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When it comes to design defect claims and FDA pre-market approved (“PMA”) medical devices, “preemption” is our reflexive reaction. That’s entirely reasonable, given the many decisions that preempt state-law design-related claims since Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  We collect then all here.

Nevertheless, there are some judges, particularly (but not…

As our PMA preemption scorecard makes clear, warning claims are preempted under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), because the preemptive language, “different from or in addition to,” precludes plaintiffs from demanding more or different warnings.  Since warning claims are the bread and butter of prescription medical product liability, plaintiffs will try…

In case you haven’t noticed, we like preemption.  We’ve even called ourselves “obsessed” with it.  And with good reason.  Preemption, where it’s available, is the most powerful defense around – capable of wiping out an entire MDL with a single motion to dismiss.  Preemption is not dependent on the strength of a plaintiff’s underlying case.  It doesn’t matter how solid medical causation might be, or how much the prescribing physician has (or has not) been suborned during ex parte chats with the other side.  If preemption applies, than it’s bye-bye claim, and often bye-bye plaintiff.  No discovery necessary.

Thus, it’s not surprising that plaintiffs’ lawyers fight preemption tooth and nail.  That’s their job.  They are just as ethically bound to represent their clients zealously within the boundaries of the law as we are.  Thus they pick every preemption nit they can find.

That’s what we’re on about today.  We’re discussing some recent decisions that address some lesser-known – but equally deadly − preemption arguments.Continue Reading Preemption 201 – Recent Cases Raising Specialized Issues

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

OK, we made that up.  It is not true at all.  A complete lie, much like “The Dallas Cowboys are America’s Team.”  Or “Eating turkey makes you sleepy because of its high tryptophan content.”  Or “The pilgrims left England because of their desire to wear stylish hats.”  Or “Lawyer advertising for drug and device cases serves an important role in improving medical care.”  If you did your duty as an American yesterday and gorged yourself on an assortment of turkey, stuffing, tubers, cranberry compotes, pie, and football, then you may be feeling somewhat bloated today.  You have many options to address that feeling, including taking a walk outside before returning to leftovers and more football.  Reading this post about a recent express preemption decision will not help with indigestion, but it should not hurt either.

The opinion in Hesik v. Boston Scientific Corp., No. 1:12-cv-00014-JMC, 2014 U.S. Dist. LEXIS 156563 (D.S.C. Nov. 4, 2014), carved up the product liability claims asserted in connection with a Class III device, specifically a cardiac defibrillator.  As our readers know, the Medical Device Amendments of 1976 served up express preemption for Class III devices—basically, those approved though a Pre-Market Application—as to state law requirements that are “different from, or in addition to” the FDA requirements.  21 U.S.C. §360k(a).  This has been interpreted by the Supreme Court to bar product liability actions premised on claims that do not impose “parallel” duties on manufacturers.  Riegel v. Medtronic, Inc., 552 U.S. 312 (2008); our numerous posts on the subject.    A parallel claim is a “narrow exception to the rule of preemption” into which some courts strain to stuff plaintiff’s claims.  We sometime post on how it grinds us that courts, particularly federal courts sitting in diversity, extend existing state law to allow a claim that would be predicted on non-compliance with an FDA requirement such that imposing liability would not add to the federal requirements on the manufacturer.  Like here.

We do not have that situation in Hesik, which (drum)sticks with South Carolina law as is.  We do have a few twists on the typical arguments we see in cases like this, including that plaintiff had the giblets to move for summary judgment himself.Continue Reading Nothing Helps With Post-Thanksgiving Indigestion Quite Like A Heaping Helping Of Express Preemption

This is from the Dechert side of the blog only.

Last week we gave you a lot of Medtronic decisions to mull over and to mostly be happy about.  And, like we mentioned, Medtronic is no stranger to preemption issues.  So, when we found yet another new Medtronic favorable device preemption case, at first we thought we might add it to one of our scorecards or cheat sheets and call it a day.  But, this is a win in a Ninth Circuit court and after Stengel, that can’t go overlooked. But, we’ll keep it short and simple nonetheless.

The case is Suckow v. Medtronic, Inc., No. 2:12-cv-01870-GMN-CWH, slip op. (D. Nev. Sept. 20, 2013) and it involves a pacemaker manufactured by Medtronic that was implanted in plaintiff in 2006.  Plaintiff had to have the device removed on an emergent basis in December 2010 and alleges she suffered injuries as a result of the removal surgery.  In addition to strict liability and breach of express warranty claims against Medtronic, plaintiff also brought negligence and misrepresentation claims against a Medtronic sales representative alleging that a few months before the removal, he evaluated the device and found it was operating normally and was fit and safe for continued use.  Slip op. at 2.Medtronic removed the case to federal court and argued that the sales representative was improperly joined.

Medtronic challenged the plaintiff’s claims against the sales representative on two grounds.  First, the sales rep had no contact with the plaintiff before December 2010.  Second, if the sales rep evaluated the device, it was at the request of the physician and it is the physician who “interprets any data and makes decisions.”  Id.  at 6.  While plaintiff argued that her claims against the sales rep weren’t preempted, she apparently neglected to address any of the arguments on fraudulent joinder.  Id.  So, it really was a no-brainer for the court to uphold removal and move on to decide Medtronic’s preemption motion.

But, we just want to take a minute to remind our readers that there are more substantive decisions out there about the risks of liability from the involvement of sales reps in the care and treatment of patients.  See our post here.  In Suckow, while the court didn’t have to reach it, it looks like defendants had a strong learned intermediary defense because the sales rep’s role was limited to the evaluation of the performance of the device, not in rendering advice, opinions, or direct care to the plaintiff.Continue Reading Another Notch on Medtronic’s Preemption Belt

We’ve just been informed of Phillips v. Medtronic, Inc., SUCV2009-05286-A, slip op. (Mass. Super. July 10, 2012), granting a preemption motion under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), in a case involving a pain pump (it’s over a week old, so it’s only “new” by non-blogging standards).  Unlike many pain pump cases,…

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