March 2010

Photo of Bexis

A peculiar situation has developed in Pennsylvania product liability law.  In Berrier v. Simplicity Manufacturing, Inc., 563 F.3d 38 (3d Cir. 2009), the Third Circuit predicted the the Pennsylvania Supreme Court would abandon its peculiar form of hyper-strict strict liability and adopt the negligence-based form of product liability described by the Third Restatement of

Photo of Bexis

The other day we put up a piece about a Twombly/Iqbal law review symposium that promised “diverse interpretations.”  From an academic perspective, it was an impressive collection of articles that attacked Twombly/Iqbal from no fewer than 12 different directions.  But from our perspective, it turned out to be something of a disappointment, since the promised “diversity” never materialized.  Instead it was the usual academic Greek chorus of criticism, with the only “diversity” being differing avenues of criticism.
Having smacked that one down, we’re feeling like Mickey Mouse as the Sorcerer’s Apprentice in Fantasia – smash one broom and two more rise up in its place.  Since that post, we’ve been deluged with additional articles….
Well, not exactly deluged, but our readers have sent us a couple.
The first of these, Edward A. Hartnett, “Responding to Twombly & Iqbal: Where Do We Go from Here?” generously views Twombly/Iqbal “as equivalent to the traditional insistence that a factual inference be reasonable.”  Id. at 1.
We think there’s quite a bit more to Twombly/Iqbal than that.  As we’ve said elsewhere, our view is that Twombly/Iqbal have taken the “a short and plain statement of the claim showing that the pleader is entitled to relief” language of Fed. R. Civ. P. 8(a)(2), and given it a different gloss – one that emphasizes the “showing that the pleader is entitled” language more, and the “short and plain” language less, than was the case under the now-discarded Conley v. Gibson, 355 U.S. 41 (1957), formulation.  From an institutional standpoint we thus view Twombly/Iqbal and Conley as equivalents, with the Court having as much authority to adopt one interpretation as the other.  But make no mistake about it, the interpretation itself has changed, and we think it’s the right one given the litigation explosion that Conley at minimum facilitated.Continue Reading Once More Into The Breach

Photo of Bexis

We can’t say much, because it’s a Dechert case, but the first Seroquel case to go to trial, Baker v. AstraZeneca (in New Jersey state court) has just ended with a defense verdict – 7-1 on the warning being adequate.  We won’t break our arms patting ourselves on the back, but we want to congratulate,

Photo of Bexis

Not too long ago, one of our plaintiff-side readers (who probably wishes to remain nameless) sent us an opinion he had won in the Aredia/Zometa mass tort.  We put it on ice for a bit, because being defense lawyers, we weren’t going to publicize a plaintiff win of any sort unless it first

Herrmann’s time-delayed comments about blogging reminded us of his practice of periodically surveying the law review literature for articles on our favorite topics. We did, and we found the exercise discouraging.
We first looked for recent scholarship on Wyeth v. Levine. We last reported on the scholarship on Levine in October. In days

Photo of Stephen McConnell
Hardly a week goes by when we don’t blow a kiss or two at Twombly/Iqbal. Frankly, we can’t understand why everyone doesn’t share our enthusiasm. What’s wrong with requiring plausibility before subjecting someone to the monetary, stress, and reputational expenses of litigation? It’s enormously frustrating when courts express hostility to Twombly/Iqbal. Sometimes it’s

Photo of Bexis

Even though he’s retired – from blogging that is, not the practice of law – our blogger emeritus, Mark Herrmann, still finds ways to increase our audience here at Drug and Device law Blog. His beyond-the-grave piece on blogging, “Memoirs of a Blogger,” has just appeared in the ABA’s Litigation magazine.  Credit has to be

Photo of Bexis

Like a bad penny, this Heisner v. Genzyme complaint keeps turning up, getting dismissed for lack of facts, and coming back again in yet another iteration.  Now at the “third amended” stage, it’s been dismissed again.  See Heisner v. Genzyme Corp., No. 08-C-593, slip op. (N.D. Ill. March 8, 2010).  As you’ll see from 

Photo of Bexis

A longtime correspondent (who wishes to remain nameless – but we thank you anyway) sent along overnight a new medical device preemption win, Wheeler v. DePuy Spine, Inc., No. 06-21245, slip op. (S.D. Fla. March 9, 2010).
You know the drill.  Class III PMA Device = preemption.  The Charite Artificial Disc (a spinal implant) is that.  So essentially the only thing left would be a “parallel violation” claim.  Concerning a implied warranty/product liability claim, the plaintiff didn’t even try.  Rather, plaintiff “specifically disavows any reliance on a statutory violation claim as to his strict liability claim.”  Slip op. at 5.  Why bother then?  After Riegel, that’s sort of like leaning in to your opponent’s best punch.  The result was predictable – summary judgment granted.  Id.
The plaintiff put up a little more fight on the negligence claim.  At least there was an allegation that the defendant violated something – although the allegations were maddeningly vague.  Wheeler was a 2006 filing – these days that kind of claim would be likely be knocked out of the starting box by a Twombly/Iqbal motion.  Again, however, plaintiff’s argument wasn’t very good.  The complaint “states that [plaintiff] seeks to ‘enforce the requirements of the FDA.’”  Slip op. at 6.  Oops.  Rarely has a plaintiff been so up front about doing something that he’s not allowed to do.  There is no private right of action to “enforce” the FDCA.  Not only that, Florida law is quite explicit that negligence per se isn’t available unless there was legislative intent to allow private enforcement.  Id. at 6-7.  So plaintiff’s “enforcement”-based violation claim goes by the boards for both federal and state-law related grounds.  Id. at 9.Continue Reading Device Preemption Win In Florida – Off-Label Use