January 2015

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This post is from the non-Reed Smith side of the blog.

Not that long ago we alluded to the idea that blogging about decisions throwing out PMA medical device claims on the basis of preemption under Riegel can be a little tedious. Every once and a while plaintiffs take a new pass at getting around medical device preemption, but in our experience most of those have turned out to be Hail Mary hurls that don’t make it into the end zone.  So, there are many routine PMA preemption decisions that simply find a home on our preemption scorecard but don’t have that something else that drives us to start tapping out a full post.  And Rodriguez v. American Medical Systems, Inc., 2014 U.S. App. LEXIS 24631 (5th Cir. Dec. 31, 2014) would be just such a case but for two things:  1) it is a circuit court decision and 2) it recognizes the extension of Riegel preemption to medical devices approved via the product development protocol (PDP) process, 21 U.S.C. §360e(f).

We blogged here about the district court decision in Rodriguez noting that it was one of very few cases to deal with the FDA’s PDP process.  PDP is a method of premarket approval where a device’s clinical evaluation and the development of information for marketing approval are merged into one process.  Indeed, we searched back through the blog ourselves and found only a handful of district court cases involving PDP products.  What we didn’t find were any circuit court decisions.  Now that doesn’t mean they don’t exist, but this appears to be the first one to hit our radar.  And, if the Fifth Circuit is the first federal appellate court to decide the issue, we are happy to report that they got it correct.Continue Reading Product Development Protocol (PDP) Preemption Recognized by Fifth Circuit

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It’s been a little slow over the holidays so we’ll go back to something that happened last year.  On December 16, 2014 – almost three whole weeks ago – the Solicitor General filed his brief responding the Supreme Court’s request for the government’s views in the case called Teva Pharmaceuticals USA, Inc., v. Superior Court Of California, Orange County, No. 13-956.  Here’s a link to the case’s SCOTUSBlog page.  The prior published opinion in this case, Teva Pharmaceuticals USA, Inc. v. Superior Court, 158 Cal. Rptr.3d 150 (Cal. App. 2013) (which we’ll call “Pikerie” because that’s the plaintiff’s name), involved preemption in the generic drug context.  Here’s our description of Pikerie from the blog’s generic preemption scorecard:

Overruling of demurrer affirmed.  A duty to update claim is not preempted.  It is not impossible to update warnings that the FDA has ordered changed, it is required. Following Fulgenzi.  A “Dear Doctor” letter claim is not preempted, to the extent that the communication followed FDA-approved updates in the labeling.

Long-time readers might recall that the last time the SG’s office was invited to weigh on the FDCA and preemption of product liability litigation, in the Stengel case, it produced a ridiculously cramped version of PMA preemption that sought to emasculate Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and would have allowed virtually every claim to escape preemption.  We reported on that here.  Equally bizarrely, after explicitly stating that “every” court of appeals since Riegel had (in his view) gotten Riegel wrong, the SG in Stengel nonetheless recommended that certiorari be denied – hardly the a position taken by a litigant confident that the Court would agree with its position.

Then we have the FDA trying to amend the FDCA administratively to eliminate generic drug preemption altogether, which we have discussed on
several occasions.

Thus, we know that this administration is at least as hostile to FDCA-related preemption as the prior administration was supportive. Given that “duty to update” cases are really lousy cases for plaintiffs for a host of reasons unrelated to preemption (that’s why they’ve never been brought before), we’d have to think long and hard before doing something that would give this same crew a chance to take shots as preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  But the generic industry seems to have concluded it’s worth it, and their lawyers aren’t dumb.Continue Reading SG’s Reign of Error Continues

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A belated Happy New Year to you, and we’ll say it softly just in case your head still hurts.  That is not an issue for us, as we greeted 2015 in Kennett Square, watching a giant lit mushroom drop from a crane.  A majestically descending fungus is even better than it sounds.  The drive there and back was pretty long, so we were sober as a judge.  (Sorry to say, we have had a couple of occasions in our career that prompted us to doubt the veracity of that phrase.)  Happy birthday to Dax Shepard, who appeared in that criminally underrated film, Idiocracy.  If you have not already seen Idiocracy, rectify that situation immediately.  You’ll be glad you did … especially after reading today’s post.

January 2 is a date we associate with depression and doltishness.  The holidays are really and truly over – unless, like the Russophile Drug and Device Law Son, you’ve made the smart move to embrace the Eastern Orthodox tradition.  But January 2 is still a date that will live in infamy, if only because on this date in 1974 President Nixon signed the bill capping the speed limit at 55.  We make no apologies for siding with Sammy Hagar in screeching that we “can’t drive 55.”

All of which is to say, here’s a case that makes us think that The Law can be depressing and dumb.   In Beyerle, Jr. v. Wright Medical Technology, Inc., 2014 U.S. Dist. LEXIS 176653 (D.N.J. December 23, 2014), the plaintiff alleged that he had been injured by an orthopedic hip implant that had “inexplicably fractured.”  The plaintiff cited the New Jersey Consumer Fraud Act (CFA) in alleging that the defendant’s advertisements about product safety were lies.Continue Reading Damage to a Product vs. Damage by a Product: Why New Jersey Law Sometimes Makes Our Heads Hurt

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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