A Georgia jury has ordered Wright Medical Technology to pay $11 million to a woman implanted with a Conserve metal-on-metal hip implant. The plaintiff was awarded $1 million in compensatory damages and $10 million in punitive damages. The bellwether trial lasted two weeks and concluded on November 24, 2015.
The woman who filed the suit was implanted with the Conserve hip implant in 2006. After the device was implanted, she experienced loosening and a displaced acetabular cup. In 2012, she underwent surgery to correct these complications. According to her lawsuit, the surgeon discovered signs of metallosis causing soft tissue damage during the procedure. The lawsuit alleges that these complications are due to the implant’s defective metal-on-metal design. Wright is accused of failing to warn about the risks. Continue reading
Boston Scientific Corp. has recalled RotaWire Elite core wires, part of a system used to open narrowed arteries and improve blood flow to the heart because the wires may crack and separate from the apparatus and cause serious injury to the patient.
If the wires of the Rotablator Rotational Atheroctomy System crack and separate, injuries can include tamponade (blood in the sac around the heart causing decreased heart function), myocardial infarction (heart attack), and migration of wire fragments elsewhere in the body, according to the Food and Drug Administration (FDA). Continue reading
The Food and Drug Administration (FDA)’s Office of Women’s Health has issued an update on the agency’s evaluation of the safety of the Essure birth control system.
Essure—a form of permanent birth control (female sterilization)—is under FDA review in response to thousands of adverse event reports. The agency is reviewing information from a September panel meeting, the public docket, and medical literature and adverse event reports that have been published or received since the panel meeting. The FDA anticipates communicating its recommendations at the end of February 2016. Continue reading
Costco’s rotisserie chicken salad has been linked to at least 19 cases of E. coli infection, the U.S. Centers for Disease Control and Prevention (CDC) announced. The outbreak has affected the following seven states: Montana, Utah, Colorado, California, Missouri, Virginia and Washington. The CDC says the pathogen implicated in the outbreak is E. coli O157:H7. No deaths have been reported so far, but five people have been hospitalized and two have developed hemolytic uremic syndrome (HUS), a type of kidney failure that can result in permanent organ damage, according to Reuters.
The contaminated ingredient has not yet been identified, the CDC says. In 14 of 16 cases, the chicken salad was bought or eaten a week before getting sick. Federal regulators notified Costco of the E. coli cases on November 20, and the company stopped selling them that same day, said Craig Wilson, vice president of food safety at Costco. Continue reading
The U.S. Food and Drug Administration (FDA) has ordered Custom Ultrasonics to recall all of its automated endoscope reprocessors (AERs), devices used to sterilized special medical scopes such as duodenoscopes. According to a Nov. 13 announcement, the recall is being issued due to “continued violations of federal law and a consent decree entered with the company in 2007”. These violations can increase the risk of transmitting bacteria, a problem that has recently come to light following several superbug outbreaks associated with tainted duodenoscopes. Custom Ultrasonics was ordered to recall all of its AERs from health care facilities, which are advised to use alternative methods to reprocess flexible endoscopes.
The recall affects some 2,800 AERs in hospitals and outpatients clinics located around the country, the FDA announcement said. All models are affected, including the System 83 Plus, System 83 Plus 2 and System 83 Plus 9. Custom Ultrasonics must submit a written recall proposal to the FDA within seven business days. William Maisel, M.D., M.P.H., deputy director for science and chief scientist in the FDA’s Center for Devices and Radiological Health, said “We are taking action because Custom Ultrasonics failed to meet its legal and regulatory obligations,” according to the announcement. “The FDA’s recall order stemmed from the company’s continued violations of federal law and the consent decree and is necessary to protect the public health.” Continue reading
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