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FDA Issues Serious Warning on Limbrel Capsules

By The Burg Simpson Ohio Team

On November 21, 2017, the U.S. Food and Drug Administration (FDA) issued an advisory statement alerting consumers about potentially life-threatening health problems linked to Limbrel Capsules. Limbrel is not a drug; rather, it is marketed as a medical food for patients with osteoarthritis. The FDA reported that it has received numerous reports of problems related… Read more »

DePuy Synthes Elbow Implant Recall

By The Burg Simpson Ohio Team

On December 29, 2016, DePuy issued a recall for over 50,000 elbow joint replacement devices known as the “DePuy Synthes Radial Head Prosthesis System.” The company reported that the device’s radial stem, which attaches the device to the lower arm, may loosen after surgery. If loosening occurs the device may not function properly and can… Read more »

FDA Issues Warning on Vancomycin Eye Injections During Cataract Surgery

By The Burg Simpson Ohio Team

On October 3, 2017 the U.S. Food and Drug Administration (FDA) issued a statement on the risk of hemorrhagic occlusive retinal vasculitis (HORV) following injections directly into the eye of a compounded triamcinolone, moxifloxacin, and vancomycin (TMV) formulation. The FDA’s statement follows a recent report of a patient who was diagnosed with HORV after being… Read more »

Amusement Park Injuries

By The Burg Simpson Ohio Team

Every year individuals travel to the hundreds of amusement parks and countless fairgrounds across the United States for what is supposed to be a day of fun. Unfortunately, accidents at these destinations are all too common. The United States Consumer Product Safety Commission, which provides raw data on injury statistics, estimates that over 30,000 individuals… Read more »

New AAJ Report Examines History of Women’s Exposure To Dangerous Drugs & Devices

By The Burg Simpson Ohio Team

Please read the new report from the American Association for Justice: From Accutane to Zonite: A History of Dangerous Drugs & Devices Marketed to Women profiles some of the most harmful medical products that have been marketed to women and highlights the important role the civil justice system has played as a backstop to enhance… Read more »

Invokana and Invokamet Increase the Risk of Leg and Foot Amputations

By The Burg Simpson Ohio Team

On May 16, 2017 the U.S. Food and Drug Administration (FDA) confirmed that Janssen Pharmaceuticals’ diabetes medications Invokana and Invokamet cause an increased risk of leg and foot amputations.  Accordingly, the FDA will now require these drugs to carry a black-box warning concerning this serious risk of injury. FDA Safety Announcement Invokana and Invokamet have… Read more »

Abbott Recalls Malfunctioning Coronary Catheters That May Lead to Surgical Complications and Death

By The Burg Simpson Ohio Team

On May 16, 2017 the U.S. Food and Drug Administration (FDA) announced that several lots of cardiac catheters manufactured by Abbott needed to be recalled due to the significant risk that the affected catheters may malfunction, possibly causing surgical complications and even death. FDA Safety Alert Announcement The affected lines of catheters include the NC… Read more »

Medtronic Recalls StrataMR Adjustable Valves and Shunts Which May Cause Fluid Buildup in the Brain

By The Burg Simpson Ohio Team

On April 19. 2017 the U.S. Food and Drug Administration (FDA) announced that Medtronic initiated an urgent recall of its StrataMR adjustable valve and shunt devices. Because of the risk that these medical devices will cause significant adverse health consequences or death, the FDA has identified this as a Class I recall, which is the… Read more »

FDA Announces Recall of Hyland’s Homeopathic Teething Tablets

By The Burg Simpson Ohio Team

On April 13, 2017 the U.S. Food and Drug Administration (“FDA”) announced the recall of all lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets by the manufacturer, Standard Homeopathic Company. This recall follows the FDA’s September 2016 warning against the use of homeopathic teething products. At that time the FDA stated… Read more »

FDA Warns IBS Drug Viberzi is Associated with an Increased Risk of Pancreatitis For Patients Without a Gallbladder

By The Burg Simpson Ohio Team

On March 15, 2017, FDA issued a Drug Safety Communication, warning that patients without a gallbladder who are prescribed the drug Viberzi (eluxadoline) face an increased risk of serious pancreatitis that could result in hospitalization or death. Viberzi is a medicine that is used to treat irritable bowel syndrome with diarrhea (IBS-D).  A recent FDA… Read more »

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