FDA Runs Protection Racket For Big Pharma

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"The FDA's claims," the brief wrote, "which are tantamount to an advisory opinion, lack the force of law and contradict the FDA's governing statute, its regulations, and its regulatory purpose."

It also noted that the FDA's current opinion directly opposes the FDA's longstanding views on preemption. "For these reasons," the brief pointed out, "a majority of courts that have considered this issue, both before and after the FDA issued the Preamble, have held that FDA approval of labeling does not preempt state failure-to-warn claims."

In denying Novartis' preemption motion, U.S. District Court Judge, Stewart Dalzell, of the Eastern District of Pennsylvania, wrote in the decision that the FDA's new "Preamble is not entitled to any special consideration in our analysis."

Where the agency attempts to "supply, on Congress's behalf, the clear legislative statement of intent required to overcome the presumption against preemption," no deference is warranted, he noted.

In reaching its decision, the court said preemption would only apply if a specific warning about Elidel and pediatric cancer had been considered by the FDA and found to be unnecessary and that had not happened in this case.

In discussing the FDA's assertions in its amicus brief, the court stated, "To be sure, because of its expertise in the area, the FDA's construction of its own regulations is likely to carry great weight."

"But where an interpretation has changed frequently in significant respects," it wrote, "the persuasive force of the argument diminishes."

The court also said that even if the Preamble represents a change of policy with the force of law, it would not apply to this case. "The FDA cannot retroactively absolve Novartis of a duty it may have owed the Perrys in 2003," it wrote.

The court also noted that the FDCA provides no remedy for an injured consumer and said, "a finding of preemption here will foreclose a remedy that was traditionally available and for which federal law provides no substitute."

In its decision, the court made an interesting observation about the viability of the preemption defense on failure-to-warn claims based on other available methods of warning the public about the dangers of a drug, stating:

"It is worth noting that, even where FDA regulations or other federal law prevent a manufacturer from modifying the approved labeling, a modification of the label is not the only form that a warning could take.

"If, for example, a plaintiff claimed that a manufacturer was negligent in not sending a letter to prescribing physicians or other health care professionals, that might present a different case, even if modification of the approved labeling were prohibited."

In conclusion, citing a September 23, 2006, New York Times report by Gardiner Harris, the court said, "given the recent concerns about the effectiveness of the FDA's safety monitoring of recently approved drugs, . . . the availability of state law tort suits provides an important backstop to the federal regulatory scheme," and further stated:

"If, at some future date, Congress determines that FDA monitoring is sufficiently effective on its own to warrant the elimination of state law incentives for manufacturers to provide adequate warnings, it also has the authority to declare that failure-to-warn suits, like the Perrys' action, are preempted."

"Until it does so, however," the court said, "in the absence of a specific FDA safety determination, such suits can go forward."

Families seeking legal advice for infants born with birth defects to mothers who were prescribed Celexa during pregnancy can contact Robert Kwok & Associates, LLP at (713) 773-3380; http://www.kwoklaw.com/about.php

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