A wrongful death lawsuit against Olympus America, Olympus Medical Systems Corp. and Custom Ultrasonics has been filed over the use of an allegedly contaminated medical scope. The suit was filed on behalf of a woman whose husband died of an antibiotic-resistant infection after undergoing a routine Endoscopic Retrograde Cholangiopancreatography (ERCP) with a duodenoscope, a device that is snaked down a patient’s throat to visualize and treat problems in the biliary and pancreatic duct systems.
Duodenoscopes came under increased scrutiny after being linked to outbreaks of “superbugs”, bacterial infections that cannot be adequately treated with antibiotics. In February, the U.S. Food and Drug Administration (FDA) warned that the complex design of duodenoscopes may impede effective cleaning; the agency cautioned that the devices may transit multi-drug-resistant bacteria even when cleaned according to manufacturer’s instructions. The FDA issued another safety alert in November stating that Custom Ultrasonic had “not demonstrated that its AERs can adequately wash and disinfect endoscopes to mitigate the risk of patient infection.” The company has been instructed to recall its automated endoscopes reprocessors (AER). Facilities who use Custom Ultrasonics AERs were urged to use different methods for cleaning the scopes. Continue reading
In a newly published report, a group of researchers says one third of the clinical drug trial results federal regulators review in approving new drugs are not published and the researchers are pushing for all trial results to be made public.
The study, published in BMJ Open, grades drug companies on their transparency, the Washington Post reports. The researchers examined thousands of pages of regulatory documents, counting the number of trials Food and Drug Administration (FDA) regulators reviewed, versus how many trials were published or publicly reported. Continue reading
The Food and Drug Administration (FDA) has issued a safety communication warning of the possibility of patient injury if the hydrophilic and/or hydrophobic coatings on medical devices separate—peel, flake, shed, delaminate, slough off—during use.
A number of factors can cause coating separation, including the difficulty of the procedure and the patient’s anatomy, the practitioner’s technique, and use of the wrong device for the procedure. Improper preconditioning of the device and improper storage can also contribute to the problem, as can issues with the device’s design or the manufacturing process. Continue reading
After receiving customer complaints of an “off odor” scent, Tyson Foods Inc. is recalling about 52,486 pounds of fully cooked chicken wing product. According to a release posted on the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) website, the product is “Tyson® Any’tizers® Fully Cooked Hot Wings® CHICKEN WING SECTIONS COATED WITH A FLAVORFUL HOT, TANGY SAUCE” produced on October 24, 2015 and October 25, 2015. The packaging dates are 2975PBF0508-23/2985PBF0500-01 and case codes are 2975PBF0508-23/2985PBF0500-01.
The recall is designated as Class II, which means that “This is a health hazard situation where there is a remote probability of adverse health consequences from the use of the product” according to USDA. Inside the USDA mark of inspection on the recalled products, the establishment number reads “P-13456”. This number is also located on the back of the bag above the heating instructions. The chicken wings were distributed to retailers around the country. Continue reading
According to the Consumer Products Safety Commission (CPSC), Home Depot, and salvagers and recyclers who got items from the retailer, continued to sell 28 products that were recalled between 2012 and 2015. The products pose hazards including fire, burns, shock or falls.
Home Depot sold about 1,300 units to consumers and sent 1,010 to salvagers or recyclers who could have sold them to consumers, according to the commission. Consumers who have any of the affected products should stop using them immediately and contact the manufacturer for information about a refund, a replacement or a repair. Continue reading
Judge Kenneth Powell of the Philadelphia Court of Common Pleas has paused a trial over an adolescent boy’s breast growth allegedly caused by the antipsychotic drug Risperdal (risperidone) so that the drug maker can turn over more evidence for the boy’s attorneys to review.
Janssen Pharmaceuticals Inc., a unit of Johnson & Johnson, must provide evidence, documents, reports and other nonprivileged information relating to “reanalysis data” to the attorneys representing the boy, Law360. The 11-year-old boy took Risperdal for about three years to treat Tourette’s syndrome, according to court documents. Continue reading
USPlabs LLC has been indicted on charges that it intentionally misbranded its dietary supplement products and lied to customers, the Justice Department announced. Star Advertiser reports that the company is accused of engaging in behavior intended to place its products on the shelves, even if it was dangerous to consumers. USPlabs has come under scrutiny following cases of liver damage and death related to its supplement product OxyElite Pro. According to the indictment, USPlabs deceived consumers about the nature and source of its ingredients, which were shipped from China. Four company executives, a consultant and S.K. Laboratories were indicted.
Principal Deputy Assistant Attorney General Benjamin Mizer, who is head of the Justice Department’s civil division, said “They falsified labeling and marketing materials to convince consumers, who prized natural ingredients, to buy their products,” according to Star Advertiser. “All of these people — regulators, retailers and consumers — trusted that the defendants were telling the truth about their products. All of these people were deceived.” Continue reading
A Texas appeals court has said personal injury claims against the manufacturer of a medical device accused of promoting off-label uses with kickbacks to doctors are not subject to the same requirements Texas imposes on health care liability claims.
The Third Court of Appeals in Austin said the manufacturer, Verticor Ltd., cannot avoid a patient’s claim the company solicited a doctor to do an off-label surgery implanting Verticor’s Eclipse Sphere device into his spine to treat a herniated disc, Law360 reports. Continue reading
Underactive Thyroid Reported in Some Infants after Use of Iodine-containing Contrast Agents for Medical Imaging
The Food and Drug Administration (FDA) has issued a safety communication advising that rare cases of underactive thyroid have been reported in infants after the use of “contrast dye,” for X-rays and other medical imaging procedures.
In all of the reported cases, the infants were either premature or had other serious underlying medical conditions. Based on available evidence, the agency believes that this rare occurrence is usually temporary and resolves without treatment or any lasting effects. Continue reading
Men who take Viagra are at higher risk for developing melanoma, and a California Viagra user who developed melanoma has filed a lawsuit against Pfizer, the maker of Viagra (sildenafil).
The lawsuit, filed in California federal court, claims that Pfizer failed to warn Viagra users of studies that connect the blockbuster erectile dysfunction drug to increased melanoma risk, Law360 reports. The plaintiff in the suit claims he would not have taken Viagra if he had been aware of the connection. The drug worked to treat his erectile dysfunction, but he said the melanoma risk far outweighs the benefits. Continue reading