Feb
11
The FDA reports that a Federal Judge sitting in the U.S. District Court of New Hampshire entered a consent decree of permanent injunction against four medical device manufacturing companies and two company officers. Between 2009 and 2013, the U.S. Food and Drug Administration (FDA) conducted ten inspections across the manufacturing sites. Inspections revealed multiple and […]
Feb
10
If you have been taking a blood-thinning drug (such as warfarin/Coumadin) or have been receiving heparin injections, you should be aware of an urgent recall of INRatio® PT/INR test strips and monitors. These products are used to test a patient’s INR (international normalized ratio) when taking warfarin and other anticoagulation medications. The goal with warfarin […]
Feb
9
Johnson & Johnson (J&J) will face trial to defend itself against claims that its antipsychotic drug, Risperdal®, causes gynecomastia, a condition that causes young boys and males to grow breasts. The lawsuit, brought in the Philadelphia Court of Common Pleas, involves a boy who ingested Risperdal® at the age of 8 and subsequently suffered from […]
Feb
9
The Wall Street Journal reports that Pfizer has agreed to pay $400 million to settle a class-action securities lawsuit alleging that the company illegally marketed several medications causing its investors to lose money, according to a filing with the United States Securities and Exchange Commission (SEC). The securities lawsuit alleged that Pfizer marketed several drugs […]
Feb
4
Law360 reports that the plaintiffs in a multidistrict litigation involving Effexor, a depression and anxiety medication manufactured by Wyeth Pharmaceuticals Inc., have sought to dismiss 26 lawsuits targeting the Pfizer unit over the drug’s alleged risk of birth defects. The multidistrict litigation is In re: Effexor (Venlafaxine Hydrochloride) Products Liability Litigation, MDL 2458. Judge Cynthia […]
Feb
3
Law 360 reports that setting aside a history of smoking and other risk factors, an expert witness told a jury in Philadelphia that the most significant contributing factor for the retired western Pennsylvania teacher, who was diagnosed with bladder cancer in 2008, was his long-term Actos use. University of Colorado oncologist and bladder cancer specialist […]
Jan
29
On January 9, Judge Cathy Seibel, who presides over the Mirena MDL in the Southern District of New York (In re: Mirena® IUD Products Liability Litigation, MDL 2434), granted Bayer’s motion to dismiss 31 cases as time-barred under Louisiana, California, Oklahoma and Ohio law. Judge Seibel ruled that none of these plaintiffs’ claims are […]
Jan
27
On January 21, Administrative Judge Kevin Dougherty of the Philadelphia Court of Common Pleas issued an Order transferring Xarelto cases currently on file in Philadelphia state court to the court’s mass tort docket for coordination. The cases will be transferred to the court’s Complex Litigation Center for further management. Plaintiffs allege that Xarelto® was introduced […]
Jan
15
The FDA announced that it has approved Savaysa (edoxaban), an anti-clotting drug manufactured by Tokyo-based Daiichi Sankyo and used to reduce the risk of stroke and dangerous blood clots (systemic embolism) in patients with atrial fibrillation that is not caused by a heart valve problems. Savaysa has also been approved by the FDA to treat […]
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