Current Events

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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The U.S. Food and Drug Administration said last month it will now require makers of benzodiazepines to outline the risks of abuse, addiction, physical dependence and withdrawal on the drugs' labels.

Benzodiazepines, or "benzos," which include brand name drugs like Xanax, Ativan, Klonopin, Librium and Valium, are used for the treatment of anxiety, insomnia, seizures, social phobia and panic disorder.

Removal of a medicine cleared after an accelerated approval would be a highly unusual step, but it is the way the process is supposed to work. The FDA grants quick clearance to medicines that fill an unmet need, while requiring additional data to further prove safety and effectiveness.

In this case, the FDA approved Makena in 2011 based on a study that showed it could help prevent preterm birth in women who had previously had an unexplained preterm birth, defined as delivery before 37 weeks. The agency then required AMAG to show the medicine could actually improve the health of babies, the ultimate goal of reducing preterm birth.

WASHINGTON (Reuters) - Honda Motor Co said on Saturday it has confirmed a 17th U.S. death tied to a faulty Takata air bag inflator.

The Japanese automaker said that after a joint inspection with the U.S.
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JACKSON, Miss. (AP) — A company that failed to adequately inform women of dangerous side effects related to permanent pelvic mesh devices will be required to pay $60 million, according to a settlement announced this week by state attorney generals across the U.S.

The money from C.R.
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