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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

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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

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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, OPerussis 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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               Current date: Thursday, 29-May-97 14:19:02 PDT
                Last Modified: Friday, 22-Nov-96 10:44:20 PST