By John Roberts, Burg Simpson Associate Fire Concerns Prompt Recall of Edwards Lifesciences’ Hospital Bedside Monitoring Systems On March 21, 2019, Edwards Lifesciences LLC initiated a recall of its EV1000 clinical platforms. “Clinical platforms” are best characterized as the bedside computer system used to monitor a patient’s pulse and blood pressure both during and after… Read more »
Ethicon Recalls Surgical Staplers On April 11, 2019, Ethicon, a subsidiary of Johnson & Johnson, issued a recall of it intraluminal surgical staplers. The surgical staplers are used in gastrointestinal tract surgeries to fire staples to create connections between structures (anastomoses). The Ethicon surgical staplers may have been used in patients who have undergone gastrointestinal… Read more »
By Kenneth M. Daly, Burg Simpson Associate Burg Simpson Files Complaint Against Endologix For Failed AFX AAA Device On April 29, 2019, Burg Simpson filed a products liability lawsuit against Endologix, Inc. (Endologix) regarding its AFX Endovascular AAA System used to repair abdominal aortic aneurysms. Plaintiff alleges, that as the result of a failed AFX… Read more »
By David C. Harman, Burg Simpson Shareholder Cook Medical Recalls Dangerous Transseptal Needle On March 13, 2019, The U.S. Food and Drug Administration (FDA) announced that Cook Medical Inc. sent an urgent recall notification letter to affected customers regarding its Transseptal Needle. Cook Medical’s Transseptal Needle is a surgical device used to gain access to… Read more »
RHEUMATOID ARTHRITIS MEDICATION INCREASES RISK OF BLOOD CLOTS IN LUNGS AND INCREASES RISK OF DEATH By David C. Harman, Burg Simpson Shareholder The FDA has alerted the public about the increased risk of blood clots in the lungs and an increased risk of death among rheumatoid arthritis (RA) patients taking Xeljanz (tofacitinib). A safety committee… Read more »
TREATMENT FOR GOUT LINKED WITH AN INCREASED RISK OF DEATH By David C. Harman, Burg Simpson Shareholder The Federal Drug Administration (FDA) recently released a Safety Announcement to warn of an increased risk of death associated with the use of a gout medication called Uloric (febuxostat). Following an in-depth analysis of clinical trial data, the… Read more »
Burg Simpson Files Complaint Against Depuy Synthes For Failed Radial Head Replacement By David C. Harman, Burg Simpson Shareholder Burg Simpson is representing two plaintiffs who received a Synthes radial head medical device but had to undergo removal and/or replacement of the device just one year after implantation. Plaintiffs, both women from Ohio, suffered fractures… Read more »
BURG SIMPSON INVESTIGATES CLASS ACTION CLAIMS FOR CONSUMERS THAT PAID FOR CONTAMINATED VALSARTAN, LOSARTAN, AND IRBESARTAN If you live in Ohio, and have received notice that your blood-pressure medication Valsartan, Losartan, or Irbesartan was recalled due to contamination with the carcinogens NDMA or NDEA, call Burg Simpson today! Burg Simpson is investigating potential class action claims that… Read more »
Treatments for Peripheral Arterial Disease Linked with Increased Risk of Death By Jessica Powell, Burg Simpson Associate The FDA recently released a letter warning physicians about a new study linking two treatments for peripheral arterial disease– paclitaxel-coated balloons and paclitaxel-coated stents– with an increased risk of death when compared to non-coated balloons or stents. In… Read more »
Reusable medical device can save lives… and spread infection By Jessica Powell, Burg Simpson Shareholder The FDA issued interim results of an ongoing, mandated post-market surveillance studies in order to “inform patients, hospitals and health care facilities of higher-than-expected contamination rates with duodenoscopes after processing.” But what does that mean? Duodenoscopes Duodenoscopes are a very… Read more »
