Product News and Recalls

Mirena lawsuits coordinated in multi-district litigation

According to a story in the National Law Journal, about 40 lawsuits filed over Bayer’s Mirena intrauterine device have been coordinated in multidistrict litigation, and will be heard by a New York federal judge. Attorneys for the plaintiffs said they expect complaints about Mirena IUDs to generate hundreds – perhaps thousands – more lawsuits in the near future.

The T-shaped flexible plastic devices prevent pregnancy by releasing hormones into the recipient’s uterus. Doctors implant it during an office visit and it can stay in place for up to five years, at which point the doctor is supposed to remove it.

But plaintiffs claim the device has a tendency to migrate from its original position, tearing the uterine wall in the process. In such cases, surgery is necessary to remove it.

The lawsuits also claim that Bayer made misleading claims about the device. In 2009, the U.S. Health and Human Services’ Division of Drug Marketing, Advertising and Communications concluded that Mirena carries risks of decreased libido, weight gain and acne. Yet Bayer circulated promotional materials aimed at “busy moms,” claiming that the device enhanced a woman’s sexual drive and made her “look and feel great.”

The company claims it provides adequate warning in the form of packaging labels that refer to “spontaneous migration.” But lawyers for the plaintiffs argue that those labels mention only the risks of perforation of the uterus when the device is inserted, not years after the initial implantation.

Last month, the National Law Journal reports, the U.S. Judicial Panel on Multidistrict Litigation ordered the cases coordinated before U.S. District Judge Cathy Seibel in White Plains, N.Y.

Patients should consult their doctors before making any changes in their medication. A consultation with a Mirena lawyer is also important if surgery was required from Mirena.

See the story here: