A New York woman is suing units of Teva Pharmaceuticals and Cooper Companies Inc in federal court, alleging she was injured when a piece of a birth control implant they make and sell broke while it was being removed.

Vanesha Johnson told the court that Teva promoted and marketed the ParaGard IUD as safe and effective and without hormones or other side effects of other birth control methods. However, they failed to warn her or her physician that the arms of the device could break while being implanted.

Johnson had to undergo surgery to have the arm of the device removed and told the court she has suffered a range of injuries as a result, including loss of reproductive health, pain, suffering, mental anguish and loss of enjoyment of life, on top of the medical bills.

She alleges Teva overstated the benefits of the ParaGard while downplaying the risks and failed to warn that it could break and injure her. According to the complaint, Teva knew or should have known about its defects based on trials, third-party studies, and consumer experience and complaints. Additionally, the complaint states that the U.S. Food and Drug Administration has received more than 1,600 reportss of the ParaGard breaking, with more than 700 of those reports considered to be serious.

Johnson is seeking unspecified damages for 11 separate counts, including negligence, common law fraud, breach of express and implied warranty, design and manufacturing defects, failure to warn, and violations of consumer protection laws.

 

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