Dangerous Side Effects of Reglan

Posted by in Dangerous Medical Products on Feb 28, 2015

After being approved by the Food and Drug Administration as treatment for gastro-esophageal reflux disease (GERD) in 1980, metoclopramide has been mass produced generically since 1985. Originally sold by Wyeth as Reglan in 1980, this compound has been tied to the development of tardive dyskinesia, a serious and often irreversible neurological disorder. People with this condition suffer from uncontrolled movements, generally on the lower part of the face. This severe side effect has already been issued on the original label, with further instructions to avoid the use of the drug no longer than 12 weeks. With the increasing number of patients who developed tardive dyskinesia after taking metoclopramide, in February of 2009 the FDA has issued a black box warning (the strongest type of warning) on the label to inform patients of their risks of tardive dyskinesia.

When additional warnings were given to the brand name Reglan, pharmaceutical companies who make generic metoclopramide are also required by federal laws to update their label warning. However, generic manufacturers have not adopted the recent updates on Reglan, and thus have put patients in danger of tardive dyskinesia. Many patients have already considered finding a Reglan lawyer to help them file an injury case against the manufacturers of the generic Reglan for their negligence on failing to warn consumers.

With the hundreds of lawsuits already filed in court, generic drug claims can now be considered following a petition for certiorari that was been filed in an appeals court in November of 2014. According to ruling given by the Iowa Supreme Court, Pliva Inc., a manufacturer of generic Reglan, can be held accountable for any injuries caused to their consumers after they have failed to provide updated warning labels to match their branded counterparts. The defendant, Pliva Inc., have already petitioned to overturn the decision, arguing that the federal law should legally preempt these type of state tort law claims made against manufacturers like them.

Through the years, the issue regarding generics manufacturers being held liable for injuries caused by their drugs due to “failure to warn” or neglecting to update their labels in accordance to their branded counterparts has been exhausted on courts throughout the United States. Presently, federal and state appellate courts are split in their views on the generic manufacturer’s argument on preemption.

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