Supreme Court Asks For Administration’s Input On Device Pre-emption Case

Article preview from "The Gray Sheet" - October 14, 2013

Supreme Court asks solicitor general to weigh in on a suit against Medtronic with implications for federal pre-emption. In other Supreme Court updates, the court decided not to hear a completely separate appeal from Medtronic on a TAVR patent infringement suit; and a physician is trying to bring his stent patent case against Johnson & Johnson to the high court.

Supreme Court Asks For Administration’s Input On Device Pre-emption Case

Article preview from "The Gray Sheet" - October 14, 2013

The Supreme Court invited the U.S. solicitor general Oct. 7 to file a brief in the case of Medtronic Inc. v. Richard Stengel, et ux., expressing the views of the United States. Medtronic had petitioned the high court to hear the case earlier this year, but the justices have yet to decide.

If the court elects to hear the case it could have important implications for the federal pre-emption protections against patient suits in state court for PMA-approved devices. The 2008 Supreme Court ruling in Riegel v. Medtronic established strong pre-emption for PMA devices, but left some opening for companies to be sued based on claims that they violated FDA requirements. (See "In Victory For Device Industry, Supreme Court Favors PMA Pre-emption" — "The Gray Sheet," Feb. 25, 2008.) The Stengel case gets to that issue, specifically regarding adverse event reporting requirements.

Medtronic petitioned the Supreme Court May 10 for a writ of certiorari to review a decision from an en banc U.S. Court of Appeals for the Ninth Circuit concerning whether the Medical Device Amendments to the Food, Drug and Cosmetic Act pre-empt a state-law claim challenging that Medtronic violated a duty under federal law to report adverse event information for its SynchroMed EL pump and catheter. The Ninth Circuit held on Jan. 10 that the statute does not pre-empt such a claim. The court also held that the Medicare Device Amendments do not pre-empt, either expressly or impliedly, the appellants’ state-law failure-to-warn claims.

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