The Recall Lawyers

Bayer's Mirena intrauterine system (IUS) is marketed as a top-of-the-line of birth control method for women who have had at least one child and prefer a long-term form of birth control.

However, in the past year, women all over the country have begun reporting suffering serious injuries. Migration of the device from the uterus leading to perforation of the cervix, uterus, and other parts of the body is among the most serious.

Mirena first arrived on the U.S. market in 2000. In 2009 the FDA approved it for heavy menstrual bleeding, as well as for contraception. Bayer's website reports that it has been implanted by an estimated 2 million women in the U.S. and 15 million worldwide.

The device is intended to be implanted by a doctor in a woman's uterus. It releases 20 mg of the hormone levonorgestrel each day, which prevents pregnancy. Once implanted, Mirena is intended to provide long-term contraception (for up to five years).

Mirena's label warns physicians that it may perforate the uterus upon insertion. It does not warn, however, that Mirena may migrate, or move from its intended position in the uterus, to other parts of the body.

The problem may be caused by the fact that levonorgestrel, in combination with the Mirena's t-shape and its intended position in the uterus, may caused a woman's uterus to thin, making it more susceptible to perforation. Once Mirena perforates the uterus, it can travel to essentially anywhere within the abdominal cavity.

When it migrates, it may perforate internal organs, or become lodged in the fallopian tube. Typically, a woman may feel severe abdominal cramps when the device migrates and perforates the uterus. Many women can't find the strings attached to the IUS (which they should always be able to find if Mirena is still in its proper place). If a woman seeks medical attention, a physician may have to use an xray or an ultrasound to even find the device.

Mirena migration and perforation can cause severe injuries and unfortunately, women may not be aware of exactly what is going on. Some women suffer from these injuries for months or even years before seeking medical attention.

The defective medical devices lawyers at JONES WARD PLC are currently evaluating Mirena cases. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Medicine should make us feel better. Usually it does. Unfortunately, however, if a doctor writes you a prescription for a pill, you may end up worse off than you were before. In our pill-obsessed culture, we sometimes turn to prescription medication when we don't need it, or we don't pay enough attention to harmful side effects. Can't concentrate? Take a pill. Feeling a minor ache or pain? Take a pill. Feeling sleepy? Take a pill? Can't fall asleep? Take a different pill.

The wonders of modern science have brought us many fantastic medicines. However, the lawyers at Jones Ward PLC understand all too well the devastating side effects of some of these pills, especially when they are overprescribed, sold off label, or put on the market following inadequate or misleading studies. Here's a short list of medicines that Jones Ward attorneys have pursued in legal claims related to unintended side effects.

• Yaz, Yasmin and Ocella (birth control) - may cause blood clots and heart attacks
• Paxil (anti-depressant) - may lead to birth defects if taken during pregnancy
• Mirapex (treatment of Parkinson's disease) - compulsive gambling
• Risperdal (bipolar disorder) - causes dangerous side effects in young boys, including massive weight gain and in some cases gynecomastia, or the growth of breasts.
• Actos (diabetes) - may cause bladder cancer.
• Reglan (gastric reflux) - tardive dyskinesia.

The hazards of prescription medication were further driven home in a terrific story in today's Sunday edition of The New York Times. The story, "Drowned in a Stream of Prescriptions," details how an otherwise healthy and bright young college student became addicted to Adderall and ultimately committed suicide. Sadly, some of these types of injuries could be prevented by better warnings or more careful marketing. But in the drive to boost their profits, big pharmaceutical companies often cut corners or don't inform consumers about all of the risks associated with their products.

If you or a loved one have been injured by a prescription drug, contact Attorney Alex Davis for a free case evaluation. In the meantime, please be careful about the medicines you take.

The news keeps getting worse for Johnson & Johnson, maker of the recalled DePuy ASR metal-on-metal hip implant.

In testimony yesterday in a California jury trial, DePuy's safety manager said the company took "inappropriate" steps to investigate risks in the design of 93,000 metal-on-metal hip implants. A company audit uncovered numerous problems with the DePuy ASR, the manager said. The ASR was recalled in August 2010. The trial in Los Angeles is one of the first of about 10,000 similar cases across the nation that could be headed to trial in the next year.

In separate testimony in the same case, the New York Times reported that a DePuy engineer, Graham Isaac, told the jury that DePuy had knowledge of the implant's design flaws as far back as 2005, before the device even hit the U.S. market.

The attorneys at Jones Ward PLC represent dozens of people across the country in Kentucky, Indiana, and other states who have been injured by the defective DePuy ASR hip implant and its similarly troubled cousin, the DePuy Pinnacle, as well as implants made by Biomet, Zimmer, Stryker, and other companies. If you or a loved one have been injured by a metal hip implant, contact attorney Alex Davis for a free case evaluation.

In one of the first full-blown trials over the defective and recalled DePuy ASR hip implant, witnesses for DePuy admitted that they knew about flaws with the implant device but the company continued to sell the product anyway.

Attorneys at Jones Ward PLC represent dozens of people who have been injured by defective DePuy ASR hip implants. Most of those people have been forced to undergo costly and painful revision surgery to have the implant removed. If it isn't taken out, the patient can get metallosis, a condition in which elevated levels of cobalt and chromium in the bloodstream cause bone and tissue damage.

More than 10,000 trials could take place across the country if DePuy and its parent company, Johnson & Johnson, do not offer fair settlements to plaintiffs. So far, they have offered reported settlements of more than $200,000 to patients, but those amounts would barely cover medical expenses and do little to pay for the years of pain and suffering that ASR recipients have endured.

In a story online, the Bloomberg news service reported the following about DePuy's attempts to cover up the truth about the defective ASR device:

Michael Kelly, the lawyer for the plaintiff in this week's trial, told a jury that "internal Johnson & Johnson documents show 37 percent of ASR hips failed after 4.6 years.

"I don't believe that was clinically relevant," he said.

Not clinically relevant? Wow. What would it take for DePuy and its hip implant team to believe that a failure rate this high would be relevant? Twenty times the rate of a competitor? One hundred times? It's sad when a company is so obviously putting money before customer safety. Fortunately, people who have suffered due to DePuy's "profits before people" business plan will be able to receive some compensation. If you or a loved one have been injured by a defective metal hip implant made by DePuy, Biomet, Stryker, or Zimmer, contact Attorney Alex Davis for a free case evaluation.

The Mirena IUD, an intrauterine device manufactured and sold by the pharmaceutical and medical device giant Bayer, has caused thousands of women to suffer significant and sometimes serious side effects. We recently blogged about a possible connection of Mirena and pseudotumor cerebri (also known as idiopathic intracranial hypertension or benign intracranial hypertension). You can read that blog post here.

Jones Ward is investigating these injuries associated with Mirena--an intrauterine system implanted in a patient by a healthcare practitioner and designed to provide contraception for up to five years. We have received several reports of women suffering from this disorder who had no signs or symptoms of the condition before being implanted with Mirena, manufactured by Bayer HealthCare Pharmaceuticals Inc.

Pseudotumor cerebri is a condition that affects the brain and mimics a tumor, but is not actually a tumor. According to experts, pseudotumor cerebri occurs when the balance of fluid surrounding the brain is disrupted, leading to elevated pressure in the skull. The fluid within and around the brain is constantly circulating and must be produced and removed at the same rate. When this balance is disrupted, the pressure increases. Often, the condition is diagnosed and in the short-term treated by a lumbar puncture, or spinal tap, which relieves the pressure by extracting some of the fluid that has built up.

It is more common in women, particularly obese women. The pressure built up in the skull can cause severe headaches or migraines and may swell the optic nerves (which connect a person's eyes to their brain). Thus, when the condition is not treated quickly, it can lead to permanent vision loss. Many patients symptoms begin with blurred vision or a "whoosing" sound or ringing in the ears.

Symptoms of pseudotumor cerebri include:

• Blurred vision
• Buzzing sound in the ears (tinnitus)
• Dizziness
• Double vision (diplopia)
• Nausea
• Vision loss

Fortunately, pseudotumor cerebri (PTC) is often reversible, and permanent vision loss or other problems may be prevented with early treatment. The condition has been associated with levonorgestrel, the hormone released by Mirena, as well as other birth controls (although not oral contraceptives, most of which, contains estrogen rather than levonorgestrel).

It appears the association between levonorgestrel and PTC has not been heavily evaluated in the publicly available medical literature. However, a quick google search of Mirena and PTC brings up dozens of forum websites containing hundreds of stories of real women suffering from this condition after being implanted with Mirena.

The defective medical devices lawyers at JONES WARD PLC are currently evaluating Mirena cases. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Bayer HealthCare Pharmaceuticals Inc., which distributes the Mirena intrauterine system (IUS), is reported to begin selling its newest IUS this February. On January 9, 2013, the United States Food & Drug Administration--responsible for overseeing medical devices and prescription drugs sold in this country--approved Bayer's newest contraceptive device, Skyla (levonorgestrel-releasing intrauterine system).

There are five obvious differences between Skyla and Mirena. First, Skyla is only indicated for the prevention of pregnancy (while Mirena is also indicated for heavy menstrual bleeding). Second, Skyla may be used for up to three years, instead of Mirena's five-year indication.

Third, Skyla is slightly smaller than Mirena, assumingly to make it more comfortable. Fourth, Skyla releases a smaller daily amount of levonorgestrel at 14 mcg/day as opposed to Mirena's rate of 20 mcg/day. Finally, and most importantly, Skyla is reportedly going to be recommended for women who have never given birth. This would allow Bayer to dominate an even greater share of the market by substantially increasing its target demographic.

The problem? We have been blogging heavily about Mirena and the range of severe injuries women have suffered because of it. Although Skyla might be smaller, it is likely Skyla users will experience some of the same problems and complications that Mirena users have reported. This is particularly significant in the case of Skyla because it will likely be used in younger women.

Mirena and Skyla are both t-shaped plastic devices intended to be inserted directly into a woman's uterus by her doctor. Both release levonorgestrel, a hormone, directly into the uterus to prevent contraception. Since Skyla has not been distributed yet, it is not entirely clear what sorts of problems and complications will arise.

However, Mirena users have reported severe injuries, many involving migration of the device from the uterus. Mirena may perforate the uterus and migrate to other parts of the body or become embedded in other parts of the body. Often, these conditions require surgery to remove the device. Some women have had to undergo hysterectomies because of the problems Mirena migration and perforation has caused.

We are also currently investigating whether Mirena is connected with a condition called pseudotumor cerebri, which is caused by fluid build up and swelling of the brain.

Jones Ward is currently evaluating Mirena IUD cases. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Jones Ward is currently reviewing and evaluating potential Mirena lawsuits concerning women who were implanted with the intrauterine contraceptive system (IUS) Mirena, and suffered injuries due to the device's tendency to migrate and perforate the uterine wall. If Mirena does migrate from the uterus, it can lead to embedment in other parts of the body.

Some women who have undergone implantation of the Mirena IUS have suffered serious injuries. Some have even experienced life-threatening side effects or had to undergo hysterectomies due to complications with the device.

Injured women across the country are suing Bayer, Mirena's manufacturer, for its failure to warn of the serious risks and for overstating the benefits of the Mirena IUS.

According to the lawsuits and adverse events regarding the Mirena IUD, the device may "migrate" from its original, implanted position after insertion, which may perforate the uterus or embed in the uterus. Mirena may also migrate outside the uterine cavity and cause lacerations and scarring. Not only do these complications require reparative surgery (to first, locate and remove the device), but they could also cause permanent infertility.

The Mirena IUS is manufactured by Bayer Healthcare Pharmaceuticals, Inc., a pharmaceutical company based out of New Jersey. IUDs have become a popular form of birth control due to their longevity (can remain for up to 5 years). Bayer is particularly known for its dangerous birth control products, including Mirena, Yaz and Yasmin.

The Mirena IUS is a small, t-shaped device made of plastic that is inserted into the uterus. The device releases a low dose of a hormone designed to prevent pregnancy. Mirena was first approved in 2000 and marketed primarily to women who have given birth. In 2010, the U.S. Food & Drug Administration admonished Bayer, stating Bayer overemphasized the device's efficacy and downplayed its side effects in parts of its marketing.

As reports of complications grow, so do claims that Bayer has failed to adequately warn of the potentially life-threatening side effects that may occur after implantation of the device.

Serious side effects that have been linked to Mirena include:

• Abscesses
• Birth of a child with a birth defect
• Embedment in the uterus
• Erosion of adjacent areas such as the vagina
• Infertility
• Inflammation of the membrane that lines the abdominal cavity and internal organs (Peritonitis)
• Intestinal perforations or obstruction
• Pelvic Inflammatory Disease
• Perforation of the uterus

The defective drug and device lawyers at JONES WARD are dedicated to bringing you the most up-to-date information regarding dangerous and defective devices, as it comes out. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

America's prescription painkiller epidemic is getting new scrutiny from a panel of the U.S. Food and Drug Administration.

Every year, hundreds of people across the nation, in states such as Kentucky, Indiana, Tennessee and West Virginia, die from overdoses on painkillers including hydrocodone and OxyContin. If you doubt the severity of the problem, take a look at this statistic: the United States accounts for 4.5% of the world population, but it consumes 99% of the world's hydrocodone.

An FDA advisory panel began a two-day conference yesterday to look at tightening the rules for prescribing hydrocodone. One proposal that is being made by the Drug Enforcement Administration would limit certain prescriptions of hydrocodone to a 90-day supply. Some refill prescriptions currently last as long as six months. The DEA also wants hydrocodone variations like Vicodin to be changed from Schedule III drug category to the more restrictive Schedule II class which is now used for OxyContin.

If you or a loved one have been injured as a result of an addiction to OxyContin, Vicodin, or another form of hydrocodone, call Attorney Alex Davis at Jones Ward PLC for a free case evaluation.

The DePuy ASR metal-on-metal hip implant has a failure rate of roughly 40 percent, according to one study, and a story in today's New York Times says the company tried to bury the information from patients and the public.

Attorneys from Jones Ward PLC and other law firms have reviewed millions of pages of documents from DePuy as they move closer to negotiating a settlement with the company over its defective and recalled ASR hip implants. Most of the details in those pages are confidential. The documents described in today's news story were just recently released from court files.

More of those insider details could become public over the coming months as the first trials over the ASR hip tragedy begin in state and federal court.

Here's an excerpt from today's newspaper article:

"An internal analysis conducted by Johnson & Johnson in 2011 not long after it recalled a troubled hip implant estimated that the all-metal device would fail within five years in nearly 40 percent of patients who received it, newly disclosed court records show.

The internal Johnson & Johnson analysis is among hundreds of internal company documents expected to become public as the first of over 10,000 lawsuits by patients who got an A.S.R. prepares to go to trial this week. The episode represents one of the biggest medical device failures in recent decades and the forthcoming trial is expected to shed light on what officials of Johnson & Johnson's DePuy Orthopaedics division knew about the device's problem before its recall and the actions they took or did not take."

The attorneys at Jones Ward PLC represent people across Kentucky and Indiana, as well as Florida and North Carolina, who have been injured by failed DePuy ASR hips over the last few years. In most cases, the only remedy for a failed metal hip is to have it removed from the patient's body in a costly and painful process called revision surgery.

If you or a loved one have been injured by a defective hip implant, whether it is a DePuy ASR, a DePuy Pinnacle, or a product made by Stryker, Zimmer, or Biomet, contact Attorney Alex Davis for a free case evaluation.

People injured by defective metal-on-metal hip implants made by DePuy Inc. would share more than $2 billion under a proposed settlement that would be finalized later this year.

The attorneys at Jones Ward PLC represent people across Kentucky and Indiana, as well as Florida and North Carolina, who have been injured by failed DePuy ASR hips over the last few years. In most cases, the only remedy for a failed metal hip is to have it removed from the patient's body in a costly and painful process called revision surgrery.

DePuy, a subsidiary of mega-company Johnson & Johnson, faces more than 10,000 lawsuits over its recalled implants. The company also makes the DePuy Pinnacle hip implant. The proposed settlement only involves the ASR, and not the Pinnacle. Bloomberg News reported this morning that the potential settlement with patients might eventually total more than $2 billion.

That would mean more than $200,000 a case. In my view, that's not nearly enough for people who have been permanently injured by these defective products, and in some cases lost years of their lives due to health problems associated with metallosis and other side effects.

Today's story by Bloomberg says the settlement discussions won't be finished until after the first trials of the lawsuits start. Some begin next week, and more are set for February and May.

More than 7,200 of the cases, including those being handled by Jones Ward PLC, are consolidated in federal court in Ohio. More than 2,000 other cases are in California state court in San Francisco.

Attorneys involved in the litigation have reviewed more than 50 million pages of documents. Bloomberg reported that the first trial starts Jan. 23 in Los Angeles; the second begins in February in Chicago; a third is scheduled for May in Ohio.

The settlement talks will probably produce a deal that would pay injured patients based on factors such as their age, the extent of their injuries and whether they had one or more surgeries to replace their failed ASR implants, Bloomberg reported.

If you or a loved one have been injured by a defective hip implant, whether it is a DePuy ASR, a DePuy Pinnacle, or a product made by Stryker, Zimmer, or Biomet, contact Attorney Alex Davis for a free case evaluation.

For those of you who follow this blog, you know I have been blogging extensively about the Mirena intrauterine system, Bayer's popular (and lucrative) IUD contraceptive system that has injured thousands of women. Most recently, I posted about the New Jersey Supreme Court's denial of Bayer's request for consolidation of Mirena cases in a New Jersey state court, and the subsequent motion, filed by plaintiffs in Ohio, to consolidate Mirena into a multidistrict litigation in the U.S. District Court for the Northern District of Ohio. You can read those blogs here and here.

Today, I want to do something different. I want to share the story of a brave mother of two who suffered severe injuries from using Mirena. Her name is Kristi.

Mirena users who have already been injured may be familiar with her blog, My Life After Mirena. On her second blog entry, she chronicles her Mirena story. Just a few paragraphs in and you can tell that this woman was not just injured by Mirena, she is a Mirena survivor.

After having her second child, and on her doctor's advice, Kristi had the Mirena IUD implanted. As many women are led to believe, she was told that Mirena was the top-of-the-line, convenient birth control for women who have had at least one child. Having had Mirena before without problem, when she started having severe and life-altering symptoms, she did not immediately connect them to Mirena. She details the symptoms she started suffering from in her second post, including anxiety attacks, trouble breathing, blurred vision, elevated heart rate and overall "fogginess."

On her blog, she talks about discovering that she suffered from silicone poisoning three months after Mirena was removed and the "turbo detox" sessions that she underwent to get rid of it.

She also blogged about discovering a connection between Mirena and pseudotumor cerebri (see my blog post here for more information on the link between Mirena and PTC). Although her doctors assured her she did not have PTC, she still has not regained her vision in her right eye. She also went through significant testing to discover if she had developed multiple sclerosis or an autoimmune disorder. On a post from October 2012, she tells her readers that her doctors have not ruled out MS, but haven't confirmed it either.

She still has bad days filled with pains and aches. She talks about "relapses" in her health. But fortunately, after the device was removed and she sought medical attention, she is finally seeing some relief from some of her symptoms.

Kristi's story is particularly noteworthy because she did everything right. She is the exact demographic the device is marketed to. Doctors are told she is the perfect candidate. She had the device implanted at least six weeks post-partum. When she began experiencing some of the symptoms she has detailed, she sought medical attention and eventually, the device was removed. Despite all this, she suffered from severe injuries for years, even after the device was removed.

In her latest blog post, from December 2012, she offers some words of comfort to those still suffering. Recently obtaining her master's degree, she tells women, 25 months after her Mirena removal, "Overall....I have my life back."

I wanted to briefly share Kristi's story because so many women are suffering from the same symptoms and experience with Mirena. I encourage anyone looking to read a real-life story of a woman who suffered real and dibilitating Mirena injuries to check out her blog.

For more information about Mirena injuries and litigation, contact attorney A. Layne Stackhouse at layne@jonesward.com.

On January 16, 2013, plaintiffs Stephanie Barnett and Kevin Crawford moved for consolidation of all federal court actions currently pending and subsequent actions filed alleging claims against Bayer HealthCare Pharmaceuticals Inc. for injuries women have sustained from use of Bayer's Mirena intrauterine system.

The motion requests that the Judicial Panel on Multidistrict Litigation order that the cases be consolidated under one judge, Judge Patricia A. Gaughan, in the United States District Court for the Northern District of Ohio, Eastern Division.

Bayer is facing at least eight lawsuits in federal courts across the country claiming injuries from Mirena. This is in addition to the sixteen or more cases in the Morris County Superior Court in New Jersey.

Most of the lawsuits have been filed in the past year. All of the cases claim the women have suffered severe injuries from complications that arose after the IUDs were implanted. The Mirena IUD is a small, t-shaped plastic device that is implanted by a doctor in a patient's uterus. The lawsuits claim that the IUDs caused complications like puncturing the uterus, migrating to other parts of the body, severe infections, significant pain and other injuries.

The motion states that consolidating pre-trial proceedings will help preserve judicial resources, avoid duplicative discovery and prevent inconsistent rulings from different judges across the country in similar cases. A "MDL" or multidistrict litigation aims to achieve these goals by centralizing all pre-trial matters in one court, under one judge, who makes decisions regarding all of the cases.

This recent push for consolidation comes after Bayer's request for centralization in a New Jersey state court, the Middlesex County Superior Court, was denied. You can read more about that here.

If the Panel agrees to consolidate the cases, they will be handles similar to a class action, in that discovery, or the exchange of information relevant to the cases, would be coordinated by one adjudicator, and the judge overseeing the MDL would rule on all pre-trial motions. However, each case would be tried individually and each plaintiff would still have to prove facts specific to her case. Two Mirena cases are currently pending in the Northern District of Ohio. The motion states that several other attorneys across the country are intending on filing more cases.

The injuries caused by Mirena are serious. Not only can Mirena lead to the severe complications mentioned above, but Jones Ward has received reports it can also cause pseudotumor cerebri (PTC), a disorder that leads to swelling of the brain. You can read more about Mirena and PTC here. We've been blogging extensively about Mirena and the pending litigation. To read more about the injuries described above, click here.

Jones Ward is currently evaluating Mirena IUD cases. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Last August, Bayer HealthCare Pharmaceuticals, Inc., one of the major Big Pharma and Device players and manufacturer of the Mirena intrauterine device system, wrote a letter to Judge Glenn A Grant, Acting Administrative Director of the New Jersey Courts, requesting that lawsuits pending in a New Jersey state court be consolidated.

Bayer sought Centralized Management of sixteen cases filed in the Morris County Superior Court. The company requested that the cases be centralized in the Middlesex Superior Court, which has a Mass Tort Court, and is the closest Mass Tort Court to Morris County, the county where Bayer's United States Headquarters are located.

In Bayer's own words, all sixteen cases contained "similar allegations of damages following use of this product [Mirena]." Specifically, "[i]n each of the matters currently pending in Morris County, the female plaintiffs allege to have had a Mirena® device inserted and allege injuries and/or damages as a result of misplacement of the device." Bayer also noted seven additional cases pending in other courts across the country, in South Carolina, Louisiana, Missouri, Texas, Georgia and New York.

Centralized Management means consolidation of pre-trial matters under one judge, in one court. The purpose of consolidation allows the parties in all cases to share information and gives one judge the authority to adjudicate pre-trial matters. A "Mass Tort Court" is a court that handles consolidated mass tort proceedings. Many prescription drug and medical device cases are mass torts because they involve one product and are not localized to one particular jurisdiction, or place.

On January 8, 2013, the New Jersey Supreme Court denied Bayer's request, determining that "all Mirena Contraceptive Device cases should continue to be filed in the appropriate counties of venue."

The Mirena IUD is a long-term contraceptive device inserted by a doctor directly into a woman's uterus. Approved for contraception by the FDA in 2000, it is estimated to have been implanted in nearly 2 million women in the U.S. and 15 million women worldwide. In 2009, Mirena the FDA approved Mirena for use in women with heavy menstrual bleeding.

In 2009, the FDA warned Bayer in a letter that its direct-to-consumer marketing campaign overstated the efficacy of Mirena and downplayed its side effects. It also warned Bayer that its representations that Mirena can make a women "look and feel great" and improve her sex life were unsupported by clinical evidence.

Women using Mirena have alleged a variety of injuries caused by the device, including migration of the IUD from the uterus and subsequent complications. Those complications can include perforation of internal organs. JONES WARD has received reports of women suffering from pseudotumor cerebri (PTC), a disorder that causes swelling of the brain, associated with Mirena. We blogged about Mirena and PTC here.

Jones Ward is currently evaluating Mirena IUD cases. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

The Mirena IUD, an intrauterine device manufactured and sold by the pharmaceutical and medical device giant Bayer, has caused thousands of women to suffer significant and sometimes serious side effects.

JONES WARD is currently evaluating Mirena claims by women injured by the system. Most recently, we have been receiving reports of women who suffer from pseudotumor cerebri, also known as idiopathic intracranial hypertension or benign intracranial hypertension, after being implanted with Mirena.

The condition, according to PubMed Health, a service of the U.S. National Library of Medicine, is a "process affective the brain that appears to be--but is not--a tumor. It is often reversible." The condition arises when fluid in the brain builds up and causes pressure. Although experts say it occurs more often in obese women approaching menopause, we have heard of several cases of young, healthy women suffering from pseudotumor cerebri post-Mirena implantation.

Symptoms of pseudotumor cerebri include:

• Blurred vision
• Buzzing sound in the ears (tinnitus)
• Dizziness
• Double vision (diplopia)
• Nausea
• Vision loss

PubMed Health also advises that symptoms may get worse during physical activity, especially when you tighten the stomach muscles. Woman may suffer severe and prolonged migraines due to onset of pseudotumor cerebri.

If these symptoms do occur, patients are advised to immediately seek a doctor's attention. A doctor testing for pseudotumor cerebri may conduct several tests, including: CT scan of the head, eye exam, MRI of the head, or a lumbar puncture (spinal tap). The condition includes increased pressure in the skull. A spinal tap may relieve pressure in the brain and alleviate vision problems.

Other treatments include: fluid or salt restriction, medications such as corticosteroids, acetazolamide or furosemide, shunting procedures to relieve pressure from spinal fluid buildup, surgery to relieve pressure on the optic nerve, or weight loss.

PubMed Health reports that the condition may disappear on its own within 6 months. However, roughly 10-20% of patients have their symptoms return and a small number of patients have symptoms that get slowing worse and lead to blindness.

According to Drugs.com, levonorgestrel (the hormone released by Mirena), is contraindicated, or never to be used, in patients with a current or past history of pseudotumor cerebri.

The defective medical devices lawyers at JONES WARD PLC are currently evaluating Mirena IUD cases. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Metal-on-metal hip implants made by companies such as DePuy, Zimmer, and Biomet would be subject to a sales ban under a new proposed order from the U.S. Food and Drug Administration.

Under the new rule, announced Thursday, all medical device manufacturers would be barred from selling metal-on-metal artificial hip joints until they are able to provide statistics proviing the safety of the products. Thousands of people across the United States have been injured by metal hips over the last five years. Some of the most problematic models include the DePuy ASR, the DePuy Pinnacle, the Biomet Magnum, the Zimmer Durom, and the Stryker Rejuvenate. Some of those models, such as the ASR and the Rejuvenate, have been recalled.

Under the FDA's new rule, manufacturers such as DePuy or Biomet that want to market new metal-on-metal products would have to conduct human test trials to measure the safety of the devices. As a lawyer representing hundreds of injured hip implant recipients in dozens of states, I believe this rule makes sense. Too many hip device manufacturers have rushed metal-on-metal products to market, only to find that after a few years the failure rates for the devices are substantially above acceptable levels.

For patients, the consequences can be devastating. Elevated levels of cobalt and chromium can lead to a condition known as metallosis, which causes bone and tissue damage along with kidney impairment and neurological injuries including memory loss and coordination problems. Here's the way the FDA describes the problem:

"In metal-on-metal hip implants, the metal ball and the metal cup slide against each other during walking or running. Metal can also be released from other parts of the implant where two implant components connect. Metal release will cause some tiny metal particles to wear off of the device around the implant, which may cause damage to bone and/or soft tissue surrounding the implant and joint. This is sometimes referred to as an "adverse local tissue reaction (ALTR)" or an "adverse reaction to metal debris (ARMD)."

If you or a loved one have been injured by a defective metal hip implant, or if you simply want to learn more about the dangers of these devices, contact Attorney Alex Davis for a free consultation. If you want to read more about the FDA's new proposed rules, check out this Wall Street Journal article by clicking here, or visit the FDA's site, which contains this extensive background on metal hip problems.