In a three-week civil trial, a woman who developed ovarian cancer and underwent a hysterectomy testified that she used Johnson & Johnson (J&J) Baby Powder and Shower to Shower Powder for decades as part of her feminine hygiene routine, Reuters reports.
The plaintiff was awarded $5 million in compensatory damages and $50 million in punitive damages. The plaintiff said she was diagnosed with cancer in 2011. She was 57 years old at the time. Continue reading
Safety checks play a vital role in the security and confidence the consumer presumably has in a medical device or apparatus. The U.S. Food and Drug Administration (FDA) is the authority the public counts on for verification of a medical product or device. Despite the approval, or lack of it, there are approximately 3,000 deaths a year resulting from medical device problems, according to the Brookings Institute, reports The New York Times.
Prescription drugs have a data base that is made public by Medicare for medical claims and is readily accessible. Medical devices, however, have a “passive system” of notification which means hospitals, nursing homes, medical device manufacturers and importers are required to notify the FDA of problems or adverse effects as they arise. Doctors, nurses, and other health care professionals are not held to the same requirement, reports the Times. The FDA categorizes this sort of voluntary data collected as potentially “incomplete, inaccurate, untimely, unverified, or biased.” Continue reading
A class 1 recall has been issued by Focus Diagnostics for herpes simplex virus 1 and 2 and group A streptococcus infection test kits due to inaccurate test results. A class 1 recall is the most serious type of recall and is defined by the U.S. Food and Drug Administration (FDA) as “a situation in which there is a reasonable probability that the use or exposure to a violative product will cause serious health consequences or death.”
The tests involved in the recall were the Simplexa Herpes Simplex Virus 1 & 2 Direct and Simplexa Group A Strep Direct kits containing direct amplification discs. The discs were used together with molecular testing to detect the presence of herpes simplex virus (HSV) 1 and 2 or group A streptococcus (GAS). The devices had insufficient overlay between the sample reaction wells, which may cause leakage into adjacent wells, which may cause cross-contamination between samples, according to the FDA. Continue reading
New York law is being scrutinized for its statute of limitation provisions in child sex abuse cases. New York Daily News reports that Assemblywoman Margaret Markey, a longtime advocate for sexual abuse victims, is proposing that the NYS Child Sex Abuse law be revised to eliminate criminal and civil statutes of limitation for child sexual abuse. The proposed bill would also provide a one-time, one-year window for victims to file if their cases were barred by former SOL. The bill is currently in the assembly, with hopes that Markey can push it through to the Senate and then to the Governor.
Current New York law states that child sexual abuse victims can bring a criminal or civil lawsuit against their abuse until the age of 23. After that, they no longer have the legal grounds to do so. According to NY Daily News, critics call the state’s archaic law “a national shame” considering the fact that many do not report the abuse until adulthood. The current SOL is one of the shortest windows in the country, and many say it gives abusers a way to dodge their actions. Since 2006, efforts to pass the Child Victims Acts have failed four times in New York. Continue reading
The Philippine Food and Drug Administration has recalled a batch of a tuberculosis drug after the drug failed a laboratory test. Test results show the drug had an insufficient amount of one of its active ingredients and it also failed a dissolution test.
According to FDA OIC-Director General Maria Lourdes Santiago, the recalled drug is Onecure, a combination of the drugs Rifampicin, Isoniazid, Pyrazinamide and Ethambutol HCl, batch EZ6369, with an expiration date of December 2016, according to the Manila Bulletin. Continue reading
The U.S. Food and Drug Administration (FDA) has been made aware of a possible contamination of Listeria monocytogenes. The agency is working with the Oregon Potato company involving bulk shipments of onions that may be contaminated with Listeria. The Pasco, Washington company deals only with bulk quantities for hotels, restaurants, wholesalers, and, therefore, the FDA has not posted a recall.
“Oregon Potato notified its customers directly of the recall because they only sell products in bulk and the customers would not be able to recognize OPC products at the retail level, “an FDA spokeswoman said. Continue reading
According to the U.S. Department of Agriculture’s Food Safety and Inspection Service, Pilgrim’s Pride Corp. is recalling roughly 4.5 million pounds of fully cooked chicken products. The recalled products may contain extraneous materials such as plastic, wood, rubber and metal, an FSIS news release states.
An initial recall was issued on April 7th for 40,780 pounds of chicken nuggets produced on Oct. 5, 2015. That recall affects the following product:
• 20-lb. cardboard boxes containing two, 10-lb. clear plastic bags of fully cooked chicken nuggets labeled as “GOLD KIST FARMS Fully Cooked Whole Grain Popcorn Style Chicken Patty Fritters” with package codes 5278105021, 5278105022, 5278105023, 5278105000, and 5278105001. Continue reading
A 22-month old boy was found dead under a fallen IKEA chest of drawers at his home in Minnesota. This follows the death of a 2-year-old boy from Pennsylvania in February 2014. Three months later, a 23-month-old boy from Washington was killed. All three tragedies involved the self-assembly IKEA Malm chest of drawers, reports the Sydney Morning Herald.
The mother of the child from Pennsylvania has filed a wrongful-death lawsuit against IKEA last May. Her claim is that the 60-kilogram dresser’s “defective and dangerous design” lacked proper warnings. Continue reading
The U.S. Navy and Northrop Grumman have been ordered by New York Governor Andrew Cuomo to allow access to monitoring wells so the state and a local water district may test water supplies for potential contamination, the Long Island Press reports.
N.Y. Senator Chuck Schumer, said testing of wells is “just what the doctor ordered” for residents in Massapequa, Bethpage and South Farmingdale. These are towns where the so-called “Grumman Plume” has threatened water supplies. The plume has been estimated as be a 4.5-mile long by 3.5-mile wide “cocktail of potentially harmful chemicals” which has been traveling south-southeast unstopped for several decades, according to the Long Island Press. Continue reading