• The Mirena IUD is Manufactured by Bayer...
    ...the same company that has indicated to shareholders that it will reserve an additional $262.5 million to settle Yaz and Yasmin lawsuits over blood clots
  • Call the Mirena IUD Helpline and speak to a female medical social worker and a Mirena IUD lawyer
  • The Mirena IUD has had serious complications
    • Perforation of the uterus
    • The IUD can gravitate and become embedded in the uterus or abdomen
    • Pregnancy even with the Mirena inserted
    • Gravitation of the IUD, change in position
    • Ectopic pregnancy
    • Group A streptococcal sepsis
    • Infertility when the IUD becomes embedded
    • Need for surgical removal of the Mirena
  • The Mirena IUD is a flexible intrauterine device that is placed into the uterus through the vagina by a GYN. Mirena releases a continuous dose of hormones (levonorgestrel) to prevent pregnancy for up to five years.
  • Over 2 million women in the U.S. have used Mirena IUD for birth control.
    Mirena is one of the most common IUDs currently on the market.
  • Uterine Perforation Symptoms From the Mirena: If you have these symptoms see a physician immediately.
    • Lower abdominal pain
    • Heavy vaginal bleeding
    • Inability to locate the Mirena IUD string
    • Bloating, rigidity and pain in the abdomen
    • Nausea, Vomiting, Chills, Fever, Rapid heartbeat

Author Archive

Mirena Perforation Lawsuits, Laproscopic Surgical Removal Lawsuit Lawyers

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News

Attention Ladies: Mirena IUD lawyers are filing lawsuits where your device migrated, become embedded in and perforated your uterus and was  removed with laproscopic surgery.

Laparoscopic surgery is a minimally-invasive type of surgery that utilizes a tool called a laparoscope, which has a light, video camera, and surgical instruments on the end. A surgeon watches a video monitor to guide surgery. The benefit of this surgery is that it minimizes risks during surgery, reduces pain, and reduces recovery time.

 Ladies with a Perforation from Your Mirena IUD
Lawyers are filing Mirena IUD lawsuits for perforations where the device must be laproscopically removed.

If your Mirena IUD moved, migrated or gravitated out of the original insertion position after a followup found everything was ok we need to hear from you ASAP  to have your case reviewed for a  MIRENA IUD  Lawsuit .

Surgical Devices Harmful To Women, Lawyers For Stryker Hip Replacement

Written by Mirena IUD Helpline on . Posted in Stryker Hip Recall

The FDA reports that these metal on metal and metal component hip implants  put women at a higher risk. Both the Stryker Rejuvinate and ABG II are  dangerous surgical implants that have a greater failure rate and complications for women.

Many articles and reports have been released that discuss hip replacements having a greater failure rate in women.

Hip replacements like Stryker Rejuvinate and ABG II are slightly more likely to fail in women than in men, according to research published Monday in JAMA Internal Medicine.  The research was financed by the Food and Drug Administration. Another report discusses hip resurfacing and states a drawback for women because of the bone weakening that accompanies menopause. Meanwhile, even advocates of resurfacing acknowledge that they have yet to agree on how best to screen women for the procedure.

“We were surprised by the results, as studies suggest that larger heads should have  lower wear and a lower risk of dislocation. However, we have seen an increase in revisions for pain and loosening, particularly in women,” says Alison Smith, a study author and statistician at the University of Bristol in the U.K. Depending on patient age and implant head size, the revision rate for all-metal hips is three to four times higher in women and two to three times higher in men compared with other implants.

The FDA Reports Women At a Higher Risk For Failure

The Food and Drug Administration, along with its safety communication, has included a list of risk factors that can increase a patient’s chances of suffering from metal on metal hip implant complications. Patients who are overweight, female, or physically active are more likely to suffer complications related to these hip replacement systems, and patients who have a sensitivity to certain metals, have kidney failure, have a suppressed immune system, or take corticosteroids are also more at risk.

It seems women are always the victims for these manufacturers that choose profits over warnings.

Hip Replacement Failure More Likely In Women, Study Says Studies on Google News Today

Hip replacements are more likely to fail in women than in men, but the overall risk of implant failure is low–according to a study published in the Journal of the American Medical Association, JAMA, and that was funded by the U.S. Food and Drug Administration.

Women account for the majority of the more than 400,000 patients who undergo either full or partial hip replacements in the U.S. each year.

“This is the first step in what has to be a much longer-term research strategy to figure out why women have worse experiences,” said Diana Zuckerman, president of the nonprofit National Research Center for Women & Families.

It appears the smaller frame and difference in the curve of the hip and pelvic region accounts for this. Anatomy appears to play a role.  Women tend to have smaller joints and bones than men, and so they tend to need smaller artificial hips. Devices with smaller femoral heads  the ball-shaped part of the ball-and-socket joint in an artificial hip are more likely to dislocate and require a surgical repair.

I wonder why there cannot be two types of replacements, one for women and one for men. But, since they are all being recalled it would just mean more injured women. I am sure there would be extensive marketing to hook women in explaining how their lives would remain active and have a better quality. If you or a wife, mother, girlfriend or female loved one has been injured by these hip implants contact us and we will direct you to a Stryker Hip Replacement lawyer.

Mirena IUD MDL Formed For Perforations In New York, Mirena IUD Lawyers Ready

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News, mirena IUD multi district litigation

An MDL ( Multi district litigation ) has formed in New York. The Mirena multi district litigation will allow for all Mirena IUD pewrforation cases to be heard under one judge in one jurisdiction. This allows for an easy and quick filing of lawsuits and means you do not need a local lawyer to file your lawsuit as all the cases will be heard in New York.

This consolidation applies to all Mirena IUD injury perforation injury lawsuits and will include all  cases filed in the the federal court system. Dangerous drugs and devices lawsuits often end up as a multi district consolidation. Now the  Mirena IUD  perforation lawsuits will be centralized before one judge, U.S. District Judge Cathy Seibel in the Southern District of New York, for pretrial proceedings in Re: Mirena IUD Products Liability Litigation, MDL No. 2434). The Transfer Order, which was filed on April 8, 2013 states that the MDL currently consists of eight cases in eight different districts.

Mirena IUD Lawsuit Checklist

The Mirena IUD causes many symptoms and complications. However to file a Mirena IUD products liability lawsuit you must meet certain criteria. Now, although you were never told you had some of these issues and believe you do not qualify, you should see a physician to be sure. Perforation of the intestine leads to leakage of intestinal contents into the abdominal cavity. This causes inflammation called peritonitis. A uterine perforation is a hole made through the wall of the uterus. Some of the medical conditions that may imply a perforation of the uterus or abdomen, or that indicate your Mirena may have moved or become embedded in an organ include:

  • Inability to feel or locate the string
  • Bleeding from vagina or bowel
  • Severe sharp pain in the abdomen
  • Lower back pain
  • Sharp jabbing pain
  • Lower abdominal pain
  • Heavy vaginal bleeding
  • Inability to locate the Mirena IUD string
  • Bloating, rigidity and pain in the abdomen
  • Nausea
  • Vomiting
  • Chills
  • Fever
  • Rapid heartbeat

Mirena IUD Lawsuit Checklist

The Mirena IUD causes many symptoms and complications however, in order to file a Mirena IUD lawsuit your Mirena IUD lawyer will be looking for the following:

1. Mirena IUD must be the product implanted

2. You must have gone to your 4-6 week follow up appointment and your doctor has confirmed that your Mirena IUD was properly implanted.

3. The Mirena IUD has perforated your uterus or other organ. The Mirena must have moved out of position, gravitated and has become embedded in your uterus or an organ and/or there is a perforation injury.

4. This usually means the Mirena , needs to be or will be surgically removed.

A lot of Mirena women either don’t go to follow up appointment or by the time they go to follow up the Mirena has already moved. If that happens this becomes a med mal issue and not a products issue. The statute of limitations starts to run when you knew Mirena perforated an organ.

Of course, consult with your doctor if you are experiencing any of the symptoms listed above to see if the Mirena has moved and caused a perforation. Consult with one of our Mirena IUD lawyers to be sure.

We need to hear from you asap. Do not delay. Every state has a statute of limitations.

 

 

 

 

 

 

 

 

 

 

Mirena IUD Lawsuit Alert, What You Need To Know To File A Mirena Lawsuit

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News, Mirena IUD Uterine Perforation Lawyers

The Mirena IUD causes many symptoms and complications however, in order to file a Mirena IUD lawsuit your Mirena IUD lawyer will be looking for the following:

1. Mirena  IUD must be the product implanted
2. You must have gone to  your 4-6week follow up appointment the and doctor has confirmed that your Mirena IUD  was properly implanted
3. The Mirena IUD has perforated uterus or other organ. The Mirena must have moved out of position, gravitated and has become embedded  in your uterus or an organ and/or  there is a perforation injury.
 4. This usually means the Mirena , needs to be or will be surgically removed
A lot of Mirena women either don’t go to follow up appointment or by the time they go to follow up the mirena has already moved. If that happens this becomes a med mal issue and not a products issue. The statute of limitations starts to run when you knew mirena perforated an organ.
To find out more about the Mirena IUD lawsuits call the Mirena IUD Helpline. Mirena IUD Helpline  lawyers are accepting  Mirena side effect cases  for embedment in the uterine wall, uterine bleeding and IUD expulsion.  Mirena lawyers are offering a free consultation to women suffering from the Mirena IUD.

Mirena News Update, MDL Hopes For Mirena IUD, March 21st Hearing

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News

A MIrena IUD MDL, Multi District Litigation would be helpful for women and set a tone for thousands of Mirena lawsuits to be filed in one central location under one judge. A Multi District litigation for the Mirena IUD would mean you do not need a local lawyer to file in a local court. This would be at the Federal level. There would be lead counsels assigned to the litigation and you would need to locate an experienced dangerous devices lawsuit lawyer.

If the Mirena IUD side effects  warrant MDL this would be good for the thousands of women who have gotten uterine perforations from the Mirena IUD… Perforation cases are currently the ones lawyers are seriously looking at.  The Mirena must have gravitated from position, become embedded in the uterus and needed to be surgically removed. There must have been no complications with the original insertion. This has to do with a concept called ” science”. A uterine perforation can be easily traced back to the Mirena. The Mirena becomes dislodged and gravitates out of position and moves. It can become embedded in the uterus or a nearby organ. The result is perforation and usually permanent infertility. These are basic facts that can be proven. Many of the other tentative symptoms cannot be traced back to the Mirena easily. They may ne very real for you but, perforations are the key complication.

 Mirena MDL Overview

In January 2013, a motion for consolidation of Mirena lawsuits was filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML). The motion requested the formation of a Mirena multidistrict litigation (MDL) or centralization of all Mirena lawsuits.   This proposed MDL could group together lawsuits that have uterine perforations as a result of Mirena.  The JPML is scheduled to hear arguments regarding the proposed MDL on March 21, 2013.

Letter To Bayer Regarding the Mirena IUD, Mirena IUD Complications

Written by Mirena IUD Helpline on . Posted in Mirena Stories and Sharing

Did you suffer  Injury because of Your Mirena IUD device? The Mirena IUD Helpline and Mirena IUD lawyers are here for you.The Mirena IUD Helpine Is always looking for information for our readers. We thought you would find this interesting.

Letter to Bayer from the FDA; DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service

Food and Drug Administration Silver Spring, MD 20993

Dear Dr. Almanakly:

The Division of Drug Marketing, Advertising, and Communications (DDMAC) has reviewed a script for a live consumer-directed program (program) entitled “Mirena Simple Style Statements Program” (150-74-0002-09) for Mirena® (levonorgestrel-releasing intrauterine system) (Mirena), submitted by Bayer HealthCare Pharmaceuticals Inc. (Bayer) under cover of Form FDA-2253. The program overstates the efficacy of Mirena, presents unsubstantiated claims, minimizes the risks of using Mirena, and includes false or misleading presentations regarding Mirena. Thus, the program misbrands the drug in violation of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. 352(n), and FDA’s implementing regulations. See 21 CFR 202.1(e)(3)(i), (e)(5) & (e)(6)(i).

Background

According to the DESCRIPTION section of its FDA-approved product labeling (PI),1 “Mirena® (levonorgestrel-releasing intrauterine system) consists of a T-shaped polyethylene frame (Tbody) with a steroid reservoir (hormone elastomer core) around the vertical stem.” The steroid reservoir contains the progestogen levonorgestrel, which is secreted slowly into the uterus over time upon the insertion of Mirena by a trained healthcare provider. According to the INDICATIONS AND USAGE section of its PI, Mirena is approved for the following indication:

Mirena is indicated for intrauterine contraception for up to 5 years. Thereafter, if continued contraception is desired, the system should be replaced. Mirena is recommended for women who have had at least one child.

The PI for Mirena also includes numerous contraindications, including “[u]ntreated acute cervicitis or vaginitis, including bacterial vaginosis or other lower genital tract infections until infection is controlled,” and “[c]onditions associated with increased susceptibility to pelvic infections.”

1 The most current version of the FDA-approved PI as of the dissemination date indicated on Form FDA-2253 was the July 21, 2008, version, and that is the version referred to in this letter. We note that the PI for Mirena was updated on October 1, 2009.

The use of Mirena is associated with a number of risks, including warnings regarding the increased risk of pelvic inflammatory disease (PID), ovarian cysts, and irregular bleeding and amenorrhea. Additional warnings include the risk of Mirena embedding in, perforating, or being expelled from the uterus, as well as the increased risk of ectopic pregnancy, and the risks to an intrauterine pregnancy that occurs with Mirena in place. Should a woman become pregnant while using Mirena, serious risks include pregnancy loss and a permanent loss of fertility.

In addition to the warnings noted above, the PI details the common adverse reactions that were observed during the clinical trials for Mirena. According to the PI, “Very common adverse reactions” (>10% of clinical trial patients) included “uterine/vaginal bleeding (including spotting, irregular bleeding, heavy bleeding, oligomenorrhea and amenorrhea), and ovarian cysts.” Adverse reactions that were reported by 5% or more of clinical trial patients include, among others, abdominal/pelvic pain, nausea, headache, nervousness, back pain, weight increase, breast pain/tenderness, acne, decreased libido, and depressed mood.

The PI also includes precautions that patients should be counseled that Mirena does not protect against HIV infection (AIDS) or other sexually transmitted diseases, and that patients should be instructed to check that the threads attached to Mirena are still in place after each menstrual period, as there is no contraceptive protection if Mirena is displaced or expelled.

Additionally, in regards to patient follow-up following the insertion of Mirena, the DOSAGE AND ADMINISTRATION, Patient Follow-up section of the PI states (in pertinent part):

Patients should be reexamined and evaluated 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.

Overstatement of Efficacy/Unsubstantiated Claims

Promotional materials are misleading if they represent or suggest that a drug is more effective than has been demonstrated by substantial evidence or substantial clinical experience. The Mirena program is a live presentation designed for a consumer audience of “busy moms.” The program is presented in a consumer’s home or other private setting (e.g. private restaurant party) by a representative from Mom Central (a social networking internet site) and a nurse practitioner (Ms. Barb Dehn).2 The script of this program submitted to FDA includes an introduction from the Mom Central representative, a presentation given by Ms. Dehn regarding the use of Mirena, and a “post-party” questionnaire for the audience.

The script includes the following statements to be delivered by the Mom Central representative (emphasis added):

“This party was brought to you by Mom Central in partnership with Bayer HealthCare Pharmaceuticals’ Mirena which may help couples keep life simple!”

2 The Mirena program submitted to FDA also references a presentation given by a fashion stylist (Ms. Angela Hastings) that immediately follows Ms. Dehn’s presentation regarding the use of Mirena. The script of Ms. Hastings’ presentation regarding fashion tips was not submitted to FDA.

Fadwa Almanakly, Pharm.D. Page 3

Bayer HealthCare Pharmaceuticals Inc.

NDA 21-225 / MACMIS 18166

“Barb Dehn is a practicing Women’s Health Nurse Practitioner, award-winning author and nationally recognized health expert from San Francisco. Barb is going to kick things off with a discussion about romance and how to find simple ways to reconnect with our partners.”

The script also includes the following statements to be delivered by Ms. Dehn (emphasis added):

“. . . And, let’s face it, when we feel good about the way we’re put together, we feel better about approaching the romance in our lives.”

“What we’re here to talk about today – is how to find those simple ways to reconnect with ourselves and our partners.”

Following the introduction of the program, the script states that “Barb [Dehn] will begin presentation with an icebreaker – an interactive Q&A – which will touch upon issues such as busy schedules, barriers to intimacy and contraception” (emphasis added). The “icebreaker” questions include the following (in pertinent part; emphasis added):

“How many of you feel so busy that you often can’t find time to take care of yourself? And do you think this impacts your level of intimacy?”

“Do you ever feel so overwhelmed by your schedule that intimacy is much more of a “to do” on a list than a desire?”

“If you didn’t have to worry about contraception, do you think you would be more likely to be intimate with your partner?”

“Do you think if you didn’t have to worry about taking your birth control everyday, it would help you be more intimate?”

Immediately following the “icebreaker” questions, the script for Ms. Dehn states (emphasis added):

“So you mentioned that convenience and reliability are among the most important benefits of your birth control method. 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 above statements clearly indicate that the use of Mirena instead of other means of contraception will result in increased levels of intimacy, romance, and by implication, emotional satisfaction. These claims misleadingly overstate the proven efficacy of Mirena. Mirena has been proven to be an effective intrauterine contraceptive device. While we note that Mirena does not involve a daily routine and is not a barrier method of contraception, FDA is 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. Claims that state or suggest such quality of life outcomes, such as those described above, must besupported by substantial evidence, as demonstrated through adequate and well-controlled trials using validated patient assessment instruments to measure the outcomes of interest. If you do, in fact, have data to support these claims, you should submit them to FDA for review.

We note that, according to the Mirena PI, at least 5% of clinical trial patients reported decreased libido as a side effect of Mirena use. Patients also experienced abdominal/pelvic pain, nausea, headache, nervousness, and depressed mood, which could adversely affect a woman’s feelings relating to romance or intimacy.

The script also includes the following statements, to be presented by Ms. Dehn (emphasis added):

• “But what this party is really about is looking at the whole picture and 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.”

The above statement goes beyond the suggestion of increased intimacy to suggest that Mirena can help patients “look and feel great.” Again, FDA is not aware of any evidence suggesting that women who are using Mirena for birth control look great or feel great. Patients using Mirena may experience various side effects, such as irregular bleeding, ovarian cysts, back pain, weight increase, breast pain/tenderness, and acne, in addition to the side effects indicated above. The experience of these side effects can prevent patients from “looking and feeling great.” Such claims of improved patient-reported outcomes must be supported by substantial evidence, as demonstrated through adequate and well-controlled trials using validated instruments to measure these outcomes of interest. If you do, in fact, have data to support these claims, you should submit them to FDA for review.

Omission and Minimization of Risk Information

Promotional materials are misleading if they fail to reveal material facts in light of the representations made by the materials or with respect to consequences that may result from the use of the drug as recommended or suggested by the materials. The script includes the following risk presentation, to be presented by Ms. Dehn (emphasis in original):

• Only you and your healthcare professional can decide if Mirena is right for you. Mirena does not protect against HIV or STDs. Candidates for Mirena have had a child, and do not have certain cancers or acute pelvic inflammatory disease. In rare cases, perforation or embedment may occur. Mirena may become completely or partially dislodged. In the uncommon event you think you’re pregnant, contact your healthcare professional without delay. Ovarian cysts may occur and typically disappear. Changes in bleeding are common in the first few months followed by shorter, lighter periods. Periods, however, may remain irregular.

The risk presentation omits the contraindications regarding untreated lower genital tract infections and conditions associated with increased susceptibility to pelvic infections, and does not adequately convey that should a woman become pregnant while using Mirena, she may lose her baby or her fertility.We refer you to the December 17, 2008, advisory letter from DDMAC to Bayer, regarding the promotion of Mirena. This advisory letter includes a change of opinion regarding the risk presentation for Mirena. The letter states (in pertinent part, emphasis added):

Because this constitutes a change in our position, you will be provided a reasonable period of time to revise any Mirena promotional materials currently in use that omit this important risk information. Accordingly, the revisions should be completed within 90 days of receipt of this letter or at the next production of new promotional materials, whichever comes first.

The promotional program at issue here was newly developed, and as stated on the Form FDA-2253 accompanying the materials, it was disseminated on February 28, 2009, after the change of opinion letter was issued. We also refer you to your January 5, 2009, response to the change of opinion letter, stating that you intend to comply with our request.

Additionally, the script minimizes the risks associated with Mirena. Specifically, the “looking and feeling great” statement referenced above, in the context of the program as a whole, minimizes the risks associated with the use of Mirena. As stated in the Background section above, the PI for Mirena includes “very common” (experienced by >10% of clinical trial patients) adverse reactions, in addition to other serious warnings, precautions, and safety issues associated with the use of Mirena. The suggestion that Mirena will help patients “feel great” minimizes the side effects that patients may experience as a result of using the drug.

False/Misleading Statements

The script includes the following statements to be presented by Ms. Dehn (emphasis added):

• “. . . Mirena has no daily, weekly, or monthly routines to comply with as compared to the negatives associated with other birth control methods.”

The above claim that Mirena has “no . . . monthly routines” directly contradicts information contained in Mirena’s PI. According to PRECAUTIONS, Continuation and Removal section (repeated in the DOSAGE AND ADMINISTRATION, Patient Follow-up section) of the PI for Mirena, “[Patients should be] reexamine[d] and evaluate[d] . . . 4 to 12 weeks after insertion and once a year thereafter, or more frequently if clinically indicated.” The PRECAUTIONS, Patient Counseling Information section of the PI also states that patients should check that the threads attached to Mirena are in place after each menstrual cycle (thus on a monthly basis), to ensure that Mirena has not become displaced or expelled, which would result in a loss of contraceptive efficacy. Therefore, the claim that there is no “monthly routine to comply with” is a false statement.

We note that the script includes instructions to check the Mirena threads monthly in a separate part of the presentation; however, this does not correct the false statement highlighted above.

Fadwa Almanakly, Pharm.D. Page 6

Bayer HealthCare Pharmaceuticals Inc.

NDA 21-225 / MACMIS 18166

Conclusion and Requested Action

For the reasons discussed above, the program is misleading in violation of the Act, 21 U.S.C. 352(n), and FDA implementing regulations. See 21 CFR 202.1(e)(3)(i), (e)(5) & (e)(6)(i).

DDMAC requests that Bayer immediately cease the dissemination of violative promotional materials for Mirena such as those described above. Please submit a written response to this letter on or before January 14, 2010, stating whether you intend to comply with this request, listing all promotional materials (with the 2253 submission date) for Mirena that contain violations such as those described above, and explaining your plan for discontinuing use of such violative materials. Please direct your response to me at the Food and Drug Administration, Center for Drug Evaluation and Research, Division of Drug Marketing, Advertising, and Communications, 5901-B Ammendale Road, Beltsville, MD 20705-1266; facsimile at 301-847-8444. In all future correspondence regarding this matter, please refer to MACMIS # 18166 in addition to the NDA number for Mirena. We remind you that only written communications are considered official.

The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for Mirena comply with each applicable requirement of the Act and FDA implementing regulations.

Mirena IUD Hopes For A Mirena Lawsuit MDL, Mirena IUD Lawsuit MDL Update

Written by Mirena IUD Helpline on . Posted in Mirena IUD Updates

The Mirena IUD Helpline receives calls daily from women with complications from the Mirena IUD. The most serious complications are perforations of the uterus, abdomen or intestines. The Mirena IUD Helpline was hoping for a consolidation of all Mirena IUD lawsuits as this makes it easier for you, the Plaintiff to file, but the manufacturer is not so happy about it.

The complications lawsuits appear to be aimed at is something called science. If the Mirena was implanted with no complications and then years later moved, gravitated or migrated and became lodged, embedded or stuck in your uterus, abdomen or intestines that is easily provable as a fault of the product based on “science”. Science appears to be an easy a equal b concept. Other complications can not as easily be equated to the IUD based on the legal concept of “science”.

Read the latest Mirena IUD News Below

Mirena IUD Helpline Keeps you Updated

Although Bayer opposes the formation of a federal MDL for the Mirena lawsuits, the drug maker did file a request to consolidate the state court Mirena litigation pending in New Jersey. However, Bayer pointed out in their recent response that the circumstances in New Jersey were unique, as all of the cases were at an early stage, with no dispositive motions pending or trial dates scheduled.

Bayer Opposes Request to Consolidate Federal Lawsuits Over Mirena IUD

Posted: 08 Feb 2013 07:30 AM PST

In response to a motion to consolidate all federal Mirena IUD lawsuits, Bayer Healthcare has filed a response opposing the centralization of the cases as part of a multi-district litigation (MDL), arguing that it would prejudice their ability to defend the safety of the implantable birth control device.

Last month, a group of plaintiffs filed a motion to establish a Mirena MDL, which would transfer all product liability lawsuits filed against Bayer over their intra-uterine contraceptive device (IUD) to one U.S. District Judge for coordinated handling during pretrial proceedings.

At that time, eight different Mirena cases filed in the federal court system were identified, with each lawsuit pending before a different judge in eight different U.S. District Courts. In addition, product liability lawyers investigating Mirena lawsuits have suggested that hundreds, if not thousands, of complaints are likely to be filed in the near future.

In a response (PDF) filed with the U.S. Judicial Panel on Multidistrict Litigation (JPML) on February 7, Bayer argued that centralization of the cases was not appropriate, and actually suggested that it would prejudice their defense by delaying the start of the first trial dates and encouraging the filing of “marginal” Mirena cases, which may require the drug maker to start negotiating Mirena settlements for business reasons, instead of legal reasons.

One of the cases identified for transfer was filed more than two years ago, and was set for trial to begin in May 2013. However, the case was stayed earlier this week pending a decision from the U.S. JPML about whether the Mirena litigation will be centralized.

Bayer argues that they would be faced with “starting over” with the MDL, which would duplicate discovery that has already been completed. The drug maker indicates that it has produced over 1.7 million pages of documents in the case and presented witnesses for depositions, suggesting that “it wants to vindicate its highly effective and currently marketed product as soon as possible.

Mirena IUD Lawsuits Involve Similar Allegations

Mirena is a T-shaped prescription intrauterine device (IUD), which is inserted into the uterus by a doctor to provide long-term birth control.

In recent weeks, a growing number of women throughout the United States have filed product liability lawsuits against Bayer alleging that they suffered severe injuries when their Mirena IUD perforated the uterus and “spontaneously” migrated following insertion.

The complaints involve common allegations that Bayer failed to adequately research the potential side effects of Mirena or warn about the risk of the IUD migrating long after it is implanted, increasing the risk of infection or serious damage to surrounding organs, often resulting in surgical removal of Mirena.

Bayer has argued that there are not sufficiently common issues of fact and law to require centralized management of the litigation, suggesting that the cases will be dominated by individual facts. The drug maker indicates that the Mirena warning label has provided information about the risk of perforation since it was introduced in 2001, so there is no need for extensive discovery about their knowledge about the risk of this complication from Mirena.

While the Mirena warning label does include information on the risk of perforation, plaintiffs argue that the language suggests that these problems only occur during insertion and that the drug maker failed to adequately warn about the risk of spontaneous migration, which may occur long after Mirena insertion. Many of the lawsuits allege that severe problems from Mirena could have been avoided if more detailed and accurate warnings had been provided.

Mirena MDL Hearing Likely in March

Consolidation of the Mirena litigation as part of an MDL, or multidistrict litigation, would result in all cases filed in U.S. District Courts throughout the country being assigned to one judge for coordinated handling in a manner similar to how a Mirena class action is managed during pretrial proceedings.

The process is designed to reduce duplicative discovery, eliminate conflicting pretrial rulings from different judges and to serve the convenience of the parties, witnesses and the courts. However, while the cases are centralized, each lawsuit remains and individual claim and if a settlement or other resolution is not reached following the MDL proceedings, each case would be remanded back to the U.S. District Court where it was originally filed for a separate trial date.

The Mirena IUD Helpline receives calls daily from women nationwide about Mirena IUD Lawsuits. “I want a Mirena IUD lawyer for a Mirena IUD lawsuit” is heard daily. Many of the complications are severe but, the ones lawyers are most interested in are Uterine and organ perforations as these are based on “science”. It appears in a lawsuit “science” means it is easy to prove. If the IUD was implanted correctly with no complications and years later migrates, moves or gravitates out of position and becomes lodged or embedded in the uterus, abdomen or intestines then it is rather straight forward. There is a long tern effect of infertility. Judges and the courts appear to look at these things in a very a equal b sort of way.

However in the hope to proceed for women injured mirena IUD lawyers were hoping to consolidate. That makes it easier for you, the plaintiff of course not enjoyed by the manufacturer that harmed you.

Ultimately, the New Jersey Supreme Court declined to centralize the Mirena cases as part of an MCL, or Multi-County Litigation. Although no details were provided by the New Jersey courts, centralized management may have been turned down because most of the New Jersey lawsuits over Mirena were already pending in one county.

It is expected that the U.S. JPML will schedule oral arguments over whether to establish a federal Mirena MDL at a hearing session scheduled to occur in San Diego, California on March 21, 2013.

 

Mirena IUD Lawsuit Moves Forward, Mirena IUD Helpline Watches

Written by Mirena IUD Helpline on . Posted in Mirena IUD Helpline, Mirena IUD Lawsuit News

The Mirena IUD Helpline , Mirena IUD lawyers,  are  watching the progress of the Mirena IUD lawsuits. ” We believe the a multi district litigation consolidation will be announced shortly. This consolidation of lawsuits under one judge in one jurisdiction will help all women file their Mirena Injury lawsuits.  As the Mirena IUD Lawsuit continues to move forward emphasis is being placed on injury where the Mirena has gravitated from the original implantation site. The device migrates and becomes embedded in the uterus or abdomen. The result is organ perforation which can lead to permanent infertility. The Mirena IUD  is surgically implanted to be effective for five years.

Mirena IUD Lawsuits are being filed by women who have  used the Mirena IUD and experienced an injury.  The Mirena IUD Lawsuit has many similarities to other mass torts currently underway. Specidic injury related to the Mirena includes: infections, dangerous scar tissue known as an adhesion,  uterine perforations, organ perforations,and infertility, abscesses, birth of a child with a birth defect, erosion of adjacent areas such as the vagina, inflammation of the membrane that lines the abdominal cavity and internal organs, intestinal perforations or obstruction, and pelvic Inflammatory Disease. There have also been some related fatalities.

Contact us today by returning the contact form or calling to discuss your specific Mirena complications with a medical social worker and get connected with a Mirena IUD lawyer.

 

 

Women”s Dangerous Drug snd Devices Helpline Update

Written by Mirena IUD Helpline on . Posted in Mirena IUD Lawsuit News, Mirena Stories and Sharing

 

Over 45,000 adverse events from Mirena have been reported to U.S. health regulators since Mirena’s introduction to the market. The most serious Mirena risks and side effects include:

The Mirena IUD Helpline has observed many drug and device lawsuits for products harming women over the past years. Our T.V screens are inundated with lawyer ads targeting these injured women. The vaginal mesh is perhaps the largest multi district litigation since the  Silicone Breast Implant Class Action. Other drugs have moved into settlement stages like Yaz and Fosamax.  There are so many specifically targeting women. Now we have the Mirena IUD causing uterine perforation s as the IUD literally tears through the cervix or the wall of the uterus.

Uterine perforation is no joke.  We speak to callers where the Mirena has moved thru the uterine wall, ripped through the cervix or entered  the abdominal cavity years after the IUD was  inserted with no initial complications. Over 45,000 adverse events from Mirena have been reported to U.S. health regulators since Mirena’s introduction to the market.  We expect 1000’s of lawsuits.

If you have been injured by the Mirena, we want to hear from you. Share your stories with others on our comments section. You are not alone.

 

 

Mirena IUD Help, Mirena IUD Florida Resources, Florida Mirena Lawyer

Written by Mirena IUD Helpline on . Posted in Florida Mirena IUD resources, Mirena IUD Helpline, Mirena IUD Lawsuit News

Mirena IUD medical resources thru Planned Parenthood of Florida.

If you are experiencing Mirena IUD side effects you may contact these locations for help. Mirena IUF lawyers are here to help you file your Mirena IUD lawsuit.

Florida Mirena IUD lawyers are concerned about women in Florida with uterine perforations and complications from the Mirena IUD. Contact the physician the implanted the Mirena. If you need additional help you may find it here:

Boca Raton Health Center

Boca Raton

8177 Glades Rd.

Bay 25

Boca Raton, FL 33434

P: 561.226.4116

F: 561.939.1344

Manatee Health Center, Bradenton

1105 53rd Avenue East, Suite 201

Bradenton, FL 34203

P: 941.567.3800

F: 941.753.3804

Fort Myers Health Center, Ft. Myers

8595 College Parkway, Suite 250

Ft. Myers, FL

P: 239.481.9999

F: 239.481.9346

Gainesville Health Center, Gainesville

914 NW 13th Street

Gainesville, FL 32601

P: 352.377.0881

F: 352.374.6823

Immokalee Center, Immokalee

419 N First Street

Immokalee, FL 34142

P: 239.262.0301

F: 239.262.7658

Jacksonville Health Center, Jacksonville

3850 Beach Blvd

Jacksonville, FL 32207

P: 904.399.2800

Lakeland Health Center

2250 E Edgewood Drive

Lakeland, FL 33803

P: 863.665.5735

F: 863.665.4422

Jean Shehan Health Center, Miami

3119A SW 22nd Street

Miami, FL 33145

P: 305.285.5535

F: 305.285.6956

Kendall Health Center, Miami

11440 SW 88th Street, Suite 109

Miami, FL 33176

P: 786.263.0001

F: 786.263.0004

7900 N.W. 27 Ave. #E240

Miami, FL 33147

P: 305.423.7933

F: 786.517.6138

Naples Center, Naples

1425 Creech Road

Naples, FL 34103

P: 239.262.0301

F: 239.262.7658

North Miami Health Center, North Miami

681 N.E. 125 Street

North Miami, FL 33161

P: 305.895.7756

F: 305.895.7763

Orlando – Eastside Clinic

11500 University Blvd

Suite B

Orlando, FL 32817

P: 321.235.5513

F: 321.235.6125

Orlando Westside Clinic, Orlando

726 South Tampa Ave

Orlando, FL 32805

P: 407.246.1788

F: 407.246.8466

Pembroke Pines Health Center, Pembroke Pines

263 North University Drive

Pembroke Pines, FL 33024

Sarasota Health Center

736 Central Avenue

Sarasota, FL 34236

P: 941.953.4060

F: 941.366.1899

Pinellas Health Center, St. Petersburg

8950 Dr. Martin Luther King Jr. Street North, Suite 102

St. Petersburg, FL 33702

P: 727.898.8199

Martin County Health Center, Stuart

1322 NW Federal Hwy., Emerald Plaza

Stuart, FL 34994

P: 772.692.2023

F: 772.692.1555

The Sally Bellamy Health Center, Tallahassee

2121 W Pensacola Street

STE B-2

Tallahassee, FL 32304

P: 850.574.7455

F: 850.575.4335

Tampa Health Center, Tampa

8068 North 56th Street

Tampa, FL 33617

P: 813.980.3555

F: 813.341.1111

Indian River (Vero Beach) Health Center, Vero Beach

3106 20th Street

Vero Beach, FL 32960

P: 772.778.0037

F: 772.778.1050

Wellington Health Center, Wellington

10111 Forest Hill Blvd, Suite 340

Wellington, FL 33414

P: 561.296.4919

F: 561.721.3474

West Palm Beach Health Center

931 Village Blvd. Suite 904

West Palm Beach, FL 33409

P: 561.683.0302

F: 561.683.9823

Winter Haven Health Center, Winter Haven

908 Havendale Blvd

Winter Haven, FL 33881