Thursday, January 24, 2013

Positive PMA Preemption Pronouncements

            We are so used to favorable PMA preemption rulings, that previously we may have just added these next two cases to our regular tallies and moved on.  In light of Stengel, however, we decided to accentuate the positive.  While we can’t eliminate the negative (well at least not immediately), we can certainly latch on to the affirmative. . . . OK, either you know where we are going with this or you don’t -- if you don’t here’s a link to catch you up.    While you watch that, we’ll move on to the cases.
            First came Sons v. Medtronic Inc., __ F. Supp.2d __, 2013 WL 164007 (W.D. La. Jan. 14, 2013); then a day later – Desai v. Sorin CRM USA, Inc., 2013 U.S. Dist. LEXIS 5795 (D.N.J. Jan. 15, 2013).  Both decisions dismiss plaintiffs’ claims in their entirety based on express preemption.  And we were sure happy to read the good news.  In short, both cases involved Class III medical devices that went through the pre-market approval process.  In both cases defendants filed motions to dismiss and plaintiffs attempted to save their claims with amended complaints.  Neither plaintiffs’ arguments or amendments were enough to survive the combination of TwIqbal  and Riegel. 
            Another similarity between the cases is that both New Jersey and Louisiana have products liability statutes.  The New Jersey Products Liability Act (“NJPLA”) and the Louisiana Products Liability Act (“LPLA”) provide the exclusive theories of liability for injuries resulting from products in those states.  Thus, plaintiffs in these cases were constrained in the claims they could bring.  Likewise, the courts here weren’t free to accept new theories of liability created by plaintiffs in an attempt to state a non-preempted parallel violation claim.  For instance, in Sons, the court had this to say about Louisiana law:
Even if plaintiff could rely on the theories of negligence and strict liability to prove his case, it is well-established that the LPLA establishes the exclusive theories of liability for manufacturers for damages caused by their products and state law claims are therefore barred under Louisiana law.  Louisiana does not recognize any claim for violations of FDA regulations. The only remedies available to plaintiffs in this case are provided in the LPLA.

Sons, at *6 (citations and quotation marks omitted).  The Desai court similarly recognized that any claims under the NJPLA would be preempted:
Plaintiffs would only be able to prevail on the New Jersey PLA claims if they proved that the lead wire, as designed, manufactured, and distributed, was defective and unreasonably dangerous. It follows that liability would necessitate a finding that the lead wire - designed, manufactured, and labeled in a way that the FDA deemed safe and effective - was both defective and unreasonably dangerous. Such a determination would necessarily constitute a requirement different from, or in addition to, the standard required by federal authorities.

Desai at *13. 
            The New Jersey court, however, went on to examine plaintiff’s proposed amended complaint which purported to include “claims of an alleged deviation from the federal requirements for Class III lead wires.”  Id. at *15.  But, that’s essentially all the amended complaint said and under TwIqbal – that’s simply not enough.  First, we should note that plaintiffs appear to be trying to assert a manufacturing defect claim and this is the one parallel violation claim that we have acknowledged may be possible -- a violation of an FDA manufacturing regulation that resulted in the production of a device that did not meet the manufacturer’s standards could state a “parallel” violation claim for manufacturing defect if that nonconforming aspect of the device was also responsible for the plaintiff’s injuries.   That said, such an allegation still has to meet federal pleading standards to overcome a motion to dismiss. Plaintiff’s proposed amended complaint did not:  “These allegations fail to assert the facts necessary, or indeed, any facts at all, to establish a claim that would parallel a violation of federal law, or even meet the federal pleading standard.”  Id. at *16.  The amended complaint also failed on causation:  “Plaintiffs also consistently fail to allege any ‘cognizable link’ between [Defendant’s] alleged federal violations and Mr. Desai’s injury.”  Id. at *17.
            Plaintiff’s response to the court finding his complaint lacking was in essence a request that the “unspecified” violations be considered a placeholder, that plaintiff be allowed to conduct discovery, and “fill in the blanks” later.  Really, we couldn’t make this stuff up.  Not surprisingly, the court had this to say about plaintiff’s suggestion to completely toss out the Federal Rules and TwIqbal:
But a plaintiff must successfully plead a claim before obtaining discovery, and not the other way around. Such a premature request for discovery is inapposite to Rules 8 and 11(b) of the Federal Rules of Civil Procedure.
. . .
Although courts have acknowledged that plaintiffs might have limited access to crucial information, this Court's research suggests that no courts have let cases enter discovery based on the type of generalized allegations that are present here.

Id. at *18-19, 21 (emphasis added) (decision has many useful citations should you be faced with this argument in one of your cases).  We consider this a nice little bonus on top of the preemption win.
            The Louisiana decision likewise gave us another favorable ruling on top of preemption.  In Sons, plaintiff tried to make a claim for failure to train or educate the surgeons and hospital staff.   Sons, 2013 WL 164007 at *6.  The court cites to a Fifth Circuit case finding such failure to train claims preempted.  But, even if not preempted, the court found such claims can’t survive:
It is well established that a medical device manufacturer is not responsible for the practice of medicine. . . . [i]t is both impractical and unrealistic to expect . . .  manufacturers to police individual operating rooms to determine which doctors adequately supervise their surgical teams. 

Id. (citations and quotation marks omitted). 
            Finally, of note in both cases, the courts took judicial notice of PMA information on the FDA website.  Desai, 2013 U.S. Dist. LEXIS 5795 at *10 (“This Court takes judicial notice of the FDA’s website, and holds that it establishes premarket approval of the Biotronik lead.”); Sons, 2013 WL  164007 at *4 (“The Court takes judicial notice of the FDA Websites stating that the Medtronic Devices are Class III PMA medical devices”). 
            So, while these decisions don’t erase Stengel, they provide some counter-balance and some reassuring positivity.

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