FDA classifies Philips ventilator recall due to low oxygen risk as most serious
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...
Remington offering $33M in settlement with Sandy Hook families
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., collectively referred to as "Remington," offered $3.66 million to each of the nine plaintiffs in the lawsuit against them...
Health care industry must provide patient notes via third-party app
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...
Consumer Reports says Tesla’s ‘Full Self-Driving’ software lacks safeguards
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,...
New York, drug distributors reach $1.18 bln opioid settlement as national deal looms
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.N), Cardinal Health Inc (CAH.N)...
Ford recalls roughly 850k vehicles, including Explorers, F-350s and Lincoln Aviators
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...
Pfizer recalls another 12 lots of Chantix anti-smoking drug for a carcinogen’s presence
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...
New Alzheimer’s drug may be a catastrophe in the making
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...
First Opioid Jury Trial Marks High-Stakes Test for Drug Industry
Jurors on New York’s Long Island are set to determine whether a group of opioid makers and drug distributors created a public health crisis and should pay for it, in a bellwether trial for lawsuits filed by communities across the U.S.
Endo International Plc, Teva Pharmaceutical Industries Ltd. and McKesson Corp. are among the companies...
Pfizer halts distribution of anti-smoking drug after finding carcinogen
June 24 (Reuters) - Pfizer Inc (PFE.N) said on Thursday it is pausing distribution of its anti-smoking treatment, Chantix, after finding elevated levels of cancer-causing agents called nitrosamines in the pills.
The drugmaker is recalling a number of lots of the anti-smoking drug. The U.S. drug regulator has in the past reached out to companies...
