No Longer Accepting Cases

May 6, 2014 — Metronic Inc. says it will pay $22 million to settle about 950 Infuse bone graft lawsuits and will set aside another $120-140 million to compensate additional claims. Another 750 lawsuits involving 1,200 people remain pending in various U.S. courts. Law firms are expected to file another 2,600 claims.

The settlement is not an admission of liability or wrongdoing, and Medtronic says it “continues to stand behind Infuse Bone Graft, which has been utilized in more than one million patients since it was approved more than 10 years ago…and will vigorously defend the product and company actions in the remaining cases.”

The Infuse bone graft includes the bioengineered bone-growth protein, BMP-2, which is used in spinal fusion surgery as an alternative to traditional bone-grafting techniques, which may require harvesting bone from another area of the body. Infuse became a blockbuster product and was used in over 1 million procedures.

Problems with Infuse first emerged in 2008, when the U.S. Food and Drug Administration (FDA) published a Public Health Notification after receiving 38 reports of complications within 4 years involving the Infuse Bone Graft. Incidents occurred when Infuse was used “off-label” in the neck, resulting in severe swelling and compression of the airway and/or nerves in the neck.

Additional problems were reported in 2011, when The Spine Journal and several investigative reports discovered that Medtronic paid a small group of prominent spinal surgeons $210 million in royalties and other payments over 15 years. Some of these doctors published papers that promoted Infuse and failed to warn about its risks. In 2012, a U.S. Senate Finance Committee found that Medtronic employees were secretly involved in writing and editing some favorable articles about Infuse.

These allegations resulted in a shareholder lawsuit, which Medtronic settled for $85 million in May 2012. The settlement resolved claims that over 85% of Infuse sales depended on “off-label” uses, in which doctors who were sometimes paid by Medtronic would use Infuse for surgeries that were not approved by the FDA.


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