Top FDA lawyer assists drug firms in legal briefs

WASHINGTON — WASHINGTON - The Food and Drug Administration's general counsel interceded in lawsuits on behalf of drugmakers including Pfizer Inc. in cases alleging the companies' products harmed patients, a move Rep. Maurice D. Hinchey said yesterday is a "radical new direction" for the agency.

Hinchey, a New York Democrat on the House appropriations subcommittee that oversees the FDA, said the agency's general counsel, Daniel E. Troy, has filed briefs aiding the cases of Pfizer, GlaxoSmithKline PLC and other manufacturers. The FDA said Troy acted properly and complied with legal and ethical standards.


The briefs responded to requests from the companies for support and break with the FDA's tradition of staying silent on lawsuits against manufacturers unless asked by the courts, Hinchey said, citing unidentified legal scholars.

Hinchey also said Troy's position poses a conflict of interest because he represented Pfizer among clients in his previous job as partner in a law firm.


"Mr. Troy is supposed to act in the interests of the public and the public health, not his former drug-industry clients," Hinchey said.

FDA Acting Commissioner Lester M. Crawford said in a statement that Troy complied with ethical requirements to recuse himself from involvement in issues connected to his previous work for a year after his appointment as general counsel.

Troy "has provided excellent legal advice to FDA since his appointment in August 2001," Crawford said. Troy declined to comment, said Kathleen Quinn, an FDA spokeswoman.

In the four cases, Troy filed friend-of-the-court briefs in which he argued that federal law preempts state laws invoked by plaintiffs in pressing claims they were harmed by drugs or devices approved by the FDA, said a statement issued by Hinchey.

In one case, Motus vs. Pfizer, Troy's position benefited Pfizer in a lawsuit over the company's prescription antidepressant Zoloft.

Hinchey said Troy's financial disclosure filing with the FDA indicates his former employer, the firm of Wiley, Rein and Fielding, received $360,000 from Pfizer for Troy's legal services the same year he left to take the FDA post. Hinchey didn't say when Troy filed the brief.

"Pfizer does not contract with individual lawyers. We contract with law firms, including Wiley, Rein and Fielding," said Pfizer spokesman Bryant Haskins.

A U.S. District Court in Los Angeles dismissed the Motus case in January 2002 and an appeals court upheld the ruling in February, Haskins said.