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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

My colleagues from ML Strategies, George Atanasov and Julie Cox, published a client alert discussing changes to the Massachusetts Pharmaceutical and Medical Device Manufacturer Code of Conduct. 
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On Monday, June 18th, the Office of Inspector General (OIG) published a notice that it intends to update its Provider Self-Disclosure Protocol (Protocol), through which health care providers can disclose potential fraud and resolve liability under the OIG’s civil monetary penalty authority. 
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In OIG Advisory Opinion 12-06, the OIG determined that two proposed arrangements between an anesthesia services provider (the "Requestor") and professional corporations ("PCs") or limited liability companies ("LLCs") that own ambulatory surgical centers ("ASCs") would potentially violate the federal Anti-Kickback Statute ("AKS") and thus would be subject to enforcement and administrative sanctions.
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Sunshine Act Implementation Delayed Until 2013

May 4, 2012 | Blog | By Brian Dunphy

With little fanfare, the Centers for Medicare & Medicaid Services (CMS) announced today on the CMS Blog that it is delaying data collection under the Sunshine Act until 2013. 
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CMS Selects 27 ACOs

April 13, 2012 | Blog | By Brian Dunphy

In another step toward implementation of Accountable Care Organizations (ACOs), on April 10, 2012, the Centers for Medicare & Medicaid Services (CMS) selected 27 ACOs in 18 states to participate in the Medicare Shared Savings Program (Shared Savings Program).
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On March 23, 2012, the Department of Health and Human Services (HHS) issued its statutorily required report to Congress (Report) describing the implementation of the Medicare Physician Self-Referral Disclosure Protocol (SRDP) and the status of disclosures under the SRDP to date. 
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2011-The Year In Review: Trends in Health Care Enforcement

February 1, 2012 | Blog | By Brian Dunphy, Samantha Kingsbury

Mintz Levin’s Health Care Enforcement Defense Group reviewed health care fraud enforcement activities in 2011 to offer a general snapshot of the environment in which health care providers and pharmaceutical and medical device manufacturers operate. 
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The Centers for Medicare & Medicaid Services (CMS) recently issued a proposed rule giving pharmaceutical and medical device manufacturers as well as group purchasing organizations some insight into how CMS intends to implement the Physician Payment Sunshine Act, which was enacted as part of health care reform.
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As discussed in a previous post, CMS recently issued a proposed rule implementing the Sunshine Act, but many pharmaceutical and medical device manufacturers are still trying to determine the scope of their continuing obligations under related state laws, such as the Massachusetts “gift ban” law. 
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Sunshine Act: Proposed Regulations Shed Some Light on Implementation

December 15, 2011 | Blog | By Brian Dunphy, Karen Lovitch

Pharmaceutical and medical device manufacturers, along with physicians and teaching hospitals, who have been grappling with how to implement the requirements of the federal Physician Payment Sunshine Act have finally received long-awaited guidance.
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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