Current Events

Painkillers with the active ingredient acetaminophen such as Johnson & Johnson (JNJ)’s Tylenol have been linked to serious skin reactions including rash and blisters, U.S. regulators said.

Reports to the Food and Drug Administration’s adverse event database reveal the most serious reactions, while rare, led to hospitalizations and deaths. The majority of cases involved single-ingredient acetaminophen products, the FDA said yesterday in a statement. The agency advised people who develop a skin rash or reaction to stop taking the drug and seek medical attention. 

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Ford Motor Co. (F) agreed to pay $17.4 million, the largest penalty the U.S. auto-safety regulator can impose, for delaying recalls involving unintended acceleration.

The June 28 agreement, announced today by the National Highway Traffic Safety Administration, involves Ford Escape SUVs the automaker recalled last year after a fatal crash in Arizona. 

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Bagged salad could be the cause of the recent cyclospora stomach bug outbreak that has sickened more than 350 people in at least 15 states.  

Iowa has reported the most cases of the cyclospora bug, with 143 people falling ill. An investigation by the Iowa Department of Public Health has linked a prepackaged salad mix to the outbreak, after the agency determined at least 80% of reported cases were exposed to the same mix, reported CBS News.

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Importers along with food companies will have to share the responsibility of food safety for the first time under far-reaching food import regulations proposed July 26 by the Food & Drug Administration.

The FDA released two long-awaited proposals to implement FDA Food Safety Modernization Act that will change the importation of foods.

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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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