Lawsuit Over Qualitest Birth Control Packaging Mixup Filed By More Than 100 Women

A group of more than 100 women have filed a product liability lawsuit, alleging that they became pregnant due to a packaging mix-up with Qualitest birth control pills, which were recalled in 2011. 

The complaint was filed in the Philadelphia Court of Common Pleas on November 5, naming Endo Pharmaceuticals and its Qualitest subsidiary as defendants. The plaintiffs include 94 women who gave birth, 17 who did not carry their pregnancies to term, and two who did not get pregnant.

The case joins a number of other Qualitest pregnancy lawsuits filed since a recall issued in 2011, due to a manufacturing error that caused the pills to be packaged upside down. This led to women taking placebo pills when they thought they were taking pills with the active birth control ingredients, leaving them unprotected against pregnancy.

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The Qualitest birth control pill recall affected more than 70 lots, including Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem and Tri-Previfem. Millions of blister packs were affected. Qualitest is a division of Endo Pharmaceuticals.

The recall was at least the third Qualitest drug labeling issue that year. In June 2011, a manufacturing problem led to labels being swapped between bottles of generic Vicodin and Fioricet. On February 5, 2011, three lots of generic Vicodin and Phenobarbital were recalled after a bottle of Qualitest generic Vicodin was found with a Phenobarbital label.

A number of similar lawsuits have already been filed in federal courts nationwide. In August 2014, the U.S. Judicial Panel on Multidistrict Litigation (JPML) rejected a request to consolidate the Qualitest birth control claims into a federal Multidistrict Litigation, or MDL. The panel said that, at the time, there were too few cases filed at the federal level to warrant consolidation.

While 3.2 million packages were recalled, Endo officials have maintained that they have only been able to confirm that one blister pack was actually defective and sold to a patient.


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