Drug Litigation Newsroom

FDA Get Involved In A Private State Lawsuit Against Pfizer That Was Ongoing In California

He was also involved with the Washington Legal Foundation, which is a "public interest" that supports weaker government regulations of drug companies and medical device manufacturers. One of Mr. Troy's clients at Wiley, Rein was Pfizer, which in the three years prior to his appointment at FDA paid Wiley, Rein $415,000 for "services provided directly by" Mr. Troy.  In July of 2002 Malcolm Wheeler, an attorney for Pfizer, called Mr. Troy, then FDA's chief counsel, and requested that FDA get involved in a private state lawsuit against Pfizer that was ongoing in California. Mr. Troy obliged and in September, less than two months later, FDA, through the Department of Justice, filed a court brief in support of Pfizer. That same July Mr. Troy also had a meeting with Michele Corash from Morrison and Foerster on "Proposition 65 issues." Morrison and Foerster, one of the world's largest firms, is based in California. At the time of this meeting, it was representing Glaxo Smith Kline in a private lawsuit in California that revolved around California's Proposition 65 or the Safe Drinking Water and Toxic Enforcement Act. Michele Corash was the lead attorney. On September 12, less than two months after that meeting, Mr. Troy's FDA filed a brief in support of Ms. Corash's client - GSK.This pattern continued in 2003. On December 12, 2003 FDA filed a Statement of Interest in the case of Murphree v. Pacesetter in support of the medical device manufacturer Pacesetter. The company was being sued in Tennessee state court for a faulty pacemaker. Congressman Hinchey's office obtained a letter to FDA, dated November 25, 2003 from the law firm of Feldman, Gale and Weber directing FDA on how it should assist its case. The firm was representing Pacesetter.In re Paxil is a fourth case in which FDA submitted an unsolicited. According to remarks by Mr. Troy, he involved FDA because he thought a California state judge's ruling in the case was "crazy."What these few cases describe are massive conflicts of interest and a pattern of collusion between a federal agency and the industry it is supposed to regulate. If FDA did for some reason need to get involved in these cases, it should have done so independently of the drug companies, not in coordination with them. Mr. Troy is supposed to be acting to protect the public's health, not his former drug company clients. Instead, he is actively seeking opportunities to help the drug companies.On December 15, 2003 Mr. Troy was the featured speaker at the 8th Annual Conference for In-House Counsel and Trial Attorneys, entitled "Drug And Medical Device Litigation." Conspicuously, this event was not noted on FDA's public calendar, which listed 44 other speeches Mr. Troy has delivered. The conference program uses his official title.It seems unlikely that omission was accidental. According to a signed affidavit of a conference participant Mr. Troy took credit for FDA's involvement in private civil litigation cases and solicited cases in which the FDA could intercede. He told the audience "we can't afford to get involved in every case, we have to pick our shots," so "make it sound like a Hollywood pitch."Mr. Troy also outlined his reason for getting involved in these cases: tort reform. He specifically stated that FDA is "deeply immersed in tort reform issues," and that it was FDA's goal to "control the flow of risk info regarding these [drug and medical device] products."MISLEADING CONGRESS Congressman Hinchey raised this issue with acting-FDA Commissioner Lester Crawford when he testified before the House Appropriations Agriculture Subcommittee on March 11, 2003. He asked about Mr. Troy's relationship with Pfizer prior to his appointment. The answer FDA provided for the record sought to minimize that relationship. According to FDA, Mr. Troy worked an average of less than 80 hours per year on matters related to Pfizer. Congressman Hinchey later discovered that Pfizer paid Mr. Troy's law firm $415,000 over three years for work performed directly by Mr. Troy. This included over $358,000 in 2001, the year Mr. Troy was appointed to his FDA post.  On a bipartisan basis, the House Appropriations Committee included language written by Congressman Hinchey in the Agriculture Appropriations report, expressing concern about the misleading nature of FDA's answer.Subsequently Hinchey uncovered additional evidence that FDA provided misleading or even false answers on the record. In that same response, FDA asserted that Mr. Troy "became involved in a case affecting Pfizer more than a year after leaving private practice." According to press reports, however, Pfizer's lawyer contacted Mr. Troy in July of 2002 about his case, which was less than a year after Mr. Troy left his firm.In response to another question Mr. Hinchey asked about FDA's history of involvement in these lawsuits, FDA again provided a misleading answer. The response sought to imply precedent for FDA actions by citing previous cases, failing to note that these cases were in response to court requests. None of the pre-Troy cases cited involved the FDA actively seeking to intervene in private lawsuits. That same answer also failed to list two other lawsuits in which FDA filed briefs under Mr. Troy, unsolicied by the court. And finally, in response to another question from Rep. Marcy Kaptur, FDA provided a list of cases and stated that those "that do not name the government (FDA, United States or HHS) are cases in which FDA has been subpoenaed to produce a witness or documents." This is simply false. There are at least four cases in which FDA got involved without being subpoenaed. Mr. Troy himself has even stated that he was "the initiator" of such cases.These five instances of misleading or false answers in response to questions from members of Congress are deeply troubling and severely undermine the credibility of the FDA.