U.S. Supreme Court Won’t Hear Drug Pump Adverse Event Preemption Case

WASHINGTON, D.C. — (Mealey’s) The U.S. Supreme Court on June 23 let stand a federal appeals court ruling that there is no preemption of a claim that medical device manufacturer Medtronic Inc. violated its duty under federal law to report adverse events to the Food and Drug Administration (Medtronic, Inc. v. Richard Stengel, et al., No. 12-1351, U.S. Sup. [lexis.com subscribers may access Supreme Court briefs for this case].).

In 2000, Richard Stengel was implanted with a SynchroMed EL Infusion System drug pump to deliver pain drugs to his spinal cord.  A granuloma developed at the tip of the catheter inside Stengel’s spine.  The catheter and the granuloma were removed, but Stengel was rendered paraplegic. 

Stengel and his wife, Mary Lou, sued Medtronic in Arizona state court, alleging that Medtronic failed to use reasonable care in warning of risks associated with the pump.  The plaintiffs alleged that the Food and Drug Administration was not aware of the risk of granulomas when it granted premarket approval to the SynchroMed pump. 

The plaintiffs say that after the pump was approved, Medtronic became aware of adverse event reports that should have been reported to the FDA and that should have resulted in a revised warning label about the granuloma problem.  They said that a warning eventually was added to the device’s label but that it came too late for Richard Stengel. 

Preemption Reversed On Appeal

Medtronic removed the case to the U.S. District Court for the District of Arizona, where the trial court dismissed the Stengels’ claims as barred by express and implied preemption under federal law. 

The Stengels appealed, and a divided panel of the Ninth Circuit U.S. Court of Appeals affirmed.  However, the court granted a rehearing en banc and in 2013 found that the claim was not preempted. 

In March 2013, Medtronic petitioned the Supreme Court for a writ of certiorari.  After the Stengels responded, the court scheduled the case for a conference and in October asked the solicitor general for the views of the United States. 

Solicitor General:  Wrong Reasoning 

In a May 20 brief, the solicitor general said that the Ninth Circuit used the wrong reasoning but said the Supreme Court should still not hear the appeal.  The solicitor general said the Stengels’ claim is not preempted either by Section 360k(a) of the Medical Device Amendments to the Food, Drug and Cosmetic Act nor by the Supreme Court’s fraud-on-the-FDA ruling in Buckman Co. v. Plaintiffs’ Legal Committee (531 U.S. 341 [2001]; See 3/1/01, Page 3).  Instead, the solicitor general said the claim closely resembles the claim against the brand-name prescription drug manufacturer that Wyeth v. Levine (555 U.S. 555 [2009]); See 3/5/09, Page 5) held was not barred by implied preemption. 

On May 30, the court was notified that Richard Stengel had died. 

The United States is represented by Solicitor General Donald B. Verrilli Jr., Assistant Attorney General Stuart F. Delery, Deputy Solicitor General Edwin S. Kneedler, Benjamin J. Horwich, Scott R. McIntosh and Sonia K. McNeil of the U.S. Justice Department and William B. Schultz of the U.S. Department of Health and Human Services, all in Washington. 

Principals’ Counsel 

Medtronic is represented by Miguel A. Estrada, Amir C. Tayrani and Erik R. Zimmerman of Gibson, Dunn & Crutcher in Washington and Michael K. Brown, James C. Martin and Lisa M. Baird of Reed Smith in Los Angeles. 

The Stengels are represented by Allison M. Zieve and Scott L. Nelson of Public Citizen Litigation Group in Washington and Thomas G. Cotter of Haralson, Miller, Pitt, Feldman & McAnally in Tucson, Ariz.

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