St. Jude Medical Inc.’s Riata defibrillator leads, which the company stopped selling last year, were recalled by the U.S. Food and Drug Administration because of their potential to injure or kill patients. The devices remain implanted in an estimated 79,000 U.S. patients. The company voluntarily sent a letter to doctors…
The FDA have added new safety warnings to the heart rhythm drug Multaq, (dronedarone) after Sanofi company study linked the medication to higher rates of heart attack, stroke and death in a subset of patients. The FDA completed a safety review of dronedarone, which showed that the heart drug increased…
The U.S. Judicial Panel on Multidistrict Litigation (JPML) has rejected calls for all federal Plavix lawsuits to be consolidated in one court for coordinated handling during pre-trial litigation. This means that the litigation will proceed as individual cases in various district courts throughout the United States. Last week, the JPML…
According to plaintiffs’ lawyers, Knauf Plasterboard Tianjin Co., (KPT) a Chinese drywall maker, agreed to pay at least $800 million to settle homeowner claims that defective building materials contaminated their homes with corrosive sulfur fumes. Knauf agreed to settle claims involving about 4,500 properties that contain the defective drywall. Homeowners…
As public awareness of problems with artificial hips and other medical implants increase, legislation was introduced in the Senate that would force manufacturers to track the performance of such products after they were approved for sale. The bill would allow the Food and Drug Administration (FDA) to compel companies to…
A motion has been filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) to consolidate and centralize all federal Wright Conserve hip replacement lawsuits. These lawsuits have been brought in courts throughout the United States by individuals who experienced injury problems after receiving the metal-on-metal artificial hip system. Several…
Transvaginal mesh plaintiffs are petitioning for the vaginal mesh litigation pending against 4 different companies to be centralized before one judge in the U.S. District Court for the Southern District of West Virginia. As described in previous blogs, thousands women throughout the United States are bringing product liability lawsuits against…
A panel of federal drug experts has recommended that the FDA require newer warnings for side effects of the Ortho Evra birth control patch. These patches may increase the risk of venous thrombosis embolism (VTE) when compared to using some older oral contraceptives. The panel did not recommend that the…
Another example of a corporation being caught with its hand in the cookie jar. Medtronic has agreed to pay the U.S. Justice Department $23.5 million to settle allegations that the company paid doctors to implant its pacemakers and defibrillators. The Justice Department investigation alleged that Medtronic paid doctors between $1,000…
This week the FDA held a 2 day meeting evaluating the newer oral, patch and ring contraceptives. This was a long overdue and highly anticipated hearing. The FDA advisory panel voted 19-5 that the benefits of the Ortho Evra norelgestromin/ethinyl estradiol transdermal patch outweigh the blood clot risks, but panel…