Current Events

Families of schoolchildren gunned down in the 2012 Sandy Hook massacre can sue Remington Outdoor Co Inc, a Connecticut court ruled on Thursday, in a setback for gun makers long shielded from liability in mass shootings.

Read More

(Reuters) - A California jury on Wednesday awarded $29 million to a woman who said that asbestos in Johnson & Johnson’s talcum-powder-based products caused her cancer.

Read More

(Reuters Health) - Mothers who smoke during pregnancy are more than twice as likely to have babies die suddenly in their sleep as women who avoid tobacco, a U.S. study suggests.

More than 3,700 U.S. infants up to 12 months old die each year of sleep-related causes like sudden infant death syndrome (SIDS) or accidental suffocation and strangulation in bed or other unknown causes, researchers report in Pediatrics. Smoking has long been linked to an increased risk of these fatalities, known as sudden unexpected infant death (SUID), but the current study offers fresh evidence of how much cutting back or quitting might help improve babies’ survival odds.

The Food and Drug Administration announced a sweeping plan on Friday to review and address the safety of surgical staplers, including a new examination of seven years’ worth of hidden reports highlighted Thursday in a Kaiser Health News investigation.

In a letter sent to health care providers Friday, the FDA said it will convene an advisory meeting on the safety of the devices and signaled that it might reclassify surgical staplers to put them under tighter control. The agency also said it plans to issue proposed recommendations to companies that make the devices, which are used in countless surgeries.

Read More

The NHTSA on Tuesday said that Audi will recall 74,881 vehicles over a fault fuel rails may leak and lead to a fire.

The recall covers certain 2015 through 2018 model year Audi A8, A7, A6, and Q7 crossover SUV, according to documents filed with the NHTSA in January. The fuel rails in certain Audi vehicles may have been improperly welded, the automaker said after conducting an internal an engineering analysis. Variations in the welding process may cause fuel to leak in the end cap area over time, though the amount of fuel will be very low, per the brand. Owners may notice a fuel odor if the problem exists.

Read More

Zoll Medical Corporation, which received FDA clearance a few years ago for both home and hospital versions of its wearable defibrillator LifeVest, is now dealing with a range of lawsuits and FDA actions over problems with the device. At least two people have died because their vests failed to activate due to an electrical problem, the FDA reports, while local media in Pittsburgh reports that other patients are having the opposite problem, with burns and rashes caused by the device activating erroneously.

Read More

The drugmaker Eli Lilly will begin selling a cheaper version of its most popular insulin, Humalog, in an effort to head off criticism about the rising costs of prescription drugs, the company said Monday.

The devices' maker stands behind Durata leads' long-term safety and durability, and the devices remain on the market.

A new study of malfunction reports says hundreds of thousands of special wires called “leads” for heart defibrillators made by St. Jude Medical are vulnerable to a problem that can cause unneeded high-voltage shocks or a sudden loss of lifesaving therapy in unsuspecting patients.

The company’s Durata leads are susceptible to internal insulation breaches that “may result in serious adverse events without forewarning,” concludes the paper, which was underwritten by the Minneapolis Heart Institute Foundation. The paper also says standard tests may not uncover these insulation defects.

Losing defibrillator therapy in this way could be fatal because patients may not realize their device won’t correct potentially lethal heart problems like ventricular tachycardia. Conversely, receiving unneeded defibrillator shocks can be psychologically traumatic for some patients.

Read More

OKLAHOMA CITY — Big pharma is facing a major test in a small courthouse 20 miles south of here: the first trial at which a jury could decide whether drug companies bear responsibility for the nation’s opioid crisis.

Thousands of cities, counties, Native American tribes and others have filed lawsuits up and down the opioid supply chain, advancing various allegations of culpability for the crisis that began with widespread abuse of powerful painkillers. Most of the cases have been consolidated in a major federal action in Cleveland. But as that case lags, smaller state cases like the one in Oklahoma are moving quickly to hear the allegations, creating an early test of how costly the opioid crisis might be for the pharmaceutical companies that made billions of dollars off the drugs.

Read More

The U.S. Food and Drug Administration is warning people not to get infusions of young blood, a risky and expensive procedure touted by some as a quick fix for conditions such as aging and memory loss.

Establishments in several states are offering infusions of plasma, the liquid part of blood that contains antibodies and proteins that help blood clot, obtained from young donors for thousands of dollars, according to the FDA guidance released Tuesday. Some clinics claim these young blood infusions can reverse the effects of aging and treat a wide range of serious illnesses including dementia, Parkinson’s disease, multiple sclerosis, and Alzheimer’s disease.

Read More

The Food and Drug Administration, drug companies and doctors mishandled distribution of a powerful fentanyl painkiller, allowing widespread prescribing to ineligible patients despite special measures designed to safeguard its use, according to a report released Tuesday.

The unusual paper in the medical journal JAMA relies on nearly 5,000 pages of documents that researchers obtained from the government via the Freedom of Information Act, rather than a more typical controlled scientific study.

Read More