Mirena IUD Can Cause Complications. Parker Waichman LLP continues to play a leading role in the Mirena IUD litigation, as new cases are being filed alleging a dangerous complication from the device known as pseudotumor cerebri. Our firm is still uncovering wrongdoing by the manufacturer, including significant deceptive advertising and misrepresentation related to the device. If you received a Mirena intrauterine implant and developed intracranial hypertension, contact our firm today to see if you might be eligible to file a lawsuit.
Bayer’s Misleading Ads
In pursuing claims for our Mirena clients, we are highlighting some of the deceptive information placed into the market by the manufacturer of the device, Bayer HealthCare Pharmaceuticals, Inc. In 2009, Bayer started running new direct-to-consumer advertising for Mirena. The corporation targeted younger women and pushed an ad campaign that told these women Mirena was the key to more freedom in their lives and improved intimacy with their partners. Specifically, the corporation sought an audience of “busy moms” through a consumer program called “Mom Central.”
The advertising stated that Mirena was a way to simplify women’s lifestyles “while still looking and feeling great” and a way to “help couples keep life simple!” In choosing Mirena, the ad said, women and mothers would have the freedom to not worry about contraception and could increase intimacy with their partners. By releasing them from the burden of remembering to take a pill every day, the ad stated, Mirena would help women who were “so overwhelmed by their schedules” turn intimacy back into a desire, rather than a “to-do.” It went on to imply Mirena allowed women to “feel better about approaching the romance in [their] lives” and stated that Mirena was a birth control method that allowed busy couples to have “spontaneous intimacy.”
Bayer continued this line of advertising in national commercials, heavily targeting young women who already had children and whose busy schedules supposedly made it difficult to remember to take a contraceptive pill. The advertising slogan for Mirena at this time was, “Keep life simple,” and the commercials’ narrator told women to “ask about Mirena. When you have time.”
All of these claims by Bayer were without supportive evidence and were designed to induce women to go to their doctors to ask for Mirena, thinking the device would change their lifestyles and their relationships. In reality, Mirena presented many dangerous risks to patients that Bayer either downplayed in its advertising or failed to warn about altogether.
In December 2009, the U.S. Food and Drug Administration (FDA) sent a warning letter to Bayer instructing it to discontinue and change some of its advertising for Mirena. The FDA concluded that Mirena was misbranded in violation of the Food, Drug, and Cosmetic Act (FDCA) because of Mirena marketing:
- Overstated the efficacy of Mirena;
- Presented unsubstantiated claims regarding Mirena;
- Minimized the risks of using Mirena; and
- Included false and misleading presentations regarding Mirena.
Specifically, the FDA said that it was “not aware of any evidence that suggests that women using Mirena for birth control experience an increase in reconnection, romance, or intimacy with their partners.” In fact, the FDA pointed out in its letter, clinical trials for Mirena indicated decreased libido was a potential side effect of the device.
In addition, the FDA wrote Bayer’s use of statements about women “looking and feeling great” minimized the “very common” side effects many women experienced from the device. The advertising also omitted important risks associated with Mirena, the FDA said, which violated the FDCA. The FDA instructed Bayer to immediately discontinue the advertising described and change all future advertising to comply with the FDCA.
Of important note, this was the FDA’s second letter to Bayer regarding Mirena advertising. In December 2008, the FDA sent a letter to Bayer stating it needed to include additional risk information in its advertising going forward. Bayer sent a response in January 2009 saying it would comply. Nevertheless, Bayer released marketing one month later that violated the FDA’s instructions and violated the FDCA. This conduct shows a clear disregard for federal regulations and patient safety.
Parker Waichman is helping women who fell victim to this misleading advertising and suffered Mirena injuries, including intracranial hypertension or pseudotumor cerebri (false brain tumor). If you believe you have a potential Mirena claim, contact our firm today. Our skilled attorneys will evaluate your claims to determine whether you can file a lawsuit against Bayer.
Parker Waichman LLP is Taking New Mirena Cases
In April 2017, a new multidistrict litigation for Mirena cases opened in the U.S. District Court for the Southern District of New York. Multidistrict litigation is consolidation in one federal court in many cases involving the same product. An MDL existed previously for specific types of Mirena cases, and this new MDL is reserved for cases in which plaintiffs experienced intracranial hypertension or pseudotumor cerebri from Mirena.
Both of these conditions refer to a fluid pressure buildup in the skull that manifests symptoms mimicking a brain tumor. Symptoms can include intense migraines, vision disturbances, ringing in the ears, nausea, and dizziness.
While many firms no longer handle Mirena cases, Parker Waichman is still taking new cases. We want to help as many women affected by this dangerous product as we possibly can, and we believe new research reveals the device is even more dangerous than we originally thought. Particularly in light of Bayer’s repeated predatory advertising in violation of the FDCA, we are going after the corporation to hold it accountable for our clients’ injuries.
We are offering free, confidential case consultations on all new Mirena claims, so contact our firm today. Time could be running to file your claim in the new MDL, and we can begin your case investigation immediately.
Call Us to Review Your Mirena IUD Injury Compensation Options
If you experienced complications from a Mirena IUD including intracranial hypertension or pseudotumor cerebri, contact Parker Waichman LLP today for your free case consultation by filling out our online form or by calling 1-800-YOURLAWYER (1-800-968-7529).