Vioxx Judge Rules Lawyers Can Depose FDA Critic Graham

Pennsylvania - New Jersey - New York - Nationwide

By HEATHER WON TESORIERO
March 16, 2006; Page D6

The judge overseeing the federal litigation over Merck & Co.'s Vioxx painkiller ruled that lawyers can depose David Graham, a Food and Drug Administration official who has criticized the agency's handling of the drug.

A cornerstone of Merck's defense as it faces almost 10,000 lawsuits has been that it provided the FDA with all of the safety data it had on Vioxx, which the agency approved for sale. The FDA has traditionally tried to avoid getting pulled into litigation, and it had denied lawyers' requests for Dr. Graham to testify.

In an opinion issued Tuesday, U.S. District Court Judge Eldon E. Fallon of New Orleans wrote that the deposition "must proceed because the FDA has acted arbitrarily and capriciously in failing to provide Dr. Graham for a deposition." A spokesman for the FDA said it is "studying the judge's opinion."

In congressional testimony, Dr. Graham called Vioxx "a terrible tragedy and a profound regulatory failure." A deposition from Dr. Graham "should further expose Merck's misconduct and dispel the notion promoted by Merck that FDA approval was tantamount to establishing drug safety in the case of Vioxx," said Thomas R. Kline, a plaintiff attorney and key player in the Vioxx litigation.

Ted Mayer, co-lead counsel for Merck, said, "We think this is a matter of Dr. Graham's individual views, not the views of the FDA."