Healthcare Fraud and Abuse
In recent years, federal and state authorities have devoted ever increasing resources to investigate and prosecute healthcare providers, life sciences companies, executives, and directors. With increased civil penalties, criminal sentences, and fines, it is more important than ever to retain legal counsel with a proven track record in defending companies and individuals against aggressive criminal prosecution and civil enforcement. Successful representation in these cases requires an in-depth understanding of not just the regulatory regimes but also the government's investigative and litigation methods, as well as experience coordinating ongoing parallel administrative, qui tam, and criminal matters. Our team has the experience that corporate boards, senior management, and practitioners trust to gather the facts, evaluate the options, and obtain results.
The complexity of the healthcare marketplace demands experienced, well-respected, and diligent counsel. Our team has built a national reputation with former federal prosecutors and accomplished trial lawyers who are some of the most highly-regarded defense counsel in the United States. Collectively, our team has handled hundreds of healthcare cases in federal and state courts around the United States, spanning government and internal investigations, criminal and civil pretrial litigation, trials, and appeals, including to the US Supreme Court.
Our lawyers build lasting relationships by providing the highest quality counsel on the most sensitive and important issues of criminal, civil, and administrative enforcement, including matters involving the False Claims Act, Anti-Kickback Statute, the Stark laws, the Foreign Corrupt Practices Act, as well as other federal and state fraud and abuse laws. We have defended healthcare providers of all sizes against allegations of medically unnecessary services, improper physician financial relationships, fraudulent billing and coding practices, and other regulatory violations. We also have extensive experience working with pharmaceutical and medical device manufacturers, executives, and other employees in defending against allegations of off-label marketing, misleading promotions, and improper pricing; defending against consumer protection claims brought on behalf of state attorney generals; and managing internal investigations related to regulatory compliance and marketing and promotional practices. With almost 1000 lawyers in offices across the United States, Europe, and Asia, we have the national and global reach you need without the cost of exhaustive global overhead.
Our team of trial lawyers is backed up by one of the most sophisticated civil litigation and regulatory practices in the country with former attorneys and advisors from the US Department of Health and Human Services (HHS), including the Centers for Medicare and Medicaid Services (CMS) and US Food and Drug Administration (FDA), among others. Whether you need top-shelf experience to address internal investigations, government inquiries, search warrants, qui tam complaints, indictments, or proactive litigation, we can rapidly assemble a premier team of trial counsel supported by experienced compliance and regulatory lawyers.
For over 100 years, our attorneys have been committed to providing excellence in legal service. When you retain our healthcare-focused defense group to investigate and defend against aggressive government tactics, we will do everything within our power to obtain the best result possible.
- Bristol-Myers Squibb and Sanofi-Aventis, in multiple federal False Claims Act and state attorney general lawsuits alleging that certain promotional activities violated federal and state False Claims Acts and consumer protection statutes.
- Endo Pharmaceuticals Inc., in multidistrict pharmaceutical pricing litigation and state attorney general lawsuits. See In re Pharmaceutical Industry Average Wholesale Price Litigation, No. No. 01-CV-12257 (D. Mass.).
- Dermatologic surgeon, in winning a complete acquittal after a 5-week criminal jury trial on federal charges of healthcare fraud, U.S. v. Bajoghli, No. 1:14-CR-278 (E.D. Va.).
- Radiation oncology practice, in winning a full dismissal of a False Claims Act qui tam suit alleging violations of Medicare requirements for supervision of medical procedures, U.S. ex rel. Parker v. Space Coast Medical Associates, L.L.P, 94 F. Supp. 3d 1250 (M.D. Fla. 2015).
- Retinal specialist, in an ongoing federal healthcare fraud prosecution in south Florida and an ongoing federal corruption prosecution in New Jersey, as a co-defendant with a US Senator; won a partial pretrial dismissal of corruption charges on First Amendment grounds, U.S. v. Menendez, 132 F. Supp. 3d 635 (D.N.J. 2015).
- Par Pharmaceutical Companies, Inc. in a large-scale, multi-year off-label promotion investigation by the US Department of Justice, FDA, and New Jersey US Attorney's Office, and a related appeal, In re: Grand Jury Matter, No. 11-2679 (3d Cir.); in a First Amendment lawsuit challenging FDA's "intended use" regulations, Par Pharmaceutical, Inc. v. United States of America, No. 11-CV-1820 (D.D.C.); and in the implementation and administration of the company's five-year corporate integrity agreement.
- Medical practice, in a First Amendment retaliation challenge to a Medicare suspension based on alleged fraud; subsequently negotiated a lift of the suspension.
- National hospital company, in multidistrict False Claims Act investigations, lawsuits, and centralization proceedings before the Judicial Panel on Multidistrict Litigation, with all actions subsequently transferred to the desired venue.
- Hoffmann La-Roche, in a False Claims Act qui tam case brought by a competitor seeking $6 billion in penalties and another $300 million in single damages, making it one of the largest such cases ever filed;. Successfully obtained dismissal of the complaint.
- Pharmaceutical company, in a 19-state Attorney General investigation against allegations that the company made false advertising claims in connection with a product with annual sales in excess of $1 billion. Negotiated favorable settlement of the dispute.
- Global pharmaceutical company, in implementing a revised worldwide compliance program, including program design and structure, code of conduct/policy revision, training, monitoring, auditing, and investigations processes.
- Global pharmaceutical manufacturer, in DOJ antitrust investigation of pharmaceutical pricing.
- Pharmaceutical and device manufacturers and senior executives, in FCPA and UK Bribery Act investigations.
- Generic drug company, in a Congressional investigation of drug pricing practices.
- Upstate New York cardiology practice, in successfully negotiating a no-fault settlement with the US Department of Justice concerning False Claims Act allegations that the practice's compensation plan violated the Stark law.
- One the largest US interventional cardiology practices, in False Claims Act litigation with the US Department of Justice over allegedly fraudulent treatment of Peripheral Arterial Disease.
- Ophthalmic surgery provider in internal investigation, as well as a later investigation by the US Attorney's Office for the Northern District of Georgia.
- Non-profit hospital, in connection with a Congressional investigation of its practices in connection with noninsured patients.
- Major US research university, in investigating allegations of scientific fraud and misconduct in industry-sponsored clinical trials.
- New York area community hospital, in a political corruption and healthcare fraud investigation being conducted by the United States Attorney's office for the Eastern District of New York.
- Medical device manufacturer executive, in a multi-year investigation of the manufacturer's promotional practices by the DOJ and New Jersey US Attorney's Office.
- Major global eye care company, in the development and execution of novel contracting processes for reimbursed and non-reimbursed products to help manage state and federal fraud and abuse risks implicated by direct purchaser arrangements.
Non-IP Litigation & Enforcement: Government Investigation/Fraud & Abuse (2012-2015)