Mispackaged contraceptives led to 113 unwanted pregnancies, claims a lawsuit filed against Qualitest, Inc., a subsidiary of Irish drugmaker Endo Pharmaceuticals Inc. last week.
The suit, filed in Philadelphia, represents 117 women from 26 states. Philly.com reported that 113 of those women became pregnant and 94 carried their babies to term.
The millions in damages sought include the costs of delivering, raising, and educating children borne of the unplanned pregnancies.
The birth control pills were packaged in the incorrect order, “rotated 180 degrees … reversing the weekly tablet orientation,” according to the lawsuit. With the order reversed, a woman’s chances of becoming pregnant increase.
Birth control pills prevent the body’s release of an egg by making it believe it has already done so.
The packaging mistake led to the women taking the placebo sugar pills, meant for the week of menstruation, at the wrong time of the month, leaving them “without adequate contraception,” ABC News reported.
In 2011, the discovery of the mispackaged contraceptives led to an FDA recall of 3.2 million blister packs from eight brands, according to court filings. According to ABC News, at the time, Qualitest said the error caused the weekly tablet orientation to be reversed and obscured the pills’ lot numbers and expiration date on certain packages.
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."