The Recall Lawyers

Jones Ward is currently reviewing and evaluating potential Mirena lawsuits concerning women who were implanted with the intrauterine contraceptive device (IUD) Mirena, and suffered injuries due to the device's tendency to migrate and perforate the uterine wall.

Some women who have undergone implantation of the Mirena IUD 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 IUD.

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 IUDs 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 IUD is manufactured by Bayer Healthcare Pharmaceuticals, Inc., a pharmaceutical giant 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).

The Mirena IUD 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.

Honda has decided to recall roughly 800,000 minivans and SUVs due the vehicles' keys being able to be removed when the vehicle isn't in park, which can lead to vehicles rolling away.

Normally, it should be impossible to take the key out of the ignition unless the automatic transmission's gear selector is in park, prohibiting the wheels from beginning to roll.

However, in some Honda vehicles subject to the recall, the mechanism that locks the key into the ignition can wear out. This problem is especially frequent if drivers repeatedly attempt to remove the key when the vehicle is not in park.

Fortunately, Honda has assured investigators that even in vehicles where the mechanism was wore out, the key will not be removable if the vehicle's engine is running.

The recall includes roughly 318,000 Honda Odyssey minivans and 259,000 Pilot SUVs from the 2003 and 2004 model years. Nearly 230,000 Acura MDX SUVs from the 2003 to 2006 model years are also subject to the recall.

So far, Honda has reported a small number of accidents due to the problem, including two resulting in injuries.

American Honda will notify owners of affected vehicles in early February. Owners will be asked to take their vehicles to a dealer to have the problem fixed at no charge. Until the recalls are fixed, Honda owners are recommended to ensure their vehicles are in park every time before attempting to remove the key from the ignition.

The motor vehicle recall lawyers are dedicated to bringing you up-to-date information regarding vehicle recalls. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Wing Enterprises has issued a recall for its Switch-it Type 1A Stepladder and Stepstool combination ladders. The Switch-it is an aluminum ladder that can be extended from a 2-foot stepstool to a 6-foot stepladder. According to reports, the inner side rails can separate from the outer side rails causing the user to fall.

Recalled Switch-it stepladder/stepstools have the following date stamps: 10622S, 10623S, 10624S, 10721S and 10722S. The date stamp is located immediately below the orange locks on the outer rails. To avoid possible injury, consumers should stop using the recalled ladders immediately.

The recalled ladders were sold nationwide from August 2012 to October 2012.
If you have any questions, contact attorney Terrance Massey at Jones Ward PLC.

Baby Jogger LLC recently issued a recall for its Baby Jogger City Versa stroller. The stroller frame can fail to lock in place and collapse while in use, posing possible injury to children in the stroller. As of today, at least six incidents have been reported.

All Baby Jogger City Vera's manufactured between May 15 and August 20, 2012 are included in this recall. Consumers can find the date of manufacture on the stroller's black plastic side hinge. For more information, contact attorney Terrance Massey at Jones Ward PLC.

Last week, the U.S. Food & Drug Administration (FDA) issued a safety update concerning the smoking cessation drug Chantix (varenicline). The FDA recently conducted a combined analysis (known as a meta-analysis) of clinical trials comparing the results of patients treated with Chantix to those of patients who received a placebo, or an inactive treatment.

The meta-analysis found that patients treated with Chantix had a higher occurrence of major adverse cardiovascular events, including cardiovascular-related death, nonfatal heart attack, and nonfatal stroke over patients receiving placebos.

The report concluded that the increased risk was small and major cardiovascular events were uncommon to both treatment groups, but the FDA deemed the meta-analysis results worthy of issuing a safety update. The FDA has yet to state that Chantix definitively increases the risk of major cardiovascular events.

Chantix was approved in 2006 as the first prescription medication to aid in quitting smoking. The drug works by blocking the effects of nicotine on the brain. The FDA first notified the public about Chantix and a possible increased risk of cardiovascular problems in June 2011. The agency required Chantix's manufacturer, the pharmaceutical giant Pfizer, to conduct the meta-analysis for further evaluation of the cardiovascular safety of the drug.

The FDA recommends that health care professionals be informed about the results of the meta-analysis and to carefully weigh the risks of Chantix against its benefits when deciding to prescribe it for an individual patient.

The defective drug lawyers at JONES WARD handle a variety of dangerous drug cases. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

We've been blogging regularly about the Mirena IUD litigation, which is heating up in New Jersey and other courts across the country. You can read our earlier posts here and here.

As the litigation advances, more and more is being uncovered about Mirena's manufacturer (Bayer HealthCare Pharmaceuticals, Inc.) and its ploys to promote the device to ensure a high profit margin.

Most notable, in 2010, U.S. Food & Drug Administration--the federal agency responsible for regulating prescription drugs and medical devices--issued a warning to Bayer concerning its live consumer-directed program entitled "Mirena Simple Style Statements Program."

Specifically, the FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC) warned that:

"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 FDA took issue with marketing claims that the Mirena IUD could enhance a women's sex life or help her "look and feel great." This conclusion is especially significant in light of the fact of frequent reports that the device actually caused weight gain, breast tenderness, and acne as less serious side effects.

The plaintiffs who have sued Bayer for its false and misleading statements concerning the Mirena IUD allege claims similar to those concluded by the FDA's warning. The pending lawsuits allege Mirena-using women suffered serious and permanent physical injuries, including sexual problems. The plaintiffs also allege that Bayer misrepresented Mirena in its marketing campaigns as being the best birth control option for "busy moms," yet Bayer failed to disclose Mirena's harmful side effects.

The dangerous medical device lawyers at JONES WARD are equipped to handle cases involving injuries from the Mirena IUD. We are 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 device (IUD) Mirena, and suffered injuries due to the device's tendency to migrate and perforate the uterine wall.

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

With over 20 lawsuits already filed in New Jersey, Bayer HealthCare Pharmaceuticals, Inc., Mirena's manufacturer, has requested that the New Jersey Supreme Court centralize and consolidate the cases into one multicounty litigation proceeding in Middlesex County. Bayer's HealthCare Division is also headquartered in Middlesex County, which may encourage the Court to consolidate there.

However, more and more cases have been filed across the country, including in federal courts in Ohio and California. If the cases do get consolidated, whether in a New Jersey state or federal court, it will allow a large number of plaintiffs claiming similar facts and injuries to benefit from combined pre-trial proceedings. Although each case will get individual attention if and when they go to trial, multidistrict litigation streamlines the pre-trial process so all parties can avoid costly and repetitive discovery of information and trial preparation.

The Mirena IUD, approved by the U.S. Food & Drug Administration in 2009, is a small, t-shaped plastic device inserted into a woman's uterus to prevent pregnancy. It was also approved to provide relief to women who wanted to use an IUD as contraceptive and have heavy menstrual bleeding.

The lawsuits allege that Bayer misrepresented the risks of the device and overstated its benefits. In addition to severe complications caused by migration of the device from the uterus, the Mirena IUD has been linked to a variety of problems. According to the FDA, Mirena side effects may include: ectopic pregnancy (a pregnancy in which the fertilized egg grows outside the uterus), intrauterine pregnancy (a pregnancy with Mirena in place), group A streptococcal sepsis, an infection called pelvic inflammatory disease, embedment of the device in the uterine wall and perforation of the uterine wall or cervix.

When such a problem occurs, surgery to remove the device is usually required. Some women have even had to undergo hysterectomies due to adverse effects from the Mirena IUD.

The defective drug and device lawyers at JONES WARD will be sure to provide regular updates on the Mirena litigation. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Jones Ward PLC partner, Lawrence L. Jones II, has been appointed by United States District Court Judge Robert Miller, Jr. to serve on the Plaintiff's Steering Committee for In re: Biomet M2a Magnum Hip Implant Products Liability Litigation, MDL 2391. The Plaintiff's Steering Committee is a select group of lawyers from around the country who are appointed by the judge to pursue the lawsuit against Biomet on behalf of other lawyers who have filed cases related to the Biomet M2a Magnum metal-on-metal hip implant device.

Larry Jones said, "I am honored that Judge Miller appointed me to serve in such a prestigious position. I take my steering committee duties very seriously and I'll work night and day to make sure that those who have been injured by the Biomet M2a Magnum metal-on-metal hip implant get justice." Jones, continued, "Nearly all of our clients have been required to have revision surgeries because they have been suffering from heavy metal toxicity, high chromium and cobalt levels, metallosis, pain, grinding, popping, dislocation and pseudo-tumors caused by their metal-on-metal hip." Like other metal-on-metal hip makers, Biomet's M2a Magnum suffers from a defective design that should have never been implanted in the thousands around the United States who have them.

Defective hip implants, like the M2a Magnum, DePuy ASR and the Stryker Rejuvenate have wreaked havoc in the medical community as doctors try to figure out how to save their patients from the horrible pain associated with metal poisoning.

The defective hip implant team at Jones Ward PLC is at the forefront of the metal-on-metal hip implant litigation, representing clients all across the United States. If you have questions about your metal-on-metal hip implant, Larry Jones will answer your questions. Just email them to larry@jonesward.com and get an immediate response from Larry.

More and more women injured by the Mirena IUD--an intrauterine device manufactured by Bayer Corporation--are filing lawsuits alleging the manufacturers failed to warn of serious and potentially life-threatening side effects.

Specifically, the lawsuits point to spontaneous migration of the device from the uterus (where it is implanted), which can lead to invasive surgery, including hysterectomy. The complaints allege that Bayer has failed to warn physicians and OB-GYN doctors of the side effects. Physicians are the parties responsible for warning consumers. But if the physicians are never adequately warned by the manufacturer--who is required to warn them by law--then they never even have the opportunity to warn their patients.

As a resource to our readers, we wanted to provide an overview of the Mirena IUD:

What is the Mirena IUD?

The Mirena IUD, like other IUDs, is a small, T-shaped plastic implant that it inserted surgically by a doctor. It is a medical device used for contraception.

How does it Work?

Although even IUD manufacturers are not entirely clear how the devices work, it is believed that they may thicken cervical mucus, thin the uterine lining, inhibit sperm movement and reduce sperm survival. Mirena is marketed as a long-term contraceptive. It is intended allow a user to avoid pregnancy for up to five years.

What are the Side Effects?

Spontaneous migration of the device from the uterus has become a major health problem to Mirena's users. This side effect can lead to all sorts of serious complications (which now form the basis of many lawsuits), including:

• 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

Less serious side effects include: amenorrhea, intermenstrual bleeding and spotting, abdominal/pelvic pain, ovarian cysts, headache/migraine, acne, and depressed/altered mood.

What do the Lawsuits Allege?

Mirena lawsuits have begun popping up all over the country in federal and state courts. Most claim that Mirena's manufacturer failed to warn of the dangers and potential complications associated with spontaneous migration of the device (which is not listed as a warning on the device's label). Injured Mirena users also allege Bayer overstated the safety and efficacy of the device while understating the risks.

In 2009, the Department of Health and Human Services' Division of Drug Marketing, Advertising and Communications determined that Bayer's marketing program called "Simple Style Program", which promoted Mirena to busy moms, made unsubstantiated claims concerning the device.

As further information is revealed, we will be sure to keep you updated. The defective drug lawyers at JONES WARD handle a variety of dangerous medical device and birth control cases. We are currently evaluating potential Mirena cases. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

There are lots of dangerous drugs out there, from Risperdal and Lipitor to birth control pills such as Yaz, Yasmin, and Ocella.

For patients, the side effects caused by some of these pharmaceutical products can be devastating. But it really underscores the hazards of some medication when a judge rules that a drug company's manager should face criminal charges. That's what happened this week when a French court charged a drug executive with manslaughter due to his involvement in marketing a diabetes and weight-loss drug that caused heart damage.

According to a story in The New York Times, Jacques Servier and six companies of the Servier group are accused of having known the risks associated with the drug, Mediator, which they produced and marketed until it was pulled from store shelve in 2009.

Investigators say Mediator may be connected to as many as 2,000 deaths in France. Two related weight-loss products made by the Servier pharmaceutical group were at the core of the fen-phen controversy in the United States.

The lawyers at Jones Ward PLC represent hundreds of people across the nation who have been injured by defective or recalled prescription medication. If you have questions about a drug injury, call Attorney Alex Davis for a free case evaluation.

A study released late last month suggests that four commonly prescribed drugs used to treat schizophrenia, dementia, bipolar disorder and other mental conditions may be less safe and effective when used long-term in older adults.

Specifically, the study, published in the Journal of Clinical Psychiatry, looked at Abilify (aripiprazole), Zyprexa (olanzapine), Seroquel (quetiapine) and Risperdal (risperidone). All four are called "atypical antipsychotics" approved by the U.S. Food & Drug Administration (FDA) for treatment of schizophrenia and bipolar disorder.

But according to experts in the medical community, doctors often prescribe these prescriptions "off-label", or for indications not approved, and therefore, not tested, by the FDA. Off-label use of the drugs are reportedly common for people with dementia, post-traumatic stress disorder (PTSD) and other mood disorders. The drugs allegedly help alleviate symptoms of psychosis, anxiety, agitation and aggression.

The study examined 332 patients, all over the age of 40, who had been diagnosed mental health problems indicated for the drugs and who also had psychotic symptoms. Among the findings, the study noted that the risk of cardiovascular disease increases with age and likewise may increase due to use of the drugs. According to the investigators, several patient involved in the study dropped out early due to adverse effects stemming from the prescription drug use, or lack of improvement.
Serious adverse events included death, hospitalization for pneumonia and other disorders, and emergency room visits for problems such as confusion, disorientation and markedly disorganized behavior. Other side effects included restlessness and agitation, drowsiness, and constipation or diarrhea.

Researchers were also concerned about an increased risk of development of metabolic syndrome in patients. Metabolic syndrome refers to a collection of symptoms that may increase the risk of a patient developing heart disease and diabetes. In the study, one-third of the patients developed metabolic syndrome within a year.

The dangerous drug lawyers at JONES WARD are dedicated to providing up-to-date information concerning prescription drugs. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Last week, British researchers released the results of a study investigating the risks of benzodiazepines, a widely prescribed class of sedatives. The investigators report that benzodiazepine-users may be putting themselves at a greater risk for developing pneumonia, a potentially life-threatening inflammatory lung infection. Perhaps more significant, they may also be putting themselves at a greater risk of dying from the infection.

The most popular benzodiazepines, and the drugs studied, include Halcyon, Librium, Valium and Xanax (shown right). Benzodiazepines are usually prescribed for anxiety, epilepsy, muscle spasm and insomnia.

Researchers suggest that further study is needed to discover the increased risk of pneumonia. The authors hope the study will prompt more research of the issue, including randomized, controlled trials and cohort studies. The report was published online December 5th in the journal Thorax.

Investigators looked at medical records of patients whose data was included in the Health Improvement Network Database, a large database of medical information collected at primary care clinics in the U.K.

More specifically, the researchers scoured nearly 5,000 records of patients diagnosed with pneumonia between 2001 and 2002. Those records were compared to nearly 30,000 of records of patients who did not contract the infection.

Among the studies findings, researchers note that patients who were diagnosed with pneumonia were more likely to have been diagnosed with the infection before, along with other serious medical problems like heart attack, depression and psychosis. Smokers were also more at risk.

The findings indicated that benzodiazepines were associated with a 54 percent increased risk of developing pneumonia. Librium was not associated with a greater risk. Further findings concluded that the risk of death within a month after contracting pneumonia was 22 percent higher among patients taking benzodiazepines.

Looking at specific patient populations, it is important to note that the elderly are both at a greater risk of developing pneumonia and are more widely prescribed benzodiazepines.

The researchers note that doctors should be more hesitant in prescribing the drugs for generalized and widespread issues like anxiety when there are other options to try first.

The defective drug lawyers at JONES WARD handle a variety of dangerous drug cases. If you or a loved one has been injured, please give us a call. For more information, contact attorney A. Layne Stackhouse at layne@jonesward.com.

Metal-on-metal hip implants made by DePuy, Biomet, Stryker and other manufacturers have been linked to a growing number of problems in patients over the last five years. Now, a report from the FDA shows these defective implants may also be tied to increased risk of depression, cancer, and neurotoxicity.

The problem with metal-on-metal, or MoM, hip devices is that the components can rub against each other over time, causing tiny particles of cobalt and chromium to be shed into the bloodstream. The health problems caused by this process can lead to a condition called metallosis. Ultimately, the problems posed by metallosis may force the patient to go through a costly and expensive second surgery to have the hip implant removed. The implant manufacturers like to call this second surgery a "revision" to make it sound less horrifying.

The new report from the FDA confirms a range of health problems linked to revision surgery that many in the legal and medical communities already knew about it, including potential nerve damage and deep vein thrombosis. But the report, issued by the FDA's Orthopaedic and Rehabilitation Devices Advisory Panel, also shows some other potential hazards of metal hips that patients should understand. Although there is a need for additional research on this issue, some studies show a higher rate of cancer and neurotoxicity in metal hip patients, while others experienced problems including vision and hearing loss, vertigo, and cognitive decline. It's also common for metal-on-metal hip patients to experience severe hip pain and loss of mobility, which can lead to depression. This is really no surprise to anyone with major hip problems. Also, as a lawyer representing dozens of hip implant recipients across the nation, I know all too well that people suffering from metallosis are frustrated and angry about not being able to participate in daily activities such as shopping, or even doing the laundry that they once took for granted. For many people with a failed implant, it's impossible to get a good night of sleep, to be sexually intimate with their partner, or drive a car. If you want to read the full FDA report, just click here.

The attorneys at Jones Ward represent patients across the nation with defective metal-on-metal implants, including the DePuy ASR, DePuy Pinnacle, Biomet Magnum, Stryker Rejuvenate, Zimmer Durom, and others. If you or a loved one have been injured by a defective hip implant, call Attorney Alex Davis for a free case evaluation.

At least five infant deaths have prompted the United States Consumer Product Safety Commission (CPSC)--in charge of regulating the safety of consumer products--to sue the manufacturer of the "Nap Nanny" to get it to acknowledge the defective nature of the product and to reimburse consumers.

The agency filed an administrative complaint Wednesday alleging the manufacturer's new model of the Nap Nanny, called the Chill, and two earlier versions, "pose a substantial risk of injury and death to infants." The CPSC is seeking an order to require the manufacturer, Baby Matters LLC, to notify the public of the product defect and to offer consumers a refund.

The agency has reported it is aware of four infant deaths due to the Nap Nanny Generation Two recliner and one from the Nap Nanny Chill. Another 70 reports of falling out of the portable foam baby recliners (shown right) have been received by the CPSC.

The first two versions of the recliners were recalled in July of 2010 after one infant death and 22 reports of infants hanging out of or falling over the side. Currently, Baby Matters' website states that the Nap Nanny has gone out of business and thus, no more are being sold. The website also indicates no returns or refunds will be provided right now.

At least Five thousand Nap Nanny Generation One and 50,000 Generation Two models were sold between 2009 and early 2012. About 100,000 Chill models have been sold since January 2011.

The dangerous product lawyers at JONES WARD are equipped to handle these types of product injury claims. If you or a loved one has been injured, please give us a call. 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 device (IUD) Mirena, and suffered injuries due to the device's tendency to migrate and perforate the uterine wall.

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

Most frequently, the device may "migrate" from its original, implanted position after insertion, which may perforate the uterus or embed in the uterus. Mirena IUDs 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 IUD is manufactured by Bayer Healthcare Pharmaceuticals, Inc., a pharmaceutical giant 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).

The Mirena IUD 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. If you or a loved one has been injured, please give us a call. For more information, contact attorney A. Layne Stackhouse at or layne@jonesward.com.