In 2011, Qualitest Pharmaceuticals recalled 1.4 million packages of birth control pills due to a packaging error that reversed the weekly tablet order. Instead of appearing at the bottom of the package, the placebo pills, which are meant to be taken the week of menstruation, were flipped 180 degrees. To be effective, birth control pills must be taken in the proper order.
Now, more than 100 women are suing Qualitest, claiming that the incorrect packaging resulted in unwanted pregnancies. All but four of the 113 women involved became pregnant, and more than 90 gave birth, the Associated Press reports.
The suit seeks millions in damages, including recovery for medical expenses, pain and suffering, lost wages and, in some cases, child-rearing expenses up to the age of 18.
The lawsuit was filed this week in Pennsylvania, where Qualitest's parent company Endo Pharmaceuticals is headquartered, directly after a federal judge in Georgia denied class-action certification to a similar suit filed in the state. Vintage Pharmaceuticals and Patheon were also named in the suit.
In a statement to ABC News, Endo Pharmaceuticals said that it had only been able to confirm one defected birth control pack that was sold to a patient.
Endo's statement, in full:
Our commitment is to patient safety and we take product quality very seriously. ... There is no new or recent product recall. The recall that forms the basis of this suit was entirely voluntary and occurred more than four years ago in September 2011. The voluntary recall occurred based on an extremely small number of pill packs that were manufactured by an external contract manufacturer. Endo has been able to confirm only one blister pack that manifested a defect and was sold to a patient. Additionally, courts have dismissed cases arising out of the recall because the plaintiff could not establish that she purchased a defective package.
The FDA's 2011 recall included the following oral contraceptives: Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem and Tri-Previfem.