The Argument of Preemption In Practice

Wisconsin Court Finds Preemption Argument to be Invalid in Paxil Case

As reported in ExpertClick on August 7 2009 - "A Wisconsin federal judge has denied GlaxoSmithKline's claim of immunity from liability for a Paxil-induced injury case, allowing the plaintiffs product liability case to move forward. "

For months arguments for and against FDA Preemption have been bandied about both here and elsewhere on the internet. Countless hours of sometimes heated discussion have passed as we speculate on preemption’s use and its affect in the real world.

In the attached article we can see the real world attempted application of FDA Preemption in a court of law. Its use as a blunt force instrument to drive plaintiffs out of the court room has failed in this case.

The case is also significant because it involves the Paxil – Suicide allegation. It will be interesting given what we already know about GlaxoSmithKline's management failures with Paxil. The court will now be able to take a deep dive into the situation.

Note that the court held, among other things -

• "Federal law does not prohibit drug manufacturers from updating their labels to warn of known risks when the FDA-approved labeling did not include the updated language. Instead, a drug manufacturer has a duty to advise consumers of risks because it 'bears responsibility for the content of its label at all times.”

• "State tort claims are harmonious with Congress' regulatory goals and do not compel application of preemption"
• ". . . the fact that the FDA approved prior Paxil labeling without an enhanced warning does not mean that the agency would oppose a request by GSK to include such a warning"
• "GSK's 'overwarning' argument also assumes that the subject drug label warns of a non-existent risk," however, the Court stated that it "refuse[s] to find that Paxil does not increase suicidality as a matter of law"
• "State law litigation provides an additional oversight on drug labeling and helps flesh out which warnings are 'substantiated' and necessary for the protection of consumers"

FRAUDULENT SLIP

Forest Accused of Fraud re: Celexa and Lexapro

My goodness, we haven't seen the Justice Department this active in pharma cases in a very long time. But after the recent major DOJ actions against Lilly/Zyprexa and Pfizer/Bextra, it looks like Forest's promotion of Celexa/Lexapro (mirror images of the same molecule) is the next target. This according to the New York times, as described here:

http://www.nytimes.com/2009/02/26/business/26drug.html?ref=business

As described in the article, the charges will remind most of us of Paxil--suppressing negative studies on the antidepressant, and particularly regarding its effect on kids. Suicidality appears to be, yet again, part of what remained unreported. And all this in the context of unapproved promotion and, it appears, some whistleblowers within the company.

From the perspective of this observer, it does appear that the Justice Department is reviving itself. This is not to say it has all happened in the last few weeks. Cases like this take years to develop. But perhaps there is a new commitment to actually friggin do something.

Pardon my Scottish.