SURGEON USING SYNTHES’ NORIAN EXONERATED BY JURY (Orthopedics This Week)
Jens Chapman, M.D., a University of Washington surgeon, implanted Synthes, Inc.’s Norian bone cement in Reba Goldman’s spine after an accident in 2007.
Goldman reportedly died on the operating table. Cindy Wilson, Goldman’s daughter sued Chapman and Synthes, Inc. and four company executives. The company reached a confidential settlement with Wilson during the trial, but Chapman left his fate in the hands of the jury.
The jury, after a five-week trial, voted 10-2 in favor of Chapman, determining that the surgeon did not act below the standard of medical care. The jury, according to Wilson’s lawyer, Rick Friedman, also found that Chapman had 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.
Michael Madden, a lawyer representing Chapman and the university, reportedly told the jury that Goldman’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.
Norian’s Rocky Road
Norian has been a sad story for Synthes ever since Synthes bought the California-based Norian Corporation in 1999.
By July 2003, adverse events began being reported and one patient death. Two more patients died in 2003 and 2004, and by January 2007, the FDA got involved and required labeling that said that Norian XR was not intended for use in the spine.
Sometime around June 2002 clinical investigators at the University of Washington told Synthes that they had found that the calcium contained in Norian SRS had a unique interaction with blood, providing both a surface on which clots could form and a chemical stimulus to clot formation. The pilot studies further showed dramatic clotting of a pig’s lung veins following injection of a small amount of SRS.
Six months later, December 19, 2002, the FDA cleared Norian XR as a general bone void filler with a label stating that XR was intended to fill only bony voids that were “not intrinsic to the stability of the bony structure” in the extremities, spine and pelvis, and further warning that XR was “not intended for treatment of vertebral compression fractures.”
One month later, January 13, 2003, a spine surgeon used Synthes’ Cavity Creation instruments on a patient who became immediately hypotensive and died on the operating table. The doctor could not rule out Norian as a cause of death.
Nine months after the first death, another spine surgeon used Norian XR with the Synthes Cavity Creation instrument. That patient also suffered a hypotensive episode and died. The doctor noted a cement leak and believed that it was the cause of the episode and could not rule out Norian XR as a cause of the death.
There were criminal and civil lawsuits and four former Synthes executives pled guilty in mid-2009 to a misdemeanor count of shipping adulterated and misbranded Norian XP in interstate commerce. Synthes paid a $23.5 million fine and was ordered to divest Norian.
More to Come
Friedman represented another client who sued Synthes, Chapman and the university for using Norian in a fatal surgery. All parties settled before trial.
After the Wilson trial started, Friedman said he was contacted by several other Chapman patients involving the use of Norian.
“We’re looking at those,” he said.
Norian continues to have a financial and moral impact on, now DePuy Synthes, but not in the way Synthes had hoped for back in 1999.