Careful What You Say – No Preemption for Statements Made in Operating Room


Makers of medical devices marketed pursuant to the Food and Drug Administration’s (FDA) premarket approval process are generally relieved from defending state law failure to warn claims by operation of express preemption, a principle elucidated by the Supreme Court in Riegel v. Medtronic, 552 U.S. 312 (2008).  The Indiana Court of Appeals, however, recently affirmed a trial court’s determination that a medical device manufacturer could not successfully assert a preemption defense in a product liability suit where the manufacturer provided “technical support” to a surgeon concerning the medical device.


The Malanders’ Lawsuit
The case, Medtronic, Inc. v. Malander, Slip op., No. 49A02-1211-CT-925 (Ct. App. Ind. Oct. 11, 2013), concerns a Medtronic defibrillator and ventricular lead implanted in the plaintiff, David Malander, in 1997.  In 2006, Malander was scheduled for another surgery to upgrade the existing defibrillator and possibly replace the ventricular lead after his surgeon discovered that the device experienced short V-V intervals.  During that surgery, a Medtronic “clinical specialist” assisted the surgeon in testing the lead, and the physician also called Medtronic’s technical services department, where he spoke with two representatives.


The surgeon requested information concerning short V-V intervals and asked whether the lead testing indicated that the lead would need to be replaced: “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?”  A Medtronic representative responded, “Don’t worry about that; it doesn’t mean anything. . . . I don’t think that’s a problem."


The surgeon chose not to replace the lead, and Malander died the following month.  Tests later revealed that the defibrillator experienced episodes of short V-V intervals prior to his death.  Members of the Malander family sued Medtronic alleging, in part, negligence for design defect, failure to warn, failure to recall the device, and failure to advise the surgeon to replace the lead.


Medtronic’s Motion
Medtronic filed a motion for summary judgment noting that, as a Class III medical device, the defibrillator and lead “are subject to a rigorous regime of premarket approval, which includes review of the device’s proposed labeling.”  Moreover, the applicable regulatory scheme governing the defibrillator and lead “forbids the manufacturer to make, without FDA permission, changes in design specifications, manufacturing processes, labeling or any other attribute, that would affect safety or effectiveness.”  Accordingly, Medtronic argued, it was entitled to summary judgment by operation of preemption.


In addition, in response to the Malanders’ opposition to the motion for summary judgment, Medtronic argued it did not assume a duty to David Malander.  Rather, Medtronic argued that the surgeon was in charge of the operation, that the surgeon was in possession of the same information as the technicians, and that the technicians are prohibited from practicing medicine.


Trial Court Decision and Appellate Review
The trial court denied Medtronic’s motion, finding that the Malanders’ suit was not preempted and that there was a question of material fact as to whether Medtronic assumed a duty of care by its representatives’ statements to the surgeon about the viability of the implanted lead.  On appeal, Medtronic raised two issues: (1) whether the trial court properly concluded that the Malanders’ suit was not preempted; and (2) whether the trial court properly denied the motion for summary judgment concerning the question of whether Medtronic voluntarily assumed a duty to the plaintiff-decedent.


The Court of Appeals affirmed.  Of particular significance to the appellate decision was the contact between the surgeon and Medtronic representatives during the 2006 surgery.  The Court of Appeals found that the oral statements made to the surgeon were not a “mere restatement of information given in the labeling,” and thus were not subject to preemption.  In addition, the Court of Appeals found that Medtronic assumed a duty by “voluntarily” providing technical support for physicians and that a question of fact existed as to whether the technicians’ advice comported with the standard of care.


The Malander decision serves as an important reminder that a manufacturer’s “warnings” are not limited to FDA-approved product labeling.  Where employees provide advice outside the approved label, the manufacturer may face liability.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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