Advertisement
(Logo: http://www.newscom.com/cgi-bin/prnh/20080317/AQM144LOGO)
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 osteoporosisin women. According to the plaintiffs, these medical claims require anapproved new-drug application to be considered legal for marketing purposes.
Advertisement
The lawsuit, filed in U.S. District Court in New Jersey by Seattle-basedHagens Berman, alleges Bayer used improper marketing tactics aimed at heartpatients fearing high cholesterol and heart disease with Bayer Aspirin withHeart Advantage, and women fighting osteoporosis with Bayer Women's Low DoseAspirin + Calcium.
"Bayer knew that these drugs were illegally targeted at consumerssusceptible to the claims -- consumers who feared heart disease and womenconcerned with fighting osteoporosis," said Steve Berman managing partner ofHagens Berman and lead attorney for the plaintiffs. "This suit is a directresponse to Bayer's scheme to convince millions of consumers to buy the drugssidestepping 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 approvedby 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'sdiagnosis and supervision. This means that these drug products cannot belabeled for use by consumers or sold over-the-counter.
The FDA normally allows over-the-counter pain reliever sales as long asthey include standard directions and labeling for the consumer. However, bothBayer drugs were labeled as a combination of a drug and dietary supplement ina single tablet. In these cases, the FDA requires drug approval beforemarketing and bans such drugs from over-the-counter sales altogether, the suitclaims.
Bayer has marketed the Heart Advantage product as an aspirin that canreduce heart attack risk by up to 30 percent, yet there is a warning on theWeb site that this drug is not to be used as a replacement for cholesterollowering medications, court documents state.
The lawsuit claims Bayer used illegal marketing to sell the combinationdrugs, a violation of the New Jersey Consumer Fraud Act, which prohibitsconsumer fraud in connection with sales and using misleading claims to sellthe drugs for a higher price than other over-the-counter aspirins.
"Not only did Bayer fail to include proper labeling and directions foruse," said Berman, "They also illegally marketed the combination drugs withadded supplements as a way to artificially inflate the price point of regularover-the-counter aspirin without proper FDA approval."
Named plaintiff, Kris Gerhard purchased and paid for Bayer Calcium duringthe period beginning in 2002 and was damaged by the actions of Bayer due todeceptive and unfair marketing, the suit claims. Gerhard seeks to representthe class of consumers that suffered economic damages from purchasing theseunapproved products and gain a full refund for their purchases.
For more information on this case, please visithttp://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, ithas developed a nationally recognized practice in class-action and complexlitigation. Among recent successes, HBSS has negotiated a $300 millionsettlement in the DRAM memory antitrust litigation; a $340 million recovery onbehalf of Enron employees; a $150 million settlement involving charges ofillegally inflated charges for the drug Lupron, and served as co-counsel onthe Visa/Mastercard litigation which resulted in a $3 billion settlement, thelargest anti-trust settlement to date. HBSS served as counsel in an $850million Washington Public Power Supply settlement and represented Washingtonand 12 other states against the tobacco industry that resulted in the largestsettlement in history. For a complete listing of HBSS cases, visithttp://www.hbsslaw.com.Steve Berman (206) 623-7292 Hagens Berman Sobol Shapiro [email protected] Mark Firmani (206) 443-9357 Firmani + Associates, Inc. [email protected]
SOURCE Hagens Berman Sobol Shapiro
