A Pennsylvania man recently filed a medical malpractice Medtronic Infuse bone graft lawsuit after suffering complications following a spinal fusion surgery.

The Medtronic Infuse, also known as a bone morphogenetic protein (BMP), is a bioengineered bone-growth protein used in spine surgery, often promoted as an alternative to traditional bone grafts. It is also used in off-label procedures that can lead to serious adverse effects, such as:

  • compression of the airway, resulting in difficulty in breathing and swallowing;
  • respiratory depression
  • nerve damage (causing pain and tingling in neck, legs, etc.)
  • death.

The FDA has received 280 reports of Medtronic Infuse side effects, about three-quarters of which involved off-label use.

Medtronic Infuse Malpractice Lawsuit Alleges

Norman Kornitzer filed the complaint in New Jersey District Court on November 14, alleging that the defective design of the Medtronic Infuse bone graft and the lack of proper medical care by his doctor caused him to suffer permanent damages after his surgery. He underwent a spinal fusion surgery and received the Medtronic bone graft in November 2010.

Kornitzer’s spinal fusion malpractice lawsuit include claims against his doctor and the New Jersey Spine Institute, alleging negligence and failing to follow the appropriate standards of medical care. The lawsuit seeks compensation for his injuries and expenses.

FDA Warns of Medtronic Infuse Side Effects with Off-Label Use

In July 2008, the FDA issued an advisory about potentially deadly Medtronic Infuse side effects when used in off-label cervical spine (neck) surgeries. The FDA warning letter stated “that the safety and effectiveness of the rhBMP in the cervical spine have not been demonstrated and these products are not approved by the FDA for this use.” Reports of adverse effects included complications from swelling of the neck and breathing difficulties, even leading to death.

In a July 2011 issue of Spine Journal, an investigation into BMP dangers found that 13 Medtronic-funded studies downplayed or left out evidence of safety issues with the Medtronic Infuse. Surgeons were paid tens of millions by Medtronic Inc. and failed to report serious Medtronic Infuse complications.

Medtronic Infuse Lawsuits Filed

Lawsuits against the Medtronic Infuse continue to be filed by patients who suffered complications from receiving the bone graft during surgery.

Medtronic Infuse lawsuits allege that the manufacturer failed to warn patients about the potential risks of the device, including the risk of excessive bone growth, which can be more likely in off-label use. In addition, the claims argue that Medtronic actively advocated the use of the Medtronic Infuse in off-label procedures that the device should have known were linked to an increased risk of adverse effects and death.

Medtronic Infuse bone graft lawsuits seek compensation for medical expenses, lost wages, pain and suffering, and more. To learn more, call a Medtronic Infuse lawyer today for a free case review: (877) 779-1414.

Published December 13, 2012 by