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Breast Implant Stories, Breast Implant Lawyers, Class Action

Written by lisaspitzer on . Posted in Breast Implant Blog

Anatomy of a Crisis: One Perspective on the Silicone Implant Story

Clinics in Plastic Surgery, Volume 26, Number 1, January 1999
Note: Long after Dow Corning went bankrupt, the National Academy of Sciences stated there is no proven link between silicone implants and systemic disease.

Since 1977 our law firm has represented a national plastic surgery organization, the largest state plastic surgery association, and the largest physician-owned medical malpractice company in the country. We believed ourselves fairly well-informed on plastic surgery and its practitioners. By 1991, silicone had been in medical use for many years, and the utilization of silicone breast implants in augmentation and reconstructive surgery was both widespread and unquestioned. Surgeons were regularly assured by the manufacturers that the product was efficacious and safe. Between 1974 and 1989, only 99 breast implant-related cases were filed against Dow Corning, the largest manufacturer of these implants.1

It is estimated that between one million and two million women had silicone breast implants between 1964 and 1992.2 Questions regarding safety, for example, whether implants increased the risk of cancer to recipients, were addressed in reassuring studies, including the Deapen survey in 1986.3 This study found no increase in the risk of cancer among approximately 3,000 Los Angeles women with gel-filled implants. Doctors were advised that continuing manufacturer research had turned up nothing of concern. Patients were satisfied with results. In 1990, the American Society of Plastic and Reconstructive Surgery evaluated 600 detailed questionnaire responses and announced that 92 percent of breast implant recipients were well satisfied with the product and 82 percent would have the procedure performed again.4

A few contradictory signs, however, appeared. In March 1991, a New York jury awarded a plaintiff $4.4 million on her claim that her polyurethane implants caused cancer.5 The verdict was reduced to $1.5 million, but the case caused an awakening in the plaintiffs' bar. (Unlike silicone, polyurethane was regarded with skepticism by the medical community, and the polyurethane-coated implants were later taken off the market.)

Silicone implants had been in use before the Food and Drug Administration (FDA) was given authority to classify medical products; as part of the regulatory catch-up process, the FDA classified breast implants as a Class III device in 1988.6 This classification required pre-market approvals (PMAs) and also entailed safety testing for certain risk factors identified by the FDA. The manufacturers were given 30 months to provide safety data for PMAs, which they submitted in July 1991. This lengthy process was considered routine both in the FDA and in the medical world.

In November 1991, as part of the PMA process, the FDA convened a scientific advisory panel to study the safety and efficacy of silicone breast implants. The panel concluded that more research was needed but noted a lack of evidence of substantial risks. It recommended that implants remain on the market as a public health necessity because of their known benefits.7 The FDA set January 6, 1992, as the date for its decision on the approval and continued marketing of implants. No change was anticipated, and approval was considered routine. There was, however, an abrupt change in the projected scenario. As a result of media uproar, on January 6, 1992, the date on which the FDA was supposed to announce its decision on the approval and continued marketing of implants, Commissioner David Kessler announced a moratorium on the sale and use of silicone implants.8

What had happened? During the period in which the FDA had convened its scientific advisory panel to evaluate implants, noted television personality Connie Chung aired her famous "green gunk" segment with an intentionally ruptured polyurethane-coated implant. Her evaluation, intoned in the style of the witches' warning in MacBeth, over national television on November 8, 1991, predicted disaster for women with implants. No distinction was made between the polyurethane product and the silicone implant.

By itself, the Chung show would probably have been just another of the sensational TV "exposés" regularly presented for our edification. But on December 13, 1991, a San Francisco federal jury awarded Marianne Hopkins $7.5 million in her breast implant lawsuit against Dow Corning. Of this amount, $6.5 million represented punitive damages. The award was based on a jury finding that Dow Corning had "falsely and maliciously" failed to warn of the potential dangers of its silicone breast implants.9 The verdict made the front page of newspapers nationwide. The effect was immediate: Across the country, attorneys started drafting complaints.

On December 30, 1991, Dan Bolton, Ms. Hopkins' attorney, wrote a letter to FDA Commissioner Kessler describing certain documents and information gathered from the Dow Corning files pursuant to discovery orders and revealed during the Hopkins trial, which the FDA believed had been withheld from its November 1991 panel hearing. None of this information contradicted the basic finding of the FDA advisory panel. But it did encourage a number of television talk-show hosts to take up the subject enthusiastically. Almost every such show featured a silicone "victim" or a silicone "expert" who criticized implants. Sidney Wolfe, MD, head of the Public Citizen's Health Research Group, wrote to Kessler advising him to ban the silicone implants immediately rather than leave them on the market while safety studies were completed. Newspapers across the country reported these developments and the concerns about the implants.

On January 24, 1992, the first breast implant class action against both doctors and manufacturers was filed in Ohio.10 In February 1992 the FDA convened a second panel of experts to review new information, particularly the Dow Corning internal memoranda that brought about the Hopkins verdict. The FDA heard from a variety of medical practitioners, manufacturers, a number of plaintiffs and their legal advocates, and assorted "consumer" groups.

On a key point, the panel found that "there was not enough evidence to establish a cause and effect relationship between gel-filled breast implants and immune-related or connective tissue disorders—that is, it is not known whether women with breast implants are more likely to have those conditions than women without implants." The FDA concluded that more research was needed to prove the long-term safety of the product, although it recommended that silicone gel implants used after mastectomy and other limited uses constituted a public health need and that implants should remain on the market for these purposes.11

To help create a groundswell of support for litigation, plaintiffs' attorneys set up educational "seminars" in all kinds of meeting places. Not only could they create a tent meeting-like atmosphere to recruit plaintiffs, they were also able to recruit instant "expert" witnesses in connective tissue disease and a host of vague afflictions. Every such meeting meant a real increase in filed cases.

Just as the fascination of the media with the breast implant crisis fed the litigation mill, the glazed look in corporate eyes revealed manufacturers totally overtaken by events. In March 1992 a widely experienced and respected senior legal advisor to Dow Corning was quoted as stating: "Given the rapidity with which this has come on, I just have not formulated a good plan yet." As it turned out, Dow Corning never did. More significantly as a harbinger of the future, the CEO of that company said that implants accounted for only 1 percent of Dow Corning's $1.7 billion in revenues, but estimates of total liability claims ranged up to $2 billion.12

On the regulatory front, FDA Commissioner Kessler had convened two scientific panels, and on April 16, 1992, the FDA announced that breast implants with silicone gel would be available only through controlled clinical studies.13

Before the Hopkins case and the Chung show, a review of manufacturers' product complaint records submitted to the FDA as part of the PMAs had shown few, if any, complaints of autoimmune or connective tissue disorders from breast implants. Now there was a mushrooming epidemic. In January 1992 there were approximately 15 active silicone breast implant cases in California. By March 1993 approximately 700 implant cases had been filed in California. By October 1993 there were 2,300 cases filed in California.14

In Texas, just before Christmas 1992, Santa Claus appeared. A jury in Harris County, the most rewarding place in the country for plaintiffs' attorneys, awarded Pamela Johnson $23 million in her case against Bristol Meyers—$5 million for actual damages and $20 million for punitive damages. Following this verdict the Harris County clerk's office was swamped with new filings. During the week following the verdict 150 new cases were filed, and by the first week of January 1993 over 1,400 cases had been filed in Harris County.15

Plaintiffs' firms borrowed large amounts of money to increase their litigation attorney roster. Experts in attributing memory loss, aches and pains, and general malaise to connective tissue disease caused by silicone were retained.

Hardly a daily television chat show aired without a segment on this growing crisis. In June 1992 the CBS program "48 Hours" had one entitled "The Fear Within" featuring women with silicone breast implants complaining of their injuries and fears. It reported that one-third of the women who had their implants removed felt better afterwards. In the same month, a woman on "Larry King Live" on CNN told how she had attempted to remove her silicone implants with a razor blade because her insurance would not pay for the procedure. Jenny Jones, on her TV program, announced that she, too, was a silicone breast implant "victim."

Women's support groups, not previously considered sources of scientific information, were now widely quoted on breast implant horror stories and became a news source for interested media. The "Silicone Sisters," the "East Coast Connection of Breast Implant Survivors," and the "Command Trust Network" all distributed information on the dangers of silicone breast implants.

And the court filings mounted, in California and Texas particularly, but generally across the nation. In 1993, the manufacturers announced a $4.7 billion settlement offer, which was later revised. By early 1996, an estimated 450,000 women had received official court notice of the revised breast implant settlement offer. The total from the state court cases cannot be accurately tallied, but every indication is that there were thousands of such cases. By the end of 1994, more than 20,000 individual lawsuits had been filed against Dow Corning alone. In many of these cases the doctor was a codefendant. 16

There is no doubt that silicone triggers a hyperallergenic reaction in some women, and some women become very sick. But a true accounting of how many became sick before they had implants, how many attributed to the implants the pain, memory loss, and the general debilitation that comes with growing older, and how many were seriously affected by their implants, became lost in a sea of litigation. Thousands of cases were filed alleging horrible illnesses. Plaintiffs argued that the medical literature, chiefly Japanese, supported the allegation that silicone gel causes autoimmune disease. Our search of the journals reached a contrary conclusion. But why weren't cases filed earlier? Did everyone suddenly get sick at the same time?

After 44 years in both public law and private practice, I have concluded that frequently the search for truth in the legal process can resemble a bear peeling a grape. It takes a long time and is painful to watch. This proved to be true of the breast implant litigation.

The Doctors Company is the endorsed malpractice insurance carrier of the nation's largest plastic surgery association. While other carriers insure significant numbers of surgeons in various states, The Doctors Company has policies covering approximately 535 plastic surgeons across the country. Of this total, approximately three-quarters are in California and two-thirds of those are in southern California. Nationwide, between one and two million women had received breast implants, and informed estimates indicated 80 to 85 percent of these women had received them for cosmetic purposes.

The first cases indicated that California would be a very active litigation venue. While the early filings gave every indication of plaintiffs seeking damages from the doctor, it was difficult to predict how such issues as informed consent and closed capsulotomies might shift liability even further away from the manufacturers to the surgeon.

Even a conservative prediction of the total cost of the lawsuits, including defense costs, associated defense expert fees, potential indemnity payments, and other related expenses, would amount to a very substantial sum that could severely affect The Doctors Company. Two of the smaller manufacturers, Mentor and McGhan, had assessed their potential costs and decided to fund a settlement pool of millions of dollars to escape the expense of repeated trials. Before the Hopkins case, only a few lawsuits had been filed against Mentor. In the next year and a half, it was served with more than 1,000 cases. No one could predict what the growing number of suits against the doctors would eventually total.

Questions relating to the doctors' relationship with the manufacturers were paramount. Would the manufacturers stand by their product, which they had assured doctors was safe and effective? Would the disclosures in the Hopkins case poison defense efforts? Would there be a strong scientific response from the research community? What would objective scientific studies show? Would there be multiple state court actions against individual doctors, or state class actions, or a federal class action? What would the FDA ultimately do?

As for the largest manufacturers, it quickly became apparent that, unlike the plaintiffs who had formed steering committees to develop a common approach to the litigation, there was no shared strategy among them. Baxter made a decision to defend these actions aggressively and won most of its cases. Bristol Meyers, particularly in southern California, appeared to devote considerable resources to discovery and depositions only to settle on the courthouse steps. Dow Corning had no apparent strategy and was truly unpredictable.

Initially, we had briefly envisioned joining the manufacturers in a spirited defense of the product. That approach was quickly discarded after noting that the manufacturers' various defenses often included pointing the finger at the doctor. After surveying the early cases being tried, we made a decision to vigorously oppose any assessment of blame to the surgeons, who had not known of any doubts the manufacturers might have had regarding silicone implants. Participation in a number of meetings with respected research authorities left us dubious of the validity of the extreme claims made by the plaintiffs regarding the product.

What gradually became clear was that plaintiffs' attorneys in California wanted no part of the developing federal class action suit assigned to the very able and experienced Judge Sam Pointer. They believed that they had a much better opportunity in individual suits. If they sued the doctor together with the manufacturer, that coupling would defeat any manufacturer's efforts to claim diversity of jurisdiction and attempt to move the case to federal court, since the plaintiff and the defendant doctor both resided in California. In addition, state juries are generally more liberal in their awards than federal juries.

A second reason to push for individual suits was found in the most unfortunate June 1993 Supreme Court decision in Daubert v. Merrill DowPharmaceuticals. In that case, the Supreme Court, against the urging of six Nobel Prize winners and the New England Journal of Medicine decided not to limit the admissibility of "junk science" as expert testimony, and refused to adopt a "peer review" test. Previously, the "generally accepted" standard of admissibility articulated in Frye v. U.S. was used by many courts, including California, to determine the admissibility of "junk science." Now, each judge would act as gatekeeper on the admissibility of expert evidence under the much looser Federal Rules of Evidence. By filing individual cases, plaintiffs' attorneys obviously hoped to be able to bring in the travelling "experts" with their novel and often bizarre scientific notions.

A third reason for individual suits was to push the doctor-defendants into quick and lower settlements that could help finance the more serious legal effort against the manufacturers, which to the plaintiffs' attorneys was starting to look like the Aztec riches of Mexico as seen by Hernando Cortez.

What the plaintiffs' attorneys did not understand is that any significant malpractice settlement paid on behalf of a doctor must be reported both to a state medical board and to the National Practitioner Data Bank in Washington, both of which constitute significant blots on a physician's record.

It was clear to us at The Doctors Company that our response had to be fast and effective, and it was. With the invaluable help of The Doctors Company's medical director, Dr. Mark Gorney, a former president of the American Society of Plastic Surgeons (ASPS) who had great knowledge and insight into the issues surrounding the controversy, we were quickly able to persuade the officers and board of The Doctors Company of the need to spend a considerable sum of money on our defense efforts.

My associate, Norman Miley, who worked closely with me on this project, had sixteen years of trial experience. I had coordinated several large cases for the state of California and had once been chairman of a plaintiffs' steering committee in a significant class action. But it was clear to us that we needed someone to devote full time to the job of implementing and coordinating our defense efforts. We chose a very able trial lawyer with whom we had previously crossed legal swords. Despite having no medical malpractice experience, Marshall Cornblum was a brilliant choice. He came with no preset notions and with an analytical mind. He joined us in March 1992. We were in constant communication with him and met on a regular basis.

We decided to bring together our most experienced The Doctors Company defense counsel from the states most impacted by the litigation. These states ranged from Connecticut to Hawaii, but we expected the most activity in California. Later, we shared ideas and strategy with counsel from the other California carriers. The Doctors Company defense group first met in April 1992. A mass of journal articles and scientific studies was evaluated. A database of what was known and when it was known was established at one coordinating law firm office, Larson & Burnham in Oakland, California. A plastic surgeon, Dr. Jack Fisher, of the University of California at San Diego, and an outstanding rheumatologist, Dr. David Kneapler, were retained as consulting experts. We also engaged the services of Katherine Newman, an anthropologist from Columbia University, who is an expert on juries and jury selection. We hired an interviewer to question all the former Hopkins jurors that we could locate. Those interviews established several points. The jury had been puzzled by the voir dire conducted by Dow Corning's counsel, and they were enraged by the documents that clearly showed that Dow Corning's own employees seriously questioned its testing procedures. In addition, the jury ignored testimony from Ms. Hopkins' two treating physicians, presented by the defense, that her adverse disease symptoms were apparent before the implants were inserted.

At the first meeting of The Doctors Company defense counsel in 1992, we outlined Marshall Cornblum's role and that of Larson & Burnham. We reviewed the history of the breast implant "problem," the types of implants and changes in design, the adverse reactions that were claimed or established, capsular contraction, gel leakage, autoimmune disease, the present status of the litigation, pending individual actions, and the class actions. In this dense case review, tactical legal issues relating to filing answers to the complaints, potential cross-complaints, interrogatories, requests for the production of documents to be sent with the answers, subpoenas for hospital records and records of other known medical providers, responses to plaintiffs' discovery requests, document production by our defendant doctors and depositions were all discussed. Trial matters—jury instructions, a trial brief, motions in limine, voir dire issues and jury selection, the development of a trial theme and general litigation approach—and legal research matters—informed consent, product liability theories against physicians, statute of limitations, including the effect of the federal class action on the statute of limitations, and a host of ancillary matters—were set out in a detailed, seven-page agenda. It also provided for the development of a computerized document-management system for medical articles, FDA hearing transcripts, Dow documents, reporting and calendaring of court matters, action matters, and discovery matters.

After our first few meetings, we were quite sure that while the manufacturers might have had doubts about their silicone studies, the doctors never knew of them and, in good faith, relied upon the manufacturers' repeated representations that the silicone implant was not only a good product, it was a safe product.

But we needed to know what an average juror would believe. To that end, we obtained a courtroom in the Los Angeles Superior Courthouse on a quiet Saturday, February 20, 1993. Drawing from a jury list in Orange and Los Angeles counties, we assembled 60 persons in the courtroom and presented a mock trial involving a woman suing her plastic surgeon, alleging various sicknesses from a silicone implant. Our selected trial counsel also attended. We intentionally left out a manufacturer/defendant so that attention could be focused solely on the doctor.

Most of the themes developed during the mock trial followed the concerns voiced during the meetings with defense counsel. Expert witnesses for both sides included a plastic surgeon and a rheumatologist echoing the best plaintiff and defense points.

Afterwards, the 60 jurors broke into five groups of 12, together with a social sciences facilitator, to discuss what they considered important in reaching their decisions. Videos of their deliberations and of the trial itself were made. Katherine Newman oversaw the operation and on April 1, 1993, presented us with a 26-page summary of the mock trial jury findings. While there were quite a few surprises, the findings confirmed our basic defense strategy and gave us clear indications of the kinds of jurors who would listen to us and what arguments would convince them. Armed with this reassuring knowledge, we reaffirmed our commitment to the maxim: "Millions for defense, but not one cent for tribute."17

Gazing across the legal ramparts, we thought we understood what our legal adversaries in the plaintiffs' bar were doing. What we could not understand was what Dow Corning was doing. In early 1993, as the number of breast implant cases in California reached more than 2,300, the manufacturers announced a $4.7 billion global settlement.18 Terms of the settlement offered the more seriously affected plaintiffs more substantial amounts, but, incomprehensibly, there would be some payment for everyone in the action. Suddenly, doctors' secretaries, who had been quite pleased with their implants for 10 or 15 years, informed these surgeons, whom we represented, that they meant no disrespect to them, but they had to get in on a good thing, and so they joined the "lotto for ladies."

Rather than ameliorating the situation, Dow Corning's announcement increased the filings and whetted appetites. In May 1995 Dow Corning threw its hands up and its executives out and filed for bankruptcy.

Against this background, the plaintiffs' attorneys at first did not believe us when we said we would not settle for even a dollar, but gradually they learned of our preparation and our determination. The number of claims asserted against The Doctors Company reached 1,046. It was anticipated that hundreds of additional cases would be filed by lawyers who were awaiting developments and The Doctors Company's reaction to the first cases before filing their actions.

Slowly, the tide receded. The claims that had not been filed were never filed. Cases were dismissed by the score. And, while a few remain in the court docket, chiefly outside California, we do not believe they constitute a real threat. The cost of this preparation was nearly $7 million, chiefly in payments to trial counsel to work up defenses for the accused doctors.

What is important, however, is that no judgment was ever entered against any of our insured doctors. Of more than 1,200 reported incidents, only two plastic surgeons insured by The Doctors Company have gone to trial over the breast implant crisis to date; both cases resulted in verdicts in favor of The Doctors Company insureds. I submit that our strategic response, while expensive, was very effective. The Doctors Company had put up actuarial reserves of $30 million against what was originally thought to be a dire threat to its very existence. That was based on a cold actuarial analysis.

As George Bernard Shaw wrote: it is not the experience that matters, what counts is what you learn from it. What have we learned?

Scientific studies had no impact on legal filings. As the evidence mounted and prestigious institutions, such as Harvard and Johns Hopkins, and others in the United States and Europe, reported widespread evidence that there were no data to support the silicone-sickness frenzy, the media finally stopped its anecdotal reporting of an epidemic. Their reports came too late, however, to affect the filed cases, which continue to have a life of their own. In 1992, our esteemed consultant asked in the New England Journal of Medicine "When will science prevail?"19 In the legal world, the answer would appear to be, not soon.

We know what this cost The Doctors Company. What it cost the manufacturers is undoubtedly much more. There are now very limited options for women who want silicone breast implants. Those who left the field, including the manufacturers of raw materials for jaw implants and other prostheses, are not likely to return.

Any problem in new and promising technology may be seized on as a threat to human survival. Witness the sorry spectacle of what happened with pedicle screws. Watch what is happening to the Norplant birth control device. The future for medical devices that might improve certain human physical conditions does not look bright. The trend towards mass litigation, mass recruiting of "victims," quick consolidation into class actions, and the push towards industry settlements to avoid huge legal defense costs are likely to lead to overseas manufacturing in areas less blessed with our tort system and subsequently with far less development of new products in the United States.

Unless we learn the lesson of what this legal system costs, we are bound by Santayana's dictum, "Those who cannot remember the past are condemned to repeat it."

 

References

    Anonymous (attributed to Public Citizen), 1992 Silicone Implant Clearinghouse, reprinted in Breast Implant Litigation, New York: Law Journal Seminars Press, 1992, pp 115, 159.
    House Committee on Government Operations Staff, The FDA's Regulation of Silicone Breast Implants, 102 Cong., 2nd Sess., Washington, DC: Comm Print, 1993.
    Deapen, D.M., Pike, M.C., Casagrande, J.T., et al: The relationship between breast cancer and augmentation mammoplasty: An epidemiologic study, Plast Reconstr Surg 77:361-7, 1986.See also Berkel, H., Birdsall, D., Jenkins, H., Breast augmentation: A risk factor for breast cancer?, N Engl J Med 326:1649, 1992.
    American Society of Plastic and Reconstructive Surgeons, Inc., Press release, November 19, 1990.
    Livshits v. Natural Y Surgical Specialties, 87 Civ. 2403 (S.D.N.Y.).
    53 Fed. Reg. 23, 862 (June 24, 1988).
    U.S. Department of Health and Human Services, FDA Press Office release, November 14, 1991.
    U.S. Department of Health and Human Services, FDA Press Office release, January 6, 1992.
    Breast Implant Litigation Reporter, Andrews Publications, March 1992, p 10. See also Griffin, W., Emerging issues in breast implant litigation, American Bar Association, 1993.
    Dante v. Dow Corning, Class tentatively certified by federal court in Cincinnati. Reported in Breast Implant Litigation Reporter, March, 1992, p 3.
    U.S. Department of Health and Human Services, update on silicone gel-filled breast implants, FDA news release, February 27, 1992.
    McKennon, Keith, quoted by Breast Implant Litigation Reporter, Andrews Publications, March, 1992, p 14.
    News Release Update on Silicone Gel-Filled Breast Implants, May 25, 1992.
    Medical Legal Aspects of Breast Implants, Leader Publications, October, 1993, p. 8.
    Medical Legal Aspects of Breast Implants, Leader Publications, January, 1993, p. 4.
    Hazelton, Dick, quoted in transcript of Frontline, February 27, 1996, WGBS Educational Foundation, p. 10.
    Adams, John (attr.), reply to Talleyrand in XYZ Affair concerning French seizure of American ships.
    Medical Legal Aspects of Breast Implants, Leader Publications, September, 1993, p. 1.
    Fisher, J., The silicone controversy—when will science prevail?, N Engl J Med 326:1696, 1992.

About the Author

Charles O'Brien, LLB, Board of Governors, The Doctors Company, Napa, California

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