Blog

Ohio Dangerous Drugs and Medical Devices

How to Report a Drug-Related Injury to the FDA

By Burg Simpson

While pharmaceutical drugs can save lives, they can also cause significant injuries if defectively manufactured, poorly designed, or improperly labeled. If you or a loved one have been harmed by a drug, you should not suffer in silence. It is important that you speak with a product liability attorney right away. You may also consider… Read more »

How to Report a Medical Device Injury to the FDA

By Burg Simpson

Medical devices can improve the quality of life for many people. However, defective medical devices can cause significant harm resulting in lifelong injuries. If you or a loved one has been harmed by a defective medical device, it is important that you speak to a product liability attorney as soon as possible. You may also… Read more »

How To Search the FDA’s Adverse Event Databases

By Burg Simpson

It is a sad fact that every day individuals suffer injuries while using products regulated by the FDA. When such injuries occur, consumers and medical providers can report these events to the FDA. Such reporting is important to allow FDA to analyze the safety of the products it regulates. Not many people know that the… Read more »

Use of Baclofen Linked to Encephalopathy

By Heidi Culbertson

Baclofen Linked to Encephalopathy in New Study Published in JAMA The use of Balcofen in older patients with Chronic Kidney Disease is associated with an increased risk of encephalopathy, according to a new study published in the Journal of the American Medical Association (JAMA). Baclofen is a drug that is approved by the FDA as… Read more »

Death, Injuries Prompt Urgent Recall of CentriMag Pump and Circulatory Support Surgical Device

By Burg Simpson

On October 30, 2019, the U.S. Food and Drug Administration (FDA) announced that Abbott initiated a recall of its CentriMag circulatory support system. According to the recall notice, the system consists of several components (a pump, motor, and console/screen) intended to work together to pump blood through a patient during open heart procedures. The system… Read more »

THE FLU VACCINE AND GUILLAIN-BARRE SYNDROME: WHAT YOU NEED TO KNOW

By Burg Simpson

flu vaccine guillain-barre syndrome

What is Guillain-Barre Syndrome? According to the National Institute of Neurological Disorders and Stroke: Guillain-Barré syndrome (GBS) is a rare neurological disorder in which the body’s immune system mistakenly attacks part of its peripheral nervous system—the network of nerves located outside of the brain and spinal cord. GBS can range from a very mild case with… Read more »

Medtronic Catheters Recalled Due to Separation and Fragmentation Issues

By Burg Simpson

Medtronic

Medtronic Catheters Recalled Due to Separation and Fragmentation Issues On October 1, 2019, the U.S. Food and Drug Administration (FDA) announced that all models of the 6 French Sherpa NX active guide catheters manufactured by Medtronic needed to be recalled due to the significant risk that the affected catheters may malfunction, possibly causing serious adverse… Read more »

Burg Simpson Files Lawsuit Against Depuy Synthes For Failed Radial Head Replacement

By Burg Simpson

Burg Simpson Files Lawsuit Against Depuy Synthes For Failed Radial Head Replacement Burg Simpson is representing an individual in Arizona who received a defective Synthes radial head medical device.  Plaintiff suffered fractures to the head of her radial bone requiring surgery for replacement of the natural radial head with a prosthetic radial head device.  Plaintiff… Read more »

Darmerica LLC Initiates Pressing Recall after Dangerous Labeling Error

By Burg Simpson

Darmerica LLC Initiates Pressing Recall after Dangerous Labeling Error A label mix-up at the production and distribution level of the prescription drug manufacturing process could have a dangerous trickle-down effect on unknowing consumers. On September 12, 2019, the FDA announced that Darmerica LLC is voluntarily recalling two lots of Quinacrine Dichloride, an “active pharmaceutical ingredient” (API) shipped… Read more »

SAPIEN 3 Ultra Delivery System Recalled over Concerns of Injury and Death

By Burg Simpson

heart valve surgery sapian 3 transcatheter aortic replacement

On August 22, 2019, the FDA reported that Edward Lifesciences, LLC recalled its SAPIEN 3 Ultra Delivery System due to reports of burst balloons during transcatheter aortic valve replacement surgery. Transcatheter aortic valve replacement surgery is a minimally invasive procedure where the aortic valve is replaced using a catheter- a thin tube inserted into the… Read more »

Top 100 National Trial Lawyers Legal 500 Best Lawyers in America Super Lawyers US News 2014 Top 25 Most Influential Lawyers