United States: E.D. Arkansas Dismisses Essure Claims

Ray Charles's musical threat of "tell your Ma, tell your Pa, gonna send you back to Arkansas" doesn't sound so bad to us after reading Green v. Bayer Corp., 2021 WL 687024 (E.D. Ark. Feb. 22, 2021). The plaintiff alleged injuries from a permanent contraceptive device and brought claims for negligent training, negligent risk management, and breach of express warranty. The defendants moved to dismiss on the grounds that the claims were preempted and insufficiently pled. The court granted the motion to dismiss and denied the plaintiff's motion to amend.

We are skeptical of the claim of negligent training. (Here is excellent article on that topic that is worth retrieving if you bump up against the claim: J. Eppensteiner & R. Nelson, "Failure to Train and Medical Device Claims," For the Defense (April 2013).) In Green, that claim was especially frail because the contraceptive product was a class III medical device subject to express preemption. Any effort to impose a training requirement beyond FDA requirements was a clear no-go. The claim could survive only if it involved a valid claim under Arkansas law that ran parallel to FDA regulations. It did not. The plaintiff stretched Arkansas law in an effort to show a voluntary undertaking, but it did not matter because the plaintiff set forth no facts showing either how the physician training departed from FDA requirements or how such departure caused the plaintiff's injuries. Goodbye, training claim.

We admit we do not even know what a claim of negligent risk management is. But whatever it is, the plaintiff in Green did not adequately plead it. The Green court was also unsure what the claim was exactly, but charitably interpreted it to assert that the defendants had not notified the FDA about problems. The complaint listed several alleged federal violations, including failure to submit certain reports. That sort of thing amounts to a fraud-on-the-FDA claim, which is preempted. In any event, the negligent risk management claim does not exist under Arkansas law. Even if it did, it suffered from the same flaw as the negligent training claim: lack of a causal link. Farewell, negligent risk management claim. We hardly knew ye. Actually, to be honest, we never knew ye.

The plaintiff alleged that the defendants falsely advertised the contraceptive product. She said she relied on representations on the defendants' websites. But she did not specify exactly how anything on the website was false. A vague/overbroad allegation that the other side lied does not cut it. Adios, warranty claim.

The plaintiff proposed an amended complaint that did not fix the dismissed claims but added claims for negligent manufacture, strict liability defective manufacturing, and failure to warn. We do not even need to read the complaint to know the manufacturing claims were bogus. They pretty much always are. But the Green court did read the amended complaint, saw no there there, saw that the failure to warn claim was premised on the same facts as the warranty claim, and concluded that amendment would be futile.

The Green court made dismissal of the product liability claims look easy. Maybe it was.

(This not our first post on the Essure litigation. For earlier examples, see here and here.)