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Ohio Dangerous Drugs and Medical Devices

Burg Simpson Shareholders Published in “Trial Magazine”

By Burg Simpson

Burg Simpson Shareholders Published in “Trial Magazine” Burg Simpson shareholders Janet Abaray and David Harman were recently published in the January 2020 issue of Trial magazine. In 2019 the U.S. Supreme Court decided Merck Sharp & Dohme Corp. v. Albrecht, which provided clarity on the difficult standard drug makers must meet to prove the affirmative… Read more »

As Breathing Difficulties Continue to Be Linked to Gabapentinoids, FDA Takes Action

By Burg Simpson

gabapentin pills

On December 19, 2019, the FDA warned the public of the association between gabapentinoid use and severe breathing difficulties. An FDA evaluation has revealed patients with pre-existing respiratory risk factors who use gabapentin or pregabalin may experience serious breathing difficulties. The respiratory risk factors of concern include old age, lung problems such as chronic obstructive… Read more »

Medtronic Recalls Drug Infusion Pump due to Permanent Stalling

By Burg Simpson

Medtronic implantable drug infusion pump

On December 13, 2019, Medtronic circulated a letter warning healthcare providers of a stalling issue with the Synchromed II, an implantable drug infusion pump manufactured and distributed by the firm. The infusion pumps are used in combination with a catheter to deliver specific prescribed drugs into a patient’s body in a controlled manner. However, Medtronic… Read more »

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 »

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