In late 2010, the FDA approved the drug called Pradaxa (dabigatran); manufactured by Boehringer Ingelheim. Pradaxa is a blood thinner and is supposed to be prescribed to patients who suffer from the cardiac disorder atrial fibrillation. Atrial Fibrillation is the most common form of abnormal heart rhythm. Patients who suffer […]
Category: Mass Torts
Has it simply become all about bean counters and number crunching for some drug companies?
If you can generate over $1.5.8 billion in sales for (5) years, for a drug you know is defective, can you afford to pay the claims that result from people being hurt or killed?
In 2010, the U.S. Food & Drug Administration approved Pradaxa (Dabigatran Etexilate). Pradaxa acts as a blood “thinner” and is promoted to reduce the risk of stroke and blood clots in people with atrial fibrillation. Atrial fibrillation, affecting over two million Americans, occurs when the heart does not beat properly […]
Pradaxa (dabigatran etexilate mesylate), a new oral anticoagulant, achieved Food & Drug Administration (“FDA”) approval on October 19, 2010. One notable advantage of using Pradaxa to replace Warfarin to prevent clot formation is the elimination of INR testing in patients taking Pradaxa. INR is the acronym for International Normalized Ratio, which is used to monitor the effectiveness of anticoagulant such as warfarin.
A U.S. Food & Drug Administration (FDA)-prompted Class 1 recall one year ago led an Ireland-based company to stop manufacturing and marketing its cancer-causing, textured breast implants and tissue expanders. The recall, the most serious type issued by the agency, followed an FDA analysis that concluded the implants made by […]
Elmiron (also known as pentosan polysulfate sodium or PPS) is a drug prescribed for over 25 years to treat painful bladder syndrome or interstitial cystitis. This chronic bladder disease includes significant bladder or pelvic pain, incontinence, and dyspareunia. The condition afflicts millions of women in the United States and a […]
Editor’s Note: Searcy Denney partner, Jack Scarola, as co-lead counsel with Adam Moskowitz of The Moskowitz Law Firm, has announced the settlement of a major national class action against the manufacturers of Prevagen, a widely and heavily advertised dietary supplement alleged to enhance brain functions. The settlement follows a hung […]
It was no April Fool’s Day joke when the U.S. Food & Drug Administration (FDA) issued a news release requiring the recall of every single ranitidine drug on the market. Ranitidine, commonly known as Zantac, an over-the-counter (OTC) heartburn medication taken by an estimated 15 million Americans, had been found […]
Previously, Drugs Manufactured by Outsourcing Facilities Were Largely Unregulated The fungal-meningitis outbreak of 2012, which infected over 750 patients across the country and caused 60-plus deaths, became a turning point for the then-little-known industry of compounding pharmacies. The prescription disaster made headlines throughout the United States and shined a much-needed […]
Years of Inspections, Reports, Letters from FDA Went Unheeded MasterPharm Compounding Pharmacy in South Richmond Hill, N.Y., has recalled a “bad batch” of a drug called Finasteride Plus, known as FinPlus, that aids in hair growth. The recall involves a lot of 1.25-milligram capsules marketed to consumers both commercially and […]
