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Articles Tagged with Mirena

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In Babich-Zacharias v. Bayer Healthcare Pharmaceuticals, Inc., a woman filed a product liability lawsuit against a pharmaceutical company in the U.S. District Court for the Western District of Kentucky after she allegedly suffered a number of adverse health effects from using the company’s intrauterine contraceptive device (“IUD”). According to her complaint, the woman developed idiopathic intracranial hypertension as a result of her use of the device that was designed to stay in the body for up to five years. If not properly treated, the condition can result in severe headaches and temporary blindness.

The woman claimed the patient pamphlet provided to her when the IUD was inserted failed to warn her of the link between her condition and use of the product. Despite this, the woman admitted the information stated further research regarding the medical product was needed. The woman also claimed that the medical device manufacturer failed to conduct sufficient clinical testing and intentionally concealed known risks associated with use of the device from patients and medical professionals in the company’s marketing products.

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The Western District of Kentucky has ordered portions of a pharmaceutical injury case to trial. In Vanden Bosch v. Bayer Healthcare Pharmaceuticals, Inc., two women filed a lawsuit against the drug manufacturer Bayer over health consequences they allegedly sustained after the women used the Mirena contraceptive product. According to the complaint, a Florida woman suffered a chronic health condition following the use of the device after it was implanted into her body in Kentucky. Additionally, a Kentucky woman purportedly became pregnant despite her use of the contraceptive product. Her child allegedly suffered an abnormal chromosome disorder as a result of her exposure to Mirena.

In response to the lawsuit, Bayer filed a Rule 12(b)(6) motion asking the federal court to dismiss the case. When such a motion is filed, the defendant in a civil lawsuit is essentially stating that, even if everything a plaintiff alleged in his or her lawsuit were true, the plaintiff did not assert sufficient information to show that he or she is entitled to a legal remedy. After determining that Kentucky law applied to the case, the federal court addressed Bayer’s motion to dismiss the lawsuit. Since Kentucky has a one-year statute of limitations for products liability claims, and the Florida woman filed her lawsuit more than one year after her purported injury, the Western District of Kentucky dismissed the woman’s negligence and other products liability causes of action against the drug company. The federal court also dismissed many of the Kentucky woman’s claims against Bayer because pregnancy “is not a legally cognizable injury” in the state.

Next, the Western District of Kentucky dismissed the plaintiffs’ breach of implied warranty claims because there was no “privity of contract” between the parties. Bayer argued that the plaintiffs’ breach of express warranty and Kentucky Consumer Protection Act claims should be dismissed as well, since the women did not purchase Mirena directly from the drug company, but the court disagreed. The federal court stated that the plaintiffs’ express breach of warranty claims required further evidence and should be fleshed out at trial. Also, Kentucky case law provides an exception to the Consumer Protection Act’s privity requirement when a manufacturer makes “valid express warranties for the benefit of consumers.” According to the federal court, the exception applied to the plaintiffs’ case.

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