On January 22, 2018, a $50 million lawsuit was filed against the U.S. Food and Drug Administration (FDA) in the Central District of California. The complaint was filed by Semler Research Center Pvt. Ltd., a contract research organization based in Bangalore, India.
The suit comes after the FDA notified a number of drug makers that marketing applications containing clinical trial data prepared by Semler would not be accepted due to concerns about the integrity of the data.
According to the FDA notification, the FDA inspected Semler facilities last fall. After the inspection, the FDA posted a notice on its web site saying that inspections found “significant instances of misconduct and violations of federal regulations, including the substitution and manipulation of study subject samples.”
According to the complaint, FDA inspectors ignored evidence that a “rogue employee” framed Semler by planting false data on the company’s computer network.
The complaint alleges that those employees were part of a scheme that involved contacting the FDA “to lead FDA inspectors to the fabricated information and raise suspicion regarding [Semler’s] procedures and the reliability of its studies.”
According to Semler, an independent audit showed that the purported data manipulation could not have occurred in the manner suggested by the suspect spreadsheet. Nonetheless, FDA officials “summarily disregarded the results” of the audit and produced the disciplinary letter.
According to Semler’s complaint, in response to the FDA’s actions, a $30 million sale of Semler collapsed, and various Semler clients are “demanding compensation” worth $20 million.
Semler’s lawsuit alleges violations of its Fifth Amendment right to due process, as well as intentional infliction of financial distress under the Federal Tort Claims Act, among other things.
The case is Semler Research Center Pvt. Ltd. v. U.S. Food and Drug Administration et al., case number 2:18-cv-00534, in the U.S. District Court for the Central District of California.