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Bayer Sued Over Marketing of 2 Aspirin Based Drug Products
A group of consumers filed a proposed nationwide class-action lawsuit earlier this week against Bayer Healthcare LLC, a subsidiary of Bayer AG, alleging the pharmaceutical giant skirted FDA requirements in marketing two aspirin-based drugs.
The suit states that Bayer markets two of its over-the-counter products -- Bayer Aspirin with Heart Advantage and Bayer Women's Low Dose Aspirin + Calcium -- as products that reduce the risks of heart disease and osteoporosis in women. According to the plaintiffs, these medical claims require an approved new-drug application to be considered legal for marketing purposes.
Furthermore, the suit alleges Bayer used improper marketing tactics aimed at heart patients fearing high cholesterol and heart disease with Bayer Aspirin with Heart Advantage, and women fighting osteoporosis with Bayer Women's Low Dose Aspirin + Calcium. While both drugs are labeled as a pain reliever with additional benefits, neither drug is approved by the FDA for use, the lawsuit claims.
Importantly, reports also indicate the 2 drugs require a health care professional's diagnosis and supervision. This means that these drug products cannot be labeled for use by consumers or sold over-the-counter.
The FDA normally allows over-the-counter pain reliever sales as long as they include standard directions and labeling for the consumer. However, both Bayer drugs were labeled as a combination of a drug and dietary supplement in a single tablet. In these cases, the FDA requires drug approval before marketing and bans such drugs from over-the-counter sales altogether, the suit claims.
Bayer has marketed the Heart Advantage product as an aspirin that can reduce heart attack risk by up to 30 percent, yet there is a warning on the Web site that this drug is not to be used as a replacement for cholesterol lowering medications, court documents state.
Named plaintiff, Kris Gerhard purchased and paid for Bayer Calcium during the period beginning in 2002 and was damaged by the actions of Bayer due to deceptive and unfair marketing, the suit claims. Gerhard seeks to represent the class of consumers that suffered economic damages from purchasing these unapproved products and gain a full refund for their purchases.
Published on Nov-19-08
The suit states that Bayer markets two of its over-the-counter products -- Bayer Aspirin with Heart Advantage and Bayer Women's Low Dose Aspirin + Calcium -- as products that reduce the risks of heart disease and osteoporosis in women. According to the plaintiffs, these medical claims require an approved new-drug application to be considered legal for marketing purposes.
Furthermore, the suit alleges Bayer used improper marketing tactics aimed at heart patients fearing high cholesterol and heart disease with Bayer Aspirin with Heart Advantage, and women fighting osteoporosis with Bayer Women's Low Dose Aspirin + Calcium. While both drugs are labeled as a pain reliever with additional benefits, neither drug is approved by the FDA for use, the lawsuit claims.
Importantly, reports also indicate the 2 drugs require a health care professional's diagnosis and supervision. This means that these drug products cannot be labeled for use by consumers or sold over-the-counter.
The FDA normally allows over-the-counter pain reliever sales as long as they include standard directions and labeling for the consumer. However, both Bayer drugs were labeled as a combination of a drug and dietary supplement in a single tablet. In these cases, the FDA requires drug approval before marketing and bans such drugs from over-the-counter sales altogether, the suit claims.
Bayer has marketed the Heart Advantage product as an aspirin that can reduce heart attack risk by up to 30 percent, yet there is a warning on the Web site that this drug is not to be used as a replacement for cholesterol lowering medications, court documents state.
Named plaintiff, Kris Gerhard purchased and paid for Bayer Calcium during the period beginning in 2002 and was damaged by the actions of Bayer due to deceptive and unfair marketing, the suit claims. Gerhard seeks to represent the class of consumers that suffered economic damages from purchasing these unapproved products and gain a full refund for their purchases.
Bayer Aspirin with Heart Advantage and Bayer Women's Low Dose Aspirin + Calcium Legal Help
If you or a loved one has suffered damages in this case, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.Published on Nov-19-08
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