Medtronic can't shake negligence lawsuit over Transvene defibrillator lead

October 16, 2013 by Brad Perriello

A negligence lawsuit filed against Medtronic over a failed Transvene defibrillator lead isn't preempted by federal law, an Indiana appeals court rules.

Indiana appeals court shoots down Medtronic's preemption argument

Medtronic (NYSE:MDT) can't use preemption to shake a negligence lawsuit filed over a failed Transvene defibrillator lead, an Indiana appeals court ruled last week.

The Court of Appeals of Indiana denied the Fridley, Minn.-based medical device company's bid for summary judgment in the case Oct. 11, in which Medtronic argued that federal preemption laws barred the negligence claim against it by the family of David Malander Sr.

Malander received a Medtronic defibrillator and the accompanying Transvene lead in 1997, according to court records. The defibrillator was upgraded in 2004, but the lead was left in place despite 9 episodes of random short V-V intervals, according to the records.

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Short V-V intervals are, in effect, false positives in which the device senses electrical activity that's not related to the heart's activity, according to court documents. Malander's surgeon, Dr. Lawrence Klein, scheduled another surgery for Dec. 7, 2006, to replace the defibrillator, but elected not to replace the Transvene lead after an on-site Medtronic representative and 2 technical services reps reached by phone told him not to worry about the short V-V intervals, according to the documents. Testing of the lead did not reveal any problems, according to the appeals court documents.