Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

The operator of an 18-wheel semi truck has been cited for reckless driving after causing a multi-vehicle traffic accident in Virginia on Monday. According to authorities in Carroll County, Virginia, 46-year-old Marco Tulio Carta Jena of Morgantown, North Carolina, crashed his rig into other vehicles that had become backed up along I-77 as another accident further up the interstate was being cleared. Investigators say that the driver was not paying attention to the road when he collided with the other vehicles.

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Exjade (deferasirox), a treatment for chronic iron overload due to blood transfusions for adults and children age 2 years and older, now has an Food and Drug Administration (FDA) black box warning alerting health care professionals and consumers of a risk of serious complications that may lead to death. A black box warning is the strongest form of warning issued by the FDA and is placed on drugs that have potentially harmful or deadly side effects. As a result of the FDA warning, new language was added to the drug’s Contraindications, Warnings and Precautions, and Drug Interactions sections of its packaging. The labeling states that the product may cause renal impairment, including failure; hepatic impairment, including failure; and gastrointestinal hemorrhage. The warning affects Exjade Tablets for Oral Suspension.

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A class of asthma drugs known as Long-Acting Beta Agonists (LABAs) should never be used alone, warns the Food and Drug Administration (FDA), and manufacturers of these drugs will now be required to include this warning in the labels of their drugs as well as steps on how to reduce overall use of the products. The warning is based on FDA analysis of clinical trials of LABAs that show the drugs are associated with an increased risk of severe worsening of asthma symptoms, leading to hospitalization in both children and adults, and death in some patients with asthma.

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Burning ear candles that manufacturers claim draw ear wax and “impurities” or “toxins” out of the ear canal should not be used because they may cause serious injury even if used according to manufacturers’ instructions, according to a warning from the Food and Drug Administration (FDA). Ear candles are hollow cones about 10 inches long and made from a fabric tube soaked in beeswax, paraffin or a mixture of the two. In ear candling, also called ear coning or thermal auricular therapy, a patient lies on his side while a candle is placed in the outer ear and lit.

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Dr. Margaret Hamburg, the newly appointed chief of the Food and Drug Administration (FDA), is flexing her muscles with drug makers over questionable product promotion, in an effort to live up to her promise to step up enforcement of oversight of drug makers, device manufacturers and other companies the agency oversees. Last year, the FDA issued 41 enforcement letters, twice as many as it issued in 2008.

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The Food and Drug Administration is updating health care professionals about a medication used to treat patients with relapsing forms of multiple sclerosis (MS) and moderately to severely active Crohn’s disease. New safety information indicates that the risk of developing a rare but life-threatening brain infection known as progressive multifocal leukoencephalopathy (PML) increases with the number of infusions received of Tysabri (natalizumab). The announcement updates a September 2009 warning about PML associated with use of the Tysabri.

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A New York City sanitation worker died while on duty in Queens last week after being struck by a milk delivery truck. Forty-one-year-old Frank Justich, who worked for the city’s sanitation department for 11 years, had been removing trash from a street corner in Queens when a tractor-trailer rounded the corner too widely and pinned Justich against his own truck.

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Many Toyota Prius owners continue to experience sporadic episodes of sudden, unintended acceleration while driving their cars, even without floor mats jamming the throttle wide open or the gas pedal sticking. Toyota included all 2004-2009 Prius models in the floor mat entrapment recall it announced last fall, but did not include the Prius in its subsequent recall of Toyotas for sticking accelerator pedals.

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Toyota’s recent recall of 2.3 million cars and sport utility vehicles over “sticking” accelerator pedals follows a larger recall last October of 4.2 million vehicles for possible floor mat entrapment. The recalls have created an undercurrent of fear of confusion among Toyota owners, many of whom no longer feel their cars are safe to drive.

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Toyota has found itself in a rather sticky situation. With more than eight million cars and trucks worldwide falling under a massive recall due to sudden unintended acceleration, the Japanese carmaker is looking for some sort of solution to pacify a growing anxious consumer base. Last fall, it blamed floor mats for the problem. Last month, Toyota announced the problem also fell on the vehicles’ gas pedals.

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