Medtronic Unit Settles Defective Spine Device LawsuitApr 29, 2011 | Parker Waichman LLP
A lawsuit involving the Danek 3-D TSRH Spinal System made by a unit of Medtronic Inc. has been settled, according to a report from Law360. The lawsuit was brought by a Puerto Rican woman and her family who claimed the Danek 3-D TSRH Spinal System caused her to suffer serious and life threatening injuries.
According to Law360, the Danek 3-D TSRH Spinal was recalled by the U.S. Food & Drug Administration (FDA) because of a manufacturing defect that could cause the implant to break during surgery or after implantation. The device implanted in plaintiff Aileen Beltrán Alicea during lumbar fusion surgery in 2009 was distributed by Warsaw Orthopedic Inc., d/b/a Medtronic Sofamor Danek USA Inc.. It consisted of four screws, two rods and a substitute for her affected disc.
Shortly after her surgery, Alicea, who according to Law360, suffered from "'spondilolistesis' and 'radiculopathy' at level L5-S1 of her spine," complained of a “a strange sensation of crushing bones” and “an unusual and unbearable pain in her right hip,” her families lawsuit said. After a second surgery, Alicea was informed by her surgeons that the allograft cage used to replace the disk had shattered.
In August 2009, after a recurrence of hip pain, it was discovered that the left screw inside the vertebra was broken, the lawsuit claimed. For a third time, Alicea underwent surgery, this time an eight hour procedure. She suffered several life-threatening complications, according to her complaint.
According to Law360, the original lawsuit sought a total of $119 million on behalf of Alicea and her family.
The lawsuit was dismissed with prejudice by Judge Daniel R. Dominguez of the U.S. District Court for the District of Puerto Rico yesterday after the plaintiffs filed a motion saying they had reached a confidential settlement with the device maker.