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Data Integrity: US FDA Seeks Dismissal Of CRO Semler’s Lawsuit For Lost Business

 
• By Sue Sutter

Contract research organization’s claims that agency improperly relied on a ‘suspect spreadsheet’ in taking actions that damaged its business are barred by sovereign immunity and exceptions to the Federal Tort Claims Act, FDA says; a federal judge in California will hear arguments on motions to dismiss Jan. 15.

Folder on lawyer table, closeup

A contract research organization’s lawsuit alleging that FDA and its employees damaged its business should be dismissed because it threatens to undermine the agency’s public health mission and the Food, Drug and Cosmetic Act, and the alleged claims are barred by sovereign immunity and exceptions to the Federal Tort Claims Act (FTCA), defendants say.

A federal judge will hear oral arguments Jan. 15 on FDA’s request to throw out a lawsuit by Semler Research Center Private Ltd

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