We have represented a broad array of drug, device and biotech companies in matters raising virtually every “hot” issue in the industry – including kickbacks, pricing, off-label promotion, “fraud on the FDA” or the Patent and Trademark Office, and Medicaid Rebates. We have a strong record of achieving declinations as well as a track record of important “firsts” – we negotiated the first major pricing settlement in the industry, the first major Corporate Integrity Agreement in the industry and the first FDA consent decree to involve substantive compliance obligations. Among other experience in this area:
- We have represented and continue to represent manufacturers in numerous investigations involving alleged kickbacks – in the form of patient assistance programs, prior authorization support programs, speaker programs, discounts, samples, grants, research support, and other arrangements. We also frequently lead internal investigations into allegations relating to these and other forms of alleged kickbacks.
- We have represented manufacturers in numerous government investigations alleging that violations of various federal statutes such as the Food, Drug and Cosmetic Act constitute violations of the False Claims Act. In particular, we have successfully represented and continue to represent major manufacturers in criminal and civil investigations involving alleged off-label promotion, risk minimization, and violations of current Good Manufacturing Practices regulations.
- We represent manufacturers in litigation with private parties and state Attorneys General relating to alleged violations of state unfair trade practices laws, including cases sounding in supposed violations of the Food, Drug and Cosmetic Act. For example, we represent a device manufacturer in a case alleging a violation of a state unfair trade practices law for failure to withdraw a device from the market.
- We have represented numerous clients in investigations relating to alleged violations of the Medicaid Rebate statute.
- We represented a major manufacturer in the first successful appeal of an AWP case. We successfully represented another major manufacturer in a settlement of allegations of Average Wholesale Price fraud involving the Department of Justice, the HHS Office of Inspector General and nearly every state. The settlement served as a template for negotiations by other manufacturers.
- We represented a major manufacturer in nationwide class actions alleging consumer fraud relating to the introduction of a new drug in the same therapeutic category as one of the manufacturer’s existing products.
- We represented major manufacturers in connection with House Oversight and Investigations Committee investigations into drug pricing and marketing issues.
- We have represented numerous manufacturers in connection with both Senate and House committee investigations into issues relating to Medicare Part D, Medicaid rebates, grants and other issues.