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

The U.S. Supreme Court this week asked the Obama administration to comment on whether it believes generic drug companies can be sued over allegations that they inadequately labeled their products. The question arose after an appeals court reinstated a lawsuit by a woman who claimed she developed a severe neurological movement disorder after taking generic versions of the heartburn drug Reglan (metoclopramide). The lawsuit had been previously dismissed by a trial judge.

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American children are taking more medications than ever before to treat chronic conditions, according to the 2010 Medco Drug Trend Report, raising the question, “How safe are these drugs for children?”

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Wyeth, Inc. and Schwarz Pharma Inc. have been dismissed from a lawsuit filed in Texas involving the drug company’s Reglan (metoclopramide), a medicine used to treat gastrointestinal conditions. The lawsuit alleged that the drug caused the plaintiff to develop a severe movement disorder known as Tardive Dyskinesia. However, the case will proceed against Activis-Elizabeth, L.L.C., makers of a generic version of metoclopramide that the plaintiff was taking.

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A new study has found that quality improvement intervention initiatives such as ongoing education and automated feedback reports of medication usage among low birth weight babies in neonatal intensive care units (NICU) can significantly reduce use of medications, some of which carry serious adverse effects.

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A combination of aspirin and the anti-nausea medication metoclopramide, marketed as Reglan, may help patients with migraines find relief from headaches and vomiting within two hours, according to data from 13 clinical trials in which patients published in the Cochrane Database of Systematic Reviews.

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For nine years, Valerie (not her real name) was prescribed and took Reglan (metoclopramide) to control her acid reflux. The drug was approved by the Food and Drug Administration (FDA) in the 1980s to treat various digestive tract conditions such as severe heartburn and gastroparesis, or the delayed emptying of the stomach contents. As the drug became more widely prescribed, the FDA began receiving reports that the drug may cause a neurological disorder. Despite the warning signs, it took the FDA almost 30 years to investigate and act.

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A New Jersey judge is calling for a statewide consolidation of all lawsuits filed against the makers of the heartburn medication Reglan that involve claims that the drug caused a serious and debilitating movement disorder known as Tardive Dyskinesia. Judge Eugene J. Codey, Jr., of the Essex County Superior Court, filed the request arguing that the New Jersey court system could better handle the mounting number of lawsuits if they were all centralized in one court. The primary defendant in the lawsuits, Wyeth Pharmaceuticals, is headquartered in New Jersey.

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Mederi Therapeutics Inc. is launching an innovative new radiofrequency device for the treatment of gastroesophageal reflux disease, also known as GERD. Mederi’s Stretta is a balloon catheter with a needle that delivers radiofrequency energy. The system is inserted into the esophagogastric junction, or the sphincter controlling the entrance of food into the stomach, and prevents stomach acids from backing up into the esophagus. The radiofrequency waves work to restore the function of the valve separating the esophagus from the stomach.

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The new health care reform bill gives senior citizens a rebate to purchase prescription medications; however, increasing availability of drugs for seniors may cause safety concerns, especially when it comes to generic versions of medication, according to a Huffington Post blog by Edward F. Blizzard.

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Salix Pharmaceuticals stock rose 5 percent last week despite news that the company received a warning letter from the Food and Drug Administration (FDA) urging the company to clarify information about its new orally dissolving heartburn treatment, Metozolv ODT, according to Local Tech Wire. The FDA said that some of the drug’s marketing materials are “false or misleading because they omit and minimize risk information, broaden the indication of Metozolv ODT, and contain unsubstantiated comparative and other claims.”

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