10 June 2015
Facing allegations that it improperly promoted its Infuse spinal fusion device for off-label uses, Medtronic Inc. has fended off lawsuits by relying on a 2008 U.S. Supreme Court case that disallows most state law tort claims arising from a medical device when the government has approved the device. That case, Riegel v. Medtronic, cropped up again on Tuesday, when a federal appeals court agreed that a Vermont woman's Infuse case should be tossed.
Siding with Medtronic's lawyer, Mayer Brown's Andrew Tauber, the U.S. Court of appeals for the Second Circuit upheld the dismissal of negligence, and failure to warn claims brought against the medical device maker. The Second Circuit ruled that some of the claims of plaintiff Koleen Otis-Wisher were pre-empted under the Medical Device Amendments to the Federal Food Drug and Cosmetics Act.
Tuesday's decision by the Second Circuit marks the latest in a string of mostly favorable rulings the firm has secured for Medtronic in Infuse litigation. In April, for instance, the U.S. Court of Appeals for the Tenth Circuit sided 2-1 with Medtronic's legal team, dismissing another Infuse case while also grappling with the scope of federal pre-emption under Riegel.
Otis-Wisher, represented by Michael Gannon of the Vermont-based Affolter Gannon & Rose, alleges she suffered painful complications after a doctor implanted one of Medtronic's Infuse devices using an unapproved surgical method. Medtronic has faced hundreds lawsuits over the devices, which are intended to stimulate bone growth to repair damaged or diseased vertebrae.
At the center of most Infuse cases, including Otis-Wisher's, are allegations that Medtronic promoted the device to be implanted using an off-label "posterior" surgical approach. Medtronic's approval from FDA was limited to implants done using an "anterior" approach, according to the suits.
Riegel dealt with the pre-emption of state laws that impose safety or labeling requirements on medical device makers that differ from federal requirements."Plaintiff's claims for strict liability failure to warn, strict liability design defect, and negligent failure to warn all seek to impose safety-related requirements on the device or its labeling beyond those imposed by the FDA," the Second Circuit wrote in a four-page summary order. "Accordingly, these claims are expressly preempted."
Otis-Wisher's lawsuit also included fraud claims, premised directly on the allegation that Medtronic promoted Infuse for off-label use. The appeals court declined to consider whether those claims were pre-empted, finding that Otis-Wisher's complaint wasn't specific enough to avoid dismissal.
Reprinted with permission from the June 10, 2015 edition of The Litigation Daily © 2015 ALM Properties, Inc. All rights reserved. Further duplication without permission is prohibited.