No haven for dangerous drugs

IN THE PAST 11 years, drug companies have had to pull 23 unsafe drugs from the market, even though all had won approval from the US Food and Drug Administration. In spite of this shoddy record of oversight, the companies want to be protected from lawsuits by victimized patients or their survivors on the grounds that FDA approval should protect them from liability. A Supreme Court that has proven only too willing to do the bidding of industry could give the companies what they are looking for.

If it does, it will be doing just what conservatives often accuse judges of doing - legislating from the bench. "This is a radical restructuring of the American civil justice system," according to Georgetown law professor David Vladeck.

The case before the court is Wyeth v. Levine. Diana Levine is a 62-year-old Vermont musician whose arm had to be amputated after an anti-nausea medication caused gangrene. Levine settled a suit against the clinic where the drug was administered and then won $6.7 million in a suit against drug maker Wyeth, on the grounds that its label did not sufficiently warn against the injection method used by the clinic.

When the court hears the case in November, Wyeth wants justices to accept its argument that FDA approval of the label implicitly pre-empts any state suits. Such immunity would be a new boon to the industry. Merck is currently offering almost $5 billion to settle 50,000 suits related to its drug Vioxx. In 2005 alone, 17,000 suits were filed against drug-industry products.

Drug companies can take heart from an 8-1 Supreme Court ruling earlier this year to grant immunity from suits to makers of FDA-approved medical devices. That ruling, however, relied on an ambiguously worded 1976 law specifically about medical devices that the justices interpreted to grant immunity to the industry. Congress already has plans to pass legislation restoring patients' rights to sue when harmed by a medical device.

In Wyeth v. Levine, the Bush administration has lined up on Wyeth's side, while Levine has support from the attorneys general of 47 states and the present and former editors of the New England Journal of Medicine. Two former FDA commissioners, David Kessler and Donald Kennedy, also have filed briefs for Levine. The FDA, they say, cannot "police the market on its own."

The withdrawal of Vioxx and other dangerous drugs demonstrates that the FDA approves medications with insufficient proof of their safety and then does not recognize their harmful effects quickly enough. The Supreme Court has no business depriving patients of their recourse to courts.