Whether you or a loved one is hospitalized, things are expected to be clean and sterile, and you expect to be helped and healed. However, this is not always the case. In some cases is it due to medical negligence; other times, further injury is the result of contaminated medical supplies or medicine.
In early 2011, Meds IV, a Birmingham pharmacy and drug compounding company, produced a total parenteral nutrition drug under poor sanitary conditions that eventually led to the deaths of at least nine patients and harmful bacterial infections in several others. On March 28, 2011, Meds IV recalled their total parenteral nutrition solution after reports of patients developing a bacterial infection.
There was a criminal investigation by the U.S. Food and Drug Administration (FDA) and the United States Attorney. On January 28, 2016 two pharmacists at Meds IV pleaded guilty to criminal charges.
What is Total Parenteral Nutrition?
Total parenteral nutrition, or TPN, is an amino acid solution given to some hospital patients through a drip IV or catheter inserted into a patient’s vein. It is meant to replace the daily nutrition a body needs should a patient be unable to eat. The direct link to a patient’s bloodstream means that TPNs must be sterile. As such, when a pharmacy fails to provide sterile lab environments for the production of TPNs it is endangering the patient’s lives.
Contaminated TPNs
It is vital that TPNs be prepared in a clean environment to prevent contaminating them. Contamination can come from bacteria found in unsterile environments and may lead to bacterial infections in humans. Some forms of contamination can be seen with the human eye—cloudy liquid and particles in the fluid. It is the producer’s responsibility to reduce the risk of contagion.
The faulty TPNs from Meds IV contained a form of bacteria known as
Serratia marcescens, that, when introduced to the bloodstream, can cause serious infections of the bloodstream that can sometimes become fatal due to the bacteria’s resistance to most antibiotics. The contamination of Meds IV was a result of unprofessionalism and carelessness. The mixtures were reportedly left unrefrigerated overnight in an unsterile room in a large pot on the floor.
Plea Agreement: Why?
David Lee Allen, 60, was the pharmacist responsible for overseeing all compounding at Meds IV, reviewing and approving TPN formulas, and filling individual prescriptions of patient-specific TPNs from Meds IV. William Timothy Rogers, 48, another pharmacist, was in charge of overseeing all day-to-day operations at Meds IV. Both men have signed plea agreements to two misdemeanor violations under the federal Food, Drug and Cosmetic Act on January 28, 2016. This plea bargain means that neither man will face a jury trial, and both get two years of jail time and revocation of their pharmacy licenses.
By pleading guilty Allen and Rogers admit to sending a sample of their TPN compound to an outside lab to test for contaminants on March 1, 2011, being told their solution tested positive for endotoxins on March 8, and continuing to ship the mixture to hospitals in the Birmingham area. On March 14, hospitals using the TPN alerted Meds IV to a problem with their TPN. Both admit that the TPNs produced in early 2011 were adulterated and contamininated.
Plea Agreement: Is It Fair?
Cory Watson cares about people. We believe that when a person enters a hospital, they should be healed; if this is not the case it should not be because of faulty medicinal supplies contaminated by the negligence of people whose job is to produce safe and clean drugs for ailing patients. Our lawyers represented one of the nine families that lost a loved one to the carelessness of these men; and we are prepared to do so again.
From the perspective of our clients, sentences of two years or less for licensed professionals whose lack of concern for human life and disregard of the values of science and medicine, is unfair. The sentences are out of proportion to the harm they caused. Nine lives were lost.
Cory Watson: Your Lawyers for Life
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