Smoking Gun E-Mail Reveals Bayer Promoted Yaz and Yasmin For Uses Not Approved By The FDA

Nov. 29, 2011 - PRLog -- Bayer unit officials may have intentionally sought to market Yaz birth control pills for unapproved uses and mislead consumers about the potential health risks associated with the drug, as evidenced in company emails, reported Bloomberg.  http://www.bloomberg.com/news/2011-11-21/bayer-may-have-touted-birth-control-pills-for-unapproved-use-e-mails-show.html.  “Considering that our clients had other birth control options available to them, yet detrimentally relied upon Yaz and all that it claimed to treat, when they actually had safer alternatives available to them, this would be a complete travesty,” commented Attorney Holly Ennis of Ennis & Ennis, P.A.

While the U.S. Food and Drug Administration approved Yaz for the treatment of premenstrual dysphonic disorder (PMDD), which is the most severe form of premenstrual syndrome (PMS), it appears as though Bayer unit officials discussed promoting Yaz for treatment of all types of PMS.  Bloomberg revealed that Matt Sample, a sales consultant for Bayer unit Berlex Laboratories, Inc., emailed the salespeople, “This article is a nice way of using Yaz for PMS treatment instead of just focusing on the specific class of women battling premenstrual dysphoric disorder,” referencing Women’s Day magazine article.   Sample went on to encourage the sales representatives to use the article to ask doctors “what percentage of your patient population suffers from” symptoms common to PMS, versus the more severe form of the disorder. http://www.bloomberg.com/news/2011-11-21/bayer-may-have-t...

Additionally, Kimberly Schillace, a former Berlix executive, had email communications with Dr. Judith Reichamn, a Los Angeles gynecologist who writes a blog on women’s health issues.  One email, in particular, noted that Schillace had spoken with Reichman, who made regular appearances on NBC’s “Today” show as a contributor on women’s health, and references that a contract was attached, however the message failed to provide the details of the agreement.  The email further states, “She definitely will mention the off-label benefits of our products.”

Bayer is currently involved in over 10,000 lawsuits wherein women allege that the drug maker failed to warn of the drug’s increased risk for blood clots and that company officials wrongfully touted Yaz to be just as safe as other birth control pills.  Lawyers involved in these lawsuits came across the company emails in the course of discovery for the subject litigation.  These lawyers claim that the emails are evidence of Bayer’s effort to have Yaz promoted for a use that was not approved by the FDA.  Interestingly, in the United States a doctor can prescribe a medicine for any condition as long as it is licensed by the FDA and proven safe and effective.  Drug makers, however, are only allowed to promote a drug for uses approved by the FDA.

In 2008, the FDA ordered Bayer to pull their television ads wherein Bayer overstated the pill’s effectiveness and minimized the serious risks associated with it.  Bayer went on to spend $20 million on corrective spots.  Shortly thereafter Bayer agreed to run new ads stating that Yaz hadn’t been approved as a treatment for all forms of PMS or acne, as part of a settlement of claims brought by 27 U.S. state attorneys general.

Despite the overwhelming evidence of a total of seven studies that confirm that Yaz and Yasmin certainly increase blood clots risks by up to 74%, Bayer continues to dispute the findings.

Yaz, Yasmin and other related drospirenone-containing pills were Bayer’s second-best-selling franchise last year with $1.6 billion in global sales.

On December 8, 2011, two FDA advisory committees are meeting to discuss the scientific findings and to determine how to proceed. http://www.fda.gov/Drugs/DrugSafety/ucm273021.htm

Attorney David Ennis recommends that women who have taken Yaz or Yasmin and experienced blood clots, pulmonary embolisms, deep vein thrombosis, stroke or gallbladder disease should fill out a MedWatch Form at www.fda.gov and obtain the opinion of an experienced Yaz lawyer to explore their legal rights. Ennis & Ennis, P.A. has been investigating Yaz and Yasmin side effect cases since 2009.

Ennis & Ennis P.A. continues to offer free, nationwide, confidential consultations for women who have suffered Yaz and Yasmin side effects by calling toll free 1-800-856-6405 or by going to www.ennislaw.com and completing an online case evaluation form.

Ennis & Ennis, P.A. is a nationwide law firm with offices in Ft. Lauderdale, Miami and Washington D.C.  Ennis & Ennis, P.A. concentrates its practice in mass torts and represents individuals against pharmaceutical companies worldwide, as well as medical device makers.

Ennis & Ennis, P.A. has been representing clients individually since 1986 and has recovered over $100 million in settlements for its clients.

Ennis & Ennis, P.A. is also investigating cases involving, Accutane, Actos, Avandia, Fosamax, Paxil, Zoloft, Prozac, Depuy Hip Recall, Zimmer Hip Recall, Depakote, Reglan, SJS/Dilantin, Yaz, Yasmin, Ocella Birth Control Pills and Transvaginal Mesh Devices.

Remember the law limits the time in which you can file a claim, so don't wait to explore your legal rights.  Call today toll free 1-800-856-6405 or visit www.ennislaw.com.