Samples, samples, samples. We dare you to make it through your local supermarket or bulk supply store without finding at least one table set up asking you to sample the latest offerings from peanut butter to frozen breakfast sandwiches; from hummus to pre-made meatballs; and don’t forget the cheese. And it’s usually more than one. By the time you’re done shopping you can have eaten an entire meal – from salsa to cheesecake. Shopping alone, this doesn’t really present much of an obstacle. Shopping with children, however, and it adds a whole new dimension. Children want to try every sample. In sample size, children love almost everything they taste. So, you then get to listen to “please, please, please” for ten aisles. “I loved it.” “I promise I’ll eat every last frozen pierogi you buy.” In occasional moments of weakness, you say yes. To nobody’s surprise, however, you’re throwing away a nearly full bag of pierogis that you found wedge in the back corner of your freezer 10 months later. Because, what tasted so good in a sample size, simply didn’t have enough flavor to desire an entrée-sized portion.
That’s sort of how we feel about today’s decision, overall it tosses out most of plaintiffs’ claims – we like those samples. But, the decision is long and when you get down to digesting all of it – some of it is a bit hard to swallow.
The case is McLaughlin v. Bayer Corp, 2016 U.S. Dist. LEXIS 37516 (EDPA Mar. 22, 2016). It’s actually five cases with identical complaints all alleging injury from plaintiffs’ use of Bayer’s contraceptive device, Essure. The device is a Class III, PMA device, so Riegel express preemption and Buckman implied preemption are both viable defenses and both were raised by the defendant in response to each of plaintiffs’ twelve claims. That’s part of the problem. Plaintiffs raised novel claims to try to avoid preemption. In fact, none of the specific theories that were allowed to survive preemption have ever actually been recognized by Pennsylvania. So, we’re sure you’re expecting an Erie discussion – but Erie isn’t even mentioned in the decision. Fortunately, TwIqbal was also successfully used by the defense, so plaintiffs really do have to go back to the drawing board on their claims. We hope that after the claims are both stripped down and beefed up, the court will see it left some really indigestible morsels on the table. We’ll take the claims in the order the court did.
Negligent Training: We know to avoid Riegel preemption, this claim would have to be a parallel claim. That is, there must be a valid state law claim that requires a duty that is the same as the federal FDA requirements. In other words, breaching the state law duty parallels a violation of FDA requirements, so there is no conflict between the two. But if you start with the assumption that there must be a valid state law claim, we think that should have been the downfall of this claim. Instead the court ruled that since Pennsylvania recognizes Restatement (Second) of Torts §324A (duty to a third party for a voluntary undertaking), negligent training is a viable claim. Then, because the FDA has imposed training requirements for this device, the state law claim parallels the federal requirements. Id. at *25-26. We have two problems with this conclusion. First, the court cites no training-related precedent to support negligent training as Pennsylvania law. Second, how can something required by law (training physicians to use the device) be voluntarily assumed? Fortunately, TwIqbal saves the day. Nowhere in the complaint could the court find an allegation that defendant’s training deviated from federal requirements or how any potentially alleged deviation may have caused plaintiffs alleged injuries. Id. at *27.
Negligent Entrustment: Here plaintiffs argued that defendant negligently entrusted the tool used to implant the contraceptive device to physicians who were not properly trained. Id. at *29. Plaintiffs tried an end run around preemption by saying that since this claim was about the tool not the device, the PMA didn’t apply and therefore preemption didn’t apply. Id. at *31. Creative, but unsuccessful. Plaintiffs aren’t alleging they were injured by the tool, the claim is about the device – which means PMA preemption comes with it. Since the duties plaintiffs alleged in this claim went beyond the PMA requirements, the court found the claim expressly preempted. Id. at *33-34.
Negligent Risk Management: This is another claim where we think the court overreached in finding it recognized under Pennsylvania law. The court relied only on some general language from Lance v. Wyeth, 85 A.3d 434, 460 (Pa. 2014) to conclude that Pennsylvania law provides “considerable latitude in labeling . . . negligence claims,” and that negligence can include “failure to investigate information about the risks.” Id. at *36-37. So, the court says it reads this claim as only seeking to hold defendant to the federal risk management standards. Id. at *37. We say, that may be true, but plaintiffs don’t have a viable state court vehicle to do so and a claim simply to enforce FDA requirements is impliedly preempted by Buckman. Once again, however, poor pleading requires dismissal. The court found plaintiffs’ “laundry list” of federal requirements and alleged breaches too muddled to discern an actually well-supported claim. Plaintiffs also missed pleading causation. Id. at *38. So this claim was dismissed as speculative.
Breach of Express Warranty: We’ve seen breach of express warranty claims survive preemption before, so that wasn’t too surprising. Id. at *43-44. But, plaintiffs again failed the plausibility standard. The complaint contained no specificity regarding which warranties were read or how any warranty became a “basis of the bargain” with defendants. Id. at *46. The court was also concerned about the lack of any allegations as to the time frame when each plaintiff saw the warranties – as it could have pre-dated implantation by several years. Id. at *47.
Fraudulent Concealment: This is a claim that defendant concealed adverse events from the FDA. Id. at *49. With allegation being grounded solely on the PMA duty to report, the court found the claim impliedly preempted under Buckman. Id. at *51. Plaintiffs tried to say the claim was based on a failure to warn, but the court found failure to warn is only a negligence claim in Pennsylvania, it doesn’t sound in fraud. Id. at *52.
Fraudulent and Negligent Misrepresentation: Misrepresentation claims are also ones we know sometimes escape preemption based on being parallel to federal requirements prohibiting misleading or false statements. Id. at *57. In this case, that was a general ruling and the court specifically reserved judgment on whether any particular alleged misrepresentation was expressly preempted and previewed its future ruling:
Indeed, if, in fact, the alleged misrepresentations appear verbatim in FDA-approved materials, it seems apparent that any misrepresentation claim based on those statements would be expressly preempted under the legal framework set forth above.
Id. at *59. In other words, the misrepresentations have to be in unapproved materials and be inconsistent with and undermined the FDA-approved statements. Id. at *57. The court only applied the Rule 9 heightened pleading standards to the fraud claim, not the negligent claim and so negligent misrepresentation survived both preemption and TwIqbal, but the court did caution plaintiffs to exercise some care in re-pleading all the misrepresentation allegations.
Consumer Fraud: The court dismissed this claim under settled Pennsylvania law that a consumer does not have a claim for violation Pennsylvania’s Unfair Trade Practices and Consumer Protection Law (UTPCLP) against the manufacturer of a medical device. Id. at *67. The presence of a learned intermediary cuts off plaintiffs’ ability to prove reliance and causation – there is no duty to warn the patient directly. Id. Also noteworthy is the court’s statement that the learned intermediary rule in Pennsylvania was not displaced by Lance. Id. at *68-69.
Strict Liability: Again, another claim not recognized in Pennsylvania for medical devices or prescription drugs. Plaintiffs tried to push open the door as to strict liability manufacturing defect, but the court found that door closed by Lance. Id. at *73-74.
Negligent Manufacturing: On this claim, plaintiffs insufficient pleadings made it impossible for the court to decide preemption. Plaintiffs’ failure to specify the federal regulations that were violated by defendant’s alleged negligence prevented the court from being able to determine if the claims were in fact parallel. Id. at *78. Further, plaintiffs failed to plead causation. There were no allegations that an actually negligently manufactured device was implanted in any plaintiff. Id. at *80.
Negligent Failure to Warn: This is where we come back to the court reaching for Pennsylvania law where it simply doesn’t exist. In their briefing, plaintiffs clarified that this is really a failure to warn claim premised on failure to report adverse events. Id. at *82. Essentially the same claim that was preempted when couched as fraudulent concealment. But call it negligent failure to warn and apparently it’s a whole new ballgame. Plaintiffs relied on Stengel and the court found that Pennsylvania’s failure to warn law was substantially the same as Arizona’s which formed the basis for the Stengel decision. Putting aside the Ninth Circuit’s interpretation of Arizona law, this court’s interpretation of Pennsylvania law appears to be based on one case that doesn’t involve any government agency. That case dealt with whether an employer was an intermediary between the manufacturer and the employee-end user of a potentially dangerous product. That doesn’t seem like firm enough ground to support an extension of state law to adopt a new theory of liability.
Pharmacovigilance: Plaintiffs state that this is a claim that defendant “had a duty to distribute, promote, and report adverse events . . . in a reasonably safe manner.” Id. at *86. Despite the above referenced liberal interpretation of negligence claims in Pennsylvania, the court could not find any support for pharmacovigilance as an independent cause of action. Instead it noted that the claim was simply an amalgamation of several of plaintiffs’ other claims. Id. at *88-89. As such it was dismissed.
To summarize – negligent entrustment and fraudulent concealment were dismissed with prejudice on preemption grounds; strict liability, violation of the UTPCPL, and pharmacovigilance were dismissed with prejudice as not recognized in Pennsylvania; plaintiffs get a second chance to plead negligent training, negligent risk management, breach of express warranty, fraudulent misrepresentation, and negligent manufacture. The only claims that survived this stage are negligent misrepresentation and failure to warn premised on failure to report.
It’s a thorough decision, but a bit mediocre on reasoning. Like that grape flavored yogurt our kids sampled, they liked the first few bites but could have done without the half-gallon container left in our refrigerator.