After a birth control pill spent months in the spotlight during commercials aimed at correcting misrepresentations about it, the pill is now at the center of a Madison County lawsuit.
Cathy M. Walton filed a lawsuit Nov. 4 against Bayer and its subsidiaries, Berlex and its subsidiaries and an unknown number of manufacturers, alleging her ingestion of the birth control pill Yasmin, which is similar to Yaz, forced her to undergo surgery to remove her gall bladder.
The suit comes after a commercial warning of some fallacies about the pill repeatedly ran on television for months.
"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 the $20 million Bayer spent on the commercial is not enough for Walton, who says the company failed to warn her about the pill's dangers before she started taking it.
"Defendants ignored the correlation between the use of Yasmin and Yaz and increased thrombosis formation despite the wealth of scientific information available," the suit states. "Upon information and belief, Defendants knew or should have known about the correlation between the use of Yasmin and YAZ and a prothrombotic effect and still promoted, sold, advertised, and marketed the use of Yasmin and Yaz."
Thomas G. Maag of Edwardsville is representing Walton.
The defending companies informed physicians and the general public that the birth control pills were safe.
However, such representations were misleading, Walton claims.
In fact, from 2004 through 2008, Yaz and Yasmin have reportedly caused more than 50 deaths, which occurred in some women as young as 17, the complaint says.
"These reports include deaths associated with cardiac arrhythmia, cardiac arrest, intracardiac thrombus, pulmonary embolism, and stroke in women in their child bearing years," 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 Yasmin and their 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, Walton 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. In another scenario, the blood clot can travel to the brain where it can cause a stroke, according to the complaint.
Progestins have had a dicey past. When birth control pills with a combined estrogen and progestin component were first introduced in the 1960s, doctors found that women 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 combined with lower amounts of estrogen in the pills, helped to reduce the risk of blood clots, heart attacks and strokes.
The drospierenone used in Yaz and Yasmin 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.
Walton says she would not have taken Yaz had she known of the risks associated with the pill before she began taking it.
In the five-count suit, Walton is seeking a judgment of more than $250,000, plus costs and other relief the court deems just.
Madison County Circuit Court case number: 09-L-1180.