Health & Patient Safety News

Following Ban on Transvaginal Mesh Devices, Panel Discusses Hernia Mesh Safety

On April 16, 2019, the FDA ordered all manufacturers of transvaginal mesh devices to stop selling and distributing their products in the U.S. immediately. This was the culmination following a series of actions meant to protect women’s health and was made in response to growing…

By Eric T. Chaffin

/ 27 Jun 2019

After Third Roundup Trial Verdict, Will Bayer Consider Settlements?

In May 2019, a California jury handed down a $2 billion verdict in the third Roundup trial to result in a plaintiffs’ verdict. The couple who brought the lawsuit claimed they developed cancer after using the weed killer and its active herbicide glyphosate for many…

By Roopal Luhana

/ 14 Jun 2019

After Third Roundup Trial Verdict, Will Bayer Consider Settlements?

FDA Ends “Hidden Reporting” Program for Medical Devices

When something goes wrong with a medical device, the manufacturer is typically required to report those problems to the Food and Drug Administration (FDA). These reports are then added to a database and made available to the public—unless the manufacturer manages to get an exemption…

By Eric T. Chaffin

/ 7 Jun 2019

FDA Ends “Hidden Reporting” Program for Medical Devices

FDA Warns of Battery Problems with Medtronic Pacemakers

The FDA recently warned patients and doctors about a potential problem with certain Medtronic pacemakers. The batteries in these pacemakers may drain more quickly than they should, presenting a danger that the device may not deliver the appropriate pacing therapy. Should that happen, patients who…

By Roopal Luhana

/ 31 May 2019

Bayer Seeks Dismissal of Roundup Cancer Verdict

Back in August 2018, a California state court jury awarded $289 million in damages to the plaintiff in a Roundup weed killer lawsuit, after which the Court reduced the verdict to $78 million. The plaintiff claimed that he developed non-Hodgkin’s lymphoma after regular exposure as…

By Roopal Luhana

/ 21 May 2019

FDA Says Allopurinol—not Uloric—Should be First-Line Treatment for Gout

Pharmaceutical company Takeda recently suffered a blow when the FDA determined that their medication, Uloric (febuxostat), should no longer be recommended as a first-line treatment for gout. After reviewing the data from a post-marketing trial required as a condition of Uloric’s approval, the FDA an

By Eric T. Chaffin

/ 14 May 2019

California Man Suffers Prolonged Pain After Hernia Repair with Parietex Products

A California man has filed a new hernia mesh lawsuit against manufacturer Covidien, L.P., and Medtronic, Inc. He claims that after being implanted with the Covidien Parietex Optimized Composite Mesh and the Covidien Parietex Hydrophilic Anatomical Mesh, he suffered permanent injuries and significant

By Eric T. Chaffin

/ 8 May 2019

California Man Suffers Prolonged Pain After Hernia Repair with Parietex Products

FDA Consulted with Expert Panel Before Requiring Black Box Warning on Uloric

When the FDA first approved the gout medication Uloric (febuxostat) in 2009, they required a warning be placed on the label that alerted doctors and patients to a potential increased risk of cardiovascular events such as heart attack and stroke. However, clinical trials that manufacturer…

By Eric T. Chaffin

/ 30 Apr 2019

FDA Consulted with Expert Panel Before Requiring Black Box Warning on Uloric

U.S. Congress Considers Bill to Ban Flavored Cigarettes

The U.S. Congress is considering new legislation that would ban flavored e-cigarettes, which are believed to be partially to blame for the increase in teenagers becoming addicted to nicotine through vaping. U.S. House Representative Diana DeGette (Dem-Colorado), introduced the bill known as the “SAF

By Eric T. Chaffin

/ 22 Apr 2019

FDA Warns Patients to Avoid Purchasing Pre-Owned Test Strips Online

Individuals with diabetes and some heart conditions are required to check their blood regularly. For example, patients with heart conditions who are taking the blood thinning medication warfarin test their blood to make sure that they are receiving the correct dosage, and to avoid developing…

By Roopal Luhana

/ 22 Apr 2019

J&J Settles Three Talc-Cancer Lawsuits: A Trend?

Johnson & Johnson (J&J) recently settled three different lawsuits concerning in which plaintiffs alleged that its talc-based products caused cancer. Though the company denied that it is entering into a settlement program to resolve the thousands of other similar lawsuits, it remains to be seen…

By Eric T. Chaffin

/ 18 Apr 2019

FDA Warns Xeljanz May Increase Risk of Blood Clots and Pulmonary Embolism

The FDA recently warned that patients with rheumatoid arthritis (RA) who are taking the 10 mg twice-daily dose of tofacitinib (Xeljanz, Xeljanz XR) may be at an increased risk for blood clots and pulmonary embolism. The FDA has not approved this dosage for patients with…

By Roopal Luhana

/ 15 Apr 2019