Chantix - FDA Concerned About Risk of Suicide

On February 1, 2008, the FDA issued a public health advisory regarding Chantix and announced new safety information and warnings to the labeling. The new labeling includes revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. Continue reading ⇒

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MDL court rejects certification of medical monitoring class

On January 3, 2008, the Hon. John F. Keenan welcomed in the new year with a memorandum and order denying class certification of three putative medical monitoring classes in the Fosamax product liability multidistrict litigation, In re Fosamax Products Liability Litigation, MDL No. 1789, 1:06-md-1789-JFK, pending in the United States District Court for the Southern District of New York. Continue reading ⇒

AVANDIA WARNING: FDA TO REQUIRE BLACK BOX WARNING OF INCREASED RISK OF HEART ATTACKS FOR AVANDIA USERS

On November 14, 2007 the FDA informed healthcare professionals of new information that was added to Avandia's black boxed warning. The FDA now requires that patients and physicians be warned of potential increased risk for heart attacks. Continue reading ⇒

AVANDIA MDL SET IN THE EASTERN DISTRICT OF PENNSYLVANIA

The Avandia multidistrict litigation docket has been created and assigned to U.S. Judge Cynthia M. Rufe of the Eastern District of Pennsylvania (In Re: Avandia Marketing, Sales Practices and Products Liability Litigation, MDL Docket No. 1871, JPMDL).  Continue reading ⇒

Sprint Fidelis

WARNING RECALL NOTICE

Sprint Fidelis Implantable Cardiac Lead Device

IMPORTANT RECALL NOTICE: On October 15th, 2007, Medtronic, the world’s leading maker of implantable heart devices, advised the FDA of a voluntary recall of its Sprint Fidelis defibrillation leads.  Continue reading ⇒

MDL Panel To Meet To Determine Location Of MDL Litigation

The Judicial Panel on MultiDistrict Litigation meets Thursday Sept. 27 in New York City for consideration of whether federal Avandia cases should be consolidated, and where. For plaintiff's lawyers with Avandia cases, the selection of the transferee MDL Judge is important, in state as well as federal cases, due to the impact of MDL progress (or lack of progress) on discovery and settlement. Continue reading ⇒

Litigation - News From California

Humdreds of cases have been filed in the California state courts. On Thursday, September 20, 2007, the Court met with the parties and adopted an aggressive schedule that may see the first four Ortho Evra cases tried sometime in April 2008. The Court permitted the plaintiffs and defendant to each select two cases for trial. Continue reading ⇒

Thosands of Ortho Evra Suits Filed - Says Johnson & Johnson

In its latest update last month, J&J said more than 2,400 Ortho Evra lawsuits are queued up in state and federal courts. Aboyt 400 have been filed in New Jersey. The NJ cases have been consolidated in the Middlesex County Courthouse in New Brunswick, just a few blocks from the health-care conglomerate's headquarters. Continue reading ⇒

AVANDIA LINKED TO AN INCREASED RISK OF BONE FRACTURES

GlaxoSmithKline Plc's own stydy has found that the use of the Avandia diabetes pill increases the risk of bone fractures in diabetic women who take it.

Women taking Avandia were found to have more than double the risk of suffering fractures than those on generic diabetes pill glyburide. Continue reading ⇒

Defective Guidant Pacemakers

A Food and Drug Administration (FDA) classified Guidant pacemaker recall was issued for certain defibrillator models on June 17th, 2005. Included in the FDA recall were Guidant implanted cardioverter defibrillator (ICD) models and cardiac resynchronization therapy (CRT) devices.

The specific Guidant devices affected by the June 17th FDA recall included: Continue reading ⇒

Lawsuits of Interest

Accutane  (isotretinoin)
Advair  (Fluticasone/salmeterol)
Avandia  (Rosiglitazone)
Bextra  (Valdecoxib)
Celebrex  (Celecoxib)
Chantix  (Varenicline)
Digitek  (Digoxin)
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