Mirena looks like a little T and is small enough to easily fit in the palm of your hand.
Made of plastic, the device releases an artificial hormone that prevents conception after placement in the uterus. While effective, the device can be dangerous, according to thousands of women across the country who filed lawsuits against the manufacturer, Bayer Pharmaceuticals.
The company is accused of selling a dangerous product, engaging in deceptive advertising and concealing the risk of complications. The devices can poke into organs, move around and cause a pressure buildup in the skull.
Injured women are seeking compensation for medical expenses, lost wages and pain and suffering.
Allegations Against Bayer
Women say Mirena’s label didn’t warn them about serious complications. They want Bayer punished, saying the company knowingly harmed them.
Lawsuits Say Bayer:
- Misrepresented Mirena benefits
- Didn’t warn them about dangerous side effects, including sudden movement of the device
- Understated the product’s complications as “uncommon”
- Used deceptive marketing
- Concealed harmful side effects
- Failed to provide adequate warnings and instructions
- Produced, sold and distributed defective products
Mirena Lawsuit Examples
Many of the lawsuits have been grouped together into a consolidated federal case in New York or a multicounty case in New Jersey. A third federal group may be formed. They make similar claims against Bayer.
Desaree Nicole Lee Johnson filed a suit against Bayer because her device moved and cut into her uterus. She underwent surgery to remove it. Later, she became pregnant but it ended in a miscarriage. Johnson is upset because she may now be infertile. In her complaint, Johnson accuses Bayer of knowingly releasing a defective and unsafe product.
Melody and Ronail Williams allege that Bayer is guilty of several actions, including negligent misrepresentation, fraud and failure to warn consumers of dangerous side effects. Melody Williams suffered from abdominal cramping and pain less than a year after receiving Mirena. The first attempt to remove the device was unsuccessful, and when a second surgery was attempted, doctors found that the device had “migrated though the opening of the plaintiff’s right fallopian tube.” She suffered from pain, infection and had to undergo numerous procedures. She accuses Bayer of negligence and “wanton and reckless disregard for the public safety.”
Katrina Everett-Carey filed a lawsuit against Bayer after a doctor diagnosed her with a condition called pseudotumor cerebri, the buildup of cranial pressure, about a year after she began using Mirena. Shortly after receiving Mirena, she experienced blurred vision and intense headaches. Her lawsuit claims: “Defendants failed to adequately and properly test the Mirena both before and after placing it on the market.” Bayer sold Mirena with “wanton and reckless disregard for the public safety,” according to her complaint.
Mirena Consolidated Litigation
In April 2013, a number of Mirena lawsuits that claimed device migration, organ perforation and related injuries were consolidated into what’s called multidistrict litigation. The cases were grouped together in the Southern District of New York under U.S. District Judge Cathy Seibel. It included 1,800 cases.
Consolidated Cases Dismissed
In 2016, Seibel excluded all “secondary perforation” experts for the women suing Bayer. The judge said they were not qualified to testify. About 1,300 cases were pending at the time, and Seibel granted Bayer’s request for dismissal. The women appealed, but the appeals court has yet to make a decision.
“The Court reaches this conclusion reluctantly, knowing that it will doom hundreds of cases, but in the Court’s view it is compelled by the law.”
- U.S. District Judge Cathy Seibel, in her order granting Bayer's request for dismissal
Mirena Cranial Pressure Buildup
The majority of existing litigation centers on organ perforation and device migration. But a new group of Mirena lawsuits emerged claiming Mirena caused pseudotumor cerebri (meaning “false brain tumor”), also known as intracranial hypertension. This condition is the result of an abnormal elevation of cerebrospinal fluid in the skull causing neurological complications, including symptoms of headache and vision problems.
The panel responsible for deciding whether to consolidate similar lawsuits previously denied a motion in July 2014, to consolidate the cases alleging “pressure on the brain.” The panel determined its ruling based on the limited number of actions pending at the time and case-specific cause of symptoms leading to diagnosis.
In February 2017, plaintiffs filed a second motion to centralize the lawsuits. In that motion, the plaintiffs argued that the litigation had expanded dramatically over the two-year time period. While the panel noted that it rarely reaches a different conclusion once an earlier denial has occurred, it will do so where a significant change in circumstances is realized. In reaching its decision in April 2017, the panel found that there had been such a change.
The number of lawsuits pending against Mirena’s manufacturer, Bayer, regarding intracranial hypertension had increased from just nine actions pending in six different districts to 113 pending actions in 17 districts. Additionally, causation for the plaintiffs’ condition now largely pointed to a hormonal component of Mirena and whether it is capable of leading to plaintiffs’ injuries.
Currently, just over 220 consolidated cases are pending before Judge Paul A. Engelmayer, whom the panel referred to as an “experienced transferee judge with the willingness and ability to manage [the] litigation,” at the Southern District of New York.
New Jersey Litigation
In 2013, the Supreme Court consolidated other cases in multicounty litigation in New Jersey under Judge Brian R. Martinotti. Then, in 2016, the court reassigned those cases to Judge Rachelle L. Harz.
“The complaints filed allege that the plaintiffs suffered injuries and/or damages as a result of misplacement of the Mirena device,” the New Jersey Judiciary Court System says online.
Plaintiffs in New Jersey had similar complaints to those in New York. Cases in New Jersey are in the middle of discovery — the phase of litigation where plaintiffs and defendants are providing each other with requested information. This may include internal documents and medical testimony.
Michelle Y. Llamas is a senior content writer. She is also the host of Drugwatch Podcast where she interviews medical experts as well as patients affected by drugs and medical devices. She has written medical and legal content for several years — including an article in The Journal of Palliative Medicine and an academic book review for Nova Science Publishers. With Drugwatch, she has developed relationships with legal and medical professionals as well as with several patients and support groups. Prior to writing for Drugwatch, she spent several years as a legal assistant for a personal injury law firm in Orlando. She obtained her English – Technical Communication degree from the University of Central Florida. She is a committee member with the American Medical Writers Association.
- In Re: Mirena IUD Products Liability Litigation. (2016, July 28). Opinion & Order, United States District Court Southern District of New York, MDL No. 2434. Case 7:13-mc-02434-CS-LMS.
- Everett-Carey v. Bayer et al. (2017, February 2017). Complaint and Demand for Jury Trial, United States District Court District of New Jersey Newark Division. Case 2:17-cv-00891.
- Sieniuc, K. (2016, August 19). Wipeout of Mirena MDL to Be Challenged at 2nd Circ. Retrieved from https://www.law360.com/articles/830589/wipeout-of-mirena-mdl-to-be-challenged-at-2nd-circ
- Food and Drug Administration. (2008 July). Mirena (levonorgestrel-releasing intrauterine system). Retrieved from http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021225s019lbl.pdf
- Chiem, L. (2012, November 8). Bayer healthcare hit with more Mirena product defect suits. Retrieved from http://www.law360.com/articles/392774
- Mass Torts – Application for Centralized Management (Multicounty Litigation) of New Jersey State-Court Litigation Involving Mirena Contraceptive Device. (2012, August 13). Retrieved from http://www.judiciary.state.nj.us/notices/2012/n120814b.pdf
- Barnett et. al v. Bayer Healthcare Pharmaceuticals. (2012, November 11).
- Williams v. Bayer Healthcare Pharmaceuticals Inc. (2012, November 2).
- In Re: Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II). (6 April 2017). Transfer Order. Retrieved from: http://www.jpml.uscourts.gov/sites/jpml/files/MDL-2767-Initial_Transfer-03-17.pdf