Dr. Sigurd Berven’s Testimony About the Off-Label Use of Spinal Implant Helps Clear Surgeon in 7-Figure Med Mal Case

In a seven-figure medical malpractice trial in the Los Angeles County (California) Superior Court, Dr. Sigurd Berven, an orthopedic surgeon, played a key role in clearing a doctor accused of improperly using a spinal implant.

Dr. William Dobkin had used Medtronic Inc.’s “Infuse” spinal implant during two lumbar surgeries on Christina Avalos. This was an off-label usage of the device and was therefore not FDA approved for this type of surgery. The device is a cage containing bone morphogenic protein that stimulates bone growth wherever it is placed. In this case, Dobkin had implanted the device between lumbar vertebra in order to facilitate lumbar spine fusion. Avalos claimed that the implanted device led to excessive bone growth in her spine that left her suffering from chronic, disabling pain. She further claimed Dobkin had not obtained appropriate informed consent since he did not tell her that it was not FDA approved for this particular procedure, and she contended he had breached the standard of care by not informing her of his relationship with Medtronic.

With dispassionate, authoritative certitude, Berven, an orthopedic surgeon specializing in pediatric and adult spine disorders from the University of California, San Francisco, attacked each of the plaintiff’s allegations. First, he calmly cast aside the claim that the operating surgeon might use the time-saving device just to allow him to move more quickly to his next surgery. Berven explains that not only does the device save time, which is advantageous to the health of patients undergoing general anesthesia, but it spares the patient the pain and trauma of harvesting a bone graft from the hip. He testifies that this ability to reduce surgery time by perhaps an hour is representative of the medical advances cutting down on surgical time over previous decades, and which all patients have benefited from.

Berven is then questioned about the cage becoming displaced, a screw discovered to be loosened, or a screw replaced, as reported by a surgeon that had reoperated on Avalos. Without hesitation, Berven concludes there is no objective evidence that any of this had actually occurred.

Deeper into the testimony, Berven is asked about the theory that there was an osteolytic reaction causing subsidence of vertebral bone after placement of the “Infuse” in the first surgery. Plaintiffs claimed that should have warned Dobkin not to use this same device in the second surgery. In response, Berven completely turns the theory on its head, by explaining that the reaction seen in Avalos was consistent with a successful procedure. Berven explains that an inflammatory reaction such described in Avalos is seen in the early stages of healing. That reaction promotes the ingrowth of blood vessels and cells that allow the bone morphogenic protein within the “Infuse” implant to form bone where the inflammation has occurred. Berven adds that this is exactly what is intended to happen, and the appearance described in Avalos would lead to “a robust bone healing reaction.” Both fusions, he concludes, were ultimately successful in this regard.

As to the question of informed consent regarding Dobkin’s relationship with the device manufacturer, the defense expert definitively answers, “No” when pressed if this needed to be disclosed. There was no equivocation. He maintains that is simply not part of the standard of care.

Beyond responding to the plaintiff’s theories, Berven goes on to detail the function of facets during the spine’s movement, and explains the drawbacks of any spinal fusion. He says the level adjacent to the fusion may wear out due to the changed dynamics of movement. This can lead to inflammation of the adjacent level and subsequent osteophyte, or bony formation, within the joint. This is an expected degenerative consequence of this type of surgery, regardless of the use of an “Infuse” implant or any other fusion technique. The seroma or hematoma that was found in Avalos is common after this surgery and usually resorbs over time, yet the fact that there remains some at the operative site is, according to the expert, “inconsequential.”

Berven also notes that the presence or prevalence of ectopic bone is similar whether or not “Infuse” is used, because “it is a function of the surgical approach.” Quoting the studies on this issue, he reinforces the point that the incidence of this ectopic bone formation is about 10% whether or not “Infuse” is used.

Berven’s testimony for the defense in this case, with his convincing explanations and authoritative manner, were crucial to the jury finding for the defense, clearing Dobkin of malpractice at a trial in which the plaintiff sought more than $6.4 million in damages.

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Gary Gansar, MD, is residency trained and Board Certified in General Surgery. He previously served as Chief of Surgery and Staff at Elmwood Medical Center and on the Medical Executive Committee at Mercy Hospital and Touro Infirmary in New Orleans, LA. Dr. Gansar also served as Clinical Instructor and Professor of Surgery at Tulane University. He received his MD and served as Chief Resident at Tulane University Medical School. Dr. Gansar joined AMFS as a consulting medical expert in 2011 and has served as Medical Director since Nov. 2015. In this capacity, Dr. Gansar provides consultation, review and guidance to attorney clients.