By Anikka Hoidal for BiolawToday.org.
In 2011, Qualitest, a manufacturer of generic medications, recalled a number of birth control packages after discovering a packaging error. Pills in the blister packs were rotated 180 degrees, reversing their order and putting the placebo pills where consumers typically found the hormonal pills. Birth control pills must be taken according to a prescribed monthly calendar that tracks a woman’s menstrual cycle, and the mislabeling of the placebo pills could have the effect of incorrectly regulating the women’s menstrual cycle and rendering them fertile. This issue recently resurfaced as a group of women filed suit in Philadelphia alleging Qualitest’s, and its parent company Endo Pharmaceutical’s, liability for their pregnancies and children’s births. A total of 113 women are involved in the lawsuit, 94 of whom became pregnant, 17 who did not carry the pregnancy to term, and 2 who did not become pregnant.[1] Qualitest denies that the oral contraceptives caused the plaintiffs’ “injuries.”[2] Despite the desire to hold Qualitest accountable for their error, the reality is that any tort-based pregnancy claims present challenges for the plaintiffs. The first challenge is that birth-related tort actions are governed by state statute and vary in plaintiffs’ ability to bring the action and in the recoverable damages. Another challenge, which this blog post specifically addresses is the common issues in establishing causation when it comes to tort-based claims involving oral contraceptives.
Incorrect Packaging
The first causation issue arises in establishing that the plaintiffs’ blister packs were affected by the packaging error. Qualitest has confirmed only one blister pack that was packaged incorrectly and sold to a consumer.[3] The plaintiffs will have to introduce evidence that their blister packs were also defective in that they were rotated 180 degrees. Given that approximately four years have passed since the recall of the affected blister packs, it likely will be difficult for the women to prove that their blister packs were among those packaged incorrectly. Despite this skepticism, evidence, including the plaintiffs’ affidavits detailing where they had their prescriptions filled and when, could establish that the plaintiffs purchased the defective blister packs.
Proving Perfect Use
Perfect use, or careful compliance with the drug’s directions, would help strengthen the plaintiffs’ case by demonstrating that the error and pregnancies arose from the packaging, not the plaintiffs’ improper use of the drug. Birth control pills must be taken at roughly the same time every day, with no missed doses. They are also not as effective at preventing ovulation when women take other medicine, such as oral antibiotics. Proving perfect use, however, will likely be an issue. Pill use is often a private matter with the woman as the only witness. Certainly some women inform someone each and every time they take their pill, indicating the exact time of consumption, however, I dare to assume that a majority of women do not practice such caution. Though the women could allege perfect use in their affidavits, my skepticism again leads me to believe that doubt exists regarding all of the plaintiffs truly using the pill perfectly. This will strengthen the manufacturer’s claims that their product defect was not the cause of the plaintiffs’ injuries.
Oral Contraceptive Failure Rate
A third issue lies in the effectiveness of oral contraceptives. Even with typical use, oral contraceptives have a failure rate of 9%.[4] Typical use includes any inconsistent or incorrect use,[5] such as taking the pill at a different time one day or missing a dose. Even with perfect use, oral contraceptives are not infallible. With perfect use, oral contraceptives have a failure rate of .3%.[6] Perfect use entails following all the directions, all the time, with no mistakes.[7] Though many women likely strive for perfection, despite the difficulty proving perfection described above, even perfection could result in an unanticipated pregnancy. As many high school sex education classes note—abstinence is the only birth control method with 100% efficacy.
Causation is notorious for sending first year law students into a frenzy while learning torts, and this case is evidence of why. On the surface, it appears there is a connection between the birth control packaging error and the plaintiffs’ pregnancies, however, on closer inspection the case is full of questions on causation. Despite these questions, the plaintiffs still have a chance at recovering damages. Tort law does not require a “beyond a reasonable doubt” burden of proof. If the plaintiffs reframe their injury as pain and suffering, show that the defect was a “substantial factor” in bringing about the injury, or show that the defective product “probably” was a but-for cause of their injury, they may still be able to recover damages, depending on the jurisdiction.
Anikka is currently a second year law student at the S.J. Quinney College of Law and is a member of the Utah Law Review. Anikka graduated from the University of Southern California in 2008 with a B.A. in Psychology. She also holds a Master of Social Work degree from the University of Utah. Anikka’s legal interests include health law and policy. Anikka enjoys riding horses, running, and spending time with family and friend.
[1] Julie A. Steinberg, Endo, Qualitest Sued Over Mispacked Birth Control Pills, Bloomberg Law (Nov. 19, 2015), https://www.bloomberglaw.com/document/X134KMQK000000?
jcsearch=bna%2520A0H5T0U9G6#jcite.
[2] Id.
[3] Jen Christensen, Birth Control Packaging Error Leads to Lawsuit, CNN, http://www.cnn.com/2015/11/12/health/birth-control-packaging-lawsuit/.
[4] See Effectiveness of Contraception Methods, Centers for Disease Control and Prevention, http://www.cdc.gov/reproductivehealth/unintendedpregnancy/contraception.htm; Contraceptive Use in the United States, Guttmacher Institute, http://www.guttmacher.org/
pubs/fb_contr_use.html.
[5] Association of Reproductive Health Professionals, Choosing a Birth Control Method, https://www.arhp.org/Publications-and-Resources/Clinical-Proceedings/Breaking-the-Contraceptive-Barrier/Use-Knowledge.
[6] Supra note 4.
[7] Supra note 5.