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From Products Liability Law Daily, September 12, 2017

Spinal implant maker not liable for patient’s injuries

By Susan Engstrom

A patient who was implanted with a cervical plate for the treatment of his degenerative disc disease failed to show that his postoperative injuries were caused by a defect in the device, the U.S. Court of Appeals for the Fifth Circuit determined, ruling in favor of the manufacturer on the patient’s Louisiana Products Liability Act (LPLA) claims. The patient failed to meet his burden under the doctrine of res ipsa loquitur to provide an inference of negligence on the part of the manufacturer, and he could not establish that the device was defective when it left the manufacturer’s control. His argument that he was entitled to relief from judgment based on newly discovered evidence and/or fraud by the manufacturer failed as well (Lyles v. Medtronic Sofamor Danek, USA, Inc., September 11, 2017, Starrett, K.).

Medtronic Sofamor Danek USA, Inc. (MSD), a subsidiary of Medtronic, Inc., manufactures and sells the Atlantis Translational Anterior Cervical Plate System (Atlantis Plate), which the patient had implanted after he was diagnosed with severe progressive myelopathy with stenosis. The product is used as a temporary aid to fusion and to help stabilize the anterior cervical spine during spinal fusions in patients with degenerative disc disease. The product consists of two separate metal components that are joined by a track and runner system to form one plate. Tiny pins within the track and runner system ensure that the plate components remain intact by preventing the runners on the top component of the plate from coming free of the tracks on the bottom component.

Following surgery, the patient complained of increased pain in his upper extremity and neck. He also had difficulty swallowing and reported having fallen twice since discharge, once backwards and hitting his head. X-ray reports indicated that while there was "slight displacement" of the plate, it had not broken and had not become unstable. However, his vertebrae failed to fuse, his pain continued, he lacked feeling and strength in his hands, and he continued to have difficulty walking. A second surgery performed to decompress the patient’s spine did not remove the device but, rather, included the addition of rods and screws. According to his surgeon, the Atlantis Plate "never failed." However, the patient retained an expert, a neurosurgeon, who opined that the device was installed properly and that there was a "mechanical failure" of the plate. He also said that "it must be assumed [the failure] occurred in the period between" implantation and the recovery room x-rays. He admitted in his deposition, though, that he could not identify definitively the cause of the failure, but that he assumed there was failure with the pins keeping the rails in track. He did not offer opinions as to whether a device characteristic contributing to its alleged failure existed when it left MSD’s control, as to the device’s design, or as to an alternative design.

The patient filed suit against the manufacturer, alleging that the Atlantis Plate was defective in construction or composition and in design. The manufacturer moved for summary judgment, contending that the patient could not establish that: (1) the Atlantis Plate contained an unreasonably dangerous characteristic due to its construction or composition or its design; and (2) an unreasonably dangerous condition existed in the Atlantis Plate at the time it left the manufacturer’s control, as required under the LPLA. The district court ruled in favor of the manufacturer [see Products Liability Law Daily’s March 25, 2016 analysis] and subsequently denied the patient’s motion to reconsider (Lyles v. Medtronic, Inc., May 4, 2016) as well as his motion for relief from judgment (Lyles v. Medtronic, Inc., August 31, 2016). The patient appealed.

Doctrine of res ipsa loquitur. The patient argued that the res ipsa loquitur doctrine applied to create a presumption that the Atlantis Plate contained a defect in construction because there were no other reasonably probable causes for the device’s breakage. Louisiana’s high court has explained that this doctrine infers negligence on the part of defendants, based on circumstantial evidence, when "the facts of the case indicate that the negligence of the defendant is the probable cause of the accident, in the absence of other equally probable explanations offered by credible witnesses."

According to the Fifth Circuit, the patient failed to meet his burden to exclude all other reasonable explanations for his injuries. Instead, he simply relied on his expert’s statement that, based on the information provided to him, he had no other reason for the Atlantis Plate’s breakage other than a defect. The manufacturer, on the other hand, pointed to several potential explanations, such as malpractice by the patient’s surgeon, which the patient did not exclude as a possible cause of his injuries. Further, even if the patient had shown that res ipsa loquitur applied to infer a defect, he failed to establish that the Atlantis Plate was defective when it left the manufacturer’s control. Although he cited testimony from his surgeon stating that MSD’s representative had retrieved the device from storage and delivered it to the operating room, there was no evidence as to where the Atlantis Plate had been stored prior to surgery or who had access to it. Therefore, the district court could have granted summary judgment on this basis as well.

In addition, the district court did not err by holding that the patient’s own allegations of malpractice against his surgeon showed that malpractice was a reasonable explanation that the patient needed to exclude in order to carry his burden under the res ipsa loquiturdoctrine. The district court did not rule that the patient’s request to the medical review panel was evidence of malpractice, but, rather, held that it presented an additional reasonable explanation for the breaking of the device. Therefore, the patient failed to show that res ipsa loquitur applied to infer a defect.

Newly discovered evidence. The patient asserted that he should be relieved from final judgment on the basis of newly discovered evidence regarding two other MSD-manufactured devices that were implanted in him during his surgery: (1) a Verte-Stack, which is a vertebral body replacement device; and (2) Progenix, a putty-like bone graft material that was mixed with bone dust. However, the record showed that the patient was aware, prior to the entry of judgment against him, that both devices were used in his surgery. The record also showed that he did not attempt to pursue the discovery of documents relating to either of those devices before the entry of the judgment. Therefore, the district court’s denial of his motion for relief from judgment was not a "clearly erroneous assessment of the evidence."

Fraud. Finally, the patient argued that the manufacturer’s failure to produce the Verte-Stack or Progenix documents in response to his production request amounted to fraud, misrepresentation, or misconduct. These documents allegedly showed that the Verte-Stack should not have been used in the cervical spine or with the Atlantis Plate. According to the patient, MSD was aware of the potential problems with the Verte-Stack and purposefully withheld the documents. However, the only evidence of misconduct that the patient produced was that MSD did not answer his interrogatory and production requests with information about the Verte-Stack. The district court did not abuse its discretion in finding that the manufacturer’s actions were in good faith because it was not unreasonable to read both the interrogatory and production requests as dealing only with the Atlantis Plate and a bone graft device (not at issue in this appeal) given the procedural history of the case, which had narrowed the MSD products down to those two devices.

The case is No. 16-30517.

Attorneys: James A. Rountree (Rountree Law Offices) for Bryant Lyles. Murray S. Levin (Pepper Hamilton, LLP) for Medtronic Sofamor Danek, USA, Inc.

Companies: Medtronic Sofamor Danek, USA, Inc.

MainStory: TopStory DesignManufacturingNews EvidentiaryNews MedicalDevicesNews LouisianaNews MississippiNews TexasNews

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