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Back in December we blogged about a medical device case that was dismissed for failure to state a claim – it involved a voluntarily recalled heart pump (which is a Class III medical device that received premarket approval).  At that time, the court found plaintiff’s claims preempted by Buckman v. Plaintiff’s Legal Committee, 531 U.S. 341 (2001) (fraud-on-the-FDA preempted) and Riegel v. Medtronic, Inc., 522 U.S. 312 (2008) (§360k of Medical Device Amendments expressly preempts claims against manufacturers of Class III medical devices).  However, the court afforded plaintiff an opportunity to amend her complaint to see if she could state a parallel state law claim of the type found not preempted by Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011).  Guess what – according to the court, she did.
We have not hidden our dislike for Hughes (here) and we are not overly fond of Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) (here) – and therefore, are not particularly enamored of the Fifth Circuit’s track record on PMA preemption.  Both of those decisions push open wider the door the Supreme Court left slightly ajar in Riegel – allowing a state law claim “premised on a violation of FDA regulations” as “parallel” to rather than in addition to federal requirements.  Riegel, 552 U.S. at 330.  Both of those cases involved allegations of failure to comply with “generally applicable” FDA regulations – incident-reporting regulations in Hughes  and quality-control regulations in Bass.  And, so for her second bite at the apple, plaintiff in Bush v. Thoratec Corp., 2012 U.S. Dist. LEXIS 89685 (E.D. La. June 27, 2012), found her own “generally-applicable” regulation and alleged it as the basis for her state law failure to warn claim.
Now, on a positive note, we have to acknowledge a fairly thorough analysis by the court of whether there is a parallel state law claim.  Unfortunately, we don’t agree with the result.  Under Louisiana law, a manufacturer has a post-sale duty to warn “of a characteristic of the product that may cause damage and the danger of such characteristic.”  La. Rev. Stat. §9:2800.57(C).  So plaintiff needed to find a “federal hook on which to hang the parallel state law failure-to-warn claim.”  Bush, 2012 U.S. Dist. LEXIS 89685 at *14.  Her “hook” was 21 U.S.C. §7.49 – “guidelines” for medical device recall notices (remember, we said the product was voluntarily recalled).  Guidelines?  Can “guidelines” really be the basis for a claim of violation of federal law?  Aren’t guidelines by definition not “requirements”?  Don’t guidelines offer non-specific guidance without establishing any hard and fast rules?  No definitions?  No parameters?  So, how exactly do you violate a “guideline”?  And, who’s to say a jury’s interpretation of a guideline wouldn’t be more stringent than the FDA’s interpretation – making the claim no longer parallel?  These were the types of questions/arguments raised by the defendant in Bush.  We don’t find the court’s answers particularly satisfying.
First, a quick look at some of the language in the recall notice guidelines.  Section 7.49 says a recall notice “should be commensurate with the hazard of the product being recalled.” Boy, that’s loaded with subjectivity.  The content “guidelines” provide:  a recall notice should be “brief and to the point;” “clearly identify the product;” “explain concisely the reason for the recall and the hazard involved;” and “provide specific instructions on what should be done with . . . recalled products.”  Bush at *15.  And, the recall guidelines themselves provide that §7.49 “recognize[s] the voluntary nature of recall by providing guidance.”  Id. at *21 (emphasis in original).
Defendant posed several arguments why the guidelines could not form the basis for a parallel violation claim:

  • The guidelines are vague, imprecise and do not “define the parameters of what constitute specific instructions in a recall notice” and therefore “there is no specific requirement to be violated, and any requirement imposed by state tort law would necessarily be a preempted additional requirement inconsistent with federal regulation.”  Id. at *17-18 (quotation marks omitted).  The court even agreed that §7.49’s guidelines are “more general than” the reporting requirements or quality-control standards allegedly violated in Hughes and BassId. at *18.  But apparently not general enough.
  • The guidelines are not mandatory and “therefore, a state tort claim enforcing those standards would be different from or in addition to federal requirements.”  Id. at 21.  How do you violate something that is voluntary?
  • The content allegedly missing from the recall notice “goes beyond the § 7.49 guidelines, rendering Plaintiff’s state claim not genuinely equivalent or parallel to the corresponding federal violation.”  Id. at *22.  Again, we’re not sure what §7.49 really requires, so any finding that the notice was deficient strikes us as an additional federal requirement.

Despite these, in our opinion, valid arguments, the court summed up the issue this way:

Thus, Louisiana law requires a manufacturer to give post-sale “adequate warning” of a potentially dangerous and damaging characteristic of a product . . . Federal law dictates that recall notices should be “commensurate with the hazard of the product being recalled,” and should be drafted in accordance with “guidelines” to include “the reason for the recall and the hazard involved” and “specific instructions on what should be done with respect to the recalled products.” Putting the two together, Plaintiff argues that Defendant violated § 7.49 by failing to include sufficiently specific instructions or a more emphatic description of the risks to the [medical device], and that the violation of that federal requirement is remediable through a state failure-to-warn claim.

Id. at *16.  And the court found that that was enough to get by a motion to dismiss.  Where we take some solace is in the court’s recognition that while plaintiff has done enough for now, defendant’s arguments might hold more water at the summary judgment stage.  See id. at *23-24 (“the meaning of § 7.49 may be more thoroughly explored in a motion for summary judgment, and it is entirely possible that Plaintiff’s claim will be defeated at that stage.).  So, we’ll be on the lookout for our second bite at the apple and hoping for a sweeter result.