Justices seek Obama administration views in medical device case

Reuters News
Posted: Oct 07, 2013 11:25 AM

By Lawrence Hurley

WASHINGTON (Reuters) - The Supreme Court on Monday sought the legal views of the Obama administration in a medical device manufacturer's appeal of a ruling that the company can be sued by a man who was left paralyzed after using one of its products.

Arizonan Richard Stengel says federal law regulating medical devices does not trump his claims under state law because Medtronic Inc failed to alert the U.S. Food and Drug Administration to known risks associated with the pain medication pump and catheter that was implanted in his abdomen.

By asking the Obama administration for its views, the Supreme Court indicated that at least some of the nine justices were interested in hearing the case, possibly signaling the court will ultimately decide to review the lower court ruling against Medtronic.

Stengel was left paraplegic as a result of his use of the device, which was implanted in 2000 and removed in 2005 after he collapsed at home.

In 2007, the FDA warned Medtronic that it had failed to disclose the risks of using the device, and the product was pulled off the market in 2008.

The case is the latest in a series of disputes before the Supreme Court over to what extent federal laws that regulate medical devices can shield companies from lawsuits filed by injured patients. In 2008 the court ruled in Riegel v. Medtronic that defective device claims under state law were barred when the device in question had been approved by the FDA.

Stengel and his wife Mary Lou claim in their lawsuit that their case is different because medical device-related amendments to the Federal Food, Drug and Cosmetic Act required Medtronic to alert the FDA about potential flaws in its products if the products were already approved by the agency. The failure to do so gave rise to a negligence claim under Arizona law that is not preempted, the couple said.

A federal judge dismissed the lawsuit. In April 2012, a three-judge panel of the San Francisco-based 9th U.S. Circuit Court of Appeals upheld that ruling. But the court later reheard the case and revived the lawsuit in a January 2013 ruling, prompting Medtronic to seek Supreme Court review.

Another case in which the Supreme Court asked for the Obama administration's views on Monday focused on whether an employee could bring a federal whistleblower claim against Takeda Pharmaceuticals Co Ltd for alleged fraud against the government.

Noah Nathan, a former sales manager with Takeda, sued the company on behalf of the federal government, saying Takeda subsidiaries Takeda Pharmaceuticals North America Inc and Takeda Pharmaceuticals America Inc had violated the False Claims Act by seeking payments under federal health insurance programs for uses of a drug that were not reimbursable.

The cases are Medtronic v. Stengel, U.S. Supreme Court, 12-1351 and Nathan v. Takeda, U.S. Supreme Court, No. 12-1349.

(Reporting by Lawrence Hurley; Editing by Howard Goller and John Wallace)