The Centers for Disease Control and Prevention investigated Lykins’ death and found 25 cases of serious bacterial infections in people receiving similar operations and identified a single company (CryoLife) as being involved in 14 of those cases. In 2002 the FDA shut down substantial parts of CryoLife’s operations saying that the company could not adequately assure patients that its products were safe.
Dr. Mary Malarkey, director of the division of case management at the FDA’s Office of Compliance and Biologics Quality was quoted in The New York Times at the time as saying about CryoLife: “We found significant violations from our regulations. What they were doing did not ensure tissue safety. CryoLife’s response was, said Malarkey, “inadequate.” CryoLife’s lawyers at the time said they would file an appeal.
The CDC said that CryoLife’s products were involved in 14 cases. The FDA cited more. With just two exceptions, CryoLife did not admit to causing any infections in any tissue recipients. We won’t recount the tortured way in which the truth finally emerged but suffice it to say that it required investigations from the Centers for Disease Control and the FDA to fully uncover all of the problems at CryoLife and to ensure that new policies and procedures were in place.
The FDA imposed some of the most severe sanctions ever imposed on a still-operating company. At one point, CryoLife had to lay off nearly a quarter of its employees.
How does this bear on the Medafor situation? CryoLife and its CEO Steve Anderson have an established track record of full-contact business tactics.
Could Anderson and CryoLife have met their match with Medafor? Or will Medafor ultimately succumb to this bad boy’s bear hug?
Stay tuned. More is on the way and it will almost certainly be interesting.
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