Prosecutors allege that bone cement manufactured by Norian and its parent company, Synthes, was used to conduct “human experimentation,” resulting in a string of deaths over the past several years.
As Fortune reports here, the deaths were the result of spinal injections of a product called Norian XR, described as “a cement that has the unique capacity to turn into bone when injected into the human skeleton.”
Norian XR was never approved by the FDA for use in the human spine. To the contrary, the FDA required the company to mark the product as ‘not approved’ for such use.
Experiments conducted at the University of Washington exposed the dangers of using the bone cement to treat human spine injuries as early as 2002. When tested on pigs, the Norian XR caused severe blood clotting, resulting in the deaths of the animals.
Synthes had acquired the California-based Norian Corporation with the intention of altering Norian XR for use in spinal treatments. Nothing was going to stand in the way of company profits.
Prosecutors say that the company launched a scheme specifically designed to get around FDA approval.
As The Dallas Morning News reports here:
CEO Hansjorg Wyss directed a few sites to perform 60 to 80 procedures in spinal surgeries using the Norian bone cement and to publish clinical results. He recruited surgeons to test-market the product on patients, court records show.
The patients who were exposed to the experimental treatment were never told that the product was not approved by the FDA.
By 2010, a string of deaths had been attributed to the company’s human experimentation.
Lois Eskind, age 70, was injected with Norian XR while a company salesperson watched. The Dallas Morning News reports, “The product leaked into Eskind’s veins and led to the clotting that killed her.”
The company did not inform the FDA of Eskind’s death. They continued to experiment on human beings without their knowledge or consent, causing the deaths of many other people, including Reba Golden and Joan Bryant.
In 2010, Synthes and Norian, along with four top executives, were convicted of conducting unauthorized clinical trials on humans. Norian paid a $22.5 million penalty, while Synthes paid $669,800 fine. The executives went to prison.
The families of Golden and Bryant recently filed a civil suit against Dr. Jens Chapman, Synthes, Norian, the University of Washington, Harborview Medical Center and Washington state. The first trial is set to begin in June.
The crimes committed by these companies are a chilling example of the risks we take in allowing our healthcare system to be controlled by profit-motivated corporations like Synthes.
Featured image via Pixabay Public Domain