Case details

Patient denied consenting to off-label use of medical device

SUMMARY

$4200000

Amount

Mediated Settlement

Result type

Not present

Ruling
KEYWORDS
cervical myelopathy, pain, radicular symptoms neck, upper back, upper extremities
FACTS
On May 11, 2009, plaintiff Jerome Lew, 46, a creative consultant in fashion and the entertainment industry, underwent an anterior cervical discectomy and fusion, and a C5 corpectomy at Los Angeles County+UCLA Medical Center, in Los Angeles. Lew was previously struck by an automobile while holding his infant son in February 2009. As a result, he experienced a sudden onset of pain and radicular symptoms in his neck, upper back, and upper extremities. Lew sought treatment with the UCLA chief of spinal surgery, Dr. Jeffrey Wang, an orthopedic spine surgeon. Based upon the reviewed imaging studies, Wang diagnosed Lew with cervical myelopathy. Wang allegedly told Lew that if he did not undergo a cervical fusion, than Lew risked a permanent nerve injury, including paralysis. Based upon preoperative discussions with Wang, Lew consented to an anterior cervical interbody fusion at C4-5 and C5-6. Lew also consented to the use of an autograft (bone harvested from the hip) during the surgery. As a result, Lew underwent an anterior cervical discectomy and fusion at the C4-5 and C5-6 levels, and a C5 corpectomy at Los Angeles County+UCLA Medical Center on May 11, 2009. During the procedure, two spinal fusion medical devices were implanted: one was intended to restore spinal stability and the other acted as a bone graft. During the first hour of the procedure, an orthopedic surgery resident and fellow performed Lew’s surgery without Wang’s direct supervision in the operating room, as Wang had another surgery that started at the same time as Lew’s surgery. Since UCLA is a teaching institution, this was explicitly allowed, as noted in consent forms that Lew executed prior to surgery. Lew experienced an initial improvement of his symptoms in the early postoperative period. However, after approximately one year, his radicular symptoms returned, and he began to experience new pain and neurologic symptoms in his upper extremities. As a result, Lew continued treating with Wang for two more years. In 2012, approximately three years after Lew’s surgery, Lew sought second opinions from a neurosurgeon in Orange County and an orthopedic surgeon at the University of California, Irvine. Both spinal surgeons reviewed Lew’s postoperative imaging studies and opined that Lew had exuberant bony overgrowth from one of the spinal fusion medical devices implanted during the May 2009 surgery that was performed by Wang. Lew sued Wang; the operator of the medical center, the Regents of the University of California; Wang’s medical offices, the UCLA Spine Center, UCLA Department of Orthopaedic Surgery, UCLA Health System Auxiliary, and UCLA Orthopaedic Surgery Clinic; and the manufacturers of the medical devices Wang implanted during the May 2009 surgery, Medtronic Sofamor Danek USA Inc. and Medtronic, Inc. Plaintiff’s counsel asserted that Wang and the Regents were negligent in their care and treatment of Lew, and that their actions in relation to the May 2009 surgery constituted a battery. Specifically, Lew claimed that he consented to the cervical fusion and the use of an autograft during the surgery, but did not consent to the use of any other bone grafting options. Thus, counsel contended that Wang only had consent to perform a fusion, not a corpectomy, and that Wang failed to gain Lew’s consent to the use of one of the spinal fusion medical devices made by Medtronic. In addition, Lew claimed that Wang never disclosed any surgical complications to him, despite a suggestion that postoperative imaging may have shown evidence of exuberant bony overgrowth in the area of the spinal fusion devices that were implanted. As to the manufacturer of the medical devices used, plaintiff’s counsel asserted that Medtronic was negligent for promoting its two spinal fusion medical devices for off-label uses that were contraindicated. Specifically, counsel contended that only one of the devices was cleared by the U.S. Food and Drug Administration for use in the thoracolumbar spine, but that it was designed and intended for use in the cervical spine, and promoted exclusively for cervical use. Counsel noted that the other spinal fusion medical device was only approved by the FDA for use in the lumbar spine in combination with a specific interbody cage, also made by Medtronic. However, plaintiff’s counsel asserted that Medtronic promoted the device for off-label use in the cervical spine and for use with devices other than the one it was cleared to be used with by the FDA. In addition, plaintiff’s counsel contended that Wang had a financial interest in the manufacturer of the medical devices that he implanted in Lew. Specifically, counsel contended that Wang had been a long-time consultant for Medtronic, the manufacturer of the device, and that Wang was a principal investigator in a clinical trial sponsored by Medtronic that was related to one of the spinal fusion devices he implanted in Lew. Counsel also contended that Wang was the subject of a United States Senate investigation that involved his relationship with Medtronic and that Wang had a research interest in the spinal fusion devices similar to those he implanted in Lew. Plaintiff’s counsel further contended that Wang was receiving royalties on the cervical plate that he implanted in Lew and that Wang had a duty to disclose those interests to Lew prior to surgery. Thus, plaintiff’s counsel asserted that Wang committed fraud and a breach of his fiduciary duty by failing to disclose his financial and research conflicts of interest in Medtronic in regard to the medical devices he implanted in Lew. Counsel also asserted that Wang’s use of the spinal fusion medical devices were off-label and contraindicated, in that their uses were never cleared or approved by the FDA. Lew also claimed that Wang never disclosed his intention to use the medical devices off-label. In addition, plaintiff’s counsel contended that UCLA’s medical device review committee specifically prohibited off-label use of one of the devices and had never approved the other device for use at UCLA. Finally, plaintiff’s counsel asserted that the Regents of the University of California and UCLA ratified Wang’s failure to disclose his financial and research conflicts of interest. Counsel contended that UCLA and the Regents have multiple policies that require disclosure of outside conflicts of interest to the university and that the UCLA consent form and policy also require disclosure of research and financial conflicts of interest to patients. Counsel also contended that for at least two years before Lew’s surgery, UCLA and the Regents were aware that Wang and other members of its department of orthopedic surgery were not complying with the university disclosure policies and that the Regents and UCLA failed to act to ensure compliance with its policies that they knew Wang and other faculty members were violating. Medtronic denied engaging in any off-label promotion of its medical devices. Counsel for Wang, the Regents, and UCLA denied there was any wrongdoing. Counsel contended that Lew consented to the C4-5 and C5-6 anterior cervical discectomy and fusion, and the C5 corpectomy, as clearly indicated on consent forms prior to surgery. Counsel also contended that Lew consented to the use of the biologic bone grafting alternative, which was again present on the consent forms executed by Lew prior to surgery. The medical defendants’ counsel also contended that off-label use of medical products, such as Infuse, was acceptable and did not fall below the standard of care. Specifically, counsel asserted that nearly 15 percent of all surgeries in 2009 involving bone morphogenetic proteins involved a cervical spine procedure such as the one performed on Lew. Counsel further asserted that Wang had no duty to disclose any potential research and financial conflicts of interest to Lew because Wang received no direct financial remuneration from Lew’s surgery., Approximately one year after the May 2009 surgery, Lew’s radicular symptoms returned, and he began to experience new pain and neurologic symptoms in his upper extremities. As a result, Lew continued treating with Wang for two more years. However, in 2012, approximately three years after Lew’s surgery, Lew sought second opinions from a neurosurgeon in Orange County and an orthopedic surgeon at the University of California, Irvine. Both spinal surgeons reviewed Lew’s postoperative imaging studies and opined that Lew had exuberant bony overgrowth from one of the spinal fusion medical devices implanted during the May 2009 surgery that was performed by Wang. As a result, the UC Irvine orthopedic surgeon performed a posterior cervical fusion on Lew in September 2012. Lew contended that the September 2012 surgery relieved some of his symptoms, but not all. He alleged that as a result, he continues to have chronic and severe pain in his neck and upper extremities. He also alleged that he has neurologic deficits in his upper extremities extending into his hands and fingers. In addition, Lew alleged that he has problems with his voice and has an eyelid droop. Lew claimed that as a result of his condition, he has been unable to return to work since the first year postoperatively. Thus, he sought recovery for past and future loss of income, and past and future medical and related expenses. He also sought recovery of damages for his past and future pain and suffering. Plaintiff’s counsel moved to amend the case to add a punitive-damages claim against Wang, pursuant to C.C.P. § 425.13. The motion was granted by the court. Counsel for the medical defendants contended that Lew was not injured as a result of the surgeries and that Lew’s current symptoms are a continuation of his preoperative symptoms and/or are known or accepted risks associated with lumbar spinal fusion surgery. Specifically, defense counsel contended that the bone morphogenetic proteins did not cause any bony overgrowth. The defense’s radiology experts presented multiple preoperative MRIs, which they opined showed that Lew had cervical osteophytes, including a left paracentral disc osteophyte complex at the C5-6 level, which was compressing the cord. The experts opined that cord compression was consistent with Lew’s reported symptoms of arm pain and weakness prior to the surgeries. The experts further opined that imaging studies taken after the study, including the CT scan taken on March 23, 2011, and the MRI taken on July 20, 2012, showed that the identical cervical osteophytes were still present. Accordingly, defense counsel asserted that what was misinterpreted by Lew’s subsequent treating physicians as bony overgrowth was, instead, pre-existing osteophytes. In addition, counsel asserted that Lew’s complaints of dysphagia and weakness are recognized risks of a cervical spine surgery, particularly one following acute trauma.
COURT
Superior Court of Los Angeles County, Los Angeles, CA

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