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.
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.
"Dr. Klein asked, ‘Did we test it properly, is this lead functioning normally … is there any information about the short V-V intervals that I need to know about. Are they okay, do they indicate a lead failure?’" according to the documents. "[A technical service rep] responded, ‘Don’t worry about that; it doesn’t mean anything. … I don’t think that’s a problem.’"
Malander died less than a month later, according to the documents, "following an incident of ventricular tachycardia on December 31, 2006. Testing revealed 361 short V-V intervals of his defibrillator between December 14, 2006, and December 31, 2006."
His family sued Klein and Medtronic, alleging negligence stemming from the advice Medtronic representatives gave during his surgery.
"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. As such, we conclude that the Malanders’ claim is not preempted by the MDA, and the trial court properly denied Medtronic’s motion for summary judgment on this issue."
The family also argued that Medtronic assumed a duty "to make ‘technical’ recommendations to Dr. Klein regarding the lead," according to the documents.
"We agree with the Malanders. In fact, Medtronic concedes that, ‘[h]aving volunteered to provide technical support, Medtronic at most assumed a duty to provide that support in a reasonable and prudent manner,’" the court ruled. "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."