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The Mammography Quality Standards Act: Misread Mammograms, Malpractice, and The Politics of Regulation

Celeste Daise Wheeler

Class of 2003

Submitted in fulfillment of the third-year written work requirement/course requirement

April 2003

Abstract: Recent studies and reports suggest that the MQSA has not been successful at improving physician interpretation of mammograms. This paper argues that in order to assess the impact of the MQSA accurately, one must look beyond its symbolic and cultural importance, both as an important women’s health achievement and as a tool in the struggle to encourage more women to be screened for breast cancer. Once this is done, it becomes apparent that many of the current problems with mammography reflect deeply rooted historical problems with the delivery of health care and the regulation of medicine. To that end, this paper looks at the response of health care systems in general to the introduction of standards and looks at representative malpractice cases to illustrate where the MQSA succeeds and where it runs into difficulties because of greater problems with the health care system. It acknowledges that the technological limitations of mammography techniques may be contributing to the physician interpretation problem. However, in the end, it suggests that perhaps the answer to current difficulties with mammography is not to create more mammography-specific rules, but to re-examine these other, more fundamental problems that plague health care.

I. Introduction

In 1992, Congress passed the Mammography Quality Standards Act (“MQSA”),[1] thereby seizing control of an industry that had been burdened by controversy long before a 1990 news report by NBC TV News [2] revealed the many problems contributing to a system-wide epidemic of substandard diagnosis and treatment of women with breast cancer. The Act was unprecedented in the scope of power it gave the Food and Drug Administration over the regulation of a medical device and the regulation of a medical process. Proponents of the Act heralded it as the beginning of a new era in mammography practice. No longer would women go to a doctor and receive a poor quality mammogram that would subject them to invasive and unnecessary medical procedures or miss a cancer that threatened to end their lives. However, in 2002, the New York Times [3] ran a series of articles criticizing the Act and questioning whether or not the regulations had been effective. It cited doctor failures as the real source of substandard mammography, thus creating even greater doubts about the effectiveness of screening of mammography and by implication, the regulations, that women had been told to trust for well over a decade.

This paper does not seek to resolve the question of the effectiveness or importance of screening mammography. While this dilemma will be discussed, it is an issue on which even the best scientific and medical experts disagree. Instead, this paper looks critically at the MQSA’s quality assurance provisions, specifically the regulations dealing with the regulation of physicians, and posits that the Act’s current failures have their origins in the initial history of the MQSA because lawmakers set out not just to resolve mammography-specific problems, but also to address physician failures that are deeply rooted in larger problems with the health care system. It argues that the Act has significant symbolic power both because of its place in the history of women’s health [4] and because of its role in the drive to arm women with more information about breast cancer prevention. This symbolic significance often obscures the ways in which many of the remaining failures of the MQSA are problems that are not just specific to mammography, but endemic to the health care system in general.

The purpose of this paper is not to argue that the MQSA has had no real effects on the health of women or on the rates of breast cancer diagnosis and cure. Despite the problems that may be associated with mammography and the Mammography Quality Standards Act, the Act itself has had some tangible positive effects, especially on the quality of mammography images produced. Instead, it seeks to highlight the importance of the symbolic significance of the Act in order to have a real discussion of the ways in which the Act has failed (or has been limited). Once the symbolic power of the MQSA is acknowledged, the question then becomes whether or not these problems should be addressed by further mammography-specific regulations or if mammography would be better served by setting aside its symbolic significance and focusing on greater system-wide efforts to improve health care.

To this end, after providing a brief background on mammography and the Act itself, Section II of the paper will discuss the history leading up to the passage of the Act. It will discuss the regulations which, contrary to what one might believe from some of the literature, were already in place in some states and discuss why the then-existing systems of accountability were insufficient both as a practical, medical matter, and as a symbolic matter. It will also highlight the powerful political coalitions that formed in order to bring passage of the Act to fruition. Section III will show how the MQSA has assumed cultural importance and how this importance gives regulators and many in the medical community incentives to downplay the problems with associated with the MQSA in order to encourage women to undergo breast cancer screening.

Sections IV and V together discuss the issue of doctor competency that has been largely cited in the media as the biggest remaining problem with the MQSA. They look critically at what the Act provides and what it seems to have accomplished. Section IV attempts to place the discussion of the high rates of malpractices suits in the area of mammography in the context of larger problems associated with the standardization of medical care. It posits that soaring malpractice rates do not reflect just problems unique to mammography, but are instead indicative of larger difficulties that arise when the health care community attempts to create greater uniformity of medical care. It examines representative cases occurring both before and after the enactment of the MQSA in order to provide a window into the types of issues that the MQSA has been successful in resolving and those that are more difficult because they reach larger questions about health care. Section IV ends by acknowledging the role that technological limitations may play in the misdiagnosis of breast cancer. Finally, Section V argues that even if doctor failures are the greatest remaining source of mammography ineffectiveness, as the medical malpractice cases and recent studies may suggest, the Food and Drug Administration is limited in its ability to control the practice of medicine. The issue of how to ensure that physicians possess the requisite skill to treat their patients is one that has troubled regulators since the professionalization of medicine.

The paper will then conclude with some reflections on the implications of the malpractice rate and the challenges of regulating the practice of medicine in the context of mammography. It will suggest that the commonalities between the failures of the MQSA and the failures of the larger health care system lead one to take a critical look at what current expenditures on mammography have accomplished and to conclude that perhaps the answer is not just to devote more regulatory resources to mammography. Instead, careful lines need to be drawn and more intensive regulations should be crafted only in those areas of mammography plagued by problems that are truly unique and different from the challenges that plague the health care system in general. Other, more systematic problems could and should be addressed by system-wide solutions. If this is done, additional regulatory resources can be used to support other efforts in the fight against breast cancer.

II. Background on Mammography and the History Leading to the Passage of the MQSA

A. Breast Cancer Statistics and Background on Mammograms

The statistics on the rates of breast cancer occurrence and death are startling. Experts estimate that 211, 300 new cases of invasive breast cancer will occur in the United States during 2003. In addition, 55, 700 new cases of in situ breast cancer are expected to occur among women during the same time period. Breast cancer is the second leading cause of cancer death among women. 40, 200 people (39, 800 women and 400 men) are expected to die from the disease in 2003. [5] Clearly, this is a disease that has a devastating impact upon the lives of many women and their families and imposes serious costs on the health care system.

There are numerous factors associated with an increased risk of breast cancer. Age, personal or family history of breast cancer, biopsy-confirmed atypical hyperplasia, increased breast cancer density, a long menstrual history (starting early or ending late in life), and obesity after menopause may all make a woman more susceptible to the initiation of the disease. Recent use of oral contraceptives or post-menopausal estrogens and progestin, having a first child after age thirty, and consuming one or more alcoholic beverages per day may also play a role.[6] However, risk factors alone cannot determine whether or not one will develop breast cancer because up to seventy-five percent of all women who develop breast cancer have none of the above risk factors. [7] Recent studies suggest that women who have inherited the susceptibility genes, BRCA1 and BRCA2 make up approximately five percent of all breast cancer cases.[8]

Given the unpredictability of breast cancer, physicians and researchers have long promoted early detection as the best defense against the disease. According to the American Cancer Society (“ACS”), “[m]ammography is especially valuable as an early detection tool because it can identify breast cancer at an early state, usually before physical symptoms develop. Numerous studies have shown that early detection saves lives and increases treatment options.”[9] Recent data shows that mortality rates have declined by 1.4% per year during 1989-1995 and by 3.2% afterwards, with the largest decline in mortality among younger women, both white and African-American.[10] Researchers attribute this decline to the increased, regular use of screening mammography,[11] a procedure in which healthy, asymptomatic women are given mammograms to check for breast disease. [12]

During a mammogram, a technician takes an X-ray image of the breast using a low-dose X-ray system and high-contrast, high-resolution film.[13] The breast is pressed between two plates to flatten the tissue and two views of each breast, one from the side and one from the top, are taken.[14] Although X-rays of the breast have been used to diagnose breast cancer for more than seventy years, modern dedicated mammography units have only been used since 1969.[15] According to current recommendations, women over the age of forty should have a screening mammogram and a clinical breast examination every year. Women between the ages of twenty and thirty-nine should have a clinical breast examination every three years and all women over twenty should perform regular breast self-examinations every month.[16] Although some studies suggest that new technologies such as magnetic resonance imaging (MRI) and ultrasound may be effective in screening patients for breast cancer, the American College of Radiology (“ACR”) and the Institute of Medicine continue to support mammography as the most effective breast cancer-screening tool and the best defense against breast cancer.[17]

However, the effectiveness of these preventative measures depends directly upon the safety and quality of mammography. Following reports of the dangers of radiation exposure from mammography, the FDA took steps to make the equipment used in mammography safer. Modern mammographic equipment provides only very low doses of radiation, about .1 to .2 rads per picture.[18] However, later studies made clear that ensuring that mammographic equipment is safe is not a guarantee of quality. In 1995, and again in 2002, the Physician Insurers Association of America (“PIAA”) found that eighty percent of claimants in breast cancer malpractice suits had either a negative or equivocal mammogram that led to a delayed diagnosis of their disease.[19] Another study found that while conventional mammography detected eighty percent of cancers, twenty-percent of cancers were undetected because of “inadequate quality images, difficulties or errors in interpretation, and problems with imaging the structure and tissue/fat composition of the breast.”[20] Although the MQSA has made some inroads in improving these three problems, as this paper will show, the ultimate goal of ensuring mammography quality has proven elusive.

B. The Legislative History of The Mammography Quality Standards Act and the Mammography Quality Standards Reauthorization Act of 1998

1. The Mammography Quality Standards Act of 1992

In early 1991 and 1992, the Senate Committee on Labor and Human Resources [21] and the House Committee on Energy and Commerce held hearings on breast cancer, and according to the Senate report, discovered numerous problems with mammography practice in the United States, including, “poor quality equipment, the lack of quality assurance procedures, poorly trained technologists and physicians, false representation of accreditation, and the lack of inspections or governmental oversight.”[22] During the course of these hearings and debates, Congress critically examined the “conflicting and overlapping patchwork of Federal, State and private, voluntary standards,”[23] that comprised the existing regulatory structure. While it believed that the ACR accreditation program deserved commendation,[24] it also knew that it provided insufficient regulation of the mammography industry because of its voluntary nature.[25] By the fall of 1992, both houses were engaged in extensive efforts to create national, uniform quality standards for mammography and believed that the pending legislation on mammography was the solution to the problems that they had discovered.[26]

All of this legislative activity culminated in the passage of the Mammography Quality Standards Act of 1992 on October 27, 1992. The Act amended the Public Health Service Act, 42 U.S.C. § 262 et seq., in order to “establish the authority for the regulation of mammography services and radiological equipment.” In it, Congress made clear that the Act would apply to all facilities providing breast cancer screening or diagnosis through mammography activities except those facilities operated by the Department of Veteran Affairs.[27] It gave the Secretary of Health and Human Services authority to carry out the goals of the Act through fiscal year 1997.

The actual text of the 1992 Act established a comprehensive outline for achieving its goals, rather than specific standards for how mammography should be improved. The Act created clear, general mandates, but largely relied upon the Secretary of Health and Human Services to develop the substantive standards for its implementation. It also included a provision establishing a National Mammography Quality Assurance Advisory Committee, comprised of experts from various sectors of the health community and the public, to help deal with the details of developing the final implementing regulations.[28]

As originally enacted, the Act required all facilities that provide mammography services to obtain a certificate issued by the Secretary by October 1, 1994 in order to continue to operate lawfully.[29] In order to receive the certificate, the facility had to give the Secretary detailed information about its equipment and the personnel who would operate the equipment. It also had to provide proof that it had been accredited by an agency approved by the Secretary to provide accreditation services as well as proof that it had adopted an appropriate quality assurance program.[30] The Secretary was charged with the responsibility for developing clear standards for accreditation bodies that would ensure that clinical images from each accredited facility would be reviewed regularly.

The Act also issued a detailed mandate to the Secretary to establish quality standards for the actual provision of mammography service. It focused on three broad areas. First, the Act called for “standards that require establishment and maintenance of a quality assurance and quality control program at each facility.”[31] Second, it instructed the Secretary to issue “standards that require use of radiological equipment specifically designed for mammography, including radiologic standards.”[32] Third, it directed the Secretary to create licensing guidelines for personnel who perform mammograms and qualification standards for interpreting physicians.[33]

2. The 1998 Reauthorization and Pending Legislation

In May of 1998, when the authority for the original legislation was about to expire, the House Committee on Commerce held new hearings on whether the legislation should be authorized.[34] It quickly decided that it should be and the Act was reauthorized through fiscal year 2002 in October of 1998.[35] The new legislation retained much of the original language of the Act, but made a few minor changes designed to improve women’s access to information about their mammograms. Specifically, it clarified that mammography facilities must retain their records so that women can access their original mammograms and mandated that facilities send patients direct written notification of their results in a report written in laymen’s terms. The Act has continued in its 1998 form to the present date. Although a bill to reauthorize the Act through the end of fiscal year 2007 was introduced in July of 2002, Congress has not yet reauthorized the legislation.[36] The proposed legislation does not include any major new changes.

3. The Implementing Regulations Proposed and Promulgated by the FDA

Shortly after the MQSA was passed, in June of 1993, the Secretary of Health and Human Services officially delegated authority to implement the MQSA to the Commissioner of the Food and Drug Administration.[37] In the face of its growing realization that it would not be able to meet the October 1, 1994 certification deadline set by the MQSA, the FDA promulgated interim rules on December 14, 1993, in order to streamline the process for the promulgation of standards.[38] In the preamble to the interim rules, the FDA explained that it was necessary to use interim rules “because of the perceived urgent public health need for Federal standards for mammography.”[39] These rules would meet the basic requirements of the MQSA by making the ACR standards for personnel, mammography facilities, and accreditation bodies mandatory, while still giving the agency more time to evaluate and develop final rules.[40]

The FDA finally published its proposed rules on April 3, 1996. The preamble to the proposed rules shows that the FDA considered a number of different regulatory approaches to the issue of how best to regulate the personnel who perform and interpret mammograms. Specifically, it asked whether the new regulations should focus on education and training requirements for interpreting physicians, medical outcomes audit statistics and acceptable ranges, periodic proficiency testing, or some combination of the three approaches. It acknowledged the difficulties inherent in regulating physician performance, both because of medical uncertainty about the limits of mammography technology and because of the potential for misuse of statistics on doctor performance.[41]

Over the course of the 90-day comment period, the agency received over 1,900 letters and approximately 8,000 comments. The FDA issued final regulations more than a year later on October 28, 1997. They became effective April 28, 1999. [42] In the preambulatory materials to the final rule, the FDA made clear that it had seriously considered all of the alternative means by which it could regulate physicians performing mammograms. However, upon reviewing the comments it decided that the use of medical outcome audit statistics would be premature because there were too many unresolved concerns with such a system.[43] It also felt that given the number of comments suggesting that proficiency testing “would be excessive, unnecessary, costly, impractical and duplicative of examinations already in place,”[44] it would be premature to require additional testing via the regulations. Instead, the FDA desired to wait until there was further consensus among experts about what the appropriate standard should be.

The current regulations implementing the MQSA, set forth at 21 C.F.R. 900.1 et seq ., can be divided into three main parts. Subpart A outlines the procedures that an entity must follow to become an FDA-approved accreditation body. Subpart B establishes minimal, national quality standards to ensure safe mammographic practice. Finally, Subpart C implements the procedures by which a State can apply to become an FDA-approved certification agency in order to certify individual mammography facilities within its borders. The regulations allow the FDA to assess civil penalties of up to $10,000 for failure to comply with its mandates.[45]

Subpart A and, specifically, sections 900.3 to 900.7, are fairly uncontroversial. They simply establish that the FDA can approve certain entities as accreditation bodies with authority to grant certificates to facilities that wish to provide mammography. Accreditation bodies must submit their accreditation and decision making process for FDA review to ensure that it meets the quality standards of the MQSA and that all personnel operating the program are qualified.[46] By accepting accreditation responsibility, an accreditation body agrees to take active steps to monitor the quality of facilities that it certifies. For example, the accreditation body can require specific equipment performance or design characteristics.[47] It also agrees to review clinical images from facilities that it has certified at least once every three years.[48] Once approval has been given, these accreditation bodies have authority to regulate mammography facilities for seven years.[49] After the accreditation license expires, the body must submit a renewal application or notify FDA of its intent to cease providing accreditation services.[50] Today, there are five accreditation bodies: The American College of Radiology and the States of Arkansas, California, Iowa, and Texas. [51] In addition, most of the FDA-certified inspectors who inspect approved facilities are actually State personnel who operate under a contract with the FDA.[52]

Subpart C is like Subpart A in that it deals with the facility certification process and reflects recent efforts to increase state oversight of mammography. It authorizes individual states to step into the FDA role and supervise quality assurance for mammography as well as issue certificates of operation to approved facilities. States who are certifiers, also called SACs, are eligible to apply for certifying status “if they have standards at least as stringent as those of section 900.12, qualified personnel, adequate resources to carry out the States as Certifiers’ responsibilities, and the authority to enter into a legal agreement with FDA to accept these responsibilities.”[53] Like the private accreditation bodies, SACs must submit an application detailing their plans for quality enforcement. However, instead of granting a seven-year license, the FDA evaluates the performance of each SAC annually to ensure that it continues to carry out the mandates of the MQSA.[54] The FDA has acknowledged that “[s]tate agencies have played a very important role in the development and implementation of the MQSA program.”[55] It continues to take its partnership with the states seriously and is committed to the success of the SAC program.[56]

As stated above, Subpart B of the regulations, codified at section 900.12, establishes the actual quality standards for mammography that have been the source of greater public debate. This section can be divided into roughly three quality control measures: standards for personnel involved in the provision of mammography, standards for equipment used in mammography, and standards for annual inspection of mammography facilities. The Act provides that only licensed physicians who are certified in an appropriate specialty area or who have three months of documented training, may interpret mammograms.[57] It also imposes continuing experience and education requirements on them.[58] Section 900.12 creates general licensing requirements and continuing education and experience requirements for the radiologic technologists who perform the actual mammographic examinations as well as for the medical physicists who conduct surveys of mammography facilities and oversee their quality assurance programs.[59]

The statute also gives detailed instructions on how mammography facilities should carry out their services. The equipment regulations mandate that only mammography-dedicated equipment shall be used to perform mammographic X-rays. They also outline highly technical specific requirements for how exams should be conducted.[60] Section C of 900.12 creates mandatory recordkeeping and reporting requirements for all facilities. In addition, pursuant to the 1998 amendments to the MQSA, every facility must send each patient a summary of her mammography report written in laymen’s terms within thirty days of her exam.[61] When a patient has a referring health care provider, that provider should also be sent a copy of the report within thirty days.[62] The regulations also require each facility to maintain a quality assurance program that meets certain criteria.[63] For example, pursuant to the statute, facilities with screen-film tests must perform an image quality evaluation test on a weekly basis.[64]

As this brief outline of the implementing regulations of the MQSA demonstrates, the lawmakers and regulators who implemented the MQSA sought to ensure that all women who receive a mammogram would receive accurate and reliable results. The drive to ensure quality covered all aspects of the process from the personnel involved in administering an exam to the equipment used to perform the test and the facility inspection process. All of this was part of a broad effort to make sure that all mammograms meet certain minimal, national standards for quality.

C. The Pre-Act History of Mammography Practice and The 1990 Revolution

Prior to the passage of the Mammography Quality Standards Act, regulation of mammography varied widely by state. Although the American College of Radiology, had introduced a voluntary accreditation program in 1987 in response to media reports about the poor quality of mammography, by January of 1991, less than twenty-five percent of the estimated total of mammography facilities had been accredited. [65] Only fifty percent of the total number of facilities had even applied for accreditation and about one-third of those who applied failed on their first attempt to become certified.[66] To further complicate matters, the federal government itself had no clear idea of exactly how many mammography facilities existed in the United States. They estimated that 10,000 machines were in use, but in the face of increasing pressure for medical insurance to cover mammography costs and because of recent legislation mandating that Medicare pay for mammography ,[67] many lawmakers had grown concerned that there was “a proliferation of low-cost, low-quality machines because of the potential profits to be made on the millions or more women” having mammograms.[68]

The states did not have a firmer grasp on the state of mammography performance. Over the course of the three years before the first Congressional hearings on the issue, thirty-two states had passed laws relating to mammography.[69] However, the percentage of states with comprehensive quality standards was “woefully small.”[70] Sixty-four percent mandated insurance coverage of mammography. Thirty-two percent required that dedicated equipment be used. Eighteen percent had some type of quality assurance program. Twelve percent had personnel standards for radiologists. Ten percent had personnel standards for radiological technologists, and only two percent provided for regular inspection of mammography facilities.[71]

This state of disarray became increasingly unacceptable as a medical matter when more and more studies began to report on the value of screening mammography in reducing the number of women who would die from breast cancer. Well before 1990, a 1963-1969 study by the Health Insurance Plan of New York and a 1973-1981 Breast Cancer Detection Demonstration Project (BCDDP) “heralded mammography as sensitive, specific, and acceptable for mass screening purposes.”[72] In the mid-to-late 1980s, additional studies confirmed this finding and led federal lawmakers and the medical profession to believe that screening mammography could be an effective tool in combating the increasing numbers of women who were falling ill from breast cancer.[73]

During the same time period, women’s health advocates began to attack the historical refusal to include women in drug studies and pushed for greater efforts to collect information on issues affecting women’s health. In 1989, female scientists and health professionals founded the Society for the Advancement of Women’s Health Research and began to lobby Washington in order to bring about changes that would increase the amount of information available to women and their physicians.[74] They were successful in prompting a General Accounting Office (“GAO”) study that concluded in 1990, that women had been neglected in all aspects of health research. This study led to the creation of the Office of Research on Women’s Health in the National Institutes of Health. During the same year, the Food and Drug Administration abolished its longstanding policy that premenopausal, fertile women could not be included in clinical trials and mandated that gender-specific investigations should be included in future studies.[75] Thus, the push to develop greater uniformity of standards for mammography practice can be viewed as part of a larger effort to expand the reach of research and information on women’s health.

Accordingly, the Congressional testimony on mammography quality includes position statements ranging from organizations such as the ACR and the American College of Obstetricians and Gynecologists to organizations like the National Black Women’s Health Project and statements of individual women affected by the disease. While the effort to improve mammography quality may be situated within larger public health efforts, it was also, both because of the nature of the disease and the larger context into which it was introduced, decidedly a women’s health issue. The bill’s proponents were quite aware of this fact. The Honorable Mike Synar of Oklahoma stated as much, saying that the nation needed uniform quality standards because “[w]omen’s health care issues in this country have been overlooked, underfunded, or ignored too often.” [76]

The testimony of the National Breast Cancer Coalition (NBCC), comprised of, as of September 1991, 127 members including among others, The Fund for the Feminist Majority, the Women’s Cancer Project, and the National Association for Female Executives,[77] confirms that the push for greater mammography regulations was part of a larger feminist effort to improve the status and understanding of women’s health. In its position statement, in addition to acknowledging the importance of mammography quality, the NBCC also included a statement of its position on the need for additional federal research in the area of breast cancer. It specifically referenced the FDA drug investigational and approval process, noting that “new uses of approved drugs, and investigational new drugs and therapies often represent the best standard of care, hope for survival, and optimal treatment modality in medical opinion for many breast cancer patients.”[78] It went on to demand that the Food and Drug Administration “adopt innovative and flexible approaches to the drug approval process,” and that “public and private insurance and resources...provide for access to clinical trials utilizing innovative drugs and/or modalities.”[79] Thus, the NBCC called on the federal government to acknowledge the seriousness of the breast cancer epidemic and use all of the resources it had available to it to improve the quality of health care for all women.

The choice of the federal government as regulator was not accidental. Although the states have traditionally regulated the practice of medicine, advocates insisted that this was an issue of sufficient national importance that only the federal government could be entrusted with its regulation. While state oversight was important, by marshalling the resources of the federal government through the FDA, lawmakers and activists could send a strong signal that women’s health issues were no longer on the margins of the nation’s public health discourse. Senator Olympia Snowe voiced the feelings of many when she said that the legislation was “of vital importance to women all over this country,”[80] and that the current regulatory situation was unacceptable. “Overlapping federal, state and voluntary accreditation standards have led only to confusion, therefore putting women at risk of misdiagnosis. We need to address this problem with a uniform approach.”[81] Accordingly, the adoption of the MQSA did address a real problem of inconsistency of mammography practice, but also was a highly political decision that reflected the efforts of numerous advocates and legislators to remedy the historical failure of the medical establishment and regulatory structure to pay the proper amount of attention to issues affecting the health of the nation’s women.

III. The Portrayal of the MQSA in the Popular Literature on Breast Cancer

As one might suspect, the symbolic significance of the MQSA continues to play a role in the portrayal of the effectiveness of mammography and the importance of the MQSA in the popular literature on breast cancer. Sometimes its significance as a women’s issue is still highlighted. More often now, however, it is employed as a tool to encourage women to undergo screening mammography in the face of increasing controversy about its reliability. The FDA and respected cancer research centers such as the National Cancer Institute and American Cancer Society continually emphasize that women should trust mammography because it is highly regulated through the MQSA. Articles and pamphlets distributed to women assure them that they can trust their mammography results because the MQSA was enacted to guarantee high quality care. However, as at least one study as shown, and as one might deduce, the effect of all the conflicting information on mammography has been to confuse patients. Far from decreasing the problems associated with mammography, this level of confusion could in fact be contributing to a malpractice crisis in breast cancer diagnosis and has the potential to divert attention away from the commonalities between problems with mammography and problems with health care in general. Accordingly, one of the greatest challenges facing future efforts to reform the regulation of mammography will be the need to look beyond the symbolic significance of the MQSA and pragmatic attempts to encourage screening mammography that partially obscure the ways in which mammography practice might be improved by improving health care in general.

Senator Barbara A. Mikulski of Maryland, one of the original sponsors of the Act, has a fact sheet on the MQSA on her website that is illustrative of this point. Although any analysis of this fact sheet must take into account the fact that it was designed to illustrate her accomplishments as a Senator and not to be a full briefing of an issue, the before and after-MQSA picture of breast cancer screening that the fact sheet paints shows how the MQSA is often portrayed in a simplified manner. The sheet asks, “What happened before [the] MQSA?” It responds under various bullet points: “Women’s health and women’s lives were jeopardized. States had varying quality control standards which resulted in inconsistent and non-uniform readings.”[82] In contrast, now [the] MQSA, “provides uniform quality control standards...improves inspection of mammography clinics.” Later it asks, “What does [the] MQSA do for women?” The response is simple: “Women can now trust that technicians and physicians are trained to perform mammography tests and read mammography X-rays. Women can expect that their mammography X-rays will be read correctly. Women can expect that their illnesses will be properly diagnosed. Women receive direct notification of their mammogram results.”[83]

This simplification of the impact of the MQSA in the Mikulski fact sheet, though an extreme example, reflects the ways in which regulators and lawmakers have often referred to the MQSA. They have given the impression that the MQSA creates uniformity of care and that the Act has cured the problem of physician error and the limits of technology such that women can be assured that their mammograms are accurate. In truth, the MQSA sets minimal levels of quality, not uniform levels,[84] and the effectiveness of the provisions for regulating physician interpretation is a matter of serious public debate. The fact sheet’s constant reference to what the MQSA does for women situates this as not just an important health issue, but also as an important women’s issue. In this sense, the importance assigned to the MQSA reflects its status as an important symbol of the success of the women’s health movement. However, as the question on what the MQSA is doing for women also indicates, lawmakers and regulators often paint this uncomplicated picture of mammography in order to convince women that mammography is their best hope for protecting themselves against breast cancer.

Following initial studies showing that screening mammography might be effective in reducing breast cancer mortality rates, the American Cancer Society embarked upon a Breast Cancer Awareness Screening Campaign. The ACS, in conjunction with the ACR, formed a Committee on Mammographic Screening that was active in developing the ACR guidelines for safety and quality control that would become the basis of the ACR’s early accreditation program.[85] In addition to formulating regulatory changes for the practice of mammography, these health professionals also embarked on a campaign to change public perceptions of mammography.

To a large extent, the public education campaign on breast cancer awareness has been successful. As late as the early 1980s, many women were afraid to have mammograms because of early reports of its danger. [86] In fact, at the initial hearings on the issue, lawmakers raised the question of why so many women were not getting mammograms and wondered if safety concerns were playing a role.[87]

Now, although there are still some problems with access for women without health care and certain populations, the situation has improved.[88] In 1997, the Centers for Disease Control and Prevention conducted a survey of women age forty and over to determine how many women were getting mammograms. The mammography rate had increased in all thirty-nine states included in the survey. Sixty-nine percent of women age forty and over reported having a mammogram in 1995 as compared to fifty-three percent of women in the same age group in 1989. State-by-state comparisons yielded similar results. Mammography rates increased by nine percent in Minnesota, which already had a high rate, and increased by almost forty-five percent in West Virginia and New York.[89] As the National Breast Cancer Coalition president, Fran Visco, testified in a hearing on the effectiveness of screening mammography:

Mammography screening of women age 40 and above has become the standard of care for women in the United States. It has become a multi-billion dollar business. Organizations exist solely to raise awareness about mammograms and breast self-examination. Legislation has proposed to teach high school students about breast self-examination. Campaigns directed to the public about the importance of screening are increasing in number. For much of the public, mammography is the most important, if not the only, issue in breast cancer.[90]

As Visco indicates, much of the literature on breast cancer has been focused on encouraging women to undergo mammography screening as their best defense against breast cancer. Health professionals and activists have devoted huge amounts of time and money to getting this message out to women.

The FDA and cancer research centers have also been involved in this effort and they have directly used the MQSA to assure women that mammography is safe and effective in order to promote the importance of screening. In a pamphlet distributed by the FDA entitled, “Mammography Today: Questions and Answers for Patients on Being Informed Consumers,” the FDA continually emphasizes that the MQSA has made mammography safe and effective. In response to the question, “How can I be sure that I’m getting a high-quality mammogram?” the pamphlet responds, “The Mammography Quality Standards Act (MQSA) is a federal law that makes sure every mammography facility meets quality standards.”[91] Later it tells women to, “Look for the MQSA certificate displayed at your facility and check its expiration date. This certificate means that your facility has to undergo regular inspections and should provide you with a high-quality mammogram.”[92] It then continues with responses to the statements, “It’s good to know that FDA protects me by regularly inspecting my facility. What happens if problems are found during an inspection?” and “This information gives me confidence about the quality of my facility. How else does MQSA help me?”[93]

Although a pamphlet is admittedly designed to provide brief, pertinent information, the “Mammography Today” pamphlet illustrates how the FDA and others are portraying the MQSA to patients. Just by reading the pamphlet alone, one would think that the MQSA is foolproof and that the risks of inaccurate readings are negligible. The pamphlet does arm women with the information necessary to make sure that they only use mammography facilities that comply with the law, but nowhere does the pamphlet indicate the real complexities of whether or not they should trust that their results are accurate. The closest it comes to addressing the doctor interpretation issue is when it describes the procedure for obtaining original copies of your mammogram should you decide to seek a second opinion.[94] Instead, it constantly reiterates that the FDA is protecting the public through the MQSA and that the MQSA makes mammograms safe.

An article that appeared in the FDA Consumer magazine was similarly designed to emphasize the importance of the MQSA and regular screening for breast cancer. The article opens with a cautionary tale about a woman who believes that her mammogram saved her life. Although she discovered the cancer too late to prevent massive intervention, she did live after being hospitalized for a mastectomy.[95] Throughout the article, the author highlights the important role that the MQSA plays in saving lives. She notes that mammograms “are only worthwhile if the equipment is properly maintained and the personnel properly trained.” The article goes on to state that the primary objective of the MQSA is to carry out these goals and “to ensure that mammography is safe and reliable,”[96] and explains all of the protective provisions of the Act in detail. Another news alert on mammography repeats recommendations for screening under the caption: “Mammography: A Lifesaving Step.”[97] (emphasis added).

Informational materials from the American Cancer Society and the National Cancer Institute, though providing a little more information about the complexities of mammography, also emphasize the quality control aspects of the MQSA. A cancer facts pamphlet entitled, “Screening Mammograms: Questions and Answers,” explains the limitations of screening mammograms both because of the limits of the technology and the risk of false negatives and positives. However, later the National Cancer Institute reassures women by referencing the MQSA. It notes that the MQSA is “a [f]ederal law designed to ensure that mammograms are safe and reliable...The FDA ensures that facilities across the country meet MQSA standards,” and makes clear that the standards apply to “the technologist who takes the mammogram, the radiologist who interprets the mammogram, and the medical physicist who tests the mammography equipment.”[98] It also tells women to remember to look for the FDA certificate. This pamphlet references the MQSA in order to inform women about the basic care that they should expect and demand, but is also part of an attempt to assuage fears that mammography results will not be reliable. Likewise, a publication of the American Cancer Society, “What to Expect from a Mammogram: Knowing What to Expect During a Mammogram Can Make it Easier,” also encourages women to obtain mammograms by focusing on the quality assurance provided by the MQSA. The sixth tip on the list notes that “The Mammography Quality Standards Act was passed in 1992 to ensure high-quality mammography services, and the act was strengthened and expanded in 1998.”[99] Thus, the literature on mammography largely reflects the aspirational goals of the MQSA and often does not indicate the complex realities of current mammography practice.

Recent studies and expose articles on the efficacy of mammography and the failures of the MQSA have only increased the need for physicians and regulators to encourage women to continue to be screened for breast cancer by having regular mammograms. In the October 20, 2001, issue of Lancet , a British medical journal, two Danish researchers, Peter Gotzsche and Ole Olsen, analyzed the results of the seven large studies that historically have been used as evidence that screening mammography saves lives. They looked at and evaluated the methods used to conduct the original studies and concluded that none of the studies were “high quality,” and that only the three poor-quality studies confirmed the finding that screening mammography has significant mortality reduction benefits. They had published a similar study a year earlier, in the January 20, 2000, issue of the Lancet , but decided to do more extensive review after there was such a large outcry from the cancer prevention community. [100]

A later Canadian study, published in the September 3, 2002, Annals of Internal Medicine , looked at the specific benefits of screening mammography for women in the forty to forty-nine age bracket. The study tracked 50,430 women, with no history of breast cancer, starting in the early 1980s. Half of the women received annual mammograms while the other half only received normal physician care and conducted breast self-examinations. After thirteen years, there were 105 breast cancer deaths in the mammography group and 108 in the group that received normal care. The difference was no greater than that created by chance. The researchers concluded that screening mammography does not have mortality reduction benefits for women who are forty to forty-nine. [101]

These studies began a flurry of news reports about whether or not mammography was working. Counter-studies emerged such as one in the August 1, 2002, issue of Cancer that found that the introduction of mammography programs had reduced cancer deaths in Sweden by forty-four percent . A January 15, 2003, study in the same journal found that women between the ages of forty-two and forty-nine who received a mammogram every two years were less likely to be diagnosed with cancer at a late stage.[102]

Physicians and regulators also set out to refute the newer studies and to exhort women to continue to be screened for breast cancer. In an interview with a women’s health magazine, Dr. Peter Greenwald, the NCI’s cancer prevention chief, stressed that the advice on screening had not changed. Studies from the 1970s and 1980s had confirmed that screening could reduce breast cancer deaths by as much as thirty percent. When asked whether the newer conflicting studies might prevent some women from undergoing testing, he replied, “I’m afraid that’s true,”[103] but still maintained that the older advice should be followed. Similarly, Dr. Robert Young, president of the American Cancer Society, emphasized that “[t]he bulk of the evidence at this point continues to endorse mammography as a useful tool in potentially reducing one’s risk.”[104] In February of 2002, the American College of Obstetricians and Gynecologists released a press report expressing its concern that “ongoing discussion in the press about the value of screening mammography ...might discourage women from having appropriate examinations ... [and] strongly urge[d] all women to follow the advice of their physicians and obtain mammograms per current guidelines.”[105] The release was signed by nineteen prominent organizations including the American Cancer Society, the National Medical Association, the American Society of Clinical Oncology and the Susan G. Komen Breast Cancer Foundation. The Department of Health and Human Services followed suit with a February 21 news conference in which Secretary Tommy Thompson reiterated that “[t]he federal government makes a clear recommendation to women on mammography: If you are 40 or older, get screened for breast cancer with mammography every one to two years.”[106]

The result of all of this conflicting evidence seems to be that women are confused about exactly how much to trust the results of their mammograms. A recent study published in the Journal of the American Medical Association illustrates the impact of the mammogram controversy. Ninety-five percent of the women who participated in the survey responded that they were paying attention to the discussion about mammography screening. However, women seemed to be both confused about the meaning of the conflicting evidence and about the safety of mammography. Eighty-three percent believed that the benefit for women aged forty to forty-nine had been proven (the group about which there is the greatest disagreement). Thirty-eight percent believed that mammography had proven benefits for women younger than forty. Half of all of the respondents believed that mammograms should begin before forty.[107] Thus, significant percentages of the women surveyed either did not accept the federal guidelines or did not understand the limitations of mammography. Many women also held differing views about why there was a controversy in the first place. Fifteen percent still believed that “the controversy was about the potentially harmful effects of radiation associated with mammography.”[108] More than half thought that the controversy was only about money, while only twelve percent thought it was about the weight of the scientific evidence supporting screening mammography.[109]

A question submitted to Harvard Women’s Health Watch in March of 2002 sums up the popular reaction to the issues surrounding screening mammography. This reader wrote: “A few months ago, I was surprised to read that a new study has raised a question about the value of screening mammograms. Is that true? I thought the importance of having such mammograms was well-established.”[110] As this reader’s question and the results of the American Medical Association’s survey illustrate, lawmakers and the health community face enormous challenges in making sure that women continue to obtain screening mammograms according to recommended guidelines. The presence of conflicting medical reports and studies in the media is creating widespread confusion. The cancer prevention community and government regulators have often cited the MQSA as additional evidence for the proposition that mammography is safe and of high quality when attempting to counter some of the information about mammography that might be misconstrued. In doing so, the real problems that are still associated with mammography, but larger than the MQSA, including problems of physician interpretation and the limits of mammographic technology can sometimes be obscured.[111] One possible result of this informational problem is that more and more patients will have extremely high expectations of a technology that is still limited in its effectiveness. This informational asymmetry could be one of the contributing causes of the rise in malpractice litigation over failure to diagnose breast cancer. However, as the next section will discuss in greater detail, other more systematic reasons have also played a large role in this increase in litigation.

IV. The Rise in Malpractice Cases Alleging Failure to Diagnose Breast Cancer

A. Early Reports of the Success of the Act

A close examination of the Congressional testimony and debates on the MQSA reveals that drafters and advocates were concerned with addressing three key failures in the area of mammography practice. First, they were disturbed by a recent GAO report that had concluded that there was a need for strong federal standards because of “great variations in image quality and radiation dose – the two critical factors in determining quality.”[112] The debate over radiation dosage had begun many years ago in 1974, when a researcher found that mammography equipment was emitting a dose of radiation that could be potentially cancerous.[113] The Food and Drug Administration took steps to lower the dose of radiation through voluntary programs initiated by industry,[114] and by 1991, experts were comfortable stating that the amount of dangerous radiation was negligible.[115] Second, the bill’s proponents expressed concern over the lack of adequate training for the radiologists interpreting mammograms and the technicians performing them. Third, they advocated for a system of inspection and discipline of those facilities that failed to meet the established standards.

The data on whether or not this system has been effective in decreasing breast cancer mortality is mixed. In a 1995 GAO report, researchers found that the impact of the MQSA had been greatest in those states that lacked quality assurance regulations prior to the Act.[116] It found that between October 1, 1994, and August 1, 1995, 7,525 mammography units from 5,510 facilities went through the ACR’s first review process and thirty-five percent failed. After a second review, two-thirds of the units passed. Most of the violations found at all of the facilities involved the use of personnel who failed to meet MQSA requirements.[117] Overall, however, the report was positive. It concluded that the Act had improved the quality of mammography services without greatly limiting access to mammography because of forced closings.[118]

A 1998 report was slightly less optimistic. While it found that the number of facilities unable to meet basic image quality tests had decreased from eleven percent when the Act took effect to two percent, the report was permeated with concerns over the inability of the Act to impact physician performance. Specifically, it asserted that there was not a methodology in place that could link improved image quality to better physician interpretation and found that the FDA had failed to establish criteria for measuring interpretation accuracy. [119] Furthermore, it noted that it was difficult to quantify the impact of the MQSA on mortality rates. The researchers reported that “[a]lthough data collection efforts now under way will probably make it easier to monitor the quality of image interpretation and the effects of mammography on cancer outcomes in the future, the absence of pre-MQSA data means that analysts may not be able to fully measure how the act itself has affected image interpretation and cancer outcomes.”[120] Thus, as early as the1998 report, the problem that the New York Times would later highlight had already been identified. The MQSA, through its detailed certification and inspection system could regulate the machines that were being used to perform mammograms, but it was significantly less effective at regulating the doctors who were interpreting them.

B. Soaring Malpractice Rates and Efforts to Regulate Physicians

The soaring malpractice rate in the area of failure to diagnose breast cancer is often cited as evidence that the MQSA is failing. Even as the Food and Drug Administration and the ACR have undertaken extensive efforts to ensure uniform quality of care for all women receiving mammograms, the number of malpractice cases in this area of medicine has risen dramatically. Between 1985 and 2002, there were 3,437 reported settlement and litigation actions over failure to diagnose breast cancer.[121] The average length of delay in diagnosis of breast cancer has also increased since 1990. In 1990, the average delay was 12.7 months. By 1995 it was fourteen months, and in 2002, the PIAA found that it had increased to 16.3 months.[122] Although this jump may be in part attributable to the increased number of women seeking mammograms, it is still startling. One would expect that increased enforcement of the MQSA would lead to fewer cases of negligence over time as the standards of care designed to ensure mammography quality become more deeply engrained, but the opposite seems to be occurring. In fact, physician failure to diagnose breast cancer has become the most commonly litigated medical negligence claim.[123] Suits against radiologists interpreting mammograms make up the largest number of claims against any medical specialty. [124] This raises serious questions as to whether or not the MQSA is working and if there are indeed life-saving and cancer-preventative benefits to the MQSA that outweigh the costs that increased regulation may be imposing upon the health care industry both through regulatory/inspection fees and the tort system.

This section argues that the rise in the number of malpractice cases is not just a reflection of MQSA failures. Instead, the rise in malpractice claims is the expected result of an increased reliance on clearly articulated medical standards and practices. Although more attention has been devoted to the regulation of mammography than to other areas, the MQSA is part of a larger trend towards greater regulation of the practice of medicine through standards of care and guidelines. It is a generally accepted principle that with these increased standards, overall quality of health care may improve, but the unwanted result is often that self-regulators open themselves up to greater potential tort liability as the once private medical process is held to increased public/peer scrutiny.

This seems to be exactly what is occurring in the field of mammography. Trial preparation materials for members of both the plaintiffs’ and defense bars indicate that attorneys view the MQSA and ACR guidelines as another tool in the plaintiff’s arsenal of weapons against negligent (or allegedly negligent) doctors. Likewise, a close examination of a sampling of malpractice case law in the periods before and after the passage of the Act indicates that the MQSA and ACR standards may indeed be having an impact on the likelihood of lawsuits as patients come to expect and demand better care from their physicians. Some of the early cases reveal that women sometimes sued over physician failures that would clearly be negligent today and hopefully would be less likely to occur given increased medical knowledge and the MQSA. For example, in light of limited understanding about the safety of mammography, a physician might fail to order a mammogram for a woman over forty with a family history of breast cancer or might fail to report the results of a mammogram to his/her patient.

Other cases indicate that the same problem which plagues the radiology field today was a problem at the time of the Act’s passage, namely that physicians may order a mammogram but then fail to interpret it properly. However, in today’s cases of failure to diagnose breast cancer, the MQSA may also be a specific reference point that lawyers and patients use in their quest to prove or disprove medical malpractice. Finally, the proliferation of suits against radiologists based on misdiagnosis leads one to wonder why the MQSA may be failing in this specific area of mammography regulation, and if there are other factors, such as the general malpractice crisis that is so-often cited in the media, that may be contributing to the increased number of suits. Section V will explore the issues surrounding the state of malpractice litigation and doctor accountability in greater detail. What is clear, however, is that when the MQSA is separated from its position of cultural importance, the problems it supposedly has failed to remedy in the area of malpractice can be viewed as mere reflections of larger difficulties associated with creating uniform systems of health care.

Although the Congressional testimony and media reports on the MQSA do not reveal it, the decision to apply more stringent standards to mammography was part of a larger, contemporaneous trend to regulate the quality of health care. In her article, “The Brave New World of Medical Standards of Care,” Eleanor Kinney highlights what she believes to be the three forces driving the increased use of standards of care in the health care field:

(1) the standard-setting movement of the 1980s, with leadership from medical specialties and pressure from third-party payers; (2) the rise of managed care in the 1990s, with health plans and providers delivering care in integrated delivery systems with computerized patient records and (3) advances in the theory and science of defining, measuring, and improving the quality of medical care. [125]

The first of these reasons, leadership from the medical specialties, is particularly important in the context of mammography. According to Kinney, medical specialties sought to create standards of care in order to preserve their authority over the delivery of health care services in the face of challenges from third-party payers and public regulators.[126] Initially, in the 1960s, public and private parties developed these standards of care in response to increased health care costs from Medicare and Medicaid. Third-party payers saw medical standards as a way to lower costs by preventing unnecessary medical procedures. By the 1970s and 1980s, “medical professional associations, specialty societies, and voluntary health organizations became more involved in developing standards of care, including medical practice guidelines, in a more rigorous fashion.”[127] In 1987, despite its concern over a potential increase in tort liability, the American Council of Medical Specialty Services announced its conclusion that the medical profession and specialty societies should do more to establish standards for quality medical care.[128] In the late 80s, the federal government, through the Health Care Financing Administration, now the Center for Medicare and Medicaid Services, also began to use standards of care in setting national health care policy and determining review criteria for Medicare.[129]

Thus, in 1987, when the American College of Radiology developed its voluntary accreditation program for mammography facilities that would later become the template for the MQSA, it was really acting in accordance with a greater movement that was happening within the medical profession. Although legislators, perhaps for political reasons did not give much credence to his testimony during the initial hearings on the Act, Dr. Donald Hesch of the ACR expressed his personal belief that the voluntary accreditation program developed by the ACR was working and that the low rate of certification would improve with the passage of time.[130] Like the greater practice of medicine, the practice of mammography had already started moving “from a paradigm of autonomous professional decision-making to a paradigm of collective decision-making based on empirically derived standards of care.”[131]

One of the possible consequences of expanded oversight in appropriate standards of care is increased exposure to tort liability. The American Council of Medical Specialty Services acknowledged this fact when it made its announcement in 1987,[132] and lawmakers considered this when discussing the development of the MQSA.[133] Not surprisingly, a great amount of scholarly attention has been devoted to analyzing the role which medical practice guidelines and standards of care may play in medical malpractice cases.[134]

Kinney identifies two types of standards of care: standards of quality and medical practice guidelines. Standards of quality “specify the minimum acceptable level of performance or results.” They are typically “made by medical specialties and medical professional organizations or private accrediting bodies in conjunction with them.” “Medical practice guidelines, [also called clinical practice guidelines],...specify the processes of diagnosing and treating particular conditions.”[135] Although standards of quality and clinical practice guidelines are different, the legal implications of the two types of standards are similar.

Research shows that physicians are reluctant to use practice guidelines because of their uncertain application in the tort context. An early article on the implications of clinical practice guidelines indicates that they can be used either in favor of plaintiffs or in favor of defendant physicians. A study of twenty-eight cases revealed that plaintiffs were able to use guidelines successfully in twenty-two cases, while defendant physicians were able to use them successfully in only six cases.[136] Florida, Kentucky, Maine, and Maryland have even adopted statutes approving the use of guidelines as evidence of the appropriate standard of care.[137] At least one scholar, Michelle M. Mello has warned against increased reliance on these guidelines, which are voluntary and “could undermine the deterrent function of tort law by increasing the amount of uncertainty physicians face in determining what the law requires of them.”[138]

Although the MQSA is not comprised of voluntary clinical guidelines, but instead of mandatory quality standards, the impact that even voluntary guidelines may have upon the tort system illustrates the potential for clearly articulated mandatory standards to increase the character and rate of malpractice litigation. Clinical practice guidelines are voluntary and may not be accepted by all physicians, yet the creation of these standards of care, regardless of how accepted or widespread they are, increases scrutiny of physician practices. Federal legislation like the MQSA, which articulates clear standards for how mammographies are to be conducted and reported, can be expected to yield similar results.

Trial practice materials and cases seem to indicate that this is exactly what is happening. The authors of a recent article in the periodical, Trial , specifically mention the MQSA as a measure of the doctor’s standard of care in trial strategy materials designed to help plaintiffs’ lawyers formulate winnable cases against negligent doctors in cases of failure to diagnose breast cancer. The article states:

The Mammography Quality Standards Act sets federal rules that radiologists must follow. Its 1998 reauthorization act requires that a patient be provided a summary of her mammography results in plain language. Make sure that your client received and understood the summary. If the results were equivocal – for example a BI-RADS[139] rating of 3—determine whether the risks of malignancy were adequately explained to her and whether any alternative diagnostic studies were suggested.[140]

Likewise, in continuing legal education materials on how to conduct direct and cross-examinations of radiologists, the authors note that, “[t]he American College of Radiologists has published a set of standards for radiologists performing mammograms. This can be a useful tool for cross-examination. Also, federal rules for mammography were promulgated in the Mammography Quality Standards Act.”[141] Similarly, in an assessment of who the most likely defendants should be in any given lawsuit, practitioners in the breast cancer litigation area noted that radiologists are the most likely defendants in future lawsuits. They cited the importance of the radiologist’s role in diagnosing breast cancer as well as the ACR standards and the MQSA as the reasons for the growing number of radiologists becoming the subject of failure to diagnose lawsuits.[142]

The defense bar is also aware of the potential for increased regulation to create greater liability for physicians interpreting mammograms. In “A Primer on Defending Breast Cancer Litigation,” Bradley Nahrstadt and Christina Ketcham advise defense lawyers to be aware of the potential impact of clinical practice guidelines. They note that “[p]laintiffs may prove malpractice by pointing to the examining physician’s failure to follow recommended guidelines.”[143] They further comment that regardless of whether guidelines and recommendations by organizations like the National Cancer Institute constitute the actual standard of care, “they can provide reference sources for plaintiffs’ attorneys and experts in establishing various standards.”[144] Thus, medical quality standards and practice guidelines may improve the care that patients receive, but it is far from true that this increased quality of care would be reflected by a decreased number of malpractice claims.

C. Representative Malpractice Cases

Accordingly, any accurate assessment of the MQSA must look beyond the impact it has had upon the number of lawsuits that have been filed for failure to diagnose breast cancer. To that end, a survey of the types of failures that may be involved in breast cancer litigation is a useful means of reviewing the changes that the MQSA has been able to accomplish and how it may be falling short. Dr. Raskin’s analysis of “Why Radiologists Get Sued,” provides a useful framework for analyzing the problems inherent in breast cancer diagnosis. According to Dr. Raskin, there are 4 primary causes of suits against radiologists: “errors in perception, errors in interpretation, failure to suggest the next appropriate procedure, and failure to communicate in a timely manner.”[145] Although Dr. Raskin was concerned with radiology in general and not just radiologists or doctors performing mammograms, his four categories of failure hold true for this area as well. Three of the errors he identifies, perception, interpretation, and failure to suggest the appropriate next step, may be termed substantive errors. The final one, failure to report results, is largely procedural. An error in perception occurs when an abnormality is present, but is missed. An error in interpretation happens when the doctor sees an abnormality but draws the wrong conclusion from it. The final two are self-explanatory.

A close examination of three cases in which the theory of suit was based upon a doctor’s failure to communicate findings to a patient indicates that while the MQSA may not be able to provide a complete remedy for interpretive problems occurring in the diagnosis of breast cancer, it can and probably has affected other, more procedural problems. For example, the reporting requirements now in place because of the MQSA provide an additional check on doctors who perform mammograms by dictating proper procedures. In MacCain v. Montgomery Hospital ,[146] the plaintiff, Mrs. MacCain, sued her physician, Dr. Belasco, for his failure to diagnose her breast cancer in a timely fashion. Although Dr. Belasco ordered a mammogram for Mrs. MacCain in 1983, he failed to notify her that the radiologist’s report suggested additional follow-up because of the possible presence of a malignancy. Dr. Belasco told Mrs. MacCain that she should not worry and that the mammogram was negative. As it turned out, he had not even read the radiologist’s report and Mrs. MacCain did not know about the results because they went directly to Dr. Belasco. By the time the cancer was discovered in 1984, the lump had grown and Mrs. MacCain had to undergo a modified radical mastectomy. Now, under the 1998 amendments to the MQSA, Mrs. MacCain would have been entitled to receive a copy of her report and perhaps her cancer would have been detected earlier.[147]

A similar failure occurred in 1994 when Mrs. Betty Smith had a mammogram at the Beaufort Naval Hospital. The test indicated an abnormality, but because the hospital was in a transition period from hand delivery to computer delivery of reports to the physicians who had ordered them, neither she nor her physician had been notified of the results. The net result of this system failure was that Mrs. Smith did not find out that her mammogram was abnormal until five months and twenty-seven days later.[148] In its decision, the court considered whether the hospital had been negligent in failing to send the results directly to Mrs. Smith. It reviewed the MQSA and found that the 1998 amendments required that patients be notified directly of their results. However, it found that “the 1992 Act did not require direct notification for all patients...[o]n May 5, 1994 [the date of the mammogram], it was not mandated by the federal government that hospital radiology departments notify patients directly concerning their mammogram results.”[149] Accordingly, the hospital and the physician had not failed the duty of care with respect to notifying Mrs. Smith of her findings.

Finally, in Jenkins v. Dyess ,[150] the plaintiff, Ms. Edna Jo Jenkins, decided to have someone evaluate a lump in her breast in 1992. The radiologist ordered a mammogram and Ms. Jenkins told him to send the results to her primary doctor, Dr. Dyess. Dr. Dyess did not notify Ms. Jenkins of the abnormalities or the radiologist’s suggestion that she schedule a biopsy. The end result was that her cancer was not diagnosed until 1997. The dissent believed that “Dr. Dyess was responsible for informing Ms. Jenkins even of a good result. Ms. Jenkins should not have been required to assume a good report from her treating physician’s silence.”[151] Although the amendment requiring direct patient notification had not been passed in 1992, the dissent cited the statute,[152] thereby indicating that the statute could been taken as a mere codification of an established standard of care that doctors owe their patients.

Thus, the 1998 amendments, by adding an additional procedural safeguard, have increased the likelihood that a patient will receive quality care and at least theoretically decreased the risk of a malpractice claim based upon procedural failures. In the post-Act environment, procedural errors such as the ones cited in the above cases would be clear grounds for liability, and thus doctors can be expected to take more care to ensure that these types of errors do not occur. As Leonard Berlin notes in an article on the radiologist’s duty to communicate findings, “although we cannot change the aspects of human behavior that cause us to err, we can find ways to reduce error and make medicine safer for patients. A key strategy for reduction in medical errors and enhancement of patient safety is to design and implement a systems approach.” [153] This approach seems to be working in the area of mammography, and the MQSA seems well suited to reducing these types of procedural errors. A 1997 Physician Insurers Association of America-ACR survey listed failure to communicate findings of mammograms as the cause of a substantial number of lawsuits. However, according to Berlin, the reporting requirements have “virtually eliminated medical malpractice lawsuits alleging failure of communication of mammographic findings.”[154]

The impact that the MQSA can have on substantive errors is less clear. A number of early cases reflect widespread reluctance to use mammographic equipment given the uncertain quality and safety of mammographic equipment and conflicting industry guidelines about when to order mammograms. Uncertainty in the safety of mammography led physicians to commit the substantive error of “failing to suggest the next appropriate procedure.” In In the matter of Estate of Davies v. Reese ,[155] the plaintiff, Marion Reese sued the estate of her deceased physician for medical malpractice. Ms. Reese had visited her physician, Dr. Davies, in April of 1970 because she had found a suspicious lump in her left breast. Dr. Davies did not order a mammogram or any other diagnostic procedures, but continued to examine Ms. Reese a total of twenty-one times over the course of eighteen months. Eventually, in November of 1972, Dr. Davies advised Ms. Reese that the growth should be removed, but he did not indicate that it might be cancerous and did not tell her that she should have surgery immediately. Ms. Reese, however, took her health into her own hands and hospitalized herself. A new doctor performed a radical mastectomy on her in 1972. In this part of the case, the court held that the statute of limitations had not run out, but had begun on the date of Dr. Davies’ last consultation with the plaintiff.

Although the main issue in this case was whether or not the statute of limitations had run on Ms. Reese’s claim, Davies reveals a number of problems that plagued the field of mammography prior to the development of the Act. While the court makes much of the fact that Dr. Davies treated Ms. Reese “without conducting the needle biopsy, mammography, or other medically recognized pathology tests,” the safety of mammography was far from established at the time of Ms. Reese’s treatment in the early 1970s.[156] Section 900.12 creates strict standards for safe use of mammography equipment. Prior to this time period, most doctors could not be assured that ordering a mammogram would outweigh the risks of radiation. Dr. Davies may indeed have been negligent even under then-existing standards, given the nature and size of the lump that Ms. Reese had found, however the safest course of treatment for Ms. Reese was far from clear.

In Better v. McCarthy ,[157] a case that took place much later, but with the relevant events occurring before the passage of ACR standards or the Act, the court specifically acknowledged the limits of past knowledge and accepted practice in the area of mammography. The plaintiff’s wife, Patricia Better, age forty-eight, visited her gynecologist regularly for annual checkups from 1973 to 1979. She did not come in for normal exam in 1980, and in 1981, her physician, Dr. McCarthy, found a lump in Ms. Better’s right breast. Dr. McCarthy then ordered a mammogram and after reviewing it, decided that Ms. Better should have a biopsy. The lump turned out to be cancerous and Ms. Better underwent mastectomies on both of her breasts. However, two years later, she discovered that the cancer had spread. She died in 1984.

The plaintiff’s theory of suit was that Dr. McCarthy had been negligent in failing to order screening mammograms for his wife. Ms. Better had a paternal aunt who had died from breast cancer and he argued that given this information and other risk factors, screening mammograms should have been ordered. At the trial level, the plaintiff lost the suit. On appeal, he once again lost. The court credited the limited state of knowledge about mammography and the possible real risks associated with mammographic equipment at the time as problematic. It relied upon an expert’s testimony that “there were studies published during the period from 1973 through 1979 which indicated that the effects of radiation associated with mammography might, in fact, cause more breast cancer than was detected.”[158] The court further noted that in addition to the fear of the carcinogenic nature of the procedure, there were other risks, including “a high percentage of false negative and false positive results which each carried their own special dangers for the patient.”[159]

Here the court has made explicit a problem that existed at the time of Davies and was addressed by the MQSA. Despite the data on the dangers of mammography, there was no compliance system in place to ensure that a given machine would be safe. Accordingly, doctors performed mammograms at the risk of their patients and at the risk of becoming subject to liability. Furthermore, the technology itself was limited. The mammogram in use at the time of Ms. Better’s illness could only diagnose tumors that were at least one centimeter in diameter. Hers was one tenth of a centimeter.[160] Thus, the technological limits of the time period as well as uncertainty about the safety of mammography equipment led to Ms. Better’s doctor’s failure to diagnose her breast cancer.

Similarly in Miller v. United States ,[161] a doctor failure to determine that a mammography would be worthwhile contributed to the death of a patient. In this case, the decedent, Ms. Petzak, eventually died from breast cancer because, despite regular check-ups, her physician did not order a screening mammogram for her. When she finally made an appointment for a mammogram she did so because she had noticed troublesome changes in her left breast. She commented on the course of her disease in a note written before her death, saying “On 1 June 83, I had a physical . . . In retrospect, a mammogram should have been ordered [by Dr. Bomar] because of previous biopsies, family history, and post-menopausal age 59.”[162] Despite all of these risk factors, her doctor failed to order screening mammograms because he was uncertain about their benefit.

Finally, in Levine v. Rosen ,[163] despite Mrs. Levine’s complaints of nipple inversion and discoloration, her physician, Dr. Rosen, did not order a mammogram. She only discovered her cancer when she decided to have a mammogram performed on her own. By that time, the cancer had progressed to the point that a radical mastectomy was necessary. At the trial court level, the jury found Dr. Rosen to be innocent of negligence. On appeal, the court held that evidence had established that there were two schools of thought on mammography. Although the American Cancer Society recommended a yearly test for women over fifty, the American College of Obstetricians and Gynecologists only recommended that mammograms be performed “regularly,” with the meaning of regularity left to the discretion of the physician.[164] The court decided that the doctor had not behaved negligently in failing to order yearly mammograms because there were two schools of thought about screening mammography.

As these cases illustrate, prior to the adoption of the MQSA, doctors were often reluctant to order mammograms. Part of this reluctance stemmed from the uncertain nature of the benefits and risks of mammography as well as the limits of the technology available during the relevant time period. While the MQSA could not remedy the technological problem, since diagnosis is always limited by the level of technological advancement, these cases illustrate that the development of equipment quality standards plays a crucial role in allowing doctors to perform the correct risk/benefit analysis in determining which procedures are appropriate for their patients. Additionally, they suggest that the development of more uniform industry standards for when screening mammograms should be performed should also have an impact on how often doctors fail to diagnose breast cancer.[165]

Of course, even when a doctor orders a mammogram, some patients will fall ill and/or die because of a doctor’s failure to interpret the mammogram properly, or because of errors in perception and interpretation. This was true before and after the development of ACR standards and the adoption of the MQSA. The MQSA’s strict regulation of mammographic equipment can remedy some of these more substantive problems by ensuring that radiologists and other doctors have the best chance of seeing an abnormality that is there. For example, increased regulation of film quality could prevent situations such as in the one in Parker v. Collins ,[166] where, the plaintiff, Ms. Parker, sued her physician for malpractice for using X-rays which several radiologists would later testify were “grossly technically inadequate and subotimpal for interpretation.”[167]

However, the MQSA may not be able to remedy the problem of misinterpretation of a result that is clearly there. It may try through mandating how many hours of training a radiologist must have and who may read mammograms, but the process will still be open to failure because the amount of room for discretion in interpretation is so great.

In Borgren v. United States of America ,[168] the plaintiff, Ms. Borgren, obtained mammograms regularly in the early 1980s as her primary care physician recommended she do because of her age (fifty-eight at first time she could have been diagnosed). However, on two occasions, the radiologists who examined her mammograms found that she did not have cancer. The first radiologist reported a “benign calcification,” in 1983, and in 1985, another radiologist found that there were no abnormalities. Ms. Borgren found her cancer on her own when she noticed a large lump in 1986. By that point, a radical mastectomy was necessary. Although this was a case against Army physicians, and would not be covered by the MQSA, but by parallel regulations under the Veterans Administration Act,[169] it is indicative of the fact that doctor interpretation problems have long existed. Notably, the first physician who failed to find the abnormality was a specialist just like the one who later discovered his error.

Similarly, the plaintiff in Donohoe v. Goldner ,[170] lost her malpractice case against a radiologist who performed a mammography on her in 1975 when she was fifty and found no abnormalities. The radiologist’s failure to diagnose the cancer early necessitated a radical mastectomy, chemotherapy, and later, treatment for cancer that had spread to her pelvic bone. However, the court cited her failure to produce a witness willing to testify to what constituted the appropriate standard of radiological care in 1975 as the reason for the dismissal of her case.

The problem of physician interpretation has continued to be a source of malpractice claims despite the passage of the MQSA and its concomitant standards for film quality and patient reporting.[171] In Baker v. Radiology Associates ,[172] the plaintiff, Anna Mae Baker, had to have a double mastectomy only to find that the cancer had spread to her lymph nodes despite having received regular mammograms from the defendants. Over the course of more than a decade from 1988 to 1998, the defendant performed nine mammograms. In 1998, a different radiologist at the center performed the mammogram and detected an irregularity. Ms. Baker’s expert expressed his opinion that the cancer was visible on the mammograms that the plaintiff received in 1994, 1995, and 1996. Her case reflects a classic error in interpretation.[173]

The plaintiff in Craig v. Murphree ,[174] Ms. Craig, alleged that both her primary care physician and her radiologist were negligent in their failure to find her breast cancer in a timely fashion. Ms. Craig had a family history of cancer and breast lumps. She was not diagnosed until 1995 despite having received a mammogram showing micro-calcifications in 1994. The result of this delay, according to her experts, was that while her chance of survival at the time of the mammogram would have been greater than fifty percent, she now could expect to live no longer than ten years. The radiologist’s interpretive failure was crucial in this case. He failed to mention the microcalcifications on his report and the primary care physician did not notice them. Ms. Craig’s primary physician testified that the radiologist’s “report that the mammograms were negative for cancer was reassuring for her.”[175] Thus, even though all of the proper reports had been filed and equipment used, a single doctor’s arguably erroneous interpretation caused a serious delay in Ms. Baker’s diagnosis and treatment. Finally, in 2001, Romona Newell, who had a previous history of breast cancer, died because the radiologist who read and interpreted a mammogram in June of 1997 failed to read it properly.[176]

Clearly, even if every procedural safeguard is taken, there will always be a possibility of substantive error on the part of the interpreting physician. The MQSA’s efforts to mandate mammography training and continuing education are important safeguards, but the process of treating patients will always involve a certain amount of discretion, and thus human error. As this section has hopefully illustrated, evaluating the success or failure of the MQSA based upon the number and character of malpractice claims that continue to be filed is a complex process. Although one might expect the overall number of cases to fall in the face of mandatory standards and regulations, this result is far from certain. First, the MQSA and the ACR standards on mammography are part of a larger trend towards providing physicians with guidance in the treatment and diagnosis process. Past experience with standards of care and guidelines, even those that are voluntary, indicate that an explosion in litigation is often the most immediate result of increased scrutiny of the medical process.

In addition, the MQSA must be considered in all of its parts. In order to accurately assess the impact of the MQSA, one must also look at all of the different types of errors that it may in fact be preventing. The case law in this area is useful in this regard. Evaluating each and every breast cancer malpractice claim would be a difficult, if not impossible task. However, a close analysis of cases from throughout the time period is instructive in revealing the types of errors that the MQSA can fix and those that it cannot in its current state. The MQSA has largely succeeded at addressing problems unique to mammography. Increased reporting requirements were necessary because mammograms were being provided so frequently and so often to patients whom a doctor had not referred.[177] Regulations addressing what type of equipment should be used were necessary because dedicated equipment was not used until 1969 and there were unacceptable radiation risks associated with screening. Thus, simple requirements such as the requirement that a physician report the results of a mammogram to the patient directly as well as more complex ones setting standards for the type of equipment that must be used, can have life-saving benefits.

However, it does appear that problems with physician interpretation remain a real problem. The MQSA provides that a radiologist must receive sixty hours of training before beginning to interpret mammograms independently and must read at least 960 mammograms during the two years prior to the facility’s annual inspection.[178] There is a real debate over whether or not this is adequate. In its 2002 report on breast cancer malpractice suits, the PIAA found that radiologists still accounted for the largest percentage of breast cancer claims (thirty-three percent).[179] 93.7 percent of these radiologists were board certified, yet the most prevalent issue associated with their treatment of patients was their tendency to misread mammograms.[180] Of the number of claims against radiologists, 75.2 percent fell into the class of misread mammograms.[181]

Of course, in reviewing these statistics, it is important to acknowledge that the level of technological advancement limits the effectiveness of mammography despite the best efforts and skills of doctors. Mammograms often miss up to twenty percent of breast cancers that are present when a woman is screened. Younger women often have higher misdiagnosis rates because they have dense breasts that make it harder to spot abnormalities.[182] Additionally, mammograms often are not effective screening tools for women with breast implants.[183] Therefore, the high rates of misdiagnosis by radiologists may be in part due to current technological limitations and not just physician error. Better technology, such as the computerized image-checking system recently developed by R2 Technology, Inc. may have the effect of further reducing the missed cancer rate.[184] Nonetheless, the current rates of misdiagnosis and in particular the disparities in the skills of individual physicians that the next section will discuss, also suggest that that the current methods of physician certification and oversight are failing. As Section V will also explain, the issue of how best to regulate the substantive quality of medical care extends far beyond mammography.

V. Mammography and the Regulation of the Practice of Medicine

While the rise in malpractice cases for failure to diagnose breast cancer is not solely the result of the failure of the MQSA, there is mounting evidence that the Act in its current form does not ensure that the physicians who interpret mammograms do so correctly. The debate over doctor error in mammography is not new. In fact, the legislative history reveals that this problem was at the forefront of lawmakers’ minds at the time of the MQSA’s enactment. However, the issue of how to correct medical error in the diagnosis of breast cancer is a complicated one. Since the professionalization of medicine in the nineteenth century, doctors have had large stakes in continuing to be a self-regulated industry. Throughout time, they have argued that since they possess superior knowledge about medicine, they are the only ones competent to judge whether or not a physician has adhered to the appropriate standard of medical care. In addition, the regulation of medicine has long been considered a state, rather than federal function. Although the grip of private physicians over the regulation of medicine has lessened with the federal government’s increased role in health care through the Medicare and Medicaid systems, the legacy of state control and private regulation of medicine remains strong. Despite the imperfect correlation between the number of mammograms read and skill in interpretation, past experience suggests that physicians will resist attempts to further regulate the provision of mammography through peer review systems or skill tests. Any attempts to legislate new requirements of this sort at the federal level would also probably face hostility as a violation of the traditional federal/state division of responsibility for health care.

Nonetheless, despite the rhetoric over the errors of radiologists, the difficulty with ensuring the quality of physician diagnosis and treatment is not unique to mammography. Government, at both the federal and state level, has long been involved in a conflict with private accreditation agencies and medical boards over the assurance of health care quality. The current malpractice crisis that is at the center of a national debate over rising malpractice insurance premiums also reflects some of these fundamental questions regarding the regulation of physicians. The widespread nature of these issues suggests that perhaps the solution to doctor error in mammography lies not in more mammography-specific legislation, but in a critical examination and overhaul of the current methods by which regulators ensure that all doctors provide their patients with quality care. This would ensure that new pressures would not be placed on mammography providers alone, but would change the whole structure of the relationship between doctors and larger regulatory systems.

A. The Physician Regulation Problem in the Legislative History and GAO Reports

Although the medical establishment was ultimately successful in limiting the reach of the MQSA over the actual provision of service, the issue of doctor failure was at the top of the agenda in the initial hearings on the quality of mammography. At the initial Senate hearing on how mammography practice was failing, the Subcommittee on Aging heard moving testimony from two women who had obtained mammograms but had a delay in their diagnosis. Senator Adams introduced their testimony by noting that “the problems of poor-quality mammography – in this instance, the misdiagnosis by a radiologist, [are] all too common.”[185] The first witness, Mrs. Everly, worked with cancer patients at the Swedish Hospital Tumor Institute. After a screening mammogram, her radiologist found a suspicious area. The doctor recommended that she wait four to six months for a follow-up. However, because Mrs. Everly worked in oncology, she pursued a second opinion. The second radiologist recognized the seriousness of the abnormality and ordered an immediate aspiration and biopsy. These additional procedures revealed that Mrs. Everly had the initial stages of breast cancer. Although the first radiologist had stated that he saw an “equivocal area of architectural distortion,” in the words of Mrs. Everly it “turned out be a very unequivocal area of breast cancer.”[186] Had she not had knowledge about the process, she would have very likely gone untreated for months and would have had significantly lower prospects for recovery.

The second personal encounter witness was not so fortunate. Despite having mammograms and breast exams starting in 1983, Mrs. Singer’s cancer was not diagnosed until 1987. Her physicians “never palpated the upper areas of the breast and therefore missed the tumor that was located in the upper left breast area.”[187] The end result of this physician failure was that Mrs. Singer had to have a mastectomy in order to stop the growth of her cancer.

In the end, however, the MQSA stopped short of ensuring that radiologists interpret mammograms correctly. Instead, the legislation mandated that only licensed doctors with special training could interpret mammograms and instituted benchmarks for the number of mammograms that a radiology-trained physician should be required to perform every year.[188] Two doctors from the University of North Carolina at Chapel Hill submitted a letter to the editor in JAMA shortly after the passage of the MQSA. They expressed their belief that although the ACR accreditation program had “significantly improved the quality of mammograms by direct measures with quality control,” the MQSA and ACR requirements failed to “evaluate[] radiologists’ interpretive skills or performance except by recommending follow-up and data collection.”[189] Although they expressed the desire to improve physician skill without additional costly regulations, they noted that “mammography is only as good as its weakest link.”[190] Thus, as early as the initial passage of the Act, commentators and lawmakers were aware that physician interpretation remained a key problem.

Several studies in the years immediately following the MQSA found that the skills of interpreting physician remained a key failure in mammography practice. In the
December 1994 issue of the New England Journal of Medicine , researches at Yale University found that there are significant differences in the ways in which radiologists interpret the same mammogram. Researchers looked at 150 mammograms from the total taken at Yale-New Haven Hospital in 1987. Twenty-seven of the women who had the mammograms were diagnosed with breast cancer, while 123 were cancer-free. The ten radiologists who participated in study, who had no previous information about the outcomes of the mammograms, were then asked to interpret them. The results were startling, they agreed on the interpretation in only ten cases. There were differences in their interpretations of questionable areas as well as on what methods of follow-up were appropriate.[191] Researchers in Milwaukee came to similar conclusions. Dr. Craig A. Beam, who was interviewed for a New York Times expose on mammography, found in 1996 that although some doctors caught every cancer in a test stack, one in four missed a third.[192] In a similar study in New Hampshire, researchers found that doctors failed to diagnose one in four cancer cases.[193]

Lawmakers and regulators are aware of this key failure of mammography legislation. In its 1998 study on the impact of the MQSA, the GAO noted that an interpretation problem persisted. The researchers reported that they “were unable to determine if MQSA has had an effect on improving the accuracy and reliability with which mammograms are interpreted, because criteria are not available to determine an appropriate measure.”[194] It summed up the controversy over interpretation as follows:

Several academic studies have shown wide variation in the interpretation of the same mammogram by different radiologists. On one hand, some experts suggest that some type of peer review or proficiency test is needed to improve accuracy. On the other hand, FDA and others take the position that such measures are too difficult and costly to implement and that a self-monitoring facility-based system of physician performance assessment is a better approach to achieve the goal of quality interpretation.[195]

The study further noted that the FDA believed that the best system of quality assurance was to require the collection of data summarizing the correlation between follow-ups on positive mammograms and biopsy results. This data would then by used by the facility itself to monitor physicians. Thus, although the New York Times article and other articles on the failure of the MQSA to improve mammography quality caused quite a ripple in the media, FDA and state regulators have been aware of these issues for quite some time.

B. A Brief Historical Overview of the Regulation of the Medical Profession

What the GAO report study does not indicate, however, is the extent to which the reluctance to impose greater interpretation quality controls in the field of mammography reflects not just a lack of consensus on the appropriate standards, but also the presence of highly political obstacles to monitoring physician performance not just in the area of mammography, but in all areas of health care. A call to mandate federal monitoring of the skills of physicians who interpret mammograms directly challenges two longstanding principles of the regulation of medicine. First, such regulation presents a direct challenge to the concept of the physician as an autonomous, licensed professional. Second, enacting more substantive regulation of the practice of mammography at the federal level contradicts the historically established principle that states are the proper vehicles for protecting the public from unskilled physicians.

The struggle by physicians to maintain autonomy over their profession is not new. Instead, it reflects a challenge that the profession has faced ever since it first came to be recognized and respected as a distinct profession. In colonial days, most professions, including medicine, faced very little regulation. Doctors faced competition from a number of different sources including many quacks.[196] Medical knowledge was crude and largely indistinguishable from these other healing arts. At that time period, according to Edward P. Richards, who has written on the issue, “there was no justification for setting some physicians up with a state-enforced monopoly through licensing them.”[197] However, as medical knowledge increased through the discovery of germ theory and anesthesia and other advances, medical science prevailed over these other healing practices, thereby giving lawmakers and citizens greater incentives to restrict the practice medicine. Physicians, as holders of the monopoly over the practice of medicine, greatly benefited from these developments.[198]

Over the course of the early twentieth century, the rise of professionalism secured the place of doctors in society. During the period from 1945-1965, physicians reached what Carl F. Ameringer calls medicine’s “Golden Age.” Physicians had reached their “pinnacle of autonomy, free from outside interference and dominant over all others in the medical field.” [199] Professional associations like the American Medical Association protected the political interests of physicians. Medical schools and hospitals also played a key role in securing this place in society by ensuring the competence of new physicians and reducing competition for doctors.[200]

Physicians also marshaled the police power of the states and the federal Constitution to protect their monopolies. Since the power to regulate medicine was not specifically entrusted to Congress, the Tenth Amendment reserves this power for the states. The police power gives states the authority necessary to pass laws that are necessary to protect the public health and safety of their citizens.[201] Accordingly, beginning in the late nineteenth century, physicians were successful in encouraging state medical boards to limit who was able to practice medicine. Texas established the first state board of medical examiners in 1875.

In 1882, in West Virginia v. Dent ,[202] the Supreme Court upheld the power of the states to regulate the practice of medicine and approved the grant of state authority to the medical profession. It found that the requirement that physicians obtain a medical license did not violate an individual’s property rights under the Fourteenth Amendment. In explaining why a medical license was necessary, the court deferred to the special skills of the physician. The court reasoned that, “[t]he physician must be able to detect readily the presence of disease, and prescribe appropriate remedies for its removal. Every one may have occasion to consult him, but comparatively few can judge the qualifications of learning and skill he possesses.”[203] Accordingly, the state had to step in to protect the public. Only then could one trust that the doctor had been judged “by an authority competent to judge in that respect.”[204] By 1900, most states had followed the direction of West Virginia and Texas and had enacted laws requiring all those who wanted to practice medicine to be properly licensed by the state. State medical boards came to serve as gatekeepers to the profession by limiting who was licensed, punishing the unqualified, and protecting existing physicians from outside criticism.[205]

In the early days of state regulation, medical boards did little to ensure that the physicians that they had licensed provided quality care. Early grounds for revocation of a license included “habitual drunkenness, criminal abortion, conviction of a crime involving moral turpitude or unprofessional or dishonorable conduct.”[206] Technical incompetence was not yet an independent ground for discipline. Some scholars have linked this to the past perception that the practice of medicine was an inexact science.[207] Ameringer surmises that perhaps this has changed in more recent years as there has been a “growing consensus concerning the diagnosis, treatment, and prevention of disease.”[208] But, until the 1950s, doctor incompetence went largely unchecked. In response to growing criticism, professional associations began forming grievance committees to hear patient complaints. Over 1100 of these bodies had formed by 1961.[209]

The climate of medical regulation began to change by the 1970s as private regulation gave way to increased public accountability. The federal government assumed an expanded role in health care regulation with the enactment of the Medicare and Medicaid programs in the 1960s.[210] In the 1970s and 1980s, the federal government made the medical field subject to antitrust regulations.[211] Consumer groups such as Shame (Stop Hospital and Medical Errors), Public Citizen, and the Citizen Advocacy Center became active participants in the move to hold the medical profession accountable.[212] With this enhanced public involvement in health care, came increased litigation over malpractice. The 1970s and 1980s were marked by a malpractice insurance crisis that threatened the existing structure of health care regulation. As Ameringer has noted, legislators were willing to reform professional liability rules but only with the concession that state boards would have to incorporate more input from the public.[213]

In light of this rise in malpractice suits, government faced increased pressure to deal with the problem of incompetent doctors. This eventually led to the development of professional standards review organizations (PSROs) in 1972 and peer review organizations (PROs) in 1982. The medical establishment fought this intrusion into their area of expertise, but was unsuccessful in eliminating them.[214] The medical establishment was successful, however, in ending federal attempts to remove incompetent physicians through random case review. PROs had become virtually powerless by the 1990s. They recommended action be taken against twelve physicians in 1991 and fourteen in 1992. Instead of policing the profession, PROs consigned themselves to “collection and analysis of data on medical outcomes and practice patterns.”[215] The result of this abdication to public efforts to improve medical quality was that the state medical boards, now more public in nature and responsive to the needs of consumers, assumed the role of using medical malpractice claims as a way of preventing incompetence. In Maryland, for example, the state medical board’s ranking jumped from forty-second to twenty-first between 1986 and 1994 based upon the number of disciplinary actions it instituted against physicians.[216] The end result according to the director of the Baltimore City Medical Center was that discipline became “a legal procedure when it used to be a procedure of education.”[217]

The story of the professionalization of medicine shows that questions about how to regulate physicians and healthcare have deep historical roots. State medical boards, doctors, and the public have long been engaged in a struggle over the power to monitor health care. More recently, HMOs have altered the accountability landscape. Thus, the problems with regulating physicians who interpret mammograms are far from unique in this respect.

C. The Current Malpractice Crisis in Health Care as It Relates to the Regulation of Physicians

In fact, the rising number of malpractice cases over failure to diagnose breast cancer is just one part of an ongoing struggle over the quality of healthcare. The public has historically used and continues to use the tort system to discipline doctors it believes are negligent. Being the subject of too many suits will theoretically form the basis of an incompetency hearing. However, the malpractice crisis that has received a lot of attention in the media as of late leads one to question whether or not tort liability is an effective regulator of the medical profession.

In January of 2003, the Physician Insurers Association of America released a statement in which it commented on the problems that rising insurance premiums are creating for the health care system. It alleged that the average paid claim rose three times as fast as inflation over the last ten years and that the percentage of claims paid at $1,000,000 or more doubled between 1997 and 2001.[218] In light of these increased judgments, doctors are being forced out of medicine or forced to move to locations that are less litigious. But, according to the PIAA, these verdicts are not because of physician error but because of serious problems with our tort system. It noted that seventy percent of all malpractice claims are resolved without the patient receiving money and that when cases do go to trial, they lose eighty percent of the time.[219] PIAA thus believes that these statistics mean that the tort system should be reformed and supports systems like the California plan that cap malpractice recoveries.[220]

The picture painted by the prominent consumer group, Public Citizen, is quite different. In its January 2003 Report on Medical Misdiagnosis, Public Citizen took issue with a number of PIAA’s claims. It believes that physician failures, not a rampant tort system and greedy lawyers, are the real cause of the alleged “crisis,” and that few suits are frivolous. After conducting an analysis of the federal government’s National Practitioner Data Bank, covering all malpractice judgments and settlements since September 1990, Public Citizen found that 5.1 percent of doctors are responsible for fifty-four percent of all malpractice payouts.[221] Further, only seventeen percent of the doctors who have had to pay five or more claims have ever been subject to discipline.[222]

Instead of reforming the tort system, Public Citizen advocates for reform of the medical system. According to the group, current medical boards do little to monitor physician performance. Medical errors cause 44,000 to 98,000 deaths of hospitalized patients annually, but in 2001, state boards only imposed serious disciplinary sanctions in 2,708 cases.[223] In its report, Public Citizen calls on the government to make physician disciplinary information more publicly available and to include more members of the public on state medical boards. They allege that state disciplinary boards have been more concerned with education than protection of the public[224] and want boards to “require periodic recertification of doctors based on a written exam and audit of their patients’ medical records.”[225]

Regardless of one whether accepts the claims of Public Citizen or the PIAA, it is clear that there is a general crisis in the area of malpractice. Some of this crisis may indeed be the result of a high level of litigiousness, but given the historical struggle over physician accountability, it is likely that many of the problems are also due to physician failures. What these two opposing positions make clear, however, is that the problem of monitoring physician performance in mammography and the rise in the number of malpractice lawsuits is not unique to mammography. Even though Public Citizen claims that state boards see their role as an educational one not a punitive one, the data on doctor failures when interpreting mammograms and medical errors suggests that this educational campaign is not working. Essentially, education after five malpractice suits comes too late.

The MQSA attempts to remedy part of this problem. It mandates that all physicians who interpret mammograms fulfill certain continuing education and experience requirements. However, these requirements are insufficient to ensure that physicians receive adequate supportive educational instruction in the art of reading mammograms. Instead, what is needed is greater support for a system that would monitor physician performance before a lawsuit occurs.

In a recent report on the state of the MQSA, the GAO recommended that further studies be conducted on whether peer review organizations might be a possible solution to the problem of inadequate interpretation. [226] Past experience suggests, however, that physicians will be reluctant to utilize more peer review processes because this will involve greater oversight into the every day practice of medicine and intrusion into a domain generally viewed as an area of professional competence. Introducing more direct control upon the provision of mammography may drive even more physicians out of the practice area as the rise in malpractice lawsuit rates and rising insurance premiums already may be doing.[227]

As one New York Times article discussing how one HMO has handled this problem suggests, private industry may provide a partial solution as more HMOs institute quality assurance programs and review of doctors in order to protect themselves from liability.[228] One thing that is clear, however, is that the issue of how to ensure that physicians provide quality care extends far beyond mammography. The problems at issue – fear of intrusion into a professional space and the desire to control medical regulation at the state level exist wherever healthcare is provided.

VI. Conclusion

The issue of how to monitor the performance level of all physicians raises the question of whether or not additional mammography-specific regulations are the most effective means of improving the current state of mammography practice. In its 2002 report on the reauthorization of the MQSA, the House requested that GAO conduct a study on the physician performance issue. This report has not yet been issued and no further action on this problem has begun.

However, as this paper suggests, the issues involved in setting mammography regulations are complex. The MQSA is more than just a quality assurance statute. The passage of the MQSA was one of the crowning achievements of numerous women’s health advocates who have struggled to bring women’s health issues, other than those involving reproduction, to the center of national discourse. Their campaign has largely been successful. Breast cancer research awareness campaigns now exist throughout the country. The MQSA is also a key tool in the drive to make sure that women understand the benefits of mammography and undergo regular screening. Regulators and the health community regularly use the existence of the MQSA to assure women that mammography will be safe and effective. These pragmatic and symbolic dimensions of the MQSA make any critiques of the current regulatory apparatus or criticisms of proposed future regulations highly controversial, while simultaneously obscuring the ways in which mammography failures simply reflect general failures of the healthcare system.

Nonetheless, recent reports on the soaring malpractice rates in the areas of failure to diagnose breast cancer as well as studies showing that physicians may not be interpreting mammograms correctly make it impossible to ignore the issue of how the MQSA is working and whether or not further changes should be made. The MQSA is a very expensive program. In its first year of full operation, 1994, $10,000,000 were appropriated for the program[229] and an additional $1,000,000 were transferred from the Center for Disease Control for its implementation.[230] The Congressional Budget Office estimates that the reauthorization of the program, due this year, will cost $12,000,000 in 2003 and an additional $77,000,000 over the 2003-2007 period (assuming adjustments for inflation).[231] Of that amount, $52,000,000 will be for program services not covered by user fees.[232] Industry also supports the MQSA program through its payment of user fees for inspection. In Fiscal Year 2000, the MQSA cost $12,767,000 in user fees. In Fiscal Year 2001, that number was up to $15,128,000, and in Fiscal Year 2002 the estimated total was $15,590,000.[233] In addition, the proposal for Fiscal Year 2003 estimated that user fees would increase to $16,400,000.[234]

Advocates of the MQSA argue that costs should not be a huge factor when the regulations at issue will possibly save the lives of so many people.[235] They rightly point out that given the number of women who suffer and/or die from breast cancer, all of the costs incurred to date to prevent this disease are well-justified and well-used. The government absolutely should use its resources to regulate an industry that cannot regulate itself. However, when considering how and when existing programs should be expanded, one must look critically at the remaining problems and whether or not more mammography-specific regulations are the best way to address them. As evidenced by soaring malpractice rates and numerous studies, one of the largest remaining problems with mammography practice today involves the performance of the physicians who interpret mammograms.

Although some may call for expansion of the MQSA to include more skills tests and training programs for doctors, it is far from clear that this is the best way to resolve this problem. Once the symbolic significance of the MQSA is set aside and once one steps back from the desire to make sure that women trust mammograms and undergo screening, it becomes apparent that the physician interpretation problem is not unique to mammography. Unlike many of the early issues that led to the passage of the MQSA, like the use of non-designated equipment that emits high dosages of radiation or generally unqualified personnel performing mammograms, the skills and performance levels of individual doctors involve issues that cut to the core of the regulation of medicine.

These questions of who monitors physician performance and whether state medical boards truly hold physicians accountable extend back for decades. The recent debate over whether medical errors are responsible for the general rise in malpractice suits illustrates that this conflict is still ongoing. If indeed the problem is more widespread, as this debate suggests, a system-wide solution would improve the quality of doctors’ interpretation skills without providing further disincentives for physicians to provide mammography services as opposed to other medical services.

Furthermore, the regulatory resources saved could be used to fund additional research for finding a cure for breast cancer or to ensure that more low-income women receive regular health care or even to improve mammography technology. For example, R2 Technology, Inc. has recently begun to manufacture the first FDA-approved Computer Aided Detection System for breast imaging. This system, which is not a diagnostic device, is able to serve as a back-up for a radiologist’s interpretation of a mammogram. It surveys mammographic images and marks those images with “generally accepted geometric characteristics of microcalcifications or masses,” that may be indicative of a problem so that the radiologist will be sure to take a second look at them.[236] Efforts such as this may do far more to improve diagnosis and cure rates than additional mammography regulations. The past significance of the MQSA should not be allowed to obscure the ways in which the present problems in mammography reflect deeper, more fundamental problems with the quality of health care.

[1] Mammography Quality Standards Act, 42 U.S.C. § 263b (2003); 21 C.F.R. § 900.1 (2003).

[2] Improving the Quality of Mammography How Current Practice Fails: Hearing Before the Subcomm . on Aging of the Senate Comm. on Labor and Human Resources , 102nd Cong. 96 (1991) (statement of McClure H. Hall M.D.) (hereafter “Improving the Quality Hearing ”)

[3] Michael Moss, Spotting Breast Cancer: Doctors Are Weak Link, N.Y. TIMES , June 27, 2002, at A1

[4] How Far We’ve Come , HARVARD WOMEN’S HEALTH WATCH . Dec. 1, 1999, available at 1999 WL 8886060.


[6] Id .

[7] SUZANNE V. COCCA , Note and Comment, Who’s Monitoring the Quality of Mammograms? The Mammography Quality Standards Act of 1992 Could Finally Provide the Answer , 19 AM. J.L & MED . 313, 318 (Fall 1993).

[8] CANCER FACTS & FIGURES 2003 , supra note 5. See also , Breast Cancer Q&A/Facts and Statistics , available at http://www.komen.org/bci/bhealth/QA/q_and_a.asp (Last visited 3/8/2003) (noting that “[t]he two most significant risks are being female and getting older. The majority of women diagnosed with breast cancer have no other known risk factors.”)

[9] CANCER FACTS & FIGURES 2003 , supra note 5.

[10] Id.

[11] Id.

[12] Diagnostic mammograms are used to detect breast cancer in women who have one or more symptoms of the disease. See AMERICAN CANCER SOCIETY , Can Breast Cancer be Found Early , available at http://www.cancer.org (Last visited 3/8/2003).

[13] Mammography , at http://www.radiologyinfo.org/content/mammogram.htm (Last visited 3/8/2003)

[14] Cocca, supra note , 7 at 319; Can Breast Cancer Be found Early? , supra note 12.

[15] Can Breast Cancer be Found Early? , supra note 12.

[16] Id .

[17] AMERICAN COLLEGE OF RADIOLOGY , Mammography Remains Essential Component in Breast Cancer Detection , available at http://www.acr.org/mammography/112602_breast_mri.html (Last visited 2/7/2003). See also , Cocca, supra note 7, at 319 (citing Dr. Jerome Levy as stating “so far, none of them can do what mammography does; its image quality remains unsurpassed.”).

[18] Can Breast Cancer Be Found Early? , supra note 12.


[20] Id .

[21] Improving the Quality Hearing , supra note 2; Failure and Success of Current Mammography Practice: The Need for Strong Federal Quality Standards : Hearing Before the Subcomm .on Aging of the Comm .on Labor and Human Resources , 102nd Cong. (1991); Access to Quality Mammography Screening Hearing on H.R. 1393 and H.R. 3462 Before the Subcomm .on Health and the Environment of the House Comm .on Energy and Commerce , 102nd Cong. (1992) (hereafter “Access Hearing ”).

[22] S. REP. NO. 102-448, at 6 (1992).

[23] Id . at 4.

[24] See H. R. REP. NO. 102-889, at 24 (1992) (stating that “[t]he Committee notes the fine work of the American College of Radiology in establishing and operating an accreditation program. The Committee expects ACR to continue that work.”).

[25] S. REP. NO. 102-448, at 11 (1992). At the time that the Senate issued its report on the MQSA, fewer than half of all mammography facilities met the ACR’s professional standards. Id . at 5.

[26] Id . at 6. (noting that the Act “guarantees sufficient oversight and enforcement to ensure the highest quality mammography possible”).

[27] Mammography Quality Standards Act of 1992, Pub. L. No. 102-539, 106 Stat. 3547 (1992).

[28] Id . at 3548

[29] Id .

[30] Id . at 3550.

[31] Id . at 3552.

[32] Id .

[33] Id .

[34] Reauthorization of the Mammography Quality Standards Act: Hearing Before the Subcomm. on Health and Environment of the House Comm. on Commerce , 105th Cong. (1998).

[35] Mammography Quality Standards Reauthorization Act of 1998, Pub. L. No. 105-248, 112 Stat. 1864 (1998).

[36] H. R. REP. NO. 107-601(2002)

[37] See Mammography Quality Standards Act: Delegation of Authority, 58 Fed. Reg. 32543 (June 10, 1993).

[38] Quality Standards and Certification Requirements for Mammography Facilities, 58 Fed. Reg. 67565 (Dec. 21, 1993). These rules became effective on February 22, 1994. Minor amendments were made on September 30, 1994. See Quality Standards and Certification Requirements for Mammography Facilities, 59 Fed Reg. 49808 (Sept. 30, 1994).

[39] Requirements for Accrediting Bodies of Mammography Facilities, 58 Fed. Reg. 67558, 67569 (Dec. 21, 1993).

[40] Id . at 67559-60.

[41] Quality Mammography Standards: General Preamble and Proposed Alternative Approaches, 61 Fed. Reg. 14856, 14861 (Apr. 3, 1996).

[42] Quality Mammography Standards, 62 Fed. Reg. 55852 (Oct. 28, 1997).

[43] Quality Mammography Standards, 62 Fed. Reg. 55852, 55863 (Oct. 28, 1997)

[44] Id .

[45] 42 U.S.C. § 263b (h)(3).

[46] 21 C.F.R. § 900.3(b)(3).

[47] 21 C.F.R. § 900.4(a)(5).

[48] 21 C.F.R. § 900.4 (c)(1).

[49] 21 C.F.R. § 900.3(g).

[50] 21 C.F.R. 900.3(c).

[51] State Certification of Mammography Facilities, 67 Fed. Reg. 5446, 5446 (Feb. 6, 2002)

[52] Id .

[53] 21 C.F.R. 900.21.

[54] 21 C.F.R. 900.23.

[55] 67 Fed. Reg., at 5446.

[56] Id . at 5447.

[57] 21 C.F.R. § 900.12(a)(1)(i).

[58] 21 C.F.R. § 900.12(a)(1)(ii).

[59] 21 C.F.R. §900.12(a)(2) & (3).

[60] 21 C.F.R. § 900.12(b).

[61] 21 C.F.R. § 900.12 (c)(2).

[62] 21 C.F.R. § 900.12 (c)(3).

[63] 21 C.F.R. § 900.12 (d).

[64] 21 C.F.R. § 900.12(e)(2).

[65] Improving the Quality Hearing , supra note 2 at 75; FLORENCE HOUN, M.D. ET AL ., The Mammography Quality Standards Act of 1992: History and Process , 50 FOOD & DRUG LAW JOURNAL 485, 486 (1995).

[66] Improving the Quality Hearing , supra note 2 at 75.

[67] In November 1990, as part of the Omnibus Budget Reconciliation Act of 1990, Congress adopted regulations stating that mammography facilities had to meet certain quality assurance criteria in order to qualify for Medicare reimbursement. Id. at 74 (appendix).

[68] Id . at 3 (opening statement of Senator Adams).

[69] Id . at 73 (appendix).

[70] Id. at 3 (opening Statement of Senator Adams).

[71] Id. at 83 (appendix).

[72] Houn , supra note 65 at 485.

[73] Id .

[74] How Far We’ve Come , supra note 4.

[75] Id .

[76] Access Hearing , supra note 21, at 5 (statement of Hon. Mike Synar of Oklahoma); See also Improving Quality Hearing , supra note 2 at 25. (“[W]e have ignored women’s health issues...That is why we have had the hearings out here this time.”).

[77] Access Hearing , supra note 21 at 81.

[78] Id. at 81 (testimony of Fran Visco, President, Breast Cancer Coalition).

[79] Id . at 85.

[80] Id . at 15 (statement of Hon. Olympia J. Snowe of Maine).

[81] Id.

[82] BARBARA MIKULSKI , Mammography Quality Standards Act Fact Sheet , at http://www.senate.gove~mikulski/press/factsheets/mqsa.htm.

[83] Id.

[84] The statute, in an effort to preserve the traditional power of the States over the practice of medicine, provides that: “Nothing in this section shall be construed to limit the authority of any State to enact and enforce laws relating to the matters covered by this section that are at least as stringent as this section or the regulations issued under this section.” 42 U.S.C. § 263b(m). Thus, the MQSA establishes a floor for mammography quality, not a uniform set of standards.

[85] COCCA , supra note 7 at 323.

[86] CAROL LEWIS , FDA Sets Higher Standards for Mammography , available at http://www.fda.gov/fdac/features/1999/199_mamm.html (Last visited 1/31/2003).

[87] Improving Quality Hearing , supra note 2 at 13 (testimony of Ms. Susan R. Everly).

[88] See Breast Cancer: Minority Women Screened in Fewer Numbers , WOMEN’S HEALTH WEEKLY , Nov. 22, 2001, available at 2001 WL 17559288.

[89] Mammography Rates Increasing Nationwide , 27 THE NATION’S HEALTH 3 , 3 (Nov. 1997).

[90] Statement of Fran Visco, National Breast Cancer Coalition, (Feb. 28, 2002), available at http://www.natlbcc.org. (Last visited 3/8/2003).


[92] Id.

[93] Id.

[94] Id.

[95] LEWIS , supra note 86.

[96] Id.

[97] CAROL LEWIS , Breast Cancer: Better Treatments Save More Lives , available at http://www.fda.gov/fdac/features/1999/499_breast.html (Last visited 1/31/2003).

[98] NATIONAL CANCER INSTITUTE . Screening Mammograms: Questions and Answers , available at http://cis.nci.nih.gov/fact/5_28.htm (Last visited 3/8/2003).

[99] AMERICAN CANCER SOCIETY , What to Expect from a Mammogram , ACS NEWS CENTER , Dec. 1, 1999, available at http://www.cancer.org (Last visited 3/8/2003).

[100] Celeste Rob-Nicholson, M.D., By the Way Doctor – Should I Still Get Mammograms? , HARVARD WOMEN’S HEALTH WATCH . Mar. 1, 2002, available at 2002 WL 7669968. Seealso AMERICAN CANCER SOCIETY , The Mammogram Controversy , available at http:/www.cancer.org (Last visited 2/7/2003).

[101] Breast Cancer Mortality Not Reduced by Mammography, said University of Toronto Study , WOMEN’S HEALTH WEEKLY, Oct, 3, 2002, available at 2002 WL 9191776. Mammograms: To Screen or Not to Screen? , HARVARD WOMEN’S HEALTH WATCH , Dec. 1, 2002, available at 2002 WL 7670018.

[102] Breast Cancer: Regular Mammography Screening Identifies Breast Cancer at an Earlier Stage , WOMEN’S HEALTH WEEKLY , Jan. 23, 2003, available at 2003 WL 8991798. See also The Mammogram Controversy , supra note 100.

[103] Breast Cancer: Scientific Dispute Raises Question: Do Mammograms Really Save Lives? , WOMEN’S HEALTH WEEKLY , Feb. 14, 2002, available at 2002 WL 9190942.

[104] Id .

[105] Press release, American College of Obstetricians and Gynecologists, Medical Experts Still Recommend Mammography , (Feb. 3, 2002), available at http://www.acog.org/from_home/publications/press_releases/nr02-03-02.cfm

[106] SUSAN J. LANDER . Mammography’s role in detecting breast cancer reinforced. AMEDNEWS.COM , Mar. 11, 2002. available at http://www.ama-assn.org/sci-pubs/amnews/pick_02/hlsb0311.htm (Last visited 3/8/2003).

[107] Steven Woloshin, M.D. et al., Women’s Understanding of the Mammography Screening Debate . 160 Archives of Internal Medicine 1434 (May 22, 2000), available at http://archinte.ama-assn.org/cgi/content/full/160/10/1434 (payment of fee required for access to study) (Last visited 3/8/2003) (on file with author).

[108] Id.

[109] Id.

[110] Rob-Nicholson, supra note 100.

[111] For example, in addition to the considerable scientific debate about the effectiveness of screening mammography, the fact that even the best doctors will not be able to detect of 15% of cancerous lesions in women who have dense mammary tissue or that 75% of suspicious lesions turn out to be benign after biopsy. Digital Mammography , HARVARD WOMEN’S HEALTH WATCH ., Nov. 1, 1997, available at 1997 WL 9498539. Mammography is also less effective for women who have breast implants. See LEWIS , supra note 86.

[112] Improving the Quality of Mammography Hearing , supra note 2, at 79.

[113] LEWIS , supra note 86.

[114] Id .

[115] Improving the Quality of Mammography Hearing , supra note 2 at 76.


[117] Id . at 9.

[118] Id. at 6, 10 – 11.


[120] Id . at 19.

[121] 2002 PIAA STUDY at 2.

[122] Id .

[123] Breast Cancer Litigation Group, ATLA Annual Convention Reference Materials, Vol. 2 (July 2001), available at LEXIS, 2 Ann. 2001 ATLA-CLE 1779.

[124] MIA I FRIEDER & ANTOINETTE D. JOHNSON , When Time is Running Out: A Delayed Diagnosis of Breast Cancer May Leave Patients with Little Hope of Recovery: Here’s How to Prove the Physician’s Negligence . 37 TRIAL 58 (Oct. 2001) at 60.

[125] ELEANOR KINNEY , The Brave New World of Medical Standards of Care , 29 J.L. MED. & ETHICS 323, 324 Fall-Winter 2001).

[126] Id. at 324.

[127] Id .

[128] Id .

[129] Id .

[130] Improving the Quality of Mammography Hearing , supra note 2 at 20.

[131] KINNEY , supra note 125 at 325.

[132] KINNEY , supra note 125 at 324.

[133] Improving the Quality Hearing , supra note 2 at 27 (acknowledging the concern that quality assurance programs would “invite damage or libel suits against the supervising organization.”)

[134] KINNEY , supra note 125 at 329.

[135] Id . at 323.

[136] Andrew L. Hyams, et al., Medical Malpractice Guidelines in Malpractice Litigation: An Early Retrospective , 21 J. HEALTH POL. POL’Y & L. 289, 293-96 (1996).

[137] KINNEY , supra note 125 at 329.

[138] MICHELLE M. MELLO , Of Swords and Shields: The Role of Clinical Practice Guidelines in Medical Malpractice Litigation, 149 U. Pa. L. Rev. 645, 709 (Jan. 2001).

[139] BI-RADS are the measures on a scale developed by the ACR to standardize terminology used by radiologists in delivering mammography reports. The scale ranges from 0, an incomplete assessment, to 5, a high likelihood of malignancy. MIA I FRIEDER , supra note 124 at 61.

[140] MIA I FRIEDER , supra note 124 at 61-62.

[141] Patricia C. Bobb, Direct and Cross-Examination of Radiologists, Breast Cancer Litigation Group Annual ATLA Convention Reference Materials. Vol. 1, (July 2000 ) (not paginated), available at Westlaw, 1 Ann. 2000 ATLA CLE 209 (2000).

[142] IRWIN M. ELLERIN ET AL ., Handling a Failure to Diagnose Breast Cancer Case , Breast Cancer Litigation Group, ATLA Annual Convention Reference Materials, Vol. 2. July 2001., available at Westlaw, 2 Ann.2001 ATLA-CLE 1779 (2001) (not paginated).

[143] BRADLEY C. NAHRSTADT & CHRISTINA D. KETCHAM , A Primer on Defending Breast Cancer Litigation ,25 AM. J. TRIAL ADVOC . 451, 464 (Spring 2002).

[144] Id. at 458.

[145] MICHAEL M. RASKIN, MD, MPH, JD , Why Radiologists Get Sued , Medscape WebMd, available at http://www.medscape.com/viewarticle/406661 (Last visited 2/28/2003) (subscription required) (on file with author).

[146] 578 A.2d 970 (Penn. 1990).

[147] 21 C.F.R. § 900.12 (c)(2).

[148] Smith v. United States of America , 119 F.Supp.2d 561, 563 (D.S.C. 2000).

[149] Id . at 580.

[150] 821 So.2d 722 (2nd Cir. 2002).

[151] Id . at 730.

[152] Id .

[153] LEONARD BERLIN , Malpractice Issues in Radiology: Communicating Findings of Radiologic Examinations: Whither Goest the Radiologist’s Duty? 178 AM. J. RADIOLOGY 809, 813 (Apr. 2002).

[154] Id. at 813.

[155] 248 N.W.2d 344 (Neb. 1977).

[156] You will recall there were concerns about the radiation risks of mammography. See LEWIS , supra note 86.

[157] 173 A.D.2d 967 (N.Y. 1991).

[158] Id . at 969.

[159] Id .

[160] Id .

[161] 932 F.2d 301 (4th Cir. 1991).

[162] Id . at 303.

[163] 616 A.2d 623 (Penn. 1992).

[164] Id . at 628.

[165] Current recommendations state that screening mammograms should begin at age 40. However, there has been scientific debate about the usefulness of performing mammograms this early. See e.g. , Position Statement on Screening Mammography, National Breast Cancer Coalition, (Jan. 2003), available at http://www.natlbcc.org/bin/index.asp?strid=560&depid=9&btnid=1 (Last visited 2/7/2003).

[166] 605 So.2d 824 (Ala. 1992).

[167] Id . at 826.

[168] 716 F.Supp. 1378 (D. Kan. 1989).

[169] Mammography Quality Standards, 38 U.S.C. § 7319 (2003).

[170] 168 A.2d 412 (N.Y. 1990).

[171] Frieder, supra note 124 at 60.

[172] 35 S.W.3d 354 (2000).

[173] However, she lost at trial and on appeal because the court found that the statute of limitations had run on her claim. The court refused to see the center’s treatment as a continuous course of treatment. Instead it treated each mammogram as a distinct event. Baker at 359.

[174] 2002 WL 988175 (10th Cir. 2002).

[175] Id . at 4.

[176] See Newell v. Ruiz , 286 F.3d 166 (3rd Cir. 2001).

[177] BERLIN , supra note 153 at 810.

[178] 21 C.F.R. 900.12(a)(1)(i)(C) &(a)(1)(ii)(A)

[179] 2002 PIAA STUDY at 10.

[180] Id .

[181] Id .

[182] National Cancer Institute, Cancer Facts, available at http://cis.nci.nih.gov/fact/5_28.htm (Last visited 3/8/2003).

[183] See LEWIS , supra note 86.

[184] See http://www.r2tech.com/prd/index.html (Last visited 4/22/03) (describing the new technology that is intended as a back-up for physicians and not a diagnostic tool).

[185] Improving the Quality Hearing , supra note 2 at 5.

[186] Id . at 8.

[187] Id . at 9.

[188] 21 C.F.R. § 900.12(a)(1)(i) – (iv).

[189] Cullen Ruff, MD and Robert McLelland, MD. 269 JAMA 3110 (June 23, 1993).

[190] Id .

[191] Interpreting Mammography , HARVARD WOMEN’S HEALTH WATCH , Feb. 1, 1995, available at, 1995 WL 10430683.

[192] Michael Moss, Spotting Breast Cancer: Doctors Are Weak Link, N.Y. TIMES , June 27, 2002, at A1.

[193] Id.

[194] 1997 GAO STUDY, supra note 119 at 11.

[195] Id .

[196] EDWARD P. RICHARDS , The Police Power and the Regulation of Medical Practice: A Historical Review and Guide for Medical Licensing Board Regulation of Physicians in ERISA-Qualified Managed Care Organizations , 8 ANNALS HEALTH L. 201 , 205 (1999)

[197] Id .

[198] Id . at 209.


[200] Id . at 14.

[201] ROSS D. SILVERMAN , Regulating Medical Practice in the Cyber Age: Issues and Challenges for State Medical Boards , 26 AM. J.L. & MED . 255, 256 (2000).

[202] 129 U.S. 114 (1889).

[203] 129 U.S. 114, 122 (1889).

[204] Id . at 123.

[205] AMERINGER , supra note 199; Id . at 14 – 16.

[206] Id . at 18.

[207] Id . (discussing the thesis of A.M. Carr-Saunders and P.A. Wilson positing that all the public wanted was “good judgment.” They did not want to undermine initiative and early boards could embark on a crusade of “heresy hunting” if they sought out to enforce strict standards.)

[208] Id . at 19.

[209] Id . at 29.

[210] TIMOTHY STOLZFUS JOST , Oversight of the Quality of Medical Care: Regulation, Management or the Market? ” 37 ARIZ. L. REV . 825, 831 (Fall 1995).

[211] AMERINGER , supra note 199 at 44.

[212] Id . at 53. See also JOST at 834.

[213] AMERINGER , supra note 199 at 48.

[214] Id . at 100; See also , MURRAY G. SAGSVEEN & JENNIFER L. THOMPSON , The Evolution of Medical Peer Review in North Dakota , 73 N.D. L. REV. 477, 478 – 483 (1997) (discussing the rise of peer review organizations).

[215] Id . at 100.

[216] Id . at 106.

[217] Id . at 106.

[218] Statement, Physician Insurer’s Association of America, Medical Malpractice Crisis, (Jan. 29, 2003), available at http://www.thepiaa.org (Last visited 3/27/2003).

[219] Id .

[220] Id . See also Press Release, Public Citzens, Medical Errors, Not Lawsuits are Real Cause of Rising Malpractice Claims (Jan. 9, 2003) (on file with author).

[221] Public Citizen, MEDICAL MISDIAGNOSIS: CHALLENGING THE MALPRACTICE CLAIMS OF THE DOCTORS’ LOBBY . (Jan. 2003) at 3 (on file with author).

[222] Id .

[223] Id . at 5.

[224] Id . at 35.

[225] Id . at 36.

[226] H.R. REP. NO. 107-601 , at 2 (2003).

[227] See e.g. , MICHAEL D. TOWLE , Missing the Diagnosis: When A Mammogram Fails, Does a Woman Have the Right to Sue , at http://mywebmd.com/content/article/13/1691_50170 (Last visited 3/25/03).

[228] Michael Moss, Mammogram Team Learns from Its Errors, N.Y. TIMES , June 28, 2002 at A1 (describing an HMO’s system for review of physician performance in mammogram interpretation).


[230] Id. at 1180.

[231] H.R. REP. NO. 107-601 , supra note 226 at 5.

[232] Id . at 6.

[233] FOOD AND DRUG ADMINISTRATION , All Purpose Table – Current Law User Fees , available at http://www.fda.gov/oc/oms/ofm/budget/2002/CJ2002/CurrLawUserFees.PDF (Last visited 3/30/03).

[234] FOOD AND DRUG ADMINISTRATION , FDA’s Budget Proposal for FY 2003 , available at http://www.fda.gov/bbs/topics/ANSWERS/2002/ANS01135.html (Last visited 3/30/03).

[235] Access Hearing , supra note 21 at 13 (pointing out that extra costs would not cause two seconds of pause if it means saving the lives of family members).

[236] See Description of the ImageChecker System, available at http://www.r2tech.com/prd/index.html (Last visited 4/22/03).