REBA GOLDEN In 2007, Ms. Golden died on the operating table during spine surgery after her surgeon injected an off-label bone cement into her spine.

The surgeon who injected a non-FDA-approved bone cement into the spine of a woman who bled out in the OR must be held responsible for her death, along with his hospital and the cement's manufacturers, a lawyer for the woman's daughter argued in court last week as the trial got underway.

Reba Golden of Seattle, Wash., underwent spine surgery in 2007, after suffering from a fall that caused compression fractures, according to court records. During this surgery at the University of Washington Harborview Medical Center, Jens Chapman, MD, allegedly used a bone cement that was known to cause adverse events, including blood clots. FDA had warned against using the bone cement in spine surgery.

In addition to Dr. Chapman and the University of Washington, the cement's manufacturers, Synthes and Norian are named in the case. Synthes and Norian, along with 4 top executives, pled guilty in 2010 for promoting the product for spine surgery despite warnings that the bone cement caused deadly blood clots.

About 15 years ago, Synthes, an orthopedic manufacturer based in West Chester, Pa., acquired the bone-cement manufacturer Norian. Synthes wanted to alter Norian's product for use in spinal surgeries, but didn't want to go through the long FDA approval process, court records state.

Instead, Synthes sent the cement out to a few select facilities to test it in spinal surgeries in the early 2000s. Company executives asked the users to report back with clinical results, court records show. Dr. Chapman was one of these test users, records show.

After Dr. Chapman and a colleague tested the cement on a pig in 2002, the animals died due to blood clotting, according to court records. Other physicians also reported clotting problems with the cement, and several patients throughout the country died after surgeons injected the cement into their vertebrae.

In 2006, the FDA approved Norian bone cement, but told Synthes that it could not be marketed or used in spine surgery. Despite this warning, Dr. Chapman continued using the cement, according to the complaint. Dr. Chapman did not take part in the test market, and he never used Norian to treat compression fractures, says his lawyer.

Lawyers for Ms. Golden's family told the jury that Dr. Chapman did not tell her or her family he was going to use the off-label cement in Ms. Golden's procedure, the Associated Press reports. After he injected the cement, Ms. Golden "began to bleed profusely" during the procedure, ultimately dying on the operative table.

Dr. Chapman has denied any wrongdoing. An attorney representing Dr. Chapman and the University of Washington argued in court that the case was simply about "a 67-year-old woman who fell and broke her back," and that Dr. Chapman used a safe procedure to try to help her, according to the AP.

The trial is expected to last 8 weeks. When reached for comment, Ms. Golden's estate's attorney, Rick Friedman, told Outpatient Surgery that he was under court orders not to discuss the case with the media. Representation for Dr. Chapman and the University of Washington did not return requests for comment.

Kendal Gapinski