Woman Sues Bayer for ‘Reckless’ Marketing of Mirena IUD

Woman Sues Bayer for ‘Reckless’ Marketing of Mirena IUD

By Jessica Tyner

Illinois resident June Davis sued Bayer Healthcare Pharmaceuticals Inc. on August 6, 2013, alleging the company negligently and/or fraudulently represented that its Mirena IUD birth control device was safe and effective. Her Mirena lawsuit was transferred two days later to multidistrict litigation consolidating all Mirena IUD lawsuits alleging perforation, embedment, or migration of the device. 

Davis says that Bayer concealed its knowledge of these Mirena side effects with the intent of defrauding other Mirena victims like as well as the medical community and U.S. Food and Drug Administration. Her Mirena lawsuit alleges that Bayer’s purpose was to make the healthcare community “recommend, implant, and/or purchase Mirena for use as a contraceptive, all of which evinced a callous, reckless, willful, depraved indifference to health, safety and welfare” of Davis and other Mirena users. 

The Mirena lawsuit also says that Bayer “negligently and improperly failed to perform sufficient tests, if any, on women using Mirena during clinical trials, forcing (people)…to rely on safety information that applies to other contraceptives, which does not entirely and/or necessarily apply to Mirena whatsoever.” 

In turn, Davis and other Mirena sufferers “have suffered and/or are at a greatly increased risk of serious and dangerous side effects including…migration, embedment, ectopic pregnancy, intrauterine pregnancy, cancer, adhesions, cysts, fetal injury, fetal death, and early/premature menopause.”

The Mirena Lawsuit Allegations

Davis is 31 years old, and when her IUD was initially implanted, her body seemed to tolerate it well. However, her IUD “later perforated her uterus, migrated and/or embedded outside” of her uterus, the lawsuit states. 

Davis had to undergo surgery to remove the IUD. Because of her faulty Mirena, Davis “suffered severe and permanent physical injuries, and has endured substantial pain and suffering. She has incurred significant expenses for medical care and treatment, and will continue to incur expenses in the future. (She) has lost past earnings and has suffered an economic loss in earning capacity,” the Mirena lawsuit states.

Davis alleges she suffered permanent injuries caused by the IUD, even though the Mirena packaging does not mention the device’s potential to migrate. The only mention of perforation on the packaging and materials is to warn of perforation during IUD insertion, and that women should have had at least one child when choosing the Mirena.

Davis claims that Mirena is adulterated, misbranded, does not contain adequate directions, doesn’t provide information about side effects, didn’t identify specific tests, is mislabeled, doesn’t meet good manufacturing practices, and isn’t safe or effective. She also alleges Bayer didn’t report adverse effects immediately, didn’t promptly investigate all complaints, didn’t review all safety information, and didn’t properly keep the Food and Drug Administration (FDA) informed. 

Overall, Bayer “failed to meet the standard of care” required of the drug maker, the lawsuit says. Bayer “failed to exercise reasonable care in the design, researching, manufacturing, marketing, supplying, promoting, packaging, sale and distribution of Mirena into the stream of commerce.”

Davis is seeking damages for counts of negligence, defective design, manufacturing defect, failure to warn, breach of warranty, fraudulent misrepresentation, fraudulent concealment, negligent misrepresentation, fraud and deceit, and punitive damages. 

The case is June Davis v. Bayer Healthcare Pharmaceuticals Inc., Case No. 13-cv-02601, U.S.  Court for the Northern District of Georgia (Atlanta Division). It was transferred to the Mirena MDL known as In Re: Mirena IUD Products Liability Litigation, MDL No. 2434.

Were You Injured by Mirena?  

If you were injured by the Mirena IUD, you may be able to pursue compensation. Find out more by visiting the Mirena IUD Injury Class Action Lawsuit Settlement Investigation and submitting your information for a free, confidential case review.