Surgical products maker Arizant, a subsidiary of 3M, has been hit with a lawsuit charging that the Bair Hugger surgical warming blanket introduced a serious infection during a patient’s hip surgery.
The complaint alleges that the plaintiff suffered serious injuries when the Bair Hugger introduced dangerous pathogens from the operating room floor into the sterile surgical site during hip implant revision surgery. The bacteria caused a Methicillin-resistant Staphylococcus aureus (MRSA) infection. Continue reading
After consumers have publicly complained about the ineffectiveness of its sunscreen, Jessica Alba’s Honest Company is under scrutiny. The Honest Company promises to sell “safe and eco-friendly household and baby care products” and markets an SPF 30 sunscreen with “broad spectrum, mineral-based protection.” According to some consumers, however, the product did little to protect them against burns. Some have taken to social media platforms to express their frustration. One twitter user posted a photo of his reddened scalp and tweeted “this is my very real result from Honest 30 SPF sunscreen. Only spent 1 hour outside. Burnt.” CNBC reports.
NBC Chicago interviewed Gretta Stabler, who applied the product on her 6-year-old daughter four times over a three hour period. “She got really burned on her arms, shoulders, legs, face, pretty much everywhere. I was angry,” Stabler said. Continue reading
Some doctors and pharmacies have confused two different drugs with similar-sounding names, the U.S. Food and Drug Administration (FDA) warned. The agency said that it has Brintellix and Brilinta. Brintellix is an antidepressant sold by Takeda Pharmaceuticals and Astra Zeneca’s Brilinta is a blood thinner prescribed to patients who have had a heart attack or severe chest pain. The FDA said it received 50 reports of medication errors; there were 12 instances where doctors prescribed the wrong drug or the pharmacy dispensed the incorrect medication. The agency is not aware of any cases where the wrong drug was taken.
The FDA says there have been reports of medication errors since Brintellix’s approval in 2013. The two drugs have some similarities in appearance; the letter T is stamped on both tablets and in some cases both are yellow. Consumers should be aware of a few differences. Brintellix is a tear-shaped tablet stamped with the letters “TL” whereas Brilinta is a round, yellow tablet stamped with “T 90”. Continue reading
Janssen Pharmaceuticals and drug distributor McKeeson Corp. were hit with a lawsuit last week in Pennsylvania federal court by a Texas woman who says the companies failed to warn of known dangers of the antibiotic Levaquin, which she alleges caused her permanent nerve damage.
The woman was administered Levaquin both during and after heart surgery in 2006, and in her complaint she contends that the drug maker did not warn either physicians or patients that using the drug could result in permanent nerve damage. The suit said that from 2004 until 2013, the drug carried a confusing label that advised consumers the side effect was rare and symptoms would disappear when the drug was discontinued, Law360 reports. Continue reading
Since July 10th, 46 people have acquired Legionnaires’ disease in the Bronx and four people have died. According WABC, positive samples of the bacteria have been found in air conditioning at a hospital and a complex with a movie theater. Authorities are currently unsure as to whether the contaminated equipment is linked to the outbreak.
According to Mayo Clinic, Legionnaires’ disease is caused by exposure to legionella bacteria and mostly affects the lungs. Initial symptoms include headache, muscle pain chills and fever that may be 104 F or higher; these symptoms may occur two to 10 days after being exposed. Coughing (may bring up mucus and blood), shortness of breath, chest pain, gastrointestinal symptoms (nausea, vomiting, diarrhea) and confusion may occur by the second or third day. Continue reading
The Food and Drug Administration (FDA) failed to disclose a serious side effect associated with the family of antibiotics known as fluoroquinolones identified in a 2013 agency report.
In an investigation, Cleveland television station ABC5 obtained a 2013 FDA report that raises concerns about possible “mitochondrial toxicity” associated with fluoroquinolones, which are marketed under brand names including Levaquin and Cipro and the generic form levofloxacin. These powerful antibiotics have been used to treat anthrax cases and are used for pneumonia and kidney infections. Continue reading
The European Medicines Agency (EMA) will be reviewing Medtronic’s InductOs following reports of contamination problems at a site that manufacturers one of the product’s components. InductOs is an implantable bone development product used in patients undergoing spinal fusion in the lower back and in surgeries to repair broken tibia. The kit InductOs is sold as contains its active ingredient dibotermin alfa and an absorbable collagen sponge (ACS) manufactured by Integra LifeSciences.
Regulatory Affairs Professionals Society (RAPS) reports that the contamination problems were from a site in the United States that manufactures the ACS in InductOs. In January 2014, inspectors identified “a number of major deficiencies” and Integra was issued a corrective action plan. Because of the contamination issues, the company was not allowed to import the sponge to the EU until inspectors could return and “assess the progress in eliminating the major deficiencies”. Continue reading
On July 23, the Consumer Product Safety Commission (CPSC) announced the recall of about 79,000 UPPAbaby strollers in the U.S. and Canada because the foam covering of the bumper bar could pose a choking hazard.
The recall includes the UPPAbaby 2015 CRUZ and 2015 VISTA strollers and 2015 RumbleSeats. The child can bite off and choke on the foam covering of the bumper bar. Continue reading
Infants and children switched from older to newer models of Medtronic Shiley Neonatal and Pediatric Tracheostomy tubes developed breathing difficulties and this prompted Medtronic Inc. to recall 8,192 of the tubes in May.
In its recall announcement, the Food and Drug Administration (FDA) said there had been 12 reports of serious injuries associated with the Shiley tubes, but no deaths have been reported to date. Continue reading
Berkeley’s cell phone ordinance, which requires retailers to warn consumers about the potential risk of radiation with cell phones, is the first measure of its kind to be passed. In May, the City Council unanimously passed the ordinance, titled Right to Know. The law goes into effect next month and warns consumers that “you may exceed the federal guidelines for exposure” to radiofrequency radiation by placing a cell phone into a bra or in a pants pocket. The warning also states that “The potential risk is greater for children” according to the New York Times.
Berkeley’s ordinance brings up questions about whether or not other cities will adopt a similar law. The city is known for its progressive actions, and has passed legislation that are sometimes seen as radical but are later implemented in other places, including health benefits for domestic partners, smoking bans, Styrofoam bans and creating sanctuaries for illegal immigrants. “If you can get it passed in Berkeley, you have a beginning,” said Berkeley Council member Susan Wengraf, according to NYT. “If you can’t, forget it, or come back three years later.” Continue reading