In recent years, U.S. federal and state agencies have significantly increased their investigations and prosecutions of pharmaceutical, medical device, and life sciences companies for various forms of healthcare fraud. Healthcare fraud enforcement will continue to take center stage as a result of enhanced coordination between U.S. federal and U.S. state agencies, growing disclosure requirements under various U.S. federal statutes and regulatory schemes, the use of non-healthcare-related statutes (such as the U.S. Foreign Corrupt Practices Act and the False Claims Act) to further enforcement priorities, and the emergence of more aggressive investigation and prosecution tactics.
We regularly represent companies and individuals in the healthcare industry who face allegations of wrongdoing, government investigations, criminal charges, and related civil litigation in connection with the U.S. Food, Drug, and Cosmetic Acts, the U.S. Anti-Kickback Statute, and other U.S. healthcare statutes. These representations range from conducting internal investigations and quietly guiding clients through government investigations – thereby helping them minimize disruption to their business and avoid charges – to vigorous defense in court.
We have represented numerous companies and individuals in connection with the U.S. government’s continued enforcement of “off-label” (not approved by the U.S. FDA) promotion of drugs and devices. We are well-versed in the various practices that government prosecutors and regulators believe constitute off-label promotion.
We also have experience with one of the few prosecutions using the so-called “responsible corporate officer” doctrine, which permits criminal prosecutions of executives for failure to prevent violations of the U.S. Food, Drug, and Cosmetic Acts, regardless of whether the executive acted with criminal intent.
We also represent clients facing government scrutiny of their good manufacturing practices (GMP), both in the United States and abroad. GMP investigations can create significant disruption of a company’s business and have significant consequences, including injunctions, administrative actions, civil monetary penalties, and criminal liability for both the corporation and its officers and employees.
In the already heavily regulated world in which healthcare companies operate, there is greater scrutiny than ever into relationships with physicians and surrogates. We counsel and represent clients in matters involving the U.S. Anti-Kickback Statute, the U.S. Stark Law, and the Physician Payments Sunshine Act. Our representations range from compliance and training advice to minimize the risks associated with physician and surrogate compensation, to rigorous defense of companies and executives accused of violating these statutes. This includes obtaining an acquittal for a pharmaceutical company executive after a three-week criminal trial that involved alleged violations of the Anti-Kickback Statute.
Many government investigations of healthcare companies arise out of whistleblower lawsuits brought under the “qui tam” provisions of the U.S. False Claims Act, which is one of the U.S. government’s primary weapons to fight fraud against the U.S. government. Through the U.S. False Claims Act, the U.S. government has recovered tens of billions of dollars, and recent amendments to the Act have broadened the statute and made violations easier to prove. We have helped clients avoid, settle, and litigate U.S. False Claims Act cases in various courts across the United States.
Morrison & Foerster has wide-ranging experience and a proven track record in healthcare fraud matters. We help our clients at every stage – from risk avoidance to aggressive defense. Our matters often involve simultaneous internal investigations, federal criminal investigations, administrative proceedings, and civil litigation.
We have the experience, resources, and geographic reach necessary to help clients obtain the most favorable outcome quickly and efficiently, thereby preserving their ability to do business and protecting their participation in federal healthcare programs.
Our lawyers provide experienced representation in the full range of issues in healthcare fraud cases, including:
Internal Investigations and Compliance Counseling: We have conducted numerous internal investigations to uncover potential or suspected violations and have advised clients on disclosure obligations stemming from improper conduct. Our lawyers represent companies, officers, directors, and other individuals – whether in connection with pending litigation or before any action is commenced. When making assessments and recommendations, we recognize that early crisis management can increase a company’s credibility with regulators and prosecutors and can eliminate or mitigate its exposure. While we handle more focused, rapid reviews and investigations on a smaller scale, we have the deep knowledge and resources to perform large, complex investigations quickly and efficiently, anywhere in the world, and in multiple locations simultaneously.
Responding to Subpoenas: We have assisted our clients in responding to grand jury and administrative subpoenas and other information requests from regulatory and enforcement agencies. In many cases, our close collaboration with our clients and strategic interaction with authorities allow us to resolve the matter at an early stage, with minimal disruption to our clients’ business.
Government Investigations and Proceedings: With experience on both sides of the courtroom, we have the experience to defend clients against potential charges, navigate quietly through a government investigation, and negotiate settlements. Our team’s deep experience gives us insight into the government’s objectives, which is critical in attaining the best outcome for our clients. In many cases, we have successfully represented clients in obtaining favorable settlements or other resolutions, including the Department of Justice or other government enforcement bodies closing their investigation with no action taken against our clients.
Litigation, Trials, and Appeals: We have a deep bench of trial lawyers that includes leading lawyers who have served as U.S. federal prosecutors and in senior positions at U.S. government agencies and as Fellows of the American College of Trial Lawyers. Our strong appellate practice includes lawyers with particular experience before the Supreme Court of the United States, having argued more than 40 cases before the U.S. Supreme Court, served in the Office of the Solicitor General, and served as law clerks to the Justices. Our lawyers include an appeals judge and a former justice of the California Courts of Appeal.
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