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Daniel Troy, former Chief Counsel of the Food and Drug Administration, took the counsel's office in a wholly unprecedented direction, repeatedly interceding in civil suits on behalf of drug and medical device manufacturers that were accused of harming patients who had used their products. In doing so, Troy worked in cooperation with the manufacturers, and ignored serious conflicts of interests. The FDA has attempted to mislead Congressman Hinchey in his efforts to look onto this matter.

 

A narrative with built-in links appears below. Or you may access specific documents here.

 

BACKGROUND
On August 20, 2001 President Bush appointed Daniel Troy to be Chief Counsel of the Food and Drug Administration. Previously, civil servants held this position. Troy was the first political appointee to the FDA post.

Congressman Hinchey has been following Mr. Troy's activities for several years now and has done extensive research and investigative work beginning in early 2004.

 

The FDA is the government agency charged with protecting the public by ensuring that foods are safe, wholesome, sanitary and properly labeled; and by ensuring that drugs and medical devices are safe and effective.

The FDA is failing in that mission in large part because of a radical new direction that Daniel Troy took FDA's Office of Chief Counsel, at the behest of the pharmaceutical industry.

 

RADICAL DEPARTURE
For the first time in FDA's history the FDA's Chief Counsel actively solicited private industrial company lawyers to bring cases in which the FDA can intervene in support of drug and medical device manufacturers.  The cases he is sought out were private state civil litigation cases. These are cases in which in which drug companies and medical device manufacturers were being sued by people harmed by their products. The court did not asked for FDA involvement in these cases. 

 

In other words, the FDA is spending taxpayer dollars to defend drug companies who are being sued in state court. Since August 2001, the FDA has expended over 600 hours to file at least six briefs on behalf of these companies in four such cases across the country.

 

Mr. Troy used the argument of preemption to shut down these cases before they could even begin and has stated that there is a well-documented precedent. Yet when Congressman Hinchey's office contacted several former FDA officials and Justice Department officials, not one had ever heard of such an action by the United States before Dan Troy came to power. Moreover, Mr. Troy's immediate predecessor stated clearly in 1997 that FDA long had a policy against preempting courts in this way.  Explaining the reason for that policy she wrote, "Even the most thorough regulation of a product such as a critical medical device may fail to identify potential problems presented by the product. ... Preemption of all such [tort liability] claims would result in the loss of a significant layer of consumer protection."

 

Legal scholars agree as well. Professor James O'Reilly from the University of Cincinnati Law School is one of the country's preeminent legal scholars on FDA issues. He is also acknowledged by the Supreme Court as an expert on FDA legal matters and is a former drug industry lawyer. Professor O'Reilly has stated that he knows of no precedent for FDA's actions.

 

In fact, in 1996, the United States argued before the Supreme Court that the private lawsuits Mr. Troy sought to kill should be allowed and are necessary to hold companies accountable for their actions (Medtronic v. Lohr). For Mr. Troy to argue the opposite, and to do so without any precedent, is completely outside the bounds of normal jurisprudence.

 

The overwhelming response from Mr. Troy's fellow lawyers is that what he did represented a radical departure from past government efforts. Not one person Mr. Hinchey's office spoke with could identify anything remotely similar to what Troy is doing at FDA.

 

MASSIVE CONFLICTS OF INTEREST
Prior to Mr. Troy's appointment to the FDA he was a partner at Wiley, Rein and Fielding - a large Washington, DC law firm. 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 the 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 was supposed to be acting to protect the public's health, not his former drug company clients. Instead, he actively sought 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 the 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 the 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 the FDA provided for the record sought to minimize that relationship. According to the 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 the FDA's answer.

 

Subsequently, Hinchey uncovered additional evidence that the FDA provided misleading or even false answers on the record. 

 

In that same response, the 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 the FDA's history of involvement in these lawsuits. The 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 the FDA filed briefs under Mr. Troy, unsolicited by the court.

 

And finally, in response to another question from Rep. Marcy Kaptur, the 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.

 

PEOPLE HARMED
It has been widely reported that drug companies are providing the public and federal officials with less and less information about possible harmful side effects of their products. We know that these companies often do not share the results of clinical trials that demonstrate problems with their drugs. This has spurred the American Medical Association and the editors of several major medical journals to call for a public registry of all clinical trials for FDA-approved drugs.

 

The lawsuits that Mr. Troy sought to shut down have become the last line of defense to get that information and hold companies accountable for misleading consumers. With whistleblowers becoming more and more rare, most scandals involving consumer products are uncovered through lawsuits just like these. Our country has relied on them for decades to ensure that consumers have a remedy and an avenue to defend their interests.

 

On July 13, 2004, Congressman Hinchey offered an amendment to the Agriculture Appropriations bill, taking $500,000 away from FDA' Chief Counsel's office. In offering the amendment, Mr. Hinchey stated his intention that the funds be cut from FDA's Office of General Counsel, which is housed in the Commissioner's office, and added to the FDA's Division of Drug Marketing, Advertising, and Communication, the office responsible for monitoring drug advertisements. The amendment was accepted without opposition.

 

Subsequently, Mr. Troy and FDA have sought to restore the funding. Mr. Troy visited legislators on Capitol Hill, distributing a copy of a letter from five former FDA chief counsels. This letter has also been submitted to the Congressional Record to refute Congressman Hinchey's assertions. The letter contains several false claims.

 

Rep. Hinchey's argument is mischaracterized in the letter from the counsels, which reads in part, "Representative Hinchey states that Mr. Troy 'has taken the agency in a radical new direction' by submitting amicus curiae briefs in cases in which courts have been asked to require labeling for pharmaceutical products that conflicts with FDA decisions about appropriate labeling for those products." That is not what Rep. Hinchey argued. The "radical new direction" refered to Mr. Troy's practice of soliciting lawyers for drug companies and medical device companies to come to him with cases in which to intervene; and submitting briefs in private civil cases in which FDA has not been asked for its opinion.

 

The letter then cites four examples of cases to show that in fact this type of activity on the part of the FDA predates Mr. Troy's term in office. None of the cases, however, provide such precedent.

Here's why:
Weinberger v. Bentex: The FDA had no choice but to file briefs since the agency was the defendant, not an intervener. Rep. Hinchey is arguing that the FDA never before intervened without being requested to do so.
Jones v. Rath Packing: The FDA submitted a brief to the U.S. Supreme Court in a case involving a government agency and the labeling of flour. Again, far different from interceding in a state civil case between two private parties about product liability.
Bernhardt v. Pfizer: The court requested the FDA's statement of interest.
Eli Lilly v. Marshall: According to the court's decision, the FDA did not submit anything in this case and the case had nothing to do with product liability.

 

The former chief counsels wrote, "In none of these cases did any court request FDA's opinion. Thus, there is ample precedent for the actions that Mr. Troy has recently been undertaking. His action is not radical or even novel." That assertion is inaccurate.

 

Congressman Hinchey wrote a letter to Acting Commissioner Crawford, requesting further documentaion in this matter. He also wrote to Agriculture Appropriations Subcommittee Chairman Henry Bonilla to refute the claims of the former chief counsels.