Essure is a small metal coil that’s placed in the fallopian tubes via catheter. The FDA said in 2015 that it received 5,093 complaints in the 13 years since Essure’s approval, including for pain or menstrual irregularities after using the device and complaints of the device breaking. In addition to five fetal deaths, there were four reports of adult deaths for reasons such as infection and uterine perforation, the FDA said.
In November 2016, the federal safety watchdog released new labeling requirements for Essure other permanent hysteroscopically-placed tubal sterilization implants. The updated guidelines madated a patient checklist to avoid possible adverse events and a boxed warning as labeling for the devices. The FDA last year mandated a new study and new labeling of Essure. In August 2016, the agnecy said it completed a review of a trade complaint which alleged that Bayer was engaged in clinical trial misconduct and altering data, finding no signs of manipulation.
A group of 94 plaintiffs from 25 states sued Bayer in January, alleging that Essure caused their injuries. In a July 14 ruling, Judge Carol Jackson of the U.S. District Court for Eastern Missouri tossed all but eight defendants, seven from Missouri and one from Illinois whose implantation occurred in The Show Me State.
Bayer and its affiliates filed a motion to dismiss, alleging lack of personal jurisdiction, forum non-conveniens for the out-of-state claims, preemption, failure to state a claim and failure to plead fraud claims with particularity, according to court documents.
Jackson ruled that the Bayer entities are not subject to general or personal jurisdiction.
“The question of general jurisdiction is easily disposed of here, as none of the defendants is incorporated in Missouri or has its principal place of business in the state. Moreover, none of the defendants have such substantial and extensive contacts such that they are essentially ‘at home’ in Missouri. Plaintiffs’ allegations that defendants conduct ‘substantial business activities’ in Missouri are insufficient to show that defendants are ‘at home,'” she wrote.
“With one exception in this case, the non-Missouri plaintiffs do not allege that they acquired the Essure device from a Missouri source or that they were injured or treated in Missouri; thus, ‘all the conduct giving rise to the nonresidents’ claims occurred elsewhere,'” Jackson added. “Moreover, defendants did not develop, manufacture, label, package, or create a marketing strategy for Essure in Missouri. And the general exercise of business activities in the state cannot create an adequate link between the claims and the Missouri forum. The sole exception is the claim of Illinois plaintiff Jennifer Dischbein, whose device was implanted in Missouri. With respect to the other non-Missouri plaintiffs, under Bristol-Myers, there is no personal jurisdiction as to their claims because there is no “connection between the forum and the specific claims at issue.”
Jackson also found that her personal jurisdiction ruling obviated the need for a ruling on the forum non conveniens argument and that the dismissal of the non-Missouri plaintiffs “negates any challenges to complete diversity. Therefore, the plaintiffs’ motion for remand will be denied.”
The remaining defendants today filed motions for reconsideration, leave to file amended complaint and to allow jurisdictional discovery, according to the documents.