Tuesday, February 23, 2010

Well ... Hell....

We've always thought that the FDA's close regulation of SSRI's (selective serotonin reuptake inhibitors) and the issue of suicide was among the best fact patterns for preemption.  So did the FDA - it entered the preemption field to preserve its control over the labeling of these drugs.

If our side can't win the preemption fight after Levine with this fact pattern, then it's going to be difficult for us to do so anywhere.  Today, we lost the first post-Levine appellate decision in this area, Mason v. SmithKline Beecham Corp., slip op. (7th Cir. Feb. 23, 2010).  It's not our best facts, as the suicide was a young adult (23 years old), and subject to an eventual FDA label change, but it's not good either.

We haven't had a chance to read it yet, but since it's going to be published anyway, we thought we'd get it out there for our readers to know about it.

6 comments:

DJ said...

By the way...it's 2010, not 2009.

Anonymous said...

This sort of post shows just how reflexively anti-consumer and anti-safety you people really are: Even without reading the decision, you're so sure that it's wrong and that you don't like it. The analysis matters not at all.

You're nothing but pathetic hired guns whose views correlate precisely with the bottom lines of the corporations that pay you. If your clients were arms dealers, you'd condemn any legal rule that got in their way. If they were tobacco companies, it would be the same.

Couldn't you have done anything better with your educations? Do you even have consciences? I realize this may sound a bit over the top, and that you might think it's funny, but I'm actually serious. How do you look at yourselves in the mirror and not feel anything but disgust?

Beck, et al. said...

We believe that our clients and the products that they make are forces of good in this world, and that those products have contributed far more to "safety" and public health than any lawsuit every could - as witnessed by the addition of several decades to the average human lifespan over the course of the last century.

All the product liability litigation in history has saved fewer lives than one vaccine, one antibiotic or one of many other treatments that our clients make.

In this particular situation, we believe that SSRIs have prevented far more suicides through successful treatment of depression than they could possibly have caused, even if the twisting of science by hired, plaintiff side experts were taken as gospel. All anyone has to do is look at the epidemiology - since warnings about teen suicide were added to SSRIs, such suicides have increased, not decreased. The folks pushing for such warnings have caused many more suicides by scaring away patients who could have been successfully treated.

Yes, we can look ourselves in the mirror every morning with pride.

Anonymous said...

Quite frankly it's one of the most bizarre circuit opinions I've ever read. The court states that it must accept the Levine majority's view of Phenergan's administrative record, but then relies on the "Levine as a whole" and the dissent's characterization of the facts to decide that the Phenergan record was strong with regard to the relevant warning about IV push. The 7th Circuit has found a way to have its cake and eat it to.

Beck, et al. said...

We agree with the second anonymous comment. We think that folding in the dissent's description of the facts, which supported preemption, as somehow recognized by the Court, when the majority refused even to admit that these facts existed, was intellectually dishonest.

Anonymous said...

The analysis and result is especially odd considering that Ms. Levine spent most of her energies arguing that the FDA paid no special attention to the risk of extravasation with regard to IV push, and Wyeth argued that it had. Now those efforts have been turned on their head, and the seemingly good job that Wyeth did in explaining FDA's review of the problem is being used against it and other drug manufacturers as a very high benchmark.