Paragard IUD Lawsuit
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IUD Lawsuit Michigan - Paragard IUD Lawyer Michigan
The ParaGard IUD is a widely used device that millions of couples have relied on for long-lasting birth control since its introduction in 1988. But no product is perfect. The ParaGard has been associated with rare serious side effects, including perforation of the uterus, pelvic infection and expulsion of the device. And these dangers haven’t always been accurately conveyed to the public in ads. This lack of transparency has prompted the FDA to address warning letters to the device’s manufacturer.
The letters were sent by the FDA’s Office of Prescription Drug Promotion, tasked with making sure drug ads meet standards of accuracy. They were sent to CooperSurgical, the current manufacturers of Paragard after acquiring it from Teva Pharmaceuticals in 2018.
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One of the letters states: “The Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) has reviewed a Direct-to-Consumer television advertisement (TV ad) entitled “Paragard 30 sec DTC Ad (Musical)”…. submitted by CooperSurgical, Inc. under cover of Form FDA 2253. The FDA Bad Ad Program also received a complaint regarding this TV ad. This TV ad makes false or misleading representations about the risks associated with ParaGard. Thus, the TV ad misbrands ParaGard within the meaning of the Federal Food, Drug and Cosmetic Act …. This violation is concerning from a public health perspective because it creates a misleading impression about the safety of ParaGard.
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Among the complaints, the ad indicated Paragard is indicated for intrauterine contraception for up to 10 years, but did not mention contraindications. The letter notes that “ParaGard is contraindicated in pregnancy or suspicion of pregnancy; in women with abnormalities of the uterus resulting in distortion of the uterine cavity; acute pelvic inflammatory disease, or current behavior suggesting a high risk of pelvic inflammatory disease; postpartum endometritis or postabortal endometritis in the past 3 months; known or suspected uterine or cervical malignancy; genital bleeding of unknown etiology; mucopurulent cervicitis; Wilson’s disease” and various other conditions.
It claims the ad fails to make clear the risks associated with the product by failing to mention possible expulsion of the device and increased risk of pelvic infection.
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The letter warns that Cooper must immediately cease running all ads that are similarly misleading.
Both Cooper and Teva have both been the subject of lawsuits from women who were harmed by uterine perforation or pelvic infection associated with the device, and claim the manufacturer failed to warn them of the risks.
The FDA received a complaint through its bad ad program, which was created to educate heath caregivers about misleading heath advertising, and allows anyone to submit an anonymous complaint. https://www.fda.gov/drugs/office-prescription-drug-promotion/bad-ad-program
IUD Lawsuit Michigan
IUD Lawsuit Michigan - Paragard IUD Lawyer Michigan
If you or a loved one suffered injuries after using the Paragard© IUD for birth control, you may be entitled to financial compensation from the manufacturer. Some injuries may include device breakage, organ perforation, device migration, hysterectomy, and scarring. Contact Vanderhyde Law today to see if you qualify. Call Toll Free 1-866-777-2557 or fill out our contact form and a Michigan IUD Lawyer will contact you to answer your questions. This is a free consultation. There are no legal fees unless you receive money. Operators are standing by. Call now.