Bayer Side Effects Claim Lawsuit. Our Class action lawsuit lawyers are investigating claims that Bayer Heart Health Advantage, a non-aspirin supplement that supposedly lowers bad (LDL) cholesterol, may not provide users with any real benefit. We believe that the type of phytosterols used in Bayer Heart Health Advantage may have few or no cholesterol-lowering properties.
More On Bayer Heart Health Advantage Class Action Lawsuit?
Bayer Aspirin Supplement Products Refund Lawyers
The lawyers and attorneys at our firm are offering free case evaluations to consumers who have purchased Bayer Women’s Low Dose Aspirin + Calcium or Bayer Aspirin With Heart Advantage. Hundreds of people from across the country have joined lawsuits claiming Bayer marketed Women’s Low Dose Aspirin + Calcium and Bayer Aspirin With Heart Advantage products without Food & Drug Administration (FDA) approval and deceived consumers with respect to the safety and efficacy of the products. These lawsuits were recently consolidated in a Multidistrict Litigation (MDL) in the Eastern District of New York.
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 and 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 the questionable claims made about the products, the Bayer aspirin supplement refund lawyers at our firm believe consumers who purchased them are entitled to compensation.
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.
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 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.
Bayer Corp. Combination Aspirin Products MDL
By April 2009, scores of consumers had filed lawsuits against Bayer for the false marketing of Women’s Low Dose Aspirin + Calcium and Bayer Aspirin With Heart Advantage. At least four such actions had been filed in federal court in the District of New Jersey, two actions in the Southern District of Illinois and one action each in the Southern District of California and the Eastern District of New York.
Parties in the lawsuits had petitioned the Judicial Panel on Multidistrict Litigation to consolidate these lawsuits in a single MDL. The panel agreed, and ruled that the Eastern District of New York was the appropriate forum for the Bayer lawsuits. The panel chose the Eastern District of New York because Bayer Healthcare LLC has its corporate headquarters in New York, thus relevant documents and witnesses will likely be found nearby. Also, the action pending in the Eastern District of New York was before a judge who has experience presiding over multidistrict litigation, but was not currently assigned to another such docket. The panel felt that this judge had the time and commitment necessary to steer these cases on a fair and expeditious course.
The Judicial Panel on Multidistrict Litigation of the United States Courts was created in 1968. Since then, it has consolidated hundreds of thousands of lawsuits that involved high numbers of plaintiffs, including litigation over asbestos, breast implants and other matters. When lawsuits are consolidated as an MDL each retains its own identity. If the MDL process does not resolve the cases, they are transferred back to the court where they originated for trial.
Class Action Lawsuit Seeking Refunds for Purchasers of Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin + Calcium
Our firm is representing plaintiffs in a class action lawsuit pending before the Bayer Corp. Combination Aspirin Products MDL. We are 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.