Bayer Healthcare settles aspirin marketing lawsuit for $15 million
  • Thu, 07/12/2012 - 12:32pm

A Bayer AG unit will pay $15 million to resolve a U.S. lawsuit regarding illegally marketed aspirin that contained supplements.

A federal judge recently approved the settlement between Bayer Healthcare LLC and U.S. consumers. 

“The settlement negotiations were extensive. Significant compromises were made by both sides,” Judge Brian M. Cogan reportedly said at a hearing.

According to Bloomberg, Bayer Healthcare was sued in 2008 over its Women’s Low Dose Aspirin + Calcium and Aspirin with Heart Advantage, which contained phytosterols. Phytosterols can be found in various plants and in foods like rice bran, wheat germ, corn oils, soybeans, and peanuts and are said to lower cholesterol, according to WebMD.

October of that year, the U.S. Food and Drug Administration warned Bayer that the aspirin mixtures had not been approved and were being marketed unlawfully.

According to the FDA:

  • Bayer Women’s combined aspirin and calcium. The label proposed that it will make bones stronger and fight osteoporosis.
  • Bayer Heart Advantage combined low-dose aspirin with phytosterols. The label proposed that it would lower cholesterol.
  • Both products' labels proposed that they would reduce the risk of heart disease.

An FDA press release stated:

Bayer Heart Advantage and Bayer Women's are misbranded because their labeling lacks adequate directions for use by consumers. In order for a drug to have adequate directions for use, the directions must be written so that consumers can use the product safely for its intended purpose, without the supervision of a health care professional. The use of these products for treatment of heart disease and osteoporosis requires diagnosis and supervision by a health care professional to ensure safe use. Therefore, it is not possible, in OTC drug product labeling, for these products to have adequate directions for their intended uses. The products also are misbranded because their labeling do not have adequate warnings and are misleading.

WebMD added, “In its warning letters to Bayer, the FDA notes that aspirin, calcium, and phytosterols could be marketed separately. But when combined into a single pill, the FDA says the combination of aspirin plus either supplement must be approved as a new drug.”

On the other hand, according to the Bayer Healthcare agency’s website, over-the-counter drugs do not normally need FDA approval as long as they follow pre-approved formulas. The FDA also admitted that it had not received reports of negative reactions to either of the abovementioned Bayer products.

All U.S. consumers who bought the drugs within a fixed timeframe are included in the settlement, but the court needs to approve the final deal.


About the Contributor

Kaitlin Gill
I report on news regarding product safety concerns for individuals and families.

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