Did you ever read something and think – I couldn’t have said it better myself. Sometimes we read opinions that give us just that feeling. A decision that ticks all of the boxes and leaves us wondering why everybody doesn’t see how easy it is to reach the right conclusion. Brooks v. Mentor Worldwide, LLC, 2019 WL 4628264 (D. Kan. Sep. 23, 2019) is such a case.
The case involved two plaintiffs suing for injuries allegedly caused by silicone breast implants which are PMA (Pre-Market Approved), Class III devices. Id. at *1-2. Plaintiffs brought failure to warn and manufacturing defect claims. The court’s decision is straight forward, logical, and concise to boot. We’ll try to be equally so in our summary.
Failure to warn: Plaintiffs argued three bases for their claims. First, that defendant had a duty to warn plaintiffs directly. Applying Kansas and Missouri law (one for each plaintiff), the learned intermediary doctrine “easily” disposed of this argument. Id. at *5. Second, defendant had a duty to warn the FDA. Plaintiffs warn-the-FDA claim was based on allegations that defendant failed to properly conduct FDA-mandated testing and failed to report negative test results. This the court dismissed as impliedly preempted:
Plaintiffs have not identified a state law that required Mentor to conduct follow-up studies in accordance with FDA regulations, nor have plaintiffs identified a state law that required Mentor to report findings to the FDA. Therefore, plaintiffs are not enforcing state law, but attempting to enforce FDA regulations. The MDA impliedly preempts this type of action.
Id. No private enforcement of the MDA. Check.
Plaintiffs’ third failure to warn argument was that defendant not only had a duty to warn physicians directly, but also indirectly by reporting to the FDA. Neither survive preemption. As for direct warning, plaintiffs argued that defendant was required to update its label with information it learned during post-marketing studies. Even if state law so required, to avoid preemption such a claim would have to parallel a federal requirement and it does not. “Therefore, any state law claim that would have required Mentor to make label updates would necessarily impose a requirement beyond those imposed by federal law.” Id. at *6. No parallel federal requirement. Check.
Plaintiffs also argued that defendant could have changed its label through the CBE (Changes Being Effected) procedure. The court correctly focused on the word “could.” “The CBE procedure is permissive, not mandatory.” Id. Therefore, state law, which would require a change, is different from and in addition to federal law which does not require a change. Differing state law. Check.
As for the indirect warning to physicians, plaintiffs argued that had defendant reported adverse events to the FDA the FDA would have made that information publicly available, something they are not required to do, which physicians may have then accessed, relied on, and altered their treatment of plaintiffs. First, the allegations are “far too speculative” to survive TwIqbal. Id. Second, there is no state tort law that requires defendant to report adverse events to the FDA. So, this is another attempt to enforce the MDA. Not grounded in traditional state law tort. Check. With that, all of plaintiffs’ failure to warn claims are dismissed.
Manufacturing Defect: Plaintiffs base their manufacturing defect claims on eight allegations. Four were preempted because they relied solely on violations of federal law: failure to comply with FDA specifications; failure to use FDA approved materials; failure to comply with federal regulations and manufacturing protocols; and selling implants in violation of federal law. Id. at *7. Because “these claims would not exist without the FDCA, including the MDA,” id., they are preempted. We’ve already checked the no state law claim box, but we don’t mind doing it again. Check.
Plaintiffs’ counter to this was that the federal regulations provide the standard of care for the state law claim. To which the court responded:
In other words, to conjure up a parallel state claim that survives implied preemption, plaintiffs argue that Mentor violated state law because it violated federal law. This is a roundabout way of asserting a negligence per se claim based on a violation of the FDCA.
Id. Which is something you can’t do under Kansas or Missouri law. In both states, negligence per se “is limited to violations of a statute where the legislature intended to create an individual right of action for injury arising out of a statutory violation.” Id. at *8n.5 (citations omitted). And, we know the FDCA does not have a private cause of action. The court dismissed plaintiffs’ negligence per se claims. No negligence per se where no private cause of action. Check.
That left four allegations as potential bases for a manufacturing defect claim. While they sounded in traditional tort law – failure to follow good manufacturing practices, failure to use proper materials, failure to properly inspect/test, failure to use proper quality control procedures – they offered nothing more than conclusory assertions. They didn’t satisfy TwIqbal. Id. With that, all of plaintiffs’ manufacturing defect claims are dismissed.
The claims were straightforward. The defendants’ arguments equally so. The court’s opinion perhaps even more so. Think outside the box may be a commonly used metaphor to inspire people to be innovative and creative but it can’t be used to overcome clear cut legal precedent. And when you check all the preemption boxes, this should be the result.