Award limits eyed in suits involving FDA-approved drugs

December 17, 2004

http://www.boston.com/news/nation/articles/2004/12/17/award_limits_eyed_in_suits\

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By Diedtra , Globe Staff | December 17, 2004

Republican congressional leaders, emboldened by President Bush's pledge to

overhaul medical liability, are expected to introduce legislation early next

year that would prevent consumers from winning hefty damage awards from

pharmaceutical companies if they are hurt by drugs and medical devices that

have FDA approval.

The proposed legislation could cap medical malpractice awards at $250,000

per injured party, a change consumer advocates and trial lawyers say would

effectively end such lawsuits.

The proposal fits within Republicans' efforts to curb malpractice and

punitive damage awards. But it also comes amid shaken public confidence in

the safety of drugs after the Vioxx withdrawal, which could undercut support

for the bill. Although the blockbuster painkiller received Food and Drug

Administration approval in 1999, its maker, Merck & Co., pulled it from the

market on Sept. 30 because of increased heart attack and stroke risks. Merck

faces billions of dollars in legal expenses from lawsuits filed by Vioxx

users.

The effort to shield drug companies from damages follows searing testimony

last month by FDA whistle-blower Dr. Graham, who said the agency's

shortcomings leave America virtually defenseless against unsafe drugs.

" This is the most egregious . . . effort to date by pharmaceutical companies

to immunize themselves from product liability lawsuits, " said Barth

Menzies, an attorney who has pursued damage cases against manufacturers of

such antidepressants as Paxil, Prozac, and Zoloft.

If the bill becomes law before Vioxx class-action lawsuits are certified,

Merck " could probably just halt most of the litigation they would be

facing, " Menzies said.

The bill makes legal sense, said Victor E. Schwartz, general counsel for the

American Tort Reform Association, a Washington-based coalition of businesses

and municipalities that, among other aims, seeks limits on punitive damage

awards. " There's something incorrect about having juries make a separate

risk-benefit analysis from the FDA, " Schwartz said.

The FDA declined to comment yesterday on the bill. But in August, acting FDA

commissioner Lester Crawford said the issue boils down to whether state

courts that hear such product liability cases have the standing to

second-guess federal FDA approvals and permit juries to grant damages.

" It is, I think, wrong and severely damaging to public health in the United

States if a company has to go . . . through the FDA approval process --

which for a human drug now costs, according to Tufts University, about $880

million . . . and then to have to fight 50 state court battles to sustain

that approval, " Crawford said.

The legislation is expected to take wording from a Senate bill introduced by

Ensign, a Nevada Republican, and cosponsored by 13 Republicans. The

measure did not garner enough support in Congress this year to pass

procedural hurdles. Called " Patients First, " the bill aimed to keep

healthcare affordable by trimming liability expenses.

" 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. "

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 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.

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

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 can be reached at dhenderson@....

December 17, 2004