Litigation

Recent Posts

Drug Pump Claims Preempted Expressly, Implicitly, 9th Circuit Panel Majority Says
Posted on 17 Apr 2012 by Tom Moylan

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... Read More

Federal Food, Drug, And Cosmetic Act Did Not Preclude Lanham Act Challenge That Asserted That Labeling, Marketing, And Advertising Was Misleading
Posted on 1 Jul 2014 by LexisNexis Legal Newsroom Staff

On June 12, 2014, the United States Supreme Court decided the case of POM Wonderful LLC v. Coca-Cola Co., 189 L. Ed. 2d 141 (U.S. 2014) . POM Wonderful, LLC (POM) filed its initial action against Coca-Cola asserting that the labeling, marketing, and advertising... Read More

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

Judge Rejects Plea Agreement In Guidant Heart Device Criminal Case
Posted on 28 Apr 2010 by Tom Moylan

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... Read More

Split Supreme Court Says Generic Drug Warning Claims Are Preempted
Posted on 23 Jun 2011 by Tom Moylan

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... Read More

Free Download: Keller & Heckman Litigation Alert: 8th Circuit Finds Adulterated Drug Claims Not Preempted
Posted on 3 Feb 2011 by Keller and Heckman LLP

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... Read More

William A. Ruskin: New Draft FDA Guidance On Off-label Uses Raises Concerns
Posted on 28 Mar 2014 by William A. Ruskin

By William A. Ruskin | On March 3, 2014, FDA made available for comment a revised draft of its " Guidance for Industry: Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices ". The revised guidance... Read More

William A. Ruskin: First Amendment Bars Pharmaceutical Company Prosecution
Posted on 14 Dec 2012 by William A. Ruskin

By William A. Ruskin The Second Circuit [on Dec. 3] rendered its much-anticipated decision in United States v. Caronia [ enhanced version available to lexis.com subscribers ], the most important Food Drug and Cosmetics Act enforcement case pending... Read More

Failure To Update Generic Metoclopramide Label Not Preempted, 6th Circuit Says
Posted on 14 Mar 2013 by Tom Moylan

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... Read More

McNeil Pleads Guilty, Pays $25M For Making Adulterated Children’s Medicines
Posted on 11 Mar 2015 by Tom Moylan

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... Read More

6th Circuit Reverses Preemption-Based Dismissal Of Diet Drug Negligence Claims
Posted on 18 Aug 2010 by Michael Lefkowitz

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... Read More