A New Jersey woman has filed suit against the manufacturers of the birth control pill Yasmin and Yaz in St. Clair County Circuit Court.
Carole Ann Grohan is suing Bayer, alleging her ingestion of the birth control pill caused her to experience a blood clot in her lungs.
She is represented by Roger C. Denton, Kristine K. Kraft, Elizabeth M. Wilkins and Megan M. Vanderbeck of Schlichter, Bogard
and Denton in St. Louis. Denton represents plaintiffs in multi district litigation involving similar claims against Bayer in federal court in East St. Louis.
The suit comes after a commercial warning of some fallacies about the pill repeatedly ran on television for months a few years ago.
"You may have seen some Yaz commercials recently that were not clear," the ad says. "The FDA wants us to correct a few points in those ads."
It goes on to say Yaz is used to treat the less serious premenstrual dysphoric disorder and moderate acne, not the more serious premenstrual syndrome or mild acne as Bayer once advertised.
But Grohan says that despite the company's $20 million advertising campaign, Bayer failed to warn her about the pill's dangers before she started taking it.
"Defendant knew or should have known that the use of drospirenone in Yaz/Yasmin causes arrhythmia, cardiac arrest/heart attack, intracardiac thombus, pulmonary embolism, deep vein thrombosis, stroke, and/or gallbladder disease," Grohan's suit states.
In fact, from 2004 through 2008, Yaz has reportedly caused more than 50 deaths, which occurred in some women as young as 17, the complaint says.
"Despite the wealth of scientific evidence, Defendants have not only ignored the increased risk of the development of the aforementioned injuries associated with the use of Yaz/Yasmin, but they have, through their marketing and advertising campaigns, urged women to use Yaz/Yasmin instead of birth control pills that present a safer alternative," the suit states.
The pill's danger possibly stems from Bayer's use of drospirenone, a new type of progestin only used in Yaz and its generic counterpart, Ocella, according to the complaint. The drospierenone causes increased levels of potassium in the blood, which can lead to a condition called hyperkalemia if potassium levels become too high, Grohan claims.
In turn, hyperkalemia can cause heart rhythm disturbances, which can then cause the slowing of blood to the heart, allowing for the formation of blood clots. Those clots can lead to heart attacks or can break off and travel to the lungs, causing pulmonary embolism, which is the condition Grohan suffered from on March 7, 2008. In another scenario, the blood clot can travel to the brain where it can cause a stroke, according to the complaint.
When birth control pills with a combined estrogen and progestin component were first introduced in the 1960s, doctors found that women who took the pill were at a higher risk of blood clots, heart attacks and strokes than those not taking the pill, the suit states.
So new progestins were developed, known as second generation progestins, which – because of the lower amounts of estrogen in the pills -- helped to reduce the risk of blood clots, heart attacks and strokes.
The drospierenone used in Yaz is considered a new type of progestin, different form the safe second generation progestins.
"Since drospierenone is new, there is insufficient data available to support its safe use," the complaint says. "In fact, studies performed prior to FDA approval indicate that drosperenone has certain effects that are different from those of traditional second generation progestins, and potentially more dangerous."
After running advertisements promoting the benefits of drospierenone as opposed to other progestins, Bayer was slammed with a warning letter by the FDA on July 10, 2003.
"FDA is not aware of substantial evidence of substantial clinical experience demonstrating that Yasmin is superior to other COCs or that the drospierenone in Yasmin is clinically beneficial," the FDA wrote in its letter. "On the contrary, FDA is aware of the added clinical risks associated with drospierenone."
Since then, Bayer began running advertisements claiming Yaz could be used to treat PMS and could reduce acne.
Again, the FDA issued a warning letter on Oct. 3, saying the marketing was misleading because the scope of medical benefits promised were beyond the limits of the FDA's approval.
The October letter led to Bayer's $20 million worth of new advertisements attempting to clear up misrepresentations.
Grohan says she would not have taken Yaz had she known of the risks associated with the pill before she began taking it.
In her eight-count suit, Grohan is seeking compensatory and punitive damages including more than $50,000 worth of non-economic damages, plus economic damages and medical expenses, attorney's fees, costs and other relief the court deems just.
St. Clair County Circuit Court case number: 10-L-677.