Roche’s New Accutane Warning Label OK, Judge Rules

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Roche’s New Accutane Warning Label OK, Judge Rules.

 

Law360, New York (April 02, 2015, 4:25 PM ET) — A New Jersey state judge found Thursday that Hoffmann-La Roche Ltd.’s heightened warning in April 2002 for its acne drug Accutane is adequate, ending all suits by New Jersey plaintiffs who took the drug after that date and putting hundreds of suits by plaintiffs from other states in doubt.
Judge Nelson Johnson, who is presiding over thousands of Accutane suits consolidated before him in the state, found Thursday that Roche’s post-2002 labels sufficiently warned of the drug’s inflammatory bowel disease risks.

The ruling, which grants Roche’s summary judgment motion, ends 27 suits by New Jersey-based plaintiffs, though it could potentially affect some 800 other suits in which plaintiffs from other states took the medication after April 2002. But Judge Johnson did not consider how his findings will affect those cases.

The April 2002 warning at issue said patients should not be treated with Accutane until they have first received “conventional” treatment, including antibiotics. The warning also acknowledged Accutane’s potential risk of posing serious health problems such as irritable bowel disease, prompting Judge Johnson’s remarks in his opinion Thursday that the drug’s possible consequences are “unmistakable.”

 

 

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