Parker Waichman LLP is investigating potential lawsuits on behalf of users of the Mirena intrauterine device (IUD). Mirena (levonorgestrel-releasing intrauterine system), also known as LNG-IUS, is a hormone-releasing system placed in a woman’s uterus to prevent pregnancy for up to five years. Mirena is also used in the treatment of heavy periods in women who choose intrauterine contraception. Levonorgestrel is a progestin hormone.
Bayer Inc., the maker of Mirena, has allegedly used deceptive tactics to market Mirena and, as a result, many women were left unaware of its potential risks and complications, some of which are very serious and may be extremely painful and may impact the lives of victims and their families for years. Some injuries are life-long and life altering, and Mirena’s complications may include uterine perforation, pseudotumor cerebri, pelvic inflammatory disease (PID), ovarian cysts, irregular bleeding, and amenorrhea (abnormal absence of menstruation). Women who have become pregnant while using Mirena may suffer a miscarriage and their fertility may be put at risk.
After previously denying a motion to centralize claims that alleged the Mirena IUD causes or contributes to the development of intracranial hypertension injuries, the U.S. Judicial Panel on Multidistrict Litigation (JMPL) reconsidered, given the mounting federal actions pending in courtrooms nationwide. In a transfer orders filed on April 6, 2017, the JPML decided to consolidate all Mirena Pseudotumor Cerebri lawsuits before one judge for more streamlined pre-trial proceedings. The motion for centralization incudes 113 pending Mirena cases in 17 districts, and another 37 potential so-called “tagalong actions,” which could bring the total number of districts to 20.
Coordination Decided on Second MDL; Mirena IUD Pseudotumor Cerebri Lawsuits Centralized in New York
Plaintiffs in Mirena IUD lawsuits brought over allegations that they developed pseudotumor cerebri also allege that they were not adequately advised of this possible adverse reaction and, had they been advised about the symptoms of pseudotumor cerebri, they might have sought a prompter diagnosis and treatment, as well as minimized permanent injuries. Many women also allege that the aggressive advertising campaign conducted by Bayer that promoted Mirena as safe and convenient was misleading.
Plaintiffs in 10 actions moved to centralize pretrial proceedings in this litigation in the Southern District of Mississippi or, alternatively, the Western District of Missouri, or the District of New Jersey. As of April 2017, this litigation consists of 113 actions pending in 17 districts. Since filing the motion, the JPML has been advised of of 37 related federal actions. Allegations involve intracranial hypertension injuries/pseudotumor cerebri associated with the hormonal component of the Mirena IUD contraceptive system. Defendants are Bayer HealthCare Pharmaceuticals Inc. (BHCP), Bayer Oy, and Bayer Pharma AG, which are together known as Bayer and which are allegedly responsible for the development, manufacture, and distribution of Mirena.
All the responding plaintiffs support centralization, but do not agree on the transferee district. Plaintiffs variously propose the Western District of Missouri, the District of New Jersey, the Eastern District of Pennsylvania, and the Southern District of Mississippi. Meanwhile, the defendants oppose centralization, but propose the Southern District of New York as the transferee district in the event an MDL is created over their objections.
This is the second time this litigation is before the JPML. In July 2014, the JPML denied a motion for centralization that had been filed by a different group of plaintiffs who alleged that Mirena’s hormonal component caused or substantially contributed to the development of intracranial hypertension/pseudotumor cerebri (In re: Mirena Levonorgestrel-Related Products Liability Litigation, 38 F. Supp. 3d 1380 (J.P.M.L. 2014). That motion sought centralization of nine actions pending in six districts, brought by the same counsel against one defendant, BHCP. There were also six potential tag-along actions. In denying centralization, the JPML indicated that it observed that the actions involved common factual issues, but found that informal coordination was preferable to centralization given the limited number of actions, the few involved plaintiffs’ counsel, and defendant BHCP’s commitment to coordinating common discovery through its national coordinating counsel. The JPML expressed concern at the time that individualized causation disputes were likely to predominate considering the non-specific nature of the symptoms of intracranial hypertension—the two key being headaches and vision problems—which the defendant argued would “give rise to case-specific inquiries over whether each plaintiff was diagnosed properly.” The JPML acknowledged that an MDL had been created in 2013 to centralize pretrial proceedings for Mirena actions alleging uterine perforation and migration injuries (MDL No. 2434, often referred to as the Perforation MDL), but found that that MDL involved a far greater number of actions, districts, and counsel, precluding effective voluntary coordination.
In this second centralization motion, the plaintiffs argue that the litigation has expanded dramatically over the past two years concerning the number of actions, districts, and distinct plaintiffs’ firms that are independently litigating the actions. Informal coordination of discovery and pre-trial motions is now impracticable, according to the plaintiffs.
Bayer opposes centralization arguing that informal coordination has been successful previously and remains preferable because the number of actions and involved counsel remains relatively limited; that the drug maker continues to maintain a national counsel coordinating its response to the litigation; that the plaintiff-specific causation issues remain central to every action and are more efficiently managed outside of an MDL; that common discovery is nearly complete, according to Bayer; and that the actions are in significantly different procedural postures, including four with trial dates in 2017.
The JPML notes that a prior denial of centralization does not preclude it from reaching a different result on a second motion. The JPML notes that it does so rarely and only when a significant change in circumstances has taken place. In this case, the JPML indicates that, upon careful review of the record, it determined that such a change has taken place given that the number of actions, districts, and counsel have significantly grown and, in addition to 113 pending actions in 17 districts, there are at least 37 potential tag- alongs, which brings the total involved districts to 20. There are now at least 12 unaffiliated plaintiffs’ firms nationwide and, despite that Bayer has national coordinating counsel, at least 20 firms litigating the underlying actions on the motion on its behalf. The JPML notes that, “the number of actions, districts, and plaintiffs’ and defense counsel make effective coordination on an informal basis impracticable.”
Also, plaintiff-specific causation issues identified by Bayer do not seem to be an obstacle to centralization, given development of the litigation in the past two years, according to the JPML. The JPML also notes that, although it expressed prior concern that individualized causation issues might predominate in this litigation, the records in the various actions filed since then show that discovery and pretrial motions concerning general causation have been, or will be, at the center of all actions. This involves if Mirena’s hormonal component may cause intracranial hypertension/pseudotumor cerebri. The JPML believes existence of individualized causation will not negate efficiencies gained by centralization.
The record shows that centralization is needed to facilitate the efficient conduct of common discovery. While fact and expert discovery has closed in the 10 longest pending actions, discovery remains open in most of the other actions and with most at a comparatively early stage of discovery or still at the pleading stage. Bayer asserts the longer pending proceedings have led to completion of all common discovery; plaintiffs heartily disagree. In fact, most plaintiffs intend to seek full discovery without being limited by prior discovery, which they argue was inadequate and over which they will seek judicial resolution.
While some actions are in advanced procedural posture, the transferee judge possesses broad discretion to formulate a pre-trial program that will account for significant differences among the actions and will ensure redundant activity is minimized or eliminated. The JPML indicates that it believes that the differing procedural postures may be efficiently managed within an MDL, except for two actions that appear to be trial-ready. These two actions, in the Western District of Missouri, have completed nearly all pre-trial proceedings and are not appropriate for centralization.
Based on papers filed and a hearing session held, the JPML finds that specific actions involve common questions of fact and “centralization will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation.” Also, the actions share factual questions arising out of allegations that Mirena’s synthetic hormone causes abnormal elevation of cerebrospinal fluid in the skull, which leads to a neurological condition referred to as intracranial hypertension or pseudotumor cerebri, and that defendants did not adequately warn prescribing physicians or consumers of this alleged risk. Issues involving general causation, background science, and Mirena’s labeling and regulatory history concerning alleged injury will be common to all actions. Centralization will eliminate duplicative discovery, prevent inconsistent pretrial rulings, and conserve party, counsel, and judiciary resources.
After weighing all factors, the JPML concluded that the Southern District of New York is an appropriate transferee district for this litigation as the district is near Bayer’s corporate headquarters in New Jersey, which is where many common documents and witnesses are likely to be located. Centralization here will provide a geographically convenient forum for this nationwide litigation and ensure any potential overlap with the Mirena litigation involving perforation and migration injuries in MDL No. 2434 is coordinated efficiently. Judge Paul A. Engelmayer is an experienced transferee judge who is willing and able to manage this litigation and the JPML indicated that it is confident Judge Engelmayer “will steer this litigation on a prudent course.”
The JPML ordered that the actions listed pending outside the Southern District of New York be transferred to the Southern District of New York and, with the consent of that court, assigned to the Honorable Paul A. Engelmayer for coordinated or consolidated pretrial proceedings. The two pending items in the Western District of Missouri have been denied for this transfer.
Mirena and Pseudotumor Cerebri Injuries
According to the Mayo Clinic, pseudotumor cerebri occurs when the intracranial pressure (pressure in the skull) increases for no apparent reason. Such pressure typically occurs when excess cerebrospinal fluid is present. Symptoms appear to be similar to those of a brain tumor; however, no tumor is present. The condition may also be referred to as idiopathic intracranial hypertension.
Increased intracranial pressure associated with pseudotumor cerebri may lead to swelling of the optic nerve, which may lead to vision loss or blindness, among other injuries, according to the Mayo Clinic. In some cases, surgery is necessary. The makers of Mirena are facing lawsuits involving allegations that Bayer minimized the tie between Mirena and neurological side effects that include pseudotumor cerebri. Symptoms of this disorder may include:
- Back pain
- Blurred vision
- Diplopia (double vision)
- Dizziness
- Headache
- Loss of peripheral (side) vision
- Mood changes
- Nausea
- Neck pain
- Permanent vision loss
- Photopsia (seeing flashing)
- Shoulder pain
- Tinnitus (buzzing, ringing in the ears)
- Vision loss
- Vomiting
Pseudotumor cerebri, may cause patients serious suffering and significant, sometimes permanent, side effects that include vision loss. The Cleveland Clinic points out that, because pseudotumor cerebri is uncommon, medications that would significantly reduce symptoms are not considered due to misdiagnosis or delayed diagnosis, allowing the condition to reach a more serious stage. When pseudotumor cerebri advances, patients may require shunt implantation to enable rapid fluid drainage that moves the fluid away from the brain. It is when the pressure on the optic nerve is severe that permanent eye damage or loss may occur.
Research is still being conducted to determine the exact cause(s) of pseudotumor cerebri; however, in recent decades, an array of studies, which include research published in 1995 in the New England Journal of Medicine, have revealed a potential tie between pseudotunor cerebri and levonorgestrel, the main hormone in the Mirena IUD.
Mirena and
Breast Cancer
In June 2015, the journal Acta Oncologica published a study investigating the link between breast cancer and the use of levonorgestrel-releasing intrauterine systems such as Mirena. The authors of the study sought to test whether devices such as Mirena increase the risk of lobular breast cancer; they noted that, while prolonged steroid hormone therapy is associated with an increased risk, the link to LNG-IUS is uncertain. The researchers found that LNG-IUS “is not only related to an excess risk of lobular cancer but also, contrary to previous assumptions, to an excess risk of ductal breast cancer.”
The researchers used data from the national Medical Reimbursement Registry of Finland to identify women between the ages of 30 and 49 who used levonorgestrel-releasing IUDs to treat or prevent menorrhagia (abnormally heavy menstrual bleeding) between 1994 and 2007. Women diagnosed with breast cancer before the age of 55 and by the end of 2012 were identified using data from the Finnish Cancer Registry. In a cohort of 93,843 women using LNG-IUS, a total of 2,015 were diagnosed with breast cancer. Use of LNG-IUS was associated with a higher risk of both lobular cancer and ductal breast cancer compared to the general population. The highest risk was found in women who were implanted with the Mirena contraceptive at least twice.
Bayer’s Mirena Deception
The Mirena IUD was originally approved as an intrauterine contraceptive (IUD), and later, as a treatment for heavy menstrual bleeding in women who had given birth at least once. Mirena works by slowly releasing the chemical progestogen levonorgestrel into the uterus and is indicated for intrauterine contraception for up to five years. At that point, the Mirena system should be replaced if continued contraception is desired. Mirena is only recommended for women who have had at least one child.
Bayer has marketed Mirena as a way in which “busy moms” may simplify their lifestyles. One of the ways Bayer did so was through “Mirena Parties.” Working with the social networking site, Mom Central, Bayer created a Mirena direct marketing program that consisted of a series of house parties hosted by members of the Mom Central community. The program was set up to be presented in a consumer’s home or other private setting (e.g. private restaurant party) by a representative from Mom Central and a nurse practitioner. The script followed by the nurse practitioner at these Mirena Parties included phrases such as “look and feel great,” “simple ways to reconnect with ourselves and our partners,” and “more likely to be more intimate.”
According to a U.S. Food and Drug Administration (FDA) Warning letter issued to Bayer in December 2009, the claims made in the script “clearly indicate that the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. These claims misleadingly overstate the proven efficacy of Mirena.”
The letter went on to say that the FDA was “not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great.” The agency also indicated that the script omitted certain information regarding the risks of using Mirena, and minimized risks by utilizing the statement “look and feel great.” Finally, the FDA faulted the script for including a statement that Mirena “has no daily, weekly, or monthly routines to comply with,” which the agency stated was false.
Bayer stopped holding Mirena Parties in early 2009. But because of such misleading information presented at these events, many women who chose Mirena for its purported convenience may not have been aware of its many serious side effects.
Mirena Side Effects
In addition to pseudotumor cerebri, since its approval, serious Mirena side effects have long included ectopic pregnancy, intrauterine pregnancy (a pregnancy that occurs in the uterus with the IUD in place), group A streptococcal sepsis, pelvic inflammatory disease (PID), embedment of the device in the uterine wall, and perforation of the uterine wall or cervix. Other common Mirena side effects include irregular spotting or bleeding, headaches, ovarian cysts, vaginitis, painful menstruation, pelvic pain, and breast tenderness.
In June 2010, the Canadian regulatory agency, Health Canada, reminded healthcare providers there of important safety information regarding reports of uterine perforation in women using Mirena. According to Health Canada, Bayer Inc. continues to receive post-market reports of uterine perforation associated with the use of Mirena.
According to Health Canada, some cases of Mirena uterine perforation were not detected during or immediately after the insertion. The risk of perforation may be increased with use in the post-partum period, during lactation, and in women with an atypical uterine anatomy (such as fixed retroverted uterus). Uterine perforation may occur with Mirena at the time of insertion or after insertion with limited clinical symptoms.
The highly experienced medical device attorneys at Parker Waichman LLP are investigating an association between the Mirena IUD and a range of serious side effects, including uterine perforation, breast cancer, and pseudotumor cerebri.
Bayer itself has warned about the potentially detrimental effects associated with Mirena’s hormones, cautioning against using the IUD “if you have a pelvic infection, get infections easily, or have certain cancers. Less than one percent of users are diagnosed with a serious infection called pelvic inflammatory disease (PID). If you have persistent pelvic or abdominal pain, see your healthcare provider.”
Legal Help for Victims of Mirena Injuries
It is impossible to know how many women chose to use Mirena because of Bayer’s promises of an improved lifestyle without realizing that the contraceptive posed serious risks. Our Mirena injury lawyers are working to hold Bayer accountable for its deception.
If you or a someone you know suffered from pseudotumor cerebri, a uterine perforation, ectopic pregnancy, infection, breast cancer, or other serious complication that might be tied to Mirena, you have valuable legal rights. Please fill out our online form or call one of our Mirena injury lawyers today at 1-800-YOURLAWYER (1-800-968-7529) for a free evaluation of your case.
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