Pharmaceutical & Device Manufacturers

Sonnenschein's Health Care Group attorneys have extensive experience counseling pharmaceutical and device manufacturers.  As a result, the Group understands the distinct but interconnected roles of each of the players in this industry:  manufacturers, wholesalers, distributors, hospitals (and other institutional providers), retail and mail order pharmacies, pharmacy benefit managers (PBMs), group purchasing organizations (GPOs), physicians, patients, and commercial and government payers.

Our attorneys use this experience and understanding to advise drug and device manufacturers in connection with a wide variety of regulatory, litigation, corporate, transactional, public policy, and other matters.  For example:

• Sonnenschein attorneys assist pharmaceutical and device manufacturers in ensuring that their various business arrangements, transactions, contracts, and marketing initiatives comply with federal and state anti-kickback, fee-splitting, physician self-referral, false claims, beneficiary inducement, Medicaid drug rebate, and other health care fraud and abuse laws and regulations.
• The Health Care Group develops health care fraud and abuse compliance programs for manufacturers and provides advice under the federal anti-kickback and Medicaid drug rebate laws in connection with various sales arrangements, nominal price offerings, consumer marketing initiatives, product rebates, disease management programs, and other value-added offerings.
• We regularly advise manufacturers on the full range of health care regulatory issues relating to the development, distribution and marketing of branded prescription drugs and medical devices, and Medicare, Medicaid and other federal and state health care program coverage, coding and reimbursement rules and regulations.
• Sonnenschein attorneys (1) defend pharmaceutical manufacturers in criminal and civil fraud and abuse investigations and cases brought by the Department of Justice, State Attorneys General, and private plaintiffs, (2) serve as special health care fraud and abuse counsel to manufacturers involved in federal grand jury investigations, and (3) negotiate and develop corporate integrity agreements on behalf of manufacturers.