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Sometimes we read an opinion and think to ourselves, we couldn’t have said it better ourselves.  That is true of the analysis of failure to report claims in McGee v. Johnson & Johnson, 2023 WL 4765454 (W.D. Pa. Jul. 26, 2023).  We’ve been railing against Stengel v. Medtronic, Inc., 704 F.3d 1224 (9th Cir. 2013) and its unfortunate progeny for 10 years now.  So, we laud McGee’s thorough review of the unstable house of cards on which that case law is built.

Plaintiff in McGee alleges she suffered injury as the result of defendants’ breast implants which are Class III, pre-market approved medical devices.  That means plaintiff has only a “narrow gap” to pursue a claim that is neither expressly nor impliedly preempted.  Id. at *3.  Plaintiff attempted to fit four claims through that opening – strict liability manufacturing defect, breach of implied warranty, strict liability failure to warn, and negligence.  Plaintiff conceded her strict liability and negligent failure to warn claim were preempted and more or less conceded the same about her breach of implied warranty claim.  On the latter, the court found the law too unsettled and therefore was unwilling to find that Pennsylvania would recognize the claim.  Both those claims were dismissed with prejudice.  Id. at *7-8.  That essentially left two claims – manufacturing defect (both strict liability and negligence) and negligent failure to report.  One survived and one did not.

Plaintiff’s manufacturing defect is premised on allegations that defendants’ manufacturing process allows problematic debris to be left on the implants.   Defendants argued that this was essentially a design defect claim trying to masquerade as a manufacturing defect.  But plaintiff was careful to plead that the alleged problem was a “sometimes” thing, the result of “shoddy workmanship” “at times,” and the result of “varying degrees of nonconformance.”  Id. at *5.  That was enough for the court to find plaintiff was in fact making a manufacturing defect claim.

Defendants next argued that plaintiff’s complaint failed to identify an appropriate specific regulatory violation to support her manufacturing claim.  But the court found plaintiff’s allegations were enough for now.  Because plaintiff did not yet have access to defendants’ confidential PMA documents, she had pled what she could “given the amount of information to which she had access.”  Id. at *7.  We take this to be a word of caution to plaintiff that her claim is vague and is going to need to be supported by an actual violation down the road. 

Now for our favorite part – failure to report is preempted because there is no recognized Pennsylvania state law claim for failure to report to the FDA.  Admittedly, plaintiff had some precedent to cite to beyond just Stengel.  Three other district courts in the Third Circuit had previously bought into the Stengel rationale and the state’s adoption of section 388 of Restatement (Second) of Torts.  Otherwise known as the sophisticated purchaser doctrine, it provides that a supplier can discharge its duty to warn by providing information to a third party “upon whom it can reasonably rely to communicate the information to the ultimate users.”  Id. at *9.  But McGee recognizes that is only part of the story.

First and foremost, nobody should be relying on Stengel anymore.  The Ninth Circuit’s decision was based on a prediction that Arizona would recognize a state law duty to warn the FDA of adverse events.  They were wrong.  The Arizona Supreme Court reached the exact opposite conclusion in Conklin v. Medtronic, Inc., 431 P.3d 571 (Ariz. 2018).  See McGee at *10, 12.  As for section 388, which is a defense not a duty, the courts that relied on it ignore that it has nothing to do with warning a federal agency, but rather is limited to “the transmission of warnings to the third person through whom the chattel is supplied.”  Id. at *10 (opinion contains full language of comment n.).  In other words, does the manufacturer discharge its duty to warn by warning the employer who purchases equipment to be used by its employees?  Nowhere does the FDA come into the equation.  Making this line of cases, a “shaky foundation” for plaintiff’s claim.  Id. at *11.  

The court agreed:

[T]he Court is not persuaded that Pennsylvania law imposes a duty upon manufacturers and sellers to report adverse events to the FDA. As discussed above, the cases cited by Plaintiff… do not currently rest on sound precedent . . ..[T]he Court is not convinced that Section 388 (or comment n thereto) creates a duty to report adverse events to the FDA under Pennsylvania law.

Id. at *12.  The claim was dismissed without prejudice, but given the state of Pennsylvania law, we don’t see the ground getting any firmer here.