Life Sciences/Healthcare Investigations & Defense
In recent years, federal and state authorities have devoted ever-increasing resources to investigate and prosecute life sciences companies, healthcare providers, 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 criminal, civil qui tam and administrative matters. Our team has the experience that corporate boards, senior management and practitioners trust to gather the facts, evaluate the options and obtain results. We’ve handled hundreds of life sciences and healthcare cases in federal and state courts around the United States—from government and internal investigations and criminal and civil pretrial litigation to trials and appeals up to the US Supreme Court.
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Trial Expertise: Experienced trial lawyers, many of whom are former federal prosecutors, backed up by one of the most sophisticated civil litigation and regulatory practices in the country with former attorneys and advisors from agencies including DOJ, HHS, CMS, and FDA .
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False Claims Act: Unparalleled experience with an impressive record of dismissals and declinations in defending pharmaceutical, medical device and diagnostics equipment manufacturers, as well as healthcare providers, in False Claims Act investigations and litigation.
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Regulatory Knowledge: We advise on the full range of issues arising under the federal Anti-Kickback Statute; the Stark Law; the False Claims Act; the Federal Food, Drug, and Cosmetic Act; and other federal and state fraud and abuse laws.
See how our experience informs the way we position every case.
Experience Highlights
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National hospital system, with in-patient facilities across 25 states, in connection with DOJ criminal healthcare fraud and False Claims Act investigations, 14 associated qui tam complaints filed across 10 different judicial districts, and proceedings before the Judicial Panel on Multidistrict Litigation, concerning alleged violations of Anti-Kickback Statute and Stark Law, medically unnecessary services, upcoding, and improper cost reporting.
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Dermatologic surgeon in winning a complete acquittal after a five-week federal criminal jury trial on charges of healthcare fraud and aggravated identity theft, and securing a full dismissal of related FCA allegations.
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Dr. Salomon Melgen, a Democratic Party donor, as lead trial counsel in 10-week federal criminal trial in District of New Jersey involving charges of bribery and honest services fraud involving Medicare and other regulatory issues. On our Rule 29 motion, the court acquitted Dr. Melgen and his co-defendant, US Senator Robert Menendez, on all political contribution counts, following mistrial where jurors hung 10-2 in favor of acquittal. DOJ subsequently dismissed all remaining charges with prejudice.
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Medical device manufacturer in successfully dismissing all claims in a complex fraud case in the U.S. District Court for the District of Delaware alleging client bribed Brazilian physicians and hospitals to use their devices.
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Former owner of sleep study businesses as lead trial counsel in a three-week federal criminal trial in the Eastern District of Virginia involving allegations of healthcare fraud, wire fraud and tax evasion.
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Wanaque Center for Nursing and Rehabilitation in its response to a deadly viral outbreak by conducting an independent investigation of the facility's response; responding to investigations, reviews, and enforcement action by multiple law enforcement and regulatory agencies; representing the facility in ongoing litigation with the Centers for Medicare and Medicaid Services; and coordinating the overall response to the media and the state legislature.
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Newark Beth Israel Medical Center and its parent RWJBarnabas Health in conducting an independent investigation, responding to multiple enforcement investigations and regulatory reviews, and overseeing the response to extensive media scrutiny and congressional and legislative inquiries following allegations in the national press that patient care in the hospital’s heart transplant program was compromised to improve survival statistics.
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Novartis in the successful defense of a qui tam suit brought in the District of Massachusetts by multiple relators, alleging off-label and kickback claims in connection with the asthma medication Xolair®. On a motion to dismiss, we obtained dismissal with prejudice of all claims, which was affirmed by the First Circuit. Relators then filed suits in Massachusetts and New York under state FCA statutes, and we successfully obtained dismissal of those cases.
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Eli Lilly, AstraZeneca, and UCB in three federal qui tam litigations filed in Texas, Washington, and Illinois, respectively, alleging violations of the AKS and FCA through the use of nurse educator and reimbursement support services. All cases have been dismissed. After Relator refiled the cases against Eli Lilly in New Jersey and Texas state courts, we obtained dismissal of the New Jersey state case and a stay of the Texas state case.
Key Contacts
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Recognition
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Benchmark LitigationWhite-Collar Crime (2024)
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LMG Life Sciences GuideWhite Collar/Government Investigations (2024)
Non-IP Litigation & Enforcement: White-Collar/Government Investigations (2023)
Non-IP Litigation & Enforcement: Government Investigation/Fraud & Abuse (2023) -
Chambers USACorporate Crime & Investigations: The Elite (Nationwide) (2024)
False Claims Act (Nationwide) - Band 1 (2024)
Litigation: White-Collar Crime & Government Investigations (Washington, D.C.) (2024)
Litigation: White-Collar Crime & Government Investigations: The Elite (New York) (2024)