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Brian P. Dunphy

Member / Co-Chair, Health Care Enforcement Defense Practice

[email protected]

+1.617.348.1810

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Brian is a health care litigator and Co-Chair of the Health Care Enforcement Defense Group. Brian is a trusted advisor for clients, and he defends clients facing government investigations and whistleblower complaints regarding alleged violations of the federal False Claims Act (FCA) and similar state laws. Brian also handles commercial litigation involving business disputes for health care, life sciences, and biotechnology companies. He defends national product liability cases for pharmaceutical and biotech companies.

Brian advises and counsels health care providers, health plans, Medicare Advantage plans, biotechnology and life sciences companies, and clinical laboratories. He represents them in government investigations, in litigation, at trial, and in arbitration.

In particular, Brian defends companies against government investigations of alleged violations of the FCA and the Anti-Kickback Statute (AKS). He conducts internal investigations and litigates qui tam FCA cases in federal courts around the country. Brian is well-versed in health care regulatory requirements, including in Medicare Advantage and risk adjustment. Brian also represents health plans, biotechnology, life sciences, health care, and technology companies in complex business disputes.

Brian is committed to pro bono work and is a member of the firm’s Pro Bono Committee. He obtained political asylum for a client who was tortured in the Democratic Republic of the Congo, and he secured a residential educational placement for a disabled student. Brian has spent more than a decade advising a non-profit organization dedicated to advancing the study, treatment, and prevention of the effects of concussions and other brain trauma in athletes and other at-risk groups.

Brian is also deeply involved in the Boston community as a member of the Board of Advisors for Life Science Cares, and the Boards of Directors of the Concussion Legacy Foundation and the Volunteers Lawyers Project. He was also a Member of the Boston College Law School Alumni Board.

Before attending law school, Brian was a project manager at Accenture, a management and technology consulting firm, where he provided project management and consulting services. Brian developed project plans and budgets, managed teams to meet project milestones, and worked with client executives to ensure projects met business objectives. He continues to utilize his project management skills working with his clients to manage matters effectively and to deliver timely results.

Brian is a health care litigator and Co-Chair of the Health Care Enforcement Defense Group. Brian is a trusted advisor for clients, and he defends clients facing government investigations and whistleblower complaints regarding alleged violations of the federal False Claims Act (FCA) and similar state laws. Brian also handles commercial litigation involving business disputes for health care, life sciences, and biotechnology companies. He defends national product liability cases for pharmaceutical and biotech companies.

Experience

  • Defended numerous clients, including laboratories, health plans, and Medicare Advantage plans, in government FCA investigations and FCA litigation in jurisdictions around the country.
  • Represented a pharmaceutical firm, laboratory, and several executives in an FCA lawsuit in federal court, and the court dismissed relator’s complaint three times
  • Obtained dismissal of a whistleblower’s state and federal FCA claims against a vendor to Medicare Advantage plans. Argued the appeal in the Second Circuit Court of Appeals, which affirmed the district court’s decision
  • Obtained a favorable resolution of an FCA case against a Medicare Advantage Organization before litigation
  • Obtained summary judgment in nine related cases against a publicly traded biotechnology company and a pharmaceutical company in multi-jurisdictional product liability disputes involving an FDA-approved pharmaceutical drug
  • Represented construction companies in a state Attorney General’s false claims act investigation related to a construction project
  • Obtained dismissal of a whistleblower’s state and federal FCA claims against a Pharmacy Benefit Manager in federal court, and the Third Circuit Court of Appeals upheld the district court’s decision in our client’s favor
  • Represented a health insurance company in an FCA lawsuit in federal court where relator alleged an industry wide drug-pricing scheme. The court dismissed the case
  • Defended companies against FCA retaliation claims before litigation, in litigation, and at trial
  • Obtained a defense verdict as trial counsel after a week-long federal court jury trial. Plaintiff, a former distributor of our client’s next-generation DNA sequencing machines, filed an 18-count, $100 million complaint against our client
  • Achieved victory in an arbitration for an international life sciences company initiated by one of the company’s suppliers. After an evidentiary hearing, a panel of arbitrators rejected the supplier’s claims and entered judgment for our client on its counterclaim, including recovery of our client’s attorneys’ fees and costs
  • Represented a life sciences company before the International Court of Arbitration of the International Chamber of Commerce in a breach of contract dispute involving the manufacture of diagnostic assays
  • Successfully defended a physician before an Administrative Law Judge against an action by the Massachusetts Board of Registration in Medicine to revoke or suspend the physician’s license
  • Conducted an internal investigation of a health care provider and prepared a self-disclosure to the U.S. Department of Health and Human Services, Office of Inspector General (OIG)
  • Successfully opposed the OIG’s proposed exclusions of a physician from federal health care programs
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viewpoints

In early March 2024 at the American Bar Association’s 39th National Institute on White Collar Crime, Deputy Attorney General (DAG) Lisa Monaco’s keynote remarks previewed the development of new and significant Department of Justice (DOJ or the Department) policy initiatives. Her speech reemphasized many of DOJ’s key themes throughout the current administration, including individual accountability, the importance of strong corporate compliance programs, incentivizing voluntary self-disclosure of misconduct, and adapting to keep up with disruptive technologies such as artificial intelligence.

 

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Health care companies using algorithms and AI applications face increased compliance risks. Previous technology-related enforcement suggests how relators and enforcement agencies might use AI to detect potential fraud and develop allegations based on how the technology is being used.

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Enforcement against Medicare Advantage Organizations continues to be a top priority for the DOJ and HHS’s Office of Inspector General as the number of Medicare Advantage enrollees continued to rise in 2023.

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Since May 2023, federal legislators have introduced more than 50 bills focused on issues related to AI technologies, with patient privacy, the role of clinicians, and health equity emerging as areas of focus. In addition, the Biden administration released an Executive Order focused on promoting AI safety in October 2023.

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A recent Massachusetts Federal District Court decision adds to divergent opinions deciding an important health care enforcement question: what causation standard applies to a False Claims Act (FCA) case based on a violation of the Anti-Kickback Statute (AKS)? The AKS states that a claim that includes items or services “resulting from” a violation of the AKS constitutes a “false or fraudulent claim” under the FCA. 42 U.S.C. § 1320a-7b(g). On September 27, 2023, Chief Judge Saylor of the District of Massachusetts issued a decision in United States v. Regeneron Pharmaceuticals, Inc., C.A No. 20-11217-FDS, which adopted a “but-for” standard of causation applicable to the AKS’s “resulting from” language.

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In this episode, Health Care Enforcement Defense specialists Eoin Beirne, Karen Lovitch, and Brian Dunphy discuss key regulatory and policy updates issued by the DOJ and their potential impact on False Claims Act cases, from self-disclosure to privacy regulations.

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Bridgette Keller speaks with Karen Lovitch, Brian Dunphy, and Eoin Beirne about the Mintz Health Care Enforcement Defense Practice’s recent edition of the EnforceMintz newsletter, Analyzing Health Care False Claims Act Cases, and key health care enforcement trends.

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Mintz's Health Care Enforcement group analyzes trends in False Claims Act (FCA) investigations and lawsuits using data compiled its Qui Tam Database, the Department of Justice's (DOJ) annual report of FCA statistics, and the DOJ’s discussion of FCA enforcement trends.

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Medicare Advantage (Medicare Part C) remained a top enforcement priority in 2022, and Medicare Advantage Organizations (MAOs) are the subject of intense scrutiny by the Department of Justice (DOJ); the Office of Inspector General for the Department of Health and Human Services (HHS OIG); and the press. MAOs undoubtedly will continue to face considerable enforcement in 2023 and beyond, particularly as Medicare Advantage continues to grow in both number of enrollees and in federal spending. As of January 31, 2023, more than 30 million people are enrolled in MAOs—nearly half of all Medicare enrollees.

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News & Press

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BOSTON –  Twenty-five Mintz attorneys have been named to Boston Magazine’s Top Lawyers list.

BOSTON – Mintz has appointed Brian Dunphy as Co-Chair of the firm’s Health Care Enforcement Defense Group with immediate effect. Brian joins Karen Lovitch, who also serves as Chair of the Health Law Practice, in joint leadership.

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In its second annual edition, 28 Mintz attorneys were named to Boston Magazine’s Top Lawyers list.

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Mintz Members Brian P. Dunphy, Joanne S. Hawana, and Jennifer B. Rubin co-authored a Bloomberg Law insights column examining potential legal liabilities for employers implementing Covid-19 workplace vaccination programs, explaining that immunity under the federal Public Readiness and Emergency Preparedness Act (PREP Act) is not absolute.
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Mintz Members Kevin Ainsworth and Brian Dunphy co-authored an article published by New York Law Journal that analyzes the conditions for, and limitations of, the Public Readiness and Emergency Preparedness Act (PREP Act) immunity during the COVID-19 global health crisis.
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Mintz Members Brian Dunphy and Laurence Freedman, and Member and Co-Chair of the firm’s Health Law Practice Karen Lovitch co-authored this Law360 expert analysis article examining trends in U.S. Department of Justice health care enforcement in 2019, noting that the False Claims Act remains the government’s most powerful civil health care enforcement tool.
Brian Dunphy a Member in the Boston Mintz office authored the second article in a four-part series discussing some of 2017’s most important False Claims Act (FCA)-related court decisions.
Mintz has elevated five attorneys to Members of the firm. “These attorneys consistently demonstrate excellence in the delivery of legal services to the firm’s clients,” said Bob Bodian, Managing Member.
This is the fourth and final installment of a series from Mintz’s Health Law team recapping key government policies, regulations and enforcement actions from 2016 and discussing their potential impacts on 2017.
Fifty-three Mintz attorneys have been named Massachusetts Super Lawyers for 2016 and thirty-one have been named Massachusetts Rising Stars. The findings will be published in the November 2016 issue of Boston Magazine and in a stand-alone magazine, New England Super Lawyers. 
Mintz Members Brian Dunphy and Larry Freedman authored this BNA’s Medicare Report article discussing the long-awaited final Medicare Overpayment Rule from the Centers for Medicare & Medicaid Services.
Brian Dunphy, a Health Law and Litigation attorney, is quoted in this Becker’s Hospital Review piece on the Center for Medicare and Medicaid Services’ final rule.
Mintz Member Brian Dunphy is quoted in this Inside CMS article on the Center for Medicare and Medicaid Service's (CMS) final rules requiring healthcare providers and suppliers to report and return overpayments by a certain date.
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Brian is a health care litigator and Co-Chair of the Health Care Enforcement Defense Group. Brian is a trusted advisor for clients, and he defends clients facing government investigations and whistleblower complaints regarding alleged violations of the federal False Claims Act (FCA) and similar state laws. Brian also handles commercial litigation involving business disputes for health care, life sciences, and biotechnology companies. He defends national product liability cases for pharmaceutical and biotech companies.

Recognition & Awards

  • Boston Magazine Top Lawyers – Health Care Law (2022-2023)

  • Volunteer Lawyers Project: 2019 Denis Maguire Award 

  • Included on the Massachusetts Super Lawyers Rising Star Health Care list 

  • Greater Boston Chamber of Commerce, Boston Future Leaders Program 

  • Boston Bar Association Public Interest Leadership Program 

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Brian is a health care litigator and Co-Chair of the Health Care Enforcement Defense Group. Brian is a trusted advisor for clients, and he defends clients facing government investigations and whistleblower complaints regarding alleged violations of the federal False Claims Act (FCA) and similar state laws. Brian also handles commercial litigation involving business disputes for health care, life sciences, and biotechnology companies. He defends national product liability cases for pharmaceutical and biotech companies.

Involvement

  • Board of Advisors, Life Science Cares
  • Board of Directors, Volunteer Lawyers Project of the Boston Bar Association
  • Board of Directors, Concussion Legacy Foundation
  • Alumni Board Member, Boston College Law School
  • Member, Boston Bar Association
  • Member, Massachusetts Bar Association
  • Member, American Bar Association
  • Member, American Health Lawyers Association
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Brian P. Dunphy

Member / Co-Chair, Health Care Enforcement Defense Practice

Boston