June 24, 2016 — Trial is underway on behalf of two women who died after being injected with bone cement in unapproved spinal surgeries likened to “human experimentation,” according to CVN
Reba Golden died in 2007 and Joan Bryant died in 2009. Both women died on the operating table during routine back surgeries gone horribly wrong.
Dr. Jens Chapman and the University of Washington are accused of experimenting with the use of bone cement for spinal surgeries — even though they knew it was unapproved and the cement could leak into the bloodstream and cause deadly blood clots.
In 2000, Norian Corporation was purchased by Synthes, a subsidiary of Johnson & Johnson. Norian developed bone cements for use in skull and arm-bone surgeries. Synthes wanted to use it for spinal surgeries — a use not approved by the FDA.
Facing a long FDA-approval process, Synthes directed a few hospitals to perform 60 to 80 spinal surgeries using bone cement and publish the results, according to court records.
In 2002, Dr. Chapman at Harborview Medical Center tried using bone cement in pigs. The cement caused clotting, killing the pigs. When it was tested on human blood in test tubes, it again caused clotting.
That same year, a medical consultant warned that unauthorized clinical trials amounted to “human experimentation.”
Yet the experiments continued. In 2003, a 70 year-old woman died in Texas after bone cement was injected into her spine. A patient died in California seven months later, and another patient four months after that. Five deaths were blamed on the experiments by 2012, according to the Seattle Times.
In 2009, four top executives at Synthes and Norian were indicted on charges of conducting unauthorized clinical trials despite knowing that bone cement caused deadly blood clots. Norian paid a $22.5 million penalty, Synthes paid $669,800, and the executives were imprisoned.
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