A school bus accident left dozens of New Jersey high school students injured in New City, New York. State police say one school bus rear-ended another while exiting the Palisades Interstate Parkway at Exit 11. Fortunately, there were no major injuries. The school buses were carrying students who attend Northern Valley Regional High School in Demarest, New Jersey.
According to Associated Press, the accident occurred on October 17th just after 2 p.m. All injuries were considered minor, and 40 to 60 students were taken to the hospital for bumps and bruises. Continue reading
In an October 2016 “Urgent Field Safety Notice”, Medtronic warned that some rechargers for its deep brain stimulation devices may be prone to an “error state” and fail to charge. According to the letter, some of its Model 37751 rechargers may become unresponsive and fail to recharge the neurostimulator until they are reset. The company has received reports of the chargers malfunctioning, where they bleep every five seconds while displaying a blank screen.
According to the letter, the “error state” occurs in 2 percent of rechargers manufactured after November 2014 and 0.2 percent of rechargers manufactured before that date. The serial numbers on rechargers manufactured November 2014 and later begin with “NKA4” or “NKU4”. Continue reading
On October 3, 2016, a mother claimed that the active ingredient in the anti-nausea drug Zofran’s caused her son to develop cleft palate and cleft lip in the womb. The woman, from Oneida, New York, filed her case in the U.S. District Court of Massachusetts, where more than 280 additional Zofran lawsuits are currently consolidated.
In 2012, researchers at Harvard and Boston University discovered that women prescribed Zofran for nausea during pregnancy were more than twice as likely to deliver children with a cleft palate. Zofran’s warning label, however, does not mention a potential increased risk for cleft palate. Continue reading
On October 11, 2016, the U.S. Food and Drug Administration (FDA) issued a safety warning for premature battery depletion of the St. Jude Medical Implanted Defibrillator. The St. Jude products in question were manufactured before May 2015 and are ICD and CRT-D models.
A medical advisory has been released by St. Jude Medical. The FDA is investigating potential cybersecurity errors that may be responsible for the rapid battery depletion of the defibrillators. There are 398,740 affected devices sold worldwide and 841 were returned for examination. The FDA will keep the public apprised of any new information as it becomes available. Continue reading
Interlogix is recalling 67,000 personal panic devices because they may fail to operate in case of an emergency. According to a recall alert posted on the U.S. Consumer Product Safety Commission (CPSC) website, “The wireless personal panic devices can fail to operate, which could result in the device not communicating with the security system if activated in the event of an emergency.” The devices were manufactured in Mexico and sold by professional security installers and distributors across the country from May 2014 to January 2016. The personal panic devices were priced from about $35 to $60.
The wireless personal panic devices are supposed to be connected to a security system so that the wearer has a quick way to call for help in case of an emergency. This is the type of device that may be purchased for an elderly family member, for example. The recall is being issued because the panic devices may fail to communicate properly with the security system. Continue reading
Johnson & Johnson is faced with a growing number of lawsuits from women who allege that Johnson’s Baby Powder and Shower to Shower body powder are responsible for their ovarian cancer.
The lawsuits include wrongful death lawsuits from the families of women who have died of the disease, Top Class Actions reports. Eighty-one named plaintiffs claim they or their loved ones were diagnosed with or have died from ovarian cancer resulting from years of use of talcum powder for feminine hygiene. Continue reading
Instances of food company executives receiving prison sentences and serving time over large, even deadly, food poisoning case are mounting. Now, some wonder why pharmaceutical and medical device company executives are not subject to the same punishments.
Stewart Parnell, former owner of Peanut Corporation of America (PCA) was at the center of an historic, massive peanut paste contamination and facing life imprisonment; his brother, a food broker, faced 17 years in prison. The case was the first time a food company official received a conviction on federal felony charges tied to a food contamination epidemic, according to CNN. Both men were charged with felony charges by the Department of Justice (DOJ) and a Georgia jury convicted Stewart on 72 counts of conspiracy, fraud, and the introduction of adulterated foods into interstate commerce. He was sentenced to 28 years; his brother was sentenced to 20. Continue reading
The family of a now-deceased Florida man has filed a lawsuit in Pennsylvania over the alleged failure of the Rex Medical Option Inferior Vena Cava (IVC) filter device. The lawsuit was filed in Pennsylvania.
In September 2014, the man was implanted with Rex Medical’s Option IVC filter. The implantation surgery was conducted to prevent a pulmonary embolism (PE). PEs take place when a blood clot that starts in the body’s lower extremities travel to the arteries in the lungs and block blood flow. Continue reading
Medtronic PLC just recalled certain lots of four of its neurovascular products. The device maker noted that the recalled devices might lead to a thromboembolic event (blood clot) in patients. The recalled Medtronic neurovascular products are:
- Pipeline Embolization Device (1742 lots affected)
- Alligator Retrieval Device (171 lots affected)
- X-Celerator Hydrophilic Guidewire (210 lots affected)
- UltraFlow HPC Flow Directed Micro Catheters/Marathon Flow-Directed Micro Catheters (1790 lots affected)
A number of lawsuits have been filed over Risperdal, an antipsychotic medication marketed by Johnson & Johnson’s Janssen Pharmaceuticals. Plaintiffs allege that the drug caused gynecomastia, or abnormal breast growth, in adolescent boys. The suits allege that J&J knew about these risks but failed to disclose them to patients, physicians and the U.S. Food and Drug Administration (FDA). The fifth Risperdal case went to trial in July; after hearing arguments from both sides, jurors awarded a $70 million verdict to the plaintiff.
One of the most compelling pieces of evidence came from former U.S. Food and Drug Administration (FDA) Commissioner David Kessler, who gave a video deposition. Kessler told jurors that J&J manipulated Risperdal clinical data in order to downplay the risks of gynecomastia. Continue reading