WASHINGTON (Reuters) - A state law allowing suits against drugmakers when fraud against federal regulators is proven disrupts the authority of the Food and Drug Administration, lawyers for Pfizer told the U.S. Supreme Court on Monday.
The court is considering a case filed by people alleging they were harmed by the withdrawn diabetes drug Rezulin, in a dispute that hinges on whether state or federal law takes precedence when the two clash.
Pfizer unit Warner-Lambert, which sold Rezulin, appealed to the high court after a federal appeals court in New York reinstated the lawsuit, in which 27 Michigan residents claimed they were harmed from the drug.
Rezulin, first approved in 1996, was pulled from the market in March 2000 after about 100 people who took the medicine needed liver transplants or died from acute liver failure.
A Michigan state law provides pharmaceutical companies immunity from such suits, but carries an exception if it can be proven the manufacturer defrauded the FDA.
The U.S. government argued for Pfizer, the world's biggest drugmaker, and told the court the law undermines the FDA's authority.
"There's just an obvious intrusion there with FDA's ability to administer its own approval process," Daryl Joseffer, assistant solicitor general at the U.S. Department of Justice, told the court.
The closely watched case comes a week after the court handed down a win for manufacturers in a decision favoring medical device maker Medtronic Inc. The high court ruled that patients cannot sue medical-device manufacturers in state court over harm from a device that has approval from federal regulators.
Pfizer's attorney argued that a precedent set in an earlier case known as Buckman applies. The court in 2001 ruled that private claims alleging fraud were preempted because of an inherent conflict with federal regulations.
A lawyer for those suing the company told the court her clients had evidence that Warner Lambert withheld information about adverse events, which constitutes fraud on the FDA.
