Today we have a guest post from Reed Smith‘s Elizabeth Minerd discussing a PMA preemption case dealing with unusual “parallel claim” allegations involving the conduct of clinical trials.  As always our guest posters are 100% responsible for what they write and deserve 100% of the credit (and any blame) for what follows.  Take it away Liz.

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Ever since Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), in cases involving premarket-approved (“PMA”) devices, plaintiffs have taken to loading their complaints with allegations of violations of federal requirements in an attempt to escape federal preemption.  Fortunately, many courts have demonstrated a willingness to sort through these allegations and throw out those that do not fit through the oft-cited “narrow gap” between express and implied preemption described in In re Medtronic, Inc., Sprint Fidelis Leads Products Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010).  See the blog’s PMA preemption scorecard.  In Gravitt v. Mentor Worldwide, LLC, 2018 U.S. Dist. LEXIS 4822 (N.D. Ill. Jan. 11, 2018), the Northern District of Illinois once again did just that.

In Gravitt, the plaintiffs alleged that the wife plaintiff was implanted with a premarket-approved silicone breast implant (in the wake of the Breast Implant mass tort of the 20th century, such implants were required to obtain PMA, and are now protected by preemption). Id. at *8-9.  The plaintiffs asserted the usual claims against the defendant manufacturer: negligence, strict products liability (manufacturing and marketing), strict products liability (failure to warn), and loss of consortium. Id. at *10.

Obviously anticipating a preemption motion, the plaintiffs packed their complaint with allegations of violations of federal requirements—including novel theories attacking the defendant’s conduct of certain post-approval studies and patient follow-up required by the FDA’s PMA letter. Id. at *4-*6.  According to the plaintiffs, the defendant’s conduct was deficient because:

  1. Participant follow-up in one study supporting the PMA application was 6 years, instead of 10;
  2. Participant follow-up in the same study supporting the PMA application was less than 100%;
  3. A post-approval study did not have a sufficient number of participants;
  4. Participant follow-up in that post-approval study was not high enough; and
  5. The defendant did not provide sufficient detail about why study participants required additional surgical intervention.

Id. at *4-*6.

The court methodically addressed each of these alleged deficiencies to determine whether any fit through the “narrow gap” between express and implied preemption. Unfortunately for the plaintiffs, fortunately for the defense, none did.  Thus, defendants achieved a rare preemption win in a court bound by the notoriously bad decision, Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010).

First, the court analyzed each deficiency through the lens of express preemption—i.e., asking, “did this alleged deficiency actually violate a federal requirement?”  The court found that the first three deficiencies (if true) would violate specific requirements enumerated in the PMA letter. Gravitt, 2018 U.S. Dist. LEXIS 4822, at *21-*22.  However, the court found no federal requirement addressing the last two purported deficiencies because “the [PMA] letter does not require any particular follow-up rate for that study” and the plaintiffs did not even allege “that the [PMA] letter or any other federal law required [defendant] to provide more detailed reasons for re-operation than it actually provided.” Id. at *18-*19.  Thus, items 4 and 5 were expressly preempted.

Second, the court analyzed the three remaining deficiencies through the lens of implied preemption—i.e., asking “did this alleged deficiency violate a traditional tort duty under Illinois law?”  Here, the court answered “no” for every one of the remaining purported deficiencies, rendering them impliedly preempted.  The court reasoned that there was no “well-recognized duty owed to [the plaintiffs] under state law” requiring the defendant to follow up with study participants for 6 instead of 10 years, follow-up with all study participants, or enroll a specific number of study participants. Id. at *24-*25 (quoting Bausch, 630 F.3d at 558).  More generally, there simply are no state law requirements relating in any way to the methodology of FDA-mandated post-approval studies. Gravitt, 2018 U.S. Dist. LEXIS 4822, at *25.  Further, the plaintiffs made no effort to analogize these alleged deficiencies to any traditional state law failure to warn claim. Id.  Accordingly, the court dismissed plaintiffs’ novel claims based on alleged deficiencies in post-approval studies, id., creating valuable precedent in case any other plaintiff tries this type of preemption dodge.

Apart from the alleged deficiencies in the post-approval studies, the plaintiffs also alleged that the defendant had violated manufacturing standards based on allegations that the FDA had cited the defendant for non-compliance with manufacturing standards several times. Id. at *7-*8.  While the court recognized that, under Bausch, such a claim might survive express preemption (id. at *22), the court dismissed this theory as impliedly preempted because the plaintiffs failed to tie the alleged non-compliance with manufacturing standards to any state law claim that her specific device was defectively manufactured. Id. at *26.

The court did allow one narrow Stengel-type (failure to report) claim to survive based on the plaintiffs’ allegations that the defendant was aware of a higher rate of implant ruptures than it reported to the FDA. Id. at *27-*28.  The court reasoned that, were the plaintiffs to prove that the defendant concealed the true rate of implant ruptures from the FDA in violation of federal law, then the defendant “may have breached its state law duty to warn potential customers—and their physicians—of the product’s risks.” Id. at *31.

Overall, a solid win for the defense that significantly narrowed the scope of the plaintiffs’ claims going forward.