Teva Pharmaceuticals faces a product liability lawsuit in Florida. On May 26th, a complaint was filed in the U.S. District Court for the Southern District of Florida by Michelle Smith. Smith indicates that she developed masses on her liver after using the birth control pills, Seasonique and Seasonale for several years.
Smith began taking Seasonale in 2003, and then switched to the Seasonique in 2009. In 2103, masses were found. According to the lawsuit, Teva Pharmaceuticals knew or should have known that there was a five-fold increased risk of hepactic ademomas after five years of use, and that number jumps to a twenty-five-fold increased risk if the drugs were used for nine years or longer.
Smith’s lawsuit states: “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.” “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 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 the following: “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.”
In 2010 the labels were changed to read the following: “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.”
Michelle Smith’s lawsuit is claiming that both labels are deficient by referring to the rate of occurrence as “rare.” Also the suit states that in the 2010 label update key information was removed, like the fact that hepactic-adenoma risk INCREASED with long-term use by only mentioning hepatoceulluar carcinoma.
Smith has presented claims for defective devices, negligence, failure to warn, and negligent failure to warn. Smith is seeking compensatory and punitive damages.
See the Complaint (PDF) HERE.
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