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Suit Against Drug Research Firm Allowed to Continue
Breaking new ground in the area of drug products liability, a
federal judge in November 2007 refused to dismiss negligence and fraud claims against contract
research firm Statprobe. In Wawrzynek v. Statprobe Inc. (U.S. Dist. Ct.
PA.) Judge Gene E.K. Pratter rejected the argument that a research firm owes
no duty of care to a patient who was later harmed by a drug that won FDA
approval....Instead, Prater found that when a research firm oversees the
clinical studies and is aware of the drug's potential side effects, it may be
held liable to patients.
Statprobe was hired by Gliatech to provide biostatistical
services for a "double-blind" clinical study of the effectiveness of ADCON-L
for use in some spinal surgeries. When the study was completed, the suit says,
Statprobe informed Gliatech that the data failed to show that the drug was
effective.
But in January 1998, at Gliatech's request, Statprobe provided
Gliatech with the code to "unblind" the status of patients in the treatment
and control groups. Gliatech personnel later performed a second reading of the
studies that changed some of the data in a manner that made ADCON-L appear
more effective, the suit alleges. Gliatech provided the new data to Statprobe,
which accepted the new study and altered its report to show that ADCON-L was
effective. The FDA then approved ADCON-L.
Gliatech pleaded guilty to federal criminal charges, including
failure to notify the FDA of reportable events occurring in medical
procedures....and submission of a report regarding a medical device that was
false and misleading in a material respect. According to Wawrzynek's suit
against Statprobe, the FDA's approval of ADCON-L was the result of a
conspiracy in which both the manufacturer (Gliatech) and the research lab (Statprobe)
manipulated data to make the drug appear effective.
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