FDA Runs Protection Racket For Big Pharma

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By Evelyn Pringle (about the author) Page 4 of 10 page(s)

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Until reading this article, its likely that most people had never realized that Mr. Troy was "forced" to file briefs on behalf of Big Pharma while he worked at the FDA.

In a March 31, 2006 paper, titled, State-Level Protection for Good-Faith Pharmaceutical Manufacturers, Mr. Troy can be found advising State lawmakers to pass shield laws for Big Pharma based on a Michigan model, to "help to reduce the negative consequences of the current pharmaceutical-liability regime," he says.

"In so doing," he states, "they would help to encourage the development of new drugs, preserve the availability of existing drugs, reduce upward pressure on drug prices, and assure rational prescribing."

Such a statement might be a wee bit credible if it also included a suggestion for the lowering of the multi-million dollar annual salary and benefit packages enjoyed by Big Pharma CEOs or a reduction in the billions of dollars that are spent each year on illegal off-label promotion and marketing schemes.

For all the whining he does about litigation keeping products off the market, Mr. Troy cannot cite a single case in which a failure-to-warn claim interfered with the FDA's federal regulatory authority or kept a drug off the market. In fact, in a lecture to Big Pharma attorneys in December 2003, on how to use the preemption defense, Mr. Troy told the attorneys that the FDA had "no good evidence" showing product liability concerns "keep good products off the market," even though he had "combed the literature" to find such evidence.

Apparently to help resolve this nagging little problem, Mr. Troy told the defense attorneys to pay for research to find some evidence to back this claim even if it was weak, stating: "you guys really shoot yourself in the foot by not funding research to this effect. ... I'll even take anecdotal evidence and stories if you have them."

Mr. Troy filed the FDA's first brief in support of Big Pharma in September 2002, in the California Zoloft case titled Motus v. Pfizer, after he was contacted by Pfizer attorney, Malcolm Wheeler, in the summer of 2002, requesting that he get the government involved to help Pfizer win the preemption argument.

Despite the fact that Pfizer had paid Mr. Troy's law firm over $358,000 in the year before he became Chief Counsel, Mr. Troy argued later that he did not become involved in the case until after the 1-year grace period in which employees may not participate in activities involving former clients. From all public accounts, the time period elapsed less then a month before he entered the case.

In the brief, Mr. Troy argued that any warning that suggested a link between Zoloft and suicidality would have been false and misleading, and the FDA would have rejected any effort to add such a warning. However, that argument contradicts 21 CFR § 314.126(b), which requires warnings to be added based on reasonable evidence of an association, even absent proof of a causal relationship. The preemption issue was never decided in Motus because the case was concluded on unrelated grounds.

Legal experts say the preemption defense will not only be used in SSRI-related suicide cases, it will be applied in SSRI cases involving the failure-to-warn about other types of injuries and deaths caused by these drugs as well.

For instance, Big Pharma will no doubt attempt to preempt cases filed on behalf of infants born with birth defects to mothers who unwittingly took the drugs during pregnancy, such as with Lacee Shore, who was prescribed Celexa during her first trimester of pregnancy and as a result, her baby, Gavin Shore, was born with serious heart birth defects and diagnosed with Shone's Complex, which can lead to the obstruction of blood flowing to the body from the left side of the heart.

Gavin has already gone through several surgeries in attempt to correct the heart defects and will have to undergo more in the future.

The successful use of the preemption argument in a case such as this, where the drug maker, Forest Laboratories, could and should have warned doctors and pregnant women about the possibility of birth defects associated with Celexa, would leave the Shore family strapped with the burden of life-long medical costs related to Gavin's condition.

According to attorney Kwok, who is handling the Shore case, the birth defect situation is even more devastating than with patients harmed by Vioxx because the Celexa victims are so young. "Their whole lives," he says, "if they survive, will be under the threat of illness and additional surgery, with a very poor prognosis."

Mr. Kwok points to a 1990 study conducted at the University of Michigan that shows the outlook for infants born with heart defects like Gavin is very poor. "One quarter of patients die after their second operation," he says.

"The second operations are very often necessary," he explains, "because of the complexity of the heart problem."

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