Not Accepting Cases

Mirena Lawsuits

Mirena lawsuits accuse Bayer Pharmaceuticals of hiding side effects and making a defective device. More than 2,400 Mirena lawsuits were pending in courts in New Jersey and New York in March 2018. Women blame the birth control device for poking holes in organs (perforation), moving around in the body (migration) and causing pressure buildup in the skull (pseudotumor cerebri).

How Mirena is Implanted
Mirena Lawsuit Facts
  1. Injuries Organ perforation, device migration, device misplacement, pseudotumor cerebri
  2. Manufacturer Bayer Pharmaceuticals
  3. Top Settlement or Verdict No verdicts or settlements as of May 2018
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Thousands of women nationwide sued Bayer Pharmaceuticals over Mirena.

Mirena lawsuits claimed the birth control device poked holes in organs. Doctors call this perforation.

Other lawsuits say the devices can move around in the body (device migration).

More recent lawsuits blame Mirena for pressure buildup in the skull called pseudotumor cerebri.

The lawsuits accuse the company of selling a dangerous product. They also claim the company used deceptive advertising deceptive advertising. They say Bayer hid the risk of complications.

Drugwatch’s legal partners are not accepting new Mirena lawsuits. That could change in the future.

Status of Mirena Lawsuits

Mirena IUD in hand
Mirena IUD resting in the palm of a hand

There are two federal multidistrict litigations over Mirena. In the first, a judge overseeing 1,775 Mirena cases dismissed most of the lawsuits in 2016. Only three lawsuits remained pending in May 2018.

The cases did not go to trial, so there were no major verdicts. Bayer did not announce a global settlement in those cases.

Another 523 lawsuits were pending in the second Mirena MDL as of May 2018. Those lawsuits blame Mirena for pressure buildup in the skull. The medical community calls the injury pseudotumor cerebri. A federal panel consolidated these lawsuits. A judge in the Southern District of New York was handling the proceedings.

Another 2,000 Mirena lawsuits say the device moved out of place and caused injuries. A judge in New Jersey Superior Court Bergen County was overseeing the lawsuits.

Injuries in Mirena Lawsuits

Mirena lawsuits blamed the device for organ perforation. This is when the device pokes a hole through an organ, such as the uterus.

Other lawsuits focus on device misplacement and device migration. They say the device moved inside the body and injured women.

A new group of Mirena lawsuits claim Mirena caused pseudotumor cerebri. This term means “false brain tumor.” This condition is also known as intracranial hypertension.

Accusations Against Bayer

Women who filed Mirena lawsuits accuse Bayer of knowingly harming them. They say Mirena’s label didn’t warn them about serious complications. They want compensation for medical expenses, lost wages, and pain and suffering.

Mirena lawsuits say Bayer:
  • Misrepresented Mirena benefits
  • Failed to provide adequate warnings and instructions
  • Understated the product’s complications as “uncommon”
  • Used deceptive marketing
  • Concealed harmful side effects
  • Produced, sold and distributed defective products

Mirena Lawsuit Examples

Johnson v. Bayer
Desaree Nicole Lee Johnson filed a suit against Bayer after her device moved and cut into her uterus. She had surgery to remove it. Later, she became pregnant, but it ended in a miscarriage. Johnson may now be infertile. She accused Bayer of knowingly releasing a defective and unsafe product.
Williams v. Bayer
Melody Williams accused Bayer of negligence and fraud. She also claimed the company failed to warn consumers of dangerous side effects. Williams experienced abdominal cramping and pain less than a year after receiving Mirena. The first attempt to remove the device was unsuccessful. During a second surgery, doctors found that the device had “migrated through the opening of the plaintiff’s right fallopian tube.” Williams suffered from pain, infection and had to undergo many procedures. She accused Bayer of “[willful] and reckless disregard for the public safety.”
Everett-Carey v. Bayer
Katrina Everett-Carey filed suit against Bayer after doctors diagnosed her with pseudotumor cerebri. Her diagnosis came about a year after she began using Mirena. Shortly after receiving Mirena, she experienced blurred vision and intense headaches. “Defendants failed to adequately and properly test the Mirena both before and after placing it on the market,” the lawsuit said.

Mirena Class Action Lawuits

There are currently no class actions pending in Mirena litigation.

A class action allows for one or more plaintiffs to file a lawsuit on behalf of a larger group of injured people. The larger group is the class.

Instead, a panel grouped federal Mirena lawsuits into two consolidated cases in New York. The courts call these multidistrict litigations (MDLs).

Others are part of a multicounty case in New Jersey.

The lawsuits in each consolidated case make similar claims against Bayer.

Mirena Multidistrict Litigations

Two multidistrict litigations involving Mirena remained open as of March 2018. One MDL includes lawsuits that claimed device migration, organ perforation and related injuries. The other focuses on lawsuits that blame Mirena for pseudotumor cerebri.

Mirena MDL Timeline: Device Migration, Organ Perforation and Related Injuries

The first Mirena MDL focused on organ perforation, among other injuries.

Bayer noted in court documents that Mirena contained a warning that said, “Perforation or penetration of the uterine wall or cervix may occur during insertion although the perforation may not be detected until some time later.”

The lawsuits argued that Mirena could perforate the uterus at any time — even without injury at insertion.

Lawsuits called this “secondary perforation,” “spontaneous perforation” or “spontaneous migration.” They alleged Bayer’s label used from 2008 through 2014 did not contain warnings for secondary perforation.

  • April 2013
    The Judicial Panel on Multidistrict Litigation grouped federal Mirena lawsuits into multidistrict litigation. The MDL panel assigned the cases to Judge Cathy Seibel at the Southern District of New York. The MDL included 1,775 cases.
  • July 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. Seibel granted Bayer’s request for dismissal. The women appealed.

“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
  • November 2016
    The MDL panel reopened the litigation. Bayer requested the reopening pending a decision on appeal. Bayer urged the panel reopen the MDL because people were filing new cases. These cases were on hold while the appeal was pending. Counsel for plaintiffs did not agree with Bayer.
  • November 2017
    The Second Circuit Court of Appeals affirmed Judge Siebel’s July 29, 2016 ruling. The appeals court found that the judge properly excluded the expert witness testimony as a matter of law.
  • March 2018
    Two cases remained pending under the MDL.

Mirena ‘Pressure on the Brain’ MDL

In April 2017, the Judicial Panel on Multidistrict Litigation agreed to group “pressure on the brain” cases into their own MDL.

At that time, there were about 113 head-related lawsuits against Bayer in 17 districts.

The cases pointed to a hormone contained in Mirena as the cause for plaintiffs’ condition.

As of March 2018, about 451 consolidated cases were pending before Judge Paul A. Engelmayer in the Southern District of New York.

Mirena Injury Lawsuits in New Jersey

In 2013, the court consolidated cases into multicounty litigation in New Jersey. Judge Brian R. Martinotti oversaw the cases. 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 ”

Source: New Jersey Judiciary Court System

Plaintiffs in New Jersey had similar complaints to those in New York. Cases in New Jersey were in the middle of discovery in March 2018.

During discovery both sides of a lawsuit provide each other with requested information. This may include internal documents and medical testimony.

Please seek the advice of a medical professional before making health care decisions.

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13 Cited Research Articles

  1. 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. Retrieved from http://www.chamberlitigation.com/sites/default/files/cases/files/17171717/Opinion%20%26%20Order%20--%20In%20re%20Mirena%20IUD%20Products%20Liability%20Litigation%20%28USDC%20-%20Southern%20District%20of%20New%20York%29.pdf
  2. 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. Retrieved from https://jc6kx1c9izw3wansr3nmip8k-wpengine.netdna-ssl.com/wp-content/uploads/2017-2-10-mirena-everett-carey-complaint.pdf
  3. 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
  4. U.S. Food and Drug Administration. (2008, July). Mirena (levonorgestrel-releasing intrauterine system). Retrieved from http://www.accessdata.fda.gov/drugsatfda_docs/label/2008/021225s019lbl.pdf
  5. Chiem, L. (2012, November 8). Bayer healthcare hit with more Mirena product defect suits. Retrieved from http://www.law360.com/articles/392774
  6. 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
  7. Barnett et. al v. Bayer Healthcare Pharmaceuticals. (2012, November 7). Retrieved from http://www.pacer.gov
  8. Williams v. Bayer Healthcare Pharmaceuticals Inc. (2012, November 2). Retrieved from http://www.pacer.gov
  9. 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
  10. In Re: Mirena IUD Products Liability Litigation. (2016, November 14). Case Management Order Re: Cases Transferred To MDL During Appeal. United States District Court Southern District of New York. Retrieved from http://nysd.uscourts.gov/file/mdl/865
  11. Lexis Legal News. (2016, November 15). Judicial Panel Reopens Mirena IUD MDL; Plaintiffs Cite Patent Hormone Disclosure. LexisNexis. Retrieved from https://www.lexislegalnews.com/articles/12636/judicial-panel-reopens-mirena-iud-mdl-plaintiffs-cite-patent-hormone-disclosure
  12. In Re: Mirena IUD Products Liability Litigation. (2017, November 16). Summary Order. United States Court of Appeals For The Second Circuit. Retrieved from http://ij.org/wp-content/uploads/2017/11/16-2890_so.pdf
  13. U.S. Judicial Panel on Multidistrict Litigation. (2018, May 15). MDL Statistics Report. Retrieved from http://www.jpml.uscourts.gov/sites/jpml/files/Pending_MDL_Dockets_By_District-May-15-2018.pdf
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