Current Events

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.

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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.

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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.

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For women trying to keep a healthy weight after menopause, the American Heart Association has a simple message: Choose water over diet drinks.

A study published Thursday in Stroke, a journal of the AHA, reveals women age 50 and above who consume more than one artificially sweetened drink a day are significantly more likely to have a stroke, a heart attack and an early death.

Even women with no history of heart disease or diabetes are considerably more vulnerable to increased health risks if they drink multiple diet beverages a day.

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WASHINGTON—Officials should consider women’s reports of pain, sexual dysfunction and other maladies as they re-evaluate a medical device used in women’s pelvic surgery that has triggered thousands of lawsuits, an advisory panel said.

The panel of outside doctors, convened to advise the Food and Drug Administration, recommended that the agency evaluate women’s medical self-reports as it decides whether synthetic mesh products should stay on the market. Such recommendations are generally, but not always, followed by the federal...

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Swan-Ganz thermodilution catheters manufactured between December 26, 2017, and April 19, 2018, are being recalled by Edwards Lifesciences, according to the US Food and Drug Administration (FDA).

The class I recall is being initiated because of incorrect assembly leading to catheter tube (lumens) reversal. If the lumens are reversed, inaccurate pulmonary artery and central venous pressure values and waveforms may result, leading to unintended treatment.

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More women have been diagnosed with a deadly lymphoma caused by breast implants, according to a report released Wednesday from the Food and Drug Administration.

In a statement, the FDA’s Dr. Binita Ashar said there are now 457 women in the U.S. diagnosed with breast implant-associated anaplastic large cell lymphoma (BIA-ALCL), up from 414 cases in the last report. There have been more than 600 cases of BIA-ALCL, a cancer of the immune system, reported worldwide. Sixteen women have died, nine in the U.S.

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Suzanne Emmett went through surgery after surgery to try to get rid of the discomfort, bleeding, infections, painful sex, and other symptoms from the vaginal mesh implanted inside of her in 2007. But the procedures couldn’t fix what the plastic-like mesh had done to her life, according to a lawsuit that claimed the mesh had a high failure rate, and caused irreversible injuries to many women.

On Thursday, a Philadelphia jury awarded Emmett, 57, and her husband, Michael, a $41 million verdict in a case they brought against medical device maker Ethicon, and its corporate parent, Johnson & Johnson. The amount included $25 million in punitive damages.

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Motorcycle maker Harley-Davidson is recalling more than 43,000 vehicles due to potentially bad brakes.

The recall involves nearly 44,000 of its Street motorcycles for a brake issue that could cause severe crashes. As a precaution, the company has temporarily halted shipping those models.

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Medical devices -- such as pacemakers, insulin pumps and MRI machines -- are increasingly vulnerable to hacking. As of today, however, there’s no federal mandate for those devices to have cybersecurity protections.

A government-backed coalition of hospitals and medical device manufacturers took matters into their own hands on Monday. They released a 53-page “joint security plan” outlining a slew of low-hanging fruit protections manufacturers should implement and hospitals should demand.

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NEW YORK (Reuters) - Additional shortages of blood pressure drugs in the United States are possible following recent recalls related to traces of a probable carcinogen found in some versions a particular class of hypertension medicines, the U.S. Food and Drug Administration said on Friday.

The drugs, including valsartan, belong to a class of widely-used medicines for treating high blood pressure called angiotensin II receptor blockers, or ARBs. Valsartan is the generic of Novartis’ Diovan.

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