False Claims Act (FCA) practitioners have been closely watching cases in which courts address the causation requirement in FCA actions based on Anti-Kickback Statute (AKS) violations....more
In 2020, over 142 million prescriptions for opioid medications were filled in the U.S. That same year, 16,416 people died from overdoses on prescription opioids—a 376% increase from 1999....more
The District of Massachusetts has joined the growing chorus of courts that have applied a heightened causation standard in False Claims Act (FCA) cases predicated on the Anti-Kickback Statute (AKS). U.S. District Judge F....more
Two Massachusetts federal district courts recently addressed—and disagreed about—an important False Claims Act (FCA) issue that has also divided the federal circuit courts: when an alleged FCA violation is based on an...more
The U.S. Department of Justice Antitrust Division ("DOJ") recently resolved a criminal case with Teva Pharmaceuticals and Glenmark Pharmaceuticals via deferred prosecution agreements ("DPAs"), which include a novel remedy for...more
The Antitrust Division has been active – like any aggressive prosecution strategy, however, its results have been mixed. Its record in criminal cases has taken serious hits – a stunning set of losses in the chicken...more
Over the last twenty year (yes, 20 years), the Justice Department’s civil and criminal enforcement record has come under greater scrutiny. Whether you call it “Too Big To Jail” or “Too Big to Fail,” questions continue to...more
Teva, the global pharmaceutical giant, was indicted last week as part of DOJ’s expanding criminal conspiracy investigation focused on illegal price-fixing and customer allocations....more
A last-minute deal between defendants McKesson, Cardinal Health, AmerisourceBergen, and Teva and plaintiffs’ attorneys means that multidistrict opioid epidemic litigation set to kick off in Ohio federal court today will not...more
In a petition for a writ of mandamus filed on April 29, 2019 with the U.S. Court of Appeals for the D.C. Circuit, an unidentified whistleblower who claims to have tipped the SEC to alleged violations of the Foreign Corrupt...more
Over the past year, State Attorneys General have stepped into what they describe as a void of antitrust enforcement at the federal level. AGs have commenced investigations and brought antitrust actions across industry...more
Anti-Corruption enforcement remained a top priority in France, the UK, and the US in 2018. Join our firm's Global Anti-Corruption Team as they explain and analyze these three countries' anti-corruption enforcement efforts and...more
For years, the Justice Department and the Securities and Exchange Commission touted the FCPA “sweep” of the pharmaceutical and medical device industries. With good reason, DOJ and the SEC turned the drug and medical device...more
A comprehensive understanding of the constantly evolving layers that make up federal anti-corruption statutes, sanctions regulations and export control restrictions is imperative for both the pharmaceutical and health care...more
Enforcement of the Foreign Corrupt Practices Act was a high priority for the Department of Justice and the Securities and Exchange Commission in 2016. There's interest in how the new administration could impact enforcement as...more
We begin the New Year with a three-part series on the FCPA: (1) A review of FCPA enforcement in 2016; (2) Trends from 2016 FCPA enforcement; and (3) Predictions for FCPA enforcement in 2017....more
Shearman & Sterling’s bi-annual Trends & Patterns in FCPA Enforcement report provides insightful analysis of recent enforcement trends and patterns in the US, the UK and elsewhere, as well as helpful guidance on emerging best...more
Anticorruption Developments - The U.S. Court of Appeals for the 10th Circuit Rules That the SEC's Use of ALJs is Unconstitutional - On December 27, 2016, the U.S. Court of Appeals for the 10th Circuit ruled 2-1...more
Just when you were thinking things could not get any bigger after the Odebrecht/Braskem Foreign Corrupt Practices Act (FCPA) enforcement action, the Department of Justice (DOJ) and Securities and Exchange Commission (SEC)...more
We are thrilled to bring you the third installment of Stinson Leonard Street's Emerging Trends newsletter. We are proud of the depth and breadth of experience and knowledge across our firm's 13 offices nationwide and are...more
The U.S. Federal Trade Commission (FTC) recently announced a settlement resolving its competitive concerns over the merger of two leading generic drug manufacturers – Teva and Allergan. In July 2015, Teva agreed to acquire...more