Mirena Intrauterine Device Causes Serious Health Complications.Hundreds of women filed claims against Bayer Pharma AG (Bayer) claiming that the company’s intrauterine device (IUD) called Mirena caused them to suffer substantial personal injuries as a result of defects in the manufacturing process, design, and a failure to warn about the possible side effects. Bayer has adamantly denied that it has done anything wrong at any stage of the design, manufacture, and marketing of its product. Courts will have the opportunity to decide whether Bayer is liable for the damages claimed by the women.
Parker Waichman LLP is a national plaintiff’s law firm whose products liability lawyers vigorously and zealously represent their clients who suffered injuries at the hands of pharmaceutical companies. Their products liability attorneys have vast experience bringing justice to people who were harmed through no fault of their own. To date, Parker Waichman has recovered over $2 billion for as compensation for the harm their clients experienced.
The Problems Caused by Mirena
Numerous women have sued Bayer for complications after they received the Mirena IUD. The plaintiffs allege that they experienced side effects after they used the IUD such as:
- Uterine perforation,
- Device migrations,
- Unwanted pregnancies,
- Hairloss,
- Extreme fatigue,
- Mood swings,
- Ectopic pregnancies (Embryos implanting outside of uterus),
- Sterilization,
- Hysterectomies, and
- Other painful surgeries.
The IUD was intended for younger women who have had one pregnancy. The device is implanted in the uterus and is designed to last for five years. Mirena releases a hormone called levonorgestrel that reduces the likelihood of the wearer becoming pregnant. A medical professional must insert the device into the uterus. A physician may perform the procedure on an outpatient basis, with or without anesthesia. Bayer provides the instructions on insertion in the packaging that accompanies the IUD.
Thedevice, which bears a resemblance to an anchor, has a thread attached to the end. The IUD measures 1.26 inches long and 1.26 inches across. The filaments may be accessed by the wearer to determine whether the IUD has shifted or moved. The threads also assist with device removal.
Bayer included comprehensive documentation and literature with its product. Bayer had updated the documentation four times since 2000 when the U.S. Food and Drug Administration (FDA) approved the device for prescription use. Mirena’s literature includes a section about therisk of a specific injury called “perforation.” Perforation, in this context, refers to the device entering the uterine wall and becoming embedded in the uterine wall or cervix. Bayer noted that the risk of perforation increased if the woman was lactating or was within the postpartum period.
The danger of perforation, aside from the device not properly working, is that it can pass through the uterine wall and become lodged outside of the patient’s reproductive system. Thisphenomenonis called migration. Bayer warned that migration is possible if an IUD perforates the uterine wall but is not discovered for some time after that. Bayer counsels that women should feel for the threads every month to confirm that the device is where it should be. The patient must contact her physician immediately if she cannot confirm the location of the device through manual examination.
Bayer included additional warnings in the literature described as a “Patient Information Booklet.” Bayer warned about the side effects of migration and perforation in the booklet. However, Bayer fails to state a timeline as to when either of these problems might occur. Bayer, unlike a competitor marketing a similar product, did not include a warning that “spontaneous migration” might occur.
Some of the plaintiffs who have filed lawsuits against Bayer acknowledge that they received the pamphlets. Additionally, some plaintiff agrees that they were appropriately warned about perforation during insertion. The plaintiffs allege that Bayer and their doctors failed to warn them about secondary perforation, or perforation at some time after introduction.Bayer denies secondary perforationcould even occur. Instead, Bayer claims that perforation can only happen during insertion, but that detection might come at a later time.
Bayer defends its actions, or inaction, by citing a study performed within the last two years in Europe as conclusive proof Mirena is safe. Bayer funded the study, which is a common practice in the pharmaceutical field. Notwithstanding that glaring conflict of interest, an independent group of researchers allegedly presided over the trials. The independent panel was charged with ensuring that the research was conducted with scientific precision of the tests and approved all literature upon which the researchers relied during the trials. The researchers concluded that no statistically significant threat existed for an IUD to perforate the uterine wall post-insertion. One might expect that would be the case when Bayer sponsored the study.
In addition to the question of whether the study conducted by Bayer is significant, the plaintiffs’ and the defense’s experts disagreed on the appropriate imagining required to determine whether the IUD perforated the uterus or migrated away from it. Bayer argued that the standard two-dimensional (2-D) ultrasound is insufficiently detailed and precise to diagnose whether the device remained in place. By contrast, Bayer claims that a three-dimensional (3D) ultrasound is the only method available to accurately determine whether the IUD is in place or has perforated the uterine wall.
The plaintiffs argued that Bayer’s literature indicates that 2D ultrasound is sufficient. In fact, Bayer suggests an ultrasound to confirm its position shortly after insertion. But, Bayer contends that the patients received the wrong test, and therefore diagnosis was delayed, therebycompounding the problem.
Bayer’s own actions compounded the problem. The company was so pleased with its perceived success with Mirena it created a social network with the intent to market its product to as many women as possible. Bayer even went so far as to hold Mirena parties where women could discuss the benefits of the device with their friends. The FDA instructed Bayer to cease and desist with this phase of its marketing program.
Current State of Litigation
Over 1,300 cases were filed across the United States. The courts did not consolidate them into a class action. However, the U.S. federal court for the Southern District of New York consolidated the cases in multi-district litigation. The lawyers for each side selected cases they believed were representative of the whole group of cases for litigation. Essentially the other cases would be bound by the decision made in these representative cases.
The plaintiffs lost the cases at the trial court level as well as on appeal. That reached the end of these types of cases — for now. New evidence and new studies could change the complexion of the landscape for Bayer. There is nothing imminent on the horizon, but women must be aware of the potential dangers Mirena and other IUDs might cause.
Drug companies always have the duty to warn their customers about the possible side effects of taking their drugs or using their medical devices. Those huge companies also bear the responsibility to label their medications correctly and not make promises it cannot keep. Additionally, they have the responsibility to design and manufacture their goods carefully, so they do not cause any harm to their customers.
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