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Heads Up! Packaging Error Reverses Tablet Orientation of Placebo and Birth Control Pills

Via the Abnormal Use blog I see that a company called Qualitest Pharmaceuticals is urgently recalling certain lots of its birth control pills, but not because anything is wrong with the pills themselves. Rather, the pills were distributed in a package in which the blister packaging was rotated 180 degrees within the card. Qualitest announced that this error had the effect of reversing the weekly tablet orientation, meaning that the "daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception." Accordingly, the company stated, "consumers exposed to affected packaging should begin using a non-hormonal form of contraception immediately and consult their health care provider or pharmacist."

The AU blog explains that the "tablet orientation" of the pills is critical because the first three weeks of pills are "hormone-producing" and prevent pregnancy, while the last week of pills are simply placebo pills. Thus, if the orientation of these weeks is altered by a packaging error, women may inadvertently end up taking placebo pills during a time that they need contraception and end up with an unplanned pregnancy.

AU observes that while packaging errors are not unheard of, this one is "curious" because it actually affects 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.

AU further anticipates that plaintiffs who have experienced an unwanted pregnancy may bring claims against Qualitest for "wrongful pregnancy," although such plaintiffs may face issues of comparative negligence for failing to notice that the placebo pills are a different color than the hormone-producing pills.

Posted by Bruce Carton on September 29, 2011 at 12:00 PM | Permalink | Comments (0)


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