FDA

Nelson Hardiman defends healthcare and life sciences clients in FDA investigations. We leverage powerful experience in government investigations and regulatory policy to run interference on a wide range of issues involving accusations of data corruption, illicit business referrals, medical device and drug safety issues, including investigations and enforcement actions related to the opioid crisis.

Recognized leaders in the regulatory arena, our experienced litigators and trial lawyers protect healthcare industry organizations facing challenging situations with the FDA. We advise on warning letters, investigations and enforcement actions against healthcare providers and their operations, including False Claims Act charges or criminal sanctions for violation of FDA laws. Nelson Hardiman helps our healthcare clients resolve issues with the FDA and its agencies quickly, and on reasonable terms, with a commitment to strategic business goals and commonsense solutions.

Our Work Includes:

  • Clinical Research Defended a physician for an inadvertently corrupted clinical research study.
  • Drug Manufacturer Defended drug manufacturer accused of coercing physicians to use their products, in alleged violation of the federal Anti-Kickback statute and Stark Law.
  • National Clinical Laboratory Defended an FDA investigation of a national clinical laboratory and persuaded the FDA to refrain from action based on adoption of corrective action plan and compliance program.
  • Neurofeedback Device Manufacturer Defended a neurofeedback device manufacturer in an FDA investigation and response to a warning letter.
  • Nutritional Supplements Represented a manufacturer of energy bars in an FDA investigation of adverse event reports allegedly related to the product.