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, false billing, off-label promotion 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 successfully represented a major manufacturer in a Department of Justice case involving off-label promotion, and we currently represent several manufacturers in separate, ongoing criminal and civil investigations of allegations of off-label promotion. Our experience in this area spans the spectrum from oncology products to mental health products. We also represent a manufacturer in civil class action litigation relating to claims of off-label promotion.
- 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 have represented numerous clients in investigations relating to alleged violations of the Medicaid Rebate statute.
- We have represented and continue to represent manufacturers in numerous investigations involving alleged kickbacks – in the form of grants or otherwise.
- We have represented manufacturers in numerous “hybrid” cases alleging that violations of various federal statutes such as the Food, Drug and Cosmetic Act constitute violations of the False Claims Act.
- 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.