COSTLY MISTAKE

Did Shoddy Birth Control Cause 113 Pregnancies?

When a pharmaceutical company made a huge packaging error, users of its birth control got pregnant, a new lawsuit alleges. Now they want answers.

11.13.15 6:00 AM ET

Turn your prescription bottle upside down and your pills will still have the same effect. A birth control packet, not so much.

A new lawsuit against pharmaceutical company Qualitest, brought by Atlanta attorneys Keith Bodoh and Steven Beard, alleges that 113 of their clients may have become pregnant as a result of a crucial packaging error affecting some of the company’s oral contraceptives, which the company voluntarily recalled in 2011.

As the FDA announced at the time, “[s]elect blisters [of the pills] were rotated 180 degrees within the card, reversing the weekly tablet orientation” and potentially leaving “women without adequate contraception, and at risk for unintended pregnancy.” This error means that some women may have taken placebo pills during the wrong week.

Shortly after the recall, Bodoh alleged in an interview with The Atlantic that the packaging error had a life-changing effect on several of his clients, including teenagers who allegedly became pregnant as a result of the mistake, women who dropped out of school, and one woman in the military who was planning to give up her child for adoption as she was facing deployment. Their stories, he said, were “heart-wrenching.”

Bodoh, who filed the suit in a Pennsylvania state court this week, told The Daily Beast that he has no further comment at this early stage.

In their official complaint, Bodoh and Beard write that the damages they seek include “the consequential damages to [their clients’] economic welfare, mental anguish and physical suffering, lost wages.” For three of their clients who live in Oregon, damages for child rearing would include “expenses for [their] college education.” Among other allegations, their suit claims that the companies are liable for these damages, and that they were negligent in the design, manufacturing, and inspection of the pills.

Their lawsuit names Qualitest parent company Endo and pharmaceutical company Patheon, which packaged the pills. Patheon declined to comment on the pending litigation, and stressed the company’s commitment to patient safety and product quality.

An Endo spokesperson told The Daily Beast that “it is not our policy to comment on pending or ongoing litigation” but offered what she termed to be “important clarifying information” in the case. The recall, she stressed, “occurred more than four years ago,” and was “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,” the spokesperson said, noting that other cases arising from the recall have been dismissed because a plaintiff could not prove that she had been affected by a defective package.

“Patient safety is our top priority at Endo and we are committed to providing high-quality, approved products that are safe and effective,” she said.

The Triangle Business Journal reviewed court records and found that only 53 out of the 507,966 blister packs returned in the recall were rotated 180 degrees—around one-hundredth of 1 percent.

So far, the case has been an uphill battle for Beard and Bodoh. As The Atlantic noted in 2012 when the attorneys were first forming a class-action lawsuit, recovering costs associated with unintended pregnancy from pharmaceutical companies for is relatively unprecedented territory, legally speaking.

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Just last week, a federal judge in Georgia denied their motion to create a class-action lawsuit out of the case, noting that the “[p]laintiffs have not proffered evidence to show that the blister packs they bought and consumed were improperly manufactured—or offered a plan for how potential class members could demonstrate that their products were defectively packaged.”

Last August, a United States Judicial Panel on Multidistrict Litigation (MDL) denied the plaintiffs’ requests to centralize their cases, writing, “It appears that individualized facts—particularly relating to whether each plaintiff received an improperly packaged Qualitest birth control product and whether she became pregnant as a result of taking the pills in the wrong order—will predominate over the common factual issues alleged by plaintiffs.”

And so the lawsuit has now come directly to Pennsylvania, the location of Endo’s U.S. headquarters. Whether or not it succeeds remains to be seen.

Philadelphia attorney Shanin Specter, an expert in pharmaceutical settlements who has no involvement in the case, told a local CBS station that mislabeling is a common error and that the plaintiffs’ requests for child-rearing costs could be reaching given the handling of similar cases in the past.