Perspectives on False Claims Act & Civil Investigations

ArentFox Schiff secured an important victory for Azurity Pharmaceuticals, Inc. when the US Court of Appeals for the First Circuit found that the Food, Drug, and Cosmetic Act permits a pharmaceutical company to pursue false advertising claims against a compounding pharmacy, Edge Pharma, LLC.

Arent Fox attorneys D. Jacques Smith, Randall Brater, and Michael Dearington spoke with Bloomberg Law about an upcoming US Supreme Court case and its potential ramifications for False Claims Act cases.

Headlines that Matter for Companies and Executives in Regulated Industries

In a recent decision, the Sixth Circuit adopted an objective intent standard: an employee alleging constructive discharge in violation of the False Claims Act need not prove that the employer took actions designed to force the employee to quit.

Arent Fox Partners D. Jacques Smith and Randall A. Brater and Associate Michael F. Dearington penned an article in the May issue of Pratt’s Government Contracting Law Report on three recent changes to the Department of Justice’s enforcement policies.

A development out of the Ninth Circuit makes relators more likely to qualify as an original source under the False Claims Act and thus survive the public disclosure bar.

The latest False Claims Act settlements indicate that the Anti-Kickback Statute continues to be an enforcement priority and a key tool for identifying and prosecuting healthcare fraud.

Arent Fox partners D. Jacques Smith and Randall Brater and associate Michael Dearington penned an article published in the April issue of Pratt’s Government Contracting Law Report on the recent reversal of a substantial False Claims Act verdict.

Earlier this week, the United States Securities and Exchange Commission sent shockwaves through the financial-industry legal-and-compliance communities, announcing its largest-ever Dodd-Frank whistleblower awards, totaling $83 million.

Attorney General Jeff Sessions announced the launch of the Prescription Interdiction & Litigation Task Force, which will use criminal and civil law enforcement tools to combat the nation’s opioid epidemic, specifically targeting drug manufacturers and distributors.

On February 8, 2018, Complex Litigation Practice Group Leader Jacques Smith was quoted in an article by Compliance Week titled, “New DOJ Policies Favor Corporate Defendants.”

A federal district court in Florida earlier this month reversed a jury verdict and vacated a $350 million False Claims Act award, joining the growing number of courts to strictly apply the materiality standard set by the US Supreme Court.

The Department of Justice recently published its annual False Claims Act (FCA) recoveries statistics for Fiscal Year 2017, reporting $3.7 billion in FCA settlements and judgments in FY 2017.

The US Attorney’s Office for the District of New Jersey recently announced an agreement with BioTelemetry Inc. to settle allegations that its recently-acquired subsidiary, MedNet, Inc., violated the Anti-Kickback Statue and False Claims Act by improperly inducing health care providers to use the com

On November 1, 2016, the Supreme Court heard argument in a False Claims Act case in which the defendant sought dismissal of a qui tam action after the whistleblower violated the FCA’s seal requirement and publicly disclosed the complaint.

Kindred Healthcare, Inc., the country’s largest provider of post-acute care, recently paid over $3 million for violating its Corporate Integrity Agreement, the largest issued for a violation of a CIA to date.

In a ruling that could, if adopted by other courts, expose all pharmaceutical discount and rebate arrangements to anti-kickback liability, on August 23, 2016, Judge Rya Zobel in the United States District Court for the District of Massachusetts denied Omnicare, Inc.’s motion for summary judgment.

Life science companies, health care providers, and government contractors will be at risk for significantly larger penalties due to substantial increases to False Claims Act (FCA) penalties and civil monetary penalties (CMPs).

In a surprising and promising development, the Senate Finance Committee released a Majority Staff Report on June 30, 2016 that gives the health care industry some hope that Congress may finally address some of the serious concerns with the implementation and enforcement of the Stark law.

In a highly anticipated decision, the United States Supreme Court issued a unanimous opinion in Universal Services, Inc. v. United States ex rel. Escobar that threw out existing law related to the implied certification theory of liability under the False Claims Act.

In a surprising move that could dramatically impact government enforcement actions against life science companies, the health care industry, and government contractors, a federal board has increased federal False Claims Act penalties by more than 100 percent. 

The Department of Justice recently announced it has reached a more than $780 million settlement with Pfizer Inc. and its subsidiary Wyeth to resolve reported false pricing allegations.

The US Supreme Court is set to hear oral arguments on April 19 in Universal Health Services, Inc. v. United States ex rel. Escobar, a key case addressing the implied certification theory of liability under the False Claims Act. 

Federal prosecutors appearing at the American Conference Institute’s 16th Annual Forum on Fraud and Abuse in the Sales and Marketing of Medical Devices earlier this month outlined recent enforcement trends that should catch the attention of the health care industry.

In an important development, the Centers for Medicare and Medicaid Services (CMS) has issued additional final regulations implementing the Stark Law as part of the Physician Fee Schedule for calendar year 2016 (see 80 Fed. Reg. 70,886 (Nov. 16, 2015)).