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.
Huge Stark Law Hospital Settlements and Physician Culpability – The New Normal Post-Tuomey?
By Tony Maida and T. Reed Stephens on Sep 29, 2015
Posted In Anti-Kickback Statute / Stark Law, Stark
After the federal government’s victory against Tuomey Hospital, we have seen an increasing number of large False Claims Act (FCA) settlements with hospitals involving Stark Law allegations. Despite the intricacies of Stark Law compliance, the U.S. Department of Justice (DOJ) has not shown much leniency in its treatment of these cases, as shown by two...
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DOJ’s “Yates Memorandum” Calls for Increased Focus on Individuals in Investigating Allegations of Both Criminal and Civil Corporate Wrongdoing
By Amandeep S. Sidhu and T. Reed Stephens on Sep 28, 2015
Posted In Uncategorized
On September 9, 2015, the U.S. Department of Justice (DOJ) released a memorandum to prosecutors nationwide regarding “Individual Accountability for Corporate Wrongdoing,” authored by Deputy Attorney General Sally Q. Yates. Dubbed the “Yates Memorandum,” this missive consolidates both long-standing DOJ policy and newly minted guidance for prosecutors and civil enforcement attorneys that could significantly alter...
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Huge Stark Law Hospital Settlements and Physician Culpability – The New Normal Post-Tuomey?
By Tony Maida and T. Reed Stephens on Sep 25, 2015
Posted In Stark
After the federal government’s victory against Tuomey Hospital, we have seen an increasing number of large False Claims Act (FCA) settlements with hospitals involving Stark Law allegations. Relators are even citing, as evidence of ongoing recklessness, that hospital executives have been e-mailing articles about the Tuomey case to their staff. Given the Stark Law’s intricate...
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The Health Care Industry and DOJ’s New Corporate Conduct Enforcement Guidelines
By Michael W. Peregrine and T. Reed Stephens on Sep 18, 2015
Posted In Compliance Developments
Health care leaders should closely note the new guidelines on corporate conduct released on September 9, 2015 by the Department of Justice (DOJ) (Memorandum from Sally Quillian Yates, Deputy Attorney General, U.S. Department of Justice, September 9, 2015, Individual Accountability for Corporate Wrongdoing (Guidelines), available at www.justice.gov/dag/file/769036/download). These Guidelines reflect a substantially increased focus on...
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The Health Care Industry and DOJ’s New Corporate Conduct Enforcement Guidelines
By Michael W. Peregrine and T. Reed Stephens on Sep 18, 2015
Posted In Yates Memorandum
Health care leaders should closely note the new guidelines on corporate conduct released on September 9, 2015 by the Department of Justice (DOJ). These Guidelines reflect a substantially increased focus on individual accountability for corporate wrongdoing, both civil and criminal, and on the importance of corporate cooperation in the context of governmental investigations. It is...
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Can Satisfying A Regulatory Requirement Now Equate To Providing Illegal Remuneration?
By Tony Maida and T. Reed Stephens on Sep 9, 2015
Posted In Anti-Kickback Statute / Stark Law, Rule 9(b) Particularity, Stark
Defending False Claims Act litigation is often a costly budget item. The disposal of weak cases by the government through the intervention decision making process has always been a critical safety valve for non-culpable defendants. Two of the more concerning trends in False Claims Act litigation, however, are (1) the increasing likelihood of relators pursuing...
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Amarin Ruling Solidifies Off-Label Marketing Options but Raises Questions About False Claims Act Enforcement Action
By Amandeep S. Sidhu and T. Reed Stephens on Aug 19, 2015
Posted In Pharmaceuticals
The Southern District of New York recently ruled in Amarin Pharma, Inc. et al. v. Food and Drug Administration, et al. that a drug company may engage in “truthful and non-misleading speech” about off-label uses of an approved drug without the threat of a misbranding action under the Federal Food, Drug, and Cosmetic Act. No....
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Fourth Circuit Rejects ‘Advice of Counsel’ Defense
By Michael W. Peregrine and T. Reed Stephens on Jul 20, 2015
Posted In Anti-Kickback Statute / Stark Law, Damages and Penalties, Stark
A major new decision from the U.S. Court of Appeals for the Fourth Circuit has important implications for the availability of the “reliance of counsel” defense, particularly in situations involving the application of complex statutes and regulations. In U.S. ex rel. Drakeford v. Tuomey, the Fourth Circuit affirmed the District Court’s prior judgment of over...
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Tuomey’s Appeal of $237M False Claims Act Judgment Denied by the Fourth Circuit
By Daniel H. Melvin, Eric B. Gordon, MD, Tony Maida and T. Reed Stephens on Jul 10, 2015
Posted In Stark
The US Court of Appeals for the Fourth Circuit affirmed the trial court’s May 2013 decision that Tuomey Healthcare System, Inc., a hospital and health system based in Sumter, South Carolina, submitted 21,730 false claims, claims prohibited by the Stark Law, to the Medicare program. The court rejected Tuomey’s request for a new trial based on...
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Fourth Circuit Upholds Judgment of Over $237 Million against Tuomey Healthcare System
By Laura McLane and T. Reed Stephens on Jul 7, 2015
Posted In Anti-Kickback Statute / Stark Law, Damages and Penalties, Knowledge/Scienter, Medical Necessity, Stark
On July 2, 2015, the U.S. Court of Appeals for the Fourth Circuit affirmed the U.S. District Court for the District of South Carolina’s judgment of $237,454,195 in damages and penalties against Tuomey Healthcare System in United States ex rel. Drakeford v. Tuomey Healthcare System, Inc. (No. 13-2219). The judgment followed a rare False Claims...
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