Last week, Qualitest Pharmaceuticals announced that it was recalling birth control pills due to a packaging error which left women at risk for unplanned pregnancies. Qualitest discovered that select blisters were rotated 180 degrees within the packaging. As a result, the weekly tablet orientation was reversed and the daily orientation was incorrect. According to the report, no immediate health risks were expected (except the possibility of pregnancy, of course). This recall poses a few intriguing issues.
First, it is rare to see a drug recalled due to its packaging under these circumstances. Drug recalls themselves are not uncommon. Certainly, we can all remember at least one drug pulled from the shelves after the discovery of adverse side effects. However, recalling a drug due to a packaging error is a completely different story. If a product is recalled due to a “packaging error,” we might expect it to be the result of mislabeling or an injury-causing plastic bottle. Seldom, does a packaging error actually affect the performance of the drug itself.
The fact that the mere 180 degree rotation of a product’s packaging can render a product completely ineffective seems curious. If Crayola accidentally packaged its product in reverse-rainbow order, the crayons would not cease to become coloring utensils. One would think that if a company is capable of designing a product that can alter reproductive hormones and prevent unwanted pregnancies, it could also design a package not affected by a reverse rotation.
Second, what legal liability may Qualitest face as a result of this error? We anticipate plaintiffs who have experienced an unwanted pregnancy will expect to hold Qualitest accountable. They may elect to assert a claim for wrongful pregnancy; however, this cause of action is typically filed against medical providers for failing to perform a sterilization procedure correctly. If a medical provider can be held liable for failing to perform a vasectomy, so too might a pharmaceutical company for negligently packaging its birth control pills. If the plaintiffs are unable to assert a wrongful pregnancy cause of action, it is unlikely their “unwanted children” would have a cause of action for wrongful life. Only a small number of states permit wrongful life actions, and those that do typically require the child to be born with some birth defect.
Third, even if plaintiffs have a cause of action against Qualitest, there most certainly would be some issues of comparative negligence. While the birth control pills may have been rotated and disoriented, they are also color-coded – the first three weeks of hormone-producing pills are one color, while the last week of placebo pills is another. By taking these pills on a monthly basis, plaintiffs would undoubtedly have noticed this distinction.
What should we learn from all of this? Two things: 1) If you are a consumer of birth control pills, check your packaging to make sure you are staying on schedule; and 2) If you are a manufacturer of birth control pills, try using circular packaging.