The Legal Intelligencer [Via Law.Com] reports on Wawrzynek v. Statprobe Inc., where, a federal judge has refused to dismiss negligence and fraud claims against a research firm that allegedly conspired with a drug manufacturer to mislead the Food and Drug Administration.
U.S. District Judge Gene E.K. Pratter rejected defendant research firm Gliatech, Inc.'s argument that it owes no duty of care to a patient who was later harmed by a drug that won FDA approval as a result of test results it helped falsify. Pratter found that a research firm that oversees clinical studies and is aware of the drug's potential side effects but conceals them may be held liable to patients.
Gliatech Inc., has already pleaded guilty to criminal fraud charges.