Litigation

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Former Acting Chief Counsel Of FDA, Jeffrey M. Senger, Joins Sidley Austin LLP
Posted on 10 Aug 2010 by LexisNexis Litigation Resource Community Staff

WASHINGTON, D.C. - Sidley Austin LLP has announced that Jeffrey M. Senger, former acting chief counsel and Deputy Chief Counsel of the Food and Drug Administration, has joined Sidley as a partner in the global food, drug and medical device regulatory... 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

Split 6th Circuit: Michigan Drug Shield Law Does Not Apply To Fentanyl Patch
Posted on 21 Jan 2014 by Tom Moylan

CINCINNATI — (Mealey’s) A split Sixth Circuit U.S. Court of Appeals on Jan. 21 reversed dismissal of a fentanyl patch overdose lawsuit, saying the trial court needs to determine whether the patch is a combination product that is not preempted... Read More

FDA Removes More Than 500 Unapproved Cough, Cold And Allergy Drugs
Posted on 2 Mar 2011 by Tom Moylan

ROCKVILLE, Md. - (Mealey's) The Food and Drug Administration on March 2 announced that it is requiring drug manufacturers to take more than 500 prescription cough, cold and allergy drugs off the market because they are unapproved. The drugs... Read More

Norton Rose Fulbright: FDA’s Expanded Oversight Of ‘High-risk’ Diagnostic Devices
Posted on 7 Aug 2014 by Norton Rose Fulbright

By Cori Annapolen Goldberg and Lidia Niecko-Najjum In efforts to ensure that in vitro diagnostic devices 1 provide accurate, consistent and reliable results, the US Food and Drug Administration ("FDA" or "the Agency") 1) issued... Read More

D.C. Circuit Says FDA Can Regulate Stem Cell Drugs; Company Properly Enjoined
Posted on 4 Feb 2014 by Tom Moylan

WASHINGTON, D.C. — The District of Columbia Circuit U.S. Court of Appeals on Feb. 4 said the federal government can regulate a company that cultures stem cells for injection in the donor patient and said a lower court did not err in permanently... Read More

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

La. Supreme Court Reverses $330M Verdict For Risperdal Medicaid Law Violations
Posted on 29 Jan 2014 by Tom Moylan

NEW ORLEANS — (Mealey’s) In a 4-3 vote, the Louisiana Supreme Court on Jan. 28 reversed a verdict of more than $330.6 million against Janssen Pharmaceutical Inc. and parent company Johnson & Johnson, finding that the state attorney general... Read More

Pa. Supreme Court Says Drug Companies Can Be Sued For Marketing Dangerous Drugs
Posted on 23 Jan 2014 by Tom Moylan

PHILADELPHIA — (Mealey’s) Pennsylvania law allows drug companies to be sued if they fail to stop marketing drugs known to be unreasonably harmful, and the manufacturers are not immune from being sued for damages for lack of due care, the Pennsylvania... Read More

2nd Circuit Lifts Stay On 2-Pill Plan B Contraceptive, Expedites FDA's Appeal
Posted on 8 Jun 2013 by Tom Moylan

NEW YORK - (Mealey's) The Second Circuit U.S. Court of Appeals on June 5 said the federal government failed to meet the standard to obtain a stay of a lower court order that the Food and Drug Administration immediately make the older, two-pill Plan... Read More