Indiana Appellate Court Holds Negligence Action Involving Medtronic Defibrillator Not Preempted by Federal Law
An Indiana appellate court decided that oral representations by a medical device manufacturer during a surgery about the function of device are not preempted by federal law. Could this be a significant exception to the U.S. Supreme Court’s seminal decision in Riegel vs. Medtronic?
In 1997, David Malander received an implanted Medtronic defibrillator and right ventricular lead (“Lead”), which remained in place until he began experiencing problems several years later. The Lead was a Class III medical device subject to premarket approval by the Food and Drug Administration (“FDA”). In 2004 Malander’s surgeon, Dr. Klein, upgraded the defibrillator but left the Lead in place. During a follow-up appointment, Dr. Klein learned that the device had experienced nine episodes of random short V-V intervals, in which the defibrillator senses electrical activity not related to the heart. Surgery was performed to replace the defibrillator in 2006, but again the Lead was left in place. At the time, Dr. Klein was aware that the Lead had a high reported failure rate exceeding 30%, but he deferred to the opinion of a Medtronic Clinical Specialist who was present during the surgery and assisted with testing the Lead, which failed to reveal any problems. Dr. Klein also contacted the manufacturer, Medtronic, during the surgery and requested all available information on short V-V intervals. He was assured that no problems were indicated with the Lead, and ultimately he chose not to replace it.
David Malander died on January 2, 2007, following an incident of ventricular tachycardia several days before. Testing later revealed over 360 short V-V intervals of his defibrillator between December 14 and December 31, 2006. Malander’s estate then filed suit against Dr. Klein and Medtronic, alleging negligence based upon Medtronic’s failure to recommend that the Lead be replaced or capped-off during the surgery. In response, Medtronic argued that the suit was preempted by the Medical Device Amendments of the Federal Food, Drug and Cosmetics Act, and also contended that the lawsuit sought to impose a duty to warn on its technicians exceeding those on the device’s labeling.
A unanimous panel of the Indiana Court of Appeals disagreed and upheld the family’s negligence claims, holding that the family was not claiming that Medtronic should have given warnings that differed from, or exceeded, those required by federal law. Second, the state’s second-highest appellate court noted that the plaintiffs were challenging the specific interaction between Medtronic’s technicians and the operating surgeon, during the procedure itself, which focused on the safety of the implanted device and its single Lead, which the appellate court found to be a localized event free from federal regulation. In this regard, the Indiana Court of Appeals found that Medtronic may have assumed a duty to the patient by voluntarily offering technical support to physicians implanting its devices.
By refusing to dismiss the claim, the appellate court distinguished the United States Supreme Court’s 2008 decision in Riegel vs. Medtronic, which held that certain common law negligence and product liability claims seeking to impose “additional requirements” on device makers, beyond those imposed by the Medical Device Amendments, were preempted as a matter of federal law. “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 court ruled.
Impact: While the Malander decision turns on the specific facts relative to a single surgical procedure, it potentially represents a significant exception from the Supreme Court’s Riegel opinion and sounds a cautionary note for manufacturers who provide real time information and advice during ongoing surgical procedures. At the time this note was published, no decision had been made by the manufacturer with respect to a possible appeal to the Indiana Supreme Court.