T. Reed Stephens
Subscribe to T. Reed Stephens's PostsT. Reed Stephens represents clients in the life sciences industry, including pharmaceutical and biotech manufacturers, wholesalers and individuals, as well as health care systems and non-health care related companies in other global industries such as the defense and financial services/banking sectors. He also represents clients in matters involving state and federal government law enforcement, voluntary disclosures and congressional investigations. Read T. Reed Stephens' full bio.
First of Its Kind: Drug Wholesaler Accepts DPA and Two Executives Face Criminal Charges in SDNY For Illegal Distribution of Opioids
By Amandeep S. Sidhu and T. Reed Stephens on May 6, 2019
Posted In Compliance Developments, Director and Officer Liability and Accountability, Government investigation, Knowledge/Scienter, Pharmaceuticals, Yates Memorandum
On April 23, 2019, the US Department of Justice (DOJ) announced it has entered into a deferred prosecution agreement with Rochester Drug Co-Operative, Inc. (RDC), one of the 10 largest wholesale distributors of pharmaceutical products in the US, and filed felony criminal charges against two of RDC’s former senior executives for unlawful distribution of controlled...
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Health Care Enforcement Quarterly Roundup – Q1 2019
By McDermott Will & Emery, Amandeep S. Sidhu, Drew Elizabeth McCormick, Irene A. Firippis, James A. Cannatti III, Jennifer B. Routh, Laura McLane, Matthew M. Girgenti, Paul M. Thompson, Sean Hennessy, Sophia A. Luby, Theodore Alexander, Tony Maida and T. Reed Stephens on Apr 26, 2019
Posted In Additional Compliance Resources, Other Notable Enforcement Actions, Pharmaceuticals
In this first installment of the Health Care Enforcement Quarterly Roundup for 2019, we continue to monitor trends we identified in 2018 and introduce new enforcement efforts that are expected to persist in the coming year. In this Roundup, we focus on increased enforcement activity against electronic health record (EHR) companies, enforcement against individuals (with an acute focus...
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Health Care Enforcement Quarterly Roundup | Q4 2018
By McDermott Will & Emery, Amandeep S. Sidhu, Irene A. Firippis, Jennifer B. Routh, Laura McLane, Matthew M. Girgenti, Natalie Colvin, Paul M. Thompson, Sophia A. Luby, Theodore Alexander, Tony Maida and T. Reed Stephens on Jan 30, 2019
Posted In Compliance Developments, Other Notable Enforcement Actions, Yates Memorandum
This latest installment of the Health Care Enforcement Quarterly Roundup reflects on trends that persisted in 2018 and those emerging trends that will carry us into 2019 and beyond. Leading off with the US Department of Justice’s (DOJ) December announcement of its fiscal year 2018 False Claims Act (FCA) recoveries, it remains clear that the...
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Health Care Enforcement Quarterly Roundup | Q3 | September 2018
By T. Reed Stephens, McDermott Will & Emery, Amy H. Kearbey, Amandeep S. Sidhu, Irene A. Firippis, Jennifer B. Routh, Laura McLane, Matthew M. Girgenti, Natalie Colvin, Paul M. Thompson, Sophia A. Luby, Theodore Alexander and Tony Maida on Oct 8, 2018
Posted In Compliance Developments, Other Notable Enforcement Actions
In the latest installment of Health Care Enforcement Quarterly Roundup, we examine key enforcement trends in the health care industry that we have observed over the past few months. In this issue, we report on: Practical applications of recent guidance from the US Department of Justice (DOJ) A recent blow to DOJ’s effort to use...
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Health Care Enforcement Quarterly Roundup | Q2 | July 2018
By McDermott Will & Emery, Amandeep S. Sidhu, David S. Rosenbloom, Emily J. Cook, Laura McLane, Matthew M. Girgenti, Monica Wallace, Natalie Colvin, Paul M. Thompson, Sandra M. DiVarco, Stephen W. Bernstein, Sophia A. Luby, Tony Maida and T. Reed Stephens on Jul 18, 2018
Posted In Compliance Developments, Other Notable Enforcement Actions
How will key trends and developments in health care policy and enforcement impact future litigants? In the latest Health Care Enforcement Quarterly Roundup, we address this question in the context of: Continued interpretations of the landmark Escobar case The latest guidance from US Department of Justice (DOJ) leadership regarding enforcement priorities The uptick in state...
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DOJ Issues Memorandum Outlining Factors for Evaluating Dismissal of Qui Tam FCA Cases in Which the Government Has Declined to Intervene
By McDermott Will & Emery, Amandeep S. Sidhu and T. Reed Stephens on Jan 29, 2018
Posted In Anti-Kickback Statute / Stark Law, Government investigation, Government Knowledge, Materiality, Other Notable Enforcement Actions, Pharmaceuticals, Public Disclosure Bar
As first reported in the National Law Journal, the US Department of Justice (DOJ), Civil Division, recently issued an important memorandum to its lawyers handling qui tam cases filed under the False Claims Act (FCA) outlining circumstances under which the United States should seek to dismiss a case where it has declined intervention and, therefore,...
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DOJ Announces Significant Shift Towards Affirmative Dismissal Of “Frivolous” Qui Tam Complaints: A New Exit Strategy For Defendants?
By Amandeep S. Sidhu and T. Reed Stephens on Nov 16, 2017
Posted In Government Knowledge, Materiality, Uncategorized
Attendees at the Health Care Compliance Association’s Health Care Enforcement Compliance Institute are reporting that, Michael Granston, Director, Civil Frauds, Commercial Litigation Branch of the Civil Division of the US Department of Justice (DOJ), announced a significant shift in policy for the DOJ in dealing with False Claims Act (FCA) complaints that are deemed “frivolous”...
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A Hospital’s Deserving Stark and AKS Victory—But At What Cost?
By Nicholas Alarif, Tony Maida and T. Reed Stephens on May 31, 2017
Posted In Anti-Kickback Statute / Stark Law, Attorney's Fees, Rule 9(b) Particularity, Stark
This April, providers cheered when a federal district court in the Middle District of Florida found insufficient evidence to support a relator’s theory that a hospital had provided free parking to physicians, in violation of the Stark Law and Anti-Kickback Statute (AKS). In the Report and Recommendation for United States ex rel. Bingham v. BayCare...
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A Closer Look at Rigsby and the Supreme Court’s Rejection of Mandatory Dismissal for Seal Violations
By Alisha A. Johnson and T. Reed Stephens on Dec 13, 2016
Posted In Damages and Penalties, Public Disclosure Bar
In light of the rising civil monetary penalties under the False Claims Act (FCA) and the looming threat of bank-breaking treble damages, avenues to dismissal are paramount to defendants operating in industries vulnerable to FCA claims, including health care. The United States Supreme Court’s unanimous decision in State Farm Fire & Casualty Co. v. United...
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A Post-Tuomey Future: Huge Stark Law Hospital Settlements
By Tony Maida and T. Reed Stephens on Oct 7, 2015
Posted In Stark
After the federal government’s victory against Tuomey Healthcare System Inc., we have seen an increasing number of large False Claims Act settlements with hospitals involving Stark Law allegations. Relators are even citing, as evidence of ongoing recklessness, that hospital executives have been emailing articles about the Tuomey case to their staff. Given the Stark Law’s...
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