Settlement Announced in Medtronic Spine Device Lawsuit

A unit of Medtronic Inc. just agreed to settle a product liability lawsuit over allegedly <"">defective spinal implants. Law 360 said that the defective surgical implant lawsuit was brought about by a family in Puerto Rico who was seeking nearly $12 million. Last year, allegations of kickbacks over its spinal fusion device business put Medtronic in the headlines.

The lawsuit was dismissed with prejudice by Judge Daniel R. Dominguez of the U.S. District Court for the District of Puerto Rico when the plaintiffs filed a motion saying the parties were able to reach a confidential settlement, said Law 360.

The lawsuit was filed in December 2009 by Aileen Beltrán Alicea and claimed that physicians implanted a defective spinal device that was distributed by Warsaw Orthopedic Inc., a firm that does business as Medtronic Sofamor Danek USA Inc., wrote Law 360. Beltrán Alicea claimed that she needed two more, painful, operations as a result of the Medtronic implant. Beltrán Alicea suffered from “‘spondilolistesis’ and ‘radiculopathy’ at level L5-S1 of her spine,” said the complaint, quoted Law 360. She underwent lumber fusion surgery August 2008.

The complaint also states that, to replace her disc, she was implanted with a Danek 3-D TSRH Spinal System, which said, Law 360, is comprised of four screws and two rods. During recovery, Beltrán Alicea stated that she felt “a strange sensation of crushing bones” and “an unusual and unbearable pain in her right hip,” according to the complaint, quoted Law 360. Her doctor determined that needed a second surgical procedure because the allograft cage involved in the disc replacement had moved, said the complaint; in fact, surgery revealed that the cage had shattered.

In August 2009, the pain returned and it was determined that the left screw within the vertebra was broken, said Law 360. According to the complaint, Beltrán Alicea underwent a third—eight hour—surgery that led to a number of complications, some life-threatening. The complaint also states the firm is liable and that the spinal implant system used in Beltrán Alicea’s initial surgery was defective and, later, recalled by the U.S. Food and Drug Administration (FDA) over a flaw that could cause the device to break during an operation or implantation, said Law 360, citing the complaint.

Meanwhile, late last year we wrote that Medtronic Inc.’s payments to a group of spine surgeons at a Louisville, Kentucky hospital raised questions about possible kickbacks. From 2004 through 2008, the group from Norton Hospital performed the third highest number of spinal fusion surgeries on Medicare patients. In the first nine months of the prior year, the surgeons were paid $7 million from Medtronic.

The payments were presented as royalties the surgeons received for helping Medtronic design a spinal fusion product. Medtronic says it does not pay surgeons royalties on devices they use in their patients, thereby removing any financial incentive for them to do more surgeries than necessary, the Wall Street Journal said last year.

Some critics claim that financial incentives caused spinal fusion surgery to become overused. The procedure, which involves using metal plates, rods, and screws to fuse together two or more vertebrae to alleviate back pain, is relatively controversial. Some surgeons argue that a spinal fusion is appropriate only for a very small number of conditions: Spinal instability, spinal fracture, or a severe curvature of the spine known as scoliosis. Some recent studies suggest poor outcomes for spinal fusion, including life-threatening complications.

Over the past several years, Medtronic has been involved in lawsuits that alleged consulting agreements with surgeons were actually kickbacks to induce them to use the company’s products.

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