was a defense and, therefore, did not authorize removal to federal court; and (2) because it was unclear whether plaintiffs' state law claims fell within the scope of the Vaccine Act, the Act could not completely preempt state jurisdiction over the case. The court also held that it lacked diversity jurisdiction, reasoning (1) the sham defendants were disregarded for diversity jurisdiction purposes; (2) the medical practitioner defendants were not fraudulently joined where the plaintiffs' complaint designated a plaintiff class of more than 30 million children against the defendant class made up of thousands of health care providers; and (3) the plaintiffs' claims were not obviously at odds with settled state law. 

2002 U.S. Dist. LEXIS 15122 (W.D. Wash.).

While disagreeing with Eastern District of Pennsylvania Judge Shapiro on the effects of complete diversity on joinder, a Maryland district court nonetheless held that removal was improper in a case where the plaintiffs had properly joined two state power companies as defendants. 

See, e.g., Oxedine v. Merck & Co., 236 F. Supp. 2d 517 (D. Md. 2002).

Plaintiffs were also remanded to state court when the federal question was found not substantial in King v. Aventis Pasteur Inc., the case of a separate medical monitoring class action for plaintiffs who have been exposed to mercury in thimerosal but are not symptomatic.  

210 F. Supp. 2d 1201 (D. Or. 2002).

Alternatively, at least one plaintiff has asked for and been remanded back to state court.

See, e.g., Shadie v. Aventis Pasteur, Inc., 2003 U.S. Dist. LEXIS 4954 (M.D. Pa.).

While not permanent, the added Homeland Security Act were provisions were an unpleasant surprise to the thousands of parents with disabled children who had pressed these and other claims against thimerosal defendants.  The extent of the litigation underscores the unexpectedness with which the rider was received. 

 

IV. 	The Omnibus Autism Proceeding

	A. 	Conversations with Legislators

Two key lawmakers of both parties have taken some first steps in crafting a more transparent legislative solution to the contentious autism debate.  By conferring with the U.S. Court of Federal Claims chief judge, they initiated an unusual move in reaching out to the judicial branch for advice.   The Chief Judge is Edward Damich, a former aide to Senator Orrin Hatch.  Gary Golkiewicz, the court’s chief special master, also participated in the discussions. 
In December 2002, staff members of Senators Bill Frist and Ted Kennedy met with aides to explain the functioning of the Vaccine Program.   Of key importance to the staffers, and by implication the senators, were three issues: (1) causation, (2) the statute of limitations, and (3) the workload of the special masters.  Damich and Golkiewicz were careful to limit their comments to how potential changes in the law could impact the vaccine compensation program and “did not make any recommendations either way.”^,   They say they provided factual information to questions such as “If you change a certain provision, what impact will it have?” and “If you change the statute of limitations from three to six years, what’s the impact on the court in terms of caseload?”  Given that both political parties were involved, some anti-thimerosal activists are not too concerned by the contacts.  One acknowledged “the utility of asking those in the trenches about the flaws in the system.” 

See Groner, supra note 9.

Id.

While these consultations between judges and members of Congress are highly unusual, the contacts do not appear to raise legal ethics concerns.  Judges are permitted to consult with a legislative official “on matters concerning the law, the legal system, and the administration of justice to the extent that it would generally be perceived that a judge’s judicial experience provides special expertise in the area.” Id. (quoting Stephen Gillers, ethics expert and professor at the New York University School of Law); see also ABA Model Code of Judicial Conduct, Canon 4(b).  Canon 4(b) seems to encourage such activities only at public hearings, but the Comment recommends a broader policy of encouraging judicial dedication to improvement of the law.  It is assumed that neither Chief Judge Damich nor Special Master Golkiewicz discussed pending cases.

See Groner, supra note 9.

Id. (quoting Barbara Loe Fisher, co-founder and president of the Vienna, Virginia-based National Vaccine Information Center).

	To date, the advice of the judge and the special master has not been incorporated into any enacted bill.  However, as will be discussed in Part V, the proposed National Vaccine Injury Compensation Program Improvement Act of 2003 could introduce welcome change into the VICP system.  More immediately, the Court of Federal Claims has produced an evidentiary solution to address the most vexing problem in VICP thimerosal claims and has deemed the procedure the “Omnibus Autism Proceeding.” 

	B. 	Overview of the Proceeding   

	As of December 2002, nearly 1,300 autism spectrum cases were filed at the vaccine court, and thousands more filings were anticipated.  In response to increasing pressure by thimerosal activists and representatives of claimants in the vaccine court, the Federal Court of Claims issued a procedural reform in July 2002.   To resolve promptly and fairly the numerous claims alleging that vaccinations caused autism disorders, the vaccine court established this procedure to produce a uniform evidentiary record addressing causation; the causation determination’s primary role will be in its consistent application to individual claims of mercury-related injury.   

Stewart ex rel. Stewart v. Secretary of Health and Human Services, 2002 WL 31965743 at *1 (Fed. Cl. Dec. 30, 2002).

“There is an epidemic of children with autism and learning disabilities. . . . The existing vaccine program simply is not set up to handle them.”  Id. (quoting Lyn Redwood, a parent activist in Atlanta and president of Safe Minds, a group dedicated to eliminating mercury compounds).

In re Claims for Vaccine Injuries Resulting in Autism Spectrum Disorder or a Similar Neurodevelopmental Disorder, 2002 WL 31696785 (Fed.Cl. Jul 3, 2002). [hereinafter “General Order 1”]  Documents filed in the Omnibus Autism Proceeding are contained in a special file kept by the Clerk the Federal Court of Claims, known as the "Master Autism File." The contents of the file are also available at the court's website: http://www.uscfc.uscourts.gov/OSM/AutismDocket.htm.

The development of General Order 1 is described by Special Master Hastings in Stewart, supra note 153, at *1.

To tackle the recurring common factual issue of whether certain vaccinations can cause autism, the Office of Special Masters (“OSM”) began with informal meetings.  At the conferences were both attorneys representing autism petitioners and counsel for respondent, which consist of Department of Justice (“DOJ”) lawyers appearing on behalf of the Secretary of HHS.  During these assemblies, it was the petitioners' representatives who proposed an innovative procedure the OSM could employ to administer the mounting autism claims as a group. 

Petitioners have alleged the disorders are linked to the thimerosal ingredient in one or a combination of the following vaccinations: diphtheria-tetanus-pertussis ("DTP"), diphtheria-tetanus-acellar pertussis ("DTP"), hepatitis type B, and hemophilus influenza type B ("HIB") vaccinations.  See General Order 1, supra note 156, at *5.

The proposal consisted of a two-step procedure.  In the first step, the OSM would address the general causation issue of these cases, namely whether the vaccinations can cause autism spectrum disorders, and, if so, in what circumstances.  In the second step, the OSM would apply the outcome of the first step, the general inquiry, to the individual thimerosal cases.  Also included in the proposal was the selection of a team of petitioners’ representatives to stand in for the interests of the autism claimants during the administration of the general inquiry into causation.   In addition, the proceeding was designed to start with an extensive discovery period to develop the general causation issue.  A designation of experts for each side would come later.  The next proposed step was an evidentiary hearing.  Subsequent to the hearing, a special master would rule on the general causation issue.   Lastly, the general causation conclusions, the bounty of the lengthy general inquiry, could be applied to the individual cases, leading to fairness and conformity in application that had lacked tribunals previously addressing causation.

See 2002 WL 31965743 at *1.

At the behest of the petitioners’ counsel and their well-crafted proposal, the OSM adopted the same general format (but not all suggestions in their entirety) in its new autism procedure.  The Chief Special Master Golkiewicz, acting on behalf of the OSM, issued Autism General Order # 1, which formally created the proceeding known as the Omnibus Autism Proceeding ("the Proceeding").  In the Proceeding, attorneys representing petitioners selected a group of counsel from the autism cases, and they are now in the process of obtaining and presenting evidence concerning the general issue of whether vaccines containing thimerosal can cause autism.  As proposed in meetings with the OSM, the results will then apply to the individual claims.
  General Order 1 also sets out an “Autism Master Schedule” for discovery, which limits the discovery period to 410 days, lists a hearing date, and builds in sufficient time to decide the causation issues within a 2-year period.  All persons with pending petitions or prospective claims are invited to opt into, or out of, the Omnibus Autism Proceeding at their discretion.  The General Order concludes with a Master Petition for Vaccine for Vaccine Compensation as well as a Short-Form Petition for persons with autism-related claims for which they have not yet filed Program petitions.   

See General Order 1, supra note 156, at **4–5.

Id. at *5.  However, given the line of Federal Court of Claims precedent regarding thimerosal claims, most petitioners can be expected to opt in.

Id. at *7–8.

Id. at *8.

The OSM also is obligated to keep interested claimants or their counsel informed of developments in the proceeding.  

Id. at *6.

	C. 	Challenges and Updates from the Special Master   

Delivering on its promise to keep petitioners updated as to the progress of the Omnibus Autism Proceeding, the “Special Masters” section of the Court of Federal Claim’s website provides reports as to the status of the program. 
Perhaps the most contentious development in the procedure is the Respondent’s Motion for Protective Order filed in November 2002 to limit the use of all discovery material produced by the respondent solely to the autism action.  In conjunction with Senators Herb Kohl and Debbie Stabenow, Senator Patrick Leahy wrote a letter protesting the order.  They criticized the protective order, saying that “[t]he timing, scope and justification of this troubling action [] will throw a cloak of secrecy over government information that many American families would like to see . . . .”  The Special Order was also extraordinarily broad, requesting concealment of all oral, e-mail, transcript, graphic, or other written or electronically stored information provided by HHS, in both the past and the future that was connected to the Proceeding.  Children with autism and their families, arguably the people most interested in the material, would not have access to it.  Alternatively, as characterized by Senator Leahy, the protective order was meant to frustrate plaintiffs’ lawyers seeking damages in the proliferating civil suits against pharmaceutical companies.    Earlier in December, Rep. Burton appealed to Attorney General Ashcroft to allow the proceedings to be open to public scrutiny and in a separate letter he requested that the government withdraw the protective order.  On December 27, the government withdrew its motion, citing recent decisions by the special master to compel discovery of documents that made its order moot. 

Respondent HHS, Motion for Protective Order (Nov. 19, 2002), available at http://www.uscfc.uscourts.gov/OSM/AutismDocket.htm

Letter from U.S. Sen. Patrick Leahy to John D. Ashcroft, Attorney General of the U.S., and Tommy G. Thompson, Secretary of HHS (Dec. 9, 2002), available at http://leahy.senate.gov/press/200212/121102.html.

Id.  The Senators also point out that the government’s motion seeking the protective order was filed on November 19, 2002, which is the same day that the Homeland Security Bill passed the Senate.  The implication is that there is was coordination in funneling all thimerosal-related civil claims to the Vaccine Compensation Program while at the same time requesting that all information produced regarding any causal effect remain in the vaccine courts.

See Committee on Government Reform, Burton Seeks Openness In Federal Vaccine Autism Proceedings (Dec. 6, 2002), available at http://www.house.gov/reform/pr.02.12.06.htm. ("The interest of the Federal government should not be to protect any particular party in this matter. The interest of the Federal government should be to find the truth and lay it out for all to see.”).

HHS had stated it would not voluntarily produce discovery material unless the protective order was entered.

	Without further elaboration, another November motion recognized that the ruling in Leroy v. HHS is “relevant” to the autism cases, and a copy of the decision was placed in the Autism Master File.   

Filed by Special Master George Hastings, Ruling by the Chief Special Master in Leroy v. Secretary of HHS 1 (Nov. 22, 2002), available at http://www.uscfc.uscourts.gov/OSM/AutismDocket.htm.

	Use of the short-form “opt-in” petition in the Proceedings was also challenged, and in late December 2002, the procedure was upheld in Stewart ex rel. Stewart v. Secretary of Health and Human Services.  In order to comply with General Order 1, claimants filing a short-form petition must allege autism injury caused by thimerosal-containing vaccines, request compensation from the VICP, not have a pending civil action for the same injury, have a previous award or settlement for same injury, and satisfy other jurisdictional issues (e.g., the 36-month Vaccine Act statute of limitations).  Noticeably absent from the simple short-form petition is any required submission of medical records.  As of November 30, 2002, more than 1100 short-form petitions or very similar petitions had been filed.

2002 WL 31965743 (Fed. Cl. Dec. 30, 2002)

Cf. 42 U.S.C. §§ 300aa-11(c).

2002 WL 31965743 at 3.

	The issue in Stewart was whether the short form petitions needed to include medical records.  During the conferences held to establish the Proceeding, respondent HHS’s representatives indicated that they could not agree to the part of the petitioners' proposal that allowed the filing of a short-form petition unaccompanied by medical records, as is required in Vaccine Act § 300aa-11(c).  General Order 1 noted this concern.  The OSM proceeded to analyze the matter in detail in a document (“the Discussion”) filed less than a week after General Order 1 took effect.  In the Discussion, the Chief Special Master acknowledged that the respondent was raising serious and important concerns, but, considering all the circumstances, concluded that it was appropriate to permit use of the short-form petitions.  

General Order 1, supra note 156, at 7 n.4.

Chief Special Master Gary J. Golkiewicz, Discussion of Issue of "Short-Form" Petitions (July 8, 2002), available at http://www.uscfc.uscourts.gov/OSM/AutismDocket.htm. [hereinafter “Discussion”]

Id. at 2–4.

In Stewart, HHS reopened the issue and argued that the Vaccine Act not only requires petitioners to submit medical records, but also that they should be submitted as soon as possible so that lawyers could evaluate statute of limitations issues and begin medical review of the claims.

2002 WL 31965743 at 3.

The special master hearing the case stressed that in the 14-year history of the Program, failure to file all of the relevant medical records with a petition has never been considered reason to dismiss the petition; moreover, each presiding special master in each Program case uses his or her discretion to regulate procedures in order to further the goals of the Program.  Special Master Hastings agreed with the conclusion reached in the short-form Discussion, holding that it is appropriate to allow the autism petitions to be filed in short-form and to permit the filing of medical records in these cases to be deferred pending the completion of the Omnibus Autism Proceeding.

Id. at 5; see also 42 U.S.C. § 300aa-12(3)(B).

2002 WL 31965743 at 8.  Special Master Hastings did suggest an alternative tactic that DOJ lawyers may employ in the future: 

Perhaps what respondent's counsel actually wish me to do in this case--and in all of the autism cases involving short-form petitions or similar petitions--is not to dismiss the petition, but to order the petitioner to supplement the petition at this time with a detailed statement concerning the vaccinee’s condition and copies of all related medical records. If that is actually what respondent seeks, then that request would strike me as a more reasonable request than respondent's stated assertion that I should dismiss the petition.

Id.

	Acting on Hastings’s cue in the Stewart case, respondent in the Proceeding recently filed a “Motion for Appropriate Relief” in each of the autism cases in which the petitioner utilized the short-form petition.  The motions all request that Special Master Hastings rule that the 240-day time goal prescribed for resolution of a NVICP claim not begin to run until the petitioner has filed all the records set forth at 42 U.S.C. § 300aa-11(c)(2).  Special Master George Hastings, who also wrote the original decision in Stewart, indicated in his latest update to the Autism Master File that he will “fully consider” the ruling in the Stewart case and then determine whether to apply the ruling to these other short-form petition cases after receiving briefs from the parties, which are due May 19, 2002.  While this proposal seems to be a concession from the respondents in the form of equitable tolling, the Proceeding as designed already provides this benefit for autism petitioners by waiting until the end of the general causation phase before any individual determination of compensation can begin.  In effect, respondent’s 240-day proposal could disadvantage anyone who has included the full panoply of medical records with her short-form petition by making such claims run early.  Even worse, there is the possibility that once the general causation inquiry ends, there will an immediate flood of medical records to the vaccine courts from petitioners who waited to take advantage of the full 240 day time period.  While it is conceded that respondents’ lawyers will need to receive medical records in a timely manner to prepare for its cases, there seem to be much more efficient and orderly ways of collecting this information than the procedure outlined in these latest motions.

See supra note 179.

Special Master George Hastings, Autism Update and Order 3 (May 9, 2003), available at http://www.uscfc.uscourts.gov/OSM/AutismDocket.htm.

42 U.S.C. § 300aa-12(d)(3)(A)(ii).

Id.

Discovery on a very large scale is underway in the Omnibus Autism Proceeding.  There are both interrogatories and requests for production pending.  Attorneys from the Department of Justice are working with the various components of HHS including the FDA, the National Institutes of Health (“NIH”), and the Centers for Disease Control and Prevention (“CDC”).  Some documents have already provided.  Many DOJ lawyers are occupied identifying, assembling, and reviewing documents, as well as considering what privileges should apply in this situation.  The DOJ attorneys also continue to work with petitioners’ counsel to find an acceptable resolution to the issues that have proved to be somewhat thornier than others (e.g., the production of materials relating to ongoing and proposed studies).

See Respondent's report on the status of his Response to Petitioners' Interrogatories and Request for the Production of Documents (Sep. 3, 2002); see also Special Master George Hastings, Autism Status Reports (Sep. 5, 2002; Sep. 25, 2002; Oct. 11 2002; Nov. 18, 2002; Dec. 26, 2002; Jan. 14, 2003; Fed. 26, 2003, Apr. 2, 2003; May 9, 2003), all available at http://www.uscfc.uscourts.gov/OSM/AutismDocket.htm.

The latest update to the Master Autism File also reports that the Petitioners’ Steering Committee has obtained separate office space for documents produced during discovery.  The update summarizes the recent new developments in the discovery phase of the Proceeding.  Submitting large batches of materials, respondents have complied with petitioners’ Requests for Production in all but two areas: (1) vaccine license applications, and (2) ongoing and proposed studies.  As mentioned above, in the second area petitioners and respondents are collaborating on an amicable solution.  Because the first round of discovery has taken longer than originally anticipated, the second round of discovery, which has yet to begin, will be shortened by 30 days to keep the Proceeding on track with its projected schedule.  Lastly, the update commends both sets of lawyers for their cooperation and good faith to date.  

See Autism Update and Order, supra note 181, at 1.

This is due to cumbersome procedures required for disclosure of information submitted by vaccine makers during the licensing process.  Id. at 2.

See id. at 2–3.

V. 	Conclusions: Implications of the Thimerosal Dispute

A.	Where Thimerosal Claims Now Stand 

Congress enacted the Vaccine Compensation Program for the twin purposes of (1) reducing tort litigation against vaccine manufacturers and administrators, along with (2) compensating individuals harmed by vaccinations.  Evaluating the progress of thimerosal claims since early 2002 under this standard leads to rather bleak realizations.  Admitting the causation issue remains undetermined, compensation has long eluded any families who do have meritorious claims.  As for the manufacturers, the failures of the administrative vaccine courts to dignify the possibility that autism might be linked to thimerosal only served to spur class action litigation.  Faced with a massive assault in the nation’s courts, it is not surprising that vaccine manufacturers sought an alternative forum to address their grievance.  What is surprising and disappointing is the devious path most legislative and administrative reforms have followed. 
	Possibly the most disturbing theme throughout the past year is the lack of transparency in measures designed to affect (or eliminate) thimerosal claims.  Prior to passage of the Homeland Security Act and Leroy, it was unclear whether injury or death from any substance intentionally added to a vaccine would be considered “vaccine-related” thereby falling within the jurisdiction of the Vaccine Act.  Section 1716 of the Homeland Security Act resolved this inquiry wholly in favor of the manufacturers: injury from any component or ingredient (i.e. thimerosal) listed in vaccine’s product license application and product label was determined to fall within the statute, and, thus, was funneled into the caseload of the Vaccine Compensation Program.  This benefited the manufacturers in several ways.  First, it laid the burden of administrative expense and increased need for litigation resources at the foot of HHS and DOJ; instead of depending solely on very costly private legal counsel, the companies could in large part sit back and watch the government make their arguments for them.  Second, the claims that were filed against manufacturers in civil courts faced even greater restrictions as to what legal arguments they could make, giving the manufacturers a substantial initial advantage.  
	It is no wonder that inclusion of these measures in the Homeland Security Act has been so controversial.  Congress has promised to repeal such amendments, and this is welcome news.  However, without these measures, claimants are again left to fight an uphill battle fraught with perhaps greater uncertainty.  The position that DOJ attorneys will take in future claims resolution is not much altered by a repeal.  They will argue that the Vaccine Act should be applied & administered as if the repealed sections had never been enacted.  Perhaps more importantly, Leroy v. HHS, the government’s most sweeping win to date, remains valid precedent in the vaccine court.  Leroy’s rule is precisely the same as the defunct vaccine-liability sections of the Homeland Security Act provision.
	So, what is the likely impact of repeal?  Given that HHS will most likely stick to the aforementioned strategy, it is unlikely to affect claims within the VICP, especially given Leroy’s placement in the Autism Master File and the development of the alternative massive causation Proceeding.  The most salient effect will be an even greater potential for ongoing civil litigation.  Thus, the decision as to whether thimerosal is separable from vaccines for liability purposes will not come from a statute but from ad hoc trial court decisions.  
Even worse, the disposition of pending and future civil actions is very unclear.  After passage of the Homeland Security Act, no actions were dismissed citing the rider.  This was probably an effect of the firestorm it created and the quick assurances the rider would be repealed, rather than any lack of effort on the part of defendant-companies to attempt to use it to their advantage.  Leroy is not binding precedent on the trial courts across the United States, meaning it is likely that not all courts will find its outcome and policy justifications persuasive. However, it would be incorrect to think Congress has washed its hands of the liability provisions.  It is quite possible that they will be reintroduced into a more comprehensive bill affecting operation of the VICP.
 	Whatever the result of repeal and re-passage, the initial inclusion of the rider has deepened suspicions of an unsavory alliance between pharmaceutical manufacturers and government actors.  Although the purposes of the Vaccine Acts have always been to encourage and protect manufacturers, the clandestine obliteration of the second balancing principle, compensation, damaged whatever fairness remains in the compensation system.  Moreover, this deepening suspicion should not end with the Homeland Security Act.  Any close observer of the progression of the vaccine court and the Omnibus Autism Proceeding would notice the extreme adversarial character the Proceeding has adopted.  
	In the vaccine court, HHS’s public position is not that claims alleging thimerosal as a cause of injury are exempt from liability, but rather that these claims must be pursued initially through the VICP as vaccine-related injuries.  But once the line of entirely unfavorable thimerosal precedent is added to the Leroy holding, claimants opting out of the Omnibus Vaccine Proceeding face a brick wall.  No doubt petitioners’ attorneys also realized this when they pushed for the mass causation determination.  In effect, manufacturers are exempted from liability in the VICP.  After all the controversy, it is at best uncomfortable to watch DOJ lawyers, representing HHS, defend the proposition that claims against thimerosal manufacturers should be exempted from liability.  
HHS has pursued this stance consistently during the Omnibus Autism Proceeding, leading many of the common adversarial criticisms of the VICP to also apply to the current Proceeding.  For example, the protective order sought by the government and its concurrent position that it would not produce documents without the OSM granting the order was thoroughly out of place in that collaborative setting.  It is also difficult to understand the benefit of secrecy in the materials produced during the causation discovery, other than to protect the pharmaceutical companies (and perhaps the government) as defendants in civil actions.  The remaining discovery disputes over vaccine applications and the ongoing and proposed studies seem to leave the same bad taste of concealment and delay.    
Has the government protection of drug manufacturers gone too far?  With mounting litigation in the civil courts, the policy behind the Vaccine Act policy has always been to support manufacturers so that they will continue to produce vaccines.  Thus, it has been proper strike a bargain with pharmaceutical companies: they continue to produce vaccines and pay to defend civil lawsuits, receiving in return the efforts of DOJ lawyers in the vaccine courts and substantial limitations as to plaintiffs’ legal claims.  However, thimerosal plaintiffs with valid claims simply do not fit well into this scheme. They suffer injuries not because of the unavoidable danger of illness or adverse reaction to the therapeutic aspects of a vaccine, but instead because it was more convenient and less expensive for manufacturers to produce multidose vials.  The government cannot be faulted for requiring additional vaccines in the later 1990s, because these are important public health measures.  However, a slew of manufacturers all using the same preservative with the toxic substance mercury could have anticipated some of the risk.  
Thousands of claims later, the Proceeding’s causation determination comprises the entire ball game, and it will be difficult for the OSM to prevent the escalation of adversarial activities.  And there is no reliable way to predict what will happen with the tort claims.  Even if the manufacturers lose the causation determination and succeed in obtaining another thimerosal rider, “[t]hey may be off the hook financially but they are not off the hook morally.” 

The Mercury Project, Consumer Groups Call On Drug Makers, Congress and the White House to Stop Thimerosal Use - Especially in Infants and Pregnant Women, Jan. 8, 2003, available at http://www.909shot.com/PressReleases/pr10803mercury.htm. (quoting Barbara Loe Fisher, Co-founder & President, National Vaccine Information Center).

B.	The Future of Thimerosal Claims 

Senator Bill Frist is set on both dealing with the thimerosal cases and revamping the Vaccine Injury Compensation Program.  H.R. 1349, the proposed National Vaccine Injury Compensation Program Improvement Act of 2003, does not provide any more guidance than its identical predecessor which failed to pass in the 107th Congress.  Proposals that could affect thimerosal litigation include: extending the Vaccine Act to claims for equitable relief, removing the $ 1000 requirement for claims, prohibiting awards in civil actions for medical monitoring claims (requiring proof of physical injury), increasing the award in the case of a vaccine-related death to $ 300,000, paying for family counseling expenses, a streamlined procedure for paying attorneys’ fees, and extension of the statue of limitation to 6 years.  For injured children with thimerosal claims, the benefit of any of these improvements is null if the Omnibus Proceeding reaches a negative causation determination.  For example, having an additional 3 years to file a petition is unhelpful if the vaccine court is unwilling to believe the claimant has a credible argument.  A spokesperson for Senator Frist said that the senator still remains undecided about what to do on the statute of limitations issue. 

See Groner, supra note 9.

See Groner, supra note 9.

	If autistic children are unable to recover money from the VICP or civil courts, should they pursue equitable solutions, i.e., such as requiring all manufacturers to produce mercury-free vaccines?   No, because this is probably a moot point today, as thimerosal has been virtually eliminated from vaccines distributed in the United States today.  Although, because there was no recall, there remain some vials of vaccines containing thimerosal that were purchased before manufacturers voluntarily phased-out the additive.  However, thimerosal is still present in some over-the-counter products and is used in flu shots for adults, including pregnant women. 

See CBER, Thimerosal in Vaccines: Frequently Asked Questions (Dec. 13, 2002), available at http://www.fda.gov/cber/vaccine/thimfaq.htm#q5 .  In response to the question “What progress has been made towards the goal of eliminating thimerosal from vaccines?” CBER posts: 

. . . [A]s of March 2000, all U.S children had access to hepatitis B vaccines that are free of thimerosal as a preservative. All Haemophilus influenzae type b (Hib) vaccines currently distributed in the U.S. do not contain thimerosal. With the March 2001 approval of a second diphtheria and tetanus toxoid and pertussis vaccine (DTaP) that does not contain thimerosal as a preservative (Aventis Pasteur’s Tripedia, trace thimerosal), all DTaP vaccines currently being produced in the U.S. are either thimerosal free or contain greatly reduced amounts (less than 0.5 micrograms of mercury per vaccine dose.)

Id.

Many of these vaccines were donated to poorer countries, the ethics of which merits its own research paper.

See Kay, supra note 119.

For families provably devastated by the introduction of thimerosal and autism into their children’s lives, there is comfort knowing that the additive has been removed.  However, they still suffer greatly.  Whether these children can or will receive compensation will be answered in large part by resolution of the general causation inquiry in the Omnibus Autism Proceeding.  For now, the future remains of thimerosal litigation remains wildly unpredictable.