Imagine a situation in which a team of firefighters responding to a vehicle fire cannot extinguish the flames. Gallon after gallon of water does not douse them. Pile after pile of foam fails to finish them off. The car keeps burning, and the smoke keeps coming. Sounds like a scene […]
Category: Product Defect
Product liability is based in “tort” law, along with legal claims like intentional torts, negligence, and strict liability. Torts are wrongful acts that cause injury to another person. Product liability claims can be based on negligence, strict liability, or breach of warranty. Product liability claims seek to hold various entities […]
According to a report from the U.S. Consumer Product Safety Commission (CPSC), there were an estimated 59,000 emergency room injuries associated with (although not necessarily caused by) nursery products among children younger than age five in 2018. This translates to an injury rate of an estimated 298 injuries per 100,000 […]
On July 2, 2020, MasterPharm, LLC, a compounding pharmacy based in South Richmond Hill, New York, announced the recall of various lots of numerous drugs compounded and distributed by the pharmacy. The recall includes compounded formulations of: Calcium citrate tetrahydrate USP powder D-Biotin Estriol Finasteride Plus Formula 82F (combination of […]
In this fifth and final installment of our series on defective medical device issues, we are discussing the lack of a national device registry in the United States. Despite calls from various advocacy groups and some preliminary efforts at the federal level, the U.S. still lacks a central repository for […]
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 […]
