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 Seattle jury.
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.
But Dr. Michael Sharp, a Synthes manager of regulatory affairs, objected and began “writing to people in the company saying, ‘We can’t do this,”‘ Friedman said.
Another doctor, Kenneth Lambert, also warned against the idea, saying while the Norian bone cement had great potential, it needed testing before being used on patients.
Chapman used it on a pig in 2002, and it died. A week later, the company went forward with the test market. Lambert again voiced concerns about the product’s safety and said sending it to untrained surgeons “amounts to human experimentation,” Friedman said.
In June 2002, Chapman submitted a proposal that laid out questions and concerns about the cement. Most disturbing, he said, was how only a small amount could cause severe clotting. He suggested a two-year timeline at the cost of about $400,000, Friedman said. But three months later, and before any studies were done, Chapman put it in a patient’s spine, Friedman said.
“Over the next five years, things did not go well for Synthes,” Friedman 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.
But when Reba Golden went to Chapman and he agreed to operate on her spine, he used the Norian bone cement and she bled to death on the table, Friedman said.
“For elective spinal surgery, no one bleeds to death,” Friedman said. “It’s like getting struck by lightning.”
In 2010, Synthes, Norian and company executives pleaded guilty to federal charges that they promoted the product for unauthorized use, Madden said.
But Chapman was not involved in the “criminal enterprise that led to the federal prosecution of Synthes,” he said. Chapman did not take part in the test market, and he never used Norian to treat compression fractures, Madden said.
Chapman, a world-renown spinal surgeon, did 300-plus surgeries and used Norian less than 1 percent of the time, Madden said.
“He was not part of any plan to profit from using Norian in the spine,” Madden said.
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