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Birth Control Injury Report

Nolan Law Group Video Report: Mirena IUD Complications

Several lawsuits have been filed against Bayer for the serious medical, physical and emotional problems resulting from use of Mirena. The lawsuits also specify Bayer knew of the risks and failed to disclose the dangers associated with using the IUD. Bayer is also accused of using deceptive marketing practices in advertising Mirena to the public. The FDA did issue a warning to Bayer for deceiving advertising practices; however, Mirena is still on the market today and available for use.

Mirena IUD Complications

The FDA did issue a warning to Bayer for deceiving advertising practices; however, Mirena is still on the market today and available for use.

Frequently Asked Questions About the Mirena Lawsuits

What is Mirena?
Mirena is one form of a long-acting birth control called an intrauterine device (IUD). The IUD is globally the most popular form of birth control with an estimated 150 million uses. Mirena must be inserted by a medical provider. The system includes a T-shaped body made from plastic and a cylinder-shaped steroid reservoir. Mirena works by slowly releasing levonorgestrel, the progestin hormone, into the uterus each day. Because Mirena thins the lining of the uterus, it also decreases menstrual bleeding.

Why are women suing Bayer Pharmaceuticals?
Bayer Pharmaceuticals is the manufacturer of Mirena. There have been more than 45,000 incidents of complications submitted by women who have used Mirena, according to AdverseEvents.com, and currently over 40 lawsuits have been filed against the drug manufacturer for serious medical concerns following or during usage of the IUD.

What kind of injuries and problems are women suffering while using Mirena?
Women across the country have complained of the following issues: abscesses, embedment of the IUD in the uterine wall, uterine perforations, infertility, infection, intestinal perforations or obstruction, Pelvic Inflammatory Disease (PID) and ectopic pregnancy. Other less severe, but still inhibiting side effects, are: acne, weight change, nausea, mood changes, breast tenderness, vaginal discharge and abnormal bleeding patterns.

What are the lawsuits alleging?
The lawsuits against Bayer regarding Mirena allege a variety of serious medical problems following or during usage of the IUD. The most common claims in the lawsuits allege migration of the IUD to other parts of the body and perforation of the uterus. A small number of claims filed contend women have suffered severe scarring, hospitalization and extended medical care.  Claims have also been filed by girls and women who have suffered some of the complications mentioned above, including ectopic pregnancy, fertility problems and infections requiring extreme medical care. Additionally, some of the suits are asserting that Bayer knowingly released a defective drug and failed to warn doctors and women about the potential risks.

I suffered health consequences following use of Mirena. What should I do if I am interested in pursuing a lawsuit?
The team of nationally and internationally recognized trial lawyers at Nolan Law Firm are currently evaluating Mirena IUD cases. We will take special care to work with you and your individual needs while seeking full and fair compensation through the legal system. Please Contact Us or call 312-630-4000 for questions or to share your story with one of our team.

What type of damages might I receive in a lawsuit?
Depending on your complaint, you may be eligible to receive compensation for medical costs, lost wages, pain and suffering, impaired quality of life and other damages. Once we hear your individual story, we can help you receive the help you deserve and need.

How a Drug gets Approved by the FDA

There have been more than 45,000 incidents of complications submitted by women who have used Bayer Pharmaceutical’s intrauterine birth control device (IUD) Mirena, according to AdverseEvents.com. Additionally, over 40 lawsuits have been lodged against Bayer alleging severe health consequences after using the IUD. These staggering numbers lead many to question how a drug that has caused everything from surgeries to infertility can be approved for use.

According to Wikipedia, President Theodore Roosevelt signed the Food and Drug Act into law in 1906. This act was the basis for the Food, Drug, and Insecticide organization, shortened to the Food and Drug Administration (FDA) a few years later. Since 1938, every new drug has been required to be approved by the FDA before U.S. commercialization.  The FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy and safety.

Mirena was approved by the Food and Drug Administration (FDA) in 2000 and is one of only three IUD’s approved for use in the United States. In 2009, the FDA expanded Mirena’s approval to treat heavy menstrual bleeding in women already using an IUD. According to the FDA’s website (fda.gov), the mission of FDA’s Center for Drug Evaluation and Research (CDER) is to ensure that drugs marketed in the United States are safe and effective. CDER does not test drugs, although the Center’s Office of Testing and Research does conduct limited research in the areas of drug quality, safety and effectiveness.
When a company wants to introduce a new drug into the market, it must submit a New Drug Application (NDA). It is the company’s responsibility to test the drug and submit evidence that it is safe and effective. A team of CDER physicians, statisticians, chemists, pharmacologists and other scientists reviews the sponsor’s NDA containing the data and proposed labeling. The documentation required in an NDA is supposed to tell the drug’s whole story, including what happened during the clinical tests, what the ingredients of the drug are, the results of the animal studies, how the drug behaves in the body and how it is manufactured, processed and packaged.

Despite this lengthy, time-consuming and expensive process, thousands of women have suffered severe medical problems while or after using Mirena. Women across the country have complained of the following issues:

  • Abscesses
  • Embedment of the IUD in the uterine wall
  • Uterine perforations
  • Infertility
  • Infection
  • Intestinal perforations or obstruction
  • Pelvic Inflammatory Disease
  • Ectopic Pregnancy

There is help if you or someone you know has suffered any harmful side effects following Mirena usage. The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena,  please Contact Us or call 312-630-4000.

A look into the Mirena lawsuits

Kelli Baugh was a typical South Carolina woman seeking birth control. Now that 20-something year old women has had a total hysterectomy, is in surgically-induced menopause and must take estrogen daily. All this because the intrauterine device (IUD) she choose to use, Mirena, migrated from her uterus, causing physical pain and the above mentioned issues.

Baugh and her husband are suing Bayer Pharmaceuticals, the maker of Mirena, alleging that the design of the Mirena IUD allows for easy migration of the device through the uterine lining. Baugh’s trial was set to begin May 6 in South Carolina and would have been the first Mirena trial in the country. Now, over 40 lawsuits regarding complications associated with the Mirena device have been filed in the United States, leading to the consolidation of all of the lawsuits, including Baugh’s, into one trial.

In another Mirena lawsuit, one of the plaintiffs, a Missouri woman, experienced no side effects after the initial implantation. Approximately one year later, she began experiencing severe cramping.  A visit to the emergency room and an ultrasound revealed that the Mirena IUD had perforated her uterine wall, leading to surgery for its removal.  Bayer did provide warnings that the device could perforate the uterus upon insertion but not after implantation for a long period of time.

Another lawsuit involves a young woman whose Mirena IUD had migrated within her body.  Her health care providers were unable to locate the IUD after its migration, and assumed that it had fallen out. Unfortunately, it had not fallen out but remained in her body for years. It was not located until she began experiencing abdominal cramping when she was 12 weeks pregnant, which required a very high risk surgery to remove the IUD.

Infertility as a result of uterine perforation is also a possibility. One woman became pregnant shortly after she underwent surgery to remove a Mirena IUD that had perforated her uterine wall. She subsequently suffered a miscarriage and now may be infertile. 

Complaints listed in the lawsuits vary, but some of the most serious health issues associated with Mirena include migration of the device from the uterus, device expulsion, pregnancy complications if a woman becomes pregnant while the IUD is inserted, ectopic pregnancy (an egg becomes fertilized outside the uterus) and pelvic inflammatory disease (PID). PID can cause infertility. Other less severe, but still inhibiting side effects, are: acne, weight change, nausea, mood changes, breast tenderness, vaginal discharge and abnormal bleeding patterns.

Additionally, several of the lawsuits claim Bayer knew of the risks and failed to disclose the dangers associated with using the IUD. Bayer is also accused of using deceptive marketing practices in advertising Mirena to the public. The FDA did issue a warning to Bayer for deceiving advertising practices.

The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena,  please Contact Us or call 312-630-4000.

Is Mirena the Next Dalkon Shield?

Mirena, a long-acting birth control called an intrauterine device (IUD) which has been responsible for over 47,000 reports of serious adverse events on adverseevents.com as well as over 40 lawsuits filed against the drug manufacturer for serious problems resulting from the device, is not the first IUD that has caused severe side effects in women.

In the 1970s, A.H. Robins Company sold an estimated 2.5 million Dalkon Shields, the first popular IUD on the market. The Dalkon Shield killed 17 and caused physical injury, miscarriages, infection and hysterectomies to over 200,000 women. The product was pulled from the market just three years later, but not before over 300,000 women filed lawsuits against the company. The largest settlement amounted to $2.2 million. A.H. Robins filed for bankruptcy in 1985 and is still engaged in legal arguments over whether the $1.75 billion it proposes as a compensatory fund to women who claim to have been injured by the shield is anywhere near enough.

Both pharmaceutical companies have been faulted for their marketing campaigns. Mirena was marketed by maker Bayer Pharmaceuticals to busy moms while Dalkon Shield was promoted as a birth control for teenagers in college and the underprivileged as a highly effective, inexpensive and non-intrusive birth control. Bayer received an official warning from the Food and Drug Administration (FDA) for overstating the effectiveness of Mirena, while minimizing the risks associated with it during its marketing campaign. A.H. Robins, through its “Designed for Greater Comfort” marketing campaign, allegedly promoted a device with an ill-designed removal string that caused bacteria in the uterus, often causing Pelvic Inflammatory Disease (PID) and sepsis (blood poisoning) which, when untreated, can cause infertility and death. Lawsuits claimed A.H. Robins knew about the poor design when it purchased the rights to the device.

There are some similarities between medical complications associated to Mirena and Dalkon Shield. However, Mirena could prove to be more dangerous in the end as most of the complaints revolve around the device spontaneously migrating or expelling from the body. Device migration is serious in that it has been shown to puncture the uterus and surrounding organs, sometimes requiring surgery and even causing infertility.  

Though it has been 40 years since the Dalkon Shield was pulled from the market, the similarities between that device and Mirena is shocking. While there are only just over 40 lawsuits currently pending against Bayer Pharmaceuticals related to Mirena, the number of lawsuits could grow to the level of Dalkon Shield given that the Mirena IUD is used by two million women in the United States and 15 million worldwide. 

The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena,  please Contact Us or call 312-630-4000.

Mirena Lawsuits Will Be Consolidated

Women across the country who have suffered side effects from the intrauterine device (IUD) birch control Mirena are celebrating as a panel has ruled most federally-filed Mirena lawsuits should be consolidated. On April 8, the United States Judicial Panel (USJP) on Multidistrict Litigation (MDL) signed a transfer order, centralizing cases in the Mirena MDL to the United States District Court for the Southern District of New York.

Specifically, the panel said lawsuits alleging the spontaneous migration of the device, perforation of the uterus, and/or the inadequacy of the warnings issued by Bayer with regard to these risks, will now be heard in the Southern District of New York. Some suits claim Bayer knowingly released a defective drug and failed to warn doctors and women about the potential risks. Over 40 lawsuits have been filed in 17 federal jurisdictions against Bayer Pharmaceuticals, the makers of Mirena. The first trial was scheduled to begin in May in South Carolina.

Mirena was approved by the Food and Drug Administration (FDA) in 2000 and is one of only three IUD’s approved for use in the United States. The small, plastic T-shaped device is inserted into the uterus by a healthcare provider, where it may remain for up to 5 years, releasing a low-dose of the synthetic progestin, levonorgestrel.

In the transfer order signed by Acting MDL Chairman Kathryn H. Vratil, the USJP noted that: “Transfer under [28 U.S.C.] Section 1407 will offer the benefit of placing all related actions before a single judge who can structure pretrial proceedings to accommodate all parties’ legitimate discovery needs while ensuring that common witnesses are not subjected to duplicative discovery demands.” The panel designated Judge Cathy Seibel to oversee the cases.

Bayer had opposed the consolidation of cases, stating that the consolidation would counteract the preparation and financial advancement the company had already invested in preparing for the first case in South Carolina. In addition, the company’s attorneys stated that consolidation would allow for weaker cases to be considered. Plaintiff’s lawyers have argued that consolidation would be more efficient as well as allow plaintiffs to share costs for pretrial preparations, costs they might not otherwise be able to afford.

Court documents also indicate that at least 47 Mirena lawsuits are also pending in New Jersey Superior Court. In August 2012, Bayer filed an application with the New Jersey Supreme Court seeking the establishment of a consolidated litigation for all Mirena IUD lawsuits filed in the state in Middlesex County. While the request was rejected, plaintiffs in those claims recently filed a new application with the court asking it to reconsider.

According to an AdverseEvents.com report, there have been more than 45,000 incidences of Mirena IUD complications submitted by women (not all of these women have filed lawsuits) who suffered issues such as:

  • Abscesses
  • Embedment in the uterine wall
  • Uterine perforations
  • Infertility
  • Infection
  • Intestinal perforations or obstruction
  • Pelvic Inflammatory Disease
  • Ectopic Pregnancy

The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena,  please Contact Us or call 312-630-4000.

New Bayer IUD Approved Despite Mirena Lawsuits

Despite lawsuits piling up against Bayer Pharmaceutical by women who have experienced serious side effects from using the company’s birth control intrauterine device (IUD), Mirena, the Food and Drug Administration (FDA) recently approved another IUD made by Bayer.

In January, the FDA approved Skyla, a low-dose hormone IUD designed to prevent pregnancy and manufactured by Bayer. Skyla is the first IUD approved for usage in the United States in 12 years. Skyla was launched for usage in the U.S. in February. Mirena was approved by the FDA in 2000.

Mirena and Skyla are similar products, both T-shaped polyethylene devices that release diminishing amounts of progestin over time to prevent pregnancy. The main difference is that Mirena is designed to remain inserted in a woman’s uterus for five years, while Skyla is approved for only three years. Also, Bayer is marketing Skyla toward younger women who have not had children previously; Mirena is marketed toward moms.

The FDA approval comes as over 40 lawsuits are pending against Bayer from women across the United States who have suffered serious problems during usage of Mirena. Most of the lawsuits claim the device migrated from the uterus, sometimes perforating other organs or the uterus itself. These injuries caused major health problems and sometimes required surgery, according to the lawsuits. Women have also complained of ectopic pregnancies, pelvic inflammatory disease (PID) and even infertility following usage of Mirena.

The Mirena lawsuits also claim Bayer’s lavish marketing plan for Mirena, entitled “Simple Style,” failed to adequately warn women about the possibility of spontaneous device migration or expulsion. The tactical marketing plan received much attention from the FDA in 2009 after it was found that many of the statements in the program were found to be more flashy than truthful. The FDA issued an official warning to Bayer, saying the manufacturer tended to downplay the possible side effects of the IUD in the marketing program.

Skyla seems to be more of the same for Bayer. Side effects for the new IUD include: bleeding pattern alterations, vulvovaginitis, abdominal/pelvic pain, acne/seborrhea, ovarian cyst and headache. In addition, there is a warning on the website www.skyla-us.com, a site designed by Bayer for marketing Skyla, that the new IUD may attach to or go through the uterus and cause other problems. It also states pregnancy while using Skyla is uncommon but can be life-threatening and may result in loss of pregnancy or fertility. Ovarian cysts could occur but usually disappear, it says.

If you or someone you know has suffered problems while using Mirena, there is help available. The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena,  please Contact Us or call 312-630-4000.

First Mirena Lawsuit Scheduled to Begin in May

A decision about whether or not to consolidate the over 40 lawsuits lodged against Bayer Pharmaceuticals  by women who have had serious problems with the company’s intrauterine birth control device (IUD) Mirena has yet to be made even as the first trial against the pharmaceutical giant is scheduled to begin in only a month.

The first Mirena trial is scheduled for May in the U.S. District Court for the District of South Carolina. The claim, one of the first Mirena lawsuits to be filed in the nation, alleges the plaintiff was never adequately warned that spontaneous migration following insertion of the device was a possible Mirena complication.

Women across the country have filed claims against the German-based company, alleging the makers of the birth control failed to adequately warn that the device could spontaneously migrate to other parts of the body and perforate a woman’s uterus. Mirena was approved by the Food and Drug Administration (FDA) in 2000 and is one of only two IUD’s approved for use in the United States.

Bayer is trying to have the lawsuit dismissed under South Carolina’s “learned intermediary doctrine,” and claims the patient’s doctor was aware of the risk of spontaneous Mirena migration.  The learned intermediary doctrine requires the plaintiff to prove Bayer’s warning to her physician was inadequate and that a different warning would have deterred the doctor from prescribing Mirena.

Bayer’s motion claims her doctor testified that the risk of IUD migration and perforation was known to her for 20 years, and that the plaintiff is unable to prove that Bayer’s failure to warn was a proximate cause of the alleged injuries. The plaintiff counters that Bayer’s warnings that accompany the Mirena IUD include a caution against perforation at the time the device is inserted.  But the plaintiff alleges she sustained her injuries as a result of Mirena migration that occurred well after insertion.

Bayer is opposing consolidation of the cases filed across the country on the grounds that it has extensively prepared for the trial in South Carolina, including production of 1.7 million pages of relevant documents. Bayer argues consolidating the cases would counteract the work and financial investment they already have made in defending this case. Bayer also said it wants the South Carolina trial to begin on time so it can prove that its warnings about the risk of uterine perforation were adequate. A consolidation could delay any proceedings for quite some time.

Plaintiffs who have filed claims against Bayer are seeking the consolidation, claiming it will be more efficient and plaintiffs can share costs for pretrial preparations, costs they might not otherwise be able to afford.

Women have complained of numerous side effects following or during usage of Mirena. The majority of the lawsuits claim migration of the IUD, perforation of the uterus or other organs and expulsion of the device. Some of these problems have caused major issues, including fertility problems and surgeries.

Women have complained of the following side effects in regards to Mirena:

  • Uterine perforations
  • Ectopic pregnancy (a pregnancy in which the fetus grows outside the uterus)
  • Intrauterine pregnancy (a pregnancy with Mirena in place)
  • Group A streptococcal sepsis
  • Pelvic inflammatory disease (PID)
  • Embedment of the device in the uterine wall
  • Perforation of the uterine wall or cervix
  • Infertility, abscesses, erosion of adjacent areas such as the vagina

Women are continuing to experience problems with Mirena. The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena,  please Contact Us or call 312-630-4000.

Makers of Mirena oppose efforts to consolidate lawsuits

Lawyers for Bayer Pharmaceuticals argued against consolidating into one court the over 40 lawsuits lodged against the company by women who have had serious health problems after using the company’s intrauterine birth control device (IUD) Mirena.

Women across the country have filed numerous claims against the German-based company, alleging the makers of the birth control failed to adequately warn that the device could spontaneously migrate to other parts of the body and perforate a woman’s uterus. Mirena was approved by the Food and Drug Administration (FDA) in 2000 and is one of only two IUD’s approved for use in the United States.

At a hearing on Thursday, March 21st before the Judicial Panel on Multidistrict Litigation (MDL) in San Diego California, plaintiffs attorneys argued that the cases should all be consolidated for efficiency’s sake in front of one judge. Bayer’s lawyer’s (Shook, Hardy & Bacon) argued that consolidating the cases would not create efficiency and would, in fact, slow the entire litigation process.

Attroneys represeting clients who have been injured using Mirena believe that by consolidating pretrial preparations potential plaintiffs could share costs that they otherwise couldn’t afford alone. One firm has evaluated over 800 potential claims in recent months, and selected the strongest cases involving uterine perforation and migration. They have asked the panel to centralize the cases in the U.S. District Court for the Northern District of Ohio in Cleveland.

Bayer stated in its brief filed with the panel that the formation of a MDL would incentivize the plaintiffs to file more suits than have already been brought forth. “The creation of an MDL would potentially make it easy for plaintiffs’ counsel to overlook the flaws in any individual case, leading to the filing of cases that they would not have filed, but for the existence of an MDL. This could inundate a defendant with hundreds or thousands of cases, thereby forcing settlement for business rather than legal reasons.”

Whether a MDL will be formed has yet to be decided although the judicial panel charged with making such a decision has recently become less receptive to centralize product liability litigation. In August 2012, the Judicial Panel refused to centralize four lawsuits against Intuitive Surgical Inc over the company’s DaVinci Robotic Surgical System, even though, in that case, both the plaintiffs and defendants agreed to the multidistrict proceeding.

It has become increasingly common for defendants to oppose the formation of MDL proceedings. Defendants see this as a tool to expand litigations and pressure companies into settling, according to lawyers who represent both plaintiffs and defendants in product liability lawsuits.

“Women who have suffered complications from Mirena usage, including migration of the device or perforation of the uterus, should not be discouraged by Bayer’s motion against a multidistrict litigation. This birth control device can cause serious health problems, and Bayer arguing against this litigation does not take away from the merit of a case. Anyone injured using this product  should seek appropriate legal counsel ,” said Don Nolan of Nolan Law Group.

The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena, please Contact Us or call 312-630-4000.

Lawsuits continue to mount against makers of IUD Mirena

Bayer Pharmaceutical’s long-acting birth control Mirena continues to be one of the most central figures in contraceptive legislation. An intrauterine device (IUD), Mirena is the subject of lawsuits across the country claiming personal injuries and emotional distress. Cases are piling up against the drug company, with some experts predicting claims could number into the hundreds, even thousands.

According to an AdverseEvents.com report, there have been more than 45,000 incidences of Mirena IUD complications submitted by women (not all of these women have filed lawsuits) who suffered issues such as:

  • Abscesses
  • Embedment in the uterine wall
  • Uterine perforations
  • Infertility
  • Infection
  • Intestinal perforations or obstruction
  • Pelvic Inflammatory Disease
  • Ectopic Pregnancy

Girls and women across the United States are suing Bayer, claiming a variety of complications and side effects from Mirena usage. The lawsuits feature claims of problems occurring immediately following insertion to issues after long-term usage. Mirena is deemed a long-term birth control, meaning it is marketed to be safe for use for up to five years.

These lawsuits include claims alleging migration of the IUD to other parts of the body and perforation of the uterus. When the IUD migrates spontaneously, it can perforate the uterus and enter the abdominal cavity, pelvis, bladder or blood vessels. This can cause pain, infection and damage to other nearby organs. Surgery is often required. A small number of claims filed contend women have suffered severe scarring, hospitalization and extended medical care.

Claims have also been filed by girls and women who have suffered some of the complications mentioned above, including ectopic pregnancy, fertility problems and infections requiring extreme medical care.

In addition, women in some of the lawsuits are asserting that Bayer knowingly released a defective drug and failed to warn doctors and women about the potential risks. Bayer’s marketing campaign of Mirena, entitled “Simple Style” received a lot of attention, and even an official warning, from the Food and Drug Administration (FDA). The FDA said in the warning in 2009 that Bayer overstated the effectiveness of Mirena, and minimized the risks associated with it during its marketing campaign.

Bayer is no stranger to contraception-related lawsuits. The company has already been involved in thousands of lawsuits in birth control related cases involving their hormonal contraceptives Yaz, Yasmin and their generic equivalents. There are over 6,000 individual Yaz and Yasmin cases filed, which has been consolidated into one single multidistrict legislation. In January 2011, Bayer indicated it had no intention of settling with the Yaz and Yasmin prosecutors.  

Mirena was approved by the (FDA) in 2000 and is one of only two IUD’s approved for use in the United States. Despite the risks associated with IUD’s, it is globally the most popular form of birth control with an estimated 150 million users.

New lawsuits continue to be filed across the country. If you have suffered any complications during or following usage of Mirena, there is help. The lawyers at Nolan Law Group are currently evaluating Mirena IUD cases. If you or someone you know has suffered an injury after using Mirena,  please Contact Us or call 312-630-4000.

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