The FDA Whistleblower Could Aid Lawsuits. The Food and Drug Administration whistleblower who has criticized the agency’s handling of Vioxx will be deposed, a judge ruled, offering evidence that could aid thousands of lawsuits over the withdrawn pain killer.
A federal judge refused to grant a government motion to quash plaintiffs’ lawyers subpoena of drug reviewer Dr. David Graham, who testified at a 2004 Congressional hearing that the Merck & Co. drug caused as many as 160,000 heart attacks and strokes.
Graham questioned the FDA’s commitment to removing unsafe drugs from the market and called Vioxx a “terrible tragedy and a profound regulatory failure.”
Scoring a deposition from Graham is a major victory for plaintiffs because as an FDA employee he counters part of Merck’s defense: Vioxx was safe because the agency approved it, said Marc Scheineson, a former FDA lawyer who now represents drug and device companies.
“I’m sure there are a lot of sleepless Merck lawyers,” Scheineson said Wednesday.
Scheineson said the FDA probably didn’t want Graham to testify
Scheineson said the FDA probably didn’t want Graham to testify because his “opinions are in direct conflict with the agency in which he works.”
The government, on behalf of the FDA and Graham, sought to quash the subpoena on technical grounds. The FDA also said such testimony wouldn’t be in the interest of the public or agency. It further added that Graham’s deposition would put the agency in the middle of a civil lawsuit and the testimony would divert time and resources, and harm the FDA’s ability to fulfill its mandate.
But in rejecting the motion, U.S. District Judge Eldon Fallon said in a ruling Monday that the agency acted “arbitrarily and capriciously” in failing to provide Graham for a deposition.
He said the FDA is already in the middle of lawsuits because it allowed Graham to testify before Congress and give numerous media interviews. Fallon also said that he failed to see how Graham’s testimony wasn’t in the public interest because thousands of patients are suing Merck.
Fallon said it was “vitally important” that plaintiffs know the truth about Vioxx including what the FDA knew about the drug, when the agency knew it, if it had all the facts and whether the FDA concealed anything from the public.
The agency had just received the order
An FDA spokeswoman, Susan Bro, said Wednesday the agency had just received the order and has not decided whether to appeal.
Graham, the FDA’s associate director for science and medicine for the Office of Drug Safety, didn’t return calls for comment. But Bro said he had asked the agency for guidance about what to do and asked that its lawyers represent him.
The FDA also expressed concern that if Graham testified at the plaintiffs’ request, Merck would subpoena other officials. Merck lawyer Ted Mayer said it was possible but no decision has been made.
Mayer said he didn’t view Graham’s deposition as a plaintiff victory because he doesn’t represent the mainstream views of the FDA. “We are looking forward to examining him,” Mayer said.
Plaintiff attorney Russ Herman said he doesn’t think jurors will care that Graham is a solo act. “He has more courage than other people (at the FDA) who just want a job at the pharmaceutical companies,” Herman said. “The FDA is supposed to be a consumer watchdog but it has become toothless. Graham can explain that.”
Merck withdrew Vioxx from the market in September 2004 after a study showed it doubled patients’ risk of heart attacks and strokes when used for at least 18 months. It faces more than 9,600 lawsuits. So far Merck has won two cases and lost one. Two cases are ongoing.