Tuesday, June 06, 2006

FDA preemption: June 30, 2006

That is the date of the FDA's position regarding Preemption of state law claims relating to unsafe drug litigation.

On SSRN, I found an article that is worth a read: "Discovering the Boundaries: Federal Preemption of Prescription Drug Labeling Product Liability Actions" which you can find by going here.

From SSRN, the article is described in this way:

The Food and Drug Administration (FDA) has promulgated a regulation which revises the format for prescription drug labeling, and, in the process, has taken the position that the regulation displaces, or preempts, state products liability laws that seek to assess liability on the manufacturer for a labelĂ‚’s warning adequacy. In the FDA'’s 100 year history, it has not taken the position that federal regulations preempt common law tort claims based on prescription drug labeling until now.

Also, in May there was the reported decision of Colacicco v. Apotex, Inc., -- F. Supp. 2d --, 2006 WL 1443357 (E.D. Pa.)

The Court ruled against a plaintiff whose wife committed suicide after taking Paxil. The Defendant relied on the FDA's recent Preamble taking the position, contrary to some earlier statements, that state-law failure to warn tort claims are preempted by the FDCA.

The court rejected specific state law claims, including a New York false advertising count. The court accepted the argument that, despite the existence of pervasive direct-to-consumer advertising, the learned intermediary doctrine precludes a prescription drug false advertising claim -- since only by fooling both doctor and patient can a drugmaker's false advertising succeed, and doctor-targeted ads aren't directed at consumers as the statute requires.

Today Mealey's will have a teleconference at 2PM Eastern on the subject. The cost is $299, and the title of the conference is: "Preemption, The FDA, & Pharmaceutical Drug Litigation." You can learn more by going here.