Nevada's Supreme Court Upholds Junk Science
by D. Dowd Muska
harlotte Mahlum is a very sick woman. The former Elko resident suffers from severe headaches, seizures, loss of muscle control, exhaustion and tingling sensations throughout her body. And shes convincedas are thousands of women with similar symptomsthat her condition has a single cause: silicone breast implants.
Mahlum, who now lives in Las Vegas, is a key player in what can properly be called a crusade. Since the Food and Drug Administration (FDA) banned silicone breast implants in 1992, implant "survivors" have filed lawsuits against the companies which manufactured what was once Americas most popular cosmetic surgery product. Urged on by trial lawyers, anti-implant feminists, left-leaning "consumer advocates," and some in the medical profession, the womenand in many cases, their husbands and childrenhave sought hefty awards in courts throughout the nation.
In 1995, Mahlum won a $14.2 million jury verdict against Dow Chemical, a 50 percent shareholder of the largest implant manufacturer, Dow Corning. In a split decision handed down last New Years Eve, Nevadas Supreme Court sliced off her $10 million award for punitive damages, but let her $4.2 million compensatory judgment stand.
For those who have not followed the silicone breast implant story since the FDAs ban, the courts decision probably seemed reasonable. That punitive award was out of control, but everyone knows that silicone really did make all those women sickgive her a break, let her keep a few million.
But the justices ruling in Mahlum was far from a rational finding of culpability on Dow Chemicals part. In fact, a look at Charlotte Mahlums entire legal struggle reveals much of what is wrongand dangerousabout Americas tort system. From its weak justifications for targeting Dow Cornings deep-pocketed parent company to its reliance on shaky medical speculation, Mahlum is a poster lawsuit for tort reform. Sadly, its also an indicator of how little Nevadas Supreme Court grasps the threat junk science poses to civil litigation.The Silicone Bogeyman ilicone breast implants ruptureof that there is no doubt. Manufacturers and anti-implant activists disagree on the rupture rate, but a certain number of defective implants do cause problems for the women unlucky enough to receive them.
"But these local complications," wrote Marcia Angell, M.D., in her book Science on Trial, "unpleasant as they were, were not the basis for most of the alarm about breast implants, nor were they the focus of the multimillion-dollar lawsuits." The litigation explosion earlier this decade stemmed from the belief that even intact silicone implants could give women connective tissue diseases. Small leaks led to silicone "poisoning," it was said, which made a womans immune system start to wage war on her body. The result? Systemic lupus erythematosus, rheumatoid arthritis, and other conditions which producedamong other thingsfatigue, joint pain and loss of muscle control.
Yet the small number of silicone lawsuits filed in the 1980s would never have mushroomed into a "mass tort" without the actions of David Kessler, the man who George Bush picked to run the FDA in 1990. With pressure mounting from Congress, the media and hopped-up liberal consumer groups (including Ralph Naders often-wrong Public Citizen), Kessler imposed a temporary ban on silicone implants in January 1992. In April, he made the ban permanent, except for women who agreed to participate in research studies.
Implant foes rejoiced, and trial lawyers salivated. Connie Chung probably felt pretty good, too. In 1990, on one of her failed newsmagazine programs, she aired a report on the possible dangers of silicone implants. Referring to "shocking news" about "an ooze of slimy gelatin that could be poisoning" implantees, Chung profiled some of the women who claimed to be victims of silicone.
That same year, Charlotte Mahlum began to get sick. Three years later, one of her implants ruptured, and both were removed. With the FDA ban now in place and silicone groupthink hard-wired into the nations consciousness, Mahlum sued Dow Corning and Dow Chemical, claiming her symptoms were the result of her ruptured Silastic II implant. (She had received both implants after a mastectomy in 1985.)
By this time, Mahlum had plenty of company. Within a few years of the FDAs ban, Dow Corning faced tens of thousands of lawsuitsand the vast majority were not by women who had experienced ruptures. Although other companies manufactured silicone implants, Dow Corning made the most, and thus it became the prime target of plaintiffs attorneys.
The Judicial Panel on Multidistrict Legislation, the federal body which consolidates similar cases that have been filed in multiple federal courts around the country, appointed an Alabama judge to oversee the mega-settlement which would resolve the silicone suits. By June 17, 1994, women had to decide whether to join the class action or go it alone. (The settlement fell apart less than a year after it was reached.) Mahlum chose the latter, but her case hit a snag when Dow Corning filed for Chapter 11 one year later. With the company now in bankruptcy protection, Mahlums lawyers went gunning for Dow Chemical, which had neither manufactured nor sold breast implants. No matter, her attorneys argued. Since the company had performed toxicology research on silicone, it was just as liable as Dow Corningeven though its tests had not involved breast implants or silicone compounds intended for use in breast implants.
Mahlum took her case to jurors in Washoe County District Court in October 1995. Dow Chemical lost. It was the first time a jury had held Dow Cornings parent company fully responsible for injuries allegedly sustained from silicone breast implants.Science Catches Up n what is surely bitter irony for Dow Chemical, the Mahlum verdict came as population studies confirmed hundreds of other scientific studies that seriously undercut the theory that silicone poisons women. Even before the verdict, several epidemiologic studies examine the possible link between silicone implants and connective tissue diseases found no direct relationship.
Thats right: the silicone scarethe FDAs ban, the class-action lawsuit, Mahlums casehad never been founded on hard science. What the hysteria had, in Angells words, was "a superficial plausibility." A womans body does react to silicone implants, just as any body reacts to the insertion of a medical device.
But its a big leap from common, predictable reactions to debilitating diseases. Trial lawyers, Naderites and women with implants who happened to be sick were willing to make that leap. Most in the scientific community were not.
The best way to test the silicone poisoning theory was to conduct large population studies of women with and without implants. The Mayo Clinic was the first brand-name medical facility to undertake such an analysis. Its finding was published by the New England Journal of Medicine in June 1994. Mayo Clinic researchers found what study after study since their work has found, that women with silicone breast implants are no more likely to develop connective tissue diseases than women without them.
In the five years since the clinics research, science has failedwith monotonous regularityto demonstrate the link so many assumed existed. In 1995, the New England Journal of Medicine published another analysis which found no connection between silicone and connective tissue diseases. By 1996, the research was so conclusive that Scientific American reporter Sasha Nemecek wrote of the "scientific consensus" which had emerged on the subject: "Indeed, studies have not found evidence for a link between silicone implants and autoimmune disorders such as lupus, scleroderma and rheumatoid arthritis."
In September 1997, the Western Journal of Medicine reached the same conclusion. And last December, a month before Nevadas Supreme Court ruled that Mahlums condition resulted from silicone, a panel of scientists appointed by the settlement judge in Alabama added to the chorus. Its membersa toxicologist, an immunologist, a rheumatologist and an epidemiologistannounced that they could find no proof that silicone breast implants make women sick. Dr. Elizabeth Connell, who tried to keep the FDA from imposing its ban in 1992, believes the panels findings "will be extremely helpful in putting the controversy to rest."
Clearly, the advantage has shifted to implant manufacturers. But perhaps the exoneration of silicone should not be so shocking, given a poll taken just before the implant scare got underway. In 1990, the American Society of Plastic and Reconstructive Surgeons surveyed women with breast implants. After almost 30 years on the market, implants enjoyed a huge customer satisfaction rateover 90 percent.Ignorance is Bliss ut what about Mahlum? She hadnt claimed that low-level silicone leakage made her sick. One of her implants actually ruptured, and her lawyers claimed that when it was removed about 10 percent of its silicone remained in her body. Thus, on the surface Mahlum had a somewhat stronger case than women who had not experienced ruptures.
Not surprisingly, her lawyers placed no emphasis on the mountain of epidemiologic data that showed woman with silicone in their bodies were not any sicker than women without it. They trotted out a number of flimsy causation theories during the trial, hoping that one might resonate with jurors. But before Nevadas Supreme Court, Mahlums lawyers relied on one theory. Anti-implant activists claim that silicone can break down into silica, a dust that has been linked to lung problems in miners. If silica made miners sick, they claim, it must make women sick as well.
Its a weak supposition, and Dow Chemical pounced on it. Linking possible silica in women with breast implants to miners who had inhaled the dust was, Dows attorneys told the justices, an incredible stretchand Washoe County District Judge Connie J. Steinheimer should not have allowed it:
Tests of breast implants themselves do not demonstrate that the gel breaks down into silica, let alone that there are adverse results attributable to silica. Because plaintiffs silica causation theory was nothing more than sheer speculation, unsupported by anything other than the conjecture of plaintiffs purported experts, the jury should not have been allowed to hear it. And, since none of plaintiffs various causation theories was grounded in scientific fact, plaintiffs failed to meet their burden of demonstrating a causal connection between Mrs. Mahlums implants and her illness.
Causation was the whole question, and Mahlums case hinged on the merits of unproven theories. If there was no conclusive proof that silicone made her sick, questions about Dow Chemicals role in toxicology research for Dow Corningand whether the company had concealed or misrepresented its findings decades agowere moot.
Jurors in Reno didnt struggle with their decision for very longthey found Dow Chemical at fault after only seven hours. Despite the undeniable weight of the research, juries in other implant cases have occasionally ruled in plaintiffs favor. As Angell writes, its fairly common for jurors in product liability suits to find "that even if the injury was not caused by the defendant, it could have been, and besides, someone should compensate the victim."
Of course, such inane thinking is the reason theres an appeals process. And on December 31, Nevadas justices did overturn Mahlums $10 million punitive award. But writing for the majority, Justice Bob Rose revealed where Nevadas high court stood on the use of junk science in the courtroom. Rose concluded that jurors had every right to buy into the loose speculation of Mahlums "experts."
"We are aware," he wrote, "that causation is a scientifically controversial component of the plaintiffs case in breast implant litigation. The Mahlums, however, did not need to wait until the scientific community developed a consensus that breast implants caused her diseases." [Emphasis added.]
Since there is no single standard on the role of expert testimony in American courts, Roses "sue first, science later" approach is permitted. In 1993, the U.S. Supreme Court did make an effort to lay down rules for distinguishing solid science from pure hooey in Daubert v. Merrell Dow Pharmaceuticals. Judges were required to allow only expert testimony which was, in Justice Harry Blackmums words, both "reliable" and "relevant."
Mahlums silica theory may have been relevant, but its reliability iswithout confirmation by independent, peer-reviewed analysisfeeble at best. But her lawyers didnt have to meet the Daubert standard. Silver State judges are under no obligation to adhere to the U.S. High Courts 1993 ruling. In other words, when it comes to junk science, anything goes. Steinheimer was free to allow Mahlums medical theories, however kooky. "We conclude," Rose wrote, "that the Mahlums introduced substantial evidence that Dow Cornings defective breasts implants caused her illnesses."Tortified n February Dow Chemicals attorneys lost their attempt to get Nevadas Supreme Courtnow comprised of seven membersto reconsider its December 31 ruling. The company is considering whether to take its case to the U.S. Supreme Court. A Dow Chemical spokesman told Nevada Journal that Dow Cornings defunct settlement agreement may be resolved this summer. If so, Dow Chemical will not face lawsuits from litigants encouraged by the news from Nevada.
As for Charlotte Mahlum, if the U.S. Supreme Court lets her award stand, she plans to use the money to pay her medical expenses and to help others who believe theyre victims of a product which science has concluded is safe. Dows money wont make Mahlum well. But as of yet, there is no evidence that the company made her sick in the first place.
Facts notwithstanding, her condition notwithstanding, Mahlum will keep fightingand keep hating the corporations that she believes have hurt her and thousands of other women. "Sometimes the only thing that would help is if I die," she told the Reno News & Review. "But thats what these companies want."
At least Americas silicone breast implant debacle has helped contribute to the passage of a badly needed tort reformone even trial lawyer buddy Bill Clinton could support. The Biomaterials Access Assurance Act (BAAA) was crafted to protect companies from frivolous lawsuits based on allegedly defective medical devices. Signed by Clinton last summer, it absolves companies which supply materials to a medical manufacturer from liability if the manufacturers end product is eventually held to be defective. Before the act passed, companies which had no role in the design, manufacture or sale of a medical device could be sued just for contributing in some way to the production process. Dow Chemical learned of this loophole the hard way.
The BAAA slammed the door on such lawsuits. And silicone had much to do with its passage. The success trial lawyers enjoyed with breast implant lawsuits has prompted them to seek out other medical devices which contain silicone. Theres a long list to choose from, including pacemaker wires, brain shunts, penile implants, heart valves and intraocular contact lenses. The birth control device Norplant already faces a number of lawsuits.
Silicone tort maniaand lawyers constant prowling for any wealthy medical corporation with a possibly defective producthas had a chilling effect on the biomaterials business. The Health Industry Manufacturers Association (HIMA), which has more than 800 members, reports that 75 percent of the suppliers of biomaterials have banned sales to U.S. medical manufacturers, all due to concerns about product liability. The BAAA will go a long way toward ensuring that U.S. companies can continue their pioneering work on implantable medical devices, which are currently used by over 8 million Americans. (At the urging of the plaintiffs bar, silicone breast implants were carved out of the BAAA.)
So some good has been salvaged from the nations silicone breast implant frenzy. But the BAAA is just one step down the path toward rational tort policy. More reforms are needed. As a Washoe County jury demonstrated in 1995and as Nevadas justices demonstrated at the start of the new yearemotion-driven speculation in the courtroom still has the ability to trump sound science.NJ
D. Dowd Muska is a contributing editor of Nevada Journal.