Special Report: Drug Safety Lawyers to the Rescue

By MICHAEL D. LEMONICK

The news about the dangers of silicone implants may have struck terror into the hearts of thousands of women, but for many trial lawyers it represents a bonanza. More than 1,000 implant-related lawsuits have already been filed by women who claim they were disfigured or debilitated by the devices. And the revelation that manufacturers may have knowingly buried facts about the dangers is causing the numbers to skyrocket. Some attorneys have even set up toll-free numbers to handle -- and encourage -- the surge.

The most aggressive of them advertise in newspapers, on billboards and even on TV with come-ons such as "Has your breast-implant surgery gone wrong? We can help." Doctors find this alarming. "They're scaring the hell out of the women who have had these things put in," complains Dr. Mark Gorney, medical director of the Doctors' Co., a large malpractice insurer. "Any woman with an implant who has a twinge in her shoulder says, 'Oh, my God, I'm going to die.' " Many attorneys also worry about the appearance of a feeding frenzy.

Alas, massive lawsuits and ambulance-chasing lawyers have become a major part of America's beleaguered system for regulating medical products. To be fair, legal action is not only a valuable recourse for patients who have been harmed; it can also expose problems overlooked by regulators. It was lawsuits in Michigan and California -- and aggressive reporting by newspapers -- that revealed Dow Corning Wright's internal memos concerning the risks of silicone- gel implants.

The fear of lawsuits also forces drug companies to be honest. "I will sue people so that I can protect women," says Connecticut attorney Karen Koskoff. An implant recipient herself, Koskoff co-chairs the implant litigation group at the Association of Trial Lawyers of America (ATLA).

Of course, forces other than altruism may be at work. Attorneys usually work on a contingency fee, collecting nothing if the action fails but pocketing at least 30% of the proceeds if the defendants pay up. The three judgments so far in implant cases have ranged from $4.5 million to $7.3 million. Cases settled out of court can bring $500,000 to $750,000.

For all the virtues of the judicial system, the courtroom is not the best place to work out scientific truths. Lawyers pursuing drug-liability suits often depend on a small cadre of "expert witnesses" to help make their case. These hired guns, complains Frank Woodside, a doctor and attorney for Dow Corning Wright, "don't always have qualifications, and prey upon the sympathy of the jurors."

Last fall, for instance, despite ambiguous evidence, a jury ordered Merrell Dow to pay a Texas couple $33.8 million; they claimed the antinausea drug Bendectin had maimed their child in the womb. And patients around the country are lining up to sue Eli Lilly, alleging that the anti-depressant Prozac induces violent thoughts -- despite FDA findings to the contrary. In some cases, companies decide to settle out of court rather than take their chances with juries. Upjohn, for example, paid an undisclosed sum to a woman who claimed the drug Halcion had driven her to commit murder. Most doctors believe the allegation is absurd.

Nor is truth served by the publicity and lobbying battles between medical societies and legal organizations. ATLA holds conventions twice a year to discuss strategies in breast-implant suits, and issues ATLA alerts to warn the public about drugs and medical products it considers dangerous. Such announcements are supposedly issued as a public service, though the lawyers clearly have an interest in the matter.

Doctors are just as organized and just as eager to get their version of the facts across. The plastic surgeons' society plans to spend about $500,000 over the next year to "tell the other side of the breast-implant story." The society has even formed a political-action committee -- PlastyPAC -- with a war chest of $120,000 to lobby and reward policymakers who help keep implants on the market.

No one can argue against compensating the victims of dangerous products. But a system based on political influence and courtroom science is just as dangerous as drug firms that hide test data. Inappropriate awards and public relations battles drive up the cost of products and can make companies think twice about bringing to market new, potentially lifesaving drugs. The best way to assure safety is through a more rigorous and independent approval process rather than scattershot lawsuits once the damage is done.

With reporting by Andrew Purvis/New York