'Stengel' Tangles MDA Preemption: Ninth Circuit Decision Creates Split On 'Buckman' Preemption Of Post-Market Reporting Requirements

Last week the Ninth Circuit created a new state-law cause of action against medical device manufacturers: "failure to warn the FDA." The en banc opinion in Stengel v. Medtronic Inc., __ F.3d __, 2013 WL 106144, 13 C.D.O.S. 365 (9th Cir. 2013), delivered by Judge Fletcher, held that the Medical Device Amendments ("MDA") to the Food, Drug, and Cosmetic Act ("FDCA") did not preempt this claim because it parallels a federal-law duty imposed by the MDA. This new cause of action opens the door, at least in the Ninth Circuit, to claims against all medical device and drug manufacturers, and could defeat Mensing preemption of failure to warn claims against generic drug manufacturers.

THE ALLEGATIONS IN THE STENGELS' AMENDED COMPLAINT

In October 2000, Richard Stengel had a SynchroMed EL Pump and Catheter—manufactured by Medtronic—surgically implanted in his abdomen to deliver pain relief medication directly into his spine. In February 2005, Mr. Stengel collapsed, reporting heaviness and decreased sensation in his right leg. At the hospital, Mr. Stengel was diagnosed with ascending paralysis. The device was removed, but Mr. Stengel became a paraplegic. Mr. Stengel claimed the device caused his paralysis.

Plaintiffs alleged that Medtronic became aware of risks associated with the pain pump before Mr. Stengel was paralyzed in 2005, but it did not inform the FDA of the risks. The FDA discovered the risks—and that Medtronic knew about them—more than a year after Mr. Stengel's injury. In July 2007, the FDA sent a warning letter to Medtronic stating that Medtronic "misbranded" its pain pump by concealing known risks. In January 2008, Medtronic sent a Medical Device Correction Letter and in March 2008, it recalled the device.

Mr. Stengel and his wife sued Medtronic, alleging that it violated a state-law duty of care by failing to report the known risks associated with the pain pump to the FDA.

THE MEDICAL DEVICE AMENDMENTS

Congress enacted the MDA to extend coverage of the FDCA to medical devices. The MDA divides medical devices into three classes according to user risk. Class III devices are those deemed by the FDA to have the highest risk—they are those that "cannot be determined to provide a reasonable assurance of safety and effectiveness under Class I or II controls and are marketed either as life-supporting or possibly causing an unreasonable risk of illness or injury." Class III devices are subject to the pre-market approval ("PMA") process of the...