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 […]
Category: Articles
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 […]
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, […]
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 […]
Belladonna is blamed for the deaths of 10 babies. The parents treated their teething phase with homeopathic teething products (gels and tablets) containing the natural substance. Another name for belladona is deadly nightshade, which it received due to its poisonous nature. Still, the plant has been used medicinally for five centuries. Food & […]
The National Park Service is celebrating its centennial – an historic occasion that will culminate Aug. 25. On that date in 1916, President Woodrow Wilson signed into law an act creating a new bureau within the Department of the Interior that would bear responsibility for protecting the then-35 parks in […]
Is Sponsor-Submitted Clinical Data Safe? The U.S. Food and Drug Administration has a tricky task at hand when it comes to reviewing, evaluating, investigating and eventually approving prescription medications. Yes, the agency has a mission to ensure patient safety, and yes, a formal process must be followed before a medication […]
A newly published study shows that drugmakers are doing a disservice to patients by inconsistently reporting side effects of medications depending on whether the information is being filed with the U.S. Food and Drug Administration or its overseas counterpart, the European Medicines Agency. Researchers compared adverse drug-reaction data for anticonvulsants […]
The U.S. Food and Drug Administration (FDA) received another blow to its ability to regulate pharmaceutical product marketing that was dealt via a court order stating it is not in the agency’s purview to control promotional statements about certain medications’ unintended uses. In the federal case of Amarin Pharma Inc. […]
The Judicial Panel on Multidistrict Litigation heard arguments at a hearing on March 31, 2016, about the need for national coordination of Viagra claims. Pfizer, the manufacturer of Viagra, did not oppose this request by the Plaintiffs. Pfizer’s attorneys also agreed with the Plaintiffs’ suggestion that all of the pending Viagra […]
