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Fewer IVC filters implanted since FDA warning

The rate of inferior vena cava (IVC) filter placement has declined nationally since reaching a peak in 2010, a trend experts say was triggered by a 2010 Food and Drug Administration (FDA) warning regarding serious risks associated with long-term use of the blood clot-catching devices. An IVC filter is a tiny, cage-like device that is implanted into the inferior vena cava – the large vein that carries deoxygenated blood from the lower body to the heart – to prevent blood clots from reaching the lungs, a condition called pulmonary embolism. The FDA warning stated that long-term risks associated with IVC ... Read More

Self-driving Shuttle Grazed by Tractor-Trailer in Las Vegas

A self-driving shuttle was involved in a minor traffic collision with a tractor-trailer less than an hour after its launch on Fremont Street in downtown Las Vegas. None of the passengers aboard the 12-seater driverless Navya Arma shuttle were injured in the incident, which was caused by a tractor-trailer that backed into and lightly grazed the shuttle. Note: Fox News and others incorrectly report the shuttle manufacturer as Navaya. Critics of self-driving cars noted that the self-driving shuttle failed to avoid the collision, citing one passenger who told KSNV News3LV Las Vegas that the shuttle “just stayed there” as the tractor-trailer ... Read More

Judge orders deposition of Xarelto sales rep

A sales representatives for Janssen Pharmaceuticals Inc., a subsidiary of Johnson & Johnson, were ordered to undergo a midtrial deposition by a Pennsylvania state judge to determine whether she tried to sway a doctor’s testimony in an upcoming trial alleging Janssen’s blood thinner Xarelto caused a man’s internal bleeding. Attorneys for plaintiff Lynn Hartman asked the judge for the deposition after they became suspicious over the timing of the drug rep’s visit to the doctor before his deposition in April, and the fact that Janssen failed to disclose the contact until just weeks before the trial was to begin on ... Read More

NTSB: Sleep Apnea, Fatigue Among Causes of Deadly Casino Bus Crash

A deadly crash between a casino bus and a tractor trailer that killed 13 people near Palm Springs, California last year likely resulted from a driver’s undiagnosed sleep apnea and an inadequate traffic management plan by the state to control traffic in a work zone, federal investigators determined. In its investigation of the Oct. 23, 2016, crash of a 47-passenger 1996 MCI motor coach operated by USA Holiday, the National Transportation Safety Board (NTSB) found that the casino bus slammed into the back of a stopped tractor-trailer at a high speed. The crash killed the casino bus driver and 12 passengers ... Read More

Zen Magnets ordered to recall all its small, powerful magnet toys

The U.S. Consumer Product Safety Commission (CPSC) ordered Zen Magnets LLC to recall all its high-powered magnet sets because they pose a hazard to children – who can easily swallow them accidentally or intentionally and cause catastrophic injuries and death. Once swallowed, the small, loose, separable magnets can become attracted to each other in the digestive system, pressing against digestive tissue and requiring surgical removal. If not removed in approximately eight hours, serious injuries and death can result, the CPSC said in a statement. “Surgery to remove multiple magnets from the gastrointestinal tracts of children has been required, and tragically, ... Read More

Patients suffer skin erosion after receiving compounded drug

Two patients who received an injection of a performance booster compounded by United Pharmacy LLC suffered tissue erosion at the site of the injection, the Food and Drug Administration (FDA) warned. The injection in question is a combination of glutamine, arginine, and carnitine (GAC). Some websites promote it as a super amino acid used to balance hormones, stimulate the metabolism, and build new muscle tissue. On April 21, 2017, the FDA was made aware that two patients who had received injections of GAC had developed tissue erosion at the injection site following administration. A sample of the product was sent ... Read More

Queensland celebrates falling melanoma rates

According to the Skin Cancer Foundation, in the past three decades more people have had skin cancer than all other cancers combined. Melanoma is the deadliest form of skin cancer. It can be treated if it is caught in its early stages, so prevention and early detection education have become key components to the work being done to try to slow the trend of rising melanoma rates. In the U.S. last year, researchers who noted that melanoma rates had been steadily rising for the last two decades confirmed that in the last seven years rates of incident for both invasive melanoma ... Read More

New Jersey Transit Pulls 44 Train Engineers After Sleep Apnea Diagnoses

New Jersey Transit pulled 44 of its train engineers from service after sleep disorder tests indicated they suffer from sleep apnea. The move followed a determination by federal investigators that a train engineer’s sleep apnea triggered a deadly 2016 New Jersey Transit crash in Hoboken. The Associated Press reports that New Jersey Transit screened 373 of its engineers for sleep disorders. Of those, 57 were sidelined pending the results of further studies. Ultimately, 44 of those engineers were diagnosed with sleep apnea and removed from service until they met the treatment requirements for the disorder, which diminishes the quality of ... Read More

Whistleblower Allegations Lead To Prison Sentence, Fines For Medical Equipment Vendor

The owner of an Iowa medical supply store has been sentenced to more than three years in prison for submitting falsified documents to federal authorities investigating fraud allegations raised by a whistleblower in a False Claims Act lawsuit. According to The (Cedar Rapids) Gazette, James O’Connor, 64, was sentenced to 37 months in federal prison and ordered to pay $350,000 in restitution to the Medicare and Medicaid programs. Mr. O’Connor owned and operated O’Connor Medical Supply Inc., a durable medical equipment vendor in the Des Moines, Iowa area. A whistleblower filed a False Claims Act suit against Mr. O’Connor and ... Read More

Opening arguments begin in latest testosterone trial

The Food and Drug Administration (FDA) repeatedly rejected Auxilium Pharmaceuticals Inc.’s requests to expand the indication of its testosterone replacement therapy Testim to include age-related drops in testosterone, yet the drug company continued to market its product for age-related symptoms, attorneys for Steve Holtsclaw said during opening arguments. As a result, Holtsclaw trusted the product was safe, but realized the error of his ways when he suffered a heart attack seven months after starting the hormone therapy. Holtsclaw’s lawsuit is the first bellwether to reach trial against Auxilium in a multidistrict litigation that names numerous manufacturers of testosterone treatments. Two ... Read More