A lawsuit has been filed in state court in Cook County, Illinois alleging that Pentax Medical, a division of Pentax of America, is liable for the death of a woman who died of a superbug infection after underoing a procedure with a duodenoscope. The August 31 lawsuit alleges that the scope was defectively designed, making it difficulty to sterilize. Duodenoscopes are snaked down the esophagus and into the small intestine to diagnose and treat gastrointestinal conditions. The devices have come under scrutiny following several outbreaks of infection from antibiotic-resistant bacteria.
The lawsuit was filed on behalf of the estate of a woman who died of infection with carbapenem-resistant Enterobacteriaceae (CRE) after undergoing Endoscopic Retrograde Cholangiopancreatography (ERCP) at Advocate Lutheran General Hospital in the Chicago suburb of Park Ridge, Illinois. The suit alleges that the hospital failed to adequately clean the scopes, leading to infections in 43 other patients. Continue reading
A number Covidien Puritan Bennett 980 Ventilator System units have been recalled because a software error may cause the amount of air being delivered to the patient (tidal volume) to be lower than the amount programmed by the clinician.
Lots with product codes 980U1ENDIUU, 980U1ENDIUUS, 980U3ENDIUU, 980U3ENDIUUS, 980N1ENDIUU, 980N1ENDIUUS, 980N3ENDIUU, and 980N3ENDIUUS are affected by the recall. These ventilators were manufactured March 2014 to June 2015 and were distributed from March 1, 2014 to June 17, 2015. A total of 657 ventilators were recalled in the U.S. Continue reading
The first of the consolidated multidistrict litigation (MDL) cases over Wright Medical Conserve metal-on-metal hip implants continues to move forward. United States District Judge William S. Duffrey, Jr. issued a 123-page order in the case on August 31. Wright Medical had claimed that the design-defect claims were preempted by the Medical Device Amendment to the Food Drug & Cosmetic Act, but this argument was rejected by the Court. The Court also denied motion for summary judgement related to the plaintiff’s claims for defective design, fraudulent misrepresentation, concealment and punitive damages.
Plaintiffs in the MDL allege that Wright’s Conserve hip implant caused serious injuries as a result of its metal-on-metal design. All-metal hip implants have come under increased scrutiny in recent years in light of multiple recalls and high failure rates. The devices were first marketed as being more suitable for younger, more active patients. However, the implants have a risk of shedding or fretting metal particles into the bloodstream and nearby tissues when the surfaces of the implant rub together. This can lead to a host of complications, including metal poisoning. In some patients, it was necessary to perform a revision surgery to remove and replace the implant. Continue reading
A team of researchers based in Boston found that osteoarthritis patients who had total knee or hip joint replacement surgery (arthroplasty) were at increased risk of heart attack (myocardial infarction) in the early post-operative period.
The findings, published this week in Arthritis & Rheumatology, a journal of the American College of Rheumatology (ACR), indicate that long-term risk of heart attack did not persist, but the risk for venous thromboembolism—blood clot in veins and lungs—remained years after the procedure, News-Medical.net reports. Continue reading
Because pure powdered caffeine products “are dangerous and present a significant or unreasonable risk of illness or injury to consumers,” the Food and Drug Administration (FDA) issued warning letters to five distributors of pure powdered caffeine and the agency has renewed warnings to consumers about this substance.
A teaspoon of pure caffeine is roughly equal to 28 cups of coffee. A tablespoon of pure caffeine can be lethal. A 100-gram package (which is about 3.5 ounces) can have as much caffeine as 400 “tall” cups of Starbucks coffee, 1,250 cans of Red Bull or 3,000 cans of Coke, the New York Times reports. In 2014, two otherwise healthy young men died after using too much pure caffeine, prompting the FDA to issue a safety warning. Continue reading
The European Medicines Agency (EMA) instituted a ban on about 700 generic medicines that were approved based in part on what were said to be flawed clinical studies conducted at GVK BioSciences, a contract research organization based in Hyderabad, India.
The U.S. Food and Drug Administration (FDA) said it found no systemic issues affecting the safety or efficacy of generic drugs tested at GVK BioSciences, but the FDA said it supports Europe’s ban, according to Outsourcing-Pharma.com. The banned medicines include different formulations and strengths. Continue reading
On Friday, the Food and Drug Administration (FDA) warned diabetes patients that an entire class of diabetes drugs can cause severe and disabling joint pain.
The drugs include Januvia (sitagliptin), Onglyza (saxagliptin), Tradjenta (linagliptin) and Nesina (alogliptin). They are all in the same class and work by making more insulin available to the body. Continue reading
The U.S. Food and Drug Administration (FDA) is implementing whole genome sequencing to quickly detect and stop the spread of foodborne illnesses, Business Insider reports. The process offers huge advantages over the previous method, where samples from sick patients were tested to see if infections were caused by the same pathogen. Once enough matches appeared, the sick individuals were interviewed by epidemiologists to see if a common food was responsible for the outbreak. This method, however, does not conclusively find the cause and is time-consuming. “While all of this was going on, more contaminated product was getting out into the public,” said Dr. Steven Musser, deputy director for scientific operations at the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition, according to Business Insider.
The FDA is now having state and federal labs map out the exact genome of strains of foodborne pathogens such as Listeria and Salmonella. The National Institutes of Health houses a public database, known as GenomeTrakr where all the sequences are uploaded. Whole genome sequences allows scientists to distinguish a pathogen from related species, as well as slight mutations within the same strain. Continue reading
FDA Takes Action Against Three Tobacco Companies over “Additive-Free” and “Natural” Marketing Claims
Three tobacco companies—ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd.—have received warning letters from the Food and Drug Administration (FDA) over “additive-free” and/or “natural” claims on their cigarette labels.
ITG Brands LLC makes Winston cigarettes, labeled additive-free; Santa Fe Natural Tobacco Company’s Natural American Spirit cigarettes are labeled additive-free and natural; and Sherman’s 1400 Broadway N.Y.C. Ltd.’s Nat Sherman cigarettes are labeled natural, WebMD reports. The companies may not represent “implicitly or explicitly . . . that the product presents a lower risk of tobacco-related disease,” the FDA news release says. Continue reading
Medical device maker Stryker Corporation is recalling nearly 17,000 orthopedic implant devices because of potential of damage during shipping.
The Food and Drug Administration (FDA) notice lists five devices included in the recall: the rHead lateral stem and Recon radial implant, both for replacement of the proximal end of the forearm’s radius bone; the uHead ulnar implant and Sigmoid Notch radial plate, both for replacement of the distal radioulnar joint; and the Radio-Capitellum to improve elbow function, Medscape reports. Continue reading