Wednesday, October 1, 2014

Clinic Lawyers Say Any Blame for Outbreak Should Be Shared

By Walter F. Roche Jr.

Lawyers for the Saint Thomas Outpatient Neurosurgical Center have named nearly a dozen other parties, including three government agencies, who they say should share any blame for a fatal 2012 fungal meningitis outbreak.
In a 113-page filing in U.S. District Court in Boston, Mass. Tuesday the attorneys for the Nashville clinic and other Tennessee defendants listed a testing company and the supplier of bulk chemical compounds along with a half dozen other parties, as bearing some responsibility for the outbreak.
The filing came in a series of suits which have been merged before U.S. District Judge Rya Zobel.
At the same time clinic lawyers said the facility and other defendants "complied with the laws and regulations applicable to them and with industry standards."
They also stated that the defendants had no reason to suspect that the steroids shipped by a now shuttered drug compounder, the New England Compounding Center, were tainted with fungus.
The outbreak led to the deaths of 64 patients while 751 were sickened. Tennessee was among the hardest hit with 16 deaths.
The filing also names state agencies in Tennessee and Massachusetts along with the U.S. Food and Drug Administration as sharing in the blame and calls the outbreak "a colossal regulatory failure."
The FDA failed to act against NECC even though the drug firm's activities "fell squarely within FDA's definition of its own regulatory authority,"clinic lawyers charged.
Others named as bearing possible liability by Saint Thomas lawyers were an organization that provided training for NECC employees and sold the company the "recipe" for the steroid drug, a heating contractor and the company that installed clean rooms for NECC.
The filing charges that Medisca, the firm that supplied NECC with the bulk materials for its products should have known NECC was not in compliance with the law simply because of the high volume of base chemicals it was purchasing.

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