• Birth-control Packaging Error Led to 113 Unintended Pregnancies

    The women who accidentally got pregnant are suing the drug manufacturer for negligence
  • Birth-control Packaging Error Led to 113 Unintended Pregnancies
  • Photo from medicaldaily.com

    Family planning is an important issue. Most couples don't want to get pregnant at all or at least not right after a pregnancy. That's why some couples turn to non-natural contraceptive methods to make sure that they don't get a bun in the oven.

    But what happens when contraceptive pills fail because of negligence by the drug manufacturer?

    In the U.S., a total 113 women are suing pills drug manufacturer Endo Pharmaceuticals, Inc., for taking its contraceptive pills and still ended up getting pregnant. The women are seeking millions worth of damages for lost of income, medical costs, and for the 94 women who went on to give birth, the cost of raising their kids. Also included in the lawsuit are other companies that made or distributed the pills.

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    The contraceptive pills, which were marketed under the brand names Cyclafem, Emoquette, Gildess, Orsythia, Previfem and Tri-Previfem, were included in a 2011 product recall of more than 500,000 packs after one customer from Iowa found that the pills were packaged out of order—rotated 180 degrees, according to the lawsuit. "As a result of this packaging error, the daily regimen for these oral contraceptives may be incorrect and could leave women without adequate contraception, and at risk for unintended pregnancy," said Endo Pharmaceuticals' parent company Qualitest and the U.S. Food and Drug Administration (FDA) on the product recall in 2011. The company, in their defense, says that the recall was voluntary and was based on “an extremely small number of pill packs that were manufactured by an external contract manufacturer.”

    The case was dismissed when it was first filed in Georgia. The judge argued that each woman also needed to testify the physical symptoms she suffered, her medical history, and “and whether her use of any allegedly defective product resulted in these physical symptoms or a pregnancy.” The case was then refiiled in Pennysylvania and is still ongoing.

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    According to an article in smartparenting.com.ph, contraceptive pills work as intended only when it is taken as prescribed, the same time every day for 21 or 28 days. It contains the hormones estrogen and progestin (in some cases, progestin only) that controls hormones that signal the body to ovulate, or produce eggs, and thins the uterine lining so if ever an egg is produced, it cannot implant itself in the uterus.

    OB-gyn Maria Carla Esquivias-Chua, M.D., who is affiliated with Capitol Medical Center and Dr. Jesus Delgado Memorial Hospital, both in Quezon City, reminds women that “as with any prescription, you have to take the pills as prescribed.” Taking the pills exactly as it’s prescribed not only helps makes the pill highly effective in preventing pregnancy, but also benefits a woman’s reproductive health. “You also need to go for regular check-ups with your OB; take a pap smear test and, ideally, a transvaginal ultrasound every year to check for overall reproductive health.” she says.        

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    Sources:
    November 12, 2015. “Birth Control Lawsuit Seeks Damages For Unplanned Pregnancies” (npr.org)
    November 12, 2015. Birth Control Mix-Up Results in 113 Pregnancies, Lawsuit Alleges (nbcnews.com)
    November 11, 2015. Lawsuit Alleges Birth Control Packing Error Led to Unwanted Pregnancies (abcnews.go.com)

     

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