Shortly before Christmas a Santa Clara County, California jury entered a $38 Million Dollar Judgment Against Pfizer, Inc. for allegedly stealing clinical data from the Ischemia Research and Education Foundation ("IREF"), concerning its acute arthritic pain drug, Bextra. Pfizer pulled Bextra from the market in 2005, followig concerns about its safety for heart patients. Not long ago Pfizer entered into a $900,000,000.00 product liability settlement for Bextra and for Cerebrex, both Cox 2 inhibitor drugs that raised safety concerns. IREF filed its suit in 2004, claiming that Pfizer obtained access to the clinical data developed by IREF after its negotiations with IREF collapsed through the device of a contract with an IREF employee and statistican, Ping Hsu.
IREF is a non-profit research organization founded by Dr. Dennis Mangano, PhD, M.D., in 1987.IREF has developed a substantial data base of clinical information through the cooperation and participation of over 300 research centers around the world in the twenty plus years of its existence. There was apparently some evidence presented to the jury that Pfizer and Mr. Hsu destroyed or otherwise attemped a coverup of the use of the IREF information. Pfizer asserts that it has been unjustly caught up in the dispute between Mr. Hsu and IREF and denies any theft of the IREF information. It will likely appeal.
The jury presumably determined that the value of the information was in the area of $38 Million Dollars. That is quite a bench mark. There is a pending claim for punitive damages that could increase the amount of the award significantly. Dr. Mangano indicated that the attorneys fees paid by his company to date were in the area of $15,000,000.00. It takes a lot of effort, confidence and nerve to maintain a case like that against a pharmaceutical giant. You might have seen Dr. Mangano's apperance on 60 Minutes last February in a story about delays by Bayer and the FDA in removing Trasylol from the market. That was a drug that was supposed to limit the amount of bleeding and thereby the necessity for transfusions during open heart surgery. 60 Minutes and Dr. Managano asserted that the delay in pullling the drug from the market mayi have cost upwards of 22,000 lives during surgery.
In the early fall of 2006, gooznews.com published an interesting story that concerned the interplay between the FDA, Bayer and IREF concerning a request by the FDA and Bayer for access to the IREF data. Both the FDA and Bayer seemed to blame IREF for not turning over its data to them, but they appear to have misrepresented the circumstances, in which IREF attempted to place some controls on how its data was "sliced and diced" and folded into Bayer's data. Dr. Mangano appears to be somebody to be reckoned with.
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