Malpractice Bill Shields Drugmakers

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http://www.washingtonpost.com/ac2/wp-dyn/A48417-2005Jan4?language=printer

 

 

 

Malpractice Bill Shields Drugmakers

 

By Jim VandeHei

Washington Post Staff Writer

Wednesday, January 5, 2005; Page A03

 

The medical malpractice bill backed by President Bush would

prevent consumers from seeking punitive damages from the makers of

Vioxx and Celebrex, two popular pain medications recently linked to

increased risks of heart attacks and strokes, according to legal

experts on both sides of the issue.

 

While Bush often touts the medical malpractice proposals as a

prudent way to stop frivolous lawsuits against doctors, the bill's

less-discussed liability protections for pharmaceutical companies such

as Merck & Co., the manufacturer of Vioxx, is generating controversy

this week.

 

The drug company provision has been in the Republican House bill,

which Bush supports, for months, but after the Vioxx and Celebrex

reports, the bill's opponents are making the provision a key argument

against the Bush plan. Supporters privately say the legislation may

have to be changed to win approval.

 

" I am sure it gives opponents a pretty good bludgeon, " said former

representative James C. Greenwood (R-Pa.), who sponsored the bill,

which passed the House but not the Senate. It must be reintroduced

this year.

 

Merck withdrew Vioxx on Sept. 30 after reporting that the

painkiller increased the chance of a stroke or heart attack. Pfizer

Inc., the maker of Celebrex, reported last month that in one study,

its pain medication increased the risk of heart attack if taken in

high doses. Pfizer has not pulled Celebrex from the market because it

says there is conflicting research on the side effects. Critics charge

that both companies sold the drugs despite warnings about side effects.

 

Both companies would be shielded from punitive damages -- those

jury awards that often reach into the millions of dollars to punish

wrongdoing -- if the medical malpractice plan becomes law.

 

The bill would protect pharmaceutical companies from punitive

damages as long as they met Food and Drug Administration standards to

win approval of their drug. Merck and Pfizer received FDA approval for

their drugs, and both say they followed FDA requirements.

 

In a statement yesterday to try to preempt Bush's speech on

medical malpractice lawsuits today, Todd A. Smith, president of the

Association of Trial Lawyers of America, said, " President Bush

unashamedly advocates legislation that would protect insurance

industry profits and prohibit any punishment for the makers of

dangerous drugs like Vioxx. "

 

There is a disagreement over how much legal protection the

Bush-backed plan would provide.

 

Greenwood, now president of the Biotechnology Industry

Organization, a corporate trade association, said he believes the

legislation would also limit damages for pain and suffering to

$250,000 for pharmaceutical companies. But others say only punitive

damages would be limited for drug companies. That would allow

consumers to seek large awards for pain and suffering in addition to

economic damages, such as lost time at work.

 

Supporters say the provision, which applies to other

health-care-related companies, is needed to create a sound judicial

system for awarding victims of medical malpractice, be it by doctors,

drug manufacturers or makers of medical devices. Under the current

system, they say, defendants face a disadvantage because plaintiffs

can threaten to seek multimillion-dollar judgments and thereby try to

force a large settlement.

 

The bill also would require drug companies to meet all FDA

standards or lose the legal protections. " There is no entitlement to

punitive damages, " said Victor E. Schwartz of the American Tort Reform

Association. " If you have done everything the law requires, why should

you be punished? "