False Claims Act Pharmaceutical Industry

The False Claims Act is a United States federal law originally enacted in 1863 to recover fraudulently acquired funds from government contractors.  In 1986, The False Claims Act was amended to increase... more +
The False Claims Act is a United States federal law originally enacted in 1863 to recover fraudulently acquired funds from government contractors.  In 1986, The False Claims Act was amended to increase whistleblower incentives and to permit the government to seek treble damages for allegations of fraud against the government less -
News & Analysis as of

Drug Distributor and Pharmacies Obtain Partial Dismissal of State and Federal FCA Claims

On June 10, 2014, a New York federal court dismissed, in part, state and federal False Claims Act (FCA) claims brought against Novartis Pharmaceuticals Corporation and pharmacies to which it distributed (CVS Caremark Corp.,...more

Commission-Based Sales Agreements for Medical Supplies and Equipment: More Whistleblower Activity on the Horizon? - A Wide Range...

The common industry practice of compensating independent contractor sales representatives on a "percentage of sales" commission basis may be creating an enhanced risk of False Claims Act liability for illegal kickbacks in...more

Supreme Court Declines to Opine on Circuit Split Over Rule 9(b) Pleading Requirements for FCA Claims

On March 31, 2014, in U.S. ex rel. Nathan v. Takeda Pharmaceuticals North America, the Supreme Court of the United States declined to review a decision by the U.S. Court of Appeals for the Fourth Circuit upholding a district...more

First Circuit Rules on Scope of FCA First-to-File Rule in U.S. v. Bristol Myers Squibb, Inc.

The First Circuit ruled last week that an earlier-filed False Claims Act complaint will preclude a later-filed complaint if it arises out of the same underlying facts, even if the allegations are not identical. The...more

Fourth Circuit Clarifies When a Regulatory Violation May Lead to a False Claims Act Violation

The U.S. Fourth Circuit Court of Appeals’ recent decision in United States ex rel. Rostholder v. Omnicare, Inc., reconfirms the well-founded principle that a civil False Claims Act (FCA) claim that is based on the defendant’s...more

Never Fear Regulatory Violations – Focus on Conditions to Payment

The U.S. Court of Appeals for the Fourth Circuit recently upheld the dismissal of a False Claims Act (FCA) suit against Omnicare, Inc., in which the relator alleged that certain drugs repackaged by Omnicare’s subsidiary were...more

Fourth Circuit Affirms Dismissal of False Claims Act Suit Against Pharmaceutical Company, Rejects Theory of Liability Premised...

Last week, the United States Court of Appeals for the Fourth Circuit issued its opinion in United States ex rel. Rostholder, et al. v. Omnicare, Inc., et al. (No. 12-2431), affirming the district court’s dismissal of the...more

The $330-Million Dollar Question

The question every false claims defendant must face is whether to pursue litigation or simply concede and settle. While many shy away from litigation, opting for an expensive but certain resolution, for Johnson & Johnson and...more

Health Services Provider’s Settlement with DOJ Includes Detailed Factual Admissions and Agreement to Cooperate Against...

On January 8, 2014, pharmaceutical provider BioScrip, Inc. (BioScrip) reached a settlement with the Department of Justice (DOJ) to resolve claims under the False Claims Act (FCA) and the Anti-Kickback Statute (AKS), stemming...more

False Claim Act: 2013 Year in Review

Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more

Justice Department Announces $3.8 Billion In False Claims Act Recoveries In FY 2013

On December 20, 2013, the Justice Department announced a total of $3.8 billion dollars in settlements and judgments from civil cases involving the False Claims Act for Fiscal Year (FY) 2013. Total recoveries under the False...more

Unsealed Qui Tams Show That Government Declination is Not Always the End

Mintz Levin’s most recent Qui Tam Update authored by our Health Care Enforcement Defense Practice provides focused analysis of four health care-related qui tam cases in which the government declined to intervene, including...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed Cases

Trends and Analysis: ..We have identified 21 health care–related qui tam cases unsealed since last month’s Qui Tam Update. Of those, two were filed in 2013, 15 were filed in 2011 or 2012, and four were filed in 2010 or...more

Supreme Court May Decide Issue of the Level of Specificity Required Under Rule 9(b) in FCA Whistleblower Suits

The United States Supreme Court recently indicated its potential interest in hearing arguments in a key False Claims Act (FCA) case that would address a circuit split over the important issue of the level of specificity of...more

Mintz Levin Health Care Qui Tam Update -- Recent Developments and Unsealed Cases: September 2013

Trends and Analysis - ..We have identified 24 health care-related qui tam cases unsealed since last month’s Qui Tam Update. Of those, only 2 were filed in 2013. Nearly half were filed before 2011. ..Among the 24...more

Whistleblowing in China and the United States

The Chinese Government’s wide-ranging bribery and corruption investigation into the pharmaceutical industry takes a new turn every week. Media reports contain numerous incidents of purported whistleblowers making allegations...more

Healthcare Law -- Aug 19, 2013

As the Healthcare Landscape Shifts, Four Issues Are Critical to Build Effective Market Access Strategies - In this time of high growth and fast change for the healthcare industry, pharmaceutical, biotechnology and...more

Mintz Levin Health Care Qui Tam Update - Recent Developments and Unsealed Cases

Trends and Analysis: ..We have identified 20 health care-related qui tam cases unsealed in July 2013. About a quarter of those were filed in 2013. ..Among the cases unsealed in July, the government has declined to...more

Doctors, Enforcement Risks And Compliance Programs

Doctors better get used to government regulation. The Affordable Healthcare Act contains a lengthy complement of new laws and regulations. ...more

"Health Care Enforcement Update: What Is in Store for the Next Five Years"

While predicting enforcement trends over the next five years is not without uncertainty, the best marker for future activity may be to look to the past. We believe that industry members and counsel can expect the Department...more

Law Enforcement In The Health Care Industry: What Do New Cases Against Novartis Tell Us?

In recent years, pharmaceutical companies have faced criminal investigations and charges in regard to alleged off-label marketing of prescription drugs and kickbacks to doctors. For this reason, the filing last month of two...more

Health Care Enforcement in 2012: A Year in Review

Last year was another busy year in health care fraud enforcement. In 2012, the Office of Inspector General for the Department of Health and Human Services (HHS-OIG) reported total expected recoveries of $6.9 billion from all...more

DOJ Recovers Up To $48 Million in False Claim Act Case Resulting From Whistleblower Report

In yet another large recovery for the DOJ, on December 6, 2012, DFB Pharmaceuticals, and its subsidiary, Healthpoint Ltd., agreed as part of a settlement to pay up to $48 million to resolve allegations that Healthpoint caused...more

Fourth Circuit Holds False Claims Act Relators to Strict Pleading Standard: Ruling Will Be Particularly Useful in Defending...

On January 11, 2013, the United States Court of Appeals for the Fourth Circuit issued an opinion reaffirming the requirement that False Claims Act relators plead presentment of a false claim with particularity. United States...more

Second Circuit Declares Off-Label Promotion Ban Unconstitutional: Implications for False Claims Act Defendants

On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from...more

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