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Pradaxa® MDL Update (MDL 2385): $650 Million Settlement Reached in Federal Multidistrict Litigation

The Plaintiffs’ Steering Committee, appointed by The Honorable Chief Judge David R. Herndon to negotiate the settlement on behalf of all plaintiffs in the Pradaxa® MDL, and Boehringer Ingelheim Pharmaceuticals, Inc. (and affiliates) have negotiated a settlement program in the amount of $650 Million to resolve approximately 4,000 Pradaxa® claims. Roger C. Denton of Schlichter, […]


Manufacturer Wockhardt Recalls Generic Toprol XL Tablets

Bloomberg reports that the Mumbai-based manufacturer, Wockhardt Ltd., is recalling 109,744 bottles of its generic version (metoprolol succinate) of the heart pill Toprol XL. The FDA is starting to crack-down on manufacturers in its efforts to monitor the safety and quality of generics. According to an FDA report, the recall was issued as a result of […]


FDA Issues New Safety Announcement: Next-Day Impairment with Sleep Aid Lunesta®

On May 15, the U.S. Food and Drug Administration (FDA) issued a Safety Announcement warning that the insomnia drug Lunesta® (eszopiclone) can cause next-day impairment that can last more than 11 hours after receiving an evening dose. A recent study of Lunesta® found that the previously recommended dose of 3mg can cause impairment to driving […]


FDA Issues Proposed Orders to Reclassify Transvaginal Mesh to a High-Risk Device

On April 29, 2014, the FDA issued an immediate release notifying the public of its issuance of two proposed orders to address risks associated with surgical mesh for transvaginal repair of pelvic organ prolapse (POP). If these orders are finalized, these orders will reclassify transvaginal mesh products from a moderate-risk device (Class II) to a […]


Black Box Warning Regarding Increased Risk of Liver Failure and Death Added to Stavzor Product Label

In March 2014, the manufacturers of Stavzor added a Black Box Warning, which is the strongest type of warning, to the product label regarding the increased risk of liver failure and death. The Black Box Warning for Stavzor reads: “Hepatotoxicity, including fatalities, usually during first 6 months of treatment. Children under the age of two years […]


New Study Reports Potential Link between Viagra and Deadly Skin Cancer

A recent article published by JAMA Internal Medicine in April 2014 evaluated the association between sildenafil use and the risk of incident melanoma among men in the United States. The study concluded that “[s]ildenafil use may be associated with an increased risk of developing melanoma.” In particular, the researchers found that men who took sildenafil […]


FDA Issues New Safety Announcement: Increased Risk of Major GI Bleeding with Pradaxa Compared to Warfarin

On May 13, 2014, the FDA issued a Safety Announcement for Pradaxa regarding a recent study finding a higher risk of gastrointestinal (GI) bleeding with Pradaxa compared to warfarin. This information is in follow-up to the FDA’s Drug Safety Communication previously issued on November 2, 2012 regarding the risk of serious bleeding events with Pradaxa. […]


The Las Vegas Herald: Las Vegas Judge Denies Attempt to Remove Her from Actos Case

The Las Vegas Herald reports that Judge Kerry Earley will not remove herself from a civil case filed by two women against Takeda Pharmaceuticals, the manufacturer of Actos. The Honorable Judge Earley stated, “I absolutely see no evidence that there’s any appearance of impropriety by me.” The Honorable Judge Earley made her ruling after attorney […]


$830 Million Settlement Reached in Endo and American Medical Systems Transvaginal Mesh Litigation

Reuters reports that a settlement in the amount of $830 Million has been reached to resolve legal claims from women who allege to have been injured by transvaginal mesh devices manufactured by Endo and American Medical Systems. Endo (although not admitting liability or fault) released a statement indicating that the settlement agreement will provide compensation […]


ABC Detroit Reports: “Pradaxa is the Most Complained about Drug in the United States”

ABC Detroit reports that Pradaxa is the most complained about drug in the United States. Since its approval by the FDA in 2010, Pradaxa has been associated with 1,158 deaths and 12,494 serious injuries in the United States, according to Tom Moore , senior scientist for drug safety and policy at the Institute for Safe […]

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