Dr. Marc Lappe & Stern trial

[Guest guest]

Thanks to Patty, creator of the Saline Support Group

....

www.BreastImplantAwareness.org/Patty.html

EXCERPT: During the Stern trial an expert witness

named Marc Lappe, called by the plaintiff to comment

on the study, pointed out the discrepancies between

the published study and the internal reports. Dow

Corning lawyers tried unsuccessfully to have Lappe’s

testimony excluded. The judge then asked to see

the documents both Lappe and the Dow Corning lawyers

brought into court, and noticed that the identifying

numbers on the dogs had been altered on the documents

Dow Corning had given the attorneys. It looked

suspiciously like the company had altered the data to

make it more difficult to get at the full two-year

results of the study.

http://66.102.7.104/search?q=cache:fLIvZlHnSjcJ:www.foodsafetynetwork...

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173•5• Silicone Breasts: Dow Corning and the Implant

Lawsuits by Conrad G. Brunk, with the assistance of

Leiss The Litigation Against Dow Corning In

May 1995 Dow Corning Corp. announced that it was

seeking bankruptcy protection in response to rapidly

escalating numbers of compensation claims for alleged

harms suffered by women who had been surgically fitted

with the silicone breast implants manufactured by the

company. The company had been found liable for large

awards by juries who were convinced by the testimony

of

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174 women and their physicians that a whole range of

health problems they suffered were caused by the

implants manufactured by Dow Corning and several of

its competitors. One of the first of these lawsuits

had been brought over ten years earlier, in 1984, when

a California jury awarded Stern $1.7 million in

damages for illnesses it was convinced had been caused

by Dow Corning’s implants. The court found Dow Corning

guilty of fraud in its handling of information the

company possessed concerning the risks to women from

its implants.1The flood of litigation against Dow

Corning did not really begin until 1991, however, when

a San Francisco jury awarded nn Hopkins $7.3

million because of its finding that Dow Corning

implants were defective and that the company was

guilty of fraud.2 After the Hopkins decision the U.S.

Food and Drug Administration (FDA) announced a

moratorium on the sale of the implants, reinforcing an

avalanche of court suits filed against Dow Corning. By

the end of 1992 the number of pending suits had

increased from 137 to 3,558. By the end of 1993 the

number had reached more than 12,0003and by 1994 19,092

cases had reportedly been filed against Dow Corning.

After many of these suits had been consolidated into a

class-action proceeding, an Alabama judge approved a

tentative $4.5 billion (U.S.) settlement between

several implant manufacturers and women who filed

injury claims with the court, the largest class action

settlement in history. Dow Corning, which manufactured

nearly 30% of the over 2 million breast implants

placed in

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175 women’s bodies, agreed to pay nearly half of this

$4.5 billion.4 The other half of the liability was

shared among several other companies: Bristol-Meyers

Squibb, 3-M Company, and Baxter International, among

them. The Alabama settlement was not the end of Dow

Corning’s liabilities, however, since the court left

the door open for claims from additional women to be

brought against the company. More claims were

forthcoming, including actions on behalf of an

estimated 50,000 Canadian women, most of whom had been

excluded from the Alabama settlement.5Once Dow

Corning’s pockets were emptied by these large

settlements, plaintiffs turned to the deeper pockets

of Dow Chemical, alleging that this parent company of

Dow Corning shared liability because it had carried

out some of the early studies on the potential affects

of silicone on the immune system.6 By 1995 over

440,000 women had registered in the global settlement

against Dow Corning. The Risk Communication Angle If a

final class-action settlement confirms Dow Corning’s

bankruptcy declaration, this will mean the loss of

their company by existing shareholders as a result of

litigation over a product which represented only one

percent of the company’s total sales. The tentative

class-action settlement entailed unprecedented court

awards for alleged damages for which there was, and

remains, little reliable scientific evidence. Despite

the scarcity of scientific evidence for many of the

alleged risks, juries had been accepting the

contention

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176 that silicone breast implants posed clearly

unacceptable risks for a wide variety of autoimmune

and connective tissue diseases, as well as many other

severe disabilities suffered by women. This public

perception of the risk supported the willingness of

numerous juries and judges to be persuaded that Dow

Corning was guilty of “injuring” many women and

consequently ought to be liable for high levels of

punitive damages. The Dow Corning case raises

fundamental issues about the relationship between

science and public regulatory policy, as well as

between “expert” and “lay” perceptions of risk. Risk

communication is, in part, the art of effective

bridge-building across the often wide spaces that

separate these domains; if this artistry is maladroit

there can be disastrous repercussions on various

levels, economic, political, and personal. In the case

of Dow Corning, the early failure to assess the human

health risks of silicone implants and to communicate

effectively the nature of these risks — and the

uncertainties associated with them — led to such a

disaster. The story of Dow Corning’s handling of the

risk issues associated with silicone breast implants

illustrates how easily a company can become the victim

of its own mismanagement of risk and risk information.

Some prominent members of the medical-scientific hold

that the implants pose little or no risk for the type

of ailments ascribed to them by public opinion and the

courts. We believe that Dow Corning’s management of

the risk issues is in large part responsible for this

discrepancy. It was the public revelation of Dow

Corning’s apparent failure to conduct a fully

sufficient risk assessment, and

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177the damaging evidence within its own internal files

suggesting suppression and misrepresentation of the

risk information in its possession, that led to the

erosion of public trust in the company. The Scientific

Support for Dow Corning Dow Corning has steadfastly

maintained that its silicone implant products did not

pose risks of the kind which led judges and juries to

award large settlements to the alleged victims.

Despite claims brought by plaintiffs in these court

cases that the company had clear scientific evidence

of various systemic health risks such as cancer,

autoimmune disease, and connective tissue disease

which it suppressed or falsified in the regulatory

process, Dow Corning argues that it did not have

significant scientific evidence of any of these risks,

and moreover that it had conducted sufficient research

to warrant its conclusion that its products were safe.

As time goes by, and additional studies of the

systemic effects of silicone implants are reported,

Dow Corning appears to be more and more vindicated in

its claims that the risks of its product have been

grossly overestimated and that the trial settlements

were wrongly imposed upon the company. The scientific

attack against the courts, lawyers, and plaintiffs’

groups has been led by the editor of the New England

Journal of Medicine (NEJM), Dr Marcia Angell. Soon

after the controversy broke in 1994, the NEJM

published the first major epidemiological study of

breast implant patients. This eight-year

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178retrospective study of 749 women who had received

breast implants at the Mayo Clinic found no

significant differences in the incidence of connective

tissue and other diseases among these women than among

a non-implant control group twice the size.7In an

editorial accompanying the publication of the study,

Angell wrote that the study showed the decision of the

FDA to remove silicone implants from the market in

1992 to be “overly paternalistic and unnecessarily

alarming.” She also claimed that the FDA decision,

which was based on the fact that the manufacturers

“had not fulfilled their legal responsibility to

collect data on the question” (not because implants

were known to pose a risk), was construed by the

public as an indictment of the implants. Frightening

stories of autoimmune and connective-tissue diseases

swept through the public and were, she said, “reified

by repetition.... The accumulated weight of anecdotes

was taken by judges and juries as tantamount to proof

of causation.”8Angell pursued this argument in a 1996

book, Science on Trial,9in which she reported

additional studies strongly corroborating the Mayo

Clinic findings.10Angell argues that this story shows

that the standard of scientific proof in the

litigation of tort claims should be changed. In her

view only scientific evidence based on a “factual

standard” (i.e., published in peer-reviewed scientific

journals) should be admitted as “expert testimony.”

However, the U. S. Supreme Court earlier had

considered and firmly rejected this demanding “factual

standard” in a 1993 case, Daubert v. Merrell Dow

Pharmaceuticals, Inc.11Instead, the court in Daubert

empowered judges to make

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179their own determinations about the scientific

credibility of expert witnesses. Angell argues that

such a legal standard permits the courts to base

decisions upon scientifically unreliable foundations

and this, in her opinion, was clearly what happened in

the breast implant cases. Although some of the media

commentary initially reinforced the allegations

against Dow Corning and contributed to the public

perception of the extensive risks associated with

breast implants, in the wake of the evidence from the

scientific studies the media interpretation also

shifted dramatically. Stories with titles such as “The

Great American Breast Implant Hoax,”12“A Confederacy

of Boobs,”13and “Lawyers From Hell,”14appeared in

major American magazines. Newspapers carried headlines

such as “Dow Corning and the Courts: A Case of Justice

or Total Travesty?”15“Why, to Science, the Law’s An

Ass,” and “Can Science Free Women and Dow

Corning?”16On 17 August 1995, the ABC show, Nightline,

expressed a mea culpa for all the media with the

comment that “it seemed we had it all wrong.”17As a

result of the growing consensus among in the

scientific and journalistic community, even the

widespread view among business ethicists that Dow

Corning had acted unethically has undergone

revision.18The company has undertaken a vigorous

public relations campaign to restore its image, which

appears to be meeting with a great deal of success.

The many groups who represent the alleged victims of

silicone breast implants, led by the lawyers who so

successfully managed the lawsuits, have responded with

complaints about

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180the way the company is spending “their” money to

restore its image after a bankruptcy declaration, and

have claimed that Dow Corning has in fact used

millions of dollars to “buy” the scientific studies

that fail to find significant systemic health risks.

The company has admitted to having funded several of

these studies, but points out that the funding of more

research is precisely what its critics have demanded

and adds that the research was carried out at

respected, independent scientific research centres.

The lawyers and victims’ groups have also pointed out

that even these most recent studies have failed to

rule out the possibility of significant risk for the

systemic complications they believe are caused by

breast implants. For example, the Mayo Clinic study

involved too small a sample to rule out as much as a

three-fold increase in the risk. One of the recent

major studies did find a slight increase in reports of

connective tissue disease among women with breast

implants.19The most recent scientific review of all

the epidemiological studies found that, while none has

indicated a greatly increased rate of well-defined

connective tissue disease or breast cancer in women

with silicone breast implants, none has ruled out a

moderately increased risk for these diseases either.

This meta-analysis concluded: “Information is

insufficient to adequately advise women who currently

have or are seeking to obtain breast implants about

the overall risk of these devices.”20Thus, the most

salient aspect of the science for these non-scientific

groups is not the fact that the risks appear low, but

that this assessment itself if fraught with

significant uncertainty.

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181Dow Corning’s Assessment and Management of the

Risks A. The Alleged Systemic Health Risks Dow Corning

began producing silicone-filled breast implants in the

early 1960s. The product was hailed as a major advance

on the original method of direct silicone injection

into the breast, since the silicone was contained in a

protective pouch designed to isolate it from body

tissue, dramatically decreasing the risk of adverse

effects from silicone migration. The implants were

introduced to the North American market years before

the U.S. government enacted the Medical Devices

Amendment to the Federal Food, Drug and Cosmetic Act

in 1976, giving the FDA the authority to review and

approve the safety and effectiveness data of new

medical devices. Because silicone breast implants had

been on the market for almost fifteen years by that

time, they were " grandfathered.” This meant that no

safety and effectiveness data on the implants were

necessary unless and until the FDA requested them.

Nevertheless, Dow Corning undertook to conduct and

sponsor research on the potential health effects of

both the silicone itself and breast implants. Included

among these were toxicological studies of the effects

of silicone and implants on laboratory animals,

including whether silicone was “biologically inert.”

Some of these studies suggested that the silicone

might not be as biologically inert as first assumed,

and that implants could produce inflammation and other

responses that are consistent with immune response.

Others suggested that silicone could enter the immune

system of rats and mice

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182and that these animals could develop sarcomas in

response to injected silicone.21After the 1984 Stern

lawsuit, Dow Corning had informed surgeons to whom

they sold the implants of “reports of suspected

immunological responses,” but the company also added

the following evaluation: “A review of the published

experimental findings and clinical experience shows

that convincing evidence does not exist to support a

causal relationship between exposure to silicone

materials and ... rheumatic and connective tissue

disorders.”22Clearly, Dow Corning scientists were

convinced there was little, if any, risk of systemic

health effects from their product. Because in their

view the evidence of risk was meagre and public

acceptance of the product during the first twenty

years was high, and because the FDA did not (until

1988) request any safety studies from the industry,

Dow Corning saw no need to conduct extensive risk

research. Nor did the company think it necessary to

make available the study results it did have to either

the final consumers of the product or to the FDA. The

company considered the initial studies it had

conducted or sponsored to have failed to establish any

scientifically significant evidence of systemic health

effects. Even though some toxicological studies were

consistent with that possibility, the observed effects

were attributed to other factors. Thus the recognized

uncertainties in the toxicological studies led to a

decision to discount the potential risks rather than a

decision to conduct further research. This decision

was supported by existing, though minimal,

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183epidemiological evidence, which gave no indication

of systemic health risks associated with the silicone

implant. Dow Corning faced a situation fairly typical

for health risk assessments, where the toxicology

indicates some risk (usually in animal studies) -- in

the sense of potential harm to humans -- that is not

confirmed by the available epidemiological evidence.

Dow Corning also made the typical choice in these

contexts — to prefer the indicators of low (or zero)

risk to the other indicators of potentially

significant risk. This choice underlay the decision

not to conduct further studies and probably also the

choice to withhold certain evidence from the

regulators, the consumers, and the public. However,

the failure to conduct more adequate risk research,

especially given the growing allegations of systemic

problems, is now seen even by some of the strongest

defenders of breast implant safety as one of Dow

Corning’s major failures. For example, even Marcia

Angell admits that although the company “was right

about the lack of evidence that the implants were

dangerous... there was also little evidence that they

were safe, because the manufacturers had not fulfilled

their responsibility to look for it.”23This is a

damning statement considering the source whence it

comes. The decision not to conduct further research

with silicone and implants became one of the major

factors in persuading juries and the general public

that Dow Corning had subjected women implant

recipients to unacceptable risk.

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184B. The Risks of “Local Complications” While the

risks of systemic health effects from implants such as

cancer or autoimmune and connective-tissue disease

seemed to be remote during this period, there were

other kinds of more immediate risks to women that were

becoming clear to the company. Dow Corning knew in the

early 1970s that the silicone could “bleed” or leak

out of the envelopes in which it was enclosed.

Although most leakage was thought to be contained in

the capsule of scar tissue the body naturally formed

around the foreign implant, there was evidence that it

could migrate to surrounding tissue and to other areas

of the body via the lymphatic system.24Most of the

evidence of silicone bleed came not from the recipient

women (who had no means of detecting the bleed

itself), but from the surgeons who implanted them. The

sales personnel who dealt directly with the plastic

surgeons received a barrage of complaints from those

surgeons that Dow Corning’s implants felt “oily” when

they were removed from their packaging. This problem

intensified in 1975 when, in response to pressure from

other manufacturers whose product was considered to

have a more “natural” shape and feel, Dow Corning

developed an implant with a thinner envelope filled

with silicone of thinner consistency, rushing the

implants to market before adequate studies of their

reliability could be carried out. Surgeons complained

that the new implants were bleeding and even rupturing

during implantation, and whole shipments were returned

to the company.25Dow Corning’s response was not to

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185remove the implants from the market, nor even to

warn recipients of the risk, but to give misleading

assurances about continuing safety studies.26Evidence

of additional health risks with the implants emerged.

Not only did the implants tend to rupture and spill

during implantation, they were doing so after

implantation as well. The result was that the breast

would lose its shape and the contents would escape

into the surrounding tissue, often producing high

levels of trauma for the recipient, requiring surgical

removal and sometimes re-implantation. The rate of

rupture has been a matter of wide disagreement between

the industry and its critics. For most of this period

Dow Corning claimed it was in the vicinity of one to

two per cent; early scientific estimates were over

five per cent. Implant victims’ groups have claimed it

to be higher than fifty percent, and have predicted

that when enough time passes it will likely prove to

be one hundred percent. In testimony before a

congressional subcommittee in August 1995 FDA

Commissioner Kessler stated: " Published studies to

date suggest a rupture rate between 5 and 51 percent —

an enormous range — and unfortunately, we do not know

with any confidence where within that range the real

rupture rate lies. " He also cited two studies

indicating that the risk of rupture increases as the

implants age. A published 1996 study by the FDA also

reports that the rupture rate is still unknown, but

clearly increases with age. The National Breast

Implant Task Force claims that in a meeting in

September, 1995 FDA officials informed them that its

MedWatch reporting system indicated a fifty percent

rupture rate.

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186These high rupture rate estimates appear to be

based upon studies done among women who report

complications with their implants, and they may not

accurately reflect the rupture rate among all

implanted women. One of the problems in determining

the exact rate was due to the fact that if the

surrounding scar tissue capsule did not break, most of

the silicone would be retained, and the rupture would

not be noticed or reported. One study of women with

implants who had mammograms showed that five percent

had unnoticed ruptures.27Recent scientific studies

lend support to the higher figures in the ranges. One

study of 300 women treated for implant problems at the

University of Alabama found that 214 (71.3%) of them

had disruption (actual rupture or severe silicone

bleed or both) of one or both implants.28Despite

evidence of significant rupture rates, Dow Corning

nevertheless continued to advise women in its product

promotional literature during the 1970s and 80s that

they could expect the implants to last a “natural

lifetime.”29Further, Dow Corning learned early on that

a normal body reaction to the insertion of the

implant, as with any foreign object, was the formation

of a fibrous capsule (a kind of scar tissue) around

it, called “capsular contracture.” This produced a

hardening of the breast which led to other

complications, such as chronic soreness and reduced

sensitivity of the nipples. Dow Corning recommended a

procedure to surgeons for post-operative amelioration

of this problem. This “closed capsulotomy” procedure

involved a forceful squeezing of

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187the breast by hand in order to break up the scar

tissue and soften the breast — until the capsule

formed again, which it usually did. Often the

procedure was only partially successful, leaving the

breast malformed. But more importantly, the procedure

regularly produced an even worse result — the rupture

of the implant itself, spilling its silicone contents

into the surrounding tissue. By 1980 the company

included in the package a warning to surgeons about

this risk.30However, no similar warning was given to

the women who received the implants. Between 1985 and

1995 the FDA received over 91,000 adverse reaction

reports associated with silicone breast

implants.31These reports included cases of leaking and

rupturing as well as of the painful hardening,

deformation, and desensitization of the breasts, which

are now widely recognized and uncontested on all

sides, including scientists and the industry. But they

included as well claims of adverse effects still not

proven to be linked to them. However, it was not the

risks of these “local complications,” but rather those

of the systemic diseases of the immune system and

connective tissue, that courts used to justify the

huge damages awarded to the plaintiffs who sued Dow

Corning. Dow Corning’s Risk Communication Dow Corning

argues that the storm of criticism the company

received for not informing patients or the public

about the known complications of breast implants is

without merit. It has steadfastly maintained that it

honestly and

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188forthrightly communicated the risks of its implants

to the appropriate stakeholders as it became aware of

those risks. The appropriate stakeholders, according

to Dow Corning managers, were primarily the surgeons

who were the direct customers of the company’s

product, and not the women who were the recipients of

the implants and the bearers of the risks. The company

argued that, like most medical device manufacturers,

it relied on patient information being conveyed

through physicians, and “physicians strongly

maintained that direct communication by the company to

patients was inappropriate and potentially interfered

with the doctor/patient eelationship.”32Further, as

the company’s health care business manager put it to a

reporter who questioned the company’s view of

disclosure: “We don’t know who the patients are.”33If

patients agreed to be fitted with silicone breast

implants without being fully informed of the known

complications, it was