Personal Injury Law

Concern Raised Over Validity of TBI Research

By Bruce Stern

On July 22, 2010, a federal jury in the Southern District of New York returned a verdict against Cornell University's Weill Medical College and a former faculty member Wilfred van Gorp, Ph.D. The jury found that the defendants submitted false claims to the National Institute of Health on three separate occasions from 1999 to 2001 arising from a grant designed to train neuropsychologists for a research career in HIV/AIDS. 

According to the press release issued by plaintiff's attorney, 'Daniel Feldman, one of the fellows working on the grant, brought suit under a federal whistleblower statute, known as the False Claims Act, alleging that van Gorp and Cornell instead used the funds for inappropriate purposes, including requiring the fellows to see an excess of private fee-for-service patients with other medical conditions.  At trial, Dr. Feldman showed that of approximately 160 clinical patients seen by the fellows over five years on the NIH-grant, only three patients were HIV- positive. Instead of seeing HIV- patients, the fellows often evaluated "medicolegal" cases, referred by insurance companies or attorneys who were in litigation over disability or worker's compensation claims, or criminal defendants."  See full story here.
 
On August 3, 2010, the Court entered judgment in favor of the plaintiff and against both Cornell University Medical College and Wilfred van Gorp in the amount of $ 887,714.
 
This jury verdict comes on the heels of a resent FDA warning letter directed to Columbia Presbyterian and Ronald Van Heertum, M.D., director of the PET laboratory at Columbia Presbyterian. According to the FDA:
 

From June 3 to June 19, 2008, the U.S. Food and Drug Administration (FDA) conducted an inspection of your PET production facility located at 630 West 168th Street, New York, NY. The inspection revealed significant deviations from the United States Pharmacopoeia (USP) compounding standards and official monograph for Positron Emission Tomography (PET) drugs in the manufacturing of your PET drugs (i.e., Fludeoxyglucose (FDG) F18 Injection, Ammonia N13 Injection, Water O15 Injection, and Oxygen 015 Gas). These deviations were listed on an Inspectional Observations (FDA-483) form issued to you at the close of the inspection. These deviations cause your drug products to be adulterated within the meaning of Section 501(a)(2)(C) [21 U.S.C. § 351(a)(2)(C)] of the Federal Food, Drug, and Cosmetic Act (the Act).
 

In a follow-up story printed in the New York Times, 'Columbia University has quietly suspended research at a nationally prominent brain-imaging center and reassigned its top managers after federal investigators found that it had routinely injected mental patients with drugs that contained potentially dangerous impurities. The investigations found that the center, regarded by experts as the nation's leader in the use of positron emission tomography, or PET, for psychiatric research, repeatedly violated Food and Drug Administration regulations over a four-year period.'
 
These two events raise real concern regarding the validity of research being conducted even by researchers, well respected in their fields.

Full post as published by Traumatic Brain Injury Law Blog on August 20, 2010 (boomark / email).