Last year we wrote a post about Froman v. Coopersurgical, Inc., 2022 US Dist LEXIS 120725, *2-3 (N.D.AL Jul. 8, 2022), calling it trifecta Tuesday because the case was dismissed on the grounds of personal jurisdiction, pleadings deficiencies, and preemption. Today’s case involves the same product, the same defendants, and the same conclusions on personal jurisdiction and preemption.

As in Froman, the plaintiff in Watters v. Coopersurgical, Inc., 2023 WL 1982347 (E.D.N.C. Feb. 13, 2023), alleges that she suffered an injury when a device implanted during her tubal ligation surgery migrated requiring explantation nearly nine years later.  She sued multiple parent/subsidiary companies, certain of which appear to be the companies that manufactured the device at the time it was implanted and others seem to be subsequent sellers of the product.  All four defendants moved to dismiss on preemption grounds and three defendants moved to dismiss for lack of personal jurisdiction.

Plaintiff conceded that court did not have general jurisdiction over the three defendants but as to two of them argued that specific jurisdiction existed based on defendants marketing and distributing the device in North Carolina, even if those activities did not take place until after Plaintiff’s 2013 surgery.  Plaintiff argued the timing of the marketing did not matter; that having marketed the device in North Carolina at all the defendants “purposefully availed” themselves of the forum and were therefore subject to jurisdiction.  Id. at *3.   The court disagreed noting that Plaintiff’s argument ignored the requirement that the “facts establishing personal jurisdiction must be tied to the same underlying controversy that gave rise to the lawsuit.”  Id.  Plaintiff’s alleged injury could not “arise out of or relate to” activities by the defendants that post dated her surgery by several years.  Moreover, the clip implanted in plaintiff was developed by a different company before these defendants entered the market.  The actions of their competitors could not provide a basis for personal jurisdiction against these defendants.

As to the third defendant, plaintiff argued that it sold the device to a distributor, the fourth defendant, to whom it gave permission to sell the device throughout the United States and that distributor did in fact sell the device in North Carolina.  But that argument essentially means defendant would subject to personal jurisdiction everywhere, which the court and ample Fourth Circuit precedent rejected.  If a manufacturer sells a product to a distributor with no direct purpose that the product be sold in a particular state, that is not enough to establish specific personal jurisdiction.  Because the distributor controlled where and to whom to sell the device, its activities could not be imputed to the manufacturer.  Id.at *4-5.

All four defendants also moved to dismiss the case as preempted. The device at issue is a Class III medical device that went through the FDA’s Pre-Market Approval process.  Therefore, Riegel and Buckman leave only a “narrow gap” through which a case may slip by preemption.  The claims must be parallel to federal requirements (to avoid express preemption) but cannot be based solely on federal violations (to avoid implied preemption).  All of plaintiff’s claims were based on allegations that defendants failed to accurately and fully report adverse events to the FDA.  And while adverse event reporting is a federal requirement, “North Carolina law does not recognize a parallel duty on manufacturers to report to the FDA.”  Id. at *7.  Further, since the crux of plaintiff’s claim is that had defendants reported different information to the FDA, the FDA would have taken different action, the claim is a preempted fraud-on-the-FDA claim.  Id. Any other claims based on allegations that defendants owed plaintiff or her doctors a duty, would serve to impose different or additional state-law obligations and thus are also expressly preempted. 

Finally, where the court pointed out that plaintiff failed to identify which specific regulations were allegedly violated, plaintiff asked for the right to take discovery “to uncover” the regulations that could possibly apply.  Absent some argument that defendants had information that was solely in their possession, the court “decline[d] to conscript defendants to find regulations for [plaintiff] to plead on her own behalf.”  Id.  Sending plaintiff back to do her own homework, the case was dismissed as to all four defendants without prejudice.