Public Citizen, a leading consumer advocacy group, petitioned the FDA to change rules that protect generic drug manufacturers from some lawsuits. Current FDA rules require generic drug labels to be exactly the same as their brand name counterparts. This may seriously hurt consumers who want to sue generic drug companies for side effects caused by their medications.
Under current regulations, if new findings come to light about ill-effects caused by a generic drug, such findings cannot be placed on the label if they are not on the label of the equivalent brand name drug. The FDA regulation shields the generic drug makers from being held liable.
Public Citizen contends that this rule prevents consumers from successfully suing for adverse effects caused by certain generic drugs.
Ordinarily, if a brand-name drug label fails to warn against a harmful side-effect, consumers can successfully sue the manufacturer, saying they were injured by the drug that didn’t carry a warning on its label of the harmful side effect.
But because of FDA regulations, this type of lawsuit may not be successful against the maker of a generic version of the same drug.
Public Citizen filed the petition after the Supreme Court handed down a ruling that favored generic drug manufacturers. The ruling may harm thousands of consumers who sue generic drug companies for harmful effects, the advocate group said.
The particular case before the Supreme Court was brought by two women who sued generic drug manufacturers because the manufacturers failed to warn about the devastating side effects of generic forms of Reglan®. Metoclopramide (the generic name for Reglan®) is known to lead to tardive dyskinesia, a movement disorder caused by the drug’s injury to the brain.
Tardive dyskinesia is characterized by uncontrollable grossly abnormal movements of the face and sometimes the fingers, limbs, and torso.
Contact the defective drug lawyers with the Flood Law Group today if you wish to seek compensation for drug side effects.