Administrative Judge Kevin Dougherty of the Philadelphia Court of Common Pleas ordered the creation of a mass tort, transferring roughly 75 cases involving the blood thinner Xarelto to the court’s Complex Litigation Center.
The lawsuits are filed against Johnson & Johnson subsidiary Janssen Pharmaceuticals and Bayer HealthCare Pharmaceuticals. The lawsuits allege that Xarelto (rivaroxaban) causes uncontrollable and sometimes fatal bleeding, the Legal Intelligencer reports. An attorney representing several plaintiffs said Xarelto can cause “bleeding that cannot be stopped because there’s no antidote. The person can bleed to death or sustain serious injuries which could have been controlled in another product.” Continue reading
A single-car accident on Long Island left one person dead and two more critically injured, Associated Press reports. The crash occurred at 4:30 a.m. Monday in Deer Park. Suffolk County Police have not yet determined the cause of the crash, but they say it was not a result of the weather.
The three occupants were in a 2003 Infiniti southbound on Straight Path when it swerved off the road and crashed into a tree south of Sagamore Lane. One of the occupants, a 28-year old man of Wyandanch, was ejected from the vehicle and pronounced dead at the scene. The other two occupants were also of Wyandanch. Police do not know who was the driving the car.
As a community downstream from the January 17 Poplar Pipeline oil spill into the Yellowstone River works to treat benzene contamination of its water supply, concerns are being raised about oversight of the nation’s aging pipeline network.
Federal investigators and pipeline company officials were trying to determine the cause of the 40,000-gallon spill, which contaminated downstream water supplies in the city of Glendive, Montana, The Associated Press (AP) reports. Continue reading
When a drug is approved by the U.S. Food and Drug Administration (FDA), it may give some the impression that it is proven to be safe and effective for a certain condition. An investigation by the Milwaukee Journal Sentinel, however, shows that this is not necessarily true. By focusing on new diabetes drugs that have been on the market, the investigation suggests that FDA approval is no guarantee of safety or efficacy.
Diabetes medications such as Januvia, Byetta and Victoza were linked to 3,000 deaths and about 20,000 hospitalizations in the last decade. Furthermore, the report showed that none of the 30 new diabetes drugs have been shown to decrease the risk of key complications associated with the condition, such as heart attacks, stroke and blindness. Continue reading
A study of Danish women of reproductive age suggests that long-term use of hormonal contraceptives is associated with an increased risk of brain tumors.
Hormonal contraceptives, which contain female sex hormones, are commonly prescribed in pill form. “The Pill” first became widely available in the 1960s and gave women all over the world control over childbearing. The new study, which appeared in the British Journal of Clinical Pharmacology, reports that taking a hormonal contraceptive for at least five years is associated with a possible increase in the woman’s risk of developing a rare tumor, glioma of the brain, Science 2.0 reports. Continue reading
The Medicines and Healthcare Products Regulatory Agency (MHRA), Britain’s drug regulatory agency, has issued a statement urging healthcare professionals to give women better information on the risk of birth defects when Depakote and other valproate medicines are used during pregnancy. These medications are used to treat epilepsy and bipolar disorder.
Following a European review last year, which found that up to 40 percent of children born to women who take valproate during pregnancy may have developmental disorders and other birth defects, MHRA moved to strengthen product information. The agency is making informational booklets available to healthcare professionals and patients and the leaflet in the drug packing is being updated with stronger warnings about the risk of developmental disorders in children exposed to valproate during pregnancy. The review found that of 35,000 women prescribed valproate, 375 become pregnant per year while taking it. Continue reading
A whistleblower who reported misconduct at Canaveral National Seashore has won a retaliation ruling against the U.S. Department of Interior, Florida Today reports. The former employee filed a suit in 2011 alleging misconduct, including contracting violations and nepotism. Continue reading
The British Medicines and Healthcare Products Regulatory Agency (MHRA) has announced the recall of Smith & Nephew Renasys negative pressure wound care devices because of the risk of maceration, infection, loss of negative pressure, or unrecognized bleeding in wounds if there is a blockage in the vacuum system of the affected devices.
A negative pressure wound therapy (NPWT) device is an electric pump system that applies a vacuum to chronic, deep cavity wounds. The systems use disposable components such as foam or gauze dressings and tubing. If a blockage in the system is not detected, fluid from the wound can build up and leak from the dressing, according to the MHRA. The affected devices may not detect blockages and the alarm will not sound even if the dressing has visibly lifted from the wound. Continue reading
The Food and Drug Administration has issued a safety alert to healthcare providers, patients, and parents and guardians that bone graft devices containing recombinant proteins or synthetic peptides should not be the first treatment considered for patients under age 18.
Certain recombinant proteins and synthetic peptides mimic bone growth substances normally found in the body and may be added to a carrier and then surgically implanted in a patient with a bone defect to promote new bone growth or to replace or heal existing bone. The FDA has approved devices such as Medtronic Infuse for orthopedic and dental use only in patients over the age of 18 who are done growing (skeletal mature). The labeling for each product provides the specific indications for use. The FDA has not evaluated their safety and effectiveness in patients under age 18, who are considered skeletally immature. Any product that affects bone growth has the potential to negatively impact skeletal development by altering normal bone formation and growth, especially if implanted near open growth plates. Continue reading
As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.
E-cigarettes, battery-powered devices that heat nicotine liquid into an inhalable vapor, have been touted as a means to wean smokers from traditional cigarettes. They do not produce smoke, and there is no carcinogenic tar produced in burning tobacco in traditional cigarettes. But smokers are not adopting the devices in the numbers expected, The New York Times reports, and some experts argue that e-cigarette manufacturers see them not as a cessation device but as a way to introduce nonsmokers, in particular young people, to smoking. Continue reading