Two more New Jersey residents have filed suits against the manufacturers of the birth control pill Yasmin and Yaz in St. Clair County Circuit Court.
Amie Nardone and Lauren Powell are suing Bayer, alleging their ingestion of the birth control pill caused them to experience gallstones and a blood clot.
They are represented by Roger C. Denton, Kristine K. Kraft, Elizabeth M. Wilkins and Megan M. Vanderbeck of Schlichter, Bogard
and Denton in St. Louis.
The four lawyers recently filed a similar lawsuit in St. Clair County Circuit Court against the makers of the birth control pill. Denton also 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 Nardone and Powell say that despite the company's $20 million advertising campaign, Bayer failed to warn them about the pill's dangers before they 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," their suits state.
In fact, from 2004 through 2008, Yaz has reportedly caused more than 50 deaths, which occurred in some women as young as 17, the complaints say.
"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 suits state.
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 complaints. The drospierenone causes increased levels of potassium in the blood, which can lead to a condition called hyperkalemia if potassium levels become too high, Nardone and Powell claim.
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, which is the condition Powell suffered from on July 14, 2003. 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 complaints.
Not only can drospierenone cause blood clots, but it can also affect the kidneys by blocking aldosterone -- a hormone that increases the reabsorption of sodium and water and the secretion of potassium in the kidneys, resulting in dehydration, the suit states. Dehydration can cause gall stones, the condition that Nardone suffered from.
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 suits state.
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 complaints say. "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.
Nardone and Powell say they would not have taken Yaz had they known of the risks associated with the pill before they began taking it.
In their seven- and eight-count suits, Nardone and Powell are 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-676, 10-L-678.>