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Lawsuit Alleges Permanent Injuries from Mirena IUD

female patient with doctorA Delaware County, PA woman is suing Bayer Healthcare Pharmaceuticals based on allegations that the Mirena contraceptive device is both defective and dangerous. According to her Mirena IUD lawsuit, the plaintiff sustained serious physical injuries and financial losses resulting from her use of the intrauterine device. She is suing on counts of defective design, manufacturing defect, failure to warn, negligence, breach of implied and express warranty, PA Unfair Trade Practices and Consumer Protection Law, and is also seeking punitive damages against the defendant for their purported reckless and wanton disregard for consumer safety.

The case joins other product liability lawsuits centralized under Mirena multidistrict litigation 2434, pending before the Honorable Judge Cathy Seibel.

Mirena lawsuit alleges device embedded in uterus

Debilitating Mirena side effects have been the topic of hundreds of claims brought against Bayer Healthcare, many of them contending that the IUD is an unreasonably dangerous product because it was sold with insufficient labeling regarding risks. Specifically, plaintiffs argue that they were not adequately warned of the risk of spontaneous migration of the IUD post-insertion.

In her complaint, plaintiff Robin Fetterolf says she was implanted with the Mirena birth control system on May 14, 2012 without complications. One week after the procedure, she returned to the doctor to confirm the IUD was in place and the strings could be felt. However, in October of that same year, Fetterolf claims she went to the emergency room complaining of persistent migraine headaches, severe nausea and vomiting. After being prescribed pain relievers, the plaintiff had a CT scan that showed no abnormalities. She was discharged and told to follow up with her primary care physician and a neurologist.

One month later, the plaintiff was admitted to Lankenau Hospital for the removal of the Mirena IUD, as the strings were no longer visible. Her doctor performed a hysteroscopy to remove the retained IUD that had become embedded inside her body.

The Pennsylvania plaintiff claims that she has incurred tremendous economic losses arising from medical treatment for her Mirena complications, and has experienced substantial pain and suffering as a direct and proximate result of Bayer’s alleged negligent and wrongful conduct.

About the Mirena intrauterine device

The Mirena IUD is a plastic intrauterine device that protects against unwanted pregnancy for up to five years. It is recommended for women who have already had at least one child. Since being approved by the FDA in 2000, it has been used by some 15 million women worldwide, thanks in part to a consumer-directed ad campaign launched in the US in which Bayer promoted the device as an easy and convenient option to “busy moms.”

The Department of Health and Human Services’ Division of Drug Marketing, Advertising, and Communications later contacted Bayer about claims made in their campaign, which “failed to communicate any risk information, inadequately communicated Mirena’s indications, and overstated the efficacy associated with the use of Mirena.”

Over the past few years, thousands of women have taken legal action against Bayer, arguing they were not made aware of the potential risks of the Mirena IUD. Bayer stands accused of failing to conduct sufficient pre and post-market tests, failing to provide sufficient instructions and labeling, and producing an IUD with manufacturing defects.

Fetterolf’s lawsuit asserts that the defendants downplayed the dangerous side effects of Mirena to encourage robust sales, and ultimately placed its profits above public safety.