Paxil Birth Defect Litigation - Battle of the Decade

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By Evelyn Pringle (about the author) Page 5 of 6 page(s)

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It should be noted that, prior to his appointment as Chief Counsel at the FDA, Daniel Troy was a partner at Washington's Wiley Rein & Fielding, where he filed lawsuits against FDA regulations in support of the pharmaceutical industry. He left the FDA in late 2004, and is now back representing drug companies and applying the preemption policy that he put in place.

Up until now, most preemption cases have involved failure-to-warn claims about the association between suicide and SSRIs.

But the stakes are higher with birth defect cases and a massive filing of preemption motions is expected, aimed at keeping these families, considered to be extremely sympathetic plaintiffs, out of the sight of a jury.

However, when it comes to preemption motions, GSK could not be up against more formidable opponents than the attorneys at Baum Hedlund. Ms. Menzies and her Baum Hedlund associate, Robert Brava-Partain, have already soundly defeated preemption arguments by SSRI makers and the FDA in numerous cases, including Witczak v Pfizer, Cartwright v Pfizer, and Zikis v Pfizer.

According to Ms. Menzies, the use of the FDA to shield the industry from liability actually began in 2002, when Mr Troy began submitting briefs in private lawsuits on behalf of drug companies arguing that state tort failure-to-warn claims should be preempted because the FDA had the final word when it came to drug labeling.

In the first brief in Motus v Pfizer, Mr. Troy argued that even though Pfizer had never asked to strengthen Zoloft's label, any warning would have been false and misleading. "Had Pfizer given a warning as to a causal relation between Zoloft and suicide, the FDA would have disapproved the warning," Mr. Troy wrote in the brief. The court never decided the preemption issue in Motus, because the case was concluded on other grounds.

In September 2002, Mr. Troy filed a brief with the same argument in another lawsuit that alleged that GSK failed to adequately warn about the withdrawal effects of Paxil. Ms. Menzies won that round when the judge held that the preemption argument "contravenes common sense" and "vitiates, rather than advances, the purpose of protecting the public."

Pfizer also tried to use Mr. Troy's brief from the Motus case, in support of a preemption motion in the Minnesota case of Witczak v Pfizer. The judge rejected it, stating:

"State consumer-protection law compliments, rather than frustrates, the FDA's protective regime. This is especially apparent 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. 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. Defendant, for example, advertises the drug involved in this case by personifying it as a happy, bouncing-oval cartoon character."

Mr. Brava-Partain, who argued for Mrs. Witczak, praised the ruling. "The Court correctly recognized that drug manufacturers, like Pfizer," he stated, "cannot hide behind the rules and regulations of the FDA when they engage in conduct that harms the public."

The fact is, FDA regulations require drug makers to add a new safety warning whenever there is "reasonable evidence" of an association between a particular hazard and the drug, and that a "causal relationship need not have been proved."

"With respect to the SSRIs," Ms. Menzies states, "drug companies have utterly failed to add warnings to the labels despite far more than reasonable evidence of an association of a serious hazard."

The claim that only the FDA can decide whether there is reasonable evidence to change the label is contradicted by its own inaction when it allowed Wyeth to strengthen the label with a warning about suicide and Effexor in August 2003, without prior approval.

According to Ms. Menzies, immunizing the pharmaceutical industry under the misplaced belief that the FDA is infallible is a threat to public health. "Recent regulatory failures," she states, "demonstrate that the agency is neither infallible nor does it have the capability of policing drug makers' negligent misconduct."

Families seeking justice for infants born with Paxil and other antidepressant related birth defects can contact the Baum Hedlund Law Firm at: (800) 827-0087; http://www.baumhedlundlaw.com/

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