LexisNexis® Legal Newsroom
Judge Rejects Plea Agreement In Guidant Heart Device Criminal Case

MINNEAPOLIS - (Mealey's) Guidant LLC's proposed plea agreement to pay a criminal fine of $254,962 and criminal forfeiture of $42,079,675 for charges that it twice violated the Food, Drug and Cosmetic Act (FDCA) by submitting false or no information about changes made to its Prizm and Renewal...

6th Circuit Reverses Preemption-Based Dismissal Of Diet Drug Negligence Claims

CINCINNATI - (Mealey's) Citing the Supreme Court's rejection of implied preemption of pharmaceutical product liability in Wyeth v. Diana Levine (No. 06-1249, U.S. Sup.; 2009 U.S. LEXIS 1774), the Sixth Circuit U.S. Court of Appeals on Aug. 18 reversed a trial court's dismissal of claims based...

D.C. Circuit: E-Cigarettes Are Tobacco Products, Not Medical Devices

WASHINGTON, D.C. - (Mealey's) Electronic cigarettes, which deliver a dose of nicotine vapor without flame or smoke, are for regulatory purposes tobacco products, not medical devices, the District of Columbia Circuit U.S. Court of Appeals ruled Dec. 7 ( Sottera, Inc., et al. v. U.S. Food and Drug...

Free Download: Keller & Heckman Litigation Alert: 8th Circuit Finds Adulterated Drug Claims Not Preempted

Consumers can sue a drug company for selling a drug that was not manufactured pursuant to good manufacturing practices (GMP) and was, thus, "adulterated" under the Food, Drug and Cosmetic Act (FDCA). Such claims are not preempted by federal law, said the Eighth Circuit Court of Appeals. ( Allen...

McNeil-PPC Enters Consent Decree For Violations At 3 Manufacturing Plants

PHILADELPHIA -- (Mealey's) The McNeil-PPC Inc. division of Johnson & Johnson on March 10 entered into a consent decree of permanent injunction with the federal government for manufacturing violations at three plants that resulted in several over-the-counter products being recalled and one plant...

Split Supreme Court Says Generic Drug Warning Claims Are Preempted

WASHINGTON, D.C. - (Mealey's) State tort law failure-to-warn claims involving the generic drug metoclopramide are preempted by federal law, the U.S. Supreme Court said June 23 in a 5-4 ruling ( Pliva, Inc., et al. v. Gladys Mensing , No. 09-993, Actavis Elizabeth LLC v. Gladys Mensing , No. 09-1039...

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...

Drug Pump Claims Preempted Expressly, Implicitly, 9th Circuit Panel Majority Says

SAN FRANCISCO - (Mealey's) In a 2-1 ruling, a panel of the Ninth Circuit U.S. Court of Appeals said April 16 that claims that a Medtronic drug pump and spine catheter caused a plaintiff to become a paraplegic are preempted explicitly and implicitly by federal medical device law and by U.S. Supreme...

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...

9th Circuit: Federal Law Doesn't Preempt Parallel State Law Device Claim

SAN FRANCISCO- (Mealey's) The Ninth Circuit U.S. Court of Appeals, sitting en banc , ruled Jan. 10 that federal law does not preempt, expressly or by implication, a state law failure-to-warn claim alleging that Medtronic Inc. violated its federal duty to report problems with a drug pump ( Richard...

Failure To Update Generic Metoclopramide Label Not Preempted, 6th Circuit Says

CINCINNATI - (Mealey's) A plaintiff's claim that PLIVA Inc. failed to add a 2004 warning from the Reglan label to its label for generic metoclopramide is not preempted, a panel of the Sixth Circuit U.S. Court of Appeals said March 13 in what it described as question of first impression in the...

McNeil Pleads Guilty, Pays $25M For Making Adulterated Children’s Medicines

PHILADELPHIA — (Mealey’s) The McNeil-PPC Inc. subsidiary of Johnson & Johnson on March 10 pleaded guilty to a federal misdemeanor criminal charge of making adulterated children’s over-the-counter medicines and agreed to pay a criminal fine and forfeiture totaling $25 million ( United...