Current Events

The FDA has reclassified surgical mesh used to repair pelvic organ prolapse as “high risk,” citing thousands of reports of complications involving its use.

The classification requires manufacturers to complete a rigorous application process demonstrating the safety and effectiveness of the implant. Companies with products already on the market have 30 months to submit the application, while those wanting to sell new devices must submit the application beforehand.

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America’s system for ensuring that medical devices are safe failed at every turn when dirty endoscopes began spreading deadly superbugs, according to a Senate investigation released today.

The report, from Senator Patty Murray, a Washington Democrat, blames device manufacturers, hospitals, and the Food and Drug Administration for infections that sickened at least 250 people worldwide since 2012 and that may have contributed to dozens of deaths.

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You wouldn't deliberately leave your car running after you pull into the garage, but if that car has a keyless push-button ignition you could forget to turn it off. With an attached garage, the carbon monoxide spewing out of the tailpipe could very easily seep into your house, causing illness or death.

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Jan 4 - Honda Motor Co confirmed on Thursday that a Takata airbag inflator ruptured in a July crash of a Honda Accord and likely led to the death of the young driver, the ninth death in the world linked to the faulty inflators.

The death, first reported by U.S. auto safety authorities last week, is the eighth in the United States and the first since April tied to the inflators that have been recalled in tens of million of vehicles worldwide.

After an inspection of vehicle components in cooperation with regulators, Honda said it "confirmed that the Takata driver's front airbag inflator ruptured" and "injuries related to this airbag inflator rupture likely resulted in the tragic death of the underage driver."

The U.S. National Highway Traffic Safety Administration said last week the death took place in July in a recalled used 2001 Honda Accord coupe near Pittsburgh. The unidentified teen-aged driver was hospitalized after a Takata airbag ruptured and died several days later.

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The Food and Drug Administration is tightening regulations for surgical mesh products used to repair a condition known as pelvic organ prolapse, following years of scrutiny by the U.S. regulator and many lawsuits by women who allege they have suffered harm from such products.

The products will be reclassified as high-risk rather than moderate-risk medical devices when used in procedures that go through the vagina to repair organ prolapse. The FDA will require all manufacturers to submit data to support the effectiveness and safety of such devices before they are allowed on the market.

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The Justice Department filed a civil complaint Monday against Volkswagen alleging nearly 600,000 cars with diesel engines in the U.S. violate emissions laws and that many were imported in violation of the Clean Air Act.

The lawsuit was filed in Detroit on behalf of the U.S. Environmental Protection Agency, which worked with the California Air Resources Board in exposing the violations last year. VW has admitted to rigging cars with 2-liter diesel engines, and the EPA found violations in vehicles with 3-liter diesels as well.

The complaint alleges that the nearly 600,000 diesel engine vehicles built since 2009 were equipped with illegal "defeat devices" installed to impair emission control systems. That resulted in higher emissions than allowed by law. The lawsuit asks for penalties of up to $37,500 per car.

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The first case against General Motors Co. over its faulty ignition switches can proceed to trial after a federal judge rejected the auto maker’s bid to dismiss the allegations in the case outright.

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From Ferrari to Subaru, the auto industry is ending 2015 with a flurry of safety-related recalls, more than 1 million in the last week alone.

Final figures for 2015 haven’t been released yet, but they’re expected to come in as a close second to the record 64 million vehicles recalled in the U.S. in 2014. And they cover a wide variety of issues and an even wider range of vehicles from faulty transmissions to fire hazards and exploding airbags.

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A Georgia law firm accused by a federal regulator of operating an illegal debt-collection lawsuit mill has settled the charges. The firm agreed to pay a $3.1 million penalty without admitting any wrongdoing.

The U.S. Consumer Financial Protection Bureau sued Marietta, Ga.-based Frederick J. Hanna & Associates PC last year, accusing it of violating federal consumer-protection laws.

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Fiat Chrysler Automobiles says it is going to recall 570,000 SUVs for fire risks.

Specifically, the recall is associated with troubles with the vehicles' mirror wiring along with the low-pressure hose.

The automaker is recalling 477,000 2011 through 2012 models of the Jeep Grand Cherokee and Dodge Durango SUVs.

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