Bayer Aspirin: Manufacturer Sued For Marketing Drugs Without FDA Approval

Pharmaceutical giant, Bayer Corporation, has been sued for marketing Bayer Aspirin with Heart Advantage and Bayer Women's Low-Dose Aspirin Plus Calcium without approval from the U.S. Food & Drug Administration (FDA). Eight separate product liability class action lawsuits have been filed against Bayer over these practices and have now been consolidated into Multidistrict Litigation (MDL) in New York.

Deceptive marketing practices

Corporation has sold aspirin for as long as anyone can remember. However, the drug manufacturer began labeling that aspirin a bit differently in January 2008 and consumers say that its done so without FDA approval. The controversy involves these two products:

  • Bayer Aspirin with Heart Advantage
  • Bayer Women's Low-Dose Aspirin Plus Calcium

Eight separate product liability class action lawsuits (four in New Jersey, two in Illinois, one in California and one in New York) have been consolidated into a Multidistrict Litigation in the Eastern District of New York in order to centralize the discovery process. The lawsuits filed against the company have similar allegations – that Bayer's marketing of these products without FDA approval, the company has, “...deceived consumers with respect to the safety and efficacy of the products.”

FDA claiming foul play; Congress investigating

The labeling of these over the counter (OTC) products claims that Bayer Aspirin with Heart Advantage contains plant sterols and may help to control cholesterol and that Bayer Women's Low-Dose Aspirin Plus Calcium helps to strengthen bones and prevent osteoporosis. However, the company never conducted any clinical trials to back up those claims and the FDA is claiming foul play. The Administration sent Bayer a warning letter stating that the, “...statements on the labeling send consumers a mixed message about the purpose of the product and the duration for which it can be safely used..."

In addition to the FDA's warning, the House Committee on Energy and Commerce has also initiated an investigation into Bayer's marketing practices. It is working with the FDA to get to the bottom of what Bayer should have done – and may still need to do – about these practices in the future.

For now, product liability lawyers are claiming that consumers who purchased these drugs relied on Bayer's false claims and are entitled to compensation.