Summary Judgment Obtained on Behalf of Class III Medical Device Manufacturer Based on Preemption

Kara Stubbs of Baker Sterchi, in collaboration with Burbidge Mitchell, secured summary judgment in a medical device product liability case before the United States District Court for the Western District of Missouri.

Plaintiffs brought suit against our clients, the entities that designed, manufactured, distributed and sold the Filshie Clip, a Class III medical device. In its Premarket Approval process, the FDA determined the Filshie Clip to be a safe and effective method of female contraception and approved the warnings and precautions found in the device’s Instruction for Use.

The device was implanted during Plaintiff Kristin Bergdoll’s tubal ligation procedure in 2004. Plaintiffs filed a lawsuit under Missouri law claiming the Filshie Clip migrated after the initial procedure causing injury and requiring surgical intervention. Plaintiffs asserted claims based on design defect, manufacturing defect, failure to warn, strict liability, negligence, violation of consumer protection laws, gross negligence and punitive damages.  At their core, the claims asserted that (i) the Filshie Clip labeling should have disclosed more warnings about migration, and (ii) Defendants failed to report adverse events involving clip migration to the FDA. It was undisputed that the FDA had reviewed and audited the manufacturer’s complaint-handling procedures and complaint files and never found non-compliance with its reporting decisions on complaints of migration. Plaintiffs alleged that the FDA did not know about scientific articles and adverse events that Defendants deemed non-reportable.

We moved for summary judgment on preemption grounds as the Filshie Clip received pre-market approval by the FDA and Plaintiffs’ contentions sought to impose standards different from, or in addition to, the federal law that exclusively regulates the Filshie Clip, and sought to privately enforce FDA requirements. The court held Plaintiffs’ claims to be preempted.

With respect to the design and manufacturing claims, the court found Plaintiffs did not provide evidence that the design or manufacture deviated from FDA approved design or that the device was manufactured in a way that violated PMA requirements. The court found these claims to be an attempt to impose responsibilities that are different from, or in addition to, the FDA requirements and, therefore, held the design and manufacturing claims to be preempted.

The court likewise ruled that the failure-to-warn claims were preempted because Plaintiffs did not allege that the Filshie Clip warnings deviated from the FDA-approved language. Instead, by alleging the warnings were inadequate despite FDA approval, the court determined that Plaintiffs sought to hold Defendants to standards that are different from, or in addition to, the FDA requirements and are, therefore, preempted.  The court also found that Plaintiffs’ allegation that Defendants failed to report adverse events and a journal article containing an estimate of asymptomatic migration rates was also preempted, recognizing the allegations as an improper attempt to privately enforce FDA requirements.

The court further found that Plaintiffs’ claims based on strict liability, negligence and violations of consumer protection laws, all stemming from the same underlying facts, were preempted for the same reasons.

In reaching its preemption decision, the court relied upon the Eighth Circuit precedent of In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig.,which states:

Riegel and Buckman create a narrow gap through which a plaintiff’s state-law claim must fit if it is to escape express or implied preemption. The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by § 360k(a), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman). In re Medtronic, Inc., Sprint Fidelis Leads Prod. Liab. Litig., 623 F.3d 1200, 1204 (8^th Cir. 2010)(internal citations omitted).