From
the consumer
law page
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 &
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, Perussis 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.) |