$2.6 Million Affirmed Against Developer of Faulty NuVasive Medical Device Posted on June 11, 2015 by Larry Bodine The California District Court of Appeals affirmed the $2.6 million judgment against a medical device developer, for false claims and advertising after one of its devices failed during spinal surgery. Due to the device’s failure, a screw was implanted near a nerve in a woman’s spine causing even more more pain. Brenda Kitrosser, the plaintiff, underwent spine surgery in 2008 performed by Dr. William R. Taylor at the University of California in San Diego. The doctor used the device known as NueroVision to perform the surgery. After the surgery, Kitrosser experienced more pain and struggled to perform daily activities. She sued NuVasive, the doctor, and UCSD. False representations to patients The plaintiff claimed NuVasive and Taylor had conspired to make “false representations to patients, including Kitrosser, about the NueroVision device that convinced Kitrosser to undergo a procedure using the instrument. Kitrosser settled her claim with Taylor and his employer for $1.75 million. The trial proceeded against NuVasive only, and the jury awarded Kitrosser $3.1 million in damages, which was later reduced to $2.6 million. On appeal, NuVasive argued the trial court erred by denying its motion for judgment notwithstanding the verdict because Kitrosser’s claim lacked facts to support the intentional theory of conspiracy. Another Interesting Read: Death & Injury Suits Pending Against Essure Birth Control Device The NueroVision The device was designed to detect the presence of nerve tissue during spinal surgery. This detection included sensitive areas of the spine, when the surgeon performed procedures accessing the spine from the patient’s side, rather than from the back. The marketing material prepared by a third party, stated the device would “ensure a safe approach to the spine.” However, the company had identified 28 ways the device would not raise an alarm when it should have, which could cause permanent injury. Additionally, NuVasive received one report where a false negative was returned and resulted in injury. Kitrosser’s Surgery Kitrosser had undergone a discectomy for the first time in 1993. She suffered a second back injury several years later. For 10 years, she endured various levels of pain. Kitrosser combed through multiple back surgeons in hopes to avoid “open back surgery.” Finally, she was referred to Dr. Taylor after experiencing pain so severe she could not function. During one visit to Taylor’s office, the plaintiff was told the surgery would be a “minimally invasive procedure” and “[Taylor] guaranteed the safety of [her] nerves.” Still unsure about the procedure Kitrosser requested more information and she was sent two Nuvasive pamphlets. The pamphlets corroborated Taylor’s consultation and the plaintiff decided to proceed with the surgery. Kitrosser experienced more pain than before the surgery after which she discovered one of the screws placed in her spine was impinging on a nerve root. The Neurovision failed to raise an alarm during and after placing the screws in her spine. Dr. Taylor and NuVasive’s Relationship Dr. Taylor consulted and engaged in business arrangements with NuVasive to develop and test new products. In many ways, Dr. Taylor became the face of NuVasive, he educated surgeons on the device, spoke at conferences, presented to the companies board of directors, and appeared as the co-inventor on a patent application. Taylor received multiple payments, fees, stock options, and other forms of compensation for his work with the developer. He received more than $220,000 per year in compensation from NuVasive in addition to his income with UCSD. USCD required doctors participating in clinical trials not to accept any compensation from the company for the duration of the trial. Initially, Taylor disclosed his compensation and was restricted by the UCSD review board. The second time and several times after, Taylor made false representations by simultaneously receiving compensation and working on the clinical trials. NuVasive was also required to submit conflict of interest forms to the FDA. NuVasive was aware Taylor submitted false information and continued with the regular course of business. The Court’s Decision To successfully prove civil conspiracy a plaintiff must provide substantial evidence that: The formation and operation of the conspiracy; Wrongful conduct in furtherance of the conspiracy; and Damages arising from the wrongful conduct. Generally, evidence of a conspiracy is inferred from the nature of the acts, the relation of the parties and the interest of the alleged conspirators. Wyatt v. Union Mortgage Co. 24 Cal.3d 773, 785 (1979). The defendant contended there was no basis for liability arising from NuVasive’s direct conduct. The company stated further, the record lacked sufficient evidence of a conspiracy theory between Taylor and NuVasive to misrepresent the product. The company wanted the courts to treat the relationship of the company and Taylor as purely business. The court disagreed, stating the focus of conspiracy is whether evidence of the conspiracy existed, not whether evidence of a different type of relationship existed. Additionally, the court stated “ we have little difficulty concluding that inferences from the direct evidence support the finding that NuVasive and Taylor conspired to misrepresent the ability of the NueroVision device to ensure Kitrosser’s nerve safety during the [procedure]. The appellate court disagreed with the defendant’s remaining arguments about the admission of evidence and the special verdict. The court believed the trial court did not err in admitting evidence of the disclosure forms. Nor did the trial court err in concluding there was sufficient evidence to establish a conspiracy to intentionally defraud with respect to the special verdict. This case is Kitrosser v. NuVasive, Inc., Case No. D064946 in the Court of Appeal, Fourth Appellate District, Division One, State of California
