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The False Claims Act is a United States federal law originally enacted in 1863 to recover fraudulently acquired funds from government contractors.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The False Claims Act is a United States federal law originally enacted in 1863 to recover fraudulently acquired funds from government contractors.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

District Court Holds That FDCA Does Not Prohibit and Criminalize Truthful Off-Label Promotion of FDA-Approved Prescription Drugs

On August 7, 2015, the U.S. District Court for the Southern District of New York released its Amarin opinion addressing whether truthful, non-misleading off-label promotion of U.S. Food and Drug Administration (FDA)-approved...more

Whistleblower Lawsuit Rests on Allegedly Withheld Documents

On June 19, the whistleblower in a False Claims Act suit argued that the court should take action to secure documents that demonstrate Abbott Laboratories encouraged off-label marketing and doctor kickbacks. The whistleblower...more

Notes From The Off-Label Underground

Keeping track of litigation over off-label use/promotion frequently sends us off on tangents. We’ve wandered into abortion cases, securities law cases, criminal cases – even cases brought by criminals....more

FinCrimes Update - February 2015 Summary, Volume 2, Issue 2

NEW YORK BANK REGULATORY CONSIDERING CYBERSECURITY REGULATIONS, RANDOM AUDITS OF BANKS - On February 25, New York DFS Superintendent Benjamin Lawsky delivered remarks at Columbia Law School focusing on how state bank...more

DOJ Settles False Claims Act Allegations Against Pharmaceutical Manufacturer

On February 11, the DOJ announced a $7.9 million settlement with a Delaware-based pharmaceutical manufacturer for allegedly violating the False Claims Act by engaging in a kickback scheme with a pharmacy benefits manager...more

Ethics in Pharmaceutical Sales: Strengthening Corporate Culture and Preventing False Claims Act Violations

“I didn’t set out to commit a crime. I certainly didn’t set out to hurt anyone… I was kind of a hero, because I helped the company make its numbers every quarter. And I thought I was doing a good thing. I thought I was...more

White Collar Watch - October 2014

In This Issue: - Government demonstrates willingness to enforce Affordable Care Act provision that could cost providers millions of dollars - Words can come back to haunt you: Boilerplate pleading could lead...more

Pharmaceutical manufacturers beware: HHS OIG issues warning about copay coupon programs

The Office of Inspector General of the Department of Health and Human Services recently issued a warning to pharmaceutical manufacturers, reminding them that copay coupons used for drugs purchased through federal healthcare...more

Blog: Litigation Round-Up: Some Recent Drug & Device Settlements, Investigations, Inquiries

Settlements - Pharmaceutical company Organon Inc. agreed to pay $31 million to settle federal and state allegations that it underpaid Medicaid drug rebates, provided kickbacks to nursing home pharmacy companies,...more

Mintz Levin Health Care Qui Tam Update - Recent Developments & Unsealed False Claims Act Cases: October 2014

Trends & Analysis - Between our last Qui Tam Update and the end of June, 65 health care–related qui tam cases were unsealed (28 in April, 18 in May, and 19 in June). Within those 65 cases...more

Recent False Claims Act Decision Provides Important Guidance To Manufacturers And Resellers About Trade Agreements Act Compliance

The United States Court of Appeals for the District of Columbia Circuit recently upheld a District Court's dismissal of a False Claims Act (FCA) complaint against a federal government contractor in a case that will be of...more

Trade & Manufacturing - October 2014

In This Issue: - Export-Import Bank Is Reauthorized Through June 2015 - Roadblocks to Bali Package Implementation Remain As Summer Deadline Passes Without A Clear Path Forward - Customs Litigation: Federal...more

OIG Issues Special Advisory Bulletin on Pharmaceutical Manufacturer Copayment Coupons

On September 19, 2014, the Department of Health and Human Services Office of Inspector General (“OIG”) issued a Special Advisory Bulletin on Pharmaceutical Manufacturer Coupons (the “Advisory Bulletin”) warning pharmaceutical...more

OIG Warns Pharma Its Copayment Coupons May Aid Crime

Brand name drugs cost a lot. So to make them more attractive, drug manufacturers issue coupons for discounts on the copayment portion of the price. They work the same as the dollar-off coupons offered by cereal manufacturers....more

OIG Issues Special Advisory Bulletin Covering Manufacturer Copay Coupons and Medicare Part D

For years, many drug manufacturers have issued coupons to help cover some or all of the cost of copayments (commonly referred to as a “copay”) for prescription medications. While the Department of Health and Human Services...more

AHA Files Joint Amicus Brief in Supreme Court FCA Case

The American Hospital Association (AHA) recently filed a joint amicus curiae brief with several other associations, including the American Medical Association and the Pharmaceutical Research and Manufacturers of America,...more

False Claims Act Update: GSA Contractor Reasonably Relied Upon Distributor Certifications Of Product Origin And Trade Agreements...

The United States Court of Appeals for the District of Columbia Circuit recently upheld a District Court’s dismissal of a False Claims Act (FCA) complaint against a federal government contractor in a case that will be of...more

Prescription Drugs: Refocusing the False Claims Act Microscope on the Rest of the Transaction

Over the last decade, it has often felt as though the pharmaceutical industry has been the government’s and whistleblowers’ main, and at times only, target for False Claims Act (“FCA”) investigations. While manufacturers are...more

White Collar Watch - July 2014

In This Issue: - Move over Big Pharma: Health care is not the only industry susceptible to False Claims Act scrutiny - Third Circuit affirms dismissal of False Claims Act suit, citing contract...more

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

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