Articles from Burg Simpson

Baxter Healthcare Recalls Infusion Pumps Following Unplanned Shutdowns and Reports of Serious Injuries

By Burg Simpson

On December 1, 2020, the FDA announced Baxter Healthcare is recalling more than a half a million of its Sigma Spectrum Infusion Pumps following reports of unplanned shutdowns that could lead to infusion delays or interruptions in treatment. Unfortunately, there have already been at least 17,493 complaints about the shutdown issue. Even scarier, there have been… Read more »

Cook Medical Recalls Fixed Core Wire Guides

By Burg Simpson

Cook Medical is recalling one lot of its Fixed Core Wire Guides because it was dropped during production. A Fixed Core Wire Guide is a small wire device that is used to insert and guide other devices, such as a catheter, into and through a patient’s vein or artery. According to the recall notice, the… Read more »

Stryker Neurovascular Recalls Device Used to Treat Ischemic Stroke: Trevo XP ProVue Retriever

By Burg Simpson

Following 11 reports of injury, including one death, Stryker Neurovascular is recalling its Trevo XP ProVue Retriever. According to the recall, this device is intended to be used in treating an acute ischemic stroke. An acute ischemic stroke is caused when the blood flow through a blood vessel (i.e., an artery, vein, or capillary) in… Read more »

Medtronic Rashkind Balloon Septostomy Catheter Class 1 Recall

By Burg Simpson

balloon septostomy catheter

On November 3, 2020, the FDA issued a Class I recall, the most serious type of recall, for the Medtronic Rashkind Balloon Septostomy Catheter. The catheters are used during surgery to create an atrial septal defect or to enlarge an existing atrial septal defect as a treatment option for patients with cyanotic congenital heart defects…. Read more »

Onion Chopper Recalled Due to Serious Laceration Hazard

By Burg Simpson

After receiving more than 100 complaints of laceration injuries to customers’ fingers and hands, Mueller Austria is recalling its Onion Chopper Pro, model number M-700. According to the recall notice, the Onion Chopper Pro has a tab that locks the blade into position (circled below); however, that tab can detach from the device when pressed,… Read more »

Birth Defects Associated With Medications To Treat Sleep Disorders

By Burg Simpson

A recent article published in the Journal of the American Medical Association (JAMA) reports findings from a pregnancy registry linking birth defects with the use of prescription drugs Provigil and Nuvigil. Provigil (generic Modafinil) and Nuvigil (generic Armodafinil) are approved by the FDA to treat excessive sleepiness in adults suffering from narcolepsy, sleep apnea, and… Read more »

Burg Simpson Files Complaint Against Janssen Pharmaceuticals For Eye Injuries Caused By Elmiron®

By Burg Simpson

On September 22, 2020, Burg Simpson filed a products liability lawsuit against Janssen Pharmaceuticals regarding its drug Elmiron®. Elmiron, also known as pentosan polysulfate, is a drug used to treat bladder pain and discomfort from a condition known as interstitial cystitis. In the filing, Plaintiff alleges that use of this drug caused the deterioration of… Read more »

Thyroid Medication Recalled Due to Sub-Potency

By Burg Simpson

On August 24, 2020, RCL Labs, Inc. recalled 483 lots of Nature-Throid ® and WP Thyroid ® after testing revealed certain lots were sub-potent. According to a recall announcement posted by the FDA, certain lots contained less than 87 percent of the labeled amount of active ingredients. Patients being treated with sub-potent Nature-Throid® or WP… Read more »

NP Thyroid Recall Update: FDA Publishes Warning Letter to Acella

By Burg Simpson

As we reported in previous posts here and here, in May 2020 Acella Pharmaceuticals recalled 13 lots of NP Thyroid after finding the product was superpotent and posed significant risks to consumers. Following the recall, the FDA sent a strongly worded Warning Letter to Acella that laid out in detail the flaws in Acella’s manufacturing process that led to the… Read more »

Global Recall of Nasal Spray Due to Risk of Seizure, Coma, and Death

By Burg Simpson

nasal spray

Burg Simpson recently reported on the August 5, 2020 recall of super potent nasal sprays that were manufactured by Ferring Pharmaceuticals and sold in the United States. Further investigation reveals that this August recall is the continuation of a global recall of Ferring Pharmaceutical nasal sprays that began in mid-July 2020. This global recall affects Ferring Pharmaceutical… Read more »

Top 100 National Trial Lawyers Legal 500 Best Lawyers in America Super Lawyers US News 2020 Top 25 Most Influential Lawyers