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Wrongful death suit alleges medical company evaded FDA tests

Losing a loved one is an emotional and painful experience, but it is made more traumatic when it is discovered that one party or organization was either responsible for or directly caused the unfortunate incident. It can take time for such evidence to come to light, but when it does, the victim's family can bring wrongful death charges against the negligent or otherwise at-fault party. Claims often include negligence, reckless endangerment, misconduct or a failure to uphold safe premises or conditions.

Sometimes, though, the claims (and, subsequently, the fatal incident itself) in a wrongful death case are far more serious. This is the unfortunate reality for one woman who lost her mother on the operating table because a medical company circumvented FDA rules, scoffed at its safety procedures and went forward with an illegal drug test.

The incident occurred in January 2003, when the woman's mother went in for surgery on her back. A company called Norian Corp., which was a subsidiary of Synthes at the time but is no longer affiliated with the parent company, was developing a new "bone cement" called SRS (Skeletal Repair System).

The substance was approved by the FDA for use in broken forearm cases -- but not spinal cord injuries, such as vertebrae fractures (an approval that Synthes and Norian both wanted). In a desperate, dangerous and highly unethical move, they gave the mother SRS so that they would have a human test to support their new "bone cement." The woman died shortly after SRS was injected into her spine.

Federal officials charged Norian with conspiracy in 2009 and four Synthes executives were jailed for their involvement. But that did not help the woman's daughter, who still was living with the pain of losing her mother in such a negligent and inhumane manner. She filed a wrongful death suit against both Synthes and Norian, charging the companies with fraudulent concealment, gross negligence, reckless misconduct and conspiracy.

Source: Courthouse News Service, "Woman Calls Drug Companies Unconscionable," Reuben Kramer, July 31, 2012

  • Our firm handles similar situations to the one discussed in this post. If you would like to learn more about our practice, please visit our Silver Spring wrongful death page.

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