The XX Factor

A Company Mislabeled Its Birth Control. Women Got Pregnant and Sued. Do They Have a Case?

Birth control pill packs usually have the placebos at the bottom. Qualitest made some with the placebos at the top.

ParentingPatch via Wikimedia Commons

In 2011, drugmaker Qualitest manufactured a faulty batch of birth control pills. The pills themselves worked fine, but the packaging flipped the order of the pills 180 degrees, putting a row of inert pills—which a patient would normally take during her period—where the first week of active hormones should be. Now, 113 women from across the United States have filed a class action suit against the company, claiming that the defective blister packs resulted in unplanned, unwanted pregnancies.

Brian Palmer wrote a Slate Explainer in 2012 that mentioned a related case, in which just one plaintiff sued Qualitest for the same messed-up birth control batch. “If you get pregnant because of faulty pills, do you have a case against the manufacturer?” Palmer asked. His answer:

Yes, in most states. The majority of U.S. courts recognize a tort called “unwanted conception” or “unwanted pregnancy,” but most cases involve tubal ligation or vasectomy rather than the pill. In such cases of botched sterilization, doctors don’t have a particularly good defense, because the procedure is extremely effective when performed correctly. The pill, by contrast, is only 98 to 99 percent effective, even when free of defects. 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. (Surgical sterilization requires no such vigilance by patients.)

Since Qualitest admitted its error and issued a voluntary recall after a woman returned her faulty pack to her pharmacy in 2011, the plaintiffs in this class action are spared from having to prove the company’s wrongdoing. But proving that a pregnancy is the direct result of a manufacturing error is next to impossible. Dates of conception are never 100 percent accurate. Oral contraceptives are only 98 to 99 percent effective when taken exactly as directed, and on top of that, they’re notoriously prone to user error. And Qualitest’s parent company has only confirmed that one of the recalled blister packs was sold in the first place.

It’s even less likely that the plaintiffs in this case will recover compensation for the entire cost of raising their unintended children to adulthood, which some of them are requesting. Historically, courts have been hesitant to award plaintiffs this kind of cash on the grounds that the benefits of parenthood (joy, fulfillment, Spanish-language education from Dora the Explorer) make up for the fact that the parents didn’t want those benefits in the first place. Courts don’t want to frame birth and parenthood as “damages” even though, for people who were taking birth control to avoid pregnancy—especially those might not consider abortion an option—they certainly are.

The plaintiffs filed their suit in Pennsylvania, where Endo, Qualitest’s parent company, maintains a U.S. headquarters. Just three years ago, it would have been impossible for the women to sue for wrongful life—in which a fetus was only conceived due to the negligence of the defendant—in the state at all. Since 1988, Pennsylvania had kept a law on the books that prohibited wrongful life suits. The law was struck down in 2012, and is currently making its way through the state’s court system on appeal. That means the 113 plaintiffs have a legitimate case against Endo—now they just have to prove it.