A decision handed down by the Alabama Supreme Court rules brand-name drug makers can be held liable if consumers experience adverse effects from that drug's generic equivalent.
The decision stems from a lawsuit filed against Pfizer by an Alabama man after he experienced adverse events from the generic version of Reglan, Pfizer's heartburn medication.
A previous 2011 court decision ruled generic drug makers cannot make changes to product labeling unless the brand-name drug maker has made the change, even if the generic drug maker learns of new side effects, according to a Wall Street Journal report. Generic drug makers must indicate their product's bioequivalence to a brand-name drug to receive approval from the U.S. Food and Drug Administration, so altering their warning labels would violate the regulations that require generic drugs to match brand-name drugs' labels. This decision indicated generic drug makers should not be held accountable for not warning against potential risks, according to the WSJ report.
In the Pfizer case, the court decided the man could sue Pfizer because Pfizer did not adequately warn physicians of the risks associated with the drug.
"When the warning to the prescribing healthcare professional is inadequate…the manufacturer is directly liable to the patient for damage resulting from that failure," reads the court's decision. "The substitution of a generic drug for its brand-name equivalent is not fatal to the [patient's] claim because the [patient is] not claiming that the drug [he] ingested was defective; instead, the [patient's] claim is that Wyeth fraudulently misrepresented or suppressed information concerning the way the drug was to be taken and, as discussed, the FDA mandates that the warning on a generic drug label be the same as the warning on the brand-name drug label and only the brand-name manufacturer may make unilateral changes to the label."
The WSJ report indicates the FDA has proposed a new rule that would allow generic drug makers add new side effect information to their labels independent of brand name drug makers. However, the report says generic drug makers say such a rule would add $4 billion to overall healthcare costs, largely due to the potential of increased litigation costs.
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