The FDA announced a recall of Zimmer Biomet’s SpF PLUS Mini and SpF XL IIb implantable spinal fusion stimulators. This is due to the high levels of potentially harmful chemicals that are potentially harmful to tissues and organs (cytotoxicity). The recall of the implantable device affects certain serial numbers that […]
Category: Articles
Janssen Pharmaceuticals’ type 2 diabetes medication is under new scrutiny. This new scrutiny follows confirmation from the Food and Drug Administration (FDA) that use of the drug canagliflozin, sold as Invokana and Invokamet, potentially increases the risk of amputation of the feet or legs. Most of these amputations have involved […]
The U.S. Judicial Panel on Multidistrict Litigation (“JPML” or “The Panel”) is a body of seven federal district judges who manage multidistrict litigation, meeting on a bimonthly basis to consider requests to establish MDLs. The Panel has the authority to determine whether civil actions pending in two or more federal […]
After the blood monitoring device INRatio recall, a class-action lawsuit filed against the manufacturer, Alere, has settled out of court. So it is safe to say the global corporation with headquarters in Waltham, Mass., that touts itself as a leader in rapid diagnostics, likely dodged a bullet. Class 1 INRatio […]
The Prelude Short Sheath is a medical device used to guide catheters into the body to treat kidney disease, thrombosis and other conditions that require access to arteries and veins. It has recently been recalled by the U.S. Food and Drug Administration. The FDA said Merit Medical’s Prelude Short Sheath could […]
A company beneath the umbrella of pharmaceutical giant Pfizer has initiated a clawback of its recalled EpiPen Auto-Injector and EpiPen Jr Auto-Injector for failing to activate in time of need. The U.S. Food and Drug Administration notified the public March 31, 2017 about the recall by Meridian Medical Technologies / […]
In April of 2016, the Judicial Panel on Multidistrict Litigation determined that coordination of federal court lawsuits involving men who developed melanoma after taking Viagra was appropriate. MDL No. 2691, styled In Re: Viagra (Sildenafil Citrate) Products Liability Litigation Viagra, was then established before Judge Seeborg, a federal court judge, […]
The Personal Care Products Council wants its name off the defendants’ list in multidistrict litigation filed in U.S. District Court in New Jersey by plaintiffs suing Johnson & Johnson over the pharmaceutical giant’s baby powder. The nonprofit operates as a national cosmetics-industry trade association that has more than 600 members […]
First, the U.S. Food and Drug Administration (FDA) issued a safety communication warning consumers about the dangerous side effects of a type of antibiotic known as fluoroquinolones. Aneurysms. Arrhythmia. Inflammation and pain to the joints, muscles and tendons. Permanent damage to the central-nervous system. Type 2 diabetes. All from the […]
Following closely its recall of its reverse total shoulder implants, Zimmer Biomet recalls plastic and ceramic implant parts that are contaminated with endotoxins. Health Canada classifies the recalled products as posing a Type I Hazard. The FDA has adopted approved standards for the presence of acceptable levels of endotoxins in orthopedic […]
