Current Events

One of the biggest product defects in recent American manufacturing history, linked to at least 124 deaths and numerous injuries, was traceable to a mundane automobile part, the ignition switch. For General Motors, the debacle over how it handled that defect scarred the organization as it had to admit to repeated failures in simply identifying the problem that reflected a corporate culture that seemed to prize inaction and deflection.

The settlement with the Justice Department that requires G.M. to pay $900 million, along with the resolution of a number of private lawsuits for which it set aside another $575 million, means the company has largely put the controversy to rest.

Read More

The U.S. Centers of Disease Control and Prevention (CDC) has announced that the recent Cyclospora outbreak sickened 546 people from 31 states from May to August. The numbers of reported cases in the U.S. have returned to baseline levels, the agency noted.

CDC stated that epidemiologic and traceback investigations conducted in Texas, Wisconsin, and Georgia by state and local public health and regulatory officials and the U.S. Food and Drug Administration (FDA) indicated that some illnesses among residents in these states were linked to fresh cilantro from Puebla, Mexico. However, the vehicle(s) of infection for non-cluster-associated cases has not been identified, the agency added.

Read more.

The recall seemed to be straightforward enough: Recaro Child Safety needed to fix some of its car seats so that they would not break free during a crash.

But the path to that announcement, made last week, was anything but.

Read more.

They sounded like three deadly strikes.

The patient had a dangerously high level of LDL cholesterol, a high risk for heart disease and an intolerance for the most common cholesterol-fighting medication. Dr. William Averill, a Torrance cardiologist, thought he had a solution: Praluent, a cholesterol-lowering drug from pharmaceutical companies Regeneron and Sanofi that had just been approved by the FDA as a treatment for people who didn't benefit from the standard cholesterol treatment.

The only problem? The drug's $14,600-a-year sticker-shocker price — 140 times more expensive than generic statins that typically cost about $100 a year.

Read more.

Specialists in infectious disease are protesting a gigantic overnight increase in the price of a 62-year-old drug that is the standard of care for treating a life-threatening parasitic infection.

The drug, called Daraprim, was acquired in August by Turing Pharmaceuticals, a start-up run by a former hedge fund manager. Turing immediately raised the price to $750 a tablet from $13.50, bringing the annual cost of treatment for some patients to hundreds of thousands of dollars.

Read more.

The Food and Drug Administration warned doctors that bronchoscopes may transmit infections among patients when inadequately cleaned, the latest alert by the regulator about the risk of reusable medical scopes.

The agency recorded 109 reports of infections or contamination related to bronchoscopes in the past five years, including 50 in 2014 alone, according to its safety notice. "A small number" of the incidents showed that the devices remained contaminated even when manufacturers’ cleaning instructions were followed, the agency said.

Read More

General Motors Co. will pay $900 million to settle a criminal probe by the U.S. Justice Department over the ignition switch flaw that has bogged down Chief Executive Officer Mary Barra in recalls and investigations since almost the start of her tenure.

The settlement is part of a deferred-prosecution agreement under which the U.S. will monitor some of the automaker’s safety policies and the company must cooperate with the government, federal prosecutors in New York said Thursday. GM was charged with conspiracy and wire fraud, claims that will be dismissed in three years if GM complies with the accord.

Read More

For the first time, a widely used modern diabetes drug has been shown to reduce deaths from cardiovascular disease, a long-sought goal of treatment, researchers announced on Thursday.

In a clinical trial, the drug — Jardiance, sold jointly by Eli Lilly and Boehringer Ingelheim — reduced the overall risk of having a heart attack or stroke, or of dying from cardiovascular causes, by 14 percent. Looking only at cardiovascular deaths, the reduction was 38 percent.

Read More

As the number of deaths linked to defective cars made by General Motors has steadily risen to 124, victims’ families have waited for the answer to a burning question: How will federal prosecutors hold the automaker accountable for its decade-long failure to disclose the defect?

On Thursday, they got their answer, and many were disappointed.

Read More

WASHINGTON — The Food and Drug Administration halted the sale of four types of R. J. Reynolds cigarettes on Tuesday, saying the company failed to prove that they were not more harmful than products already on the market.

The agency ordered retailers who sell any of the cigarettes to stop immediately and to dispose of them within 30 days or face financial penalties or criminal prosecution.

Read More