November 13, 2015
More than 100 women across 28 states have filed a lawsuit against a pharmaceutical company whose packaging error caused them to become pregnant and altered the course of their lives.
The suit was filed Wednesday in Pennsylvania state court against Qualitest Inc., a subsidiary of Ireland-based Endo Pharmaceuticals, which has U.S. headquarters in Malvern. The case stems from a 2011 FDA recall of eight birth control pills encompassing about 1.4 million packs of the oral contraceptives, according to ABC News.
Qualitest acknowledged at the time that a packaging error resulted in a reversal of weekly tablet orientation, as well as barely visible lot numbers and expiration dates. Since birth control depends on controlled doses of estrogen and progesterone to block the release of an egg, the reversal caused many women to start the contraceptive at the wrong end, taking inactive pills whose purpose is to enable women to get their menstrual period.
While the final four of seven pills are made a different color, an inexperienced birth control user might not necessarily know this, creating what one doctor described as "a substantive chance of getting pregnant."
An initial attempt to file a class action lawsuit in Atlanta was rejected last week, but the 113 women were then able to successfully file suit in Pennsylvania.
The women are seeking millions of dollars in damages and some are asking for the total cost of delivering, raising and educating children from unplanned pregnancies, which they claim were caused by the defective packaging.
In a statement to ABC News, Endo Pharmaceuticals emphasizes that the 2011 recall was voluntary and that their liability is questionable in part because of the source of the error:
"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."
In 2011, Qualitest accounted for about 2 percent of the oral contraceptive market. The products cited in the lawsuit are Cyclafem, Emoquette, Gildess, Orsythia, Previfem, and Tri-Previfem. There have been reported cases of the packaging error resurfacing since the initial recall.