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Radiologist In FDA Lawsuit Has Sued Before

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A radiologist who is one of the central figures in the controversy over secret Food and Drug Administration e-mail monitoring has filed several previous lawsuits, The Wall Street Journal reported Friday.

Robert C. Smith, MD, JD, was among six scientists who sued the FDA last September over the monitoring. The extent of the surveillance became evident with the accidental release of more than 80,000 documents captured by the program. The New York Times recently revealed the mistaken Internet posting, as we said last week.

Dr. Smith, a 52-year-old radiologist, was one of several FDA scientists who expressed doubts about the safety of medical devices for computer-assisted mammograms, CT colonographies, and other procedures. The FDA approved some of the devices anyway. But the scientists’ complaints apparently played a part in an FDA decision to withdraw approval of a knee-surgery device.

The Journal said Dr. Smith has filed two previous “whistle-blower” lawsuits against hospitals where he worked and another such lawsuit, in conjunction with other scientists, alleging that medical-device manufacturers defrauded Medicare and Medicaid by filing false claims in FDA applications.

Said the newspaper:

E-mails from within the FDA reviewed by The Wall Street Journal, along with legal and other records, portray him as a highly skilled radiologist who was given to contentious interactions with bosses and colleagues.

Judges dismissed the allegations against both of the hospitals, but Dr. Smith won a jury award of more than $250,000 in the first case because he claimed the hospital retaliated against him for raising the allegations. Retaliation claims in the second hospital lawsuit were reportedly settled.

Dr. Smith’s lawsuit regarding the claims in FDA applications was dropped last year. In 2009, the FDA took Dr. Smith’s safety concerns to the Department of Health and Human Services inspector general. Two investigations there didn’t find that FDA managers had broken FDA rules.

The Journal also reported:

FDA officials brought in Kelly, Anderson & Associates to look into Dr. Smith’s allegations. But the consulting firm found in December 2010 that it was Dr. Smith who ‘appeared to meet the criteria of creating a hostile work environment,’ according to a copy of its report.

Responding to the Journal article, Dr. Smith’s lawyer, Stephen Kohn, accused FDA managers of “a classic smear campaign” and said the Kelly, Anderson report was biased.

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Could the University of Iowa and embattled radiology professor Malik Juweid, MD, possibly find yet another issue to argue about? Find out on our Facebook page. (Hint: yes.)

Related seminar: UCSF Musculoskeletal MR Imaging (all-new release)

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