Packaging Error for Birth Control Pills Leads to Unintended Pregnancies, Defective Drug Lawsuit
Although the company issued a voluntary recall in 2011, a pharmaceutical company faces a defective drug lawsuit from over 100 women who used the birth control pills as directed but got pregnant anyway.
The birth control pills were manufactured by Qualitest Pharmaceuticals, a subsidiary of Endo Pharmaceuticals. According to court documents, the company issued a voluntary drug recall because the pills were rotated 180 degrees, which meant that the placebo week of pills were first instead of last, and women did not receive protection from pregnancy as they should have.
Qualitest issued a recall for the defective drugs in 2011, which covered 3.2 million packages of pills. However, spokeswoman Heather Zoumas-Lubeski said on the company’s behalf: The recall was based on “a tiny number of pill packs manufactured by an external contract manufacturer. Endo has confirmed only one blister pack that manifested a defect and was sold to a patient.
As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect,” the FDA and Qualitest said in 2011 of the recall, “and could leave women without adequate contraception, and at risk for unintended pregnancy.
Of the plaintiffs, 94 women had unintended pregnancies and now have children, while 17 of the women did not carry their pregnancies to term. Two other women who are part of the defective drug lawsuit did not get pregnant. The lawsuit, which was filed in Philadelphia on November 5th, more than 100 women in 28 states seeks millions of dollars in damages from the company due to emotional and physical pain and suffering, as well as attempting to recoup the costs of raising a child.
Most states do give plaintiffs the ability to pursue civil litigation against a doctor or pharmaceutical company for unintended pregnancies, but many of those cases involve tubal ligation or vasectomy, not hormonal birth control. The difficulty in pursuing a similar lawsuit for hormonal birth control involves the nature of the drug – journalist Brian Palmer wrote a piece for Slate in 2012 when another manufacturer issued a recall for hormonal birth control pills for a similar reason. He said, “The pill, by contrast, is only 98 to 99 percent effective, even when defects-free. So it’s hard to prove an unwanted pregnancy is due to a flawed pill. In addition, if a woman chooses to sue, the manufacturer can try to convince a jury that she didn’t take her pills on schedule.”
In addition, only 53 of half a million returned blister packs were defective.
An attorney for the case said of his clients: “When they sell the pills to the public, they’re supposed to have adequate safety measures in place so that no defective products reach the shelf … But it makes it more egregious when you learn that the products were on the shelf for at least 10 months in some cases.”
If you suffered from a mislabeled or defective drug, contact us today for legal help.
