Wednesday, February 27, 2013

The Gray View on Device Preemption


As we trudge through these gray days of Winter, we cannot help but think we have made a mistake.   Our calendar and geography are askew.  February in Philly is joyless.  We line up grimly on I-95 or I-76, forming a vast concatenation of complaint.  Expect no kind words from us today.  We see error all around us. 


It does not help that the prior two posts this week have virtually dared today’s writer to join debate on the merits of the recent Academy Awards.  On Monday, Sullivan’s heart ached for the injustices done to Django Unchained.  Yesterday, Yeary heaped praise on the musical numbers.  We have no witty riposte, since we were in midair headed for a hearing whilst the statuettes were doled out (apparently all of the technical sound awards were distributed to the villains from the Die Hard movies).  A viewer of Sunday night’s festivities would be pardoned for thinking that he or she had turned on a time machine, as several of the musical numbers came from Chicago, a Best Picture winner (ha!) from ten years ago.  Naturally, the producers for the Oscars broadcast had been the producers of Chicago.  You see, there are all sorts of ways to attain artistic immortality.  By the way, we despise musicals.  We’d rather fill our ears with tartar sauce than hear someone dream a dream, or refuse to go, or bloviate through an autotuner about the circle of life.  There is a phrase that the Drug and Device Law heirs use that fits pretty well with how we take in musicals:  if we watch them at all, we "hate-watch" them. 


Anyway, it is not as if anybody expects the Academy to get things right.  These are, after all, the folks who chose Dances with Wolves over Goodfellas.  And while we are mentioning a Scorsese masterpiece, let’s consider his career as a little window into Academy ineptitude.  The Academy ignored Mean Streets and Taxi Driver, chose Ordinary People over Raging Bull, and belatedly recognized Scorsese for one of his weaker films (The Departed).  The Hollywood gerontocracy also used another rare Scorsese clunker, The Color of Money, as a vehicle for slinging a Best Actor award to Paul Newman that was only about 20 years overdue.  That’s a pretty terrible batting average.  We even think Jersey courts get expert witness issues right more often than that. 


This year, Error seemed to be the theme of the Academy Awards.  Several films indulged in various levels of bad history.  We all understand that Django Unchained, like Tarantino’s earlier mash-up, Inglorious Basterds, was a counter-historical romp.  It is not meant to be taken seriously.  Rather, it is an exercise in bloody wish fulfillment.  It is okay to get things wrong if you acknowledge that you are getting things wrong.  Ben Affleck was canny in the marketing of Argo, admitting that the dramatic chase scene at the airport never happened.  Reality had to be sacrificed at the altar of drama.  Stamping passports and waving people through would be a little short on suspense.  There shouldn’t have been much suspense in Lincoln.  We all know how it turned out.  (And MacFarlane’s joke about that wasn’t that bad.  Honestly, is 148 years really still ‘too soon’?)  Spielberg and that nutty actor/shoe cobbler pretended to be making the most historically faithful film of the lot, but then why are two nay votes on the 13th Amendment attributed  to representatives from Connecticut, when that never-ever happened?  Look – the writer of Lincoln was Tony Kushner, one of the country’s best.  But when he tries to explain the dramatic necessity of his historical error, it rings hollow.  The actual nay votes were from Illinois – Lincoln’s state!  Isn’t that more dramatic?  Gratuitous mistakes are the worst kind.  Finally, Zero Dark Thirty seems to have had its Oscar chances eliminated by the controversy over its depiction of the role of torture.  We have heard some people call the picture pro-torture and some have called it anti-torture.  Is it possible it is neither?  We get the sense that the people behind the picture were not trying to exploit the torture issue and were trying to report the facts as they understood them – even as the sources for such things are inherently unreliable.  To our mind, Zero Dark Thirty was the victim of character assassination.  But we’ll let it go.  As government screw-uppers have been known to say, mistakes were made. 


Today’s case is another mistake.  In Gray v. Stryker Corp., 2013 U.S. Dist. LEXIS 22848 (S.D. Ind. Feb. 20, 2013), the court rendered a perfectly horrible decision on both TwIqbal and the dreaded “parallel claim” exception to Riegel preemption.  Though the decision is a mistake, it is inevitable, as it is compelled by another mistake, the Seventh Circuit’s execrable decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010).  We have wept over Bausch here and here and several other places.  Where’s a Tarantino counterfactual scenario when you most need one? 


In Gray, the plaintiff brought claims against Stryker for violations of the Indiana Products Liability Act related to the alleged failure of the Trident hip replacement prosthetic device.  So, yes, it is just like Bausch.  Following her hip replacement surgery, the plaintiff began experiencing hip pain and began hearing “squeaking” and “popping” noises while walking.  Ultimately, the Trident device failed, resulting in another hip replacement surgery.  The plaintiff alleged that the Trident device had a defective bearing that was caused by manufacturing problems and poor quality control.  Specifically, … well, there are no specifics.  More about that later.   


Defendants filed a motion to dismiss the Amended Complaint because the plaintiff’s claims were preempted by the Medical Device Amendments.  The district court denied that motion, and hardly seemed to break a sweat in so doing.  Bad law, like Bausch, can sometimes make things easy.  The Gray court applied the parallel claim exception because the causes of action in the Amended Complaint “reference violations of the requirements set forth by the FDA as the cause of the alleged defects, not that the device violated Indiana products liability laws despite compliance with federal regulations and requirements.”  2013 U.S. Dist. LEXIS 22848 at * 11.  Hence, the claim is parallel.  But what claim?  And parallel to what federal requirement?  Shhhhh.   “It is not necessary that Ms. Gray include the specific federal laws or regulations at issue in her Amended Complaint, only that she put the Defendants on notice that her claims are premised upon allegations that some federal law or regulation was violated.”  Id.   There it is.  That’s the Bausch we’ve all come to know and love to hate.  (It turns out that, as with musicals, we hate-watch Bausch and its progeny.)  The parallel claim exception ceases to be an exception; it is an incantation that swallows up the very notion of preemption. 


As in Bausch, the defendant in Gray had the temerity to inquire whether, under United States Supreme Court precedent, the plaintiff might politely be invited to supply some facts.  As in that crazily-wrong Best Picture winner Oliver!, there was a plaintive request:  “Please Sir, may I have some more?’  And as in the movie, the request was greeted with contempt:  “Defendants believe that Ms. Gray should have included in her Amended Complaint facts showing that the problems with her prosthetic device were the result of manufacturing defects and not physician error, how the FDA’s findings relate to the defect that she alleges, and state which specific device components were manufactured inappropriately.”  Id. at *12.  Seems fair, doesn’t it?  Er, no?  Oops.  Sorry.  The court informs us that “this level of specificity is not required to be included in the complaint under the “plausibility” standard applied in Iqbal and Twombly.”  Id.   Well, maybe not in the Seventh Circuit.  Not right now.  Posner and Easterbrook and Wood – why aren't you riding in with Jamie Foxx, doctrinal guns blazing?!  Surely, as in Argo, this is pure suspense conjured up for amusement, right? 


As in Bausch, the Gray court drearily justifies its evisceration of preemption and TwIqbal by recounting how difficult it is for plaintiffs to round up any facts before engaging in what the rules call formal discovery, but what some flinty-eyed folk call extortion:  “Plaintiffs in these medical device defect cases are not expected to plead violations of specific federal laws or product specific information, not only because it is not required under the notice pleading standard of Federal Rule of Civil Procedure 8 (a)(2) but also because plaintiffs often do not have access to product-specific information about the manufacturing of these devices, which are kept confidential by federal law, until they are able to obtain this information through discovery.”  Id. at *12-13.  Again following the dance-steps laid out on the floor by Bausch, the Gray court  rather bizarrely repeats the bromide that “[t]here are no special pleading requirements for product liability claims in general, or for Class III medical device claims in particular.”  Id.  at *13. Who is asking for special pleading requirements?  How about just following the regular, applies-to-all-federal-cases TwIqbal requirements? 


The Gray opinion, like the The Grey movie, offers the opposite of a happy ending.  But we are reminded of the ending of Argo, and that charming little phrase the Hollywood people used whenever they mentioned the title of the faux film. 

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