PENNSYLVANIA RECORD

A Pennsylvania woman is suing the makers of the Yaz birth control drug over allegations that she sustained deep vein thrombosis as a result of her taking the oral contraceptive.

Dana Dougherty filed suit on Sept. 3 in federal court in Philadelphia against Bayer Pharmaceuticals, Berlex Laboratories and various subsidiaries of the two drug companies over claims that she became injured due to her ingestion of Yaz and/or Beyaz.

The plaintiff was diagnosed as having deep vein thrombosis on Sept. 7, 2011, the lawsuit states.

Yaz, which obtained FDA approval in 2006, has the active ingredient drospirenone, a diuretic, which creates unique risks compared to other oral contraceptives and is known to cause problems including deep vein thrombosis, the complaint states.

“Despite the wealth of scientific information available, Defendant ignored the correlation between the use of Yaz and Beyaz and the significantly increased risk of deep vein thrombosis and still promoted, sold, advertised, and marketed the use of Yaz and Beyaz without sufficient warnings,” the lawsuit reads.

The complaint goes on to state that the Food and Drug Administration issued a warning letter to Bayer in the fall of 2008 admonishing the company for misleading advertisement, reiterating that the marketing for the drug was misleading because it promoted Yaz for medical conditions “beyond the limits of FDA approval,” and adding that because Yaz contains drospirenone, the medication has additional risks such as the possibility that it could cause hyperkalemia in some patients, possibly resulting in potentially serious heart and other health problems.

The FDA also warned in the letter that Yaz does not result in completely clear skin – the drugmaker had advertised that the medication had the added benefit of preventing or reducing acne – and the government chastised Bayer for its television advertisements that “misleadingly overstate the efficacy of the drug,” according to the complaint.

“Bayer ultimately agreed to spend at least $20 million on corrective TV advertisements and to submit all Yaz advertisements to the FDA for advanced screening for the next six years,” the suit reads.

Overall, the plaintiff accuses the defendants of failing to provide adequate warnings to doctors, the health care community and the public about the risk of serious adverse events such as those described in the complaint.

Dougherty, the plaintiff, says she suffered a deep vein thrombosis in her right leg in early September 2011 while taking Yaz and/or Beyaz.

The injury required inpatient hospitalization and continuing medical treatment.

“Despite the fact that Defendants knew or should have known of the serious health risks associated with the use of Yaz/Beyaz, Defendants failed to warn Plaintiff and/or her health care providers of said serious risks before she used the product,” the lawsuit states.

Had Dougherty been aware of the true risks and dangers associated with the birth control medication, she would have never used the drug, the suit says.

Dougherty claims her injury could complicate potential future pregnancies.

The lawsuit contains counts of fraudulent concealment, strict liability, breach of warranty, negligent failure to warn, negligent misrepresentation, negligence, fraud, and violations of the Deceptive Trade Practices Act.

The plaintiff seeks compensatory and punitive damages in excess of $350,000, plus costs, attorney’s fees and other relief.

Dougherty is being represented by Glenside, Pa. attorney Brian P. McVan, of the firm McVan & Weidenburner.

 

The federal case number is 2:13-cv-05135-NIQA.