Massachusetts: Big Pharma can be held liable for Generic Labeling
Innovator Liability
The Massachusetts Supreme Judicial Court held that Pharmaceutical Companies such as Merck could be held liable for injuries resulting from generic labels even when another company manufactures the generic version of the drug. Known as innovator liability, this precedent could hold big pharmaceutical companies accountable for intentional, reckless conduct where they control the content of a generic drug label and fail to update labeling.
Federal Law Generic Labeling Requirements
Plaintiffs must show that the brand-name drug maker was reckless, not merely negligent in their conduct. According to the United States Supreme Court in PLIVA, Inc. v. Mensing, federal law requires generic drug companies to use the same label as the brand-name version precluding generic drug companies from lawsuits for failing to provide adequate label warnings. This would leave a plaintiff unable to receive compensation for injuries sustained by a generic drug.
Holding Big Pharm Accountable
In this case Brian Rafferty vs. Merck & Co., Inc. Massachusetts Supreme Court Chief Justice Ralph Gants writing for the court said “Where a brand-name drug manufacturer provides an inadequate warning for its own product, it knows or should know that it puts at risk not only the users of its own product, but also the users of the generic product.”
Rafferty had initially sued Merck for negligence for failure to warn after taking finasteride for an enlarged prostate. Finasteride is the generic version of Proscar, manufactured by Merck. Not long after taking the drug, Rafferty experienced side effects including erectile dysfunction and decreased libido. Despite stopping the medication, Rafferty continued suffering the side effects. While finasteride’s label warned of potential side effects including sexual dysfunction, it failed to warn that the side effects would continue after stopping the use of the drug. Finasteride’s label was identical to the label for Proscar as required by federal law. Rafferty alleges that despite knowing about the continued side effects and even changing the label in other countries, Merck did not update the label in the United States. Rafferty alleges that Merck had a duty to warn him of any adverse reactions since they control the label as the brand-name manufacturer.
While the court dismissed the negligence claim, they did recognize the need to protect consumers stating, “to shield brand-name manufacturers entirely from liability for the failure to warn generic drug consumers, (we) would leave those consumers with no chance of obtaining compensation for their injuries because generic manufacturers are already immune from State law claims.” The court found that there is a duty not to intentionally or recklessly cause harm to others.
Other Courts Agree
The California Supreme Court issued a similar ruling regarding innovator liability stating that generic drug users could sue brand-name manufacturers. In T.H., et al. v. Novartis Pharmaceuticals Corporation the California Supreme Court held that “brand-name manufacturers have a duty to use ordinary care in warning about the safety risks of their drugs, regardless of whether the injured party (in reliance on the brand-name manufacturer’s warning) was dispensed the brand-name or a generic version of the drug.”
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