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LE Magazine December 2002

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$1.3 billion complaint filed against the FDA

On October 2, 2002, Emord & Associates, on behalf of Jerome Stevens Pharmaceuticals, filed a $1.3 billion complaint against the FDA, HHS and the United States under the Tort Claims Act, Administrative Procedures Act and the Fifth Amendment to the U.S. Constitution for the unauthorized publication of its trade secrets and confidences. The complaint was filed in the U.S. District Court for the District of Columbia.

In August 2000, Jerome Stevens became the first company to be granted approval for a stabilized version of levothyroxine sodium, a drug used to treat thyroid ailments. That approval positioned the company to become a leader in the third largest drug market in the United States. After granting approval, however, FDA violated federal, civil and criminal laws by posting on the FDA website a drug approval package that included Jerome’s trade secrets and confidences. In addition, FDA allowed other drug companies to continue to sell unapproved, unstable versions of levothyroxine sodium until 2003 despite finding significant health risks with those versions in 1997.

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An electronic copy of the complaint can be retrieved from the Emord & Associates website at www.emord.com. Hard copies can be obtained by calling Katie Bond at (202) 466-6937.

 


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