Science on Trial

...But the law had placed the burden of proof on manufacturers to prove that they were safe...

...So, as juries continued to find against them, and as journalists and "public interest" groups also began getting into the act-accusing the FDA of colluding with manufacturers to "cover up" the baneful effects of breast implants-Kessler made his decision: On April 16, 1992, he announced the virtual ban of silicone-gel-filled implants from the market...

...Basically, Angell blames three groups-lawyers, doctors and journalists-for the breast implant fiasco...

...17 have avoided most of their subsequent problems...

...For in 1976 the Medical Device Amendment to the Food, Drug and Cosmetic Act extended the FDA's authority to "devices" like breast implants, and the FDA would surely have required Dow Corning to demonstrate the safety of its product before granting marketing approval...

...They're not countrythey're clones...

...The practice should be routine...

...Not until 1988, after plaintiffs, charging that their implants had caused "connective tissue disease" and other disorders of the autoimmune system, had won huge settlements from manufacturers, did the FDA ask Dow Corning and others to demonstrate the safety of their product...

...What sense does it make," she asks, "for a woman to be able to smoke two packs of cigarettes a day, but not be able to obtain a breast implant...

...he had plenty of professional help...

...According to Angell, they "resented" the FDA's request and-believing that their product's excellent track record spoke for itself and that devising appropriate safety tests would prove cumbersome and time-consuming-decided to ignore it...

...Language on Your Own...

...There has never been a time when country music was so disrespectful of its elders...

...some, more impatient, took a razor blade to their breasts and tried to do the job themselves...

...The combination of killer-lawyers, corrupt doctors, and investigative journalists always ready to uncover new examples of corporate wrongdoing proved unstoppable...

...He was not amused by the manufacturers' foot-dragging...

...Hell," Thomas Hobbes observed, "is truth seen too late...

...Although judges now have the option of appointing such witnesses, they rarely do so...

...Many went to their plastic surgeons to have the implants removed...

...A typical course includes 10 to 12 audio cassettes, recorded by native speakers, plus a 250-page book...

...Dow Coming alone saw a surge in lawsuits from about zoo at the end of 1991 to io,ooo by the end of 1992...

...Though he has enjoyed hits well into the nineties, his music hasn't been played on the radio for years...

...By 1992, it is estimated that between 1 and 2 million American women had silicone-gelfilled implants-about half of which were manufactured by Dow Corning...

...artists making records about life who haven't yet lived much life...

...Science on Trial: The Clash of Medical Evidence and the Law in the Breast Implant Case MarciaAngell, M.D...

...The last thing any sane person should want is to involve scientists in bitter political controversies, for the inevitable result of such an involvement would be the politicization of science, not the rationalization of politics...

...Computer networking among plaintiffs' attorneys made it possible to generate lawsuits with unprecedented speed...

...Angell's proposed reform would change that...

...Though he again became a chart-topping solo artist after Wynette's departure, it was his drinking career that really took off...

...For some reason, these embodiments of enlightenment are always looking for ways to shortcircuit the political process by placing power in the hands of an elite-judges, scientists, and other "experts...

...JOSEPH SHATTAN is consulting editor of The American Spectator...

...Indeed, so successful was O'Quinn that one of his cases became the subject of a teaching videotape...

...Instead of bragging, he presents his exploits with a humble reserve, as if still nursing a lifethreatening hangover...

...In Nashville recently I...

...for Jones it was just another episode amidst the booze-addled decades...

...Kessler, a forty-something Wunderkind who had simultaneously earned a medical degree from Harvard and a law degree from the University of Chicago, was someone who took himself very seriously and expected to be taken equally seriously by others...

...After all, by 1992 breast implants had been in use for thirty years, and no major ill effects had been detected...

...On one tour he was inebriated so often that his handlers wrapped him like a mummy with gauze tape to keep him standing upright behind the mike...

...What, then, was the breast implant controversy all about...

...As matters stand now, scientists can do their research and publish their papers without looking over their shoulders at the PC police...

...cally sophisticated, Information Age America...

...Neither it nor subsequent studies found any "association between breast implants and the connective tissue diseases we studied...

...They were still ignoring it in November 1990 when President Bush appointed Dr...

...Remarkably, too, he bears no grudges and settles few scores in these pages...

...In April 1994, the major manufacturers agreed to pay $4.25 billion to women with breast implants-$1 billion of which was earmarked for plaintiffs' attorneys...

...She argues that in banning the implants "the FDA responded like a political body, not a regulatory body...

...They convinced O'Quinn "that blue-collar men make ideal jurors in breast implant cases, because they are guilty about pressuring women to acquire large breasts...

...Ironically, only two months later, the New England Journal of Medicine published the first serious study of the health effects of breast implants ever conducted...

...the freshly scrubbed young acts that monopolize the airwaves today are as bland as a beer commercial, their test-marketed careers a far cry from the world of Jones's nitty-gritty: I don't care much for many of today's young country singers...

...Socking it to those breast implant manufacturers may have felt good, but it was not, in Angell's view, good science...

...By [1994], Dow Coming claimed to be the target of 30,000 lawsuits, many of which were evidently clones, since they contained the same typographical errors...

...These "strongest elements," it turned out, definitely did not include the fact that O'Quinn's client, Pamela Johnson, had not come down with connective tissue disease, and that all the symptoms she reported-fatigue, sore throat, respiratory problems - might well have resulted from her smoking habit...

...It was titled "Look Over Here: Johnson v. Bristol-Myers Squibb Compa ny," and subtitled "How Houston Plaintiff's Lawyer John O'Quinn Won the Largest Breast Implant Verdict to Date by Keeping a jury on the Strongest Elements of His Case...

...That is the question Dr...

...Norton / 256 pages / $27.50 REVIEWED BY Joseph Shattan S...

...I look at the shape of contemporary coun try music, and I'm saddened...

...By the late '70's he was living in an old yellow Cadillac in downtown Nashville, down to just loo pounds from a diet of blended whiskey and cocaine and clinging to an old publicity photo of Hank Williams...

...How could such a tidal wave of hysteria and panic sweep through technologi...

...Unfortunately, Angell's suggestion is an example of a cure that's worse than the disease...

...W.W...

...She therefore suggests that we empower judges, acting in consultation with established scientific organizations like the National Academy of Sciences, to appoint expert witnesses...

...Interested lawyers could easily learn the status of relevant lawsuits throughout the country and modify the wording of promising ones for their own use...

...Evidently, Kessler was not unaware of the scientific shakiness of his decision...

...Curiously, all this went on despite the fact that scientific studies had never shown breast implants to be hazardous...

...Most Americans are not regular readers of the New England Journal of Medicine...

...Jones credits his survival to his fourth and present wife...

...In Angell's view, it illustrates the difficulty our civil justice system has in evaluating scientific evidence...

...The result was the largest class-action suit in American history, and the bankruptcy of Dow Coming, the leading silicone implant manufacturer...

...Had Gerow had his brainstorm fifteen years later, he and Dow Corning would not have been permitted to go from drawing board to breast within a single year...

...Even without conducting exhaustive tests, it was obvious that the health risks associated with breast implants were marginal...

...Nobody sings a weeper like George Jones...

...So, shortly after banning the implants, he wrote an article for the New England Journal of Medicine justifying his action on legalistic rather than scientific grounds...

...Be that as it may, he soon convinced sili The Great Big American Breast Implant Scare 73 The American Spectator . August r996 cone manufacturer Dow Corning that his breast implants-which resembled smooth plastic bags filled with clear jellycould prove highly lucrative...

...To them, it seemed self-evident that the FDA would never have yanked a product that had been around for thirty years unless some pretty damaging information had suddenly come to light...

...If only the implant manufacturers had conducted such a study in 1988, they might 44 By banning the devices, FDA Commissioner Kessler argued, he had never meant to suggest that they were unsafe...

...Learn ;~ _'-%, Another °ua°wP...

...Dow Corning and the others had not complied with the letter of the law, leaving Kessler with no option but to act as he did...

...In essence, they would interpret for the court the current scientific knowledge about the matter at hand...

...In most lives such a point would mark rock-bottom...

...Angell points out that the first women to use silicone to enlarge their breasts were Japanese prostitutes eager to satisfy the expectations of their American patrons in the aftermath of World War II...

...Marcia Angell, executive editor of the New England Journal o f Medicine, addresses in Science on Trial...

...But because, when the Medical Device Act was passed, breast implants were already widely in use, and no serious side effects had been reported, the FDA exempted breast implants from its safety requirements...

...To be sure, O'Quinn didn't win his case single-handedly...

...David Kessler commissioner of the FDA...

...It is said," notes Angell, "that Gerow was impressed by the similarity between the consistency of a plastic transfusion bag containing blood and the feel of a breast...

...In the next two years, more than 16,ooo lawsuits, brought by over a thousand lawyers, on behalf of women with breast implants were filed in federal and state courts...

...And, in a refreshing twist on the recovering-celebrity-confession genre, he denies finding salvation in AA or the Lord...

...Predictably, however, Kessler's fine distinctions as to where the burden of proof lay were lost on the public...

...In 1962, Gerow implanted his silicone-gel-filled sacks into a woman who wanted her breasts enlarged (that woman, now a 64-year-old grandmother, still has her original implants and is satisfied with them) and from then on, the breast business boomed...

...saw an elderly woman listening to an old George Jones song on WSM-AM, one of just a handful of stations in the country still broadcasting the classics...

...Unfortunately, many politicians -especially Democratsdepend heavily on trial lawyers' political contributions, and have therefore shied away from meaningful product liability reform...

...Now, one might suppose that any corporate executive worth his golden parachute who believed that his product was safe, and who was faced with the prospect of an endless series of lawsuits alleging that it wasn't, would jump at the chance to win over the FDA...

...His sole display of anger is reserved for today's booming country music industry...

...It is all the more worrisome in view of the fact that the diseases sought are so ill-defined...

...Respect for one's elders -it's the kind of old-fashioned idea you'd expect from a man whose music harks back to an America that worked hard and played hard, a people who craved song not as mere entertainment but as some reward that made life worth living...

...To me, as a physician," writes Angell, "the most sobering aspect of the breast implant litigation in Texas is the collaboration between a small group of doctors and plaintiffs' attorneys...

...The arrangement is problematic at best...

...Even so, her book is an eye-opening account of how our civil justice system works-or rather, how it fails to work...

...Yet inasmuch as the U.S...

...Rather, O'Quinn had managed to convince a Houston jury to award his client $25 mil 74 August r996 • The American Spectator lion (of which forty percent went to him) by making her a representative of all the thousands of women who might, some day, somewhere, be stricken with connective tissue disease because of their breast implants...

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...What lifts his account of the down-and-out above a simple grocery list of bad behavior is his sense of shame...

...44 How could such a tidal wave of hysteria and panic sweep through sophisticated, Informa tion Age America...

...She sat ever so still, her hands clasped and her head bowed as if in prayer, as Jones wailed about the glorious pain of heartbreak...

...Unfortunately, the liquid silicone injected directly into a woman's breasts was often contaminated with bacteria, leading to all manner of hideous complications...

...auQIaicaRum Room F802, 96 Broad St., Guilford, CT 06437 75 The American Spectator - August 1996...

...Unfortunately, she has little to say about a fourth group-liberal Democrats-who in many respects are the most culpable of all...

...From Japan the technique spread to Nevada and California, where showgirls and aspiring actresses underwent breast augmentation for professional reasons...

...Also helping O'Quinn were physicians who, for a hefty fee, managed to diagnose all sorts of mysterious maladies in his clients...

...By banning the devices, he argued, he had never meant to suggest that they were unsafe...

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...Other professionals who helped O'Quinn were scientists-mainly secondraters-who for a mere $5oo an hour proved willing to sit in a witness box and spin complicated, wholly unsubstantiated theories about how breast implants might cause connective tissue disease...

...One plaintiff's attorney who was especially adept at winning huge settlements from breast implant manufacturers was Texas-based John O'Quinn...

...Our 25th year...

...Since the Garth Brooks revolution, a cleanedup version of country has become the most popular music in America...

...Jones also confirms the oft repeated story that he once rode a lawn mower eight miles to a liquor store after his wife had hidden the car keys...

...more than once he apologizes for deeds he can barely remember...

...Jones is repentant throughout, and writes like a man finally facing up to a wayward life...

...Then, in 1961, one of the unsung benefactors of the human race, a Houston plastic surgeon named Frank Gerow, designed a new implantable device-a rubbery silicone envelope containing silicone gel...

...But if Angell's suggestion is silly, it is also typical of the liberal Democrats' approach to social problems...

...When the Republican-dominated Congress finally succeeded in passing a cap on punitive damages this year, it was promptly vetoed by President Clinton...

...Thus: The FDA ban was followed by a tidal wave of litigation...

...When the song ended, she looked up and her eyes were welling with tears...

...These witnesses would be neutral-that is, they would represent neither side...

...ome time in the early 19go's, tens of thousands of women became con vinced that their silicone breast implants, with which they had been perfectly satisfied for years, and in some cases for decades, were a mortal threat to their health...

...And when, finally, evidence began to accumulate that breast implants were perfectly safe, this, too, seemed to have no impact on the public...

...To begin with, there were the consultants from the Wilmington Institute, "a jury research organization in Dallas, who studied the attitudes of potential jurors on the breast implant issue...

...and nearly all consulted their lawyers...

...The obvious way to deal with the problem is to impose a cap on "punitive damage" awards, and the only people who can pass such laws, of course, are our elected representatives...

...But executives in the breast implant business saw things differently...

...Call toll-free 1-800-243-1234, (203) 453-9794, fax (203) 453-9774, e-mail: 74537.550ia compuserve.cam, or write us at the address below...

...Surely, Angell would have included Clinton-and other liberal Democrats like him-in her rogues' gallery of professionals responsible for the current collapse of our civil justice system, were she not a liberal Democrat herself...

...upper-middle-class white women are the worst, because they are likely to have considered implants, but rejected the idea...

...leads the industrialized world in the cost of judgments stemming from civil justice cases, judges are the last persons we should expect to fix our civil justice system...