THE VIRGINIAN-PILOT
Copyright (c) 1995, Landmark Communications, Inc.
DATE: Sunday, November 5, 1995 TAG: 9511040067
SECTION: DAILY BREAK PAGE: E1 EDITION: FINAL
SOURCE: BY ANN G. SJOERDSMA
LENGTH: Medium: 89 lines
ONCE AGAIN, the people's ``law'' and science have collided in a courtroom, and science and reason are the worse for it.
Last week an eight-person Reno, Nev. jury ordered Dow Chemical Co. to pay $13.9 million to a woman who claimed her chronic physical maladies - unspecified fatigue, muscle pain, nerve disorders - were caused by silicone-gel breast implants that had ruptured.
Now the collision: Current medical opinion, based in part on studies by the Mayo Clinic and the well-known Harvard Nurses' Health Study, does not support an association between silicone implants and connective-tissue diseases (lupus, rheumatoid arthritis, scleroderma) or any of a number of other health complaints. Studies have been overwhelmingly negative: Women with silicone implants have no greater incidence of connective-tissue disease than women without them.
But the Washoe District Court jury of five men and three women cared not a whit about medical science.
Instructed to disregard unsupported plaintiff's evidence suggesting that Dow Chemical had withheld information about silicone health hazards, the Nevadans acted to the contrary, punishing the big corporation with the deep pockets, exacting ``social justice.''
In favoring Charlotte Mahlum, 46, who had breast implants installed in 1985 after a double mastectomy, the jury was emphatically, and emotionally, anti-science, anti-physicians, anti-drug companies, and, to my mind, anti-women. Their verdict, in effect, denies millions of women a product for ``their own protection,'' long before a denial is reasonably called for.
It also links Dow Chemical, part-owner of now-bankrupt silicone implant manufacturer Dow Corning Corp., for the first time to health problems arising from silicone implants. The Food & Drug Administration banned these implants in 1992, except in limited cases and pending further studies.
By the time the FDA's studies are completed, however, no sane company will be in the silicone-implant business. Such devices will go the way of contraceptive research, chilled by litigation costs.
Dow Corning and other silicone implant manufacturers have already agreed to a $4.2 billion settlement fund. If the Nevada verdict is not set aside by a judge, as I expect it will be, Dow Chemical may follow suit, even declare bankruptcy. (Dow has appealed.) This could happen with the medical establishment still squarely behind the implants' safety - a preposterous situation.
Juries in big product-liability cases often reject medical-science (read: statistical) analyses that confuse them and respond instead to a plaintiff's plight, regardless of its cause, and as enhanced by dramatic plaintiff's lawyers. A glut of such lawyers, representing thousands of women nationwide, now waits eagerly at Dow Chemical's opened door.
I do not mean to suggest that Dow Chemical is an ethical paragon among chemical companies; that Dow Corning, during its 30 years of marketing implants, was conscientious in testing their safety and effects on women's long-term health; that silicone implants are without their risks (there are a number, routinely revealed for years now by plastic surgeons); or even that Mahlum's ill health was not caused by the implants.
Nor do I do advocate implants as therapy for a great many women who get them.
What I do say is that current medical knowledge does not support Mahlum's claim. Until it does, the jury's verdict is wrong.
In the 1980s, when mass personal-injury lawsuits (asbestos, Dalkon Shield) became the rage, I reported on the exorbitant and seemingly endless litigation over Bendectin, an effective morning-sickness drug that allegedly caused birth defects.
Nearly 30 epidemiological studies proved the drug's safety - unexplained birth defects occur in 5 percent of all births - but sympathetic juries continued to award millions to plaintiffs. The sight of physically deformed children, and the heartfelt sway of their lawyers, won them over. Repeatedly, judges overturned the verdicts.
The manufacturer eventually removed Bendectin from the market and agreed to a $120-million settlement fund. It didn't end there, though. Litigation stopped only after the U.S. Supreme Court refused to review a lower court decision favoring the drug company.
Pregnant women, many of whom are debilitated by morning sickness, lost a safe medication.
Though breast augmentation by silicone implants is an elective cosmetic surgery, a therapeutic argument can be made for many women who seek it, especially the 21 percent who have had mastectomies. Millions of women have been happy with the results. No surgery is risk-free.
Consumers need protection, of course, but not at the expense of informed choice. Medical science deserves some respect, too. Until the data are more conclusive, the jury should remain out. MEMO: Ann G. Sjoerdsma is a lawyer and book editor for The Virginian-Pilot.
by CNB