Wyeth v. Levine update

Categories: Big Pharma, Drug Safety, FDA, Prescription Drugs | Tags: , , | Posted On:


From the Wall Street Journal Law Blog:

After the arguments wrapped up in Wyeth v. Levine…we called around and spoke to a couple lawyers who were present at the scene. Based on those convos, and an AP report, we were able to cobble together an overview of the back-and-forthing…

…the Justices took issue with Wyeth’s argument that it couldn’t update its label to add stronger warnings without first getting FDA approval. “Wyeth could have gone back to the FDA anytime” to update the label, said Justice Souter. “And it simply didn’t do it.”

But Seth Waxman, who argued the case for Wyeth, argued … that, when the FDA has specifically considered the risk involved and rejected the sort of warning that Diana Levine seeks, then the claim is preempted because it directly conflicts with the FDA’s own determination.

The plaintiffs, on the other hand, argue that the FDA regulations are merely a floor, not a ceiling, and that state tort law augments those regulations by providing companies with incentives to inform of all possible risks…

Indeed, when Justice Kennedy asked Levine’s lawyer when preemption should apply, the lawyer said that if the FDA had adequately weighed the risks and benefits … and included those details on the label, then his client wouldn’t have a case. However, the lawyer argued, those details weren’t provided. Therefore, preemption doesn’t exist in this case.

Sounds to me like the Levine argument is more than reasonable. She was awarded $6 million after having her arm amputated — which also sounds reasonable.

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Why on earth would ANYONE favor government deregulation AND the de-fanging of our tort system? Without both of these protections, consumers are completely powerless when they are injured by the actions or negligence of large corporations.

Please, don’t buy into this nonsense about tort reform being about people who are awarded $100 million dollars for spilling hot coffee on themselves. That just doesn’t happen — and in the very rare instance when it does, the monetary award is always subsequently reduced or eliminated (even if this reduction doesn’t make the headlines.)

If you want to know how hard it is for people to collect money from large corporations or wealthy individuals who have wronged them, look at the Exxon Valdez case — or the O.J. Simpson civil case for that matter. Neither Exxon nor Simpson have paid a dime since those big-money judgments made the news.

The tort reform movement is funded by large corporations. They fund tort reform because they want to make more money, plain and simple. If you buy into it, you’re not reducing your costs — you’re just increasing their margins. You’re playing into their hands.

A decision on Wyeth v. Levine is expected this week. Kaiser has a great overview of the case here.

About Cary Byrd

eDrugSearch founder, Cary Byrd, has been called an “e-health innovator” by MarketIntellNow, interviewed by top pharmaceutical industry journalists, invited to Matthew Holt’s Health 2.0 Conference and a Consumer Report's health summit, and highlighted on numerous health blogs.

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