One by one, the lawsuits filed against Medtronic Inc. (NYSE:MDT) over its faulty Sprint Fidelis defibrillator leads are falling by the wayside.
Last week the Minneapolis-based medical device monolith agreed to pay $268 million to settle one pack of cases over the leads, which Medtronic pulled from the market in 2007. The wires were prone to fracture, meaning defibrillators could either fail to deliver the shock needed to regulate a haywire heartbeat or send unneeded shocks. The defective leads, which were implanted in an estimated 268,000 patients, are implicated in more than 100 deaths, although Medtronic has said that only 13 fatalities had the leads as a “possible or likely contributing factor.”
Now the U.S. Court of Appeals for the 8th Circuit has put another group of cases behind the company, upholding a lower court’s decision that the Food & Drug Administration’s pre-market approval process preempts the cases.
Lawsuits against Medtronic over the Sprint Fidelis leads have not fared well since the 2008 preemption rule enshrined by the Supreme Court in Riegel vs. Medtronic (PDF). In that case, the Supremes held that once a medical device has been approved by the Food & Drug Administration, product liability lawsuits based on state tort laws have no standing — in other words, the federal approval preempts state law. In October 2009, a Minnesota state judge dismissed 600 personal injury lawsuits against the Fridley, Minn.-based medical device monolith.
And last month the U.S. Appeals Court for the Eighth District shot down the appeal of a ruling dismissing a shareholders lawsuit, saying the plaintiffs failed to prove that Medtronic deliberately concealed problems with the leads.
