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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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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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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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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A Missouri woman is seeking more than $600,000 in damages from the makers of Reglan (metoclopramide) for not adequately warning her of the risk of a serious, permanent, disabling neurological condition known as Tardive Dyskinesia.

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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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