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Trial begins in lawsuit over spinal bone cement

By MARTHA BELLISLE, Associated Press – June 27, 2016


SEATTLE (AP) — The physician who used a non-FDA-approved bone cement during a woman’s spinal surgery and the company that ran an illegal test market to promote the dangerous product should be held accountable for her death, a lawyer for the woman’s daughter told a jury Monday.

Reba Golden was vibrant and healthy when she agreed to let Dr. Jens Chapman operate on her back in 2007, but the surgeon never told Golden or her family that he planned to use a bone cement associated with blood clotting and patient deaths, said attorney Rick Friedman, who represents Cynthia Wilson in a lawsuit against the surgeon, the University of Washington and Synthes Inc.

Chapman and Jansjoerg Wyss, former CEO of Synthes, knew the product’s risks but continued to use it on patients in a scheme that one doctor called “human experimentation,” Friedman said in opening statements of the trial.

This case is about “two men who could not admit they made a mistake,” Friedman.

Michael Madden, a lawyer representing Chapman and the university, said Friedman distorted and ignored the facts by claiming Chapman “put the interests of Synthes and Mr. Wyss ahead of the best interest of his patient.”

“This is a case about a 67-year-old woman who fell and broke her back,” Madden told the jury. The injury caused her extreme pain, and Chapman used a safe procedure to try to help her, Madden said. He added Chapman did not use the Norian bone cement in a way that put Golden at risk.

The trial before King County Superior Court Judge Jim Rogers is expected to last up to eight weeks.

Wyss recognized in the 1990s that as baby boomers aged, they were more susceptible to spinal injuries and if he could get a bone cement on the market to use in surgeries, the product would be worth about $500 million, Friedman said. Synthes bought a California-based company called Norian and altered one of its products to be used on the spine, the lawyer said.

Taking the product through the normal regulatory process would be time-consuming and costly. Instead, Wyss and other company executives wanted 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.

Josh Sandberg

Josh Sandberg is the President and CEO of Ortho Spine Partners and sits on several company and industry related Boards. He also is the Creator and Editor of OrthoSpineNews.

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