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Ohio Dangerous Drugs and Medical Devices

Lemtrada Linked To Stroke and Tears In Artery Linings

By Heidi Culbertson

On November 29, 2018, FDA issued a safety announcement warning that multiple sclerosis drug Lemtrada has been linked to cases of stroke and tears in the lining of the arteries in the head and neck. These serious injuries can lead to permanent disability and death. Given the nature of these risks, FDA has announced that… Read more »

Failure Reports Associated with ATTUNE Total Knee Systems Continue to Mount

By Burg Simpson

Total Knee System Recall - Ohio Burg Simpson

DePuy’s ATTUNE Total Knee System is reportedly failing at unusually high rates, requiring patients to undergo painful and complicated revision surgeries. According to a 2017 article published in the Journal of Knee Surgery, a review of three hospital databases found unexpectedly high reports of implant failures in patients that had received the ATTUNE Total Knee… Read more »

Valsartan Recall Continues to Expand and FDA Addresses Cancer Risk

By Burg Simpson

Valsartan Recall- Ohio Burg-Simpson

On August 20, FDA announced that yet another manufacturer of Valsartan-containing products, Torrent Pharmaceuticals Limited, was recalling certain lots of its drugs following FDA testing that revealed contamination with NDMA – a known cancer causing agent. View the Expanded Recall Announcement Here Torrent Pharmaceuticals’s Valsartan products can now be counted among the more than 50… Read more »

Valsartan Recall Expands as FDA Investigation Continues

By Burg Simpson

Valsartan – Mass Tort Litigation – Ohio Burg Simpson

On August 8, 2018, FDA announced an expanded list of recalled Valsartan drugs due to their contamination with the known cancer-causing agent NDMA. While the original FDA announcement on July 13, 2018, only concerned the Valsartan-containing products from three pharmaceutical manufacturers, the most recent list published by the FDA reveals that the contamination was much… Read more »

Urgent Recall of Popular Blood Pressure Drug Valsartan

By Burg Simpson

Valsartan Recall- Ohio Burg-Simpson

On July 13, 2018, the Food and Drug Administration announced that several pharmaceutical companies are recalling all of their Valsartan-containing drugs due to their contamination with a known cancer-causing agent. Valsartan is a popular drug used to treat high blood pressure and heart failure. Unfortunately, Valsartan products from Major Pharmaceuticals, Solco Healthcare, and Teva Pharmaceuticals… Read more »

FDA Issues Warning for Patients That Had Aneurysm Repair With Endologix AFX Device

By Burg Simpson

Aneurysm Repair - Mass Tort Lawyers - Ohio Burg Simpson

On June 19, 2018, the U.S. Food and Drug Administration (FDA) issued a Letter to Health Care Providers regarding the risk of Type III endoleaks with the use of a certain endovascular graft systems. Endovascular graft systems are used to repair abdominal aortic or aorto-iliac aneurysms. An aneurysm is an abnormal bulge in weak artery’s… Read more »

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 »

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