False Statements and Omissions to the FDA

Pharmaceuticals and certain medical devices must be approved by the Food and Drug Administration (“FDA”) before they can be sold to the public. As a consequence, new drugs and devices must undergo testing in clinical trials by pharmaceutical companies and device manufacturers to demonstrate their safety and efficacy. Providing false data to the FDA or withholding negative data from the FDA about the efficacy of a pharmaceutical drug or medical device in clinical research trials to get FDA approval to sell and market the pharmaceutical drug or medical device can form the basis of a qui tam/whistleblower action.

If you know or suspect that a pharmaceutical company or device manufacturer has made false and misleading statements or omissions in connection with the approval process for a drug or medical device, please contact Michael S. Bigin and Laurence J. Hasson.