June 24, 2016 — CVN is broadcasting the first trial over bone cement that was used in unapproved spinal surgeries.
The victims are Reba Golden, who died in 2007, and Joan Bryant, who died in 2009. Their families sued Dr. Jens Chapman at the University of Washington’s Harborview Medical Center.
Dr. Chapman injected bone cement into each woman’s spine. It leaked into their bloodstream and caused severe blood clots. Both women died on the operating table in unapproved surgeries.
The bone cement in question was created by Norian Corporation for use in skull and arm-bone surgeries. After Norian was purchased by Synthes in 2000, executives began pushing it for spinal surgery.
Instead of going through a long and expensive FDA-approval process, executives told a few hospitals to perform 60-80 spinal surgeries and publish the results. In 2002, a medical consultant likened this to “human experiments.”
Lawyers say Dr. Chapman should have known about the risks because he tried using bone cement in pigs. The cement caused blood clots that killed the pigs. It also caused clotting in vials of human blood in test tubes.
According to the Seattle Times, at least five people had died by 2012 — including a 70 year-old woman in Texas in 2003.
In 2009, four top executives at Synthes and Norian were indicted on charges of conducting unauthorized clinical trials despite warnings that bone cement caused deadly blood clots. Norian agreed to pay $22.5 million, Synthes paid $669,800, and the executives were jailed.
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