Glaxo Fights Against Public Paxil Trials

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He told Ms Loudon that someone in his supervisory chain at the FDA even initiated a criminal investigation to identify the person who had leaked the information to the media.

With the SSRIs, he says, the FDA should have insisted on a signed informed consent form, that said three things: (1) these are the antidepressants available and only Prozac has been shown to work for children; (2) all the other drugs are no better than placebos; and (3) all these drugs appear to have the ability to increase the risk of suicidal behavior.

As a parent, he stated, if I saw that in writing and the doctor was going to write the prescription for some drug other than Prozac, I could say, "Doc, why are you putting my child on a drug that doesn't work in kids."

According to Dr Graham, the FDA did not want patients to have that information, so it refused to require signed informed consent. And, the companies didn't want parents to have that information because all of a sudden the lucrative "off-label" use of the drugs would have dried up.

Dr Graham also explained that, if the FDA pulls a drug off the market due to safety issues, it not only hurts the marketing of the drug, but also calls into question why it was approved in the first place.

"Therefore," he said, "you get this culture of cover-up, this culture of suppression, this culture of denial, and this culture that demonstrates above all else that industry is the client and not the American people."

Most Americans do not realize that a preemption decision on whether to throw out a lawsuit largely hinges on the judge assigned to the case. Attorneys James Beck and Mark Herrmann run the "Drug and Device Law" blog and they post their personal views on topics that arise in the defense of pharmaceutical company product liability litigation.

On May 17, 2007, they posted a piece called, "Picking Spots In Preemption Cases." The bloggers lamented that "two adverse preemption decisions over the last couple of weeks
[ ] have us scratching our heads."

The opinions referred to were Barnhill v Teva Pharmaceuticals, No 06-0282, (SD Ala Apr 24, 2007), and Kelly v Wyeth, 2007 WL 1302589 (Mass Super Apr 12, 2007).

In their blog, Mr Beck and Mr Herrmann discuss the importance of filing preemption motions with judges who are already known to be unsympathetic to private plaintiffs who sue drug companies.

"With respect to Kelly," they state, "the most salient point for us is why a preemption motion was brought at all in a state trial court in Massachusetts a known pro-plaintiff jurisdiction."

"There's certainly no history of success with preemption motions in prescription medical product cases in Massachusetts," they point out.

"Part of preemption strategy is choosing the jurisdictions in which such motions would have a reasonable likelihood of success," they explain.

"In plain English, you gotta pick your spots," the attorneys advise.

"If defendants go running helter skelter into courts filing preemption motions no matter how hostile the jurisdiction well, the result is going to be decisions like Kelly," they warn.

"That doesn't do the filing defendant any good," they state. "Nor does it do anyone else defending prescription drug cases any good."

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