Search results for: pma preemption scorecard

We’ve blogged repeatedly about preemption in PMA medical device cases.  We’ve also had a lot to say about using TwIqbal (that is Ashcroft v. Iqbal, 129 S.Ct. 1937 (2009), and Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007)) to police plaintiffs’ persistently poor pleading habits.
Today we’re synergizing the two, and looking at what defendants can do when they mix TwIqbal and PMA preemption together.  We’ll tell you this up front – the result is quite to our liking – more like peppermint and egg nog, rather than, say, chocolate and ketchup.
What makes PMA preemption cases so amenable to TwIqbal treatment is that, after Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), PMA cases basically boil down to “parallel” violation claims.  This limitation means that, to plead an unpreempted claim, a plaintiff has to allege something that’s:  (1) a violation of the Food, Drug and Cosmetic Act (“FDCA”), and (2) also a violation of independent state law.  This is also something we’ve discussed at length, for instance here, here, and here.  But we’re not doing doctrine today, we’re doing pleading, so simply accept that legal framework for now.
There are a lot of plaintiffs out there who don’t do their homework. If they’re aware of the Riegel problem at all, they’ll try to fudge things by throwing in a warning letter if they’ve got one.  But a lot of the time, we’ll get a standard, fill-in-the-blanks, form product liability complaint with a PMA device filled in.  That’s not because plaintiffs’ lawyers are any lazier than the rest of us (we don’t think), but more a reflection on how contingent fees affect incentives to do legal spadework.  When time isn’t money, time consuming (not to mention money consuming) things don’t get done.
The standard complaints don’t require very much TwIqbal.  See Lemelle v. Stryker Orthopaedics, 698 F. Supp.2d 668, 678 (W.D. La. 2010) (TwIqballing claim that didn’t mention a violation at all); Yost v. Stryker Corp., 2010 WL 1141586, at *4-5 (M.D. Fla. Mar. 23, 2010) (complaint “only asserts a state law, without reference to a federal violation, [and] is preempted”); McQuiston v. Boston Scientific Corp., 2009 WL 4016120, at *7 (W.D. La. Nov. 19, 2009) (“[a] claim asserting that [defendant] did not comply with FDA specifications simply does not exist in the petition”).  They’re pretty much sitting ducks for Riegel preemption motions because all they allege is garden variety negligence, strict liability, and warranty claims.Continue Reading TwIqbal & PMA Preemption, Perfect Together

One way that some plaintiffs seem to be responding to TwIqbal is simply to make up the facts needed to plead a plausible claim.  That happened in Cornwell v. Stryker Corp., 2010 U.S. Dist. Lexis 116824 (D. Idaho Nov. 1, 2010).  Cornwell involved a PMA medical device (a total hip implant), so obviously preemption…

Sometimes we discus broad issues, like TwIqbal; sometimes we don’t. Today we’re not.
While we don’t claim to know much about the specifics, we’re aware that the FDA is going (or maybe already has) to lower the classification of percutaneous transluminal coronary angioplasty (that mouthful is thankfully abbreviated “PTCA”) catheters from Class III to…

Two recent cases, one good and the other not, have us thinking about the presumption against preemption in the context of “parallel” claims – that would be medical device preemption – and allegations of fraud on the FDA, which could be either.  We think it would be a good idea for defense counsel to review…

One of the things we really like about blogging is that it puts us in touch with smart defense lawyers all over the country.  Sometimes, when we know who’s litigating certain issues in particular mass torts, well give him/her a call to check if s/he knows anything new on that point.  Other times, somebody will…

Not too long ago, the Sixth Circuit – in an unpublished opinion in a below-the-radar case – held that a PMA medical device plaintiff had successfully threaded the preemption needle in Howard v. Sulzer Orthopedics, Inc., ___ Fed. Appx. ___, 2010 U.S. App. Lexis 12290, slip op. (6th Cir. June 16, 2010) (it’s also in our device preemption scorecard).  The one claim that the court held survived summary judgment was a negligence per se claim in the nature of a manufacturing defect claim based upon an FDA Good Manufacturing Practices regulation that the court admitted could be read two different ways.  Slip op. at 8 (“The provision, as we say and as the dissent illustrates, can reasonably be read either way”).  Based on some language it found in FDA “comments” and guidance documents, the court concluded that the plaintiff was interpreting the regulation in a way consistent with the FDA’s reading, and thus held that the regulatory-based claim survived preemption.  Id. at 7-8.
We don’t know enough about either the device or the regulatory history of the particular section that the plaintiff in Howard hung his hat on to say anything particularly useful.
What we’re interested in is where a defendant goes from here.  We were all set to pummel the defendant for ignoring the state-law based defenses to negligence per se that we’ve pontificated about at length when we noticed this in the Sixth Circuit’s opinion:

We also leave it to the district court to consider [the defendant’s] alternative ground for summary judgment: namely, whether Oklahoma law recognizes a negligence per se action based on violations of FDA regulations. All that we decide today, rather, is that [plaintiff’s] negligence per se claim for GMP violations is not preempted.

Slip op. at 9.  So it wasn’t the defendant’s fault.  If it was anyone’s, blame the court for reaching a constitutional issue when there were non-constitutional grounds available.Continue Reading PMA and Negligence Per Se Post Preemption – Then What?

In Heisner v. Genzyme, No. 08-C-593, 2009 U.S. Dist. LEXIS 37322 (N.D. Ill. Apr. 30, 2009), Heisner allegedly died as a result of an allergic reaction to Seprafilm, an anti-adhesive surgical barrier implanted in her body during a surgery. Seprafilm is a Class III medical device approved by the FDA through the premarket approval process.…

We’ve decided to blog on a less depressing preemption subject than Wyeth v. Levine today. We’ve seen a couple of recent medical device preemption cases that just about bookend the field. In Hofts v. Howmedica Osteonics Corp., 2009 WL 331470 (S.D. Ind. Jan. 12, 2009), the court found just about as little preemption (and…

It was probably inevitable, but our drug preemption scorecard has prompted some folks who must be gluttons for punishment to request a similar rundown of how medical device preemption has been faring lately. Since we’re always looking for things to blog about (and because of the identity of some of the people asking us) we’re…

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