Award limits eyed in suits involving FDA-approved drugs

Page 2 of 2 -- "Medical liability reform is critical if we want our citizens to have access to quality healthcare," Ensign said yesterday in a statement. "In my home state of Nevada, too many pregnant women and patients needing specialized care don't have that access."

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The bill would shield pharmaceutical companies from paying punitive damages for faulty medical products that had been approved by the FDA. The provision that trial lawyers most fear also would shield such potential parties as doctors, HMOs, nursing homes, and hospitals from sharing liability for damages for FDA-approved products.

Nearly 50 percent of Americans take at least one prescription medication, according to a recent study by the Centers for Disease Control and Prevention.

But until the bill's precise wording is completed, it is unclear whether it would apply to drugs prescribed off-label, for purposes not approved by the FDA. It is common for doctors to prescribe a drug for uses besides those approved by the agency.

A $250,000 cap on malpractice awards "would end all of the pharmaceutical litigation in the country," said Texas attorney Andy Vickery, since the attorney's share of the damages would merely cover the expense of trying the case.

"Who would spend $150,000 on a roll of the dice where the best you could do is recoup your money?" Vickery said.

According to the Association of Trial Lawyers of America in Washington, which opposes the legislation, the proposal would make pharmaceutical companies subject to punitive damages only if they lie to the FDA or bribe an FDA official to gain approval.

The bill supports the FDA's stance against second-guessing of its approvals by state courts.

The FDA's chief counsel in 2002 began filing legal briefs in product liability cases around the country that argued state court judgments should not trump FDA's approval decisions for such drugs as Paxil.

The legal briefs drafted by then FDA chief counsel Daniel E. Troy, used by pharmaceutical companies in other cases, has stalled two wrongful-death lawsuits related to FDA-approved antidepressant Zoloft, now under appeal in Texas.

The prospect of paying stiff damage awards, trial lawyers and consumer advocates say, is what propels companies both to conduct studies that ferret out potentially lethal side effects before a drug is approved for use by millions of people and to remove dangerous drugs from the market.

George M. Fleming, an attorney who won a $29 million suit against the manufacturers of Fen-Phen in 2000, said large punitive damage awards are "part of what keeps drug companies honest today, I think. More than the FDA."

Congress in previous years has granted immunity from liability to manufacturers of nonprescription drugs, cosmetics, and vaccines, said James T. O'Reilly, an adjunct professor of law at the University of Cincinnati and a food and drug law specialist.

"The Republicans have such a dominance in the Senate now" that the bill on prescription drug liability "would be very likely to garner strong Senate support," O'Reilly said. "The history has shown the pharmaceutical lobby has done exceedingly well in the House."

Diedtra Henderson can be reached at dhenderson@globe.com.