Lawsuit Filed Against Bayer Corporation over the Yaz/Yasmin Birth Control Pills

The newest form of combined oral contraceptives has given birth to a mass tort.
Several lawsuits have been filed in federal court against Bayer Corp. over Yaz/Yasmin birth control pills, alleging that a new ingredient in this “fourth generation” contraceptive presents dangerous risks that the company failed to warn about.
The plaintiffs claim injuries that include deep vein thrombosis, gallbladder damage, kidney stones, heart attacks, pulmonary embolisms and strokes.
The lawsuits also allege fraudulent concealment of safety information.
Hundreds more suits are expected to be filed in the near future, with lawyers around the country looking into these cases.
“We’ve filed four cases this week, and we will file more this week and every week as we go forward. There are a substantial number of cases,” said Janet Abaray, a managing shareholder of Burg Simpson Eldredge Hersh in Cincinnati, Ohio and co-lead counsel for the Ortho-Evra (contraceptive patch) litigation.
Daniel Gallucci, an attorney with RodaNast, P.C. in Lancaster, Pa., who filed one of the first lawsuits, said that he is investigating hundreds of cases.
Joseph Weinstein, an attorney with Squire, Sanders & Dempsey in Cleveland who represents Bayer Corp., declined comment for this article. Bayer Corp. did not return a call seeking comment.
‘Fourth generation’
Yaz, which was approved by the FDA in 2006, and Yasmin, which was approved in 2001, are fourth generation combination oral contraceptives that combine estrogen and progestin to prevent pregnancy.
What makes both drugs “fourth generation” and different from any other birth control pills is the progestin component, called drospirenone.
Plaintiffs’ attorneys allege that drospirenone, a diuretic, causes an increase in potassium which can lead to “hyperkalemia” or unsafe levels of potassium that disrupt heart rhythms and slow the flow of blood. This can lead to blood clotting.
“No other birth control uses a diuretic as an active ingredient,” said Gallucci, who noted that the number of adverse events reported to the FDA appears disproportionately higher for Yaz and Yasmin than for other birth control pills.
Between 2004 and 2008, over 50 deaths of Yaz and Yasmin users were reported to the FDA, according to the suit filed by Ohio plaintiff Anne Marie Eakins, who used Yaz for four months in 2007 and suffered multiple bilateral pulmonary emboli.
Another common injury in these cases is gallbladder damage, said David Zoll of Zoll, Kranz & Borgess in Toledo, Ohio, who authors the Yaz, Yasmin and You blog.
“The diuretic causes you to lose water and so you develop sludge or bile that wipes out the gallbladder,” he said.
Gallucci said some of his clients are women who were not of child-bearing age and suffered gallbladder removal or sudden death after taking the pills for acne.
According to the British Medical Journal, the Dutch College of General Practitioners recommends that its members prescribe older, second generation birth control pills instead of Yaz/Yasmin because of 40 cases of venous thrombosis, including the death of a 17 year-old.
Abaray contends that after first generation birth control pills were found to cause health risks because of the levels of the estrogen component ethinyl estradiol, the second generation pills dropped the level of hormones and the risks went way down.
“We’re sort of going in a circle,” she said. “Now that the patents ran out, they have started patenting ‘new and improved’ progestins by monkeying with the levels again, and we’re seeing increased risks of blood clots.”
FDA warnings
The makers of Yaz and Yasmin have been warned about their marketing.
In 2003, the FDA warned Berlex Laboratories, which has since been purchased by Bayer, about TV ads which used the tagline: “Ask about Yasmin and the difference a little chemistry can make.”
The FDA said that the ads overstated the safety of the drug and failed to communicate that increased potassium is a risk, in contrast to the bolded warnings in the package insert.
In 2008, the FDA warned Bayer about TV ads that claimed Yaz was effective for treating acne and premenstrual syndrome (PMS), as opposed to the more severe disorder premenstrual dysphoric disorder (PMDD), for which Yaz is approved.
In those ads, women sing “We’re not gonna take it” while kicking and pushing away words such as “IRRITABILITY,” “MOODINESS,” “BLOATING” and “FEELING ANXIOUS.”
The company has released new ads designed to clear up the FDA’s concerns.
But Zoll said that the cases are not limited to those occurring before the new round of ads.
“Even with the new ads, the warnings are still grossly inadequate,” he claimed.
“The warning currently says if you are taking medication that is also increasing potassium you should have your potassium levels checked, but there is no warning of increased risk of blood clots compared to other birth control pills,” said Abaray.
Questions or comments can be directed to the writer at: sylvia.hsieh@lawyersusaonline.com