Some Good News On SSRI Preemption


Finally, a judge with some common sense....

We've always thought (and the FDA did too) that the adult suicide/SSRI warning claims were the strongest possible claims for implied preemption in the prescription drug context. C'mon, the FDA looked and looked again at the suicide data for these drugs and found that there was no scientific basis for the contention - and for adults, that's true today. But Levine got there first, and since then the courts seem to view all preemption claims involving prescription drugs, no matter how strong on the evidence, through the Supreme Court's sludge-colored glasses.

But now we have Dobbs v. Wyeth Pharmaceuticals, No. CIV-04-1762-F, slip op. (W.D. Okla. June 13, 2011), where the court actually bothered to look at the "clear" evidence. Anyway, in Dobbs the guy who killed himself was 53 years old when he did the deed in December, 2002. He was taking an SSRI for depression - the leading cause of suicide in any event - for only a few days.

Levine says there has to be "clear evidence" that the FDA would have rejected a warning if it had been proposed. Levine never defined what that was, finding no evidence of the likelihood of such a rejection. The lower courts have all applied a sort of "know it when we see it" standard, and never saw it. Dobbs, slip op. at 8-9. Well, in Dobbs the court saw it clearly.

Please see full article below for more information.

LOADING PDF: If there are any problems, click here to download the file.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

© Dechert LLP | Attorney Advertising

Written by:


Dechert LLP on:

Readers' Choice 2017
Reporters on Deadline

"My best business intelligence, in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:

Sign up to create your digest using LinkedIn*

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.

Already signed up? Log in here

*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.