Contraceptive Packaging Error Leads to Lawsuit

November 12, 2015
Caroline Hroncich

Caroline Hroncich was associate editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International from 2015 to 2017.

Lawsuit alleges birth control packaging error led to 113 unwanted pregnancies.

One-hundred-thirteen women have filed a lawsuit in a Pennsylvania court against a drug manufacturer after the women became pregnant as a result of ingesting mislabeled and improperly packaged oral contraceptives.

The civil lawsuit was filed on Nov. 5, 2015 in the Court of Common Pleas of Philadelphia against Qualitest Inc., an Irish subsidiary of Endo Pharmaceuticals with US headquarters based in Pennsylvania. The lawsuit also mentions Vintage Pharmaceuticals LLC, Endo Pharmaceuticals, and Patheon Inc., as either manufacturing or distributing the defective pill packages.

An Atlanta based lawyer filed a similar class action lawsuit in 2014, but a federal judge in Georgia rejected the request. The lawyers then refiled in Pennsylvania, the location of Endo Pharmaceuticals’ US headquarters.

Court documents allege the women took the contraceptives according to instructions, however, the “blisters found inside the pill box were rotated 180 degrees, reversing the weekly tablet orientation.”

This reversal caused the women to take a placebo instead of an active pill.

A total of 113 women from 28 different states were named in the lawsuit as seeking compensation for damages, some of which include: medical expenses, lost wages, pain, suffering, loss of consortium, and child-rearing expenses.

In Oregon, child-rearing expenses can include the cost of a college education.

According to the FDA, in 2011 Qualitest Inc., issued a national recall of eight brands of oral contraceptive: Cyclafem 7/7/7(norethindrone ethinyl estradiol), Cyclafem 1/35 (ethinyl estradiol norethindrone), Emoquette (ethinyl estradiol desogestrel), Gildess FE 1.5/30 (ethinyl estradiol norethindrone acetate), Gildess FE 1/20 (norethindrone acetate ethinyl estradiol), Orsythia (ethinyl estradiol levonorgestrel), Previfem (ethinyl estradiol norgestimate), and Tri-Previfem (ethinyl estradiol norgestimate).

In a statement to ABC News, Endo Pharmaceuticals said: "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."

Related Content:

Industry News | PharmTech News