Law360, New York (May 08, 2009) — Several plaintiffs have added claims for damages in a proposed class action against Bayer Healthcare LLC over the company’s allegedly illegal marketing of aspirin products as drug dietary supplements that prevent heart and bone disease.
In a first amended complaint filed Thursday in the U.S. District Court for the Eastern District of New York, the plaintiffs, two residents of California, added claims for punitive and compensatory damages.
Their suit against Bayer alleges it markets its Bayer Heart Advantage and Bayer Women’s aspirin products as over-the-counter drug-dietary supplements, even though the inclusion of aspirin in the products requires U.S. Food and Drug Administration approval.
According to the complaint, Bayer is required to obtain FDA approval prior to marketing the products as treatments for heart and bone disease and is specifically prohibited by the California health and safety code from advertising that such drugs have any effect on bone and joint or heart and vascular diseases.
“Bayer’s marketing and sale of the Bayer drugs has thus short-circuited the proper regulatory process and put consumer health and welfare at risk,” the complaint said.
Dan Mogin, an attorney for the plaintiffs, said the amended complaint was filed because under California law, any plaintiff suing under the Consumer Legal Remedies Act cannot allege a claim for damages until at least 30 days have elapsed from the original filing.
The original suit was filed in California Superior Court in November after the plaintiffs, Anne McCabe and Frances Martinez, on behalf of a class of all California consumers who purchased Bayer drug dietary supplement products, sent the pharmaceutical company a letter demanding it stop marketing the drugs as treatments for heart and bone disease and refund their purchases.
On April 15, the suit was transferred to the Eastern District of New York by the Judicial Panel on Multidistrict Litigation, joining more than a dozen cases currently pending in the MDL.
According to the complaint, Bayer is illegally marketing the two aspirin products as drug dietary supplements that are not drugs, and therefore, are not required to undergo premarket clearance by the FDA.
However, because Bayer is labeling Bayer Heart Advantage and Bayer Women’s as combination drug and dietary supplements that are effective to treat bone and heart disease, the products are defined as drugs by law and must be approved, the complaint said.
Neither drug is approved for uses other than pain treatment, and in October, the FDA warned Bayer about the illegal marketing and said it would take enforcement action.
The complaint contends that Bayer’s actions compromise consumer safety because products that are being marketed for preventing or treating heart attacks, heart disease and osteoporosis require a physician’s supervision.
The plaintiffs also claim that the drugs are misbranded because Bayer has failed to adequately disclose significant safety risks associated with the use of its products that combine aspirin with phytosterols, which Bayer’s Health Advantage does, and aspirin with calcium, which Bayer’s Women’s does.
As a result of the unlawful labeling, marketing and advertising alleged in the complaint, Bayer has been able to charge significantly more — including up to six times — for the products than its regular aspirin products, according to the complaint.
Counsel for Bayer could not be reached for comment Friday.
The plaintiffs are represented in this matter by the Mogin Law Firm PC and the Law Offices of Alexander M. Schack.
Bayer is represented in this matter by DLA Piper and Bartlit Beck Herman Palenchar & Scott LLP.
The case is McCabe et al. v. Bayer Healthcare LLC et al., case number: 09-cv-01541, in the U.S. District Court for the Eastern District of New York.
The MDL proceeding is In re: Bayer Corp. Combination Aspirin Products Marketing and Sales Practices Litigation, case number: 09-md-02023, in the U.S. District Court for the Eastern District of New York.