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Bayer Aspirin Supplement Products Refund Lawyers

Keywords: Bayer Aspirin Lawyer Heart Advantage Womens Calicum Low Dose Lawsuit

The lawyers and attorneys at our firm are investigating a potential class action lawsuit on behalf of consumers who purchased Bayer Women’s Low Dose Aspirin + Calcium or Bayer Aspirin With Heart Advantage.  In October 2008, the Food & Drug Administration (FDA) warned Bayer that these two aspirin supplement products were being sold illegally, and that claims made on their labels were misleading. 

If you or someone you know used either Bayer Women’s Low Dose Aspirin + Calcium or Bayer Aspirin With Heart Advantage,  you may be entitled to a refund.  Please contact one of our Bayer aspirin supplement refund  lawyers right away to protect your legal rights.
 

Bayer Aspirin Supplements FDA Warning Letter

Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin With Heart Advantage are both sold over the counter.  Bayer Aspirin with Heart Advantage contains plant sterols and claims on its packaging to help control cholesterol, while Bayer Women's Low Dose Aspirin + Calcium claims to help strengthen bones and prevent osteoporosis.  However, Bayer never conducted clinical trials to prove these claims. Because of this deception, the Bayer aspirin supplement refund lawyers at our firm believe consumers who purchased these products are entitled to compensation.
 

The FDA began examining Bayer  Heart Advantage after it was introduced in 2008.  Michael Levy, acting assistant director of compliance in the FDA's drug division told Bloomberg.com. that the agency was especially concerned about that product because ``it is a combination that we have not seen before."  The FDA also decided to examine the women's aspirin, introduced in 2002, ``in the interest of consistency,'' he said.
 

Supplements such as plant sterols, vitamins and herbs do not have to be proven safe and effective before they can be sold in the United States. But according to the FDA warning letters sent to Bayer in October 2008, adding them to already-approved drugs - such as aspirin - makes them entirely new products that must be subject to FDA review before being sold.  Bayer never submitted either aspirin supplement product to the agency for review.
 

``The marketing of these unapproved drugs is troubling,''  Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said  in a statement. ``The overuse or misuse of these aspirin-containing products can put consumers at risk for internal bleeding and other adverse events.''
 

The FDA said that no adverse events have been reported in relation to Bayer Women’s Low Dose Aspirin + Calcium and Bayer Aspirin With Heart Advantage.  However, many drug side effects are never reported to the FDA, and our Bayer aspirin supplement refund lawyers believe that these illegal medications have the potential to injure thousands of people.
 

The FDA warning letter also said that claims that the drugs control cholesterol and help prevent osteoporosis were misleading.  "These statements on the labeling send consumers a mixed message about the purpose of the product and the duration for which it can be safely used," the warning letter said.
 

The FDA did not direct Bayer to remove the aspirin supplements from the market, but the letter gave the company 15 days to respond.  Bayer could either stop selling the products or conduct clinical trials and seek FDA approval.  If a company does not respond to a warning letter within the specified time period, the FDA may seize the product, seek an injunction or take other legal steps.
 

Bayer Aspirin with Heart Advantage Congressional Investigation

Bayer Aspirin with Heart Advantage is also the subject of a congressional investigation. The probe is part of a House Committee on Energy and Commerce investigation into  misleading and deceptive direct-to-consumer  advertising that began in January 2008.
 

 On October 14, 2008, Representatives John Dingell and Bart Stupak, both  Michigan Democrats, wrote  to the Health and Human Services Department, which oversees the FDA, questioning whether the Heart Advantage product violated agency rules. The lawmakers cited a May 2000 FDA letter that warned that the addition of a new ingredient to an already-approved drug could affect the safety and effectiveness of a product.  The  FDA recommended that drug makers refrain from marketing products that combine drug and supplement ingredients.
 

The lawmakers also wrote to Gary S. Balkema, President of Bayer HealthCare LLC, questioning the safety and effectiveness of Bayer Aspirin with Heart Advantage.  Dingell and Stupak asked Balkema why Bayer ignored FDA recommendations to refrain from marketing such combination products.
 

On October 28, the lawmakers said they supported the FDA's action in regards to the Bayer supplements.  “The FDA appears to have responded to our investigation with appropriate action against Bayer Aspirin with Heart Advantage,” Stupak said in a statement. “While we appreciate the warning letter being sent, the FDA should not rely solely on Congressional oversight to notify them of such concerns. We need an FDA that is proactive rather than reactive when it comes to protecting public health.”
 

Class Action Lawsuit Seeking Refunds for Purchasers of Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin + Calcium

Our firm is offering free case evaluations to anyone who purchased either of these Bayer aspirin supplement products.  We believe that anyone who purchased these drugs because of Bayer's misleading claims is entitled to a refund.  If you or someone you know would like to joint this class action lawsuit, please fill out our online form or call 1-800 LAW INFO (1-800-529-4636) to discuss your case with one of our Bayer aspirin supplement refund lawyers.