Current Events

For three years, Donald Camp has used a breathing device to sleep. He has severe sleep apnea, so without this device, his breathing is obstructed and he gasps for air.

But in June, Mr. Camp and many others began learning that more than a dozen Philips Respironics machines that deliver pressurized air through a mask were recalled because of potential health risks from faulty components. Since then, millions of people in the United States, and their doctors, have been scrambling to find alternatives for those with common sleep disorders, breathing problems and respiratory emergencies.
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Boston Scientific Corp. (NYSE: BSX) has recalled about a decade's worth of its Ingenio pacemakers, citing the risk that the products might permanently go into a backup setting called "safety mode" and lose their ability to pace properly.

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Aug 13 (Reuters) - Pfizer Inc (PFE.N) said on Friday it is recalling four additional lots of its anti-smoking treatment, Chantix, after finding elevated levels of cancer-causing agents called nitrosamines in the pills.

In June, the drugmaker said it was pausing distribution of certain lots of the anti-smoking drug out of an abundance of caution and pending further testing.

Including Friday's recall, Pfizer has paused distribution of 16 lots of the drug. The lots were distributed to wholesalers in the United States and Puerto Rico from June 2019 to June 2021.
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Aug 3 (Reuters) - The U.S. Food and Drug Administration on Tuesday classified the recent recall of some of Philips' (PHG.AS) ventilators as Class 1, or the most serious type of recall, saying the use of these devices may cause serious injuries or death.

This is the second Class 1 recall initiated by the company this year.
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Gunmaker Remington Arms Co. has offered around $33 million to settle a lawsuit brought by nine families of the victims of the Sandy Hook Elementary School shooting.

Remington Arms Co. LLC and Remington Outdoors Co. Inc.
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July 19, 2021 - The federal Open Notes Rule (the "Rule") implements a portion of the federal 21st Century Cures Act (Cures Act) related to "information blocking." It specifies that clinical notes are among electronic health information (EHI) that must not be "blocked." The notes must be available free of charge to patients and their representatives. Such access is through a patient portal or health applications on a smart device. The Rule significantly changes the way patient information will be shared and effectively mandates a Cloud for EHI.
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WASHINGTON, July 20 (Reuters) - Consumer Reports said Tuesday that Tesla Inc's (TSLA.O) "Full Self-Driving" software lacks safeguards and raised concerns the system's use on public roads puts the public at risk citing reports from drivers.

The influential consumer publication cited videos posted on social media of drivers using it and raised concerns about issues, including "vehicles missing turns, scraping against bushes, and heading toward parked cars."

Consumer Reports said it plans to independently test the software update known as FSD Beta 9, as soon as its Model Y receives the update.

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NEW YORK, July 20 (Reuters) - The three largest U.S. drug distributors agreed mid-trial to pay up to $1.18 billion to settle claims by New York state and two of its biggest counties over their role in the nationwide opioid epidemic, the state's attorney general said on Tuesday.

McKesson Corp (MCK.
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Ford on Friday announced several recalls affecting roughly 850,000 trucks, cars and SUVs.

The recalls include 34,939 Ford F-350 Super Duty vehicles for rear axle issues and 40,995 Lincoln Aviator vehicles for improperly secured battery cable wire harnesses. The largest recall is 774,696 2013-2017 Explorer vehicles following six allegations of injuries related to a seized cross-axis ball joint.

Drivers of the affected SUVs may notice “a clunk noise, unusual handling, or a misaligned rear wheel,” according to a Friday news release.

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Pfizer has announced a recall of varenicline, the anti-smoking drug sold under the brand name Chantix, for the second time in two weeks. Both recalls, the latest on Friday, concern the presence of N-nitroso-varenicline.

Pfizer says these lots have more than the company’s, not the FDA’s, acceptable daily Intake level.

“Long-term ingestion of N-nitroso-varenicline may be associated with a theoretical potential increased cancer risk in humans, but there is no immediate risk to patients taking this medication,” says the Pfizer-written, FDA-posted recall notice. “The health benefits of stopping smoking outweigh the theoretical potential cancer risk from the nitrosamine impurity in varenicline.
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The FDA’s approval of a new Alzheimer’s treatment — the first one in almost two decades — should have been a cause for celebration. Instead, it has become a scientific and financial mess.

Why it matters: Experts from all corners of the health care world fear the FDA’s decision will undermine medical standards, explode the federal budget and fill millions of desperate people with false hope.

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