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...

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...

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...

William A. Ruskin: First Amendment Bars Pharmaceutical Company Prosecution

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 in the country. Not only did the court's 2-1 holding...

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...

William A. Ruskin: New Draft FDA Guidance On Off-label Uses Raises Concerns

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 seeks to clarify and expand upon FDA's 2009 draft...

Federal Food, Drug, And Cosmetic Act Did Not Preclude Lanham Act Challenge That Asserted That Labeling, Marketing, And Advertising Was Misleading

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 for one of Coca-Cola’s juice blends...