And patience is a virtue…all great achievements require time…trust the process.  All easier said than done.  Waiting can be a breeding ground for discouragement or frustration—like in litigation where, unfortunately for defendants that waiting usually comes at the significant cost of having to defend against and conduct discovery.  Especially when the result after all that discovery feels like it could have come much earlier.  Which may be what the defendants in Arnold v. Coopersurgical, Inc., 2025 U.S. Dist. LEXIS 34520 (S.D. Ohio Feb. 26, 2025) are feeling.

A year and a half ago we brought you the decision in Arnold on defendants’ motions to dismiss.  The court dismissed all of plaintiff’s claims as preempted except for failure to warn—finding plaintiff’s warning theory to be “not well defined” but good enough to survive the pleadings stage and for the case to proceed to discovery.  Id. at *12-13.  It came as no surprise to us that discovery didn’t fix plaintiff’s problems.

The product at issue is a Filshie Clip, a medical device used in tubal ligations.  The device was pre-market approved by the FDA in 1996 and has been sold throughout the United States ever since.  In plaintiff’s case, she underwent her tubal ligation in 2003 and nearly 20 years later, an x-ray of her pelvis after a fall on the ice revealed that a clip had migrated in her abdomen.  Id. at *7-8.

Medical devices that undergo pre-market approval, PMA devices, are subject to FDA requirements imposed as part of their approval.  Therefore, any state law requirement that is “different from, or in addition to” the FDA’s PMA requirements is expressly preempted.  21 U.S.C. § 360k(a).   Further, some claims that are not expressly preempted can still be impliedly preempted because the Supreme Court has held that the FDA is the “exclusive enforcing body of the FDCA.”  Id. at *18.  Thus, a plaintiff cannot sue a defendant for violating the FDCA.   Each of plaintiff’s failure to warn claims ran afoul of either express or implied preemption.

Plaintiff’s first theory was that defendants failed to adequately warn about the risk of migration both at the time of her surgery and thereafter.  Specifically, plaintiff wanted defendant to warn that the clips had a 25% migration rate—a warning that the FDA never requested or required.  Id. at *19-20.  Therefore, plaintiff is asking the court to impose a warning requirement that is beyond what was required by the FDA.  Such a claim is expressly preempted.  Id. at *20.  Plaintiff’s post-sale failure to warn claim suffered the same fate.  As part of the PMA process, the FDA requires continuous updates, in part so that it can assess the need for new warnings.  The undisputed evidence in the case is that defendants complied with the FDA post-PMA reporting requirements and the FDA never required the clip’s warning to include the 25% migration rate.  Because the FDA’s requirements extend to post-sale warnings, this claim was also expressly preempted.  Id. at *21-24.

Plaintiff’s second failure to warn theory was actually a failure to report claim.  She argued that defendant should be liable for not reporting adverse events to the FDA and/or to her and her surgeon directly.  Failure to report to the FDA is just another way of saying fraud-on-the-FDA which is impliedly preempted under Buckman. Id. at *25-26.  Further, plaintiff could not identify any state law duty to report adverse events to the FDA.  In other words, plaintiff claim is entirely based on an allegation that defendant violated the reporting requirements of the FDCA.  Another reason her failure to report claim was impliedly preempted.

As far as direct reporting of adverse events to patients and doctors—again there is no state duty requiring such reporting.  For good reason.  “Adverse event reports are not warnings.”  Id. at *27.    Far from it. They merely report that an event occurred, not that the device caused or contributed to the event.  Moreover, the FDCA does not require that manufacturers report adverse events to patients or doctors, so any state law requirement to that effect would be different from or in addition to federal requirements and therefore preempted.  And the court acknowledged that this conclusion comports with decisions by courts across the country on the same claims. 

While defendants may have been vexed that they did not obtain this result at the dismissal stage, they can take solace in a summary judgment win that is better late than never.  Or all’s well that ends well…a smooth sea never made a skilled sailor…there’s light at end of the tunnel…….