Oral advice from Medtronic representatives to physicians during a heart device procedure are not preempted from federal law, an Indiana state appeals court has ruled.
Judge Theodore M. Sosin in the Indiana Court of Appeals has upheld a trial court's decision in dismissing Medtronic's motion for summary judgment. The medical device maker argued the allegations, pertaining to technical support provided to a physician during a 2006 operation, were prevented by a federal law.
David Malander received a Medtronic defribillator and right ventricular lead in 1997. He underwent another surgery in 2006, in which Lawrence Klein, MD, was to upgrade the defribrillator and possibly replace the lead. During that surgery, a Medtronic clinical specialist was present and helped Dr. Klein test the lead.
After testing did not identify any problems, Dr. Klein called Medtronic's technical support department and requested more information on testing the lead. Ultimately they decided not to replace it. Mr. Malander died in January 2007 from ventricular tachycardia, and testing showed electrical activity in his heart related to the defribillator and lead.
Mr. Malander's family filed suit against Medtronic and Dr. Klein. They claimed the device maker was negligent by failing in its design of the lead, failing to recall the lead and failing to recommend the lead be removed during the 2006 surgery. The Malanders argued that Medtronic "assumed a duty" to Mr. Malander when the device maker's technicians advised Dr. Klein about the lead but did not advise he replace it.
Medtronic argued the Malanders' claims were prevented by federal law, or the Medical Device Amendments to the Federal Food, Drug and Cosmetics Act. Namely, Medtronic argued that the claim that its technicians should have provided more warnings above and beyond the device's labor is preempted by the MDA. Under the MDA, once a device has received premarket approval, the manufacturer cannot — without permission from the Food and Drug Administration — make changes in design specifications, manufacturing processes, labeling or any other attribute that would affect safety or effectiveness.
The Malanders counter that their claim is not preempted by the MDA because it involved negligent oral representations by Medtronic's technicians, not the device's labeling. A trial court denied Medtronic's October 2011 motion for summary judgment. Judge Sosin decided the case last week, upholding the trial courts' dismissal of the motion for summary judgment.
In his decision, Judge Sosin concluded the Malanders' claim was not preempted by the MDA, and the trial court properly denied Medtronic's motion for summary judgment on this issue. The judge wrote that the Malanders' challenge "involves negligence of Medtronic's technicians in giving [Mr. Malander's] physician allegedly faulty advice regarding the performance of one specific lead," according to the summary. The claim does not involve "the mere restatement of information given in the labeling" of the device but allegedly faulty clinical advice.
The judge also found that Medtronic assumed a duty to Mr. Malander by "voluntarily [undertaking] to perform the technical support for physicians to assist the physician in using their devices," according to the summary. Medtronic had argued that Dr. Klein was in charge of the surgical procedure regardless of any advice given by its technicians.
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