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.

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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.

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“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.

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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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