Birth Control Pills Are Recalled Over Packaging Error That Could Lead to Pregnancy
Posted Sep 29, 2011 4:10 PM CDT
By Mark Hansen
A pharmaceutical company is recalling certain lots of its birth control pills over a packaging error that leaves women at risk for unplanned pregnancies.
The recall was announced last week after the company, Qualitest Pharmaceuticals, discovered that select blisters in some of its packaging were rotated 180 degrees, which had the effect of reversing the weekly tablet orientation and could leave women without adequate contraception.
The recall raises some interesting issues, according to Abnormal Use, the products liability blog.
While drug recalls are not uncommon, it says, it is rare to see a drug recalled over its packaging. And one might expect that a packaging error would be the result of mislabeling or an injury-causing plastic bottle.
"Seldom does a packaging error affect the performance of the drug itself," it says.
The blog also finds it "curious" that the rotation of a product's packaging can render the product completely ineffective. The first three weeks of hormone-producing pills are one color; the fourth week of placebo pills is another.
"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," it wrote.
The blog says it anticipates that plaintiffs who experience unwanted pregnancies may try to hold Qualitest accountable by asserting wrongful pregancy claims against the company. But even if the plaintiffs are found to have a cause of action against the company, they may face the issue of comparative negligence for failing to notice that the hormone-producing pills are a different color than the placebos.
The episode offers two lessons, according to the blog. If you use birth control, check your packaging to make sure you're on schedule. If you make birth control pills, try using circular packaging.
Hat tip to Legal Blog Watch.