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Ohio Dangerous Drugs and Medical Devices

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 »

Infant Warmers Urgently Recalled due to Falling Risk

By Heidi Culbertson

Baby

Infant Warmers Urgently Recalled due to Falling Risk On July 12, 2019, the U.S. Food and Drug Administration (“FDA”) announced the Class I recall of GE Healthcare’s Giraffe and Panda i-Res Infant Warmers after GE received reports of infants suffering injuries, including fractured skulls, associated with the warmers. A Class I recall is the FDA’s… Read more »

Millions of Medical Device Injuries and Malfunctions Hidden from the Public

By Heidi Culbertson

Medical Devices

By Jessica L. Powell, Burg Simpson Associate Millions of Medical Device Injuries and Malfunctions Hidden from the Public  5.7 million reports of device injuries and malfunctions were hidden from the public, according to Kaiser Health News. Medical device manufacturers are required to notify the FDA about certain device injuries and malfunctions, called “adverse events.” Generally,… Read more »

Multiple Drops/Medications for the Eyes Recalled due to Sterility Concerns

By Burg Simpson

On July 3, 2019, the FDA announced that Altaire Pharmaceuticals voluntarily recalled certain eye drops, eye lubricants, and prescription eye ointments sold over the counter under the Walgreens brand name, as well as some prescription products. According to the FDA, Altaire initiated the recall “due to management concerns regarding the sufficiency of Quality Assurance controls… Read more »

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