The Regents of the University of California (UC system) have agreed to pay almost $8.5 million to two patients who alleged that UCLA and surgeons misled them about spinal surgical procedures at the teaching hospital.
The patients, Jerome Lew and Ralph Weiss, sued the Regents, Jeffrey Wang, M.D. and others, alleging that the university failed to disclose financial ties between the defendants, and Medtronic plc, Biomet, Inc., and SeaSpine. Dr. Wang was the co-director of the UCLA Spine Center at the time of the surgeries.
The patients further alleged that they were implanted with Medtronic’s Infuse bone-growth product in an off-label fashion and were deceived because the defendants failed to obtain their consent for the off-label use. They also accused Dr. Wang of failing to let them know that he and the university had received money from the company over the years.
Further, Lew alleged that because surgeons at UCLA operated on him using devices in an off-label manner without his specific consent, he was, in effect, an experiment. Weiss alleged that, despite his insistence, part of his surgery was not performed by Dr. Wang and the surgeon who did perform the surgery, operated on the wrong disc.
No Wrongdoing Admitted
The UC system and Dr. Wang, now co-director of the privately owned USC (University of Southern California) Spine Center, denied any wrongdoing in the settlement.
The Regents agreed to settle the two cases, “so that UCLA Health and the David Geffen School of Medicine at UCLA could move forward with their ongoing commitment to excellence in patient care, research, education and community service.”
Medtronic denied any wrongdoing and said it did not promote off-label use of its products. The company was dropped as a defendant in the Weiss case and it agreed to a separate, confidential settlement with Lew.
None of these allegations are new or proven, but the settlement may clear a cloud that has hung over Dr. Wang, who is treasurer of the North American Spine Society (NASS).
Lew Allegations
Jerome Lew had surgery in May 2009 for an anterior C5 vertebrectomy and corpectomy, and C4-C6 anterior interbody fusion.
In his complaint, Lew claims Dr. Wang was a consultant for Medtronic and Biomet and that he used implants from both companies in his surgery. He claims that UCLA was hosting a clinical investigation on Infuse at the time of his surgery and that Dr. Wang was the original principal of that investigation. He claims that the defendants failed to disclose and misrepresent the financial relationships with Medtronic and that Dr. Wang was fined by the California Fair Political Practices Commission in 2010 for failing to disclose ties to Medtronic.
Even after the fine, Lew says UCLA promoted Dr. Wang to vice chair of the UCLA Department of Orthopedic Surgery.
Prior to his surgery, Lew claims he was told that an autograft would be used and was offered no alternatives. He said there was no conversation about using Infuse. But Infuse was used in an off-label manner with a Biomet cervical plate. He claims sales reps from both companies were in the operating room.
Then, claims Lew, UCLA submitted billing codes to his insurance provider for standard anterior cervical discectomy and fusion using an autograft. “No billing codes were submitted for the use of the Infuse Bone Graft Product, ” according to the complaint. He said the defendants knew that the medical and billing codes have been “falsified.”
After his surgery, Lew says he began to experience pain but was told this was normal and that the fusion had worked. He said the defendants didn’t tell him that Infuse had been used and that bony overgrowth continued. UCLA took no corrective steps, said Lew.
Finally, a CT scan in March 2011 ordered by Dr. Wang and done at UCLA showed evidence of bony overgrowth. But he said the hospital failed to disclose the evidence of bony overgrowth seen on the CT scan.
Because of that alleged bony overgrowth, Lew said he underwent a cervical laminectomy and bilateral neural foraminotomies in September of 2012.
Lew said the defendants “engaged in human experimentation” without his informed consent. He says he was not provided a copy of the experimental subjects’ bill of right. He alleges that defendants were aware that the proposed surgery was experimental and concealed the experimental and investigational nature of the surgery from him.
He charged the defendants did this to, “further their own research and financial interests.”
According to Lew, the defendants covered up their own “negligent and fraudulent actions, ” and, “fraudulently falsified” his medical and billing records. Had he known the “concealed material facts, ” he says he would not have consented to the May 11, 2009, surgery, would have requested alternative treatment, and would have sought immediate care for his post-operative complications.”
Weiss Allegations
Ralph Weiss sued the hospital system, Dr. Wang, Mark Mikhael, M.D. and Arya Nick Shamie, M.D.
Weiss had four surgeries in September and November 2010 and January 2011. He says he gave approval for an L5-S1 discectomy and spinal fusion and an expansion to include the L4-L5 disc if found advisable after Dr. Wang opened him up.
He claims the defendants never informed him or sought his consent to use Infuse, or warn him of the dangers. He also claims that it was not disclosed to him that a SeaSpine Spacer would be used in an unapproved manner with Infuse. He further claims there was no disclosure of Dr. Wang’s financial ties to Medtronic.
In his complaint, Weiss alleges that Dr. Wang received “at least $275, 000 in unreported royalty and consulting payments from Medtronic from 2002 to 2009.” Further, he says Dr. Wang didn’t inform him that he had received $200, 000 from SeaSpine from 2005 to 2010 and was continuing to receive royalties during the time of surgery.
The defendants, according to Weiss, were aware that Medtronic had withdrawn a clinical trial of BMP (Bone morphogenetic proteins) in single-level posterior lumbar procedures such as the contemplated surgery after, “an unusually large number of adverse events were reported.” But, says Weiss, this was not disclosed to him.
Weiss says he knew that UCLA was a teaching hospital and as a condition of his approval for the surgery, Weiss says he received assurances that, “Dr. Wang and only Dr. Wang would perform the surgery.” He then agreed to the surgery.
But that didn’t happen, claims Weiss. According to surgical records cited in his complaint, Dr. Mikhael began the surgery at 7:45 am and cutting began at 8:31 am. Dr. Wang arrived at 10:20 am.
Upon Dr. Wang’s arrival, Weiss claims Dr. Wang found that his assistant had operated on the wrong level disc and, “had destroyed the structural integrity of the spine at L3-L4.” The error necessitated extension of the procedure to include L3-L4 and L4-L5.
Soon after surgery, Weiss says he experienced symptoms that “any competent physician” would recognize as an infection.
Not until after Weiss shared his findings with Christopher Wolf, M.D., did defendants treat the infection, according to the complaint. The findings, according to Weiss, “revealed a long, present and growing pocket of infection which was many times larger than it would have been if his post-surgical treatment and assessment had been performed in a manner consistent with the standard of care.”
He also accused the system of allowing Dr. Wang to schedule multiple surgeries at the same time in violation of university policy.
Informed Consent and Disclosure
The gist of the complaints is that Lew and Weiss weren’t properly informed about their surgeries and their surgeon and hospital. Had they been properly informed, they say would not have granted permission for the surgeries. And the hospital did it to make money.
This is not the first time UCLA has been in court over the “informed consent doctrine.” In fact, a famous 1990 case titled Moore v Regents of the University of California went all the way to the California Supreme Court.
In Moore, the Court said that financial relationships are automatically to be considered material to patients, and therefore, must be divulged in informed consent discussions.
California has gone further regarding informed consent rules than most states. One legal expert told us that many states have reviewed the Moore doctrine and have either rejected it or at a minimum failed to adopt it for one reason or another. A common element in these rulings has been that the legal claims must be about the standard of care and informed consent requirements should be reviewed relative to matters relating to the standard of care rather than financial relationships.
Wang, NASS and Politics
Ironically, Dr. Wang, through his leadership position with NASS, has played a role in spurring Congress to impose expanded disclosure rules in the Affordable Care Act. The Act requires companies to disclose financial relationships between companies, surgeons, and hospitals.
When the university removed Dr. Wang as a co-executive director at the spine center in 2009, we reported that from our perspective, it appeared as though UCLA had thrown one of its research and surgery stars under the bus to get U.S. Senator Chuck Grassley off their back.
We noted that Dr. Wang had disclosed his financial ties to NASS as part of his published papers and podium presentations. Furthermore, Dr. Wang enjoys one of the most sterling reputations in spine and has repeatedly been selected by his peers as one of the top spine surgeons in the U.S.
After this 2009 episode, UCLA developed and implemented a new faculty disclosure process that supplements the annual disclosure of outside activities.
In our 2009 report, Robin Young, the publisher of Orthopedics This Week, said, “UCLA bears culpability in this matter. We know from our own research that Dr. Wang had disclosed his financial ties in other venues, most notably at the North American Spine Society. Furthermore, UCLA itself suffers from a lack of transparency, which undermines the legitimacy of their actions. Finally, we believe strongly that many of the problems attributed to Dr. Wang are quite likely the result of institutional mismanagement and confiscatory rules that affect not only research dollars coming into UCLA but also legitimate consulting contracts coming to its best and brightest researchers.”
Now, with some battered reputations, UCLA is finally ending this episode of financial disclosures.
