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.
The lawsuit claims Bayer used illegal marketing to sell the combination drugs, a violation of the New Jersey Consumer Fraud Act, which prohibits consumer fraud in connection with sales and using misleading claims to sell the drugs for a higher price than other over-the-counter aspirins.
"Not only did Bayer fail to include proper labeling and directions for use," said Berman, "They also illegally marketed the combination drugs with added supplements as a way to artificially inflate the price point of regular over-the-counter aspirin without proper FDA approval."
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.
For more information on this case, please visit http://www.hbsslaw.com/bay.
About Hagens Berman Sobol Shapiro
Hagens Berman Sobol
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