Our firm is investigating potential lawsuits on behalf of users of the Mirena IUD. 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.
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.
Mirena injuries 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. Women who have become pregnant while using Mirena may suffer a miscarriage and their fertility may be put at risk.
MDL Coordination Decided
The United States Judicial Panel on Multidistrict Litigation (MDL), In Re: Mirena IUS Levonorgestrel-Related Products Liability Litigation (No. II) MDL No. 2767 Transfer Order involves plaintiffs in 10 actions who are moving to centralize pretrial proceedings in this litigation in the Southern District of Mississippi, the Western District of Missouri, or the District of New Jersey. This litigation currently consists of 113 actions pending in 17 districts.
The Panel was notified of 37 related federal actions that involve alleged intracranial hypertension injuries caused by the hormonal component of the Mirena IUD contraceptive system. The Defendants are Bayer HealthCare Pharmaceuticals Inc. (BHCP), Bayer Oy, and Bayer Pharma AG, which together are described as Bayer. Bayer is allegedly responsible for the development, manufacture, and distribution of Mirena.
The responding plaintiffs support centralization; however, they differ on the transferee district proposing the Western District of Missouri, the District of New Jersey, the Eastern District of Pennsylvania, and the Southern District of Mississippi. Defendants oppose centralization, but propose the Southern District of New York as the transferee district in the event the Panel creates an MDL over Bayer’s objections.
The Panel indicates that this litigation is a second litigation. In July 2014, the Panel denied a motion for centralization that was filed by a different group of plaintiffs who alleged that Mirena’s hormonal component caused or substantially contributed to the development of intracranial hypertension. The motion sought centralization of nine actions that were pending in six districts and were brought by the same counsel against one defendant, BHCP. At that time, there were six potential tag-along actions. When centralization was denied, the Panel 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 plaintiffs’ counsel, as well as BHCP’s commitment to coordinating common discovery through its national coordinating counsel. The Panel expressed concern that individualized causation disputes were likely to predominate considering the non-specific nature of the symptoms of intracranial hypertension, primarily headaches and vision problems, which Bayer claimed would give rise to case-specific inquiries if the plaintiffs were appropriately diagnosed. The Panel 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, known as the Perforation MDL), but observed that MDL No. 2434 involved significantly more actions, districts, and counsel, which precluded effective voluntary coordination.
This second motion for centralization involves plaintiffs who argue that the litigation has expanded significantly in the past two years over the number of actions, districts, and plaintiffs’ firms independently litigating the actions, as well as informal coordination of discovery and pretrial motions becoming impracticable.
For its part, Bayer opposes coordination because it claims that informal coordination has been successful and remains preferable given that the number of actions and involved counsel is somewhat limited, and that Bayer “continues to have national counsel coordinating its response to the litigation; plaintiff-specific causation issues remain central to each action and are more efficiently managed outside of an MDL; common discovery is, from Bayer’s perspective, nearly complete; and the actions are in substantially different procedural postures, including four with trial dates this year.”
The Panel pointed out that a prior denial of centralization does not preclude it from reaching a second motion, although this is done rarely and when a significant change in circumstances has occurred. After review of the record, the Panel found that there has been a significant change concerning the number of actions, districts, and counsel. The motion for centralization includes 113 pending actions in 17 districts and at least 37 potential tagalong actions, bringing the total number of involved districts to 20. The number of plaintiffs’ counsel involved also expanded and there now are at least 12 unaffiliated plaintiffs’ firms across various geographic locations. While Bayer continues to have national coordinating counsel, at least 20 firms are litigating the fundamental actions on the motion on its behalf. In the Panel’s judgment, the number of actions, districts, and plaintiffs’ and defense counsel make effective coordination on an informal basis impracticable.
The second motion for centralization includes 8 of the 15 actions before the Panel in 2014. The other actions then before the Panel were terminated in the past two years—two on summary judgment and five through voluntary dismissals.
Bayer’s plaintiff-specific causation issues do not appear to be an obstacle to centralization given the development of the litigation over the past two years, according to the Panel. While the Panel specifically expressed concern that individualized causation issues might predominate litigation, the records in the many actions that have been filed since show that discovery and pretrial motions concerning general causation have been, or will be, the focus of all actions. Specifically, is the hormonal component in Mirena capable of causing intracranial hypertension? The Panel believes that the existence of individualized causation issues will not negate the efficacy of centralization.
The record also shows that centralization is needed to facilitate the efficient conduct of common discovery. Discovery remains open in nearly actions, with most at a relatively early stage of discovery or still at the pleading stage. Bayer asserts that the longer pending proceedings have completed common discovery; however, plaintiffs strongly disagree. Most plaintiffs plan on seeking full discovery without being limited by prior discovery, which they claim was insufficient and have identified various significant common discovery issues to which they will seek a judicial resolution. Discovery in this litigation is expected to be complex.
While some actions are in an advanced procedural posture, the transferee judge has broad discretion to create a pretrial program that will consider for any significant differences among the actions and ensure duplicative activity is reduced or eliminated.
The Panel believea that the differing procedural postures may be efficiently managed within an MDL, with the exception of two actions that are trial-ready.
On the basis of the papers filed and the hearing session held, the Panel finds that the actions listed involve common questions of fact and centralization will be the best course for all involved parties and encourage the fair and efficient conduct of this litigation. The Panel indicated that, “These actions share factual questions arising out of allegations that the synthetic hormone released by Mirena causes abnormal elevation of cerebrospinal fluid in the skull, resulting in a neurological condition referred to as intracranial hypertension or pseudotumor cerebri, and that defendants did not adequately warn prescribing physicians or consumers of the alleged risk. Issues concerning general causation, the background science, and Mirena’s labeling and regulatory history with respect to the alleged injury will be common to all actions. Centralization will eliminate duplicative discovery, prevent inconsistent pretrial rulings on Daubert and other issues, and conserve the resources of the parties, their counsel, and the judiciary.”
The Panel also concluded that the Southern District of New York is an appropriate transferee district for this litigation given its proximity to Bayer’s corporate headquarters in New Jersey, where many of the common documents and witnesses are likely to be located. Centralization in this district also provide a geographically convenient forum for the nationwide litigation and that any potential overlap with the Mirena litigation involving perforation and migration injuries in MDL No. 2434 is efficiently managed. Judge Paul A. Engelmayer is an experienced transferee judge with the willingness and ability to manage this litigation. The Panel remains confident he will steer this litigation on a prudent course.
Mirena and Pseudotumor Cerebri Injuries
According to the Mayo Clinic, pseudotumor cerebri occurs when the intracranial pressure (pressure in the skull) increases for no obvious 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.
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. In some cases, surgery is necessary. The makers of Mirena are facing lawsuits involving allegations that they minimized the tie between Mirena and neurological side effects that include pseudotumor cerebri. Symptoms of this disorder may include:
- Back pain
- Blurred vision, double vision
- Neck pain
- Shoulder pain
- Tinnitus (buzzing, ringing in the ears)
- Vision loss
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 one of these Mirena Parties included phrases like “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, Health Canada indicated.
The highly experienced medical device attorneys at Parker Waichman LLP are investigating an association between Mirena IUD and a range of serious side effects, including uterine perforation and Breast Cancer.
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’s 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 right now 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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