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Medtronic Defibrillator Lead Litigation Not Preempted: Indiana Appeals Court

Oct 18, 2013

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An Indiana appeals court ruled that a negligence lawsuit filed against medical device maker Medtronic over a failed Transvene defibrillator lead isn't preempted by federal law. The issue preventing preemption: Medtronic representatives offered improper advice during a surgical procedure.

On Oct. 11, the Court of Appeals of Indiana denied Medtronic’s motion for summary judgment in a lawsuit filed against it by Lori Malander, individually and representing David Malander Sr., deceased, and Kathleen Malander.

In its motion for summary judgment, Medtronic had argued that federal preemption laws barred the negligence claim against the company by the family of David Malander Sr.

In 1997, Malander was implanted with a Medtronic defibrillator including Transvene right ventricular lead, according to the published opinion. The lead was a class III medical device and therefore had been subject to the U.S. Food and Drug Administration (FDA)’s premarket approval, or PMA. “Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury,” the FDA notes on its website, where it defines PMA as “the most stringent type of device marketing application required by FDA. The applicant must receive FDA approval of its PMA application prior to marketing the device. PMA approval is based on a determination by FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s). An approved PMA is, in effect, a private license granting the applicant (or owner) permission to market the device.”

Malander’s defibrillator was upgraded in 2004, but the same lead was left in place – despite nine episodes of what is called “random short V-V intervals.” Short V-V intervals are basically like false positives in which the device is sensing electrical activity unrelated to the heart's activity, the published opinion noted.

Dr. Lawrence Klein, Malander's surgeon, scheduled another surgery for Dec. 7, 2006, to replace the defibrillator. During that procedure a Medtronic Clinical Specialist was present and assisted the doctor with testing the lead. Testing didn’t reveal any problems with the lead, according to the published opinion. Still, Dr. Klein called Medtronic during the surgery and discussed the lead with two additional Medtronic personnel, both members of the device maker’s technical services department. The doctor requested “all the information they possessed on short V-V intervals,” the published opinion read. Dr. Klein eventually chose not to replace the Transvene lead, based on the advice of the three Medtronic representatives and the fact that testing revealed no problems with the lead.

Malander died on January 2, 2007, not even one month later, after suffering a ventricular tachycardia on December 31, 2006. Testing of his defibrillator revealed that it had experienced 361 short V-V intervals between December 14, 2006, and December 31, 2006, according to the published opinion.

The family filed a complaint against both Dr. Klein and Medtronic, alleging the advice Medtronic representatives gave during surgery was negligent. The family found Medtronic, specifically, negligent on three counts; Medtronic claimed all three charges were preempted by federal law. The Indiana appeals court, in its opinion, ruled that the first two charges – which had to do with the design of, and failure to recall, the lead, respectively – were preempted but that the third was not; the third claim alleged that the company was negligent because it had failed “to recommend that the… lead be removed or capped off during David Malander’s December 7, 2006 surgery.”

As the published opinion noted: “… the Malanders argued that… Medtronic’s negligence during the December 2006 surgery… was not preempted. The Malanders argued that Medtronic assumed a duty to David when its technicians advised Dr. Klein regarding the Lead but did not advise him to replace the Lead.”

"The Malanders' claim here relates to oral representations made by a manufacturer's representatives during a surgical procedure regarding a specific device's performance, not general allegations regarding the labeling, design, or manufacture of the device," the appeals court found. "Rather, the Malanders' challenge involves negligence of Medtronic's technicians in giving David's physician allegedly faulty advice regarding the performance of one specific lead.”

The family had also argued that Medtronic had assumed a duty "to make 'technical' recommendations to Dr. Klein regarding the lead," according to the published opinion.

"Medtronic's failure to exercise reasonable care in giving technical support would clearly increase the risk of harm to a patient. Medtronic voluntarily undertakes to perform the technical support for physicians to assist the physician in using their devices. The Malanders designated evidence that Medtronic's technician was present in the operating room and that Dr. Klein talked on the telephone to additional technicians regarding the short V-V intervals experienced by David's lead. The Malanders also designated evidence that Medtronic's technicians failed to follow the recommendations of its own internal memoranda regarding the short V-V intervals associated with this particular lead."

The appeals court concluded that the Malanders' claim was not preempted, and that the trial court had properly denied Medtronic's motion for summary judgment.

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