Case details

Patient denied consenting to extend fusion to other levels

SUMMARY

$4250000

Amount

Settlement

Result type

Not present

Ruling
KEYWORDS
lower back, lumbar spine, pain, severe neuropathic pain, spinal fusion
FACTS
On the morning of Sept. 3, 2010, plaintiff Ralph Weiss, 55, an attorney with a private practice, presented to UCLA Medical Center, Santa Monica and Orthopaedic Hospital to undergo surgery on his lumbar spine. Weiss had a long history of primarily lower back pain with some pain radiating into his lower extremities. As a result, he managed his back pain conservatively, but between 2008 and 2010, Weiss consulted with numerous spine surgeons in the Los Angeles-area, including Dr. Jeffrey Wang, an orthopedic spine surgeon at UCLA. In July 2010, Wang recommended an L5-S1 spinal fusion with the use of Medtronic’s Infuse Bone Graft, which consists of an engineered bone morphogenetic protein. Wang also recommended a potential fusion of the L4-5 level, if warranted, based upon intraoperative findings. Weiss consented to the L5-S1 fusion and gave his conditional consent to the addition of the L4-5 level, only if it was indicated by Wang’s intraoperative findings. When Weiss presented for his spine surgery on the morning of Sept. 3, 2010, an orthopedic surgery resident presented him with a surgical consent form on the gurney outside of the operating room. The consent form listed an L5-S1 fusion and a possible L4-5 fusion. The resident and Dr. Mark Mikhael, an orthopedic spine surgery fellow, began the surgical exposure without direct supervision by Wang and accidentally exposed the wrong level by disrupting the facet capsule at L3-4. As a result, the resident and Mikhael telephoned Wang from the operating room approximately two hours after the surgery began. After Wang arrived at the operating room, Mikhael exited to discuss extending the fusion to L3-4, L4-5 and L5-S1 with Weiss’ wife, telling her that absent such an extended fusion, Weiss’ spine would be unstable. Weiss’ wife subsequently gave her consent. During the converted three-level spinal fusion, Medtronic’s Infuse Bone Graft was used at all three levels with SeaSpine’s Hollywood interbody spacers. Due to the converted procedure, the surgical time doubled in length from the preoperative estimate. Weiss ultimately required a second, subsequent surgery, which was performed by Dr. Arya Nick Shamie and Dr. Christopher Wolf, and included an additional fusion at the lumbar spine levels. During that second lumbar fusion procedure, the doctors implanted additional Infuse Bone Grafts directly on the spine, in the lateral gutters, and outside the confines of the SeaSpine interbody spacers. Weiss sued Wang; Mikhael; Shamie; Wolf; the believed names of the hospital, Santa Monica UCLA Medical Center & Orthopedic Hospital and Santa Monica UCLA Orthopedic Hospital; the operator of the hospital, the Regents of the University of California; Dr. Roger Lee; and the believed manufacturers of the Infuse Bone Graft, Medtronic, Medtronic Inc., Medtronic Sofamor Danek USA Inc., and UCA Inc. Wolf, Shamie and Lee were dismissed during the course of litigation, and the Medtronic defendants were also dismissed. The matter ultimately continued against Wang, Mikhael, and the Regents of the University of California only. Weiss claimed that, with the understanding that UCLA was a teaching institution, he requested that Wang perform the entire surgery himself and that Wang agreed. However, he claimed that despite not having any other scheduled surgeries that day, Wang was not in the operating room when the surgery began and that, in fact, Wang did not enter the operating room until two hours after the surgery began. Weiss alleged further claimed that Wang only arrived at the operating room after the resident and Mikhael, who had started the surgery without Wang and had mistakenly operating on the L3-4 level, contacted him. Specifically, plaintiff’s counsel contended that the resident and Mikhael exposed the wrong level by disrupting the facet capsule at L3-4, causing a destabilization of the spine at the L3-4 level. Weiss claimed that he never consented to any surgery at the L3-4 level and Weiss’ wife claimed that she only agreed to have the physicians convert the surgery after she was told that, absent such an extended fusion, her husband’s spine would be unstable. As a result, what was supposed to be a one-level, possibly two-level surgery, was converted to a three-level spinal fusion. Thus, Weiss claimed that he never consented to any surgery in Wang’s absence and only provided consent for surgery at the L4-5 level on the condition that Wang felt it was necessary based upon his intraoperative findings. In addition, he claimed that the L4-5 level surgery was only necessitated because of the mistaken compromise of the facet capsules at L3-4. Thus, plaintiff’s counsel argued that the defendants were negligent in their care and treatment of Weiss. Counsel further argued that the defendants performed a battery upon Weiss in relation to the Sept. 3, 2010 surgery by Wang not performing the entire surgery himself and by operating on the L3-4 level, a level that Weiss never consented to before the surgery. Plaintiff’s counsel noted that Medtronic’s Infuse bone morphogenetic protein was used at all three levels with SeaSpine Hollywood interbody spacers, which were again used during the later surgery. However, Weiss claimed that Wang never disclosed specific complications associated with Medtronic’s Infuse bone morphogenetic protein, including the potential for exuberant bony overgrowth that could result from its use. Plaintiff’s counsel contended that Wang had a research and financial interest in the bone morphogenetic proteins, Medtronic and SeaSpine, manufacturers of medical devices he implanted in Weiss. Specifically, counsel contended that Wang had been a consultant for Medtronic and SeaSpine, and was a principal investigator in a Medtronic-sponsored clinical trial related to Infuse Bone Grafts. Counsel also contended that Wang was an inventor of the SeaSpine Hollywood spacer that he implanted in Weiss. Thus, plaintiff’s counsel argued that Wang was being paid royalties on sales of the Hollywood spacer at the time of Weiss’ surgery and that Wang had an ownership interest in SeaSpine in the form of stock options that were worth hundreds of thousands of dollars when exercised months after Weiss’ surgery. Counsel further argued that Wang’s involvement with Medtronic and SeaSpine constituted conflicts of interest that should have been disclosed to Weiss. In addition, plaintiff’s counsel argued that Wang never disclosed to Weiss that the U.S. Food and Drug Administration had not approved the Seaspine Hollywood Spacer for use with the Infuse bone morphogenetic protein. Plaintiff’s counsel argued that Wang committed fraud and a breach of his fiduciary duty by failing to disclose his financial and research conflicts of interest in bone morphogenetic proteins, and the manufacturers of the medical devices he implanted in Weiss. Counsel also argued that Wang’s use of Medtronic’s Infuse product and SeaSpine Hollywood spacers were off-label uses that were never cleared or approved by the FDA and that Wang never disclosed to Weiss the intention for off-label use of the products. In addition, plaintiff’s counsel argued that UCLA’s medical device review committee specifically prohibited off-label use of Medtronic’s Infuse at UCLA hospitals and that the same UCLA committee had never approved the SeaSpine Hollywood spacers for permanent use at UCLA. Finally, plaintiff’s counsel argued 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. However, plaintiff’s counsel argued that UCLA and the Regents were aware for at least three years before Weiss’ surgery that Wang and other members of its department of orthopedic surgery were not complying with the university disclosure policies. Thus, counsel argued that the Regents and UCLA failed to act to ensure compliance with its policies that they knew Wang and other faculty members were violating. In addition, counsel argued that before Weiss’ surgery, the Regents and UCLA were aware that Wang was the subject of a United States Senate investigation and California governmental investigation that involved his relationship with Medtronic and that months before Weiss’ surgery, the Regents and UCLA were aware that Wang stipulated to a violation of California law and paid a fine for, in part, failing to disclose his financial relationship with Medtronic. Defense counsel argued that the consent form indicated that Weiss understood that resident physicians and/or students would assist Wang; that the resident physicians may perform part of the surgery; and that Wang may be out of the room for some or all of the surgical tasks performed by resident physicians. Counsel also argued that, as shown by the consent forms that Weiss executed, Weiss was also aware that residents and fellows would assist in the surgery at the teaching institution. Wang also testified that the decision to extend the surgery to the two levels was made during the discussions with Weiss and his wife preoperatively. However, the resident testified that Wang made the decision that morning to extend the surgery to the L4-5 level. Wang and Mikhael denied any wrongdoing. They contended that the exposure of the L3-4 level was not a substantially different procedure from what was consented to by Weiss. Defense counsel contended that prior to surgery, Weiss had a severely diseased back — including Grade 1 spondylolisthesis, degenerative disc disease, and stenosis — and that, as such, Weiss’ spine had significant subluxation and spondylolisthesis, which caused the L5-S1 and L4-L5 facet joints to be on top of each other and appeared to be one joint. Accordingly, defense counsel contended that due to the aberrant anatomy resulting from Weiss’ severely diseased spine, the L3-4 level appeared to be the L4-5 level, which Weiss consented to have surgery on. Counsel further contended that Wang had no duty to disclose any potential research and financial conflicts of interest to Weiss because Wang received no direct financial remuneration from Weiss’ surgery., Weiss had a long and complicated postoperative course. He developed a large and aggressive spinal infection and seroma at the surgical site. As a result, he required three additional spinal surgeries to irrigate and debride the surgical area over the next four months. He also underwent a second surgery that included an additional fusion at the lumbar spine levels. Weiss contended that he never fully recovered from his surgeries and that he continues to suffer from chronic and severe neuropathic pain as a result of the surgeries and exuberant bony overgrowth of the Infuse bone morphogenetic protein. He alleged that as a result, he will require pain management for the rest of his life. The plaintiff’s spinal surgery expert and the plaintiff’s treating surgeon also opined that it is likely that Weiss will require an additional lumbar fusion. Prior to his surgery, Weiss was a competitive tennis player, advanced skier, and an avid cyclist who even rode his bike for approximately 25 miles the day before his surgery. In addition, he alleged that between the time of the preoperative consent discussion with Wang in July 2010 and the surgery on Sept. 3, 2010, his symptoms improved and on two separate occasions in July 2010, Weiss was a guest aboard U.S. aircraft carriers. Weiss claimed that while aboard the aircraft carriers, he climbed countless flights of stairs and flew on planes landing on and catapulting off the carriers. Weiss claimed that he communicated his active lifestyle to Wang prior to undergoing the surgery. However, Weiss claimed that as a result the surgery, he can no longer engage in the recreational activities that preoperatively were his passion. Weiss is a practicing attorney in the Los Angeles area. He alleged that as a result of the surgeries and his related injuries, he has been forced to significantly cut back on the number of hours he works and the types of cases he takes on. Thus, he claimed that he suffered a loss of income and continues to suffer a loss of income. Thus, Weiss sought recovery of past and future medical costs, and past and future loss of earnings. He also sought recovery of damages for his past and future pain and suffering, and recovery of punitive damages against Wang. Weiss’ wife, plaintiff Deborah Weiss, brought a derivative claim, seeking recovery of damages for her loss of consortium. Defense counsel argued that the fact that Weiss became infected with a very slow-growing bacteria – specifically, Propionibacterium acnes — was completely unrelated to the bone morphogenetic proteins. Counsel contended that the infection occurred in a manner completely unrelated to the bone morphogenetic proteins and was more of a reflection of Weiss’ poly-morbid condition. Thus, defense counsel argued that Weiss was not injured as a result of the surgeries and that Weiss’ current symptoms are a continuation of his preoperative symptoms and/or a known or accepted risk associated with lumbar spinal fusion surgery.
COURT
Superior Court of Los Angeles County, Los Angeles, CA

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