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Plaintiffs Demand Compensation from Medtronic for Bone Graft Injuries

On August 9, 2013, an Infuse bone graft lawsuit was filed against Medtronic on behalf of Florida residents Dainora Maciene and Egidijus Macy, husband and wife. Currently, the case is proceeding in the U.S. District Court for the Middle District of Florida under Judge Elizabeth A. Kovachevich. The complaint contends that the defendants marketed the use of their Infuse bone graft product for off-label use and that they did not fully disclose the potential for dangerous side effects, which allegedly led to significant medical complications for Maciene.

Plaintiff underwent revision surgery

Patients who undergo spinal surgery, such as a spinal fusion, may require bone grafts. A bone graft replaces the damaged or diseased bone matter. Some bone grafts are taken from the patient’s own body, some are extracted from cadavers, and some are synthetic. The defendant designed, manufactured, and marketed a synthetic bone graft, known as the Infuse bone graft, from recombinant human bone morphogenetic proteins and bovine collagen.

In 2011, Medtronic reported almost $900 million in sales from the Infuse product, which has been categorized by the FDA as a medical device. The product is used in about 100,000 spinal fusion procedures each year in the U.S. alone, including in the plaintiff’s spinal surgery.

The plaintiff, Maciene, underwent lumbar spinal surgery in July 2009, which refers to a procedure performed on the lower part of the spine. The Infuse bone graft was implanted during the surgery. According to the complaint, she subsequently suffered from bone graft problems, including uncontrollable growth of bone, which resulted in significant pain and physical injuries. The plaintiff allegedly suffers from “bone resorption, possible pseudoarthorosis, and cystic bony changes.” She contends that during her recovery period, she experienced worsening back pain and required a revision surgery to remove excessive bony growths, which may have possibly been compressing nearby nerves.

The plaintiff further claims that she continues to experience significant pain from her Medtronic Infuse spine surgery injury and that she has been unable to work since her original surgery.

FDA expressed concerns over off-label uses

In their complaint, the plaintiffs note that the Infuse bone graft was used in an off-label manner which had not been granted approval by the FDA. The Infuse product was only approved for use in spinal surgeries using an anterior approach, which refers to incisions through the abdomen. The plaintiff’s surgery involved a posterior approach, or through the back. Furthermore, the FDA-approved surgery makes use of a device known as an LT-Cage, and this device was not used in the plaintiff’s surgery.

The lnfuse bone graft lawsuit highlights that the FDA expressed concerns over any off-label use of this medical device. However, according to the complaint, the defendants aggressively marketed and over-promoted the use of Infuse for off-label uses.

Complaint lists slew of allegations

In addition to the allegation of promotion of the bone graft for off-label use, the Infuse bone graft lawsuit contends that Medtronic’s representatives “downplayed to physicians and spine patients its dangerous effects” and that the company should be held liable for failure to warn.

Maciene claims she never would have consented to the use of the Infuse product had she been aware of the potential risks, and claims that her spine surgeon relied on misleading promotional material when the decision to use the bone graft was made. Medtronic is alleged to have been aware that Infuse was not safe for off-label use. Furthermore, Medtronic is accused of manufacturing a product that is defective in design. The lawsuit reasons that since the defendants promoted the off-label use of Infuse, it should have been reasonably safe to use in this manner.

Plaintiff Macy demands compensatory damages for the loss of consortium of his wife as a result of her injuries. Plaintiff Maciene demands compensation for her physical injuries and pain, and for economic losses, including medical expenses and lost wages. The plaintiffs also request punitive damages regarding the alleged defective design of the product, and the allegedly misleading and overly aggressive marketing campaign launched by the defendants.