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Nolan Law Group Files Lawsuit Stemming From National Airlines Crash in Afghanistan

Nolan Law Group has filed a wrongful death lawsuit on behalf of the families of six crewmembers who died aboard National Airlines Flight 662 when it crashed into a mountain outside Kabul, Afghanistan on October 12, 2010.

The Lockheed Model L-100-20 (L-382E) airplane was operated under contracts with National Air Cargo, Inc. and Transafrik International Limited, among others, as National Airlines Flight 662, enroute from Bagram Air Base to Kabul International Airport.

In its Complaint, the Nolan Law Group alleged that National Air Cargo, Inc. and others were negligent and careless in procuring and providing an aircraft for use in commerce that was not airworthy or in a safe condition. It was likewise alleged that the said aircraft’s terrain avoidance warning system was inoperative, the autopilot was unserviceable and the traffic collision avoidance system was inoperative in flight, among others. Furthermore, the lawsuit included a claim against the entity providing the air traffic control services in the airspace near and around Kabul International Airport, for negligence and failure to provide the aircraft command with adequate warning and necessary instructions to keep a safe and proper separation between the aircraft and the surrounding terrain. This case is currently pending with the District Court of New York.

Earlier, Nolan Law Group has filed wrongful death claims on behalf families of victims who were killed in a Russian Mi-8 Hip helicopter under contract to NATO, which crashed in Kandahar Air Field in the Southern Afghanistan on July 19, 2009, killing 16 passengers and wounding five. The lawsuit was filed against the victims’ subcontracting employer who failed to exercise reasonable care and was negligent in ensuring that the chartering company whose services it procured was aware of the safety standards applicable to performance under the subcontract. This case was later settled by the parties.

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.

Even Doctors May Be Clueless About Realities of IUDs Like Mirena

A new study shows the shocking unknowns about long-acting birth control products called intrauterine devices (IUD’s), like Mirena, even amongst the doctors who are prescribing these drugs. Claire Brindis, a director of the Bixby Center for Global Reproductive Health at the University of California, San Francisco, and her colleagues reviewed information from 273 health practitioners (including doctors, nurses, doctor’s assistants and certified nurse midwives).

Brindis and her team specifically took a look at surveys from 2010 and 2012 when family planning agencies had pushed to increase education about IUD’s among health care providers in Iowa and Colorado, where the survey occurred. This study was presented at the American Public Health Association meeting in San Francisco. It was conducted in collaboration with Ashley Philliber and colleagues at Philliber Research Associates, an independent research and evaluation firm in Accord, N.Y.

Only half of the providers interviewed in the study said they considered IUD drugs like Mirena safe and reliable for preventing pregnancy in women who just had babies. In addition, 30 percent of respondents said these IUD’s were not safe for women who recently had abortions. Both of these views conflict with new recommendations from the American College of Obstetrics and Gynecology, which said last year that almost all women, including those who have recently had a baby or abortion, can safely receive IUD’s.

Moreover, the study showed that health care providers at family planning clinics are likely more informed about IUD use than the average doctor. Therefore, the misconceptions among doctors in general could be even more widespread, said Brindis.

This study shows doctors prescribing IUD’s like Mirena don’t know the facts about who can safely use these types of birth control. Does this mean that doctors also don’t know the possible severe and traumatic side effects associated with Mirena? Does this mean that women areunknowingly using this long-term birth control device that could spontaneously migrate or expel from the body, cause pelvic inflammatory disease (PID) or even infertility? Or are flashy marketing campaigns and slogans by Bayer Pharmaceuticals, the manufacturer of Mirena, leading to the influence of doctors?

No matter what the cause of the misinformation, women need to be aware of possible side effects when using Mirena. These serious side effects may include:

• 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 suffering from these side effects have already spurred several lawsuits against the makers of Mirena. The pending lawsuits allege women who used Mirena suffered serious and permanent physical injuries, including sexual issues. The plaintiffs also claim that Bayer misrepresented the drug in its marketing campaign and never failed to divulge the harmful side effects.

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.

Women Experience Serious Side Effects While Using Mirena

Most prescription, and even over-the-counter medications, come with a list of warnings about possible side effects. The side effects for women who have used the hormonal intrauterine device (IUD) birth control Mirena are often extremely serious and can even cause lasting or permanent harm, including infertility. One of the most severe consequences is migration of the device, which is explained extensively in this blog post. Women have also experienced other debilitating unforeseen side effects while using Mirena.

Many women have experienced migration of the IUD out of the uterus, but others have also had the device spontaneously expelled from their body. If a woman does not realize that the device has been expelled, she is then left inadvertently unprotected from a pregnancy. According to drugwatch.com, spontaneous expulsion occurs in 6 percent of women and is more likely in women who have never given birth. Symptoms of this side effect include cramping, bleeding or spotting, pain during sexual intercourse and lengthened or absent device strings. (At the end of the vertical piece of the IUD, there is a small loop with attached polyethlyne strings that are used to remove the device. They can also be used to ensure the device is still in place.)

There is a chance that a woman can become pregnant even when Mirena remains in place. This occurrence can cause serious issues for the pregnancy and the woman. Therefore, doctors usually recommend removing the zygote (fertilized egg) immediately. Otherwise the woman may experience a septic abortion, a condition in which the uterus becomes septic, endangering both the woman and the pregnancy. Becoming pregnant while on Mirena can also cause miscarriage and a premature delivery.

Half of the women who become pregnant while on Mirena will have an ectopic pregnancy. Ectopic pregnancies occur when the egg becomes fertilized outside the uterus and are also referred to as tubal pregnancies since the fertilization often occurs in the fallopian tubes. An ectopic pregnancy usually threatens the life of the mother, and women who have ectopic pregnancies often undergo surgery to remove the fertilized egg. This may also lead to infertility.

Pelvic inflammatory disease (PID), another serious side effect of Mirena usage in some women, may also lead to infertility in some cases. PID is a bacterial infection that occurs in the female reproductive system. The infection can damage the uterus, ovaries and fallopian tubes and thus may lead to infertility. PID can occur as quickly as three weeks after insertion of the IUD.

Other less serious, but still unsettling side effects of Mirena usage include, acne, weight change, nausea, mood changes, breast tenderness, vaginal discharge and abnormal bleeding patterns.

These harsh side effects, including the horrifying possibility of becoming infertile, have led to numerous lawsuits against Bayer Pharmaceuticals, the manufacturer of Mirena. These lawsuits claim Bayer knew the dangerous risks of the device before releasing it to the public. The women claim Bayer willfully endangered them and are suing for punitive damages as well as compensation for medical costs and pain and suffering costs.

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.

Migration of Mirena IUD Outside of the Uterus Can Cause Serious Medical Problems

Women hoping for an easy, long-acting birth control might believe Mirena, a hormonal intrauterine device (IUD) manufactured by Bayer Pharmaceuticals, is the perfect choice. However, as a large number of lawsuits and women suffering physical harm can attest, Mirena is not as ideal as it seems.

One of the most dangerous side effects of Mirena is the likelihood of the device migrating from its normal positioniuddislodged inside the uterus. This notion is actually disputed by the manufacturer despite the fact that several women, and a study from a reputable healthcare facility, have shown otherwise. Bayer representatives have stated that the migration is a rare occurrence. However, a study published by the Department of Radiology at the Ronald Reagan UCLA Medical Center found that this is actually a “frequently encountered complication.”

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. When the IUD migrates, doctors are forced to use ultrasound or x-ray to locate the device and then perform surgery to remove the device. In a few cases, women have had to have multiple surgeries to remove the device since it is sometimes difficult to locate and remove. The risk of perforation of the uterus is increased in women who use Mirena immediately following delivery of a child, and that risk remains elevated for at least six months following delivery. Spontaneousiudperforation migration of Mirena can also cause other side effects including: abscesses, tissue erosion, fertility problems, peritonitis, Pelvic Inflammatory Disease, uterine wall embedment and ectopic pregnancy.

A woman in South Carolina is suing Bayer after her IUD spontaneously migrated. The claim, one of the first Mirena lawsuits in the nation, alleges that the plaintiff was never adequately informed about the danger of migration following insertion of the device. Bayer is working to have the lawsuit dismissed, claiming the woman’s doctor was aware of the migration risk. However, the plaintiff in this lawsuit contends the warnings that accompany the insertion of Mirena include a caution against perforation at the time the device is inserted. The plaintiff in this case said she suffered injuries from perforation of the uterus as a result of Mirena migration well after the device was inserted.

In a brief filed in conjunction with the lawsuit, the “plaintiffs note that it is quite impossible for Bayer to argue on the one hand that spontaneous migration not associated with insertion of Mirena is ‘biologically implausible,’ and on the other hand argue that Bayer’s duty to warn of said event was satisfied,” the brief argues.

At least 16 other women have made similar claims about problems stemming from Mirena migration in lawsuits filed in Morris County, New Jersey.  According to Bayer, additional complaints are also pending in various other state courts.

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.

Clever marketing strategy can’t overshadow severe complications of IUD device Mirena

Women living in this fast-paced, instant information age are seeking quick fixes and simple solutions to problems. So in 2000 when the pharmaceutical company Bayer introduced the birth control Mirena, an intrauterine device (IUD) inserted directly into the uterus to prevent pregnancy, as part of its “Simple Style” program targeted toward busy moms, the new birth control choice became an instant hit. The pharmaceutical company continues to market the IUD with the tagline “Keep Life Simple” and upon its release claimed the device would not only serve as a birth control method but also increase libido and make women “look and feel great”.

Bayer’s multi-million dollar advertising campaign of its IUD directly to the consumer helped create a surge in the use of IUD’s in the United States. In 2009, the use of IUDs implanted in American women using birth control had doubled in just two years (about 7.5 percent of all American women using birth control had IUDs.)

The tactical marketing plan received much attention from the Food and Drug Administration (FDA) after it was found that many of the statements in the “Simple Style” program were found to be more flashy than truthful. The program tended to also downplay the side effects of Mirena. These side effects may include:

  • 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

The FDA issued an official warning to Bayer in 2009 for overstating the effectiveness of Mirena, while minimizing the risks associated with it. The German pharmaceutical giant had already received a similar warning, along with a large fine, from the FDA regarding how it advertised Yasmin and Yaz products, other birth control products. A fax from The Department of Health & Human Services, the umbrella organization of the FDA, to Fadwa Almanakly, the associate director of advertising and promotions for Bayer, states that FDA’s Division of Drug Marketing, Advertising, and Communications (DDMAC) reviewed the script for the live consumer-directed program entitled “Mirena Simple Style Statements Program.”

The DDMAC found that statements directly from the “Simple Style” program misled women. For example, according to the fax, the “Simple Style” script included the following statements: “Do you ever feel so overwhelmed by your schedule that intimacy is much more of a ‘to do’ on a list than a desire?” and “One strategy that I recommend for busy couples is choosing a birth control method that allows for spontaneous intimacy and which you don’t have to think about every day, such as the intrauterine contraceptive, Mirena.” The DDMAC concluded that these statements, and several others in the script, indicated that the use of Mirena will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. The fax warning goes on to say that these claims misleadingly overstate the proven efficacy of Mirena. The DDMAC noted that Mirena does in fact not involve a daily routine, but they are 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, 5 percent of clinical trial patients reported decreased libido as a side effect of Mirena use.

Also included in the warning from the FDA to Bayer, was a concern that the “Simple Style” program was also leading women to believe that Mirena can help patients “look and feel great” by stating during the program that “…figuring out steps to take to simplify your lifestyle while still looking and feeling great. One of those ways is finding a birth control that is compatible with your busy lifestyle.” In the warning, the FDA stated that it is not aware of any evidence suggesting that women who use Mirena look or feel great. It goes on to state that patients using Mirena may experience various side effects such as: irregular bleeding, ovarian cysts, back pain, weight increase, breast pain/tenderness and acne. These side effects may thus keep women from “looking and feeling great.”

In the warning, the FDA states that Bayer’s claims that Mirena improves quality of life, such as intimacy or romance increases, or claims that Mirena help women look or feel better, must be supported by substantial evidence, as demonstrated through adequate and well-controlled trials using validated patient assessment instruments to measure the outcomes of interest. The FDA asked Bayer that if it does have substantial evidence to prove these claims, that they submit them to the FDA for further review.

There are now several lawsuits against Bayer for its false and misleading statements concerning the Mirena IUD. These suits allege claims similar to those concluded by the FDA’s warning in 2009. The pending lawsuits allege Mirena-using women suffered serious and permanent physical injuries, including sexual issues. The plaintiffs also claim that Bayer misrepresented the drug in its marketing campaign and never failed to divulge the harmful side effects.

The lawyers at Nolan Law Group are equipped to handle cases involving injuries from the usage of Mirena. We are currently evaluating Mirena IUD cases. If you or someone you know has suffered after using Mirena,  please Contact Us or call 312-630-4000.