High court mulls state courts' role in FDA product cases

The Supreme Court Monday grappled with the question of whether state courts should be allowed to second-guess the FDA's approval of a drug while trying lawsuits seeking personal injury damages from the manufacturer. Led by Justice Stephen Breyer, several justices argued that would interfere with the FDA's authority to police the industry, and be tantamount to substituting the judgment of a randomly selected jury for that of the agency with the expertise to decide whether a drug with lifesaving potential should be permitted on the market despite side effect risks. "That's what worries me," said Breyer. "What if the jury is wrong?"

Justice Samuel Alito suggested FDA would be swamped by discovery requests, the processing of which would disrupt the workings of the agency. Lawyers for the plaintiffs said there was no evidence the agency would be unduly burdened by state court probes of drug approvals. "The ... state courts should be trusted to keep discovery under control," said attorney Allison Zieve. Joined by the Justice Department, opposing lawyers argued that state courts looking into FDA approvals of drugs would have to replay the agency's entire deliberations to arrive at a fair assessment. "If you were going to seriously litigate something like this, you would have to have everything the FDA had before you," said Assistant Solicitor General Daryl Joseffer.

The case is being watched closely as a test for a series of other court actions concerning immunity of drug manufacturers from liability claims. It stems from a lawsuit filed in Michigan, where state law bar claims involving FDA-approved drugs unless the plaintiffs prove that the makers -- Warner-Lambert in this instance -- misled the agency. The suit alleged injury from Rezulin, a Type 2 diabetes drug that was ordered off the market by the FDA in 2000 after it was linked to 400 deaths and hundreds of liver failure cases. Rezulin had known liver risks, as the company acknowledged on the label.

Twenty-seven plaintiffs accused Warner-Lambert of negligence and incompetence in the design and production of the drug, and of deceiving the FDA on the extent of the threat posed by Rezulin. A federal district court threw out the lawsuit in 2005, citing a 2001 Supreme Court decision ruling that state fraud-on-FDA cases were pre-empted by federal law. The lawsuit was then reinstated by the 2nd U.S. Circuit Court of Appeals.

The court took a narrower view of the 2001 decision, ruling that while it did invalidate stand-along FDA fraud cases in state courts, it did not apply to ordinary tort claims, even when they had to be backed up by showings that drug companies deceived the agency. "The 2nd Circuit is wrong and should be reversed," Carter Phillips, an attorney for Warner-Lambert, told the court. Zieve stressed that Michigan was "unique" in requiring findings of fraud on the FDA to clear the way for damage claims against a drug manufacturer. She said the Michigan law was "the most deferential to the FDA of any law in the country." Justice Antonin Scalia said he would have been more sympathetic to her arguments if Rezulin had not been withdrawn.