Ranked Band 1 in Chambers USA for False Claims Act
“A nationally acclaimed practice with significant pedigree in the healthcare, pharmaceutical and life sciences fields, where it represents a number of highly significant players in extremely contentious FCA matters. The practice also demonstrates considerable skill in handling FCA matters in the cybersecurity and financial service spaces.”
Achieved a landmark victory in the First Circuit for a global pharmaceutical company in a FCA case brought by the U.S. Attorney’s Office for the District of Massachusetts. The case involved allegations of Anti-Kickback Statute (AKS) violations in connection with donations to an independent charitable foundation assisting low-income Medicare beneficiaries in accessing the company's breakthrough treatment. The unanimous First Circuit ruling set a significant precedent for the industry by determining that the Department of Justice must prove that the AKS, often the basis for FCA lawsuits, requires proof that kickbacks directly changed medical treatment decisions.
Achieved a landmark victory in the First Circuit for a global pharmaceutical company in a FCA case brought by the U.S. Attorney’s Office for the District of Massachusetts. The case involved allegations of Anti-Kickback Statute (AKS) violations in connection with donations to an independent charitable foundation assisting low-income Medicare beneficiaries in accessing the company's breakthrough treatment. The unanimous First Circuit ruling set a significant precedent for the industry by determining that the Department of Justice must prove that the AKS, often the basis for FCA lawsuits, requires proof that kickbacks directly changed medical treatment decisions.
Favorably resolved an enforcement action for a health care investment private equity firm and its portfolio company, a multi-state physician practice, which resulted in the lifting of a CMS-imposed multi-year Medicare payment suspension. The private equity firm was released from liability.
Won three motions to dismiss on behalf of a multinational medical device company in an FCA qui tam action alleging that the company misrepresented its compliance with federal regulations for certain devices reimbursable through Medicare. Secured a favorable settlement following the 9th Circuit’s affirmance for much of the lower court’s dismissal.
Represented a home health care provider in connection with a CID issued by the DOJ concerning Medicaid claims submissions for home health care visits using Electronic Visit Verification. The investigation, which resulted from a relator’s qui tam claim, closed without further action.
Representing several Medicare Advantage vendors in connection with investigations by DOJ and the U.S. Attorney’s Office for the Southern District of New York into whether such vendors caused the submission of false claims via submission of improper diagnosis codes.
Secured favorable resolution for a global pharmaceutical company in connection with an investigation by the DOJ into an entity the company acquired. The investigation focused on the acquired company’s relationships with hundreds of physician speakers who were paid to educate other prescribers about a novel, newly approved medication.
Defending a French multinational pharmaceutical and health care company in a qui tam action filed by a hospital operator against several drug manufacturers alleging FCA violations resulting from overcharges for 340B program drugs.
Advising a large private equity firm and several of its portfolio companies in an FCA inquiry concerning Paycheck Protection Program loans received by the firm’s portfolio companies.
Representing a global aerospace and defense company in response to subpoenas issued by the U.S. Attorney’s Office for the District of Massachusetts related to alleged criminal and civil FCA violations.
Representing three large U.S. universities in responding to subpoenas from the NASA Office of Inspector General, who has become increasingly aggressive in investigating universities that are receiving NASA funds.
Represented a private equity-owned healthcare software and EHR company in an FCA and AKS investigation conducted by the U.S. Attorney’s Office in Vermont and U.S. Department of Justice Civil Frauds.
Won summary judgment for a Fortune 200 health care provider in an FCA case alleging more than $100 billion in liability.
Successfully resolved a civil FCA investigation involving allegations of unlawful billing of services for a leading dental services organization with a no-admission settlement and no CIA.
Filed amicus briefs on behalf of multiple companies to represent their interests and express their point of view in the United States Supreme Court in connection with FCA cases, providing the Court with the benefit of Ropes & Gray’s extensive experience and industry knowledge.
Prevailed on behalf of a global pharmaceutical company in a long-running FCA case—appealed to the 9th Circuit after a successful motion to dismiss—which raised novel First Amendment issues involving claims of off-label promotion.
Secured dismissal on behalf of a global health and community care technology company in FCA litigation alleging fraudulent upcoding of Medicare claims. The dismissal was affirmed by the 6th Circuit. We then convinced the U.S. Supreme Court to deny certiorari, which had been sought on the perennial pleading question of what is required to satisfy Rule 9(b)’s particularity pleading requirements when alleging an FCA violation.
Negotiated a comprehensive civil resolution for a well-known diagnostic laboratory facing a wide-ranging federal civil and criminal investigation involving the U.S. DOJ, U.S. HHS-OIG, and various state agencies. Secured a favorable resolution on claims alleging anti-kickback, FCA, Stark law, and other violations stemming from the marketing and billing of our client’s services. The resolution includes the dismissal, with prejudice, of all claims in four qui tam lawsuits.
Representing a global leader in advanced semiconductor technology and U.S. government contractor in connection with a CID it received from the NASA Office of Inspector General in presenting potential FCA liability.
Trial counsel for a multinational pharmaceutical company in a case brought by the Massachusetts Attorney General seeking to recover the state share of alleged damages following the national resolution of the federal share of Medicaid reimbursement with the U.S. DOJ. In a case involving state consumer fraud, FCA, common law fraud and unjust enrichment claims, secured a significant post-trial victory on behalf of the company when the U.S. District Court judge dismissed as legally invalid the principal false claims count against the company, as well as a breach of contract claim brought by the Commonwealth as a third-party beneficiary of the Medicaid Rebate Agreement. The ruling reduced liability by more than $190 million, and the key aspect of the ruling is significant for FCA cases more broadly.
“Controlled Substances and the False Claims Act: Reducing Legal Risk Amid the Expanding Reach of the FCA,” ACI Controlled Substances: Regulation, Litigation, and Enforcement (July 2022)
