FDA OK’d Labels don’t Nix Claims

posted on:
July 3, 2007

author:
Staff

U.S. Food and Drug Administration approval of a drug label doesn't clear the manufacturer of claims that its warnings were inadequate, a judge ruled in a decision potentially affecting thousands of federal lawsuits against Merck & Co. for the painkiller Vioxx.

"The FDA's current view on the question of immunity for prescription drug manufacturers is entirely unpersuasive," U.S. District Judge Eldon Fallon wrote in the opinion handed down Tuesday.

Had Fallon sided with Merck, the drug company also could have challenged claims brought by thousands of other plaintiffs who say it is to blame for heart attacks and other cardiovascular problems.

That "would have been like wiping the whole board clean and wiping out all possible victories" against Merck, said David Logan, dean of the Roger Williams University School of Law in Bristol, R.I.

But the judge rejected Merck's attempt to throw out lawsuits brought by two people who began taking Vioxx after April 2002, when the FDA approved a label warning that the drug might increase the chance of such problems.

Russ Herman, spokesman for the plaintiffs' lawyers in the federal cases, did not immediately return a call for comment.

Merck is considering an appeal, lawyer Ted Mayer said in a statement e-mailed to The Associated Press. "We have always believed that this would be an issue to be resolved by the appellate courts and ultimately the Supreme Court," Mayer wrote.

Like thousands of others, Lene Arnold, who had a heart attack in December 2003, and the family of Joe G. Gomez, who died of one in January 2003, say the warning was inadequate. The Arnold case was filed in federal court in New Orleans while the Gomez case originated in Texas.

"Failure to warn" is a state claim, but where there is no parallel federal law, federal courts apply state laws in the jurisdiction where a lawsuit is filed.

In a preamble to rules set in 2006, the FDA contends its requirements set limits for prescription drug labels, pre-empting state claims that a company failed to warn users of a danger.

"FDA is the expert federal public health agency charged by Congress with ensuring that drugs are safe and effective, and that their labeling adequately informs users of the risks and benefits of the product and is truthful and not misleading," the FDA wrote.

And, the agency said, rulings relying on state laws can frustrate its work.

However, Fallon wrote, "Because there are no federal remedies for individuals harmed by prescription drugs, a finding of implied pre-emption in these cases would abolish state-law remedies and would, in effect, render legally impotent those who sustain injuries from defective prescription drugs."

The FDA's claim is part of a growing trend among federal agencies, said Catherine Sharkey, a New York University law professor who recently published an article about it in the DePaul Law Review.

The Consumer Product Safety Commission and the National Highway Traffic Safety Administration have made similar statements, said Sharkey.

She said others have called it tort reform in disguise, in a process that doesn't include congressional debate.

The U.S. Supreme Court recently agreed to hear a related – but not identical – case involving medical devices, Sharkey said. Unlike the prescription drug rule, the law covering medical devices does cancel claims based on state law, she said.

About two dozen courts had ruled on the FDA assertion as of June 2007, and have split fairly evenly, she said.

Two of the most recent are Fallon's ruling Tuesday and one last week by a New Jersey state judge, who made a similar decision in a case over Wyeth's hormone replacement drug Prempro.

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