We have made it no secret that we think the Ninth Circuit wrongly decided Stengel v. Medtronic. That is the case where the Ninth Circuit reversed express preemption of claims involving a pre-market approved medical device by divining a “parallel” state-law duty to report adverse events to the FDA. As we have said here and here (and other places), we are not convinced that such a duty even exists. That is why we liked the district court’s order from last year dismissing the Complaint in Ebrahimi v. Mentor Worldwide LLC, mainly because the district court emphasized another befuddling aspect of Stengel: How on Earth can a plaintiff plead and prove that a purported failure to report adverse events to the FDA caused him or her any injury?
The plaintiff in Ebrahimi could not allege causation last year, and despite multiple opportunities to amend, she still can’t, resulting in another order granting another motion to dismiss. The order is Ebrahimi v. Mentor Worldwide LLC, No. 16-cv-7316 (C.D. Cal. May 25, 2018) (you can view the order here), and the pleading at issue was the Second Amended Complaint. The plaintiff again alleged injuries resulting from treatment with silicone-gel breast implants, and as in the initial Complaint, she alleged two failure-to-warn theories: (1) The defendant allegedly failed to report “adverse events” to the FDA, and (2) the defendant allegedly failed adequately to warn patients and doctors. Id. at 3.
But neither of those theories stated a parallel claim sufficient to avoid express preemption. The Medical Device Amendments expressly preempt any state-law requirement that is “different from or in addition to” any federal requirement related to safety or effectiveness. See 21 U.S.C. § 360k(a). Under the much-misunderstood “parallel claim” exception, a plaintiff can sometimes plead a non-preempted state-law claim if the asserted state law duty “parallels” the federal requirement. Theoretically, that claim would not be “different from or in addition to” federal requirements.
The alleged failure adequately to warn doctors and patient was clearly preempted. Imposing a state-law duty to warn that is different from what federal law requires runs headlong into the Medical Device Amendments’ express preemption provision. That is Riegel v. Medtronic to a tee.
As for the alleged failure to report adverse events to the FDA, that was not an actionable “parallel claim.” As the district court observed, “To state a parallel claim under California law, Ebrahimi ‘will ultimately have to prove that if [the manufacturer] had properly reported the adverse event to the FDA as required under federal law, that information would have reached [her] doctors in time to prevent [her] injuries.’” Id. at 3 (quoting Stengel v. Medtronic, Inc., 704 F.3d 1224, 1234 (9th Cir. 2013)).
Of course, this gloss on a parallel claim assumes that a state-law claim for failure to report claim to the FDA actually exists, and we don’t think one does. But setting aside that fundamental disagreement, this district court has again correctly zeroed in on causation as essential to pleading a claim based on an alleged failure to report adverse events. This plaintiff failed for two reasons. First, the “adverse events” that she alleged were not “events” at all. Plaintiff alleged “potential statistical issues” with six post-approval studies, but none of those “issues” was an “ailment or injury resulting from gel bleed.” Id. at 3-4. Second, and we think more importantly, the plaintiff failed to allege a “causal nexus” between her injuries and the manufacturer’s alleged failure to report:
In particular, she does not allege any specific facts showing that had [the manufacturer] not “covered up” these purported adverse events, the FDA would have required [the manufacturer] to modify its labeling and marketing materials or otherwise warn patients and doctors that “significant gel bleed was a potential risk. . . .” Therefore, Ebrahimi’s failure-to-warn claim cannot escape express preemption because she has not shown that [the manufacturer’s] failure to report adverse events to the FDA resulted in her injury
Id. at 5. We have blogged on parallel claims on multiple occasions, but Ebrahimi is particularly strong on folding causation (or lack thereof) into defining which claims avoid express preemption and which do not. This is more than TwIqbal. This is a district court ruling that federal law preempts your claim unless you can allege specific facts showing that the violation of a “parallel” state-law duty actually caused you harm. Other courts should do this, too.
This time around, the district court dismissed the failure-to-warn claims without leave to amend, which makes sense. The plaintiff filed a First Amended Complaint, and then a Second, and if she has not alleged a non-preempted claim by now, she never will. The district court did grant leave to amend for the manufacturing defect claim, based on allegations that the implant suffered from “poor workmanship” and the like. Id. at 5-6. So she gets another chance, but if all she is left with is a manufacturing defect claim in a medical device case, she does not have much.
Kudos to the attorneys at Tucker Ellis for achieving this result, and our thanks to Dustin Rawlin for sending the order our way.