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John P. Bueker

Partner

Boston+1 617 951 7951

John.Bueker@ropesgray.com

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Laura G. Hoey

Partner

Chicago+1 312 845 1318

Laura.Hoey@ropesgray.com

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Michael B. Lampert

Partner

Boston+1 617 951 7095

Michael.Lampert@ropesgray.com

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Andrew O'Connor

Partner

Boston+1 617 235 4650

Andrew.OConnor@ropesgray.com

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Amy D. Kossak

Partner

Washington, D.C.+1 202 508 4665

Amy.Kossak@ropesgray.com

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Overview

When leading companies, institutions and investors face False Claims Act (FCA) enforcement actions, they turn to Ropes & Gray. Our clients have favorably resolved FCA cases with the help of our Chambers Band 1-ranked practice.

Set apart by a track record of excellence. When the stakes are highest, we have achieved success in FCA cases on behalf of our clients, which include:

Fortune 500 companies
Leading pharmaceutical companies
Medical device manufacturers
Diagnostic laboratories
Digital health companies
Nursing homes

Biotechnology firms
Hospital systems
Academic medical centers
Health care providers
Private equity firms

We assist in defending both whistleblower and government actions, from the start of an investigation through trial court and appeal. When you need help with your most critical and complex FCA matters, we’re your first call.

A high-profile team with unmatched capabilities. When you work with us, you get a Chambers Band 1-ranked team, a deep bench and a breadth of cross-practice experience that includes:

Enforcement/white collar criminal defense
Civil litigators
Health care

FDA regulatory & compliance
Data security
Labor & employment

The government demystified. Our team includes former federal prosecutors from the U.S. Department of Justice and U.S. Attorney’s Offices, as well as a former assistant to the U.S. Solicitor General with extensive Supreme Court FCA experience. We understand the government’s approach to FCA matters and can offer creative and practical strategies.

360° perspective on health care and life sciences. Teaming with Ropes & Gray’s market-leading health care and life sciences attorneys, our FCA group handles some of the most significant investigations and litigations in these industries. Clients benefit from our collaborative approach, in-depth understanding of the industry, and extensive knowledge of applicable regulations and government interpretations based on firsthand experience.

Skilled at parallel investigations and more. FCA cases may run parallel to criminal, agency and state investigations; congressional inquiries; prosecutions under state law; or other civil actions. We offer strategic advice on navigating these concurrent legal challenges, as well as those that follow FCA matters, including consumer and third-party class actions, securities litigation, product liability claims, state consumer protection investigations and litigation, and employment disputes.

At a Glance

Represented a private equity-owned healthcare software and EHR company in an FCA and Anti-Kickback Statute (AKS) investigation conducted by the U.S. Attorney’s Office in Vermont and U.S. Department of Justice Civil Frauds.
Secured a district court dismissal of FCA and state law claims against a company that provides services to the home health industry.
Won a 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.
Represented a private equity company in a multiyear investigation by the U.S. Attorney’s Office for the Middle District of Florida and in a related qui tam lawsuit relating to alleged FCA violations.
Represented a global health and community care technology company in FCA litigation, alleging fraudulent upcoding of Medicare claims. The case was dismissed by the district court and appealed to the Sixth Circuit, where the dismissal was affirmed. 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 a FCA violation.

Representing two elite U.S. universities in responding to subpoenas from NASA Office of Inspector General, who has become increasingly aggressive in investigating Universities that are receiving NASA funds. One of the universities recently retained Ropes & Gray to handle a FCA CID focused on potential research misconduct in connection with grants by the National Institutes of Health.
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. Ropes & Gray secured a favorable resolution on claims relating to alleged 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.
Representing an American biotechnology company in a pending FCA case filed by the U.S. Attorney’s Office for the District of Massachusetts predicated on a purported violation of the AKS in connection with the Company’s donations to an independent charitable foundation that provides financial assistance to low-income Medicare beneficiaries seeking access to the Company’s breakthrough treatment.
Represented several pharmaceutical companies in a sweeping, industry-wide FCA investigation conducted by the USAO in Massachusetts and DOJ into charitable donations to independent patient assistance programs that provide financial assistance to Medicare patients. We represented the companies throughout their investigation, which included intensive negotiations with both the USAO in Massachusetts and DOJ, as well as with the HHS-OIG. The resolutions for our clients who were part of this industry sweep by the DOJ were extremely favorable.
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.
Representing a software company in responding to a CID seeking information about the encryption security features of software it sold to the U.S. government under the Federal Acquisition Regulation.
Representing an electronic health records software provider in a qui tam action alleging violations of the FCA based on alleged cybersecurity weaknesses in the company's EHR system.
Represented a global pharmaceutical company in an investigation by the U.S. Attorney’s Office for the N.D. Cal. and a related action under the False Claims Act concerning alleged off-label promotion and kickbacks to physicians. The relator also filed suit in California state court based on similar allegations under California’s private-payor qui tam statute. We negotiated a settlement on behalf of the company with the USAO, DOJ and several states, resolving the USAO’s investigation and federal qui tam action for a civil-only payment, with no Corporate Integrity Agreement with the HHS Office of Inspector General. Additionally, the federal relator voluntarily dismissed his related California state law action, which had been pending first in Los Angeles Superior Court and then in C.D. Cal.
Secured a successful civil settlement on behalf of a major pharmacy company following a complex, multiyear investigation by the U.S. Attorney’s Office for the Southern District of New York and various states’ Attorneys General into allegations that the pharmacy had violated the FCA.
Won summary judgment for a global pharmaceutical and biotechnology company in an FCA lawsuit filed by two former sales representatives (“relators”) who alleged that the company continued to promote a drug for a number of off-label uses and paid kickbacks to doctors following a previous settlement with the federal government. The court granted the company’s motion for sanctions against relators’ counsel and awarded the company attorney fees for opposing counsel’s failure to comply with a court order to produce documents that were won through successful discovery motion practice.

“2024 U.S. Health Care Fraud, Waste & Abuse Trends (Part I): Advisory Opinions on Patient Inducements,” R&G Podcast (March 2024)
“Health Care Operations & Compliance, Professional Perspective – Medicare Advantage Enforcement Trends To Watch in 2024,” Bloomberg Law (January 2024)
“Insights from OIG’s Strategic Plan for Oversight of Managed Care (Part II),” R&G Podcast (January 2024)
“Insights from OIG’s Strategic Plan for Oversight of Managed Care (Part I),” R&G Podcast (January 2024)
“6 Biggest Healthcare Fraud Cases of 2023,” Law360 (December 2023)

“OIG Strategic Plan for Oversight of Managed Care,” Westlaw Today (October 2023)
“Recent Cigna Settlements Demonstrate Government’s Continued Scrutiny of Medicare Advantage Organizations: Considerations for Plans, Providers, and Vendors,” R&G Alert (October 2023)
“OIG Strategic Plan for Oversight of Managed Care,” R&G Alert (September 2023)
“Thomas Dissent Could Signal ‘Twilight’ for False Claims Act,” Bloomberg Law (June 2023)
“High Court Underscores DOJ's Role In Policing FCA Litigation,” Law360 (June 2023)
“Sixth Circuit Requires But-For Causation and Narrowly Defines Remuneration under AKS,” R&G Alert (April 2023)
“The Hottest FCA Cases & Trends to Watch in 2023,” Law360 (January 2023)
“High Court Won't Address FCA Pleading Standard,” Law360 (October 2022)
“Industry Backs Broad FCA Dismissal Authority At High Court,” Law360 (October 2022)
“Third Time’s the Charm: U.S. Supreme Court Grants Certiorari to Examine the Government’s Ability to Dismiss FCA Qui Tam Actions,” R&G Alert (June 2022)
“What’s at Stake in Justices’ FCA Qui Tam Dismissal Review,” Law360 (June 2022)
“OIG clarifies anti-kickback rules for MD inventors with start-up equity,” Technology Transfer Tactics (May 2022)
“The Hottest FCA Cases and Trends to Watch In 2022,” Law360 (January 2022)

“Hot Topics in Life Sciences Enforcement,” Boston Bar Association Webinar (February 2024)
“From Prep to Verdict: Trial Advocacy Advice from Trial and Appellate Counsel,” ACI 11^th Annual Advanced Forum on False Claims & Qui Tam Enforcement (January 2024)
“The DOJ’s Civil Cyber Fraud Initiative in Action: The Latest Cross-Industry Trends and How Companies Can Become Compliant,” ACI 11^th Annual Advanced Forum on False Claims & Qui Tam Enforcement (January 2024)
“Data, Privacy & Cybersecurity,” 2^nd Annual Ropes & Gray False Claims Act Webinar Series (November 2023)
“Supreme Court Cases,” 2^nd Annual Ropes & Gray False Claims Act Webinar Series (October 2023)
“Post-Supervalu: The Future of Government Enforcement Around Drug Pricing,” Medicaid Drug Rebate Program Summit in Chicago (September 2023)

“Clinical Decision Tools,” 2^nd Annual Ropes & Gray False Claims Act Webinar Series (September 2023)
“Private Equity Sponsor Liability,” 2^nd Annual Ropes & Gray False Claims Act Webinar Series (July 2023)
“Medicare Advantage & Risk-Bearing Providers,” 2^nd Annual Ropes & Gray False Claims Act Webinar Series (June 2023)
“Criminal Enforcement, Priorities and Practices,” ABA National Institute on Health Care Fraud (May 2023)
“Health Care Fraud Enforcement – Current Trends and Trial Tactics,” ABA 38th National Institute on White Collar Crime (March 2023)
“Navigating FCA Appeals,” FBA Qui Tam Conference (February 2023)
“SCOTUS Watch: The Latest in the Debate Over DOJ’s Dismissal Authority and the Requisite Pleading Standard for False Claims Act Qui Tam Claims,” ACI 10th Annual Advanced Forum on False Claims and Qui Tam Enforcement (January 2023)
“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)
“Anti-Kickback Issues,” Ropes & Gray False Claims Act Webinar Series (August 2022)
“The False Claims Act | COVID-19,” Ropes & Gray False Claims Act Webinar Series (July 2022)
“Overview and Recent Developments,” Ropes & Gray False Claims Act Webinar Series (July 2022)

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.

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At a Glance

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