An Indiana appeals court just ruled that Medtronic cannot use so-called “preemption” to get out of a negligence lawsuit filed over a failed Transvene defibrillator lead.
Preemption is legal concept that a number of medical device makers have used in liability lawsuits that have been filed over devices that have received U.S. Food and Drug Administration (FDA) approval, MassDevice.com previously reported.
In this case, the Court of Appeals of Indiana denied Medtronic’s bid for summary judgment. Medtronic argued that federal preemption laws barred the negligence claim against it, according to MassDevice.com.
In 1997, the plaintiff was implanted with a Medtronic defibrillator and a Transvene lead, court records indicated. The defibrillator was upgraded in 2004; the lead remained in place, although records indicate nine episodes of random short V-V intervals, MassDevice.com reported. Short V-V intervals are false positives that involve the lead sensing electrical activity that does not involve cardiac activity, according to court documents.
The plaintiff’s surgeon scheduled surgery for December 7, 2006 to replace the defibrillator, but opted against replacing the Transvene lead after an on-site Medtronic representative and two technical services representatives, who were contacted by telephone, advised the surgeon not to be concerned with the short V-V intervals, court documents indicate. Appeals court documents also indicate that lead testing did not reveal the issue, according to MassDevice.com.
According to the documents, the physician asked a number of questions regarding the short V-V intervals, including if the issue was indicative of lead failure. One of the technical service representatives said, according to court documents: “Don’t worry about that; it doesn’t mean anything…. I don’t think that’s a problem.” The plaintiff died less than one month later, “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,” according to court documents, MassDevice.com reported. The plaintiff’s family sued the surgeon and Medtronic and allegation claims include negligence stemming from the advice Medtronic representatives provided during his surgery, MassDevice.com noted.
“The” plaintiffs’ “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” plaintiffs’ “challenge involves negligence of Medtronic’s technicians in giving” the deceased’s “physician allegedly faulty advice regarding the performance of one specific lead. As such, we conclude that the” plaintiffs’ “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” the surgeon “regarding the lead,” according to the documents. “We agree with the” deceased’s family. “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” family’s “designated evidence that Medtronic’s technician was present in the operating room and that” the surgeon “talked on the telephone to additional technicians regarding the short V-V intervals experienced by” the deceased’s lead. The” family “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.”
Most recently, a preemption bid made by Medtronic and Stryker to dismiss a lawsuit filed over their bone protein products was rejected. That case involved the alleged off-label marketing of Stryker’s OP-1 Putty used with its Calstrux bone-filler and Medtronic’s Infuse bone graft. And, in another case in which Medtronic sought reconsideration of a ruling, Medtronic asked Judge G. Murray Snow, U.S. District Court for Arizona, to dismiss a lawsuit on the grounds that Infuse is protected under federal preemption, MassDevice.com previously reported. Judge Snow ruled that federal preemption does not apply in a case in which Medtronic is accused of marketing Infuse off-label; the plaintiff accused Medtronic of touting Infuse for procedures that were not FDA-approved, according to MassDevice.com.