Recently, 950 plaintiffs settled with Medtronic a company that manufactured the “Infuse Bone Graft” for $22 million. A further $140 million is estimated to also settle about 3,800 additional claims.
Medtronic “continues to stand behind INFUSE bone graft” and does not admit liability in the settlement. The injuries spurred from off-label use of the product. The majority of the lawsuits claimed that Medtronic illegally promoted the Infuse off-label which means that the company allegedly claimed that the product could be used for non-FDA approved uses. Complications linked to the product included swelling of the airways, which could cause difficulty breathing, speaking, and swallowing. Medtronic Infuse has also been liked to retrograde ejaculation which could lead to male sterility.
An estimated 2,300 surgeons have used Medtronic products in the United States before any serious side effects were reported. A number of these doctors are facing medical malpractice lawsuits which include a failure to obtain informed consent and fraud. During the past 15 years, Medtronic has paid $210 million in royalties and other payments to a group of 13 doctors and two corporations linked to doctors. Many of the suits claim that it was by paying spinal surgeons, the company was able to promote the off-label use of Infuse.