Off-Label Promotion

News & Analysis as of

Federal and New York State False Claims Act Case Against Novartis Survives Motion to Dismiss

Last week, a New York district court found that the government alleged with sufficient detail that Novartis violated federal and state false claims acts by paying doctors kickbacks to prescribe drugs. See U.S. ex rel. Bilotta...more

Court Rejects Workers Comp Insurer’s Challenge to Big Pharma

Pharmaceutical manufacturers that promote off-label uses for prescription drugs have become litigation targets for third-party payors—especially after Kaiser received a nine-figure RICO award last year against the...more

Eighth Circuit Dismisses Whistleblower's Suit Finding Facts Were Already Publicly Disclosed

In an August 7, 2014 opinion, the Eighth Circuit upheld the dismissal of a whistleblower’s suit alleging that a number of pain pump device makers had violated the False Claims Act (FCA) by marketing their pain pumps for...more

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

FDA Promises Guidance on Lawful Off-Label Promotion

In June, the U.S. Food and Drug Administration (the "FDA") announced that by the end of the year, the agency would issue a draft guidance document addressing the contours of lawful and unlawful off-label promotion. The...more

Lawsuit Against Medtronic Alleges Racketeering Over Infuse Bone Graft

When one big industry sues another we learn a lot about how business as usual is conducted. In this case Humana, a giant health insurer, has sued the medical device company Medtronic, maker of the Infuse bone graft. ...more

GlaxoSmithKline Fined Again – The Cost of Doing Business?

It is seen as the cost of doing business. It may be illegal, but is also highly profitable, so why stop? That seems to be the attitude of many pharmaceutical companies – and the latest proof of that comes in the form...more

Court enforces False Claims Act’s first-to-file rule to bar complaint alleging details of off-label promotion scheme about which...

In Brief - When an alleged scheme to market drugs for unapproved “off-label” uses had already been identified by an earlier complaint, a later complaint providing additional details, but alleging the same “essential...more

Federal Court Invalidates 340b Orphan Drug Regulation

Last Friday a federal district court invalidated a regulation that had authorized the 340B discount for critical access hospitals, sole community hospitals, rural referral centers and free-standing cancer hospitals when they...more

False Claims Act Litigation Update: Bayer Decision Sheds Light on Pleading in False Claims Act Cases

A recent win for a large company in a False Claims Act suit (a seeming rarity as of late) alleging illegal off-label promotion could provide some helpful insight to similarly situated manufacturers and support dismissals of...more

First Amendment And Off-Label Promotion – Prosecute What I Do, Not What I Say

On December 3, 2012, the United States Court of Appeals for the Second Circuit vacated the conviction of Alfred Caronia (“Caronia”), who had been tried and convicted of participating in an unlawful conspiracy to introduce a...more

Stay Off My Turf! How to Protect Field of Use in a Biotechnology License Agreement

To protect a licensor’s rights, a key element of a biotech license is the licensor’s right to restrict the scope of the license by limiting the field of use, often to a particular disease area. But the license agreement only...more

After Arkansas Supreme Court Reverses $1.2 Billion Medicaid False Claims Verdict, Will State Attorneys General Rethink the Use of...

On March 20, 2014, the Arkansas Supreme Court reversed a $1.2 billion judgment against Johnson & Johnson and its related companies over alleged Medicaid fraud stemming from the off-label marketing of the drug Risperdal. This...more

FDA Updates Reprint Guidance, Reiterates Narrowness of Off-Label Safe-Harbor

FDA updates its recommendations for distribution of reprints, making requirements more specific and addressing additional types of materials typically distributed....more

Biotech Company to Pay over $22 Million for Marketing Off-Label Use of Products

Two whistleblowers used the qui tam provisions of the False Claims Act (FCA) to file lawsuits against biotechnology company Genzyme Corp. for teaching doctors and other medical staff how to create a "slurry" version of its...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

Hodgson Russ Helps Clients in Largest-Ever False Claims Act Settlement In Risperdal Lawsuits Against Johnson & Johnson

The Justice Department announced that Johnson & Johnson will pay $1.273 billion to the federal government and most states to settle a civil False Claims Act investigation into its off-label marketing of its antipsychotic drug...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

D.A.R.E. to Market Off-Label Uses of Prescription Drugs? Make Sure You are in the Second Circuit: United States v. Caronia and the...

Truthful, non-misleading off-label promotion of prescription drugs is not illegal. At least, not in the Second Circuit. This, despite the billions of dollars in civil and criminal penalties assessed against pharmaceutical...more

’Orphan drug’ rule raises off-label worries for drugmakers

The U.S. Department of Health and Human Services last week clarified when hospitals are allowed to buy socalled orphan drugs at sharply discounted prices, but it left open questions for drug manufacturers about the risk of...more

Is Filling an Off-Label Prescription an Invitation to False Claims Act Liability?

On May 17, 2013, the U.S. District Court for the Northern District of Georgia issued an order that joins an unsettling line of decisions suggesting that before filling prescriptions, pharmacies must serve as the arbiters of...more

First Circuit Vacates Denial Of Class Certification In Opinion Concerning Pfizer’s Off-Label Marketing Of Neurontin

In Harden Manufacturing Co. v. Pfizer, Inc., 712 F.3d 60 (1st Cir. 2013), one of three cases addressing Pfizer’s off-label marketing of the anticonvulsant drug, Neurontin, the First Circuit vacated the district court’s denial...more

Business Litigation Report -- April 2013

In This Issue: - Firm News: DoJ Star Healthcare Fraud Prosecutor Joins Washington, D.C. Office; and Quinn Emanuel Wins Top Honors at the Inaugural U.S. Benchmark Annual Awards - Main...more

False Claims Act Focus - April 2013

EDITOR’S NOTE - The last few months have not failed to provide interesting False Claims Act (FCA) activity in the courts. We begin our newsletter by examining a case brought in the energy sector, alleging that a...more

The First Amendment and Off-Label Promotion: United States v. Caronia

For years, the U.S. Department of Justice has aggressively pursued and brought charges over “off-label promotions”—the promotion of drugs for uses that have not received FDA approval—by pharmaceutical manufacturers and their...more

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