Bilzin Sumberg regularly provides legal advice, litigation representation and regulatory assistance to companies in the health care industry, including pharmaceutical entities. We represent clients in regulatory and enforcement matters relating to food, prescription and non-prescription drugs, biological products, medical devices and cosmetics brought by the FDA, FTC, DEA and other governmental agencies.
Our practice includes extensive representation of clients before the FDA and other governmental agencies and our team has significant experience advising and defending clients with regard to regulatory enforcement, internal investigations, product liability and class action matters.
We have assisted clients in performing self-audits and voluntary disclosure of problematic billings to governmental payor programs, defended clients in qui tam whistleblower lawsuits alleging false claims against governmental health care programs, assisted clients in resolving allegations of fraudulent billing or overpayments arising out of coordinated multi-jurisdictional enforcement efforts and we have assisted clients in settling disputed reimbursement claims filed by commercial health care plans.
Bilzin Sumberg has experience with the Federal Anti-Kickback Law, Federal False Claims Act, Federal Food, Drug and Cosmetic Act, federal health care fraud, HIPAA, mail and wire fraud, qui tam, RICO, the Stark Law and its implementing regulations, state fraud and abuse laws, and state reporting and disclosure laws. We have represented and defended numerous health care entities in matters involving health care fraud and abuse, alleged improper marketing activities and related matters. In particular, our lawyers regularly advise clients with respect to all manner of arrangements with physicians, including physicians who serve as consultants to device and/or drug manufacturers as well as service and employment arrangements between physicians and hospitals and other institutional providers.
Represented Leon Medical Centers Health Plans, Inc. (“LMCHP”) and its stockholders in connection with the acquisition by HealthSpring, Inc. (NYSE: HC), of all of the outstanding capital stock of privately-held LMCHP for $405 million in cash and HealthSpring stock as well as the negotiation of a 15-year exclusive medical services agreement.
Defended pharmaceutical company in class actions alleging that marketing of pharmaceutical invaded patient privacy, and constituted deceptive and unfair trade practices. The lawsuit received widespread publicity in local and national press. The court granted summary judgment and dismissed the case.