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Can Generic Consumers Sue a Name Brand Drug Manufacturer for Injuries? New Case Law

Do you take prescription medication? If so, do you take the name brand medication, or do you sometimes turn to its generic counterparts? If you are like many of us, you have probably ingested generic prescription medications.

Under federal regulations, upon first releasing a brand name medicine, the drug manufacturer must prove that the drug is safe, which includes proof that the warning labels on the drug are adequate and accurate. The process is slightly different for generic drugs, however: there is a simpler and speedier approval process, whereby the manufacturer of the generic drug has to show that it contains the same active ingredients of the brand name drug, and that the warning label is the same as its brand name counterpart. Thus, while a brand name manufacturer has a duty to ensure its label is adequate and accurate, the generic manufacturer only has a duty to ensure its label is identical to the brand name one. Moreover, only the brand name manufacturer has the power to alter the label.

So, what happens when the brand name manufacturer updates its warning label, but the generic manufacturer doesn’t? When a generic drug fails to include adequate warnings about the medicine and its side effects, could an injured party sue the manufacturer of the name brand medicine, which originally drafted the warning label?

This issue was recently discussed by the Massachusetts Supreme Court in the case of Rafferty v. Merck. At issue was whether an injured party may bring a common-law general negligence claim and a statutory consumer protection claim against the brand-name drug manufacturer that created the warning label of medication which caused injury to the plaintiff.

In the case, the plaintiff was prescribed the drug finasteride in order to treat an enlarged prostate. Shortly after he started taking the generic version of the drug, the plaintiff began to experience side effects causing sexual dysfunction. Though he weaned himself off the drug, the side effects continued. The plaintiff was eventually diagnosed with hypogodanism and androgen deficiency allegedly induced by the finasteride, and his treatments will continue indefinitely. Though the product label warned of the side effects in question at the time the plaintiff took the drug, the label noted that the side effects would resolve after discontinuing the drug.

The plaintiff sued Merck in the Massachusetts Superior Court, asserting claims of negligence for failure to warn, and a violation of the state consumer protection statute. The plaintiff alleged that by the time he was prescribed finasteride, several reports and studies had already emerged suggesting that those side effects could in fact persist even after discontinued use, but Merck had not changed its warning label. He further alleged that although he never took Merck’s name brand version of finasteride, Merck nevertheless owed him a duty to warn of its dangers because, under Federal law, Merck controlled the label on the generic version. The trial judge allowed Merck’s motion to dismiss. The plaintiff appealed, and the Supreme Judicial Court transferred the case on its own accord.

The high court discussed the difficulties in federal labeling laws. “This allocation of labeling responsibilities under Federal law has proved difficult to reconcile with the duties required of generic drug manufacturers under State tort law,” the Court explained. “Many States, including this one, impose on manufacturers a duty to warn consumers of dangers arising from the use of their products where the manufacturers know or should have known of the dangers.”

Normally, the Court acknowledged, a defendant’s common law duty of care would not extend to a product which was technically not its own. However, based on public policy reasons, the Court also acknowledged that imposing no liability on brand name manufacturers leaves the consumer with zero chance of obtaining compensation for their injuries. Essentially, the Court needed to balance various competing considerations: imposing liability might chill invention, but failing to do so might leave consumers in a lurch.

“Having weighed these considerations, we conclude as a matter of public policy that allowing a generic drug consumer to bring a general negligence claim for failure to warn against a brand-name manufacturer poses too great a risk of chilling drug innovation, contrary to the public policy goals embodied in the Hatch-Waxman amendments. But we also conclude that public policy is not served if generic drug consumers have no remedy for the failure of a brand-name manufacturer to warn in cases where such failure exceeds ordinary negligence, and rises to the level of recklessness,” the Court held. “We therefore hold that a brand-name manufacturer that controls the contents of the label on a generic drug owes a duty to consumers of that generic drug not to act in reckless disregard of an unreasonable risk of death or grave bodily injury. This recklessness standard strikes the most appropriate balance between competing public policy interests, limiting liability for brand-name manufacturers while also providing remedies for the most serious injuries and deterring the most dangerous forms of conduct.”

By establishing a “recklessness” standard, the Court noted that it stayed within the confines of established tort law and required proof of more than mere negligence in order to hold a brand name drug manufacturer liable in this situation. The Massachusetts court here deviated from the majority of courts, which do not impose a duty to warn generic consumers on brand-name manufacturers. It also created the only ruling to limit the scope of liability to a reckless disregard standard. “Under this standard, a brand-name manufacturer that intentionally fails to update the label on its drug to warn of an unreasonable risk of death or grave bodily injury, where the manufacturer knows of this risk or knows of facts that would disclose this risk to any reasonable person, will be held responsible for the resulting harm,” the Supreme Judicial Court noted.

Ultimately, the high court vacated the dismissal of the case and remanded it to the Superior Court, in order for the trial court to decide the question of whether the plaintiff stated a failure to warn claim that meets the standard of a reckless disregard of an unreasonable risk of death or grave bodily injury.

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