Bayer Healthcare LLC, a unit of Bayer AG, paid $15 million to settle a
U.S. consumers lawsuit involving illegally marketed aspirin in supplements.
Judge Brian M. Cogan in Brooklyn, NY, who approved this settlement, said
that the "settlement negotiations were extensive" and that "significant
compromises were made by both sides."
In 2008, U.S. consumers sued Bayer Healthcare LLC over two of its products:
Bayer Women's Low Dose Aspirin & Calcium and Bayer Aspirin with
Heart Advantage. Both aspirins were mixed with a supplement named phytosterols;
according to U.S. Food and Drug Administration protocol, aspirin mixtures
with supplements like phytosterol are considered as "unapproved new
drugs." Despite the FDA warnings, Bayer Healthcare continued to sell
the two drugs in the market since over-the-counter drugs do not require
FDA approval. This issue highlights the blurry boundaries regarding the
sale of unapproved drugs, particularly in the market of over-the-counter drugs.
The settlement includes all U.S. consumers who purchased either drugs;
the exact timeframe and details are yet to be approved by the court.