The family of a woman who died on the operating table during an unapproved trial of the Norian bone cement product has filed suit against Johnson & Johnson’s Synthes unit, claiming the company and its Norian unit “concealed the illegality, experimental nature and substantial risks of the surgery.” As we’ve reported previously, four Synthes executives were sentenced to prison last year for their roles in the unapproved Norian bone cement clinical trials cited by the lawsuit.
According to a complaint filed on July 27 in federal court in Philadelphia by her husband and two adult children, Lois L. Eskind died on January 13, 2003, during spinal surgery. Her death occurred moments after her surgeon injected her spine with a mixture of the Norian bone cement product and barium sulfate. The mixture quickly leaked into her venous system, and she suffered cardiac arrest. Eskind was one of three people to die during illegal tests of the Norian bone cement.
“I feel like my mother was murdered,” Sloan’s daughter told the Philadelphia Inquirer on Monday. “I wanted to destroy them, and I didn’t know any other way. I might only be a bumble bee to them, but I want them to know I’m ticked off. Well, I’m more than ticked off.”
As we’ve reported previously, the U.S. Food & Drug Administration (FDA) approved the Norian product for use elsewhere in the body, but not the spine. In fact, its FDA-approved label warns against use in the spine, and studies have shown that such use can cause clots that could become lodged in the lungs, leading to death. The Norian bone cement was pulled from the market after Synthes received a warning letter from the FDA in November 2004 regarding improper marketing of the product for vertebral compression fractures. Synthes and its Norian unit agreed in 2010 to plead guilty to federal charges that between 2002 and 2004 they conspired to conduct unauthorized clinical trials using the bone cement in a type of spinal procedure. The company agreed to pay $24 million in fines to settle the charges, while four former Synthes executives pleaded guilty to one misdemeanor count each for their roles in the case.
According to the Philadelphia Inquirer, the Sloan family lawsuit has been assigned to U.S. District Judge Legrome D. Davis, who sentenced the four Synthes executives to prison terms ranging from five to eight months, after calling their conduct “egregious.”
The families of the two other patients who died during the illegal bone cement trials filed suit against Synthes this past spring in California state court.