On April 8, 2013, after a number of complaints were filed, the United States Judicial Panel on Multidistrict Litigation determined that federal suits against Bayer AG for their Mirena IUD should be consolidated into the Southern District of New York for the pre-trial proceedings. The order came nearly three months after plaintiffs had petitioned consolidation in the Northern District of Ohio.
Bayer AG produces the IUD device, and, in recent years, thousands of women have alleged that Mirena caused them serious harm, some of which is likely to be irreversible. Numerous lawsuits have been filed, largely stemming from the manner in which Mirena was advertised and the harm caused by the device.
The Elements of Litigation
Mirena is an intrauterine contraceptive device (IUD) that is implanted directly into the uterus to prevent pregnancy and limit menstrual bleeding. The FDA officially approved Mirena for sale in 2000. Mirena works by releasing the synthetic hormone levonorgestrel, which is used in a number of oral contraceptives.
While marketing the drug, Bayer sponsored “Mirena Parties,” where a nurse would make a scripted presentation on the benefits of using Mirena. Bayer asserted that the IUD required no routine, but some participants allege that the manufacturer did not elaborate on the different risks associated with its use. Following the “parties,” in 2009, the FDA sent a warning letter to Bayer, stating that they were misrepresenting the issues with Mirena and needed to modify their advertising and presentations. Additionally, in 2012, a study found that nearly half of doctors were not informed of the risks associated with Mirena.
Harm from Mirena occurs when the device perforates the uterus, embeds itself in the uterus, or travels outside the uterus. Once the device is out of its normal positioning, a number of health concerns need to be accounted for. Some examples of documented harm include:
- Severe cramping
- Pelvic inflammatory disease
- Ectopic pregnancy
- Ovarian cysts
Another possible risk, which claimants insist was not properly presented to them, is infertility. Generally, infertility is difficult to quantify. While common law does provide some metrics, claims arising from new medical devices have different variables that juries use in the calculation of damages. If this issue becomes a specific point that factors into the calculation of damages, the damage awards are likely to be much higher. Therefore, finding an appropriate expert to speak to both the psychological and physical effects of being infertile is critical to finding the appropriate measurement of a plaintiff’s award.
Current Events 2013
In February 2013, a group of plaintiffs who claimed that they were harmed by Mirena requested that their cases be consolidated and removed to multi-district court in Ohio. The subsequent removal to the Southern District of New York is beneficial to plaintiffs. Legal analysts suggest that this action is an acknowledgment of the merits of the plaintiffs’ cases, and such a removal removes any home-field advantage that Bayer would have in specific state courts.
This issue of home-field advantage came up in August 2012, when Bayer attempted to consolidate all New Jersey state claims into one court in the state. The measure failed, but when the plaintiffs tried to consolidate all federal claims in New Jersey, Bayer issued a statement that they did not support consolidation. They argued that there were factual differences in the cases, specifically regarding alleged injuries, which were not similar enough to merit consolidation. This argument, however, was conspicuously absent when Bayer was arguing for consolidation of state cases.
The results of the removal proceeding will be an important step in the cases of the potential plaintiffs. With the denial in New Jersey, allowing the action in New York will help Mirena users gain traction in collectively litigating their claims. With over two million women using the product, and around 6% of women requiring medical treatment for issues associated with the use of Mirena, the potential pool for a mass tort action is quite large. The positive ruling to consolidate the claims may inspire other women who feel that they have been harmed by Mirena to sue Bayer.
How Can the Experts Weigh In?
In most cases, an expert witness in Obstetrics and Gynecology (Ob/Gyn), familiar with Mirena, is essential to describe explaining the specifics of the device and any subsequent treatment. Also, given the allegations of improper warnings, a medical device labeling expert, in addition to a nursing expert, may be important to describe the proper procedures and explanations of warning for devices like Mirena. Measuring harm, and specifically becoming infertile, however, may require economic damage experts, and experts in mental health, to describe the full effect that the device had on the plaintiff’s life. When painting a full picture of the plaintiff’s experience with Mirena, the jury is able to better understand the impact of the device, and award damages accordingly.