The Ninth Circuit has confirmed in quadrophonic sound that plaintiffs cannot avoid preemption by relying on vague and speculative allegations to establish a parallel claim. The court affirmed the dismissal of four lawsuits by plaintiffs claiming they were injured by breast implants on the grounds that their claims are barred by the 1976 Medical Device Amendment to the Food, Drug and Cosmetic Act (MDA). Sewell v. Mentor Worldwide, LLC, et al., no. 19-56393; Vieira v. Mentor Worldwide, LLC, et al., no. 19-56394; Billetts v. Mentor Worldwide, LLC, et al., no. 19-56398; Nunn v. Mentor Worldwide, LLC, et al., no. 19-56391.
In each case, California plaintiffs alleged their breast implants were defective and caused them to experience fatigue, muscle pain, and migraines. The district courts dismissed the complaints for failure to state a claim on grounds of preemption, and plaintiffs appealed.
The Ninth Circuit issued four separate but substantively identical opinions. Reviewing the preemption dismissal de novo, the court first held that the state-law failure-to-warn claims were preempted by the MDA.
Plaintiffs’ warnings claims were based on allegations that the defendant failed to report adverse events related to the breast implants to the FDA. That liability theory has been recognized under California law, see Coleman v. Medtronic, Inc., 223 Cal.App.4th 413 (2014), and the Ninth Circuit had previously read Arizona law to adopt the theory, and held it constitutes an actionable parallel claim escaping preemption. Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013) (en banc). The Arizona Supreme Court later held that Stengel had misread Arizona substantive law. Conklin v. Medtronic, Inc., 245 Ariz. 501 (2018). Our prior post on Stengel and Conklin can be found here.
In these four recent decisions, the Ninth Circuit held that, even where state law recognizes a theory that would present an un-preempted parallel claim, that claim must still be adequately alleged to avoid preemption. The plaintiffs had merely speculated that if the defendant had conducted its post-approval studies differently, with added follow-up, then additional adverse events would have come to light that defendant would then have reported to the FDA. The Ninth Circuit held these allegations were too “conclusory and speculative” to state a parallel failure-to-warn claim.
“Speculative” is a rather charitable description for these allegations. In fact, although not mentioned by the court, this was speculation on top of speculation. The failure-to-report theory of liability is itself inherently speculative. It posits that adequate reporting to the FDA would then have resulted in a label change that would then have timely reached the doctor and then caused the doctor to reject the device, thereby preventing plaintiff’s injury. That causal chain consists of several increasingly weak and inherently speculative links.
The plaintiffs’ allegations sound more like a disguised post-sale failure-to-adequately-test theory than the dubious failure-to-report theory discussed in Stengel and Coleman. In any event, the Ninth Circuit noted that this theory would be impliedly preempted, as it asserts no state law duty that runs parallel to any federal requirement.
Finally, the court noted that plaintiffs’ true failure-to-warn argument – that defendant failed to warn plaintiffs’ doctors directly – would also be preempted, because there is no federal requirement to do so.
The court also held that the plaintiffs’ manufacturing defect claims were preempted, because they likewise did not allege a violation of any particular FDA requirement. Rather, the plaintiffs alleged only vaguely that the breast implants contained unidentified materials that differed in some unstated respect from those approved by the FDA. These claims also foundered on insufficient detail, were consequently preempted, and therefore properly dismissed.
The court also reviewed the district court’s denial of plaintiffs’ motions to remand the case to state court. Plaintiffs’ motions had challenged the removal to federal court as untimely. According to the court, the removal was timely because taken soon after deposition testimony revealed that the non-diverse defendant, NuSil, had been fraudulently joined. That testimony demonstrated the company had not been involved in manufacturing or supplying silicone used in the implants. Therefore, there was no possibility of recovery against NuSil, and removal in the wake of the deposition was timely and proper.
These opinions are a valuable reminder that even parallel claims that are sufficient in theory to avoid preemption are still subject to dismissal if not adequately supported.