LexisNexis® Legal Newsroom
Pa. High Court: Drug Company Lacks Standing To Challenge State’s Outside Counsel

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 ( Commonwealth of Pennsylvania, et al. v. Janssen Pharmaceutica...

Allergan To Pay $600M For Off-Label Marketing Of Botox

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. In addition, Allergan said it will dismiss its...

Novartis To Pay $422.5M In Marketing, Kickbacks Case

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. The company agreed to plead guilty to distribution...

Neurontin MDL Judge Grants Summary Judgment Against All But 2 Class Plaintiffs

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 marketing influenced prescribing physicians ( In...

2 Drug Makers To Pay $214.5 Million For Off-Label Marketing Of Zonegran

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 v. Elan Pharmaceuticals, Inc. , No. 10-10431,...

Scios To Plead Guilty, Pay $85 Million For Off-Label Marketing Of Natrecor

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 probation, according to a brief filed Sept. 14...

Go-It-Alone Whistle-Blowers Force $14.5M Pfizer Settlement For Off-Label Promotion

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 by the plaintiffs on Oct. 20 and a federal...

Abbott To Pay $1.5 Billion In Civil, Criminal Penalties For Depakote Off-Label Promotion

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 that it was not effective for those purposes...

Johnson & Johnson, 2 Units Plead Guilty, Pay $2.2 Billion In Criminal, Civil Penalties

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 cases for off-label marketing of three drugs, for...

Ballard Spahr LLP: Pharmaceutical Companies Get Off-Label Marketing Victory

. . . 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 traditional compliance analysis regarding the legality...

Cadwalader: Pharmaceutical Manufacturer's Preemptive Suit Secures Preliminary 1st Amendment Protection for Script to Promote Off-Label Use

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 its drug, Vascepa, for off-label use through...