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Hagens Berman: Patients Seek to Force FDA to Release Records Showing US Distribution of Thalidomide
Date:11/17/2011

SEATTLE, Nov. 17, 2011 /PRNewswire/ -- Attorneys representing a group of U.S. citizens suffering from severe birth defects they believe were caused by the drug thalidomide have filed a lawsuit in federal court to compel the FDA to release records they believe will show the drug was widely distributed in the United States.

The suit seeks to compel the FDA to respond to a number of Freedom of Information Act (FOIA) requests by attorneys representing the patients, some filed more than a year ago. Under Federal law, the FDA has 20 business days to respond to a FOIA.

Thalidomide is a drug marketed throughout Canada and Europe during the late 1950s and early 1960s that caused thousands of deaths and extreme, disfiguring birth defects when used by women during pregnancy.

The drug was never approved for use in the United States, but newly uncovered documents show that hundreds of women in the US may have taken the drug as part of a marketing scheme conducted by Richardson-Merrell, a US drug distributor now owned by Sanofi-Aventis (NYSE: SNY), according to a lawsuit filed by Hagens Berman. The company gave physicians across the US as many as 2.5 million doses of the drug, the lawsuit claims.

According to court documents filed by the attorneys, the FDA archives contain lists of the physicians who were part of the marketing efforts.

"The conventional wisdom in this case has been that information about thalidomide is readily available, when in reality, the FDA is withholding key information and documents," said Steve Berman, managing partner for Hagens Berman. "These documents may prove what we have believed for some time; that thalidomide was given to pregnant women throughout the United States."

The FOIA lawsuit was filed by Kay Gunderson Reeves, co-counsel with Hagens Berman, who filed a lawsuit on Oct. 25, 2011, against Sanofi-Aventis, GlaxoSmith
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