Mike Gass, Christine Savage
Diana Lloyd, Jack Cinquegrana, Melissa Tearney
Choate represents companies and individuals in connection with major Department of Justice healthcare fraud investigations and prosecutions. Recent matters include the defense of national pharmaceutical companies and their officers and employees, a national health insurer in an aggressively litigated qui tam case, and one of the state’s largest managed care health plans.
Defended significant government enforcement matters related to the healthcare, industry for two decades. Healthcare fraud practice includes seven partners, three of whom are former federal prosecutors, and over 20 associates.
Represent companies and individuals in investigations, prosecutions and civil litigation regarding pharmaceutical and medical device marketing practices, regulatory violations, anti-kickback claims, false claims and qui tam defense, and grants management practices. Counsel clients in broad range of compliance matters related to these issues.
Below is a partial list of our engagements related to the healthcare industry.
- Pharmaceutical Company – We recently represented one of the world’s largest pharmaceutical companies in a government investigation regarding its voluntary withdrawal of a product. It was one of the most extensive healthcare fraud investigations ever conducted by the Department of Justice.
- Teaching Hospital – We currently represent a major teaching hospital in a healthcare fraud investigation involving the use of medical devices.
- Pharmacy Chain – We currently represent a pharmacy chain in responding to state and federal investigations claiming that the chain's discount generic drug program pricing was required to be passed on to various federal and state healthcare programs.
- Medical Device Company – We currently represent a medical device company in a government investigation relating to sampling practices. Previously, we represented the company in a government investigation regarding the interactions of the orthopedic device industry with consulting physicians. That investigation resulted in an industry-wide settlement of over $200 million, a deferred prosecution agreement for our client, and oversight by federal monitors.
- Pharmaceutical Benefits Management Company – We currently represent one of the nation's leading PBMs in a qui tam action alleging violations of the False Claims Act and other laws.
- Pharmaceutical Company – We conducted an internal investigation for a Massachusetts-based pharmaceutical company regarding disclosure of clinical trial results and reporting to the FDA, in response to whistleblower allegations.
- Generic Drug Manufacturing Companies – We currently represent two generic drug manufacturers in qui tam actions pending in Massachusetts and Louisiana.
- Pharmaceutical Company – We currently represent a leading pharmaceutical company in a government investigation concerning alleged violations of the Food, Drug & Cosmetics Act, the Anti-Kickback Statute and other laws.
- Health Insurer – We represented one of the nation’s leading group health insurers in qui tam litigation regarding the submission of government claims and achieved a very favorable settlement in 2010.
- Pharmaceutical Company – We represented a major pharmaceutical company in a government investigation regarding sales and marketing practices. This matter resulted in a settlement of over $700 million.
- Leading Research University – We represented this university in a government investigation regarding the alleged misuse of federal grants by a researcher at an affiliated medical center, resulting in a favorable civil settlement and minimal administrative findings. We currently represent the university in similar matters.
- Pharmaceutical Company Employees – We represented more than 10 executives and employees in an investigation regarding off-label marketing, which resulted in a multi-billion dollar settlement with the Department of Justice.
- Pharmaceutical Executive – We represented a senior executive in a civil and criminal investigation regarding the FDA’s Current Good Manufacturing Practices. We obtained a declination from the Department of Justice.
- Pharmaceutical Executive – We represented a senior executive in a Park Doctrine investigation regarding off-label marketing. We obtained a declination from the Department of Justice.
- Pharmaceutical Company Employees – We represented more than 20 executives and employees in an investigation regarding alleged off-label marketing, which resulted in a settlement over $80 million with the Department of Justice.
- Pharmaceutical Company Employees – We represented numerous corporate executives and employees in a government investigation of a major pharmaceutical company which resulted in a settlement over $400 million with the Department of Justice.
- Dialysis Company – We represented one of the nation’s leading providers of dialysis services in a criminal and civil investigation regarding anti-kickback and false claims allegations which resulted in a settlement over $400 million with the Department of Justice. We also represented the company in a civil false claims investigation in the Eastern District of Pennsylvania, resulting in a favorable civil settlement.
- Health Insurers – We have represented a number of health insurers in Massachusetts in connection with various government inquiries.