Thursday, March 31, 2016

Former FDA Head Charges Fraud In Meningitis Outbreak

By Walter F. Roche Jr.

The former head of the U.S. Food and Drug Administration has testified that he believes the operators of a Nashville clinic and officials of a defunct Massachusetts drug compounding firm "were engaged in a fraud" involving faked prescriptions for a spinal steroid that proved deadly.
Testifying in a lengthy deposition, David A. Kessler M.D. stated that the record "clearly evidences that STOPNC, the Saint Thomas Outpatient Neurosurgical Center and NECC (the New England Compounding Center) were engaged in a fraud."
Kessler was head of the FDA from 1990 to 1997, more than a decade before the fatal fungal meningitis outbreak which is at heart  of the pending litigation.
Citing prescriptions that included the name "Mickey Mouse" Kessler said, "Those were not prescriptions. We know that."
The testimony comes in a suit brought by victims of the outbreak which sickened 778 patients and killed 76. Tennessee was one of the hardest hit states and most of the victims were injected with fungus laden methylprednisolone acetate from NECC at the Nashville outpatient surgical center.
Tennessee reported that 153 patients were sickened in the outbreak including 16 who died.
The deposition, which took place last month in California, was marked by repeated sharp exchanges between opposing lawyers. C. J. Gideon of Nashville, representing the outpatient clinic and related clients,  already has filed a motion to force Kessler to undergo another 3.5 hours of questioning.
"It's been a long time since I've seen a witness this unresponsive," Gideon said as the daylong deposition came to an end early last month. "It's ridiculous."
Gideon said in an email response to a request for comment that he would respond on Friday.
Gideon also made frequent mention of the fact that Kessler has been charging $1,000 an hour for his services in behalf of plaintiffs in the case.
"C.J. quit whining," Nashville attorney Mark Chalos retorted at one point.
Gideon also repeatedly challenged Kessler about the FDA's failure to take action against the Framingham, Mass. drug firm despite a decade long record of complaints.
Asked by Gideon why the FDA did not investigate whether the drug firm was mass producing compounded drugs without the required patient specific prescriptions, Kessler said he regretted that the matter wasn't exposed.
"I mean yes, you are right, I very much wish, okay, that this whole scheme that your client and NECC were engaged in was discovered and exposed. That would have been very nice," Kessler testified.
But under repeated questioning by Gideon, Kessler insisted that actions by Congress and conflicting court opinions left FDA's authority over NECC in question.
"It was unclear," Kessler said when asked about the FDA's authority over NECC. "I think that anyone looking at this would have to say it is unclear what the law governed at the time. I think it is fair to say there was confusion."
 Gideon cited FDA and other records showing that the agency had evidence long before the 2012 outbreak that NECC was mass producing compounded drugs without the required individual patient prescriptions.
Records cited included internal NECC emails in which two of NECC's owners discussed the selling of compounded drugs to the Massachusetts Eye and Ear Clinic without required prescriptions.
"And (Barry) Cadden says to (Gregory) Conigliaro, "unless she's a complete fool, she'll know what we are up to," Gideon related.
But Kessler responded by citing the Nashville clinic and its relationship with NECC.
"What (the Nashville clinic) here was to facilitate this scheme of this wrongdoing by signing these things called prescription order forms and giving names when they weren't prescriptions and there wasn't a physician-pharmacist relationship," Kessler testified.

No comments:

Post a Comment