Sokolove Success Blog – Our Perspective on Legal News that Matters

To plaintiffs’ lawyers, the claim is all too familiar.  Major drug manufacturer gets FDA approval for a new treatment, but the marketing campaign for the new drug allegedly overstates the benefits and downplays the risks.

Today, that claim is being levied at Bayer HealthCare Pharmaceuticals with respect to popular birth control pills Yaz and Yasmin.

The National Law Journal has the story here (free registration required).

In 2008, the pharma giant reached an agreement with FDA to run a $20 million corrective ad on the benefits and risks of Yaz.  The FDA had previously issued a warning letter to Bayer about its marketing activities.

This month, we’re seeing the first lawsuits being filed on this issue. According to the NLJ, the lawsuits allege: “that Bayer failed to warn women and their doctors of the pills’ increased risk of injury — most notably blood clots — while over promoting the benefits of the drugs.”

Janey Abaray, an attorney with Burg Simpson Eldredge Hersh & Jardine (A Sokolove Law affiliate) said there may be additional risks.  Here’s what she said in the NLJ story:

“ (our) firm has amassed evidence that shows that there are many more adverse events reported to the FDA for Yaz and Yasmin than for other birth control pills that have been around longer… We expect to be filing consistently over the next several weeks and months. We have many cases. It’s just a matter of getting all of the medical records”.

A spokesman for Bayer offered the typical “it’s perfectly safe if used as directed” response, which of course completely ignores the question of whether the advertising was fair and accurate, or whether the company adequately warned patients.

As always, stay tuned as we’re likely to see many more cases in this area.