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JAMES M. BECK is Reed Smith's only Senior Life Sciences Policy Analyst, resident in the firm's Philadelphia office. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LinkedIn page is here.

The last couple days’ dialogue with our subscribers suggests that the blog’s email outage was uneven.  Some subscribers may have lost email transmission of our post for more than a month.  We’ve already apologized, but we think we should do more.  Here’s a list of what we posted about – with links – between June

We can’t provide any commentary or analysis, because of our firm’s involvement in the litigation.  But we thought our readers would benefit from knowing about three recent opinions excluding certain plaintiff experts in an HT case.

Just the holdings, then:

Opinion #1:  Hines v. Wyeth, 2011 WL 2680814 (S.D.W. Va. July 8, 2011).  Experts: 

We gave you our quickie analysis of Goodyear Dunlop Tires Operations, S.A. v. Brown, ___ U.S. ___, 2011 WL 2518815 (U.S. June 27, 2011); and J. McIntyre Machinery, Ltd. v. Nicastro, ___ U.S. ___, 2011 WL 2518811 (U.S. June 27, 2011), here, the day after those cases were decided.  We weren’t alone.  Our partner, Sean Wajert, analyzed these cases on his blog the day after. The Prawfs’ network  was even quicker out of the blocks than we were, and later posted an even more interesting followup here.  SCOTUSblog posted an article about the two cases here.  There’s lots more, see here and here.
This post, however, is “2.0.”  We’re not going to rehash (much) the facts of Brown and Nicastro or offer detailed point-by-point analysis of the reasoning.  We already did that.  Today we’re thinking in terms of what the Court did, and how that affects what we do going forward.
Initially, as we pointed out back when the Court first granted certiorari, both Brown and Nicastro were relative outliers.  Both of them pushed the jurisdictional envelope pretty hard.
Brown held that there could be general personal jurisdiction – where a defendant could be sued about anything, such as a Korean business deal gone awry – based solely on a “stream of commerce” test if a few of its products (a few thousand tires (or as they say in Europe, “tyres”) out of millions sold) ended up in the jurisdiction.  Under that rationale, the plaintiff in Brown, an in-state resident injured abroad, could probably have brought the same suit in most, if not all, the states in the country, since some tires were probably shipped to each state.  That ruling easily lent itself to apocalyptic “what if” hypotheticals of remote and overlapping jurisdiction.  It was in our minds, a “cert. granted with intent to reverse” waiting to happen.Continue Reading Personal Jurisdiction 2.0

We’d like to apologize to those of you (all 700+) who subscribe to our email feed through the Google Group function.  Somehow, we’re not sure how, the Google Group became separated from our account.  We don’t know when this started, but yesterday we started getting complaints and investigated.  We believe it has now been fixed.

Was anyone else out there struck, like we were, that the Court described the preemptive FDA action it recognized in Pliva, Inc. v. Mensing, ___ U.S. ___, 2011 WL 2472790 (U.S. June 23, 2011), in terms of “equivalence”?  Here’s what we mean:

Under this law [Hatch-Waxman], “generic drugs” can gain FDA approval simply by

We’ve discussed the so-called “Berrier question” – whether the Third Circuit’s prediction that Pennsylvania law would switch to the Third Restatement from the old Azzarello form of super-strict liability should continue to apply – before.  Our position is that stare decisis required application of Berrier, until the Pennsylvania Supreme Court said otherwise, and

With the ink barely dry on the Supreme Court’s recent decision that pharmaceutical detailing is First Amendment protected commercial speech, see Sorrell v. IMS Health Inc., ___ U.S. ___, 2011 WL 2472796, at *8 (U.S. June 23, 2011), the industry is trying again for clarity in the morass that is the FDA’s current regulation

A friend of ours, we’ll call him “Anonymous,” let us know about the recent decision in Forman v. Novartis Pharmaceuticals Corp., ___ F. Supp.2d ___, 2011 WL 2559386 (E.D.N.Y. June 27, 2011).  We reviewed it, and were somewhat taken aback that – after the court in Desiano v. Warner–Lambert & Co., 467 F.3d 85 (2d Cir. 2007), presumed to know more about Michigan law than either the Michigan courts (Taylor v. Smithkline Beecham Corp., 658 N.W.2d 127 (Mich. 2003)) or the Sixth Circuit (Garcia v. Wyeth-Ayerst Laboratories, 385 F.3d 961 (6th Cir. 2004)), with jurisdiction over Michigan – yet another court out of New York now presumes to know New Jersey law better than the New Jersey courts (McDarby v. Merck & Co., 949 A.2d 223 (N.J. App. Div.2008)), and the New Jersey federal courts, which have followed McDarbySee Stanger v. APP Pharmaceuticals, LLC, 2010 WL 4941451, at *4 (D.N.J. Nov. 30, 2010); Baker v. APP Pharmaceuticals, LLC, 2010 WL 4941454, at *4 (D.N.J. Nov. 30, 2010); Haggerty v. Novartis Pharmaceuticals Corp., 2009 WL 5064779, at *4 n.4 (D.N.J. Dec. 15, 2009).
We made that point to our friend.
His response?
“Hey, its New York!  You’re looking for humility?”
We wouldn’t dream of going that far.  After all, we know more than a few Yankees fans.
We’d just like to see a little comity every now and then.
That would preferable to the current, absurd situation where, in a prescription drug case in Michigan, or in a punitive damages case involving drugs in New Jersey, the plaintiffs lose under those states’ application of the fraud-on-the-FDA preemption rule of Buckman Co. v. Plaintiffs’ Legal Committee, 531 U.S. 341 (2001), to their own law.  But if plaintiffs can somehow wheedle their way into court in New York, then the same claims survive.
We made this last point in our initial discussion of Desiano way back in 2006, where we urged federal courts to “remember federalism” and not construe state causes of action differently from the courts of those states.  With New York courts continuing to boldly go where no courts have gone before (or since), and forum-shopping plaintiffs following them, we think it’s time to review this issue.
First, Buckman (with the caveat that Bexis’ role in that case gives us more than the usual defense interest in its correct application).Continue Reading No Stand Up Comity In New York

The new case, Williams v. Mast Biosurgery USA Inc., ___ F.3d ___, 2011 WL 2566426 (11th Cir. June 30, 2011), raises two fascinating issues, but we only offer our opinions about one of them. The facts in Williams are unfortunate, as is true with most of the cases we handle.
The plaintiff, a young lady, was being evaluated for possible infertility.  Her treating gynecologist (doctor #1) found an ovarian cyst and drained it.  During that procedure, he also found “significant dense adhesions that had resulted from a prior surgery some years before,” 2011 WL 2566426, at *1 – surgery that, oddly in our view, was not further described or discussed.
More on that later.
More significant surgery, to remove these adhesions, soon followed.  To prevent adhesions from recurring, doctor #1 inserted the medical device in question, a “bioresorbable” (that is, designed to break down and gradually be destroyed by the body’s biological processes) barrier manufactured by the defendant.
Anyway, since we’re describing a product liability suit, things necessarily went awry.  Within a month after this surgery, the plaintiff returned, in bad shape.  A colonoscopy (performed by doctor #2 in a different medical specialty) revealed “several stiff, hard and brittle pieces of plastic” perforating the plaintiff’s colon.  Id.  This required a second surgery – by a doctor #3 – which “cleaned out” the material and a significant accompanying infection.  Doctor #3 “suspected” the material was from the barrier that had been implanted in the second surgery.
A pathologist (doctor #4), also examined the material.  He echoed doctor #3’s suspicions, but his testimony turned out to be incompetently based solely on a product label he had been given.Continue Reading Of Treating Physicians And Manufacturing Defects

Not that we need any, but the recent decision in McFarland v. APP Pharmaceuticals LLC, slip op., 2011 WL 2413797 (W.D. Wash. June 13, 2011), is another reason to like TwIqbal.
The wife plaintiff was administered an anticoagulant drug and, lo and behold, her “platelet counts dropped dramatically.”  2011 WL 2413797, at