Current Events

The FDA announced on Monday a class I recall of GE Healthcare's nuclear medicine systems stemming from a patient death reported last month.

On June 5, the company learned that a patient at a VA Medical Center had been crushed and killed when part of an Infinia Hawkeye 4 Nuclear Medicine System fell during a scan. The Wall Street Journal identified the victim as a 66-year-old patient at the James J. Peters VA Medical Center in New York City.

"Bolts securing the camera to the gantry were loose, thereby stressing the support mechanism and resulting in the incident," the company determined after inspecting the system.

GE Healthcare sent two letters to hospitals regarding the issue. The first, sent on June 17, "identified the affected product, recommended that qualified service personnel maintain the equipment and that Preventative Maintenance procedures were executed according to labeling," in addition to asking that the Safety Chapter Sections be re-reviewed with hospital personnel, the FDA said in its recall notice.

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While most of the massive litigation against Toyota involved alleged defects with the electronic throttle control system, the first trial claims that Toyota failed to install a brake override system that would have automatically shut off the engine and saved a life.

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Advances in technology have allowed us to do things once thought impossible. However, working smarter may lead to unforeseen errors thanks to malfunctioning technology or other related issues. How many errors occur that lead to adverse events, and how can medial professional hope to avoid these errors if they are coming from useful equipment?

In a new study, researchers performed a comparison of 28 studies regarding medical errors. Researchers found that medical errors affect up to 16 percent of patients admitted to hospitals. Close to 50 percent of these adverse events are attributable to surgical procedures. Similarly, operating room contents were found to be part of the reason: 70 percent of errors are related to equipment available in operating rooms, 44 percent are due to configuration and settings of equipment in the room, as well as how accessible it was, and 34 percent are related to direct malfunctioning of equipment during use.

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A federal appeals court has affirmed a $105 million judgment for New York City against Exxon Mobil Corp. over the petroleum giant's contamination of groundwater with the gasoline additive methyl tertiary butyl ether, or MTBE, used until the mid-2000s to reduce emissions.

On Friday, in In re: MTBE Products Liability Litigation, 10-4135, a three-judge panel of the U.S. Court of Appeals for the Second Circuit rejected Exxon's arguments that the city's claims were preempted by the federal Clean Air Act and that the trial was tainted by juror misconduct. Judge Susan Carney wrote the opinion, joined by Judges Barrington Parker Jr. and Peter Hall.

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Today, the U.S. Food and Drug Administration is warning consumers that they should not use or purchase Healthy Life Chemistry By Purity First B-50, marketed as a vitamin B dietary supplement. A preliminary FDA laboratory analysis indicated that the product contains two potentially harmful anabolic steroids—methasterone, a controlled substance, and dimethazine. These ingredients are not listed in the label and should not be in a dietary supplement.

“Products marketed as a vitamin but which contain undisclosed steroids pose a real danger to consumers and are illegal,” said Howard Sklamberg, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research. “The FDA is committed to ensuring that products marketed as vitamins and dietary supplements do not pose harm to consumers.”

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The oil services giant Halliburton agreed Thursday to plead guilty to destroying evidence during the Deepwater Horizon oil spill disaster in 2010, admitting to one count of criminal conduct and agreeing to pay the $200,000 maximum statutory fine, according to the Justice Department.

In a startling turn in the three-year-old criminal investigation, Halliburton said that on two occasions during the oil spill, it directed employees to destroy or “get rid of” simulations that would have helped clarify how to assign blame for the blowout — and possibly focused more attention on Halliburton’s role.

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The FDA has taken an initial step toward regulating -- and possibly banning -- the use of menthol in cigarettes.

On Tuesday, the agency issued an Advance Notice of Proposed Rulemaking, which requests information from the public regarding the effects of menthol in cigarettes and possible regulatory options. The comment period will last for 60 days before the FDA makes a decision. If a rule is ultimately proposed, there will be another comment period.

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General Motors announced last week that it's voluntarily recalling almost 900 2014 Chevy and GMC half-ton pickup trucks to replace the passenger airbag that might not fully inflate during an accident.

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Toyota has spent well over $1 billion settling lawsuits involving unintended acceleration, but the world's largest automaker still faces hundreds of other cases awaiting trial.

First up is a suit filed by the heirs of Noriko Uno, a 66-year-old bookkeeper who was killed when her Toyota Camry unexpectedly sped to 100 mph on a city street in Upland in 2009.

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The NCAA likes to talk about culture.

In a news conference last July discussing the draconian penalties against Penn State in the Jerry Sandusky sexual abuse scandal, president Mark Emmert used the word eight times.

“Certainly, the lesson here is one of maintaining the appropriate balance of our values,” Emmert said. “Why do we play sports in the first place, and does that culture ever get to a point where it overwhelms the values of the academy, those things that we all hold dear?”

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