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

Makers of generic drugs who do not adequately label their products to warn consumers of possible risks are not exempt from liability, according to a ruling by the U.S. Court of Appeals for the Eighth Circuit. The court ruled on a product liability lawsuit brought by Gladys Mensing, who was prescribed metoclopramide to treat diabetic gastroparesis, a debilitating condition in which the stomach empties too slowly. Following use of the medication, Mensing developed a serious movement disorder known as Tardive Dyskinesia. Research has shown that the condition can be caused by long-term use of metoclopramide. Mensing sued several makers of generic metoclopramide, known by the brand name Reglan, for not adequately warning consumers of the risk of developing the movement disorder.

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Elizabeth Conte was prescribed Reglan, a brand-name of metoclopramide used to treat gastrointestinal conditions such as heartburn, GERD and gastroparesis. For four years she took the medication, unaware that she was slowly developing a debilitating and incurable movement disorder known as Tardive Dyskinesia. What she soon found out is that her involuntary head jerks and facial twitches were caused by long-term use of metoclopramide.

More and more cases of consumers taking metoclopramide and subsequently developing Tardive Dyskinesia were reported to the Food and Drug Administration (FDA), and by early 2009, the agency had ordered a black box warning be placed on the medication. New warnings and precautions were written into the drug’s packaging that included an up to 20 percent risk of patients developing Tardive Dyskinesia during long-term use of the medication.

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People with movement disorders that are inherited or caused by infection or other occurrences, such as Parkinson’s disease, have a bevy of resources available. But for those whose debilitating condition came as a result of medication have little support. The National Empowerment Center, an organization dedicated to those with mental illness, is raising awareness and educating the public about such conditions in hopes to change that trend.

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The medication metoclopramide, used in the treatment of some gastrointestional conditions, has received much press lately. Earlier this year the drug fell under a black box warning by the Food and Drug Administration (FDA) after studies showed that patients who took the prescription medication were at high risk of experiencing involuntary movements of their face, hands and torso. The condition, known as Tardive Dyskinesia, is a debilitating disorder that often doesn’t go away even after the offending medication has been discontinued. The result has been measured in countless lawsuits against manufacturers of metoclopramide.

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Prokinetic drugs, such as Reglan (metoclopramide) are those that increase the movement of ingested material through the gastrointestingal tract. They are usually prescribed to treat diabetic gastroparesis, heartburn and nausea and vomiting in chemotherapy patients. Unfortunately, some prokinetic drugs may produce a number of serious side effects.

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Are little Jessica’s sudden head jerks a side effect of the heartburn drug Reglan? It’s a question posed along with a video of the toddler by Fiestagrill on YouTube.

Reglan, also known as metoclopramide, is generally prescribed to treat diabetic gastroparesis in adults and gastroesophafeal reflux in adults and children. Recent clinical studies have shown that it is safe for the treatment of morning sickness in women who are pregnant. However, a recent FDA warning has made people like Fiestagrill question whether the medication is causing serious injury to babies as well as children.

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Kecia Neal of Arkansas was prescribed Reglan in 2005 to help her overcome a medical condition that involved the paralysis of stomach muscles. What she didn’t expect is for the medication to make her even sicker.

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Last March, the U.S. Supreme Court upheld a $6.7 million ruling stating that federal law cannot protect pharmaceutical companies from liability lawsuits that are filed in state court, meaning drug companies are responsible for damages created by products even when the FDA has approved drug labels that include warnings of side effects. That ruling is based on a lawsuit involving Wyeth Pharmaceutical drug Phenergan. As a result of the ruling, numerous lawsuits against pharmaceutical companies that had been lying dormant are finally beginning to move toward trial, according to Bloomberg.

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