FDA, Mass. Board Can be Found at Fault for Outbreak

By Walter F. Roche Jr.

A federal judge has ruled that the U.S. Food and Drug Administration and a state pharmacy board can be found at fault for the 2012 fungal meningitis outbreak that took the lives of some 77 patients who had been injected with fungus contaminated drugs.
In a nine-page ruling issued today U.S. District Judge Rya Zobel concluded that lawyers for a Tennessee pain clinic had presented sufficient evidence in her Boston, Mass. courtroom for the claims that the two agencies acted recklessly to go forward.
Zobel denied a motion filed by attorneys for some 20 Tennessee victims of the outbreak to dismiss claims by the Specialty Surgery Center in Crossville, Tenn. that the government agencies could be found at fault for failure to take action against the New England Compounding Center, the maker of the deadly spinal steroids.
Citing a "special duty" provision of Tennessee's comparative fault law, Zobel concluded that the clinic's lawyers presented "sufficient assertions to state an affirmative defense of comparative fault" against the FDA and the Massachusetts Board of Pharmacy.
Under Tennessee law, Zobel's ruling could clear the way for any damages awarded against the surgery center to be reduced by the percentage of fault found by a jury against the FDA and the Massachusetts board. However, the two agencies, who are not parties to the suit, could not be forced to pay anything to victims.
Chris Tardio, one of the clinic lawyers, said the ruling means "we may present the jury with a full picture of how the meningitis outbreak occurred, including how it could have been prevented by those responsible for monitoring NECC's activities."
Noting that the ruling is only a preliminary one,  a victims' attorney expressed confidence in the ultimate outcome, adding "We are confident that once we present this to the court on a full factual record that the court will find that the governmental agencies were not reckless."
Zobel did dismiss parallel comparative fault claims against the Tennessee Health Department and the Tennessee Board of Pharmacy.
Zobel cited the claims by the surgery center lawyers that the FDA received numerous complaints that NECC was violating the FDA's guidance on drug compounding but "nevertheless failed to take any subsequent action to address the serious nature of the complaints which proximately caused the alleged injuries."
She noted that as early as 2002 the FDA was made aware of problems at NECC and four years later issued a warning letter but then failed to act.
"Defendants allege the FDA acted recklessly because it knew NECC had sterility and potency issues but failed to take any substantive action," the ruling states.
As for the Massachusetts board, Zobel cited evidence presented by the clinic's lawyers showing the the board "was aware of NECC's failure to comply with applicable state and federal law and manufacturing guidelines, failed to inform other state pharmacy boards of  of the threat to public health caused by NECC's non-public track record of regulatory noncompliance with state and federal law."
In a footnote Zobel noted the November 2012 congressional testimony of then Massachusetts Health Commissioner Lauren Smith that the state pharmacy board's failure to take decisive action against NECC in response to the 2006 complaints "has contributed to these tragic events."
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