United States: PMA Preemption Revisited In Pennsylvania

Last Updated: March 15 2017
Article by Michelle Yeary

Back in October we posted about the Eastern District of Pennsylvania decision McLaughlin v. Bayer Corp, 2016 U.S. Dist. LEXIS 37516 (EDPA Mar. 22, 2016) saying that while we liked the ultimate result – tossing out most of plaintiffs' claims – some pieces of the decision weren't as strong as we would have liked. Well, McLaughlin's back and it's still not a slam dunk, but plaintiffs' don't have too much left of their cases either.

As a reminder, this is actually a decision in 5 cases each alleging injury from plaintiffs' use of a Class III, PMA contraceptive device, Essure. McLaughlin v. Bayer Corp., 2017 WL 697047, at *1 (E.D.Pa. Feb. 21, 2017). Several of plaintiffs' original causes of action were dismissed with prejudice, but they were given an opportunity to amend to try to salvage their claims for negligent training, negligent risk management, breach of express warranty, fraudulent misrepresentation, and negligent manufacture. Negligent misrepresentation and failure to warn premised on failure to report survived the first motion to dismiss.

The decision methodically goes through each cause of action.

Negligent Training: In its first decision, the court opined it was possible to state a parallel claim for negligent training, but since plaintiffs failed to specify how defendant's training deviated from federal training requirements or how those deviations caused plaintiffs injuries, the claim had to be dismissed as insufficiently pled. Id. at *3. In the amended complaint, plaintiffs alleged 6 such failures by defendant. As to 3, the court couldn't find any federal directive that required defendant to do what plaintiffs alleged it failed to do. So, as to those 3 allegations, the claim was dismissed as expressly preempted. Id. at *4-5. As to the remaining 3 alleged violations, defendant challenged them on causation grounds but was unsuccessful. The court found the complaint sufficiently alleged that because defendant failed to properly train the doctors, the doctors in turn did not properly place the device causing it to migrate and cause plaintiffs' injuries. Id. at *5. The complaint, however, lacked any specific allegations about the actual doctors who performed plaintiffs' surgeries. The court didn't find that fatal at the pleadings stage – that was for discovery. Id. at *6. But if you look at what the 3 bases for the failure train claim are, they appear to all be things plaintiffs could have asked their doctors about before filing these lawsuits. Did the doctor successfully complete 5 preceptorings? Did the doctor read and understand the training manual? Did the doctor successfully complete the simulator training? If the answers to those 3 questions are yes in each case – this claim is over.

Negligent Risk Management: We'll briefly reiterate that we think the court is overreaching in recognizing such a claim under Pennsylvania law and without a viable state law claim, a claim to enforce federal risk management requirements should be impliedly preempted under Buckman, But, that was one of the not well-liked pieces of the first decision. So, what did plaintiffs plead the second time around? Essentially, they re-pleaded their failure to report adverse events claim and alleged that (1) because the adverse events were not disclosed to the FDA, they weren't disclosed to the plaintiffs who wouldn't have had the device implanted if they were aware and (2) that if the adverse events had been properly investigated, defendant should have removed the product from the market. Id. at *6. The court found the second part of the claim preempted. Plaintiffs argued that the assertion that the device should have been withdrawn from the market "is an allegation, not a cause of action." Id. at *7. But the court found that to be a distinction without a difference. One of plaintiffs' theories of causation is that he product shouldn't have been on the market, which clearly is different from federal regulations. Id.

Indeed, we can perceive of no basis to distinguish between a negligence cause of action that alleges a breach of a duty that does not parallel a federal requirement and a negligence cause of action that relies on a theory of causation that is dependent upon proof that the defendant should have taken a subsequent safety action that is not required by federal law.

Id. As to the part of the claim that alleges plaintiffs weren't adequately warned because defendant failed to disclose adverse events to the FDA, defendant argued that claim should be stricken as duplicative of the failure to warn claim. Plaintiffs allege the duties that form the basis for the two claims are distinct – failure to warn versus failure to engage in risk management. We think the court should have found a distinction without a difference here to, but instead found that plaintiffs have "latitude in labeling their claims," and allowed the claim to survive. Id. at *8.

Breach of Express Warranty: This claim was originally dismissed for failure to plead the actual warranties with specificity or plead how any warranty became a "basis of the bargain" with defendant. The court found plaintiffs fixed this problem on their second go-round. The amended complaint "now includes the date on which each Plaintiff encountered each warranty, where each Plaintiff was when she encountered the warranty, and the source of each warranty." Id. at *10. Defendant challenged 2 specific warranties alleged by plaintiffs because they were both from the device website directed to physicians not consumers. The court granted the motion to dismiss as to those 2 warranties. Id.

Fraudulent Misrepresentation: The first time around, plaintiffs did not satisfy the heightened pleading requirements of Rule 9. This time, they alleged 21 specific misrepresentations. Plaintiffs, however, weren't paying close enough attention to the court's first ruling in which it said to survive preemption

Plaintiffs would need to allege that Bayer made false or misleading statements in unapproved advertising or other promotional materials that were inconsistent with specific statements in approved FDA materials and that undermined the approved and required statements in those materials.

Id. at 12. The decision walks through each of the 21 misrepresentation claims. Three were not challenged, but as to the remainder the court found all but 1½ claims were preempted. Each preempted claim was found to be consistent with at least one FDA-approved statement. Id. at *13-15. With respect to the 4½ claims not preempted, defendant argued that they should be dismissed for plaintiffs failed to plead that defendant made the statements knowing they were false or with a reckless disregard for the truth and that defendant intended to induce reliance. With respect to knowledge, the court found plaintiffs did not plead facts to support that element for the ½ claim that survived preemption. The court also found no intent to induce reliance as to one of the statements not challenged on preemption. So, in total, of the 21 statements set out in the complaint, plaintiffs' claims survived as to only 3. Id. at *16-17.

Negligent Manufacturing: On this last claim, the court originally said it was too poorly pleaded to even allow a preemption determination. In the amended complaint, plaintiffs alleged defendant failed to adhere to 6 federal regulations, 3 federal statutes, and 1 provision of the PMA. Id. at *18. However, plaintiffs still missed the mark on causation. Plaintiffs alleged no facts as to how the supposedly non-conforming materials, misleading labeling, or unsanitary manufacturing conditions were related to plaintiffs' alleged injuries. Id. The negligent manufacturing claim was dismissed in its entirety.

So, given a second chance on 5 claims, plaintiffs managed to hold on to 4 of them – albeit severely scaled down versions. Some of the surviving claims should probably not have escaped round one. But we are happy at least that they were thoroughly scrutinized in round two.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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