Failing Fluoroquinolones – FDA Requires Manufacturers of Potentially Dangerous Antibiotics To Update Drug Labels

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 little pills intended to clear … Continued

Zimmer Biomet Recalls Polyethylene and Ceramic Implants in US and Canada

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 devices. This recall was announced … Continued

Zimmer Biomet’s Class One Recall of the Reverse Shoulder Implant

In December 2016 Zimmer issued a Class one recall of its Comprehensive Reverse Shoulder Implant System Humeral Tray. Zimmer received 510(K) clearance to market this device in 2008. According to the FDA’s Recall Database, approximately 300 lots of the shoulder implant are being recalled because of a higher than anticipated rate of fracture due to … Continued

Baby Powder Lawsuits – $200 Million and Counting?

Lawsuit No. 4 in the case against Johnson & Johnson and its ovarian-cancer-linked talc product has headed to the courtroom in Missouri.  It is the fourth in a series of baby powder lawsuits filed nationally. Defense attorneys will watch it closely to see whether monetary damages are awarded for the fourth time. Plaintiff Nora Daniels, a … Continued

Potential Eliquis MDL Discussed at JPML Hearing in Miami Beach

Miami Beach was the place to be for mass tort lawyers last week, with two drug and medical device conferences as well as a critical hearing before the Judicial Panel on Multidistrict Litigation (also known as the “JPML”). The Judicial Panel, a group of federal judges that meets every two months to consider requests to … Continued

FDA Adverse-Event Reports Go Public

Years of adverse-event reports documenting problems associated with compromised food, dangerous drugs and harmful cosmetics are now available to the public. The information can be obtained, free of charge, via a downloadable report to be updated quarterly. The data currently spans twelve years. Advocacy Groups Find Adverse-Event Reports Helpful for Protecting Consumers Business leaders, consumer groups and law firms … Continued

Bacteria Found in Cardiac Patients Linked to Heater-Cooler Machine

Heater-Cooler Machine Spreads Germs in Sterile Areas The medical device sounds well-intended enough: a heater-cooler machine used during heart surgery to control a patient’s body temperature. Doctors employ them in the hundreds of thousands of cardiac procedures they conduct every year in hospitals across the country. Turns out, the LivaNova PLC (formerly Sorin Group Deutschland GmbH) … Continued

Essure Birth Control Urged To Warn Women About Product Risks

The U.S. Food and Drug Administration is concerned that women are not as knowledgeable as they should be about the risks associated with permanent Essure birth control. The agency now recommends a black-box warning for the product along with a new patient checklist. The New FDA Guidance on Essure Birth Control The new guidance addresses hysteroscopically placed … Continued

Januvia, Byetta, Claims Headed for Appeals Court

The fate of diabetic patients who suffered pancreatic or thyroid cancer after ingesting incretin-based therapy drugs is now in the hands of the Ninth Circuit Court of Appeals after the claims were dismissed by the California federal court judge who oversaw the national coordinated litigation. In September of 2016, the plaintiffs whose individual lawsuits were … Continued

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