16. April 2012 14:54
Bayer HealthCare has agreed to pay an average of $220,000 per patient to settle 500 lawsuits over the safety of its birth control pills Yaz and Yasmin (drospirenone).
The German company is accused of misleading patients and clinicians about the risk of venous thromboembolism (VTE), leading to cardiovascular events, to women taking the drug.
The settlement means Bayer will pay a minimum total charge of $110m – and if rolled out across all the current lawsuits, could cost the company over $2bn.
Safety reviews of drospirenone-containing birth control pills led to FDA’s decision to include VTE risk warnings in the product labels.
Bayer is currently facing more than 11,000 lawsuits in the US alleging harm caused by the use of Yaz, Yasmin or authorised generic equivalents.
Yaz is one of Bayer’s most successful brands, earning $1.1bn in 2011.
Rosemarie Yancosek, a spokesperson for Bayer, said: “Bayer HealthCare confirms that some cases pending in the current Yaz/Yasmin litigation in the US are being settled.”
Bayer’s settlement strategy contrasts with the more defensive approach taken by Johnson & Johnson over the marketing of its antipsychotic drug Risperdal.
31. May 2011 16:56
Chiesi, Eli Lilly and Bayer Healthcare have all been named in advertisements for breaches of the ABPI Code of Practice, while Bayer Schering Pharma has been publicly reprimanded.
The first three companies have each been found guilty of bringing discredit upon, and reducing confidence in, the pharma industry – Clause 2 of the Code.
Chiesi was found guilty of providing a clinical support service that was assisting GPs to switch to a Chiesi medicine, while Eli Lilly provided “inappropriate hospitality” to two healthcare professionals.
Bayer Healthcare has been ‘named and shamed’ for making misleading claims about its contraceptive Yasmin and underplaying its side effects.
Bayer Schering Pharma’s public reprimand was the result of a prescribing policy document for Levitra that did not include the prescribing information (a breach of Clause 4.1) and for circulating the document more widely than was acknowledged to the PMCPA.
The advertisements appeared in The Nursing Standard, the BMJ and The Pharmaceutical Journal.