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| Medtronic was rebuffed by the U.S. Supreme Court in an ongoing lawsuit over its SynchroMed infusion pumps.--Courtesy of Medtronic |
Medtronic ($MDT) lost a fight in an ongoing legal battle over its infusion pain pump, as the U.S. Supreme Court refused to hear the company's appeal in a lawsuit from a man who became paraplegic after receiving the implant.
The nation's high court left the federal appeals court decision intact, allowing the suit to move forward against the Minneapolis-based company, Bloomberg reports. Richard Stengel and his wife had sued Medtronic under Arizona state law, claiming that the company's faulty SynchroMed pump left him paralyzed and that the injury could have been avoided if Medtronic had reported the problems to the FDA sooner. Stengel has since died.
Medtronic fought back, arguing that patients cannot use state law to sue devicemakers for violating federal regulations. A district court initially upheld the company's claim, but a San Francisco-based 9th U.S. Circuit Court of Appeals rejected the argument. The court said patients could sue under state rules that are "parallel" to federal requirements, and that the Stengel's could proceed with their claims.
Medtronic's attorneys declined to comment on the ruling, but the company said in an emailed statement that is was disappointed with the denial, Cronkite News reports. The company added that FDA oversight should govern the safety and efficacy of medical devices.
"Without pre-emption, there would be no central standard for device safety, effectiveness, testing, labeling and marketing," the devicemaker said in a statement.
The latest ruling continues Medtronic's SynchroMed pump saga, as Stengel originally brought the suit against the company in 2000, according to court records. In 2005, Stengel suffered paralysis in his lower limbs due to inflammation that formed in his spine at the tip of the pump. Physicians removed the device, but Stengel eventually lost use of his legs.
Medtronic has since issued repeated warnings about its SynchroMed line, and was slapped with a Class I recall from the FDA for its pumps last year. Problems with the infusion system have led to 14 deaths since 1996, with 11 deaths resulting from improper infusion, two from blockages, and one from an electrical short.
- read the Bloomberg story
- get more from Cronkite News
- here's the U.S. Supreme Court petition (PDF)