Today we report on a recent decision dismissing manufacturing-defect, warranty, and failure-to-warn claims arising from an allegedly defective breast implant. Although the decision, D’Addario v. Johnson & Johnson, 2021 WL 1214896 (D.N.J. 2021), does not stray far from the beaten path, it covers ground worth revisiting. The decision is a useful (if cursory) reminder that plaintiffs challenging the safety or effectiveness of Class III medical devices with premarket approval may not rely on the res ipsa loquitur doctrine to satisfy their pleading obligations. It is also a good reminder that dismissal on pleading grounds is possible even when a court gets the preemption analysis wrong.

Plaintiffs sue when they are injured by a medical product (and sometimes when they are not). But injury by itself does not state a claim. To state a claim, plaintiffs must allege that they were injured because the product was defective in some regard. Recognizing that federal law generally preempts design-defect claims implicating medical devices with premarket approval, plaintiffs typically claim that their injury was caused by a manufacturing defect that the manufacturer failed to warn of.

To state a manufacturing-defect claim, a plaintiff must allege that the particular unit they received deviated from its intended design or from other ostensibly identical units, and that this deviation caused the plaintiff’s injury. Thus, in federal court, where Twombly and Iqbal reign, and in state courts that enforce fact-pleading standards, a plaintiff attempting to state a manufacturing-defect claim must allege facts that, if true, would show that their injury was caused by the particular unit’s deviation from its intended design.

Frequently, however, plaintiffs asserting manufacturing-defect claims do not allege any facts suggesting that that the particular unit they received deviated from its intended design. Instead, they rely on the res ipsa loquitur doctrine to evade their pleading obligation. When applicable, the doctrine allows a court to infer tortious conduct from the mere fact that an accident has occurred. Plaintiffs often maintain that they would not have injured by an FDA-approved product unless something went wrong during the manufacture of the product. In other words, plaintiffs often argue that one can infer from their injury alone that the unit they received suffered from a manufacturing defect.

The D’Addario court rightly rejected that argument. Indirectly quoting a recent Ninth Circuit decision in another breast-implant case, the court stated that plaintiffs “cannot simply demonstrate a defect or a malfunction and rely on res ipsa loquitur” to state a manufacturing-defect claim. 2021 WL 1214896, at *4 (ultimately quoting Nunn v. Mentor Worldwide, LLC, — Fed. App’x —-, 2021 WL 406304, at *2 (9th Cir. 2021)). As the Ninth Circuit had previously explained in another case, “the FDA’s premarket approval of the process by which a Class III device is manufactured ‘does not guarantee that every device manufactured in that process will work.’” Weber v. Allergan, Inc., 940 F.3d 1106, 1111 (9th Cir. 2019) (quoting Banner v. Cyberonics, Inc., 2010 WL 455286, at *4 (D.N.J. 2010)). On the contrary, “the FDA performs a cost-benefit analysis” when reviewing PMA applications and “may approve devices” and their manufacturing processes despite “knowing that [the devices] sometimes will fail.” Id. at 1111–12. Therefore, because a malfunction might occur even if the manufacturer adheres to the FDA-approved manufacturing process, one cannot infer a manufacturing defect from the mere fact that a Class III medical device has malfunctioned. Thus, a plaintiff cannot rely on the res ipsa doctrine to avoid having to plead facts that, if true, would establish a particular unit’s deviation from its intended design.

Evidently recognizing that their manufacturing-defect claims would be preempted unless based on the violation of a federal requirement applicable to the breast implant, the D’Addario plaintiffs, like plaintiffs in many medical-device cases, alleged that the implant’s manufacturer had violated the FDA’s Current Good Manufacturing Practices (CGMPs). In a misstep, the court stated, without any analysis, that purported CGMP violations “potentially set forth a state-law claim based on a violation of federal law that would fall within the ‘parallel claim’ exception to preemption.” 2021 WL 1214896, at *4 (emphasis omitted). While some other courts have also so held, yet other courts have rightly rejected that proposition. Although a future blog post will offer an additional ground on which CGMP-based claims should be rejected, the courts that have held alleged CGMP violations insufficient to support a manufacturing-defect claim that escapes preemption under 21 U.S.C. § 360k(a) as interpreted in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), have generally done so on the ground that the CGMPs are, by design, “intentionally vague and open-ended.” Ilarraza v. Medtronic, Inc., 677 F. Supp. 2d 582, 588 (E.D.N.Y. 2009). Because the CGMPs “are inherently flexible” and “require manufacturers to develop their own quality-system controls,” these courts hold that any tort claim predicated on an alleged CGMP violation would inevitably be enforcing a state-law requirement “different from, or in addition to,” the federal requirements applicable to the device. In re Medtronic, Inc. Sprint Fidelis Leads Prod. Liab. Litig., 592 F. Supp. 2d 1147, 1157 (D. Minn. 2009).

As noted, the D’Addario was prepared to accept that manufacturing-defect claims predicated on alleged CGMP violation might escape preemption. Nonetheless, the court the court dismissed the plaintiffs’ claims on pleading grounds. Although the court’s reasoning is somewhat opaque, it seems to have found that the plaintiffs’ “laundry list of alleged CGMP violations” was, without more, insufficient to state a claim because plaintiffs did not tie the purported violations to “a defect in the manufacture of the specific” implant they received. 2021 WL 1214896, at *4. Their allegation that the defendants’ manufacturing process resulted in allegedly harmful matter being left on the implant’s surface was also insufficient, the court found, because plaintiffs failed to allege how, if at all, that process deviated from the process that had been approved by the FDA. Id. at *5.

As many other plaintiffs have done since the Ninth Circuit’s misguided and since discredited decision in Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir. 2013), the D’Addario plaintiffs asserted a failure-to-warn claim based on the defendants’ purported failure to submit adverse-event reports to the FDA. The court did not reject the claim as preempted on its face, as it should have, but dismissed the claim nevertheless. Without holding that failure-to-warn claims can never be predicated on an alleged failure to file adverse-event reports, the court found that the plaintiffs had failed to state a cognizable failure-to-warn claim because their particular claim was based not on the failure to report known adverse events but on the failure to report adverse events that the plaintiffs alleged would have been discovered if the defendants had conducted the post-approval studies that they were supposedly required to conduct. That, the court said, was impermissibly speculative.