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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.

Mirena: An Overview

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 users. Manufactured by Bayer Pharmaceuticals, 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. In 2009, the FDA expanded Mirena’s approval to treat heavy menstrual bleeding in women already using an IUD.

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.

Clinical trials have proven that Mirena is extremely effective in preventing pregnancy. In the studies, 1,169 women 18-35 years of age used Mirena for up to 5 years. The pregnancy rate over the 5 years was 0.7 per 100 women, or 0.7 percent. After Mirena was removed, 80 percent of women who wanted to become pregnant were able to do so within a year after removing Mirena.

Unfortunately, the drug does not come without a fair share of serious side effects and problems. 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.

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.

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.

ANATOMY OF A LAWSUIT

Pre-trial
• Litigation is the act of bringing a lawsuit against a person or company for a perceived wrong. A civil lawsuit can be settled out of court, or it can follow the steps of the litigation process. Before starting the litigation process, the wronged party, or plaintiff, usually tries to come to an agreement to resolve the conflict and avoid litigation. If no settlement can be agreed upon, the plaintiff files a complaint with the court and a copy is sent to the other party, or defendant, in the form of a summons. The defendant is given time to respond to the complaint. Once on notice, the defendant may choose to settle the case. A judge may order the suit into arbitration, in which a third party attempts to help the parties come to a compromise, or the case moves on to the next step.
Representation
• The hired attorney spends time reviewing the merits of the case, researching other legal precedents, interviewing witnesses and gathering facts. Discovery takes place between the representatives of both parties. They share information formally through written requests. Each attorney may choose to interview the other party’s witnesses in a deposition. During a deposition, the witnesses are under oath and the proceedings are recorded by a court reporter. Expert witnesses are found to testify for both sides about technical issues or bring their expertise to bear on the argument of either side by explaining what happened from their perspective. Both sides typically file motions to clarify procedures and resolve disputes prior to the trial. Sometimes evidence is asked to be held back or an attorney requests a summary judgment, asking the court to dismiss the case before it continues any further based on evidence that’s been gathered.
Trial
• A trial may be held in front of a jury or a judge. During the trial, both sides present their evidence. The plaintiff’s side goes first, and witnesses are called to testify, then cross-examined by the opposing counsel. After both sides present their evidence and witnesses, the attorneys speak to the jury in closing arguments that summarize their cases. The jury then leaves the room and enters a private place where they discuss the case and decide on a verdict. Once a decision has been reached, the losing party may ask for the decision to be changed by the judge. The losing party also may appeal the decision and request another court to review the case. An appeal can prolong the litigation process for up to a year or more.

U.S. Outbreak death toll has reached 24

The U.S. death toll fungal meningitis outbreak due to injections of tainted steroid medication has reached 24. Indiana is now reporting a third death, the Centers for Disease Control and Prevention said on Wednesday, Oct. 25th.

Eight new cases of meningitis were reported, pushing the total nationally to 312 cases in 17 states, the CDC said. Five joint infections caused by injections also have been reported, bringing the total number of infections to 317.

The number of cases has continued to climb despite the recall of the product by the New England Compounding Center (NECC). New cases were reported in Michigan, New Jersey and Virginia in addition to the death reported in Indiana.

If you suspect you have received contaminated steroid injections, symptoms may include fever, headache, stiff neck, nausea, vomiting, photophobia, altered mental status. People often feel like they have a severe case of the flu.

http://nolan-law.com/nlg2014/pdf/necc-preliminary-report-10-23-2012.pdf

The Contaminated Steroid Shot is Methylprenisolone

Methylprednisolone (Brand name: Depo-Medro) is a corticosteroid hormone. It is used to treat pain and swelling that occurs with arthritis and other joint disorders. It is recommended usually be outpatient clinic physicians to be given as a shot in the arthritic joint and pain is supposed to subside within days of receiving the shot.

This medicaion may also be used to treat various conditions such as blood disorders, severe allergic reactions, certain cancers, eye conditions, skin/intestinal/kidney /lung diseases, and immune system disorders. It decreases your immune system’s response to these conditions and reduces symptoms such as swelling, pain, and allergic-type reactions. Methylprednisolone may also be used with other medications in hormone disorders.

This medication is usually injected into a joint as directed by your doctor. Methylprednisolone may also be injected into a muscle or into abnormal skin tissue. The dosage is based on your medical condition and response to treatment

This medication should appear milky white. Before using, check this product visually for particles or discoloration.
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If this medication is injected into a joint, be careful how much pressure you put on that joint, even if it is feeling better.

Normal side effects include: weakness, weight loss, nausea, muscle pain, headache, tiredness,and dizziness when this drug is suddenly stopped. To prevent these withdrawal symptoms when stopping methylprednisolone, your doctor may reduce your dose gradually

Birth Control Pill Injury Report