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

Stryker Subsidiary, Ex-CEO Plead Guilty, Pay $79 Million For Illegal Device Marketing
Posted on 9 Dec 2014 by Tom Moylan

NEWARK, N.J. — (Mealey’s) Stryker Corp. subsidiary OtisMed Corp. and the former OtisMed chief executive officer on Dec. 8 pleaded guilty to marketing the unapproved OtisKnee Orthopedic Cutting Guide medical device after the Food and Drug Administration... 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 This ruling, while not precedential, alters the...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

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

Stryker Biotech Pleads Guilty, Will Pay $15 Million For Promoting Bone Repair Products
Posted on 18 Jan 2012 by Tom Moylan

BOSTON - (Mealey's) Stryker Biotech LLC on Jan. 17 pleaded guilty to one federal misdemeanor count of misbranding a medical device and agreed to a $15 million fine for promoting the mixing of its OP-1 and Calstrux orthopedic repair products to health... Read More

10th Circuit Majority Says Infuse Off-Label Claims Are Preempted By Congress
Posted on 21 Apr 2015 by Tom Moylan

DENVER — (Mealey’s) In a 2-1 decision, a panel of the 10th Circuit U.S. Court of Appeals on April 21 affirmed that a plaintiff’s claim alleging off-label promotion and use of Medtronic Inc.’s Infuse bone graft system is 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

Florida, Kentucky Residents Sue Zimmer Alleging Hip Implant Defect
Posted on 17 Mar 2010 by LexisNexis Litigation Resource Community Staff

WEST PALM BEACH, Fla. — Wendy R. Fleishman of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein LLP announced March 11 that Todd Lovelace and Christine Walker have filed separate personal injury lawsuits against... Read More

Lawsuit Alleges Defective Zimmer Artificial Hip Has Caused Extreme Pain, Hardship
Posted on 27 May 2010 by LexisNexis Litigation Resource Community Staff

NASHVILLE, Tenn. - Mark P. Chalos from the Nashville office of the national plaintiffs' law firm Lieff Cabraser Heimann & Bernstein LLP , announced that on May 20, Walter Thomas filed a lawsuit in federal court in Nashville against Zimmer Inc... Read More

Durom Cup Lawsuits Filed Against Zimmer Allege Pain, Injuries From Artificial Hip
Posted on 23 Jul 2010 by LexisNexis Litigation Resource Community Staff

LOS ANGELES - The national plaintiffs' law firm Lieff Cabraser Heimann & Bernstein, LLP recently announced several lawsuit filings against Zimmer Inc., the nation's largest producer of orthopedic devices, over the allegedly defective hip implant... Read More