Women File Lawsuit for Birth Control Packaging Error

More than 100 women have filed a lawsuit after a birth control packaging error led to unplanned pregnancies.

The birth control packs manufactured by Qualitest Pharmaceuticals were rotated 180 degrees, which reversed the tablet orientation and caused the women to take placebo pills when they were meaning to take active pills, according to court documents.

Qualitest issued a national recall of Cyclafem 1/35, Cyclafem 7/7/7, Emoquette, Gildess FE 1.5/30, Gildess FE 1/20, Orsythia, Previfem, and Tri-Previfem in September 2011 because of this packaging error. A total of 3.2 million blister packs were recalled, according to court documents.

The catalyst for this recall was a woman who returned her birth control to a pharmacist after noticing the reversed weekly tablet orientation.

In its recall notice posted on the FDA’s website, Qualitest claimed that these product defects “do not pose any immediate health risks,” although it advised that “consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately and consult their health care provider or pharmacist.”

Of the women involved in the lawsuit, 94 gave birth following unexpected pregnancies, 17 didn’t carry their pregnancies to term, and 2 women were never pregnant.

The women are seeking damages in their claim to compensate for their pain, suffering, lost wages, and the expenses associated with raising a child.

State laws vary on how the cost of raising a child is calculated. In Oregon, child-rearing expenses include the cost of sending a child to college.

Qualitest is a subsidiary of Ireland’s Endo Pharmaceuticals, which has US headquarters in Pennsylvania.

A spokeswoman for Endo stated that while there is no new or recent product recall, the company emphasizes that “patient safety is our top priority.”