Current Events

Federal officials have announced a recall for a specific model of heart catheter made by Medtronic PLC that regulators said is responsible for one death and two injuries.

The action Tuesday involves 142 Rashkind balloon septostomy catheters that were distributed in the United States from May 2018 to August 2020.

"Quality issues ...

(CNN) -- Two lots of a widely used type 2 diabetes medication, metformin, are being recalled due to possible contamination with a potentially cancer-causing compound. Metformin is designed to lower glucose levels.

Nostrum Laboratories Inc., based in Kansas City, Missouri, announced Monday that it is voluntarily recalling its metformin HCl extended release tablets, USP 750 mg, according to a recall posted by the US Drug & Food Administration.

In early April the Trevecca Center for Rehabilitation & Healing in Nashville received an urgent call. At the time, Tennessee had only 3,000 coronavirus cases, compared with more than 100,000 in the state of New York. But the caller, the nursing director at a nearby kidney dialysis center, was worried. She said one of the home’s residents had been given a routine test before an appointment and had tested positive for the coronavirus. She said she believed that Trevecca, a 240-bed nursing home, might have an outbreak on its hands.
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NEW YORK (AP) — The U.S. Justice Department vastly expanded an inquiry Wednesday that could determine whether New York is undercounting coronavirus deaths among nursing home residents, demanding detailed data from hundreds of private facilities.

The demand ratchets up pressure on Democratic Gov. Andrew Cuomo after months of bipartisan criticism that the state’s official tally of 6,722 dead at long-term care facilities is probably off by thousands.
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The COVID-19 pandemic has put a damper on the FDA's on-site inspections in 2020, but that doesn't mean the agency isn't making the rounds and putting drugmakers on notice. A second U.S. company making prescription thyroid meds is on the receiving end of FDA's ire this year for potency concerns.

FDA investigators cited Phoenix-based RLC Labs for failing to adequately address a host of quality-control issues that led to the recall of 483 lots of two of the company's thyroid meds, according to a warning letter posted online Tuesday.
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WASHINGTON – Purdue Pharma, the company whose OxyContin painkiller contributed to a nationwide opioid epidemic, has agreed to plead guilty to federal criminal charges as part of a settlement with the government that includes fines of more than $8 billion, the Justice Department announced Wednesday.

The company, according to the agreement, will plead guilty to fraud and violations of the federal kickback laws. The criminal charges do not, however, absolve the company's owners, the Sackler family, of future criminal liability, federal authorities said.

Part 1 of this article addressed proof of diminished chance for a cure or better outcome or increased injury and pain and suffering as a substantial factor or proximate cause of injury in failure to diagnose cancer cases. This article will address the application of law and evidence to medical malpractice cases dealing with failure to diagnose other medical conditions and illness.

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Alyssa Fiorino was supposed to look out for her 89-year-old grandfather during his eye doctor appointment. But on his first trip out of the house during the pandemic, he sat down in the exam room with no mask on his face, and no mask on the ophthalmologist’s either, she said.

Fiorino said she tried to drop a hint by apologizing that her grandfather had pulled off his N95 mask in the lobby, when he complained that he couldn’t breathe after waiting for two hours in a parked car. The doctor scoffed at the idea of putting on masks, she said, then he went on with the exam.

The FDA issued a drug safety communication about nonsteroidal anti-inflammatory drug (NSAID) use during pregnancy, mandating that product labels include warnings about risk of a rare but serious kidney complication in infants.

Use of over-the-counter or prescription pain medications -- including aspirin, ibuprofen, naproxen, diclofenac, and celecoxib -- after 20 weeks of pregnancy could potentially cause fetal kidney problems resulting in low levels of amniotic fluid and pregnancy complications, the agency said.

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In medical malpractice cases competent poof of a diminished chance for a cure or better outcome or increased injury and pain and suffering may be a substantial factor or proximate cause of injury. Part 1 of this article will deal with such evidence as presented in failure to diagnose and treat cancer cases while part 2 of this article will address such evidence as presented in failure to diagnose other medical conditions and illness. 

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(CNN) - A widely-used diabetes drug has been recalled after manufacturers found it contained unacceptably high levels of a cancer-causing contaminant.

Indian pharmaceutical company Marksans Pharma Limited is recalling metformin hydrochloride extended-release tablets because their levels of NDMA, a "probable human carcinogen," were higher than the acceptable daily intake limit of 96 nanograms per day, according to a recall published this week by the US Food and Drug Administration (FDA).

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