NEW YORK, Aug 28 (Reuters) - The maker of Tylenol
defeated a lawsuit by consumers who said they were deceived into
overpaying for "Rapid Release" gelcaps that did not relieve pain
faster than cheaper tablets, including those labeled Extra
Strength and Regular Strength.
In a decision on Tuesday night, U.S. District Judge Andrew
Carter in Manhattan agreed with Kenvue ( KVUE ) that the federal
Food, Drug, & Cosmetic Act preempted the consumers' claims under
New York state law.
Evie Collaza, the Bronx, New York resident who led the
proposed class action, had cited a 2018 study that found Rapid
Release gelcaps took longer than regular tablets -- 3.94 minutes
versus 3.56 minutes -- to dissolve by at least 80%.
But the judge said it would make no sense to ignore Food and
Drug Administration labeling rules for "immediate release"
acetaminophen products only because that agency did not use the
exact words "rapid release."
He said some judges have ruled similarly in lawsuits against
the grocer Albertsons ( ACI ), though one suggested in a lawsuit
against pharmacy chain Rite Aid ( RADCQ ) that "immediate" and
"rapid" were not synonymous.
"To hold that the FDA's regulation of acetaminophen
dissolution rates ought not control simply because a drug
producer markets or prices several of its qualifying 'immediate
release' products in varying manners would be to create an
end-run around the FDCA's express preemption clause," Carter
wrote.
Kenvue ( KVUE ), based in Skillman, New Jersey, was part of Johnson &
Johnson ( JNJ ) before being spun off in August 2023.
Lawyers for Collaza did not immediately respond to requests
for comment. Kenvue ( KVUE ) and its lawyers did not immediately respond
to similar requests.
The case is Collaza v Johnson & Johnson Consumer Inc, U.S.
District Court, Southern District of New York, No. 23-06030.