Teva Pharmaceuticals faces a product liability lawsuit, which alleges that inadequate warnings were provided for women and the medical community about the risk that side effects of Seasonique and Seasonale birth control pills may cause liver tumors.
In a complaint (PDF) filed in the U.S. District Court for the Southern District of Florida on May 26, Michelle Smith indicates that she developed masses on her liver after using the birth control pills for several years.
Smith began taking Seasonale in 2003, and switched to Seasonique in 2009, before masses were found in 2013.
According to the lawsuit, Teva knew or should have known that there was a five-fold increased risk of hepatic ademomas after five to seven years of use, and a 25-fold increased risk after use longer than nine years.
“Defendants have known that there is a proved association between the use of oral contraceptives and the development of hepatic ademoma. Evidence indicates that estrogen consumption is the primary risk factor for their development,” Smith’s lawsuit states. “Defendants have also known that the longer the duration of use, the greater the risk for developing a hepatic ademona.”
According to the complaint, Teva at first downplayed the risks of hepatic adenomas in the warning labels for Seasonale and Seasonique, claiming that their occurrence is rare in the U.S. Those warnings appeared on the 2003 label of Seasonale and the 2006 label of Seasonique, stating:
“Benign hepatic adenomas are associated with oral contraceptive use, although their occurrence is rare in the United States. Indirect calculations have estimated that attributable risk to be in the range of 3.3 cases/100,000 for users, a risk that increases after four or more years of use.”
However, the labels were changed in 2010, stating:
“Studies have shown an increase risk of developing hepatocellular carcinoma in long-term (>8 years) [oral contraceptive] users. However, the attributable risk of liver cancers in [oral contraceptive] users is less than one care per million users.”
The Seasonale and Seasonique lawsuit claims that both labels are deficient, by calling the rate of occurrence rare. It also notes that the 2010 update removed the fact that hepatic-adenoma risk increased with long-term use by only mentioning hepatoceulluar carcinoma.
Smith presents claims for defective design, failure to warn, negligence, and negligent failure to warn. She is seeking compensatory and punitive damages.