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Bone Cement Leaks into Bloodstream and Causes Clotting
May 24, 2016
Reba Golden hurt her back after falling two floors while building an addition to her house in Honduras. But when she returned to Seattle for a routine spinal surgery, she suffered blood clots, severe bleeding and died in 2007 on the operating table.
Joan Bryant’s back had bothered her since a car accident, so in 2009 she sought help from a Seattle spinal surgeon, but she bled out and could not be revived.
Like at least three spinal surgery patients before them — including a woman in Plano — Golden and Bryant died after their doctor injected bone cement into their spine and some of the material leaked into their bloodstream, causing clotting.
The patients were never told that Norian bone cement wasn’t approved by the Food and Drug Administration. Instead, Norian and parent company Synthes used surgeons in what one doctor called “human experimentation.” Federal prosecutors say the aim was to skirt a long, costly regulatory process.
The Golden and Bryant families have filed lawsuits against Dr. Jens Chapman, the companies, the University of Washington, Harborview Medical Center and Washington state. The lawsuits say that Chapman knew the cement caused lethal clotting and that the university and hospital knew or should have known the product had been prohibited for such use. The first trial is scheduled for June in Seattle.
Synthes and Norian had been sued before. In 2012, they were accused of wrongful death and negligence by the family of an Oklahoma woman who died at the Texas Back Institute in 2003.
A surgeon injected the bone cement into the spine of Lois Eskind, 70, while a sales representative for the companies watched, court records show. The product leaked into Eskind’s veins and led to the clotting that killed her, according to the woman’s daughter.
The daughter told a Pennsylvania court that the companies failed to file a report about the death with the FDA and that the surgeon had simply told the family: “I’m sorry. She didn’t make it.”
Eskind’s family, Synthes and Norian settled the lawsuit through private mediation, according to court documents.
Synthes and Norian, along with four top executives, were indicted in 2009 on charges of conducting unauthorized clinical trials despite warnings that the bone cement caused deadly blood clots. Norian agreed to pay a $22.5 million penalty, Synthes paid a $669,800 fine, and the executives went to prison.