The self-identified primary author of the preemption language in the new drug labeling rules, former FDA Chief Counsel Daniel Troy, is a partner at a major law firm where he now represents the very same companies that benefit from the new policy.
Mr Troy was the first political appointee to ever hold the job of Chief Counsel. Prior to the Bush Administration, civil servants held that position.
Before his take-over of the FDA's legal department, Mr Troy was a partner at the Wiley, Rein & Fielding law firm, where he represented tobacco-giant Brown & Williamson in a successful effort to fend off FDA oversight of tobacco.
Back in the 1990's, he also played a primary role in the campaign by the Washington Legal Foundation Washington, a so-called "public interest" group that supports weaker regulations for the pharmaceutical industry, to lift advertising restrictions on prescription drugs which made it easier for companies to promote drugs for "off-label" uses.
The language in the new labeling rule seeks to bans failure-to-warn lawsuits against doctors. "Pre-emption would include not only claims against manufacturers," it states, "but also against health-care practitioners for claims related to dissemination of risk information to patients beyond what is included in the labeling."
The inclusion of this statement extends protection to doctors who prescribe drugs for off-label uses which have never been tested or approved even though the FDA-approved labeling carries no information about the benefits or risks of prescribing a drug for an unapproved use.
Mr Troy was also the author of the original preemption argument made against citizens in private litigation. In the summer of 2002, Pfizer attorney Malcolm Wheeler asked Mr Troy to file an amicus brief to support Pfizer's preemption argument.
Even though Pfizer had paid him over $358,000 in the year before he took office, Mr Troy filed the FDA's first brief in September 2002 on behalf of Pfizer in Motus v Pfizer, a suicide case involving the selective serotonin reuptake inhibitor antidepressant Zoloft, claiming that the FDA would not have allowed Pfizer to warn about a suicide risk and that any such warning would have been false and misleading and constituted misbranding of the drug.
The preemption argument was not reached in Motus because the case was resolved on other grounds, but Pfizer continued to use Mr Troy's brief in other cases. In 2005, two courts rejected the argument and allowed the claims to proceed in Witczak v Pfizer, 377 F Supp 2d. 726 (D Minn July 2005) and Cartwright v Pfizer, 369 F Supp 876 (ED Tex 2005).
In Witczak v Pfizer, the court specifically stated that the FDA has no authority to declare that a label is false and misleading and that the government must initiate an enforcement action to establish that the drug is, in fact, misbranded.
"State consumer-protection law compliments, rather than frustrates, the FDA's protective regime," the judge wrote.
"This is especially apparent," the court said, "when one considers that prescription drugs were once marketed primarily to trained health care providers -- sophisticated and discerning intermediaries."
"Today, on the other hand, pill-rolling apothecaries and the mortar and pestle have disappeared," the court stated. "They have been replaced by drug manufacturers who urge the use of their drugs in mass-market print and television advertisements targeted directly at the public."
As an example, the judge pointed out that Glaxo had advertised Paxil, "by personifying it as a happy, bouncing-oval cartoon character."
The court rejected Pfizer's arguments, stating that it declined to treat statements from a single FDA brief as declarations afforded the preemptive force of law and called the arguments perverse and a public policy argument gone awry.
The truth is that the FDA knew about the risk of suicidality in children taking Zoloft, because the agency's review of Pfizer's clinical trial data in 1996 showed the risk to be five times that of adults on Zoloft and caused enough concern that FDA reviewer Dr James Knudsen wrote to Pfizer asking for an explanation.
In 2006, a Nebraska court also refused to allow preemption in Jackson v Pfizer, 432 F. Supp 2d 964. US District Judge Joseph Bataillon pointed out that, after the boy committed suicide, the FDA had made a change and now "requires the black-box label to include a warning of the possibility of suicide in pediatric patients."
The court also noted that if Pfizer had revised its label to warn patients and physicians about the risk of suicidality sooner, that change would not have constituted misbranding.
In fact, the FDA is inserting twisted logic in these amicus briefs because the FDA cannot revise the labeling unless a company agrees to the change. On March 1, 2005, the FDA's deputy director for the Office of New Drugs, Dr Sandra Kweder, testified at a hearing before the Senate Committee on Health, Education, Labor and Pensions and was asked whether the FDA had the authority to demand that a new warning be added to a label.
Dr Kweder testified that the FDA does not have the authority to require a specific label change and that the agency has to negotiate with the company about how information should be worded, placement, etc.
In perhaps the most perverse example of the corruption of judicial proceedings to date, Malcolm Wheeler is now showing up in courtrooms all over the county, claiming that lawsuits against Pfizer should be dismissed based on the same "false and misleading" statements that he instructed Mr Troy to include in the Motus brief in 2002.
In one case, the court asked him: "Would there have been a conflict in this case if your client had taken up the plaintiff's invitation and strengthened its warning sua sponte before 2004 to address adolescent suicidality?
"Plaintiffs argue that it's inconceivable that that would be deemed misbranding if your client had earlier come up with at least the same label that FDA required after January of 2005," he noted.
"Isn't that correct logically?" the court asked.
"No, it's not, your Honor," Mr Wheeler stated.
"In fact," he said, "it's quite illogical in light of the fact that in September of 2002, the agency filed a brief telling not just the court in Motus, but obviously telling Pfizer that there was no reasonable evidence of an association and it would be misbranding to add any kind of additional language, certainly any strengthened warning with respect to suicidality."
"Pfizer didn't have to infer anything," he stated.
"The FDA told it specifically there is no reasonable evidence of misassociation, it will be misbranding if you do this, and it said it again after June of 2003," he told the Court.
To begin with, the "false and misleading" argument is ridiculous because federal regulations require a manufacturer to provide warnings on a drug's label "as soon as there is reasonable evidence of an association of a serious hazard with a drug."
In fact, during a Vioxx trial in March 2006, New Jersey federal judge Carol Higbee told the jury: "I just want to advise you that the law under FDA regulations does allow a company to change their warnings, to warn consumers and physicians about dangers they find out about after the label is approved."
"They're allowed to make changes," the judge said, "through a special procedure, without prior FDA approval."
On March 1, 2004, attorney Jessica Rae Dart filed an affidavit in support of Plaintiff's Motion for Reconsideration and Alternative Motion for Clarification of the Opinion and Order dated February 20, 2004, in Dusek v Pfizer. In addition to being Counsel in this case, she was also one of the attorneys in both Motus v Pfizer and In Re Paxil.
In the affidavit, she summarized what she heard Mr Troy say when she attended a December 15, 2003, presentation for pharmaceutical companies and defense attorneys entitled, "The Case for Preemption," at the Annual Conference for In house Counsel and Trial Attorneys, Drug and Medical Device Litigation, in New York.
The advertised and actual content of his talk included a discussion about the FDA's involvement in both In Re Paxil and Motus v Pfizer, she noted.
According to Ms Dart, Mr Troy told the defense attorneys that, "minimizing product liability is not part of the FDA's mandate, but we are aware that our decisions do effect liability and we think it's consistent to step into litigation and still fulfill our mandate."
He also told them that he did not think that plaintiffs should be allowed to depose agency officials because it would be a waste of FDA resources and said, "the minute the deposition of an FDA official is allowed, I will stop filing amicus briefs," Ms Dart reported in her affidavit.
She also points out that when asked by plaintiff's counsel, the two FDA officials who appeared at the February 2, 2004, SSRI advisory panel hearing, Doctor Russell Katz and Dr Robert Temple, who were most responsible for reviewing the risks of SSRI's and approving new applications and labeling, both stated that they were unaware that an amicus brief had been filed on behalf of the FDA in Motus v Pfizer.
When questioned further, she said, Dr Temple even stated that it would be inappropriate for the FDA to get involved in private litigation and that the only brief they were aware of was the one filed in In Re Paxil involving Glaxo's "non-habit forming" television commercial.
These are the men with the authority to claim that SSRI makers would be misbranding a drug by adding "false and misleading" suicide warnings, and they obviously knew nothing about Mr Troy's claims to that effect.
Congressman Maurice Hinchey (D-NY) conducted an investigation and found that Mr Troy's involvement in the Paxil withdrawal case occurred after Mr Troy had met with Michele Corash from the California Morrison and Foerster law firm in July 2002.
At the time, the firm was representing Glaxo in a private lawsuit, and Mr Corash was the lead attorney. On September 12, 2002, less than 2 months after the meeting, the FDA filed a brief in support of preemption for Glaxo in a case that alleged Glaxo failed to give adequate warnings about the withdrawal problems with Paxil.
The FDA's intervention did not go over too well with the judge. In rejecting the argument, the federal district court in California wrote:
"FDA's and [defendant]'s position vitiates, rather than advances, the FDCA's purpose of protecting the public. That is, FDA and [defendant] invite the Court to find that in enacting the FDCA for the purposes of protecting public health, Congress not only declined to provide for a private cause of action but also eliminated the availability of common law state claims. This position contravenes common sense . . . ." In Re Paxil Litig (CD Cal Oct 18, 2002).
During his investigation, Congressman Hinchey's office contacted several former FDA and Justice Department officials, and not one had ever heard of any such action by the United States before Dan Troy came to power. Not one person his office spoke with could identify anything remotely similar to what Troy was doing at FDA.
In fact, in 1996, the United States argued before the Supreme Court that the private lawsuits should be allowed and are necessary to hold companies accountable for their actions in the medical device case of Medtronic v Lohr.
In July 2004, Rep Hinchey successfully called on Congress to cut FDA funding by $500,000, with the intention of slashing the budget of Mr Troy's office. "The FDA's Chief Counsel," he said in a speech on the House floor, "has wasted taxpayer money on pursuits that are undermining FDA's basic mission."
He pointed out that since taking office, Mr Troy had spent over 622 hours on civil litigation in what he called a "pattern of collusion" with drug companies and medical device makers in state court lawsuits.
"For the first time in history," he said, "FDA's Chief Counsel is actively soliciting private industrial company lawyers to bring him cases in which FDA can intervene in support of drug and medical device manufacturers."
He informed his fellow congressmen that Pfizer was one of Mr Troy's previous clients at Wiley, Rein, & Fielding, and that in the 3 years prior to his appointment as Chief Counsel, Pfizer had paid the law firm $415,000 for services provided directly by Mr Troy.