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Vaccine Manufacturers and Breast Implant Manufacturers:

Same Game, Same Strategies. A Mere Coincidence?

by Michael R. Hugo, Esq.
4 Faneuil Hall Market Place, 3rd Floor
Boston, Massachusetts 02109
617.973.9777
Copyright Michael Hugo 1996

The Consumer Law Page is pleased to honor this work by attorney Michael Hugo. His compelling analysis comparing the misconduct of vaccine and breast implant manufacturers is commended to you.

Mr. Michael Hugo, a respected advocate, legal scholar and caring practitioner, stands in the vanguard of American lawyers who are advocates for the public good. He serves as a leader in the plaintiff's committee on breast implant litigation and is highly regarded for his conscientious commitment to the cause of justice for victims of corporate abuse.

This article was first published by the Association of Trial Lawyers of America in its 1996 Boston Convention Syllabus where it was discovered by The Consumer Law Page. We are extremely pleased to have Mr.Hugo's permission to reprint his work here. We salute his distinguished efforts on behalf of the victims of breast implants and we commend him as a leader in the legal profession to be emulated by all aspiring attorneys.

It is indeed appropriate that he makes his office in historic Faneuil Hall, a stone's throw from the site of the Boston Massacre and the home of America's most distinguished lawyers whose clients included a new nation at its birth.

To Mr. Hugo and his colleagues fighting for the cause of women and children victimized by medical devices, vaccines and drugs, our highest compliments for your vigilant efforts on the side of human justice. Godspeed in your efforts to achieve justice for the victims of corporate abuse. You are a tribute to the legal profession.

Richard Alexander, Publisher
The Consumer Law Page
October 26, 1996

I. Introduction

If pertussis vaccine is administered to children who have pre-existing conditions or have had a severe reaction to a previous administration, the result can be devastating. Pediatricians must be ever vigilant. For manufacturers of vaccine to allay the fears of pediatricians by suggesting that DTP is safe is one thing; for them to do so under the auspices of a reputable peer reviewed journal, by authors who fail to disclose their financial interest, is quite another.

II. Revealing Critical Conflicts of Interest Regarding DTP

One such journal, the Journal of the American Medical Association (JAMA) ran an article several years ago. ^[1] In an editorial run in the same issue, the writer sought to convince readers that pertussis vaccine encephalopathy was a "myth." ^[2] The editorial was authored by James D. Cherry, M.D., the leading defense expert witness in vaccine litigation. Dr. Cherry failed to disclose his significant financial ties to Lederle Laboratories, Wyeth Laboratories, Connaught Laboratories, Parke-Davis & Company, or Eli Lilly & Company -- the major DTP vaccine manufacturers in this country. Similarly, Dr. Edward Mortimer, of Case Western Reserve School of Medicine, failed to disclose his ties to the industry in the underlying article that appeared in the same issue. ^[3] JAMA authors must sign a statement that they have no financial interest in the subject matter, including "consultancies" between the author and the manufacturer of the drug being reported. There is an editorial policy of JAMA concerning ethical and financial conflicts of interest. In any publication, the integrity of the articles is a direct function of the integrity of the authors. As peer reviewers for JAMA, Drs. Cherry and Mortimer ^[4] have been entrusted to ensure the scientific integrity of the works they review for that journal. The obligation of a journal's editorial board members is to come forward with information concerning potential ethical violations prior to the publication of an article in the journal if they know of the existence of such conflicts.

Dr. Cherry has been actively reviewing DTP cases on behalf of the pharmaceutical manufacturers since the early 1980s. He was a collaborator in the UCLA/FDA study carried out in the late 1970s. That study revealed an incidence of 1:1750 seizures and an additional 1:750 hypotensive hyporesponsive episodes within 48 hours following DTP administrations. The study was originally funded to examine 50,000 administrations of DTP, but was terminated after 15,752 DTP and 784 DT administrations. The study was plagued by an unacceptably high incidence of seizures in the first 1500 doses. Dr. Larry Baraff, the principal investigator of that study, reported to Wyeth Laboratories on September 6, 1978, that DTP vaccine has produced 5:1500 (1:300) generalized seizures, all in infants under six months of age which is below the usual lower limit defined for febrile seizure disorders. There had been 2:1500 (1:750) incidents of hypotensive hyporesponsive shock collapse.^[5]

Following the completion of the UCLA/FDA study, Dr. Cherry was named associate editor of the Report of the American Academy of Pediatrics Committee on Infectious Diseases, known as the Red Book. He served under Dr. Jerome O. Klein, the editor, and Dr. Vincent A. Fulginiti, the chairman of the committee, and is a current member of the JAMA editorial board.

At about this time, in December of 1981, Dr. Cherry was contacted by Patrick Hast, a lawyer representing Parke Davis in a DTP case. So began his participation in hundreds of lawsuits on behalf of defendants being sued for vaccine liability.^[6] Dr. Cherry recently began a presentation at the National Institutes of Health (NIH) with an unpublished slide of an elephant that had various parts depicting the factions in the vaccine injury controversy. He selected the anus as the lawyers.^[7] In 1988, Dr. Cherry estimated that he was making about $50,000 per year testifying for manufacturers, based on an hourly fee of $200, in about 90 cases. Today. he charges over $260 per hour and has reviewed hundreds of cases.^[8]

In addition to these sums, Dr. Cherry has attained $400,000 in grant funds for UCLA, much of which is applied to his research, expenses, and salary. Although this sum is applied to his department at UCLA, Dr. Cherry eventually receives the benefit of most of it. Dr. Cherry's department has also recently received $450,000 in unrestricted funds he calls a "gift," from Lederle. This was so designated to allow Dr. Cherry free access to more of the money.

When confronted with his failure to declare this money on his JAMA financial disclosure form which he signed prior to publication of his editorial, Dr. Cherry, a member of Lederle¹s editorial board, told a television reporter, "I don't know what I signed." Following the airing of the television news story on WHDH Television in Boston, the Los Angeles Times, Dr. Cherry's home-town newspaper, viewed the WHDH-TV film and contacted Dr. Cherry for further comment. From the time WHDH spoke with him to the time the Los Angeles Times contacted him, Dr. Cherry amended his response, telling the Los Angeles Times, "When I signed this thing, I actually thought about it and read it sort of carefully because I know this is a sensitive area. As it turns out, I did think about this. I thought this is generic, not really specific."

The rationale behind the "generic" comment is explained in the Los Angeles Times as Dr. Cherry's belief that his article did not concern Lederle's product in specific, but referred to pertussis vaccines in general. Because he is a consultant for Lederle, Cherry did not believe it was necessary to declare the existence of the funding. He stated, "[t]his particular editorial relates in no way to a specific manufacturer, it relates to the pertussis vaccine." Lederle, one of two United States manufacturers, is by far the largest supplier of DTP in this country. While WHDH-TV has discussed Dr. Cherry's ties to Lederle only, Dr. Cherry has also taken grant money and consulted for Wyeth Connaught, Parke Davis, Merrell Dow, Burroughs-Wellcome, and Connaught Canada. Additionally, Dr. Cherry has shared his manuscripts with the legal department of at least one manufacturer prior to submission for peer review and publication. How can he claim that he is not in conflict?

Dr. Mortimer, one of the co-authors of the Griffin study, has also failed to reveal a conflict of interest. Dr. Mortimer has testified that he participated in many case reviews for DTP manufacturers. He failed to disclose that, as a member of the AAP Red Book Committee, he participated in a policy decision to testify on behalf of the manufacturers in DTP suits. He testified under oath that:

Several years ago, because of the increasing number of litigation over DTP, members of the so called Red Book Committee . . . agreed in a sense that we would sort of divide up the cases to try to help the manufacturers in these lawsuits, and therefore I and a number of my colleagues agreed to serve as expert witness[es].^[9]

Dr. Mortimer has gone on at least three trips to Japan on behalf of Wyeth Laboratories. Like Dr. Cherry, he has appeared in litigation for most of the manufacturers, and has lectured to Wyeth's team of defense attorneys on how to better defend themselves against the vaccine-damaged children. Dr. Mortimer has also consulted for Lederle on a large scale. He has lectured to their legal staff and assisted them with defense strategies. In addition, he has lectured lawyers for Connaught and Parke Davis in similar strategy sessions. Dr. Mortimer failed to disclose this to the JAMA in the submission of his manuscript, notwithstanding the position of trust bestowed upon him as a member of peer review staff.

The casual mention accorded the endowment of the chairs occupied by Drs. Griffin and Ray, as Burroughs-Wellcome Scholars in Pharmicoepidemiology at Vanderbilt University is also an incomplete statement of the truth. The article should have mentioned that Burroughs-Wellcome is the largest supplier of DTP vaccine to the United Kingdom.

It should also be mentioned that Dr. Griffin, notwithstanding her connection to that DTP manufacturer, is also a member of the Institute of Medicine¹s Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines. This is supposed to be an impartial and uninfluenced committee. During his prefatory remarks at the public meeting of the committee held on January 10, 1990, the chairman of that committee, Dr. Harvey V. Fineberg, stated:

I wanted to emphasize that the committee is dedicated to seeking the scientific basis of evidence and will not be influenced by political, financial, or legal considerations.^[10]

These are not doctor versus lawyer issues. These are doctor-patient issues. Politics and self interest must never take a part in such considerations.

III. Cover-Ups Involving Silicone Breast Implants

Similarly, and more recently, the manufacturers of silicone breast implants have affected the medical literature in an attempt to color the studies in a light most favorable to their litigation agenda. Some of America's largest companies have spent millions of dollars attempting to persuade the public that breast implants do not cause disease despite the growing body of evidence demonstrating that silicone breast implants do, in fact, cause harm. The manufacturer¹s position is based on two seriously flawed population-based studies that purport to show a lack of causal connection between breast implants and disease.

Similar to that of the vaccine manufacturers, this campaign has two purposes. The first is to improve its position in the litigation over breast implants by attempting to persuade the public that implants are safe. The second, and more devious reason, is to divert public attention from the fact that they sold a medical device intended for long-term implantation in the human body without any testing to determine whether it was safe or defective. Indeed, the information they possessed raised serious questions about the safety of implants, but the companies elected to put profit before public safety. Contrary to the manufacturers' media oriented assertions, there was and is compelling scientific evidence that silicone breast implants cause atypical diseases in women -- diseases that can be seriously debilitating and come with tremendous cost to the individual and society. Most of this information comes from studies conducted by the manufacturers before implants were marketed. Moreover, the breast implant controversy is another tragic example of the way in which women have been injured by inadequately tested products.

In 1962, Dow Corning Corp., a joint venture of the Dow Chemical Co. and Corning, Inc., introduced the first silicone breast implant. Prior to the introduction of liquid silicone gel implants, women had liquid silicone injected directly into their breasts. These injections caused, in most if not all cases, severe complications. The liquid based silicone gel implant was intended to remedy the problems caused by direct injections of silicone.

These implants, promoted as being fit to last a lifetime, were constructed of a rubberized silicone shell surrounding a silicone gel which, in finished form, is 80 to 85 percent liquid silicone. By the late 1960s, silicone manufacturers were aware that this silicone gel would bleed out of the implants and migrate throughout the body. Indeed, in 1965, one Dow Corning scientist wrote "we know that something is getting out of the bag . . . ." And by 1980, the manufacturers were aware that silicone gel would pass through breast milk. The manufacturers never informed the public of these or other findings that raised further serious questions about the safety of implants.

The chemical makeup of silicone gel implants was virtually identical to the chemical makeup of liquid silicone that was injected into the breasts of women. The known complications associated with liquid silicone injections included atypical immune diseases that the researchers at the time termed "human adjuvant disease."

Silicone gel implants did not remedy the problems caused by direct injections, and even caused other equally serious problems. The shell was fragile; it permitted the silicone to leak out of the implant and into the women¹s bodies and rupture under normal use. The gel, largely made up of fluid, escaped from the shell and moved throughout the woman's body.

Dow Corning was not alone in its discoveries. By the 1970s, all of the manufacturers had become aware of a growing leakage and rupture problem. Indeed, as plastic surgeons began to see complications in their patients -- complications that appeared remarkably similar to those seen with liquid silicone injections -- they expressed their alarm to the manufacturers.

Notwithstanding these complaints, the manufacturers assured the plastic surgery community that its concerns were unwarranted. They repeatedly restated their position that silicone was biologically inert and was safe for use, despite having no long-term studies to support this claim.

Shockingly, while making those representations, the leading manufacturer, Dow Corning, was engaged in a secret program, in conjunction with its parent Dow Chemical Co., to utilize liquid silicone as pharmaceutical drugs, vaccines, and insecticides. Indeed, in the late 1960s and early 1970s, Dow Corning conducted a series of research studies that concluded that silicone does stimulate the immune system. This is in contrast to the position they now assert that liquid silicone from their implants does not stimulate the immune system.

At the same time, Dow Corning and Dow Chemical, to whom the other manufacturers looked for leadership, were also investigating the use of liquid silicone as insecticides, fungicides, and herbicides. The same liquid silicone found in breast implants succeeded in killing cockroaches. The public, and specifically the women who were being induced to purchase implants, were never told of these studies, nor the potentially toxic properties of the silicone.

Again, Dow Corning was not alone in its failure to look into possible problems with the implants. One of its competitors, Heyer-Schulte, had been an early manufacturer of intracranial hydrocephalic shunts. Prior to introducing those shunts, undeniably medically necessary products, Heyer-Schulte spent three years studying potential consequences. It, like other manufacturers, did no such research on breast implants.

The manufacturers did not maintain any registries of implanted women so that their health and complication rates could be tracked over the years. Such registries are common among manufacturers of potentially hazardous products. Michelin Tire Co. and Chrysler could not accomplish a meaningful product recall without maintaining such registries. Surely, a manufacturer of an implantable medical device should be held to a standard at least as rigorous as that of an automotive manufacturer or a software development company.

Even though the manufacturers put implants on the market without any long term testing of their safety, the manufacturers had ample evidence of local complications long associated with implants -- evidence they chose to ignore. For example, problems of contracture (severe hardening of the breasts), rupture, bleeding, and migration of the silicone to various parts of the body were well known to the industry. When a medical device is implanted into a human body, a capsule forms around the implant as part of the body's attempt to wall off the implant. Such a reaction is not abnormal. With breast implants, however, the manufacturers quickly learned that the capsules were different. In many women (estimates as high as 80 percent), the capsule, consisting of scar tissue, would tighten and compress the implant, causing severe pain, hardening of the breasts, deformity, and, in some instances, rupture of the implants.

Coupled with the contracture was the development of chronic inflammation. All breast implants bleed, allowing silicone to escape into the body, even if the implant shell does not rupture. At first the manufacturers denied that the implants bled, but when faced with uncontroverted evidence that liquid silicone was escaping from the implant shell, they changed their marketing strategy, asserting that "low bleed" was beneficial. Again, they had no medical or scientific evidence to support such a claim.

But the local complications do not stop with contracture and chronic inflammation. The shell of the implant was fragile and became increasingly fragile in use as silicone fluids passed through the shell and the shell interacted with body fluids. Doctors often had a difficult time determining whether implants ruptured due to hardening of the breasts, and rupture rarely showed up on mammography.

The consequences of ruptured silicone breast implants are serious and deforming. The surgery to remove the ruptured implant and the attendant loose gel can result in serious disfigurement because the surgeon often must scrape and cut away large amounts of otherwise viable breast tissue in order to excise the gel.

In recognition of the potential harm caused by liquid silicone, the manufacturers admitted that ruptured implants should be removed. The migrated silicone has been found, in large amounts, in lymph nodes, knees, arms, and even, in a recent case, in spinal fluid. One woman found silicone gel in her elbow, gel that had migrated from her ruptured Heyer-Schulte implant. In fact, her plastic surgeon has testified that he removed a half Dixie cup full of silicone from her arm. Repeat surgeries to remove continuing evidence of silicone have led to further disfigurement not to mention serious financial demands on women.

IV. Autoimmune Conditions and Breast Implants

As painful as the disfigurement may be, an even more serious problem exists -- silicone breast implants cause severe and debilitating autoimmune conditions.

In the early 1960s, medical literature reported diseases and conditions caused by liquid silicone injections. Many doctors who have seen and attempted to treat women with these conditions believe that this atypical autoimmune presentation is the result of a chronic immune response to the silicone that the body is exposed to when the implant bleeds or ruptures. Indeed, from the early manufacturer studies to more recently published studies, the silicone gel and the fluid contained therein has been proven to be a powerful booster of immune response.

While the silicone fluid and gel have been proven to have their own immune effects, even more disturbing is research conducted by both the manufacturers and independent scientists demonstrating the breakdown of the gel in the body and attendant formulation of even more toxic substances. Recent studies show that the gel degrades into other substances, including silica. Numerous epidemiological studies have demonstrated that exposure to silica leads to a variety of autoimmune conditions. Because it may take years for the body to break down silicone into its constituent silica, symptoms in many women may not surface until six to ten years or longer after implantation. This is similar to the latency period for asbestos-related diseases, which at times did not appear for decades.

Recent controlled epidemiology studies show that women with breast implants have elevated antibodies, which are the most common markers (indications of) for autoimmune disease. These studies used blood samples from exposed women and compared them to double blinded controls and have led to the conclusion that the serologic hallmarks of autoimmune disease are found in women with implants and not in women without implants. Similarly, one researcher has recently published DNA/genetic susceptibility.

The symptoms of this atypical disease process include: sicca symptoms (climically determined dry eyes, dry mouth, and dry vagina); joint pains; muscle pains; and cognitive dysfunction. In its more serious presentation, the disease includes central nervous system impairment (often as a result of an immunological response), kidney failure, and even death. The unique group of symptoms seen in women with breast implants is not seen in the general population.

From animal studies, which demonstrate convincingly and unassailably that silicone produces chronic immune response, to well-conducted clinical studies, which report on the results of examinations and evaluations of thousands of women with breast implants, to controlled epidemiology studies proving elevated antibodies in implanted women, the scientific evidence overwhelmingly shows that silicone breast implants cause systemic disease. Moreover, the data submitted to the Claims Office in Houston showing that one in ten women with breast implants suffers from an atypical disease further bolsters this conclusion.

V. Conclusion

In 1991, facing a growing public outcry over implants and their consequences, the president of Dow Corning Wright Co. wrote, "the cover-up is going well." Since 1991, the manufacturers have deliberately engaged in a campaign designed to misdirect public attention and to cover up the very real and serious consequences that women with implants suffer. The centerpiece of the manufacturers' efforts has been the design and funding of several misleading statistical studies. These studies were narrowly designed to look for a limited set of classical diseases, rather than for the atypical disease process now recognized to exist in thousands of women with breast implants. The studies were reviewed, not by the company scientists, but by the company lawyers in an effort to ensure that the results would support the manufacturers' position in litigation.

Neither the much-touted Harvard Nurses' Study nor the oft-cited Mayo study looked at the atypical disease process that the literature says is caused by implants. Indeed, neither even address the issue of whether silicone causes atypical disease and neither look at the issue of latency. In fact, the Harvard study of 876 women included one woman who had her implants for thirty days. More shockingly, however, that study also included at least two women whose implants preceded the date of invention of the device, according to the text of the study. These two studies were carefully designed not to find the obvious, or the truth.

The manufacturers' attempts to cover up the real science is consistent with their pattern of covering up the real consequences of their products.

Endnotes

1. M.R. Griffin et al., Risk of Seizures and Encephalopathy after Immunization with Diphtheria-Tetanus-Pertussis Vaccine, 263 JAMA 1641-45 (1990).

2. J.D. Cherry, ŒPerussis Vaccine Encephalopathy: It is Time to Recognize It as the Myth That It Is, 263 JAMA 1687-96 (1990).

3. Drs. Griffin and Ray are Burroughs-Wellcome Scholars in Pharmicoepidemiology at Vanderbilt University School of Medicine. Burroughs-Wellcome is the major DTP manufacturers in the United Kingdom. Dr. Mortimer has long been the DTP vaccine consultant to Wyeth Laboratories, and Parke Davis, former DTP manufacturers and current litigants involving liability for their vaccine. In addition, Dr. Mortimer has long been a consultant to Lederle Laboratories and Connaught Laboratories, the sole commercial suppliers of DTP in the United States.

4. The 1989 JAMA Peer Reviewers List, 263 JAMA 1687-96 (1990).

5. C.L. Cody et al., Nature and Rates of Adverse Reactions Associated with DTP and DT Immunizations in Infants and Children, 68 PEDIATRICS 650-60 (1981).

6. Cherry, supra note 2, at 1680 (calling for a study free of the influences of "special interest groups" and calling personal injury lawyers a "uniquely destructive force").

7. National Institutes of Health, Status of Acellular Pertusis Vaccines & Swedish Trial Update (Feb. 8, 1988).

8. Deposition of J.D. Cherry, M.D. at 49, Hardaway v. Metropolitan Gov't of Nashville, et al., __________ (19__).

9. Deposition of E. A. Mortimer, M.D. at 11, Krause v. Aboussy, et al., No. 82-1232, (Stark Cty., OH, September 6, 1984). 10 Opening remarks at the Institute of Medical Division of Health Promotion and Disease Prevention, Committee to Review the Adverse Consequences of Pertussis and Rubella Vaccines, Public Meeting, January 10, 1990. (Emphasis added.)

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