A tricky solution?

[Guest guest]

http://www.pegasus.rutgers.edu/~record/articles/vol25/25rlr1/implants2.html

25 Rutgers L. Rec. 1

SALINE BREAST IMPLANTS: A TRICKY SOLUTION By A. Orr

Cite as: A. Orr, Saline Breast Implants: A Tricky Solution, 25 Rutgers L. Rec. 1 (March 1, 2001).

(1) Since the dawn of the modern breast implant era in 1962(1), thousands of women have filed suit against the manufacturers of breast implants and the doctors and hospitals who oversaw their surgical installation. As with any elective surgery, there are risks of infection, allergic reaction to anesthetics and medication, and human error. Certainly, women who suffer from complications such as these bring meritorious lawsuits on valid causes of action. (2) However, many women claim that silicone gel breast implants are responsible for a host of physical ailments that cannot be linked directly to their implants. Evidence proves that silicone gel breast implants cause the ills complained of by plaintiffs. Therefore, silicone gel breast implant plaintiffs, as classes and as individuals, have enjoyed success in their mass tort litigation. By 1992, the silicone gel breast implant industry had become a billion dollar business, between Dow Corning and five other manufacturers.(2) (3) This success has resulted in numerous million-dollar verdicts and has been largely responsible for forcing Dow Corning, the corporation most largely responsible for inventing and manufacturing silicone gel breast implants, into bankruptcy.(3) (4) Most of the furor and litigation over breast implants has been over connective tissue diseases such as lupus, arthritis, and scleroderma, and immune system disorders that plaintiffs claim are caused by silicone gel breast implants. Silicone gel breast implants were also largely trouble free until increased media attention focused on their possible health risks. In 1992, Kessler, head of the Food and Drug Administration (FDA), announced that silicone gel breast implants were being removed from the market. Following this decision, silicone gel breast implant related litigation exploded. Prior to the FDA's April 1992 announcement, the silicone gel breast implant industry had suffered a total of only 200 tort claims filed against them over an almost thirty year period.(4) By December of 1992, a mere eight months after the FDA's moratorium on silicone gel breast implants, 10,000 tort claims in connection with silicone gel breast implants had been filed.(5) (5) The FDA is currently engaged in the pre market approval (PMA) phase of analyzing and summarizing data received from the manufacturers on the safety of saline breast implants.(6) A public recommendation will follow.(7) For now, the devices are "approved.(8)" Aside from common medical malpractice claims for local complications attendant to any surgical procedure, saline breast implants have been relatively trouble, and litigation, free. While women with saline breast implants have largely been silent, a negative recommendation by the FDA could trigger an explosion of saline breast implant litigation similar to that of silicone gel breast implants: (6) The silicone gel breast implant litigation followed the typical mass tort cycle: a series of single plaintiff trials with mixed results and then an event, or in this case, two events - a well-publicized plaintiff's verdict and FDA removal of the product from the marketplace - that led to the filing of larger numbers of lawsuits.(9)(7) Certainly, the potential exists for saline breast implants to cause harm similar to that allegedly caused by silicone gel breast implants; both devices contain silicone. If courts and juries are willing to give credibility to evidence which is not definite, yet this evidence is damning to manufacturers, in saline breast implant cases as was permitted in silicone gel breast implant cases, the resultant harm and downpour of litigation could be enormous. Merely because Kessler and the FDA say that saline breast implants are okay today, does not mean they won't change their position tomorrow. (8) Silicone is used in over 500 medical products.(10) In 1962, Dow Corning introduced silicone gel breast implants.(11) In the 1970s and 1980s, there were four primary types of breast implants. Three of these are silicone gel implants. Silicone gel breast implants consist of an outer shell made of solid silicone that is then filled with a silicone gel.(12) Foam or sponge covered implants are identical to silicone gel breast implants except for a foam or sponge coating and a double lumen implant. Double lumen implants have an inner shell surrounded by an inflatable outer layer.(13) Saline filled breast implants have the same solid silicone outer shell of these other implants, however they are filled with a saline, or saltwater, solution.(14) Most breast implant litigation has centered on the various silicone gel filled breast implants and not the saline filled variety.(15) (9) The FDA did not regulate breast implants until 1976, although they were introduced in 1962. It was not until 1988 that the FDA classified breast implants as "strictly regulated medical products".(16) After four years of evaluating the safety data presented, along with evidence that Dow Corning had failed to disclose all it knew about the safety of silicone gel breast implants,(17) the FDA concluded that silicone gel breast implants had to be removed from the market because the manufacturers had not satisfactorily complied with data collection guidelines on the subject.(18) In April 1992, FDA commissioner Kessler announced the devices would no longer be available.(19) However, even at the time of this pronouncement, Kessler acknowledged that there was "no evidence that breast implants cause connective tissue disease."(20) In 1990, 100,000 women had had breast implants of all varieties surgically implanted.(21) In the year 1992, a total of 32,600 of the devices were installed.(22) Certainly, the FDA's announcement had a chilling effect on the implantation of all breast implants, not just silicone gel breast implants. Critics of the FDA decision, including doctors, scientists and silicone gel breast implant manufacturers, decry the FDA's decision claiming there is no connection between silicone gel breast implants and plaintiff's sickness and damages.(23) Despite the lack of conclusive scientific evidence that silicone gel breast implants cause the injuries for which plaintiffs are suing, silicone gel breast implant manufacturers have paid out billions of dollars in settlement money and Dow Corning, the largest manufacturer has declared bankruptcy.(24) (10) Concurrent with the FDA's ban on silicone gel breast implants, came a ringing endorsement of saline breast implants. The FDA recommended to physicians that, "aline-filled implants can be used when breast implants are medically necessary."(25) The suggestion that saline breast implants are safe is partly based on the fact that saline, unlike silicone gel, is not a substance foreign to the human body, and therefore not harmful.(26) Since 1992's low of 32,000 women receiving breast implants,(27) the industry has rebounded. In 1994, 69,000 women received saline breast implants(28) and in 1996, over 87,000 elected the procedure.(29) The public's confidence in saline breast implants has apparently been restored.(30) (11) Today, only two manufacturers of breast implants survived the 1992 silicone gel breast implant moratorium and continue to manufacture saline breast implants; Mentor H-S and McGhan Medical.(31) They are most at risk if the FDA changes its position on saline breast implants. (12) United States courts have largely supported verdicts in cases where evidence is given that silicone gel breast implants cause health problems in the women who have them. Although the formal medical and epidemiological(32) data supporting such awards is inconclusive at best, juries are no doubt influenced by the fact that silicone, a substance foreign to the body, is implanted. While silicone is not known to cause any human health complications,(33)silicon, in appreciable amounts does.(34) It is not the chemical composition or toxicity of silicone and silicon, rather it is the microparticles of silicon that the implant sheds, in the form of silicone gel, which cause any systemic responses.(35) Silicon does exist in silicone, both in the silicone in silicone gel breast implants and in the shells that surround both silicone gel breast implants and saline breast implants. Silicone contains silicon, oxygen and other organic elements that are chained and cross-linked together at the molecular level.(36) The length of these chains, and the complexity of the cross-linking determines how hard or soft the silicone will be.(37) By varying the combinations of the elements present, and by using heated or vacuum conditions, the molecular weight of the silicone changes, and the silicone can range in viscosity from a hard resin, to the more fluid like gel(38) in silicone gel breast implants. Although silicone-gel, has been labeled the "bad boy" in most treatments of the subject, the identical components are present in all silicones, including the silicone envelope of saline filled breast implants. (13) Traditionally(39) courts have adopted rather stringent standards for expert scientific evidence.(40) However the application of these standards is in a constant state of change; hence the admissibility of trial evidence that, from a scientific standpoint, proves nothing relevant to whether breast implants cause medical complications:(41) (14) Consequently, while most scientists hesitate to acknowledge a causal connection between silicone gel and auto-immune system breakdown, the law allows juries to draw their own conclusions regarding the controversial opinions of plaintiffs' expert witnesses, perhaps weighing in their sympathy for the implant recipient and their possible hostility toward the large corporate manufacturers[.]"(42)(15) Scientists, doctors and epidemiologists have high standards that must be met before an opinion can be rendered with scientific or medical certainty. Their criteria are the framework for modern scientific thought, which replaced alchemy and wizardry centuries ago. Nonetheless, juries in silicone gel breast implant cases have found causation present between silicone gel breast implants and systemic disorders where science has not.(43) The occurrence of diseases, such as connective tissue diseases complained of by many women with silicone gel breast implants, is not by itself proof that a single factor causes the disease.(44) For example, every year, approximately 100 women with breast implants are expected to be diagnosed with the connective tissue diseases lupus and scleroderma by chance alone, based on how many non implanted women get the disease and the fact that approximately two million women in this country have breast implants.(45) This is called a coincidence, not a causal link. (16) Evidence that silicone from silicone gel breast implants causes health complications is inconclusive. A leading study by Harvard Medical School concluded there is no link between silicone gel breast implants and connective tissue diseases, one of the primary ailments or disorders complained of by silicone gel breast implant plaintiffs.(46) The study looked at 87,000 nurses, 1,183 of whom had breast implants over a fourteen year period from 1976 through 1990.(47) The 1995 study concluded that women with breast implants were actually less likely to develop certain diseases and that breast implants caused no ill effects.(48) No causal associations between silicone gel breast implants and connective tissue disease have ever been established in any subsequent scientifically sound report.(49) Researchers, however, readily acknowledge the limitations of even the best studies, and studies can be cited that support even the most bizarre conclusions.(50) (17) Nonetheless, plaintiffs have been able to succeed in court. Hopkins v. Dow Corning Corp., is a case illustrating just how far the courts will go in permitting expert evidence that, while legally convincing, falls short of medical standards of causative proof.(51) The court applied the standards enunciated in Daubert v. Merrell Dow Pharmaceuticals,(52) with respect to permissible expert testimony. Plaintiff's experts put on their show, the jury believed it, and came back with an award of $84,000 in compensatory damages and $6.5 million in punitive damages.(53) Despite the fact that the standards under the Daubert decision are less stringent than those required for epidemiological proof in the medical community, the courts allow them to be the guiding light in expert evidence testimony and, in this case, held that plaintiff's experts "based their opinions on the types of scientific data and utilized the types of scientific techniques relied upon by medical experts in making determinations regarding toxic causation where there is no solid body of epidemiological data to review."(54) (18) Although the FDA has endorsed saline breast implants as safe, the agency also acknowledges certain risks that are associated with the devices.(55) Local risks acknowledged by the FDA include: capsular contracture (a painful build up of scar tissue that hardens and deforms the implant and breast); calcium deposits around the implants requiring extraction; follow up surgery to correct implants that deflate or reposition; post surgical infection; hematomas or bruising requiring draining of the damaged tissue; poor healing of the insertion wound; and change in sensation around the breast and nipple.(56) Systemic risks, identified as possible but unknown are:(57) autoimmune disease; effects on breast fed children;(58) and enhanced risk of cancer.(59) The FDA also acknowledges that bacterial or viral infection of the saline solution may occur. This conclusion seems to have been born out of studies concluding that a variety of microbes may grow inside saline breast implants that were improperly cared for before their implantation. Whether the proliferation of viruses and bacteria in saline solution poses a threat to the health of implantees is unknown.(60) However it is clear that saline breast implants can become engorged with other bodily fluids, including water, glucose and protein, that permeate through the silicone shell.(61) The addition of these fluids causes marked enlargement of the implant and discoloration of the saline, visible through the shell. Researchers described the former saline solution as a "brownish yellow material that had the consistency of serum."(62) Certainly knowledge that bacteria, viruses and other "germs" were living in that liquid, inside a saline breast implantee's body could cause an adverse emotional reaction. Indeed, researchers noted that reports of such occurrences, "have caused considerable alarm and fear to saline implant recipients."(63) (19) More troublesome than offensive liquids and colonies of microbes inside saline breast implants is the possibility that some saline breast implants, more so than silicone gel breast implants, may put silicone into the body. Capsular contracture, or fibrous scar tissue around the implant, is a common condition caused in part by the unnaturally smooth surface of the breast implant.(64) To combat the effects of capsular contracture, many women were implanted with saline breast implants with a textured or rough surface.(65) Silicone shells do shed fragments of silicone into the body. Unfortunately, textured shells, as opposed to smooth shells, are more likely to shed silicone into the body.(66) Some believe that these particles of silicone (as opposed to the subtle chemical difference between silicone gel and the firmer silicone of the envelope) cause the systemic problems associated with silicone gel breast implants.(67) While silicone gel breast implants have long been known to weep or bleed the gel through the shell into the system(68), saline was thought to be safe. (20) The sensational nature of the "infected" saline breast implants and textured saline shells that shed fragments of silicone into the system certainly pose a threat to the reputation of saline breast implants. Still, there is no proof that these complications or any of the risks that the FDA has identified, pose any systemic threat to women with saline breast implants. Claims of this nature make up most of the complaints about silicone gel breast implants and are the focus of the mass litigation. Regardless, if plaintiffs learn of these complications, fears may arise, and so may suits against McGhan and Mentor. However, what could possibly happen to bring this obscure medical information to the forefront of the public's consciousness? (21) In 1992, the FDA's ban on silicone gel breast implants came in the wake of many public influences as well as the manufacturer's final safety data. The FDA was responding to plaintiff's complaints that silicone gel breast implants "caused" their systemic disorders, and to consumer group pressures.(69) (22) Perhaps most integral to the FDA's decision was the sensational media coverage of silicone gel breast implants.(70) One source declares, "(t)he exasperated agency was bludgeoned by the press for neglecting to review the devices until the controversy reached a media boiling point."(71) Another stated that the "hysteria of the American public, fomented by the media's coverage of the "alarm of the day"' contributed greatly to the ban on silicone gel breast implants.(72) Perhaps the most disturbing consequence of an FDA ban on saline breast implants is the fact that such an act may in itself create anxiety that leads to consumers believing that saline breast implants cause health problems and that the "government ban" is prima facie evidence of wrongdoing on the part of manufacturers. With the silicone gel breast implant moratorium, that may certainly have been the case. Prior to the FDA's April, 1992 announcement, the breast implant industry had a total of 200 tort claims brought against them.(73) By December of that same year, 10,000 suits had been filed.(74) (23) Dr. Marcia Angell,(75) an outspoken critic of the breast implant plaintiff's movement, lays the blame for the increase in silicone gel breast implant litigation squarely at the feet of the FDA's announcement: (24) [T]he agency's ban, premised upon no sound scientific evidence of serious systemic side effects . . . needlessly provoke[d] incalculable consternation and anxiety on the part of more than one million women who had previously undergone silicone gel breast implant surgery. . . Almost on signal, the FDA announcement in 1992 turned what had been a trickle of products liability suits against breast implant manufacturers into a flood.(76)(25) The news media is quick to herald any health related story to the American public. Newspapers, magazines and perhaps most sensationally, television newsmagazine programs jump on the bandwagon and under the guise of journalism, bring to the forefront news of any recent medical development that, ostensibly, will have an appreciable effect on the health of the citizenry, especially stories involving health dangers.(77) (26) The interest in, and reaction to, health related stories stems from a combination of cynicism and gullibility in the psyche the American public.(78) As our lives become more and more governed by technology and science, our ability to effectively understand and process the barrage of information is compromised, and the public, in a reaction governed by both fear and consternation, becomes more and more willing to believe what it is told. This phenomenon is founded in distrust and paranoia.(79) As social conditions erode, it seems more likely that government and big business are in bed together and that, therefore, each is covering up the other's mistakes. Specifically, worries over jobs, personal income, crime all contribute; "[w]hen they see greed and corruption all around them, [people] come to distrust nearly everything."(80) With respect to silicone gel breast implants, Dr. Angell is convinced that the public believed that, "the breast implant manufacturers had knowingly marketed dangerous devices and that the FDA had let them get away with it for years."(81) Citizens' advocacy and consumer watchdog groups, movies, and books all strengthen the belief that the big guy out there does not care about the private citizen.(82) This functions to create a cynicism. A distrust more complex than mere skepticism, cynicism is a thought process that begins with the belief that drug manufacturers, health care givers and the government are aligned and then moves towards confirming the theory, rather than beginning with a neutral outlook, then weighing all factors evenly. Time magazine published an article with the title, "Can Drug Firms be Trusted?" that speared large corporations such as Upjohn, Hoffmann-La Roche, Eli Lilly, Bristol-Myers Squibb and, of course, Dow Corning, for marketing drugs and medical products or devices whose safety had come into question.(83) The same article also attacked the FDA for being asleep at the wheel, implying that the FDA and the manufacturers had some reciprocal relationship.(84) (27) Gullibility comes from an inability to distinguish facts from theories. Everything becomes equally likely.(85) Cynicism, then, creates a disdain for traditional theories and solutions, and gullibility allows the public to believe in alternative ones. Specifically, symptoms of fatigue and ennui were initially attributed to a disease called "neurasthenia", later "chronic mononucleosis" became the diagnosis, and currently, the name for this series of ailments common to man throughout history is "chronic fatigue syndrome."(86) The cynical and gullible public, gobbles it all up. In this social vortex, a belief that silicone gel breast implants cause a variety of ailments was born, and the result was mass litigation. (28) Despite the fact that there is no proof that silicone gel breast implants cause systemic physical maladies, there exists the very real danger that if the media,(87) the watchdog groups, and the underground conspiracy theory newsletters(88) decide, for whatever reason, to conclude that saline breast implants cause a host of ailments, the American people will believe they do and litigation will result. (29) While difficult to gauge precisely, breast implant consumers have had their faith in breast implants restored by saline breast implants. Both the FDA and physicians groups believe that saline breast implants are a desirable alternative to silicone gel breast implants and tout them as safe.(89) However, if the FDA ever chooses to conclude that saline breast implants are not safe, or is sketchy, inconclusive or otherwise not favorable, the possibility of the FDA pulling saline breast implants from the market is real, especially as a third alternative, soybean oil, looms on the horizon.(90) If, as Dr. Angell might suggest, the FDA bans the device, and the media picks up the story, the cynical and gullible breast implant consumers of this nation may be willing to psycho-somatically relate their various maladies and complaints to their saline implants. Litigation over saline breast implants could quite easily follow the route of the silicone gel breast implant cases. (30) Certainly, the implantation of a device into the body can cause any number of local problems. Both manufacturers and doctors have acknowledged these risks.(91) However, the systemic diseases plaintiffs claim are caused by silicone gel breast implants may, by a slight extension of legal (not scientific) logic, may also be caused by saline breast implants, since both devices contain significant amounts of silicone in the shell. Because no research has determined that the problems theoretically caused by silicone come from the gel in silicone gel breast implants, the silicone causing the problems may just as well be coming from the envelope or shell. (31) Here is how saline breast implant plaintiffs can establish their roots to legal precedents established in earlier silicone gel breast implants cases; it's the silicone in the envelope, not the gel inside, that causes problems. Therefore it is irrelevant that the envelopes are filled with saline. (32) Only a handful of reported decisions exist that mention saline breast implants. Their doctors told these plaintiffs that they were receiving saline breast implants. Instead, when they learned they had received silicone gel breast implants, they sued.(92) The significant is that at least one of these plaintiffs sued for the express reason that she became aware of problems associated with silicone gel breast implants through the media's coverage; "Bess became aware of media coverage regarding the dangers of silicone gel implants. She then went to the hospital to review her records, and discovered for the first time that her implants consisted primarily of silicone gel."(93) This case accurately depicts how susceptible persons are to stories presented by the media.(94) Presumably, these plaintiffs did not feel that earlier class action suits were applicable to them because they believed they were implanted with saline breast implants, not silicone gel breast implants. It is unknown how commonly held these beliefs are. (33) Assuming that saline breast implant plaintiffs choose to decide their health complications are caused by their implants, manufacturers McGhan and Mentor may have a fresh fight on their hands. Numerous factors have been identified as contributing to mass tort lawsuits, such as the silicone gel breast implants.(95) With respect to saline breast implants, all are present and suggest that regardless of whether or not the FDA decides to ban the device, the possibility that saline breast implants plaintiffs could litigate extensively is real. (34) One of these factors has already been discussed; the Mass Media.(96) In addition to the media's contribution to the silicone gel breast implant litigation media attention on other devices and drugs has resulted in mass litigation and class action lawsuits.(97) Given consumers' interests in their health, and the cynicism and gullibility discussed earlier, saline breast implants have the same potential. Moreover, the media is quick to bring sensational settlements to the forefront, that could encourage women who tend to blame their maladies on their implants in order to tap into a huge reservoir of money.(98) (35) Also identified as a relevant factor inspiring class actions and mass litigation are Social Networks.(99) "Ad hoc groups, such as the Asbestos Victims of America, the Dalkon Shield victims organizations and the Silicone Breast Implant organizations. . . facilitate the growth of mass litigation by continuing to direct media attention to the inquiries underlying the litigation and to the litigation itself."(100) Given implants' connection with mastectomies, cancer organizations have an interest present,(101) along with women's groups, and one organization called "Public Citizens Health Research Group," which litigated the issue over whether the courts should force the FDA to expedite their saline breast implant recommendation.(102) (36) Finally, plaintiffs' lawyers specializing in breast implant litigation are a contributing factor to the potential for overwhelming litigation respecting saline breast implants.(103) Lawyers are especially well organized, and prepared to take up litigating saline breast implant cases. Combined with an entire newsletter devoted to litigating breast implant cases, called Medical/Legal Aspects of Breast Implants, legal newspapers and journals regularly run "how to" articles on tapping into the huge and (potentially) hugely profitable realm of litigating breast implant cases against manufacturers.(104) Moreover, lawyers are not shy about advertising that breast implant cases are their specialty and that women who have them should consider litigation over their complaints.(105) Attorneys aggressively advertise their breast implant litigation expertise in newspapers and on billboards and television, and at least one law firm has set up a toll free hotline to encourage women contemplating litigation to call their office.(106) Even the Association of Trial Lawyers of America has a implant litigation group, whose co-chair declares, "I will sue people so that I can protect women."(107) (37) The stage appears to be set: if the F.D.A. ever concludes that saline breast implants are unfit for public use, it will ban them. The media will pick up the story and sensationalize it to make a profit. Women with saline implants will become frightened. Despite earlier settlements naming saline implanted women as class members, many saline implanted women who opted out of those classes or weren't notified of the action will file suit, and will have no trouble finding experienced attorney to represent them. Given the current state of the admissibility of scientific evidence at trial, juries will be able to reasonably conclude plaintiff's injuries were caused by saline implants. The settlements will be staggering. (38) The manufacturers' only affirmative defense is that silicone gel was the original culprit, not the silicone shell, and that saline implants do not have this compound present.(108) Aside from other procedural defenses such as prophylactic legislation and statute of limitations,(109) manufacturers' defenses are few. The nation's judicial system must prepare to deal with this seeming eventuality.

FOOTNOTES

1. While many surgical and quasi surgical methods of enlarging breasts were attempted over the years, silicone implants of various descriptions were not used until 1962. See H. Hennekens et al., Self Reported Breast Implants and Connective Tissue Diseases in Female Health Professionals, 275 JAMA 616 (1996). 2. See McCormick, Keeping Women in the Dark: Lessons Not Learned and the Real Sins of the Breast Implant Manufacturers, 17 B.C. THIRD WORLD L.J. 413, 413. Bristol-Myers Squibb, Baxter International, Bioplasty Inc., Mentor Corporation and McGhan Medical Corporation (now known as Inamed) were the other manufacturers. See DR. MARCIA ANGELL, SCIENCE ON TRIAL: THE CLASH OF MEDICAL EVIDENCE AND THE LAW IN THE BREAST IMPLANT CASE 34 (1996). 3. See Ray Chao, Study says Breast Implants Not the Source of the Disease, 7 LOY. CONSUMER L. REP. 124 (1995). 4. See Jack W. Snyder, Silicone Breast Implants: Can Emerging Medical, Legal and Scientific Concepts be Reconciled?, 18 J. LEGAL MED. 133, 161 (1997). 5. Perhaps the most recent example of this FDA ban and resultant litigation phenomenon is that surrounding the diet drug combination fen/phen (dexfenfluramine and fenfluramine). See Who's to Blame for Redux and Fenfluramine?, TIME, Sept. 29, 1997, at 78. "If the finger pointing that followed last week's abrupt withdrawals of two of the country's favorite diet pills looked like a multiple-choice law-school torts exam, the similarity was hardly coincidental. Even before the FDA urged the recall of (the diet drugs) scores of lawyers across the nation had already started filing law suits. After the recall, the legal assault turned into a stampede." Id. 6. See FDA Issues First Mass Downclassifications of Preamendments Class III Devices, The Gray Sheet, Vol. 25, issue 12, available on Westlaw as 1999 WL 10789629. 7. See The Directory of New Medical Technologies' Status, Vol. II: Surgery and Anesthesia, 1996, available in Lexis, -Med SALI0302.15. 8. See id. 9. Francis E. McGovern, The Defensive Use of Federal Class Actions in Mass Torts, 39 ARIZ. L. REV. 595 (1997). 10. See Snyder, supra note 3, at 133, 135-36. 11. See id. at 135. 12. See id. at 136-37. 13. See Snyder, supra note 3, at 133, 136-137. 14. See id. at 137. 15. See id. at n.23. 16. Snyder, supra note 3, at 133, n.145. Breast implants also became classified as a CII device in 1976. See 21 C.F.R. § 878.3540 (1990). 17. The information gathered by the FDA was sketchy, at best. The women were not closely or personally evaluated and information was gathered from medical charts. See J. Hilts, Amid Heavy Lobbying, Government is Considering Ban on Breast Implants, N.Y. TIMES, Oct. 21, 1991, at A1. Moreover, the women were never followed up with. Seeid. The information about Dow Corning's safety concerns was taken from several internal memos at Dow Corning. See Snyder, supra note 3 at 133, n.150. 18. See Krista R. Stine, 63 Silicone, Science and Settlements: Breast Implants and a Search for Truth, DEFENSE COUNS. J. 491 (1996). 19. See Kessler, The Basis for the FDA's Decision on Breast Implants, 326 NEW ENG. J. MED. 1713 (1992) (declaring an end to the use of silicone gel breast implants for solely cosmetic purposes and thereby effectively eliminating their use). 20. ANGELL, supra note 14, at 110. 21. See Delia M. Rios, Societal Pressures Putting Image Ahead of Risks, Many Women Take Their Chances with Breast Implants, CHI. TRIB., Oct. 5. 1997, at 2. 22. See id. 23. See generally ANGELL, supra note 14 (describing the inconclusive and non-probative nature of the scientific evidence in silicone gel breast implant tort cases). 24. See McCormick, supra note 14, at 413. 25. Panel Recommendations on Silicone-Gel-Filled Breast Implants Follow Moratorium, FDA MEDICAL BULLETIN, Apr. 1, 1992, available in 1992 WL 2778744. 26. See Snyder, supra note 3, at 133, 137. 27. See Rios, supra note 20. 28. See The Directory of New Medical Technologies' Status, Vol. II: Surgery and Anesthesia, 1996, available in WESTLAW, -Med SALI0302.15. 29. See Rios, supra note 20. 30. See id. 31. See McGahn Faced Back-orders, Raises Prices on Implants, HEALTH INDUSTRY TODAY, April 1992, at 2. Dow Corning withdrew from the implant market in 1992, shortly before the FDA issued its April 1992, moratorium, See Strategic Withdrawal, TIME, Mar. 30, 1992, at 51. 32. Epidemiology is the science of surveying the "incidence of disease in samples of different groups." ANGELL, supra note 14, at 23. 33. However, a 1988 Dow Corning study did show an increased incidence of cancerous sarcoma in rats after the administration of silicone gel. See The Directory of New Medical Technologies' Status, Vol. II: Surgery and Anesthesia, 1996, available in WESTLAW, -Med SALI0302.15. Experts are quick to explain that sarcomas occur frequently in rats as a response to any implanted object, and that in humans, sarcomas are extremely rare. Seeid. The conclusion is that the risk of cancer to humans would be "very small." Id. See also, Louise A. Brinton et al., Breast Implants and Cancer, 89 J. NAT'L. CANCER INST., 1341, (1997) (concluding that there is little evidence to determine that breast implants increase the risk of breast cancer and that data on whether silicone breast implants predispose implantees to other types of cancer is insufficient). 34. See Teri Randall, Implants Aside, Silicon is No Stranger to the Body, 267 JAMA 2442 (1992). 35. See id. 36. See id. 37. See Silicone Gel Breast Implants, 270 JAMA 2602 (1993). 38. "Silicone gel is a silicone fluid embedded but not bound in a loose network of cross-linked polydimethylsiloxane gel chains; components of the fluid are capable of diffusing through the elastomeric implant shell". Id. 39. Supreme Court and Federal Court rulings have been instrumental in guiding state courts on the admissibility of scientific evidence. See Snyder, supra note 3 at 133, 197. The most influential case in establishing guidelines for courts to use in allowing scientific evidence is Daubert v. Merrel Dow Pharmaceuticals. See 509 U.S. 579 (1993) (establishing that scientific evidence must have a sufficient scientific foundation under the Federal Rules of Evidence). 40. For expert evidence in conjunction with scientific evidence, the Federal Rules of Evidence promulgate standards in a section called "Opinions and Expert Testimony." See Snyder, supra note 3 at 133, 195. The rules that most significantly impact medical and scientific evidence are Federal Rules of Evidence 702, 703, 705, 401, 402, and 403. See id. at n.307. The case of Daubert v. Merrel Dow Pharmaceuticals, is currently the leading case law on the use of this rule and provides for a two step analysis of the evidence proffered. See generally 509 U.S. 579 (1993). The first prong is whether the testimony offered as evidence represents valid scientific knowledge, not an absolute statistical certainty. See id. at 590. The second prong is whether the reasoning or methodology used in reaching the scientific knowledge offered as evidence, is sufficiently relevant to the case at hand. See id. at 592. The resulting standard of proof, while often sufficient to meet the legal preponderance of the evidence standard at a civil trial, falls far below that which doctors, scientists and epidemiologists consider convincing. See ANGELL, supra note 14, at 114-15. 41. See ANGELL supra note 14, at 198-205 (explaining that despite the enunciation of standards and criteria for scientific and medical evidence, courts are uncertain as to their applicability and inconsistent in their usage and adherence). 42. See Charlotte , Jurisprudence of Breasts, 5 STAN. L. & POL'Y REV., 83, 86 (1994). 43. See D. Whitaker, Civil Evidence, 52 smu l. rev. 799, 803 (1999). 44. See s , Scientific Authority: The Breast Implant Litigation and Beyond, 80 va. L. rev. 801, 809-810 (2000). 45. See Stine, supra note 17. 46. See Chao, supra note 2. The unfortunate irony is that the renowned study was published one month after Dow Corning, one of the leading manufacturers of silicone gel breast implants and a chief defendant in breast implant litigation, declared bankruptcy. See id. 47. See id. 48. See id. This statement is, no doubt, a tongue in cheek comment on how misleading statistics can be. For example, perhaps fewer implanted women in the study than the national average ever contracted rabies, a disease with almost no plausible connection to breast implants, but nonetheless, a (hypothetical) fact. 49. See Snyder, supra note 3 at 133, 154. 50. Also problematic is the fact that many silicone gel breast implant plaintiffs claim connective tissue diseases, such as rheumatoid arthritis, that cannot be classified or substantiated due to the subjective nature of their symptoms. See Stine, supra note 17 at 500. The doctor of several plaintiffs has even coined an acronym for the complaints suffered by women with breast implants - BIAS, for Breast Implant Associated Syndrome. See id. This diagnosis comes from complaints of "fatigue, muscle aches, difficulty with concentration, weakness, numbness, tingling, joint pain, rashes, digestive problems, and complaints of fever. None of these symptoms is unique to women with breast implants. . . and thus the opinion surrounding the disease is nothing more than mere speculation." Id. 51. See 33 F.3d 1116 (9th Cir. 1994). 52. See 509 U.S. 579 (1993). 53. Plaintiff had been diagnosed with mixed connective tissue disease three years after receiving her silicone gel filled implants. See Hopkins, 33 F.3d at 1118. 54. Id. at 1124. 55. See FDA Advises Physicians On Risks Involved in Saline Breast Implants, MEDICAL/LEGAL ASPECTS OF BREAST IMPLANTS, July 1995, at 6, available in WESTLAW, 3 No. 8 Med. Legal Aspects Breast Implants 6. 56. See id. 57. See id. 58. The implication here is that not only may chemicals in the implant themselves pose a threat to breast fed infants or fetuses in the womb, but naturally produced biomolecules produced by the woman may harm the immune system of the children of women with implants. See Snyder, supra note 3, at 133, 159. 59. However, a 1997 summary of epidemiologic studies on cancer and women with implants actually suggests, "that breast cancer risk might be reduced among women with implants, although the biologic mechanism remains undefined." Louise A. Brinton, Breast Implants and Cancer, 89 J. NAT'L CANCER INST. 1341, 1341 (1997). 60. While two studies published simultaneously reached different conclusions on the issue of whether viruses and bacteria can thrive in saline breast implants, the conclusions are read for different reasons. A study by researchers at Florida Atlantic University determined that there was "no evidence of microbial contamination" in saline breast implants if used properly. H. Becker, et al., Do Saline Breast Implants Harbor Microbes?, ANNALS OF PLASTIC SURGERY, April 1996, at 342, 342. Presumably improper use of saline implants would include exposing the saline solution to airborne contaminant prior to insertion in the implant. See DA Pegues, Serratia Marcescens Surgical Wound Infection Following Breast Reconstruction, AM. J. MED. Sept. 1991, at 173. The study by researchers at Massachusetts General Hospital concluded that microbes that had been purposely inserted into saline breast implants were able to thrive and multiply due to the diffusion of glucose across the implant shell. See NT Chen et al., Bacterial Growth in Saline Implants: in Vitro and in Vivo Studies, ANNALS OF PLASTIC SURGERY, April 1996, at 337. 61. See OG , Jr. et al., Spontaneous Autoinflation of Saline Mammary Implants, ANNALS OF PLASTIC SURGERY, Aug. 1998, at 114, 118. 62. Id. at 114 63. See H. Becker, et al., Do Saline Breast Implants Harbor Microbes?, ANNALS OF PLASTIC SURGERY, April 1996, at 342, 342. 64. Compounding this painful condition is the procedure most often used to relieve it. Closed capsulotomy is the external kneading or squeezing of the implant until the underlying scar tissue breaks apart, a practice not recommended by Dow Corning, yet common regardless. See Snyder, supra note 3 at 133, 143-44. 65. See id. n.1 at 55. See alsoPlastic Surgeons' Society Tells What it Knows About Saline Implants, CANCER WEEKLY, April 19, 1993, at 8. But see E. Tarpila et al., Capsular Contracture with Textured Versus Smooth Saline-filled Implants for Breast Augmentation, 99 PLASTIC RECONSTRUCTIVE SURGERY 1934-39 (1997) referencing a study concluding that textured shells do not result in decreased incidence of capsular contracture in a double blind study of 21 women; each had a textured and smooth implant inserted). 66. Curiously, saline breast implants with textured shells appear more likely to shed fragments of silicone than silicone gel breast implants with textured shells. See Vreeland, Saline Breast Implants May Not be so Safe, AMERICAN HEALTH, July 1, 1994, at 11 (concluding that 24 out of 20 textured shells shed fragments of silicone into tissue surrounding the breast and none of the smooth shells did). 67. See Teri Randall, Implants Aside, Silicon is No Stranger to the Body, 267 JAMA 2442 (1992). 68. See Vreeland, Saline Breast Implants May Not be so Safe, AMERICAN HEALTH, July 1, 1994, at 11. 69. The Women's Implant Information Network (WINN) is a consumer group currently that stands behind the FDA's decision to keep saline breast implants on the market and damns the FDA for a hasty removal of silicone gel breast implants. SeeGroup Speaks Out on Breast Implant Safety, CANCER BIOTECHNOLOGY WEEKLY, Feb 20, 1995, at 13. The group claims that the removal of any medical device should be based on scientific evidence and never sensationalistic media reports and anecdotal evidence or case histories See id. WINN blames the removal of silicone gel breast implants solely on "an emotional reflex to anecdotal reports blaming implants for a variety of diseases". Id. at 13. Seegenerally McCormick, Keeping Women in the Dark: Lessons Not Learned and the Real Sins of the Breast Implant Manufacturers, 17 B.C. THIRD WORLD L.J. 413, 414 (1997). 70. Decisions by the FDA are not made in a "statutory and regulatory vacuum" and are no doubt influenced by public opinion and sentiment. See McCormick, Keeping Women in the Dark: Lessons Not Learned and the Real Sins of the Breast Implant Manufacturers, 17 B.C. THIRD WORLD L.J. 413, 414 (1997). 71. Robin Margolis, Breast Implant Controversy Leaves FDA Facing Messy Clean-Up, HEALTHSPAN June 1992, 17. 72. See McCormick, Keeping Women in the Dark: Lessons Not Learned and the Real Sins of the Breast Implant Manufacturers, 17 B.C. THIRD WORLD L.J. 413, 418 (1997). 73. See Snyder, supra note 3, at 133, 154. 74. See id. 75. Dr. Angell is a physician, and the executive editor of the NEW ENGLAND JOURNAL OF MEDECINE. See ANGELL, supra note 14, at 9. Dr. Angell became involved in breast implant litigation when she reviewed two manuscripts on silicone gel breast implants submitted to the Journal, one in 1992, and one in 1994. See id. Because Dr. Angell believed the proposed articles were so important, and the science so suspect and colored by public opinion, political interests and the law, she included an editorial on the articles submitted. See id. at 10. 76. Snyder, supra note 3 at 133, 153. 77. "Danger is a story; safety is not." ANGELL, supra note 14, at 154. 78. See id. 79. See id. at 156. 80. Id. 81. Id. 82. Specifically, Dr. Angell references Ralph Naders's Public Citizen's Health Research Group, the book THE HOT ZONE, and the film OUTBREAK as contributors to the public's burgeoning gullibility in a conspiracy between government, business, and special interest organizations. See id. at 156-57. Dr. Angell also suggests that the public enjoys being scared about health risks and considers it a form of entertainment. See id. at 157. 83. See Gorman, Can Drug Firms Be Trusted?, TIME, Feb. 10, 1992, at 42. 84. After briefly outlining how marketing unsafe products is bad for manufacturers interests, given our nation's tort and economic systems, the author declares, "a relationship of trust between the medical-products industry and the FDA Historically, the agency has counted on the pharmaceutical firms, when they apply for approval of a new drug or device, to carry out the necessary testing and to do it honestly." Id. Without saying so, but by providing facts about the FDA and using phrases such as "a bureaucrat with limited power," to describe FDA commissioner Kessler, the article seeks to cast doubt and suspicion on the relationship between manufacturers, the FDA and the free market system. Id. 85. See ANGELL, supra note 14, at 158. Gullibility is caused, in part, by the inability to process and make sense of the complex technological world we live in. Fueling gullibility, is the belief that science and scientists cannot be trusted. See id. at 178. 86. See id. at 159. 87. Certain news outlets have acknowledged the impact the media has on health related issues. One journalist comments, "(w)ith any medical procedure or appliance, for example, there is an element of risk¼(y)et media coverage of both breast implants and (other devices) focused on the horror stories suffered by a small percentage of the women involved." Joe Saltzman, Seeking an Answer to "What is News?", USA TODAY MAGAZINE, Mar. 1, 1997, at 87. He then goes on to suggest that, "(p)erhaps a revised definition of news should include the usual as well as the unusual as a means of reference." Id. He hastens to add, however, "But where's the fun and headlines in all of that?" Id. See also Purvis, Time Bombs in the Breasts? Reports Linking Some Types of Silicone Implants to Cancer Stir Up Fears - But They May Turn Out to be Exaggerated, TIME, Apr. 29, 1991, at 70. 88. A recent movie, CONSPIRACY THEORY, starring the popular actors Mel Gibson and , was about how such a conspiracy theory newsletter theorist was ver close to the truth in one of his far fetched allegations, resulting in a very real danger to his person. The popularity of this movie, released after the publication of Dr. Angell's book, strengthens her arguments that the American public believes the government fosters a cloak of secrecy, designed to hide the truth from them. See alsogenerally, TheX-Files (FOX television broadcast). 89. See Snyder, supra note 3 at 133, 137. 90. Soybean oil filled, silicone envelope breast implants are currently being tested in individuals to determine their safety. SeeA Roundup of Medical News Drawn from Sources Around the Country, MEDICAL/LEGAL ASPECTS OF BREAST IMPLANTS, May 1995, at 8, available in WESTLAW, 3 No. 6 Med. Legal Aspects Breast Implants 8. For at least the testing phase of these silicone shell, soybean filled implants, each device will include a tiny computer chip that can be read by a scanning device to assist in the tracking of any problems that may develop. See id. This gives rise to the possibility of the mass tort cycle repeating itself when safety data or PMAs are due on the safety of soybean filled breast implants. 91. See Snyder, supra note 3, at 133, 138. 92. See Massaro v. Ftaiha, 1997 W.L. 135754 (E.D. Pa. 1997); also Weinberg v. Bess, 638 N.E.2d 841 (Ind. Ct. App. 1994). 93. Weinberg v. Bess, 638 N.E.2d at 843. Upon learning that she had been implanted with the silicone gel device, plaintiff concluded that the pain she had been feeling in her breast was a result of the implant being silicone gel rather than saline, and sued her doctor. See id. 94. Defense counsels should note, however, that in at least one case, attorneys for defendant breast implant manufacturer unsuccessfully argued that the plaintiff was a victim of "mass media hysteria, not defective implants." Kerith Cohen, Truth & Beauty, Deception & Disfigurement: A Feminist Analysis of Breast Implant Litigation, 1 WM. & MARY J. WOMEN & L. 149, 174 (1994). This does not seem to be an effective defense strategy. 95. See generally, Deborah R. Hensler et al., Understanding Mass Personal Injury Litigation: A Socio-Legal Analysis, 59 BROOK. L. REV. 961 (1993). 96. See id. at 1020. 97. For instance, a 1979 article in the tabloid newspaper the NATIONAL ENQUIRER is credited with triggering the mania, and subsequent manufacturer's withdrawal of the product Bendectin, a medicine prescribed to counteract morning sickness and other unpleasant side effects of pregnancy. See Deborah R. Hensler et al., Understanding Mass Personal Injury Litigation: A Socio-Legal Analysis, 59 BROOK. L. REV. 961, 978 (1993). A similar expose on the Dalkon Shield that aired on the television news magazine Sixty Minutes had like results. See id. at 1021. 98. See e.g. Kolata, Details of Implant Settlement Announced by a Federal Judge, N.Y. TIMES, Apr. 5, 1994, at A1 (announcing jury award of 3.7 billion dollars in a breast implant class action suit.); see also M. Burton, Settlement Over Breast Implants Gets Final Approval From Judge, WALL ST. J., Sept. 2, 1994, at B2 (spelling out details of a 4.2 billion dollar breast implant settlement). 99. See Deborah R. Hensler et al., Understanding Mass Personal Injury Litigation: A Socio-Legal Analysis, 59 BROOK. L. REV. 961, 1023-24 (1993). 100. Id. at 1024. 101. Groups such as the American Cancer Society, Y-ME, the National Alliance of Breast Cancer Organizations, the National Coalition for Cancer Survivorship and the K. Komen Foundation are a few of the organizations involved in disseminating breast implant information and resources. See Effort Launched to Educate Women About Saline Alternative; Clinical Trial of Saline Implant, CANCER BIOTECHNOLOGY WEEKLY, Aug. 14, 1995, at 6. 102. See In Re Public Citizens Health Research Group, 1995 W.L. 118039 (D.C. Cir. 1995); see also Further U.S. Ban of Breast Implants is Urged, N.Y. TIMES, Aug. 5, 1994, at A15. Important to note, however, is the American Society of Plastic and Reconstructive Surgeons has also formed a group, PlastyPAC, that will devote its time and energy to lobbying Congress and lawmakers to keep breast implants legal, as well as to tell "the other side" of the breast implant story. D. Lemonick, Lawyers to the Rescue, TIME, Feb. 10, 1992, at 46. Seealso Barbara Ehrenreich, Stamping Out a Dread Scourge (Small Breasts), TIME, Feb. 17, 1992, at 88. 103. See Deborah R. Hensler et al., Understanding Mass Personal Injury Litigation: A Socio-Legal Analysis, 59 BROOK. L. REV. 961, 1025-26 (1993). 104. One such article clucks, "®ather than being disheartened by the small size of the verdict, the plaintiff's bar should be encouraged, and count Duke (sic) as another plaintiff's victory in the implant litigation." M. Dunleavy, A Plaintiff's Perspective on Duke Trial - Lessons to be Learned, MEDICAL/LEGAL ASPECTS OF BREAST IMPLANTS, June 1997, at 1, available in WESTLAW, 5 No. 7 Med. Legal Aspects Breast Implants 1.; also M. Levine, Fundamental Issues in Litigating Breast Implant Cases, PRACTICING LAW INSTITUTE, Nov. 12, 1992, at 15, available in WESTLAW, 451 PLI/Lit 15. 105. See Deborah R. Hensler et al., Understanding Mass Personal Injury Litigation: A Socio-Legal Analysis, 59 BROOK. L. REV. 961, 1025-26 (1993). 106. See D. Lemonick, Lawyers to the Rescue, TIME, Feb. 10, 1992, at 46. 107. Id. 108. Although the difference between silicone gel and the silicone envelope is only slight, the compounds are chemically distinguishable; "(s)ince each molecular specie may have differing potential for biologic mobility and activity, it is mandatory to evaluate each product for safety and avoid inappropriate extrapolations among differing chemical entities." Silicone Gel Breast Implants, 270 JAMA 2602 (1993). See alsoProduct Liability Defenses Applicable to Breast Implant Litigation, PRACTICING LAW INSTITUTE, Nov. 17, 1993, at 189, available in WESTLAW, 487 PLI/Lit 189 (discussing the relatively weak defenses of Assumption of Risk and Comparative Fault, among others). 109. See generally Dana , Departure from Established Tort Theories Inappropriate for Breast Litigation, 8 LOY. CONSUMER L. REP. 71 (1995-96) (discussing how market share liability and concert of action liability defense strategies will not work for breast implant manufacturers).

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