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Malpractice bill shields drug makers

Wed., Jan. 5, 2005

WASHINGTON – 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, are 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 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 Tuesday to try to preempt Bush’s speech on medical malpractice lawsuits today, Todd 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 Schwartz of the American Tort Reform Association. “If you have done everything the law requires, why should you be punished?”


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