Doctor Fails to Disclose Financial Relationship With Medical Device Used in Spinal Surgery

Case Overview

Case Name: Brenda Kitrosser v. William R. Taylor, M.D.; Judd Laraway, P.A.; The Regents of the University of California; and NuVasive, Inc., No. 37-2009-00099700-CU-MM-CTL

Case Type:

• Negligence Per Se
• Fraud – Misrepresentation; Fraudulent Concealment
• Intentional Torts – Battery
• Medical Malpractice – Informed Consent
• Professional Negligence – Breach of Fiduciary Duty

Injury:

• back – nerve impingement
• neck – nerve impingement
• epidermis – numbness
• urological – neurogenic bladder
• neurological – nerve impingement; neurological impairment

Plaintiff Attorney(s):

• Robert F. Vaage; Law Offices of Robert Vaage
• John F. McGuire, Jr.; Thorsnes, Bartolotta & McGuire

Defense Attorney(s):

• Thomas E. Lotz; Lot, Doggett & Rawers; San Diego, CA for William R. Taylor, M.D., The Regents of the University of California, Judd Laraway, P.A.
• Daniel G. Lamb; Pillsbury Winthrop Shaw Pittman LLP; San Diego, CA for NuVasive, Inc.
• Marilyn M. Jager; Morris Polich & Purdy; Los Angeles, CA for NuVasive, Inc.

Case Outcome: Verdict-Plaintiff against NuVasive

Settlement agreement between plaintiff and Dr. William R. Taylor, M.D., and The Regents of the University of California. Judd Laraway, P.A. was dismissed from the case.

Award Amount:

NuVasive to pay plaintiff $3,099,412 for product liability claims

Dr. Taylor and The Regents settled for $1,075,000 for the medical negligence claims

What Happened?

A retired special education teacher, Brenda Kitrosser, suffered back pain for years before having a laminectomy and microdiscectomy in 1993. Doctors perform these two spinal surgeries to help patients suffering from pain, numbness, and discomfort caused by an injury. Doctors also perform these spinal surgeries to help patients with a herniated disk or spinal canal narrowing. Patients with tumors that put pressure on nerves in the spine may also undergo these surgeries. In a laminectomy, surgeons remove part or all the vertebral bone. Microdiscectomy procedures involve taking out a portion of the intervertebral disc that may be compressing the traversing spinal nerve root.

Four years after these spinal surgeries, Kitrosser had an industrial accident that flared up and worsened her back pain. She then chose conservative management treatment for her ongoing back pain several times, declining to undergo surgical procedures. In 2007, she sought treatment and advice on her condition from Dr. William Taylor, M.D. Dr. Taylor is a surgeon at the University of California, San Diego Medical Center. Taylor then recommended a minimally invasive procedure he called eXtreme Lateral Interbody Fusion (XLIF).

He told his Kitrosser that the lateral approach to the spine in this surgery avoided cutting muscles. Furthermore, Taylor told her that this approach would make her heal faster than with traditional procedures. XLIF involved the use of NeuroVision, a nerve monitoring device, which would protect Kitrosser’s nerves during the procedure, Taylor also said. NuVasive is the manufacturer of NeuroVision.

Spinal Surgery

Based on Dr. Taylor’s recommendation and after later reading NeuroVision pamphlets, Kitrosser consented to the spinal surgery. The NeuroVision pamphlets said the device would “provide real-time, precise, and reliable feedback to ensure your nerve safety.” The pamphlets also said that the device would “ensure safe approach to the spine.” There was also some indication on the NeuroVision pamphlet that Dr. Taylor had authored it.

On Sept. 3, 2008, Taylor performed the XLIF procedure using the NeuroVision device on Kitrosser’s spine. The doctor then turned the patient over and implanted pedicle screws and rods into her spine. During spinal surgery, the device didn’t indicate any nerve proximity or nerve injury during the XLIF method or regarding the screw placements. However, Brenda woke up experiencing severe pain and manifesting neurological deficits.

A CT scan the next day then revealed that an abnormally positioned screw in her spinal canal was impinging on the nerve root. A fact that Kitrosser says Dr. Taylor failed to tell her. Two months later, Taylor removed the ill-placed screw and a rod, giving some relief to the patient. However, when Kitrosser’s condition worsened later, she endured additional surgeries to take out the rest of the hardware.

Allegations and Testimony in the Spinal Surgery Case

Claims Against the Doctor and University Hospital

Kitrosser then filed a lawsuit against Dr. Taylor and his physician’s assistant, Judd Laraway. The lawsuit also listed the hospital’s operator, The Regents of the University of California. Eventually, the physician’s assistant Laraway was dismissed from the case. Kitrosser asserted that the defendants’ actions constituted a lack of informed consent, fiduciary duty breach, battery, fraud by concealment, fraud by misrepresentation, and negligent misrepresentation. Moreover, Kitrosser alleged medical negligence by the defendants.

Brenda claimed that the permanent nerve damage from the procedures caused severe back and lower extremity pain. She also said she lacked bladder control and experienced numbness as well. Additionally, Kitrosser stated that she needed ongoing help with daily activities, pain management, and physical therapy because of the defendants’ actions.

Kitrosser also maintained that her consent to the XLIF procedure was based on her reliance on Dr. Taylor’s representations and the nerve-protecting statements in the NeuroVision pamphlet.

Failure to Disclose

The plaintiff also claimed that Taylor failed to tell her he was a consultant for NuVasive. Furthermore, Kitrosser claimed that Taylor failed to disclose that he had a financial interest in the company. The doctor also didn’t share with her that he was running NeuroVision clinical studies to determine if XLIF was an effective treatment for her underlying pathologic condition at the time he suggested she have the procedure. Moreover, she would not have qualified for the clinical study, given her presentation. Additionally, Kitrosser argued that Taylor didn’t disclose his role as principal investigator in a study to evaluate NeuroVision’s capacity to detect nerves during spinal procedures.

In response, Taylor and The Regents alleged that Kitrosser consented to the placement of the pedicle screws during her spinal surgery. The doctor in this case also said that malpositioned pedicle screws are a known complication of spinal surgery. He also maintained that he didn’t have a duty to disclose that he had a financial relationship with NuVasive. Furthermore, Taylor argued that he had no financial interest related to her XLIF procedure. Lastly, Taylor said he did tell Brenda about the CT results. However, she declined surgery to remove the offending hardware.

Finally, in December 2012, Taylor and The Regents agreed to a $1.75 million settlement with Kitrosser.

Claims Against NuVasive

After learning that Taylor was a paid consultant with financial interests in NuVasive during discovery in her first lawsuit, Kitrosser filed a separate action against NuVasive Inc. She then sued the company for negligence per se, fraud by misrepresentation, negligent misrepresentation, and fraud by concealment.

In February 2011, the two actions were consolidated. After the doctor and hospital settled, the NuVasive action went to trial.

The plaintiff contended that NuVasive made false statements about the precision of the nerve protection capabilities of the NeuroVision device that had informed her consent to the procedure. However, NuVasive alleged the statements were not false or misleading and were intended to complement discussions with her physician. This defendant also argued that a pre-existing back and leg pain caused Kitrosser’s situation.

Who Won the Spinal Surgery Case?

Dr. Taylor and The Regents of the University of California agreed to pay Kitrosser $1.75M in a settlement agreement.

After a trial, a jury found that the NuVasive pamphlet statements about the NeuroVision device were false. The jury also found that NuVasive conspired with William Taylor to commit fraud. The jury awarded Kitrosser $3,099,412 in related damages.

The award to Brenda Kitrosser broke down as follows:

• $921,634 personal injury: future economic loss
• $700,000 personal injury: past non-economic loss
• $1,477,778 personal injury: future non-economic loss

Expert Specialities

The plaintiff retained expert witnesses in:

• Neurology
• Neuroradiology
• Urology
• Physiology
• Neurosurgery
• Pain Management
• Economic
• Life Care Planning

The defendants retained expert witnesses in:

• Orthopedic Surgery
• Biomechanics
• Life Care Planning
• Physiology
• Economic
• FDA Regulatory Affairs
• Neurosurgery
• Ergonomics/Human Factors
• Urology

Key Takeaways

Plaintiff attorneys should take note that the doctor and university regents elected to settle this medical malpractice case rather than litigate it publicly before a jury. This could indicate that a respected plaintiff expert witness or consultant was involved to shoot down Dr. William’s claim that “malpositioned screws” are simply an accepted occurrence in spinal surgeries.

Also, the defendants likely viewed a “he said, she said” debate at an expensive trial over whether Dr. Williams told Kitrosser about the CT showing abnormal screw placement as a waste of time and money. Therefore, plaintiffs’ counsel will do well to hang tough in negotiations. Corporate defendants will frequently make a business decision to cut their losses and settle for a favorable amount.

The widespread practice of physicians taking leadership roles in clinical trials for new drugs and medical devices presents complex issues concerning a doctor’s duty to disclose their involvement to a patient when discussing the use of a novel approach. The practice of authoring promotional pamphlets for novel products can also be problematic for doctors as we see here. Plaintiffs’ counsel and their clients would be well-served to go after doctors who cross these lines and end up injuring people.