FDA Whistleblower Has Blown the Whistle Before

FDA Whistleblower Has Blown the Whistle Before

July 23rd, 2012 // 2:36 pm @


An FDA scientist, who is a key player among the whistleblowers that have filed suit against the agency for monitoring their e-mails, had also filed lawsuits against two hospitals where he worked and sued a dozen medical device makers, The Wall Street Journal writes. And the disclosure is prompting his attorney to accuse the FDA of conducting a smear campaign in order to detract criticism of its campaign to spy on agency employees.

Along with several FDA colleagues, Robert Smith complained three years ago to members of Congress and their staffs, as well as some consumer watchdogs and journalists, that the agency forced them to approve devices they insisted posed unacceptable risks. Earlier this year, they filed a lawsuit after discovering the agency monitored personal e-mails. The FDA has defended its actions over concerns that confidential info was being disclosed (read here and here).

Smith, however, has blazed a controversial trail before. In a 2005 lawsuit, he alleged that “Yale University and Yale-New Haven Hospital defrauded the government and risked patient safety by charging Medicare and Medicaid for thousands of radiology images that had no diagnostic or therapeutic use,” the Journal writes. The lawsuit was dismissed (read this) and retaliation claims settled. Smith won a state court jury award of more than $250,000 from the hospital, the paper adds.

Later, he worked as a radiologist at New York-Presbyterian Hospital/Weill Cornell and alleged another fraud in the handling of X-rays and other medical imaging. Again, Smith charged that he suffered retaliation for raising fraud claims, the Journal continues. A federal judge dismissed the fraud claims, which the hospital had denied, in 2007 (see here), and the retaliation claims were settled.

Fast forward to 2009, when the FDA responded to the allegations raised by Smith and the other FDA scientists. The agency asked the US Department of Health & Human Services Office of Inspector General to investigate the charges, but the OIG found the employees had not broken any rules. As we reported previously, the agency then hired a consulting firm, which late last year issued a report that found Smith and his colleagues caused a “hostile working environment.”

The report was undertaken at the direction of the US Office of Personnel Management and cost $800,000, according to a source familiar with the episode. As we reported previously, the report noted the FDA deployed four different managers to appease the employees and gain control of the situation, according to our source, who added the employees were transferred to another office so they would not work for a manager they disliked.

Smith, meanwhile, cancelled several different appointments to meet with outside investigators, but never spoke with them, says our source. His attorney, Stephen Kohn of the National Whistleblowers Center, has called the report biased and alleges the agency is violating the law by leaking employee information. Kohn, by the way, also represented Smith in his lawsuits against the two hospitals.

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