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As evidenced by our PMA Preemption Score Card, on which today’s case became the 651st entry, defendant manufacturers of FDA-approved Class III medical devices generally do pretty well with preemption motions.  But plaintiffs keep filing PMA medical device complaints, so we’ll keep posting about them. 

Which brings us to today’s case, Arnold v. Coopersurgical, Inc., 2023 U.S. Dist. LEXIS 118490 (S.D. Ohio Jul. 10, 2023).  Plaintiff alleged she suffered injuries as the result of Filshie Clips, 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.  Before getting to the preemption issues, the court ruled on three defendants’ motions to dismiss for lack of personal jurisdiction.  One defendant began selling the device years after plaintiff’s surgery, but before the device was explanted.  The court denied that defendant’s personal jurisdiction motion, focusing on defendant’s forum-related activities that could have contributed to the delay in identifying the problem with the medical device.  Another defendant was the parent corporation of the manufacturer.  That defendant’s motion was granted because plaintiff failed to plead any alter ego allegations and even those raised in briefing were insufficient to pierce the corporate veil.  The final defendant was a non-US manufacturer.  That defendant’s motion was denied without prejudice and plaintiff was granted the opportunity to conduct limited jurisdictional discovery.  All of these motions were discussed in detail in the opinion, but the analyses are largely fact specific and so we are not going into detail here.      

Moving on to preemption, the court examined each of plaintiff’s three strict liability claims – design defect, manufacturing defect, and failure to warn.  On design defect, the court noted that plaintiff failed to allege that the device was designed differently than the design approved by the FDA.  So, to prevail on this claim, plaintiff would have to establish that the device should have been designed in a manner different than that approved by the FDA.  That claim is expressly preempted by Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  Id. at *43.

Plaintiff also alleged that her design defect claim was based on defendant’s failure to comply with non-identified FDA manufacturing regulations.  While the complaint did not cite any specific FDA regulations, the crux of plaintiff’s allegations were that defendants had information at the time of the PMA and thereafter that they failed to disclose to the FDA.  Plaintiff posits that had those disclosures been made, the FDA could have changed the labeling, could have warned healthcare providers, could have stopped sales of the device, or could have recalled the device.  But calling it design defect based on a failure to disclose doesn’t change the fact that this is really a fraud-on-the-FDA claim which is impliedly preempted by BuckmanId. at *46-47.  “[I]t is for the federal government to prosecute suites for noncompliance with the MDA—not private plaintiffs.”  Id. at *48.  Design defect was dismissed.

Plaintiff’s manufacturing defect claim also had a fatal flaw – no allegation that defendants deviated from any FDA-prescribed manufacturing requirement.  Id. at *49.  So, allowing this claim “effectively results in a holding that an FDA-approved manufacturing process could nevertheless be legally insufficient and expose defendant to liability.”  Id. (citation omitted).  Since that would encroach on the FDA’s regulatory authority, this claim is also expressly preempted. 

That left only plaintiff’s failure to warn claim, which would normally follow the same logic as above.  Any claim that defendant should have given a warning different from or in addition to those authorized by the FDA for a PMA medical device is preempted.  The court, however, read plaintiff’s complaint as avoiding alleging defendants failed to provide warnings beyond those required by the FDA.  The reasoning is a little murky, but it essentially consists of three parts.  First, plaintiff “limits her FDCA failure-to-warn allegations to those that parallel Ohio’s product liability laws.”  Id. at*53.  Second, because it is a traditional state law claim it is permitted by Buckman.  Third, the court relied on a Sixth Circuit case that suggested that a failure to warn claim could survive preemption at the pleadings stage if it was based on information acquired subsequent to FDA approval that would lead a reasonable manufacturer to warn patients.  As we understand it then, plaintiff has a narrow failure to warn claim limited to newly acquired information.  The court did note, however, that plaintiff’s allegations lack clarity.  Not enough to warrant dismissal but enough to hinder the court’s ability to conduct a full analysis, leading the court to believe that the failure to warn claim is better suited for summary judgment after discovery.  So, not only was plaintiff left with one narrow claim, but an admonishment from the court that the preemption hurdle has been cleared for now, but plaintiff has some work to do to make that stick.