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 St. Clair County lawsuit.
Kerry Sims filed a lawsuit Aug. 18 against Bayer and Walgreens, alleging her ingestion of the birth control pill Yasmin, which is also known as Yaz, caused her to experience a blood clot in her lung and infection surrounding the clot.
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 Sims, who says the company failed to warn her about the pill's dangers before she started taking it.
"Plaintiff Kerry Sims reasonably relied upon Defendants' representations to her and/or her healthcare providers that Yaz/Yasmin was safer than other types of oral contraceptives for human consumption and/or use and that Defendants' labeling, advertisements and promotions fully described all known risks of the product," Sims's suit states.
However, such representations were misleading, Sims claims.
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.
"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 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, Sims 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 Sims suffered from. 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 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.
Sims says she would not have taken Yaz had she known of the risks associated with the pill before she began taking it.
She included Walgreens in the suit because she purchased Yaz at the store.
"In selling, Yaz/Yasmin to plaintiff, Walgreens expressly and impliedly warranted that Yaz/Yasmin was safe for its intended use, was free from manufacturing or production defects, and would perform as indicated," Sims's suit states.
In the 10-count suit, Sims is seeking compensatory and punitive damages including more than $350,000 worth of non-economic damages, plus economic damages and medical expenses, attorney's fees, costs, punitive damages of more than twice the compensatory damages and other relief the court deems just.
Roger C. Denton, Kristine K. Kraft and Elizabeth M. Wilkins of Schlichter, Bogard and Denton in St. Louis will be representing her.
St. Clair County Circuit Court case number: 09-L-437.