A Bayer AG unit will pay $15 million to settle a U.S. lawsuit claiming it illegally marketed aspirin mixed with supplements.
The settlement between the unit, Bayer Healthcare LLC, and U.S. consumers received preliminary approval today from a federal judge in Brooklyn, New York.
“Clearly, this was a hard-fought case,” Judge Brian M. Cogan said at a hearing. “The settlement negotiations were extensive. Significant compromises were made by both sides.”
Bayer Healthcare was sued by consumers in 2008 over its Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin with Heart Advantage, containing the supplement phytosterols.
The U.S. Food and Drug Administration warned the company the same year that it considered the aspirin mixtures “unapproved new drugs” and that they were being sold unlawfully. Over-the-counter drugs don’t typically require FDA approval as long as they conform to pre-approved formulas, according to the agency’s website.
The settlement would include all U.S. consumers who purchased the drugs within predetermined timeframes. The deal requires final approval by the court.
Anne Coiley, a spokeswoman for Leverkusen, Germany-based Bayer, didn’t have an immediate comment on the settlement.
The case is Goldberg v. Bayer Healthcare LLC, 1:08-cv-04623, U.S. District Court, Eastern District of New York (Brooklyn).