Ex-employees of pharmacy in 2012 meningitis outbreak lose appeals
2/26/21 REUTERS LEGAL 21:44:35
Copyright (c) 2021 Thomson Reuters
Nate Raymond
REUTERS LEGAL
February 26, 2021
A sign for pharmaceutical compounding company New England Compounding Center (NECC), a producer of the steroid methylprednisolone acetate, is seen in Framingham, Massachusetts October 8, 2012. REUTERS/Jessica Rinaldi
BOSTON (Reuters) - A federal appeals court on Friday upheld the convictions of three pharmacists accused of committing fraud and other crimes that helped the New England Compounding Center thrive before a deadly 2012 fungal meningitis outbreak fueled by its tainted drugs.
The 1st U.S. Circuit Court of Appeals in Boston said jurors did not wrongly convict former NECC employees Gene Svirskiy and Christopher Leary for helping defraud its customers, nor did jurors err in convicting Alla Stepanets for filling prescriptions for obviously fake patients like "Fat Albert" and "Wonder Woman."
Their lawyers - Christopher Iaquinto for Svirskiy at Holland & Knight, Paul Kelly of Jackson Lewis for Leary and John Cunha of Cunha & Holcomb for Stepanets - either declined to comment or did not respond to requests for comment.
Their appeals came after the 1st Circuit in July upheld the convictions of Barry Cadden, NECC's ex-president and co-founder, and Glenn Chin, its former supervisory pharmacist, who are serving sentences of nine and eight years, respectively.
Jurors convicted both men of racketeering and fraud but cleared them of second-degree murder over the deaths of 25 patients who received mold-tainted steroids produced by NECC. Those drugs sickened 793 people, more than 100 of whom have died.
Svirskiy, Leary and Stepanets were not charged over the contaminated steroids but were accused of other crimes that enabled Framingham, Massachusetts-based NECC's business.
Svirskiy was sentenced to 2-1/2 years in prison and Leary received eight months of home confinement. Stepanets, who was convicted of six misdemeanor counts of violating the Food, Drug and Cosmetic Act, was sentenced to time served.
Jurors convicted Svirskiy of racketeering, racketeering conspiracy and 10 counts of mail fraud, most of which related to allegations he helped conceal from hospital customers that an unlicensed pharmacy technician was involved in producing drugs.
Spvirsky's lawyers argued that to the extent NECC's marketing materials claimed its technicians were "certified," no customers testified to seeing such a representation.
But U.S. Circuit Judges David Barron, writing for the three-judge panel, pointed to testimony by an NECC salesperson who said that such representations were made in documents provided to its hospital customers.
Jurors convicted Leary of charges including mail fraud related to three shipments of compounded drugs to hospitals that were misled about the quality of NECC's drugs and the extent it tested its products before shipping them.
His attorneys argued the evidence was insufficient to show that he was aware the drugs were prepared in violation of specifications for the compounding of sterile medications that pharmacists are required to follow.
But Barron said "the evidence clearly establishes that Leary was aware of NECC's frequent practice of sending out untested lots of medication and that he personally approved of the production of such lots without the mandated testing on a number of occasions."
Stepanets, who worked in NECC's packing area, was convicted of misdemeanor charges that she dispensed misbranded drugs. She argued that in her role as a "checker" of orders before they shipped out could not legally be considered dispensing of drugs.
But Barron said "nothing in the statute supports the notion that only those who deliver misbranded drugs directly to patients - without any intermediaries - 'dispense' such drugs."
He also rejected her argument that her conviction on so-called strict liability charges that did not require a showing of intent violated her due process rights.
The case is U.S. v. Svirskiy, 1st U.S. Circuit Court of Appeals, No. 19-1595.
For the United States: Ross Goldman of the U.S. Justice Department.
For Svirskiy: Christopher Iaquinto of Holland & Knight
For Leary: Paul Kelly of Jackson Lewis
For Stepanets: John Cunha of Cunha & Holcomb
References
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