Archive for August, 2009

Hot Off The Presses – Statute of Repose Defense Win in Fen-Phen Appeal

Friday, August 28th, 2009

This is a Bexis only post. Herrmann represents Wyeth and doesn’t want to go on record on this.

We mentioned the Montgomery v. Wyeth case before, here. Well we’re pleased to report that the Sixth Circuit today affirmed the defense summary judgment in Montgomery, slip op. here. The moral of Montgomery is – be on the lookout for statutes of repose, they can be your friends.

That goes double (more…)

Rule 11 Discovery Allowed In Digitek MDL

Thursday, August 27th, 2009

This just in:

(Actually, it came in late yesterday, but we were first busy and then tired. Sorry.)

In April 2008, the FDA recalled all lots of the drug Digitek (distributed by Mylan and UDL Laboratories), because the tablets may have contained too much of the drug’s active ingredient, exposing certain patients to risk.

First the recall, then the MDL.

The defendants served requests for admission aimed at (more…)

From Zyprexa To Aredia – Summary Judgment And Case Selection

Thursday, August 27th, 2009

We’ve been following with interest the recent activities in the Zyprexa litigation, since it looks like the plaintiffs in this batch of cases are dropping like flies. We admit, though, that we haven’t been particularly complete about those developments, since our prior posts describe only five summary judgment grants.

We’re not sure whether the Zyprexa summary judgments are drawn from some pre-selected pool of plaintiffs (more…)

The Life Expectancy Of A Legal Blog

Monday, August 24th, 2009

Whenever we start thinking about blogging, rather than about drug and device law, Bexis gets spooked.

So this post was written by Herrmann alone, ruminating about the life expectancy of a newborn legal blog.

What prompted the rumination?

The professors who previously manned the Product Liability Prof Blog and the Civil Procedure Prof Blog have apparently given up the ships. As of last week, the Law Profs Blog Network (more…)

Viagra Causation Goes Limp

Friday, August 21st, 2009

Imagine this: The only published article in the medical literature reaching a statistically significant result concerning a drug and an outcome turns out not to have been what it seems. Rather, over a third of the subjects in the relevant category turn out to be misclassified. When properly reclassified, the statistical significance between the drug and the outcome goes away.

If that study had been sponsored by the drug company, and involved (more…)

Moving To Dismiss MDL Master Complaints

Sunday, August 16th, 2009

Suppose you have a product liability MDL.

Individual lawsuits are arriving by the mailbagful.

You need a system to sort out which claims can proceed and which should be dismissed as a matter of law. What’s a judge to do?

On the one hand, you could order defendants to file motions to dismiss each of the hundreds of separate complaints and then start ruling on those motions one by one.

On the other hand, (more…)

Defense Briefs Filed In Pennsylvania Contingency Prosecution Case

Thursday, August 13th, 2009

Back in January, we put up a short post noting the filing of a petition for extraordinary (“King’s Bench”) review in the case of Commonwealth v. Janssen Pharmaceutica, Inc., No 0108002818 (Pa. C.P. Phila. Co.). It’s a case involving alleged off-label promotion of Risperdal, a widely prescribed “atypical” anti-psychotic medication. We posted a copy of the petition challenging the state’s decision (more…)

New Stuff Filed Under “A” (Accutane and Acetabular Hip)

Tuesday, August 11th, 2009

A couple of brief notes on new decisions:

(1) In Accutane litigation, plaintiff’s expert Ronald Fogel is now 0-2 under Daubert. The latest opinion excluding his testimony does so because his opinions overreached the medical literature on which they were based. The holding:

Both [the articles], in their review of the existing literature, case reports and scientific data, only formed hypotheses, not opinions of causation. (more…)

D. Utah Goes 1-1-1 (Lake-Allen v. J&J)

Tuesday, August 11th, 2009

We keep score here.

We keep the Drug/Vaccine Preemption Scorecard, collecting cases addressing preemption in the context of prescription drugs.

We keep the Device Preemption Scorecard, tracking device preemption cases since Riegel.

We keep the Cross-Jurisdictional Class Action Tolling Scorecard, tracking . . . well, if you understand what those words mean, you know why it matters.

And today we’re keeping (more…)

Scientific Articles As First Amendment Protected Speech

Friday, August 7th, 2009

We just ran across Bracco Diagnostics, Inc. v. Amersham Health, Inc., ___F. Supp.2d ___, 2009 WL 1743699 (D.N.J. June 30, 2009). Yeah, we know, it’s over a month old — ancient by blawg standards. In our defense, all we can say is that it’s a Lanham Act case, and we pay more attention to the products area.

Anyway, the claim there was that the defendant violated the Lanham Act by causing the publication of supposedly untrue articles (more…)