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- BUSINESS, Page 46Special Report: Drug SafetyLawyers to the Rescue
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- Legal action helps keep drug companies honest, but it's a crazy
- way to regulate an industry
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- By MICHAEL D. LEMONICK -- Reported by Andrew Purvis/New York
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- 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.
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- 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.
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- 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.
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- 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).
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- 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.
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- 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."
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- 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.
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- 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.
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- 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.
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- 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.
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