Woman alleges pill caused death of unborn baby, sues drug maker

Michelle Massey, East Texas Bureau Sep. 29, 2009, 8:47am

A pregnant woman claiming her birth control pills are responsible for her blood clot and the death of her unborn baby has filed a wrongful death lawsuit against the drug's manufacturer.

Candice Richardson took the oral contraceptive Yaz/Yasmin and, according to her suit, "thereafter suffered blood clotting and related injuries, requiring hospitalization and resulting in the stillbirth of her daughter at 27 weeks of pregnancy."

She alleges that the drugs' manufacturers misrepresented the pills' benefits and concealed their adverse side effects.

Richardson, individually and as representative of the estate of Jane Doe, deceased, filed a wrongful death lawsuit against Bayer Corp., Bayer Healthcare Pharmaceuticals Inc. and Bayer Healthcare LLC on Sept. 18 in the Beaumont Division of the Eastern District of Texas.

Richardson states she was prescribed the oral contraceptive Yaz/Yasmin. The drugs are a contraceptive that contains an estrogen component and a progestin component. Together the components suppress ovulation, fertilization and implantation. Yaz is a lower-dose version of Yasmin.

The suit does not indicate when or for how long Richardson used the pill, or which specific product she took.

Studies have shown that women who take birth control pills containing estrogen may be at a higher risk of blood clots, heart attacks and strokes.

The drugs at issue contain the estrogen component ethinyl estradiol, which is used in lower dosage birth control and is reported to have a lower risk of blood clots.

Yaz and Yasmin are the only birth control pills marketed United States containing drospirenone as the progestin component.

According to the complaint, the drug can cause a possible increase in potassium, causing a condition called hyperkalemia. The plaintiff states that hyperkalemia can cause heart rhythm disturbances and blood clots.

According to court documents, during the time that Yaz and Yasmin have been sold in the United States, there have been hundreds of reports of injury and death associated with the drug's use.

The drugs' manufacturers have marketed Yaz/Yasmin as providing the same efficacy in preventing pregnancy as other birth controls pills but with additional benefits. The FDA required the defendants to correct previous misleading advertisements regarding the drug's effects on acne and premenstrual syndrome.

"Bayer ultimately agreed to spend at least $20 million on corrective TV advertisements and to submit all Yaz/Yasmin advertisements to the FDA for advanced screening for the next six years."

The plaintiff alleges that the drugs were defective in their manufacture and construction and deviated from product specification.

"The Yaz/Yasmin birth control pills manufactured and supplied by defendants were defective in design or formulation in that, when it left the hands of the defendants, the foreseeable risks of the product exceeded the benefits associated with its design or formulation, or they were more dangerous than an ordinary consumer would expect," the complaint states.

The plaintiff states that due to defendants fraudulent` concealment of the side effects of the drug the applicable statute of limitations should be tolled.

Causes of action filed against the defendants include manufacturing and design defect, defect due to inadequate warning, negligence, negligent misrepresentation and/or fraud, breach of express and implied warranties and violation of the Deceptive Trade Practices Act.

Richardson is seeking damages for medical expenses, pain and suffering, attorneys' fees and punitive damages.

Beaumont attorney Gilbert T. Adams III is local counsel for the plaintiff. St. Louis, Mo., attorneys John J. Carey, Joseph P. Danis, Andrew J. Cross, Francis Flynn and Sarah Hale Bale of Carey and Danis LLC and Eric D. Holland and Steven L. Stolze of Holland, Groves, Schneller and Stolze LLC are also representing the plaintiff.

The plaintiff is requesting a jury trial.

U.S. District Judge Thad Heartfield will preside over the litigation.

Case No 1:09cv00857

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