Case details

Manufacturer made false claims about medical device: patient





Result type

Not present

back, neck, nerve impingement, neurological, neurological impairment
In 2007, plaintiff Brenda Kitrosser, a retired special education teacher in her 60s, was referred to William Taylor, M.D., a surgeon at the University of California, San Diego Medical Center. Kitrosser had suffered from back pain for a number of years, and underwent a laminectomy and microdiscectomy in 1993. When her back pain continued and worsened following an industrial injury in 1997, she sought treatment with conservative management and declined to undergo open surgical procedures multiple times. After presenting to Taylor in 2007, Kitrosser was told about a minimally invasive surgical procedure called eXtreme Lateral Interbody Fusion, a lateral approach to the spine developed by the medical product manufacturer NuVasive Inc. Taylor allegedly explained to Kitrosser that she would heal more quickly than with a traditional open procedure, that he would not have to cut into the muscles in her back, and that a device would be monitoring her nerves to protect them from injury. He also allegedly told her that he had performed XLIF procedures on numerous occasions and trained other surgeons in the procedure. Kitrosser later received patient pamphlets in the mail that were published by NuVasive and that suggested that Taylor was the author. The pamphlets stated that a “NeuroVision” nerve monitoring device manufactured and sold by NuVasive Inc. would “provide real-time, precise, and reliable feedback to ensure your nerve safety” and that the NeuroVision device “will ensure safe approach to the spine.” Taylor also allegedly told Kitrosser that the nerve monitoring device would ensure her nerve safety. As a result, Kitrosser consented to the XLIF procedure, and on Sept. 3, 2008, Taylor performed the XLIF procedure on L2-3, L3-4 and L4-5 levels of Kitrosser’s spine. During the surgery, Taylor utilized the NeuroVision device during the XLIF approach, and then turned Kitrosser over and implanted screws and rods into her spine. The NeuroVision device showed no indication of nerve proximity or nerve injury during the XLIF approach or during placement of pedicle screws. However, Kitrosser woke up in severe pain and suffering from neurologic deficits. As a result, a CT of her lumbar spine was done the day after the surgery and showed the left L2 pedicle screw placed in the spinal canal, impinging the nerve root. As a result, the malpositioned pedicle screw was removed nearly two months later. Kitrosser sued Taylor; his physician’s assistant, Judd Laraway; and the hospital’s operator, The Regents of the University of California. Kitrosser alleged that the defendants’ actions constituted lack of informed consent, breach of fiduciary duty, battery, fraud by concealment, fraud by misrepresentation, and negligent misrepresentation. She also alleged that the defendants’ actions constituted medical negligence. As discovery proceeded, Kitrosser learned of Taylor’s extensive involvement with NuVasive Inc., learned more about NuVasive and its product, the NeuroVision device, and discovered evidence of an alleged conspiracy between the doctor and the company to make misrepresentations about NuVasive’s products to patients. As a result, Kitrosser filed a separate action against NuVasive Inc., which included causes of action for negligence per se, fraud by misrepresentation (including fraud by conspiracy allegations), negligent misrepresentation, and fraud by concealment. In February 2011, the two actions were consolidated. Kitrosser alleged that during the procedure, Taylor turned her over and implanted screws and rods into her spine without her knowledge or consent. She also alleged that despite the CT finding that the left L2 pedicle screw was placed in her spinal canal and impinged on the nerve root, Taylor did not tell her about the malpositioned pedicle screw, causing a delay in having it removed. Kitrosser also alleged that she relied on representations made by Taylor and stated in NuVasive’s pamphlet about the nerve monitoring device protecting her nerves during surgery when she consented to the XLIF procedure. However, she claimed that Taylor did not tell her he was a consultant for NuVasive and that he was netting hundreds of thousands of dollars a year moonlighting for NuVasive while working by day as a public employee of The Regents. She also claimed that Taylor did not tell her that he held stock options in NuVasive; that he received royalties on sales of the company’s spinal surgery products; that as part of his consulting agreement, he was paid to run clinical studies, and advise on and test NuVasive products; and that NuVasive considered him to be instrumental in the success of the company. Kitrosser further claimed that Taylor did not tell her that at the time he was proposing the XLIF procedure, NuVasive was conducting clinical studies to determine whether XLIF was an effective treatment for degenerative scoliosis, her underlying pathologic condition, and that she would not have qualified for the clinical study, given her presentation. In addition, she claimed that Taylor did not tell her about the ongoing clinical study by NuVasive to determine whether the NeuroVision nerve monitoring device could detect nerves during the surgical approach to the spine and that he was a principal investigator in this clinical study. Plaintiff’s counsel contended that NuVasive made false statements about the NeuroVision device being precise, reliable and would “ensure” nerve safety. Counsel also contended that, contrary to what NuVasive represented to Kitrosser, NuVasive stated in the information provided to the Food and Drug Administration as part of the 510(k) process that the NeuroVision procedure was not 100-percent effective, and it identified 28 different ways the device could give false information to the surgeon that could lead to a patient’s nerve injury. Thus, Kitrosser alleged that had she been told of the numerous connections between Taylor and NuVasive prior to her surgery, or told of the fact that the NeuroVision could not ensure her nerve safety, or told of the fact that instrumentation would be implanted during the surgery, she would not have consented to Taylor performing the XLIF procedure. Taylor and The Regents alleged that Kitrosser consented to the placement of the pedicle screws during her surgery. Taylor also alleged that he had no duty to disclose to Kitrosser his financial relationship with NuVasive because he had no financial interest related to her XLIF procedure. He further alleged that malpositioned pedicle screws are a known complication of spine surgery and that he told Kitrosser about the malpositioned pedicle screw when he had the CT results, but that Kitrosser refused another surgery to reposition the screw. NuVasive alleged that the representations about the NeuroVision device in its patient pamphlets were not false or misleading, and that the pamphlets were intended to be used as part of an informed consent discussion with the surgeon where risks are discussed. It also alleged that it was not reasonable for a person to view the representations in its pamphlets as a guarantee of nerve safety. In December 2012, Taylor and The Regents agreed to a $1.75 million settlement with Kitrosser. Laraway was ultimately dismissed from the case. Thus, the matter proceeded to trial against NuVasive only., Kitrosser claimed that she woke up in excruciating pain after the procedure that was performed by Taylor. CT scans revealed abnormal positioning of the left L2 pedicle screw. She claimed that there was also evidence that one or more could have occurred during the XLIF procedure while traversing the psoas and the lumbar plexus. As a result, Kitrosser returned to Taylor on Oct. 24, 2008, and a removal of the left pedicle screw was recommended at that time. As a result, Taylor removed only the left-sided pedicle screws and stabilization rod on Oct. 29, 2008, and left the right-sided hardware in place. Although Kitrosser originally had some improvement of her symptoms, eventually her pain and neurologic deficits worsened. As a result, she required additional surgeries to remove the remaining hardware. Kitrosser claimed that she now suffers from permanent nerve damage, causing her to have difficulty walking without the assistance of a walker or cane. She also claimed she suffers lower extremity numbness and weakness, severe pain in her low extremities and back, and a neurogenic bladder. Based on her allegedly significant disabilities, Kitrosser claimed that she now requires assistance with activities of daily living, such as assistance with shopping, cooking and light housekeeping. In terms of future health care needs, Kitrosser alleged that she will require pain management for the rest of her life. She also alleged that she will require pain medications and periodic physical therapy to maximize her mobility. NuVasive’s counsel argued that Kitrosser was not injured as a result of the surgery on Sept. 3, 2008. Instead, counsel contended that Kitrosser had significant pre-existing back and leg pain, including complaints of pain being 8 or 9 out of 10, resulting in disabilities that included an inability to walk more than 100 feet within several months of the surgery. Thus, counsel argued that Kitrosser’s current situation was unrelated to the surgery performed by Taylor and was related to a continuation of Kitrosser’s pre-existing degenerative back condition.
Superior Court of San Diego County, San Diego, CA

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