In our 50-state survey on failure to report claims, we described Missouri as an “up in the air” state, with courts on both sides of the issue failing to cite or consider prior significant precedent. Now the Eastern District of Missouri has weighed in bringing the issue a little closer to the ground.
In Schnulle v. Somatics, LLC, 2022 WL 194350 (E.D. Mo. Jan. 21, 2022), plaintiff alleged she was injured by defendants class II medical device. Her claims included negligence, strict liability, breach of implied and express warranty, and fraud. Plaintiff’s negligence claim was in part based on traditional failure to warn allegations. But it was also based in part on allegations that defendant failed to properly investigate reported adverse events, failed to report adverse events to the FDA, and generally failed to comply with the Federal Food, Drug, and Cosmetic Act (“FDCA”). Id. at *2. Defendant argued that these claims are impliedly preempted under Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341 (2001) as impermissible attempts at private enforcement of the FDCA.
The court agreed.
As there is no common law duty in Missouri to [investigate the reports of serious adverse events], this allegation is based on a federal requirement with no correlative state law duty, and it is impliedly preempted.
Id. at *3. The same was true of plaintiff’s claims based on failing to report adverse events to the FDA and on failing to comply with federal regulations for medical devices generally. Id. Those claims were therefore dismissed.
Defendants also argued that plaintiff’s traditional failure to warn claims should be dismissed because plaintiff did not plead facts sufficient to show that they would not be barred by the learned intermediary doctrine. Id. at *4. Under Missouri law, however, the learned intermediary rule is an affirmative defense and therefore something plaintiff did not have to plead around. Id.
The court did dismiss plaintiff’s breach of express warranty claim because plaintiff failed to allege that any of the “purported warranties” were made to her or her doctor and for lack of the required pre-suit notice. Id. at *5. Plaintiff also failed to plead her fraud claims with the specificity required by Rule 9(b). Without specific allegations of the who, what, where and when, plaintiff’s fraud claims were also dismissed. Plaintiff abandoned her implied warranty claims. Id. at *5.
So, at the end of the day plaintiff is left with a failure to warn claim with a learned intermediary hurdle to overcome and design and manufacturing defect claims that got by TwIqbal by the thinnest of margins, or barest of allegations. Id. at *4-5. In other words, plaintiff has a lot fewer claims and a lot more work to do. And, we have another no duty to report case tipping the scales in defendants’ favor.