Product Defect

On May 12, 2020, MasterPharm, a compounding pharmacy based in New York, issued a recall of its popular hair regrowth formulation FinPlus. This medication, compounded by MasterPharm by prescription from a physician, includes finasteride 1.25 mg and a combination of Biotin, L-Lysine, Zinc, and riboflavin (vitamin B2) that are used […]

So far, our series discussing issues associated with defective implantable medical devices has focused on specific deficiencies in the U.S. Food and Drug Administration’s (FDA) approval and safety monitoring systems. First, we discussed the inherent conflicts of the 510k clearance process.  Then, we discussed the limited recall requirements for implantable […]

Issues with defective medical devices are so common that the U.S. Food and Drug Administration (FDA) has implemented a system designed specifically to identify and address medical device defects. This system, known as Medical Device Reporting (MDR), requires device manufacturers and importers to report known product defect or safety issues, […]

In Part Two of our series on defective medical device issues, we are talking about recalls. Implantable medical device recalls are common, and they can vary in terms of what they mean for patients. As the U.S. Food and Drug Administration (FDA) explains: “FDA uses the term ‘recall’ when a […]

Implantable medical devices offer invaluable benefits to individuals suffering from a broad range of ailments. They help people breathe, they help people walk and they provide an enhanced quality of life that simply is not available through other forms of medical treatment. Unfortunately, they can also be dangerous. Over the […]

Contraceptive Is Linked to Injuries and Deaths and Now Is the Subject of Lawsuits Bayer, the company that manufactured and marketed the dangerous birth-control device Essure, is looking more and more like a bad actor as the facts unfold. The target of lawsuits filed on behalf of patients who were […]

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 […]

Crushing injuries occur when a portion of a person’s body is compressed between opposing surfaces. These accidents occur in various situations ranging from truck accidents to car accidents to on-the-job equipment malfunctions. The aftermath of crushing injuries often leaves victims with serious and life-changing injuries. Due to the devastating nature […]

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 […]