Litigation

Recent Posts

Study: Harmful Medical Devices Get Approval Too Easily
Posted on 17 Feb 2011 by LexisNexis Litigation Resource Community Staff

CHICAGO - (AP) Most medical devices recalled in recent years because of deaths or life-threatening problems were cleared for approval under less stringent regulations that don't require human testing, an analysis found. The report comes as the Food... 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 This ruling, while not precedential, alters the...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

3 Years' Probation Added To $296M In Fines, Forfeiture In Guidant Heart Device Plea
Posted on 18 Jan 2011 by Tom Moylan

MINNEAPOLIS - (Mealey's) Guidant LLC was sentenced Jan. 12 by a Minnesota federal judge to three years' probation and ordered to pay $296 million in fines and forfeiture for failing to tell the Food and Drug Administration about defects in three... Read More

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

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

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

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