In recent years, federal and state agencies have significantly increased their investigations and prosecutions of pharmaceutical, medical device and life sciences companies for various forms of health care fraud. Health care fraud enforcement will continue to be robust as a result of enhanced coordination between federal and state agencies, growing disclosure requirements under various federal statutes and regulatory schemes, the use of non-health care 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 health care industry who face allegations of wrongdoing, government investigations, criminal charges and related civil litigation in connection with the Food, Drug, and Cosmetic Act, the Anti-Kickback Statute, and other health care 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 government’s continued enforcement of “off-label” (not approved by the 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 Food, Drug, and Cosmetic Act, 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 health care companies operate, there is greater scrutiny than ever into relationships with physicians and surrogates. We counsel and represent clients in matters involving the Anti-Kickback Statute, the 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 health care companies arise out of whistleblower lawsuits brought under the “qui tam” provisions of the False Claims Act, which is one of the government’s primary weapons to fight fraud against the government. Through the False Claims Act, the 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 False Claims Act cases in various federal courts.

How Morrison & Foerster Can Help

Morrison & Foerster has wide-ranging experience and a proven track record in health care 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 health care programs.

Our attorneys provide expert representation in the full range of issues in health care 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 expertise 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 expertise 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 federal prosecutors and in senior positions at federal government agencies and as Fellows of the American College of Trial Lawyers. Our strong appellate practice includes attorneys with particular experience before the Supreme Court of the United States, having argued more than 40 cases before the Court, served in the Office of the Solicitor General, and served as law clerks to the Justices. Our attorneys include an appeals judge and a former justice of the California Courts of Appeal.

Representative Health Care Matters

  • Representation of global pharmaceutical company in Department of Justice and Federal Drug Administration investigations into alleged off-label promotion and related fraud claims
     
  • Internal investigation of whistleblower allegations at research facility of global pharmaceutical company
     
  • Representation of pharmaceutical company in civil False Claims Act litigation concerning Medicare and Medicaid reimbursement violations
     
  • Representation of international pharmaceutical company in off-label promotion investigation by U.S. Attorney’s Office in San Francisco
     
  • Representation of former officer in health care fraud investigation related to GMP violations by Fortune 500 multinational pharmaceutical and medical device manufacturer
     
  • Acquittal of former executive of pharmaceutical company, EMD Serono, after trial involving alleged violations of federal Anti-Kickback Statute in connection with the sales and marketing of anti-AIDS medication
     
  • Representation of compliance director at global pharmaceutical company involving investigations into marketing and promotion of arthritis pain medication
     
  • Internal investigation of off-label promotion issues for global pharmaceutical company
     
  • Representation of president of European biotech company in criminal proceedings related to off-label promotion of prosthetic bone cement used in spinal surgery
     
  • Representation of health care data analysis company in investigation of cholesterol medication
     
  • Representation of executives in investigations of marketing and off-label promotion of pain medication Oxycontin
     
  • Representation of executives in investigations relating to marketing and off-label promotion of cancer medication
     
  • Representation of durable medical equipment company in connection with compliance issues
     
  • Representation of senior vice president of national health and hospital corporation in connection with federal health care fraud and abuse investigations and related civil lawsuits
     
  • Representation of employees of national health and hospital corporations in defense of civil Federal Claims Act lawsuits
     
  • Representation of sales directors of pharmaceutical company in investigation of off-label promotion of appetite stimulant medication

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