Today’s guest post is by Aggie Lee of Tucker Ellis, about a PMA preemption win that she briefed in California. The medical device is a hemostatic matrix, which is unusual, and this type of device isn’t usually targeted in product liability litigation. As is always the case, our guest posters are 100% responsible for their submissions, so Aggie deserves all the credit (and any blame) for what follows.
Judge Gonzalo P. Curiel in the Southern District of California has been in the national spotlight since then-candidate Donald Trump questioned his impartiality in the then-pending Trump University lawsuits. While now-President Trump might not number among his admirers, we like Judge Curiel’s recent contribution to Premarket Approval (PMA) preemption, where he recently dismissed with prejudice all of plaintiffs’ claims in Weaver v. Ethicon, Inc., No. 16CV257-GPC(BGS), 2017 WL 680725 (S.D. Cal. Feb. 21, 2017).
But it took a long time and many motions to get there, specifically four complaints, one personal jurisdiction-based motion to dismiss, and three preemption-based motions to dismiss. Defendant Ethicon, Inc., finally prevailed when the Court dismissed Plaintiffs’ Third Amended Complaint with prejudice.
The Surgiflo Hemostatic Matrix Kit is a hemostatic agent distributed by Ethicon, Inc. It is used during surgery to aid in stopping the flow of bleeding when controlling bleeding through conventional methods is ineffective or impractical. The complaint alleged that the Surgiflo used during Ms. Weaver’s sinus surgery failed to absorb into the surrounding tissue as it was designed to do, which necessitated another surgery two weeks later, and caused headaches, neuralgia, nasal pain, and other injuries. 2017 WL 680725, at *2.
Surgiflo is also a Class III medical device, obtaining FDA approval through the PMA process. Once Plaintiffs understood that PMA preemption was at play, they really, really tried to allege a parallel claim, but without supporting facts or, indeed, a clearly stated theory of liability. The Court granted Ethicon’s previous motions to dismiss, noting the claims were preempted. But sympathetic to the predicament that plaintiffs claim they face when much of the information regarding the PMA approval process is confidential and in the manufacturer’s control, the Court granted leave to amend with clear direction (on at least two separate occasions) to Plaintiffs on what would and would not constitute a valid parallel claim.
In spite of all the Court’s repeated hints, guidance, and suggestions, in the end, Plaintiffs could not cobble together the facts they had to allege to rescue their claims. First, Plaintiffs attempted to tie two prior recalls to Ms. Weaver’s product to salvage a manufacturing claim, but Ethicon pointed out (and the Court agreed) that there was no evidence that Ms. Weaver even received a recalled and expired lot, especially since any such recalled lots expired more than a year before Ms. Weaver’s 2014 procedure. 2017 WL 680725, at *5. As the Court stated flatly, “Plaintiffs’ theory requires the Court to make inferences and assumptions that are not reasonable and not supported by the facts.” Id. Second, the failure to warn claim (i.e., failure to submit adverse event reports to the FDA—which the Ninth Circuit views as “parallel” to a state-law inadequate warning claim) was based on: (1) a 2010 adverse event (four years prior to the surgery here); and (2) the alleged failure to report Ms. Weaver’s own injury. But, the Court explained, a solitary adverse event would not have been enough to put Ethicon on notice, and any failure to report Ms. Weaver’s own injuries could not possibly have caused Ms. Weaver’s injuries. Id. at *8.
The Weaver opinion is one more illustration of why the tightened pleading standards following Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662, 678 (2009), are critical in “parallel claim” preemption cases. The importance of pleading causation cannot be overestimated, as this element often defeats otherwise arguably unpreempted claims. Recall-based claims must match the product actually used by the plaintiff. Failure to report claims must involve enough reports, and occur at a time, that could conceivably make a difference.