A jury has found in favor of a University of Washington surgeon who was sued by the daughter of a patient who died after the doctor used a non-FDA-approved bone cement during the woman’s spinal surgery, a lawyer said.
In a 10-2 decision after a five-week trial, the jurors reached the decision on Friday that Dr. Jens Chapman did not act below the standard of medical care when he used the Norian bone cement on Reba Golden’s back in 2007, according to Rick Friedman, a lawyer for Golden’s daughter, Cindy Wilson, who filed the lawsuit.
Golden died on the operating table but Wilson didn’t learn until 2012 that the FDA had prohibited the use of Norian for spinal surgeries.
The jury also found that Chapman failed to inform Golden about the risks associated with using Norian but concluded that an informed person would have opted to use the cement anyway, Friedman said.
Wilson also sued Synthes Inc., the maker of Norian, and four company executives, but they reached a confidential settlement with Wilson during the fourth week of the trial, Friedman said.
Wilson says that she’s disappointed with the jury decision: “I never dreamed a jury would exonerate him knowing all the facts in the case, I never wanted money. I wanted somebody to nail this guy because what he did was wrong.”
Tina Mankowski, a spokeswoman for Chapman and the university, said in an email: “The university is very sorry for the loss to the family of Mrs. Golden. We are grateful to the jury for its diligence in reviewing the medical facts and using them to reach its decision.”
Mindy Tinsley, a spokeswoman for the DePuy Synthes Franchise said in an email that the company sympathizes “with the Golden family on their loss” and added that Synthes is no longer a defendant in the lawsuit and was not a party to the verdict. She did not immediately respond to questions seeking comment on the claims made against Synthes during trial.
Synthes bought California-based Norian and altered one of its bone-cement products to be used on the spines of aging baby boomers who were susceptible to spinal injuries, Friedman told the jury in his opening statement at the trial in King County Superior Court. That product had the potential to be worth about $500 million, he said.
Instead of taking the product through the normal regulatory process, Synthes officials planned to send the bone cement to surgeons across the county, who would use it and publish articles that could be used to secure Food and Drug Administration approval, Friedman said.
“Over the next five years, things did not go well for Synthes,” he said.
By July 2003, there were three adverse events and one patient death. Two more patients died in 2003 and 2004, and by January 2007, the FDA demanded that Synthes put a label on the product saying it can’t be used on the spine, Friedman said.
The company, however, continued with its plan and in 2010, Synthes, Norian, and company executives pleaded guilty to federal charges that they promoted the product for unauthorized use.
After Reba Golden suffered a spinal injury during a fall, Chapman used the bone cement on her spine. She suffered massive blood clots that caused her to bleed out on the operating table.
Michael Madden, a lawyer representing Chapman and the university, told the jury that Golden’s spine injury caused her extreme pain, and Chapman used a safe procedure to try to help her. He added Chapman did not use the Norian bone cement in a way that put Golden at risk.
Wilson disagreed, saying her mother’s injury caused some pain, but Chapman’s lawyers “made it sound catastrophic.”
If Chapman had fully explained the risks of using Norian in her spine, including details of Chapman’s own experiments that showed massive clotting, she never would have agreed to the use of Norian, Wilson maintains.
Friedman says they are considering appeal options in the case.
Friedman represented another client who sued Synthes, Chapman, and the university for using Norian in a fatal surgery, but all parties settled that case ahead of trial.
After the Wilson trial started, Friedman’s law firm was contacted by several other Chapman patients involving the use of Norian, Friedman says.
“We’re looking at those,” he says.
Filed Under: Industry regulations