Medtronics Infuse LawSuits – How Medtronics Bioscience Could Be at Fault
The lawsuits, three investors, sued Medtronic Inc. and Medtronics Bioscience, a division of Medtronics Corporation, for alleged injury and death caused by their Medtronic implants. The plaintiffs claimed they were injured when they attempted to remove a bone from their leg. They also claimed they died as a result of the injuries caused by the defective devices. The shareholders, three doctors and nurses, who also work in the surgical department at the hospital filed lawsuits against the hospital for medical malpractice, negligence and breach of warranty.
Medtronics Infuse lawsuit. The lawsuit claimed that Medtronics Inc. and the subsidiaries were negligent in the design, manufacture, maintenance, and administration of its Medtronic Infuse spinal decompression system. The plaintiffs alleged that the device was defective due to lack of adequate postoperative instructions, inadequate knowledge of proper postoperative procedures, the inadequate quality of materials used in the production of the device, and inadequate testing of the device prior to distribution. The lawsuit claimed that the plaintiffs suffered from serious bone loss, multiple injuries and death as a result of the defects, and medical malpractice and breach of warranty. The lawsuit was settled out of court.
Medtronics Infuse litigation. The plaintiffs claimed that Medtronics Inc. and the subsidiary manufacturers manufactured defective Infuse devices; however, the lawsuit claimed the device was not defective; it was improperly designed and the manufacturer failed to take necessary steps to make it safe or to provide adequate postoperative instructions.
Medtronics Bioscience lawsuit. The lawsuit claimed that Medtronics Corporation and subsidiary manufacturers manufactured and distributed devices, including the Medtronics Bioscience spinal decompression device, that did not meet the criteria set by FDA for such devices. According to the complaint, the devices were unsafe and not safe for patients with medical conditions like degenerative disc disease and spondylosis.
The lawsuit was settled out of court. It was alleged that the plaintiffs were suffering from debilitating pain because of the devices; however, the plaintiffs’ physician failed to refer the patients to an expert to obtain further information. In addition, the plaintiffs’ physician provided inadequate instructions for patients undergoing the procedure. Although the devices had been approved for treatment of a wide range of medical conditions, the devices were not approved for treatment of spinal decompression in patients with degenerative disc disease and spondylosis.
Medtronics Bioscience lawsuit. The lawsuit alleged that Medtronics Corporation and its subsidiary manufacturers failed to design, manufacture, distribute, market, or maintain the Medtronics Infuse spinal decompression device in a manner that complied with FDA guidelines for use of the device. According to the complaint, the device was unsafe and unacceptably dangerous because it did not allow the patient sufficient time to adjust his/her posture and weight.
According to the complaint, the devices were not appropriate because they placed the patient’s spine in a state of partial or total flexure or dislocations, which causes stress on the surrounding muscles. Additionally, the device allowed the patient to return to normal function after the device was removed, thereby making it unsafe for patients to return to work or school. Finally, the device was defective because it did not provide patients with adequate postoperative instructions; the device did not allow the patient enough time for recovery; the device was defective because it left the patient with a noticeable amount of pain and pressure. and because the device was defective because it caused the patient’s body to retain the trauma from the device in place.
The lawsuit was settled out of court. The complaint was dismissed as to whether it could be proven that the company intentionally violated FDA guidelines.