Brian is a member of the Health Care Enforcement Defense Group, and he defends clients facing government investigations and whistleblower complaints regarding alleged violations of the federal False Claims Act and similar state laws. Brian also handles commercial health care litigation involving business disputes, and he defends national product liability cases for pharmaceutical and biotech companies.
Brian advises and counsels health care providers, biotechnology and life sciences companies, clinical laboratories, health plans, Medicare Advantage plans, and pharmaceutical and medical device manufacturers. He represents them in government investigations, in litigation, and at trial. He is a member of the firm’s Health Care Enforcement Defense Group and is a frequent author on health care fraud and abuse issues.
In particular, Brian defends companies against government investigations of alleged violations of the False Claims Act (FCA) and the Anti-Kickback Statute (AKS). He conducts internal investigations and litigates qui tam FCA cases in federal courts around the country. Brian also defends pharmaceutical and biotech companies in national product liability cases and represents biotechnology, life sciences, and technology companies in complex business disputes.
Brian is committed to pro bono work. He is a member of the team that manages the Massachusetts Civil Appeals Clinic. He obtained political asylum for a client who was tortured in the Democratic Republic of the Congo, and he obtained 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 Boards of Directors of the Concussion Legacy Foundation and the Volunteers Lawyers Project. Brian serves as a committee member of the United Way's BoSTEM Leadership Breakfast to benefit STEM education in the Boston Public Schools.
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.
Education
- Boston College (JD)
- Boston College (BA)
Experience
- Defended numerous clients, including laboratories, health plans, and Medicare Advantage plans, in government FCA investigations and FCA litigation in jurisdictions around the country
- 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
- 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. Azco Biotech, Inc. v. Intelligent Bio-Systems, Inc., 12-cv-2599-BEN, U.S. Dist. Ct. (S.D. Cal.). Plaintiff, a former distributor of our client’s next-generation DNA sequencing machines, filed an 18-count, $100 million complaint against our client. Following extensive discovery, we persuaded the court to narrow the case to a single breach of contract claim. The jury returned a unanimous verdict in our client’s favor
- 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
Recognition & Awards
- 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
Involvement
- Board of Directors, Volunteer Lawyers Project of the Boston Bar Association
- Board of Directors, Concussion Legacy Foundation
- Committee Member, United Way BoSTEM Leadership Breakfast
- Alumni Board Member, Boston College Law School
- Member, Boston Bar Association
- Member, Massachusetts Bar Association
- Member, American Bar Association
- Member, American Health Lawyers Association
Recent Insights
Viewpoints
COVID-19 Relief Programs: Mitigating and Responding To Enforcement Risk
June 22, 2020 |Blog
News & Press
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.
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.
Viewpoints
COVID-19 Relief Programs: The Anticipated Wave of False Claims Act Cases and Oversight Agency Enforcement Activities
July 2, 2020 | Blog | By Brian Dunphy, Geoffrey Friedman, Caitie Hill, Jane Haviland, Karen Lovitch
Leading up to a webinar on July 15, 2020, we are publishing a blog series covering the risks of enforcement against companies that received COVID-19 relief funds under the CARES Act and strategies for mitigating these risks. This second installment of our series discusses our predictions related to litigation and enforcement activities. We expect a substantial number of False Claims Act (“FCA”) investigations and lawsuits initiated mainly by whistleblowers (also known as “relators”). The FCA remains the government’s primary enforcement tool for pursuing alleged fraud by recipients of government funds, and FCA claims present substantial risk because the statute permits treble damages and significant per-claim penalties. For example, an erroneous $100,000 loan under the Paycheck Protection Program (“PPP”) can result in $300,000 in FCA damages, or more.
Read more
COVID-19 Relief Programs: Mitigating and Responding To Enforcement Risk
June 22, 2020 | Blog | By Brian Dunphy, Jane Haviland, Nicole Henry, Karen Lovitch
Since the early days of the pandemic, Mintz’s COVID-19 Compliance & Enforcement Defense Task Force has closely monitored and advised clients on the evolving COVID-19 relief programs, including those created by the Coronavirus Aid, Relief, and Economic Security Act (CARES Act). The CARES Act provided for over $2 trillion in relief funds, which is the largest emergency assistance package in American history. The numerous CARES Act programs have continued to develop through, among other things, the passage of the Paycheck Protection Program and Health Care Enhancement Act, the Paycheck Protection Program Flexibility Act of 2020, and rapidly changing regulatory guidance and FAQs. As one example, the government recently wrestled with whether to make public the list of about 4.6 million entities that received more than $500 billion from the Paycheck Protection Program (PPP) under the CARES Act. After initially refusing to disclose PPP loan recipients, the Small Business Administration and Treasury Department decided to make public the names of entities that received loans larger than $150,000, as well as the dollar range of each loan.
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DOJ Files False Claims Act Lawsuit Against Anthem for “One-Sided” Chart Review Practices
April 7, 2020 | Blog | By Brian Dunphy, Nicole Henry
The Department of Justice recently filed suit against Anthem, Inc. (Anthem) alleging that the Medicare Advantage Organization (MAO) violated the False Claims Act when it knowingly failed to delete inaccurate diagnosis codes submitted to the Centers for Medicare and Medicaid Services (CMS) for risk adjustment purposes. As predicated in our 2020 outlook post, we continue to see enforcement activity and ongoing litigation against Medicare Advantage plans. Notably, this trend is referenced in SDNY’s complaint, alleging that the government has “sought to enforce” data accuracy in the risk adjustment system by “actively pursuing legal remedies against [] MAOs that have knowingly submitted inaccurate and untruthful diagnosis data to CMS[.]” The complaint provides four examples of settlements obtained from 2012-2019 against MAOs and healthcare providers who, purportedly like Anthem, submitted inaccurate diagnosis codes to CMS or allegedly failed to delete unsupported diagnosis codes.
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Federal Government Provides Liability Immunity to Manufacturers and Distributors in Fight Against COVID-19: What Companies Need to Know
April 7, 2020 | Blog | By Joe Blute, Brian Dunphy, Daniel Herling, Alain Mathieu
Over the past several weeks, the Firm has received a number inquiries from clients (on both coasts) who are interested in manufacturing or selling test kits, respirators, masks, and other PPE in response to the COVID-19 pandemic, with respect to potential liability risks associated with such activities.
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Landmark AseraCare Case Finally Ends in Settlement
March 2, 2020 | Blog | By Samantha Kingsbury, Brian Dunphy, Laurence Freedman
As many of our readers know, the AseraCare case was closely watched over the last several years because of its significance to efforts by the Department of Justice (DOJ) to allege that submission of claims for services lacking “medical necessity” violate the False Claims Act (FCA) as well as to efforts by providers to defend such cases. On Wednesday, we learned that the AseraCare case has reached its dramatic conclusion with an agreement to resolve $200 million in alleged damages for the agreed amount, as reported by AseraCare, of $1 million.
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Health Care Enforcement Year-in-Review and 2020 Outlook: Civil Fraud Enforcement Developments and Trends
January 21, 2020 | Blog | By Brian Dunphy, Laurence Freedman, Karen Lovitch, Julianna Hanlon, Nicole Henry, Clare Prober
As discussed in our article recently published by Law360, 2019 brought yet another year of robust health care enforcement activity, and the False Claims Act (FCA) remains the government’s most powerful civil health care enforcement tool. This post will give an overview of our article, which covers these issues and more in great detail.
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CMS Finalizes Changes Expanding the Scope of the Open Payments Program
November 18, 2019 | Blog | By Brian Dunphy, Rachel Yount
On November 15, 2019, the Centers for Medicare & Medicaid Services ("CMS") finalized changes to the Open Payments Program as part of the CY 2020 Physician Fee Schedule Final Rule. Perhaps most importantly, CMS broadened the list of Covered Recipients. Starting for data collection for CY 2021, manufacturers will be required to track and report payments and transfers of value made to physician assistants, nurse practitioners, clinical nurse specialists, certified registered nurse anesthetists, and certified nurse midwives. CMS also added three new nature of payment categories – debt forgiveness, long-term medical supply or device loan, and acquisitions. CMS also consolidated the two payment categories for continuing education programs – accredited/certified and unaccredited/non-certified – into one payment category for all continuing education programs. Lastly, in a move expected to impose a substantial burden on medical device manufacturers, CMS added a reporting requirement for the ‘device identifier’ component of the unique device identifier for devices and medical supplies.
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Eleventh Circuit Rules in AseraCare Case that Disagreements in Clinical Judgment, Without Objective Falsity, Do Not Prove Fraud Under the FCA
September 11, 2019 | Blog | By Samantha Kingsbury, Laurence Freedman, Brian Dunphy
On Monday, the U.S. Court of Appeals for the Eleventh Circuit issued its long-awaited and closely watched decision in United States v. AseraCare Inc.. The court ruled that a claim cannot be deemed false under the False Claims Act (FCA) based on a difference in clinical judgment. Instead, there must be proof of an objective falsehood. More than three years have passed since the U.S. District Court for the Northern District of Alabama issued the series of rulings that gave rise to the Eleventh Circuit case.
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Open Payments Program Expansion
August 12, 2019 | Blog | By Brian Dunphy, Rachel Yount
On July 30, 2019, the Centers for Medicare & Medicaid Services (CMS) announced more proposed changes to the Open Payments Program, otherwise known as the Sunshine Act. The proposed changes include new requirements that are expected to impose burdens on pharmaceutical and medical device manufacturers.
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Third Circuit Dismisses FCA Case Under Pre-ACA Version of Public Disclosure Bar
July 10, 2019 | Blog | By Jane Haviland
The Third Circuit Court of Appeals recently dismissed a relator’s False Claims Act (“FCA”) case under the pre-Affordable Care Act (“ACA”) version of the public disclosure bar. The court decided in U.S. ex rel. Denis v. Medco that to escape the FCA’s public disclosure bar by qualifying as an “original source” under the pre-ACA version of the FCA, a relator must have first-hand, non-derivative knowledge of conduct giving rise to the FCA claim.
Read more
News & Press
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.
2019 Trends In DOJ Civil Health Care Fraud Cases
January 15, 2020
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.
2017 Health Care Enforcement Review: FCA Case Law
January 17, 2018
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 Promotes Five Attorneys to Member
May 26, 2017
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.
Health Care Enforcement Review And 2017 Outlook: Part 4
January 19, 2017
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.
Eighty-Four Mintz Attorneys Named 2016 Massachusetts Super Lawyers and Rising Stars
October 18, 2016
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.
The Medicare Overpayment Rule: Implications for Compliance and Health Care Enforcement
February 26, 2016
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.
CMS Relaxes 60-Day Overpayment Rule Requirements: 5 Things to Know
February 11, 2016
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.
Events
Jul
15
2020
Received COVID-19 Funding? How to Mitigate and Respond to Enforcement Risks and Government Actions
Webinar
View the Webinar Recording
Speaker
Oct
2
2019
Mintz's Annual Boston Employment Law Summit
Boston, MA
Speaker
Jan
31
2018