SEATTLE, Nov. 19 /PRNewswire/ -- A group of consumers filed a proposed nationwide class-action lawsuit earlier this week against Bayer Healthcare LLC, a subsidiary of Bayer AG (FRA: BAY), 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.
The lawsuit, filed in U.S. District Court in New Jersey by Seattle-based Hagens Berman, 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.
"Bayer knew that these drugs were illegally targeted at consumers susceptible to the claims -- consumers who feared heart disease and women concerned with fighting osteoporosis," said Steve Berman managing partner of Hagens Berman and lead attorney for the plaintiffs. "This suit is a direct response to Bayer's scheme to convince millions of consumers to buy the drugs sidestepping FDA oversight."
While both drugs are labeled as a pain reliever with additional benefits, neither drug is approved by the FDA for use, the lawsuit claims. If approved by the court, the class action case would represent purchasers of the over- the-counter drugs across the country.
Reports also indicate the two 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.
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 Shapiro is based in Seattle with offices in Chicago, Cambridge, Los Angeles, Phoenix, San Francisco and New York. Since 1993, it has developed a nationally recognized practice in class-action and complex litigation. Among recent successes, HBSS has negotiated a $300 million settlement in the DRAM memory antitrust litigation; a $340 million recovery on behalf of Enron employees; a $150 million settlement involving charges of illegally inflated charges for the drug Lupron, and served as co-counsel on the Visa/Mastercard litigation which resulted in a $3 billion settlement, the largest anti-trust settlement to date. HBSS served as counsel in an $850 million Washington Public Power Supply settlement and represented Washington and 12 other states against the tobacco industry that resulted in the largest settlement in history. For a complete listing of HBSS cases, visit http://www.hbsslaw.com.
Steve Berman (206) 623-7292 Hagens Berman Sobol Shapiro Steve@hbsslaw.com Mark Firmani (206) 443-9357 Firmani + Associates, Inc. Mark@firmani.com
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