Litigation

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Novartis To Pay $422.5M In Marketing, Kickbacks Case
Posted on 1 Oct 2010 by LexisNexis Litigation Resource Community Staff

PHILADELPHIA - (AP) Novartis Pharmaceuticals Corp. will pay $422.5 million in penalties for marketing an epilepsy medicine for unapproved uses and for paying kickbacks to doctors to prescribe it and five other drugs, federal officials announced Thursday... Read More

Tags: off-label marketing , Food and Drug Administration , bi-polar disorder , Novartis , misbranded drug , epilepsy medicine , Tekturna , U.S. Attorney Zane Memeger , Diovan , FDA , Marketing , whistleblower lawsuits , Litigation , lawsuit , Sandostatin , Trileptal , Zelnorm , kickbacks , Exforge

2 Drug Makers To Pay $214.5 Million For Off-Label Marketing Of Zonegran
Posted on 16 Dec 2010 by Tom Moylan

BOSTON - (Mealey's) Drug maker Elan Corp. PLC on Dec. 15 pleaded guilty to misdemeanor branding for the off-label marketing of the epilepsy drug Zonegran and will pay more than $203.5 million in criminal and civil penalties ( United States of America... Read More

Tags: False Claims Act , Medicare , off-label marketing , Elan Corp. , Zonegran , United States of America v. Elan Pharmaceuticals , Whistleblowers , Medicaid , epilepsy drug , Litigation , lawsuit , United States of America v. Elan Corporation

Abbott To Pay $1.5 Billion In Civil, Criminal Penalties For Depakote Off-Label Promotion
Posted on 8 May 2012 by Tom Moylan

ABINGDON, Va. - Abbott Laboratories Inc. on May 7 pleaded guilty to one misdemeanor criminal charge and agreed to pay $1.5 billion in criminal fines, civil penalties and forfeiture for off-label marketing its anti-epilepsy drug Depakote despite knowing... Read More

Tags: drugs , Depakote , off-label marketing , Abbott Laboratories , epilepsy , Virginia Medicaid Fraud Control Unit , Food Drug and Cosmetic Act , FDCA , Litigation

Neurontin MDL Judge Grants Summary Judgment Against All But 2 Class Plaintiffs
Posted on 10 Dec 2010 by Tom Moylan

BOSTON - (Mealey's) The Massachusetts federal judge overseeing the Neurontin multidistrict litigation on Dec. 10 granted summary judgment against all but two class action plaintiffs after finding no direct evidence that Pfizer Inc.'s off-label... Read More

Tags: In Re: Neurontin Marketing Sales Practices and Products Liability Litigation , off-label marketing , RICO , Pfizer , personal injury , Warner-Lambert Co. , Racketeer Influenced and Corrupt Organizations Act , product liability , Neurontin , Litigation , multidistrict litigation , lawsuit , bipolar disorder , New Jersey Consumer Fraud Act , torts

Go-It-Alone Whistle-Blowers Force $14.5M Pfizer Settlement For Off-Label Promotion
Posted on 21 Oct 2011 by Tom Moylan

BOSTON - (Mealey's) Two whistle-blowers who went it alone in prosecuting a False Claims Act lawsuit against Pfizer Inc. in a Massachusetts federal court have forced a $14.5 million settlement for the off-label marketing of Detrol, according to announcements... Read More

Tags: False Claims Act , off-label marketing , David Wetherhold , Pfizer , benign prostatic hyperplasia , United States of America v. Pfizer , Marci Drimer , Litigation , Settlement , enlarged prostate gland , BPH , whistle-blowers , Detrol

Pa. High Court: Drug Company Lacks Standing To Challenge State’s Outside Counsel
Posted on 18 Aug 2010 by Tom Moylan

PHILADELPHIA - (Mealey's) Janssen Pharmaceutica Inc. lacks standing under Pennsylvania law to challenge the hiring of outside counsel to represent the state in a Risperdal off-label marketing lawsuit, the Pennsylvania Supreme Court ruled Aug. 17 ... Read More

Tags: drugs , Pennsylvania Office of General Counsel , Pharmaceutical Assistance Contract for the Elderly , off-label marketing , Risperdal , personal injury , Pennsylvania Supreme Court , Bailey Perrin Bailey , Pennsylvania , antipsychotic , Medicaid , Litigation , Janssen Pharmaceutica , PACE , torts , Johnson & Johnson

Cadwalader: Pharmaceutical Manufacturer's Preemptive Suit Secures Preliminary 1st Amendment Protection for Script to Promote Off-Label Use
Posted on 18 Aug 2015 by Cadwalader, Wickersham & Taft LLP

On August 7, 2015, the U.S. District Court for the Southern District of New York invoked the First Amendment, granting Amarin Pharma, Inc. ( Amarin ) preliminary protection against federal criminal prosecution for misbranding and allowing Amarin to promote... Read More

Tags: New York , drugs , off-label marketing , pharmaceutical companies , Food and Drug Administration , United States v. Caronia , Amarin Pharma Inc. et al v United States Food & Drug Administration et al , product liability , FDA , medical devices , Cadwalader OneWorld International Practice , for off-label use , Litigation , torts

Allergan To Pay $600M For Off-Label Marketing Of Botox
Posted on 1 Sep 2010 by Tom Moylan

IRVINE, Calif. (Mealey's) - Allergan Inc. said Sept. 1 that it will plead guilty to a federal misdemeanor charge related to off-label marketing of Botox and will pay a total of $600 million to the federal government in criminal and civil penalties... Read More

Tags: Botox , False Claims Act , U.S. Department of Health and Human Services , off-label marketing , botulinum toxin A , U.S. Department of Justice , Litigation , lawsuit , Allergan

Scios To Plead Guilty, Pay $85 Million For Off-Label Marketing Of Natrecor
Posted on 15 Sep 2011 by Tom Moylan

SAN FRANCISCO -- The Scios Inc. subsidiary of Johnson & Johnson has agreed to plead guilty to a misdemeanor charge related to the off-label marketing of its Natrecor heart drug, to pay an $85 million fine and to serve three years' organizational... Read More

Tags: False Claims Act , heart drug , off-label marketing , United States of America v. Scios , Johnson , Natrecor , Food Drug and Cosmetic Act , Scios , Litigation , Johnson &amp

Ballard Spahr LLP: Pharmaceutical Companies Get Off-Label Marketing Victory
Posted on 18 Aug 2015 by Ballard Spahr LLP

. . . A federal judge ruled that the Food and Drug Administration (FDA) cannot prohibit a pharmaceutical company from marketing its drugs for off-label uses if its claims are truthful and not misleading. This ruling, while not precedential, alters the... Read More

Tags: New York , drugs , off-label marketing , pharmaceutical companies , Food and Drug Administration , United States v. Caronia , Amarin Pharma Inc. et al v United States Food & Drug Administration et al , product liability , FDA , medical devices , for off-label use , Litigation , Ballard Spahr , torts

Johnson & Johnson, 2 Units Plead Guilty, Pay $2.2 Billion In Criminal, Civil Penalties
Posted on 4 Nov 2013 by Tom Moylan

WASHINGTON, D.C. — (Mealey’s) Two Johnson & Johnson subsidiaries have pleaded guilty, and the parent company and two subsidiaries will pay $2.2 billion in criminal fines, civil penalties and forfeitures in one criminal and several civil... Read More

Tags: drugs , Medicare , off-label marketing , Risperdal , Natrecor , Medicaid , Litigation , Invega , United States of America v. Janssen Pharmaceuticals , Janssen Pharmaceuticals Inc. , Scios Inc. , diabetes , Johnson & Johnson , antipsychotic drug , U.S. Justice Department