Medtronic Petitions Supreme Court Concerning Preemption and Adverse Event Reports

Medtronic, Inc., has petitioned the U.S. Supreme Court to review a decision from the Ninth Circuit Court of Appeals concerning whether the Medical Device Amendments (MDA) to the Food, Drug and Cosmetic Act (FDCA) preempt a state-law claim alleging that Medtronic violated a duty under federal law to report adverse-event information.

Background

In 2000, Richard Stengel had a SynchroMed EL Pump and Catheter, manufactured by Medtronic, surgically implanted into his abdomen to deliver pain relief medication directly into his spine. In 2005, after a hospitalization, he was diagnosed with ascending paralysis of his lower body, caused by the catheter, and a neurosurgeon removed the catheter. Stengel remained paralyzed after the surgery. In 2006, the FDA inspected a Medtronic facility and discovered that Medtronic was aware of the risks associated with the pump and catheter, and had known about them prior to Stengel’s paralysis. The FDA issued a warning letter to Medtronic, stating that Medtronic had misbranded the device by concealing known risks. Medtronic recalled the device in the spring of 2008, three years after Stengel’s paralysis.

The Stengels claimed that Medtronic was negligent under Arizona law because it allegedly failed to provide the FDA with information about adverse events involving the pump and catheter. The Ninth Circuit held that the state-law claim was not impliedly or expressly preempted by the MDA. Further, the court held that the general duty of care under Arizona common law incorporated a requirement to furnish adverse-event information to the FDA. (Stengel v Medtronic Incorporated, 704 F.3d 1224, January 10, 2013).

Petition for Certiorari

The Medtronic petition to the Supreme Court notes that courts of appeal have been divided regarding the applicability of both implied and express preemption under the MDA to state-law claims based on alleged violations of duties imposed by federal law. Regarding whether the MDA impliedly preempts state-law claims, the Ninth Circuit in this case and the Fifth Circuit in Hughes v Boston Scientific Corp., 632 F.3d 762 (2011) have said “no”; while the Sixth and Eighth Circuits have said “yes.” (See In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig (623 F.3d 1200, 1205-06 (8th Cir 2010); and Cupek v Medtronic, 405 F.3d 421, 423-24 (6th Cir. 2005)).

The circuit courts are also split on whether the MDA expressly preempts state-law claims alleging a violation of a generalized, rather than a device-specific, federal requirement. In Riegel v Medtronic, Inc. (552 U.S. 312 (2008)), the U.S. Supreme Court held that 21 U.S.C. sec. 360k expressly preempts state common-law claims regarding medical devices that have received premarket approval, unless those claims are based on state-law duties that are parallel to—and thus do not impose requirements different from, or in addition to—federal requirements. In the wake of Riegel, two circuits have held that this parallel duty exception is not applicable where a state-law duty is alleged to be parallel to a generalized federal duty that applies to all medical devices; four circuits have held the contrary position.

The petition further notes that the Ninth Circuit’s decision “would effectively eviscerate” the U.S. Supreme Court’s earlier decisions in Riegel and Buckman Co. v Plaintiffs’ Legal Comm. (531 U.S. 341 (2001)). “A claim concerning a device that has received pre-market approval can avoid preemption only if it is based on a state-law duty that is both (1) independent of (Buckman), and (2) parallel to (Riegel), a duty imposed by federal law,” according to the petition.

The petition concluded that this case is an “ideal vehicle for addressing a recurring question of exceptional importance to device manufacturers and the public health.”