Birth Control Pill Promoted for PMS and PMDD Is Now the Subject of Thousands of Lawsuits; Caused Blood Clots and Gallbladder Injury, Plaintiffs Claim

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More than 7500 lawsuits are pending in state and federal courts over alleged damages from Bayer Pharmaceuticals Yaz and Yasmin birth control pills. Dr. Daniel Heller of PMS Comfort spoke with Attorney Brenda Fulmer, who sits on the National Discovery Committee in the MDL.

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"The most common injuries attributed to Yaz, Yasmin, and Ocella are deep vein thrombosis, pulmonary emboli, and gallbladder disease. There are also filed cases for women who suffered strokes, heart attacks, or sudden cardiac death."

More than 7500 lawsuits are pending in various state and federal courts as a result of blood clots and gallbladder injury that allegedly resulted from the use of Bayer Pharmaceutical’s Yaz and Yasmin birth control pill products, according to Brenda Fulmer, a partner at the Florida law firm of Searcy Denney Scarola Barnhart & Shipley.

In an interview with Dr. Daniel Heller, founder of PMS Comfort, an e-commerce brand dedicated to helping women learn about PMS (premenstrual syndrome) and PMDD (premenstrual dysphoric disorder), Ms. Fulmer pointed out that the number of serious medical incidents allegedly resulting from the use of these medications may be even higher than the number of lawsuits, as many cases are yet to be filed. She also indicated that the number of injured girls and women could continue to grow, since the products are still actively marketed to women and doctors, and prescribed by health care professionals. Prior reports had predicted the eventual number of cases filed could reach 25,000.

In a post to the website InjuryBoard, Ms Fulmer explained that the cases are based on allegations that Bayer did not adequately warn about the risk of potentially serious side effects from the use of Yaz and Yasmin, and that it marketed these medications as being safer than other birth control products and as having additional benefits, such as relief of PMS symptoms.

Recent peer-reviewed published studies (Jick and Hernandez, British Medical Journal 2011; Parkin et al, British Medical Journal 2011; and others) have shown that compared to oral contraceptives containing levonorgestrel, drospirenone-containing oral contraceptives have up to four times the risk of blood clots. These studies indicate that 2nd generation progestins such as levonorgestrel have a history of safe use and a lower risk of blood clots and complications compared to 3rd generation progestins such as drospirenone. Drospirenone is also present in Ocella, Gianvi, Beyaz, Loryna, Safyral, Syeda, and Zarah.

Ms. Fulmer, whose law firm represents more than 100 women and teenage girls from Florida as well as other states who suffered blood clot-related injuries, commented specifically on the claims regarding Bayer's marketing:

“Much of the marketing for Yaz, Yasmin, and Ocella was directed at very young women, including use of social media, youth-oriented themes, and young product spokespersons. Many of my clients were younger than 25 years of age when they suffered harm, including a number who were teenagers when they suffered pulmonary emboli, DVTs, strokes, and other serious medical conditions.”

She also clarified the types of medical injuries that are alleged to have resulted from the medications: "The most common injuries attributed to Yaz, Yasmin, and Ocella are deep vein thrombosis, pulmonary emboli, and gallbladder disease. There are also filed cases for women who suffered strokes, heart attacks, or sudden cardiac death."

These conditions are ordinarily rare among young women and teenagers.

One of the current lawsuits, filed in St. Clair County Circuit Court in Illinois (St. Clair County Circuit Court case number 11-L-451) claims that up to 50 girls and women have died to date as a result of complications from Yaz and Yasmin. That lawsuit represents plaintiffs from 13 states. Multi-district litigation (MDL) proceedings have been centralized before Judge David R. Herndon in the U.S. District Court for the Southern District of Illinois (Case ID MDL No. 2100 – Yasmin and YAZ (Drospirenone) Marketing, Sales Practices and Products Liability Litigation.) Trials in these cases are slated to begin in 2012.

To date, Bayer Corp. has not publicly indicated that it intends to settle these cases.

Brenda Fulmer can be reached at 800-780-8607.

Dr. Daniel Heller, founder of Professional Health Solutions LLC, has created PMS Comfort to educate, inform, and empower women with PMS and PMDD, and to provide natural solutions for premenstrual symptoms. The PMS Comfort website includes a premenstrual symptoms self-assessment tool, as well as research-referenced articles on PMS and PMDD symptoms and Dr. Daniel Heller’s PMS Comfort Blog.


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