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Tylenol maker defeats lawsuit over labeling
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Tylenol maker defeats lawsuit over labeling
Aug 28, 2024 9:47 AM

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.

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