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Xarelto Lawsuit Filed Over Bleeding Risks And Injuries

August 13th, 2014

Virginia Stuntebeck sued Johnson & Johnson and Bayer AG in Pennsylvania Court earlier this year, alleging that she suffered severe internal bleeding stemming from use of the blood-thinning drug Xarelto. In the Xarelto lawsuit, which appears to be the first tort suit filed over the medication in Philadelphia, Stuntebeck said the drug should not be sold because of the high risks surrounding its use.

Xarelto-pill_MainStuntebeck confessed that she was hospitalized in February 2013 for severe internal and gastrointestinal bleeding as a result of using the drug. As the manufacturers and distributors of Xarelto, Johnson & Johnson knew or should have known that Xarelto use was associated with irreversible bleeds. Stuntebeck’s lawsuit claims the warning label on Xarelto fails to properly convey the true risks of the drug as it relates to uncontrolled bleeding events and other serious injuries including death.

Xarelto is now being likened to its competitor Pradaxa which is the subject of more than 2,000 injury lawsuits in a multidistrict litigation and occasionally referred to as “the most complained about drug” in the U.S.

Both Pradaxa and Xarelto claim in their marketing that you don’t need to monitor a patient taking the drug to prevent blood clots and stroke. This is supposedly an advantage of these blood thinners since the more well-established anticoagulant warfarin (Coumadin) frequently requires medical monitoring and doctor supervision.

28367The U.S. Food and Drug Administration originally approved Xarelto in July 2011 to reduce the risk of blood clots and pulmonary embolism. They extended the recommendation to include the treatment of abnormal heart rhythm or a-Fib which leads to strokes later that same year. But the subsequent approval was against the recommendation of FDA staff who noted serious safety concerns with Xarelto. Recently, the FDA has refused a third expansion of the Xarelto’s use.

At Childers, Schlueter and Smith LLC, we feel that drug manufacturers and medical professionals should be at fault when their treatments cause serious side effects and put people in danger. If you suffered internal bleeding event or some other injury as a result of Xarelto, you may have a legal claim.

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Xarelto: More Dangerous than Warfarin?

August 11th, 2014

Cases have recently been filed in courts around the U.S. relating to bleeding injuries and death caused by the drug Xarelto.

Xarelto-pill_MainXarelto is an oral anticoagulant manufactured by Bayer Pharmaceuticals and Janssen Pharmaceuticals (a Johnson & Johnson affiliate).  It was brought to market in 2011 and has been extensively promoted as an alternative to warfarin (coumadin).  Xarelto was originally approved to prevent blood clots (and stroke) in patients with atrial fibrillation and in patients undergoing knee or hip replacement surgery.

Until the release of Xarelto and other new oral anticoagulants (“NOACs”), warfarin had long been the standard care for preventing blood clots.  The NOACs, including Xarelto and Pradaxa, have been widely marketed by their manufacturers as better alternatives to warfarin because patients would no longer have to undergo regular blood testing and frequent doctor visits to monitor proper dosage and kidney function.

It has since been demonstrated, however, that the claim of added convenience of Xarelto comes at a steep and often devastating cost to many patients.  Xarelto has been linked to medical complications including intestinal bleeding, rectal bleeding, blood clots, brain hemorrhaging, pulmonary embolism, and deep vein thrombosis.  Many of these conditions can lead to severe disability or death.  Ironically, it appears that these devastating bleeds could often be prevented if the patients on the NOACs underwent regular blood testing – just like patients taking warfarin – to ensure that their dose was appropriate.  Such a recommendation, however, would be in stark contrast to the marketing strategy for Xarelto – that it is more convenient and thus superior to warfarin.  As a result, no such recommendation has been made by the manufacturers of Xarelto.

xarelto 2The failure of manufacturers to recommend blood monitoring in patients taking Xarelto is even more dangerous in light of the fact that, unlike warfarin, there is no known antidote to stop bleeding caused by this medication. If you develop a bleed from taking warfarin, simple vitamin K therapy is generally sufficient to treat the condition and promote clotting.  This is not the case with Xarelto.  Until an effective antidote is created and approved for use in Xarelto patients, there will continue to be an unreasonably high number of uncontrollable bleeds and deaths caused by the drug.

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Risperdal Use May Cause Breast Development in Boys and Men

August 8th, 2014

Risperdal 1Risperdal (risperidone) is a medication used to treat schizophrenia, bipolar disorder, and autism spectrum disorders in children and adults.  Some doctors also prescribe Risperdal off-label (meaning that it is given for a condition other than what has been approved by the FDA) for attention deficit hyperactivity disorder (ADHD), sleep disorders, anxiety, and depression.

ds00850_im02136_m7_gynecomastiathu_jpgA serious side effect of Risperdal is the abnormal growth of breast and glandular tissue in boys and men.  This condition is called gynecomastia, and it is caused by high levels of prolactin (the hormone that stimulates breast growth and lactation in women) that result from use of the medication.

Patients may experience varying levels of growth in one or both breasts, and in some cases may discharge breast milk.  Severe cases may result in significant breast growth, comparable to a women’s cup size D or larger.

Patients suffering from gynecomastia often face considerable social stigma and isolation.  Boys and young men may experience extreme emotional distress as a result of negative reactions from peers (including teasing and bullying).  Mental health conditions such as those the medication is intended to treat – schizophrenia, bipolar disorder, and autism spectrum disorder – are in and of themselves extremely challenging.  A damaging side effect such as this has the potential to increase the level of anxiety and depression that may already accompany these diseases.

In some cases, surgery may be required to resolve gynecomastia.  Options may include liposuction, breast reduction surgery, or mastectomy.

Several hundred lawsuits have been filed against Johnson & Johnson and its subsidiary Janssen Pharmaceuticals due to damages caused by Risperdal

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Mirena IUD Linked to Pseudotumor Cerebri (PTC)

August 7th, 2014

The Mirena intrauterine device (IUD) has been linked to development of pseudotumor cerebri (PTC), a debilitating condition caused by an accumulation of cerebrospinal fluid in the skill. The fluid causes increased pressure on the optic nerve and results in symptoms such as:

  • Migraine-like headaches
  • Vision problems such as blurred or double vision
  • Temporary blackouts

If pseudotumor cerebri goes untreated or is not treated promptly, the pressure and damage to the optic nerve can be irreversible and can even cause permanent blindness. The Mirena IUD contains the synthetic hormone levonorgestrel, which is released daily to prevent pregnancy. This hormone has been linked to PTC and papilledema for many years.

What is Mirena? 

Mirena is a type of long-lasting, reversible birth control known as a hormonal intrauterine device (IUD) manufactured by Bayer Pharmaceuticals. The Food and Drug Administration approved Mirena, one of only two hormonal IUDs approved for use in the U.S., in 2000. In 2009, the FDA expanded Mirena’s use to include the treatment of heavy menstrual bleeding in women already using IUDs. 

Globally, the IUD is the most popular form of reversible birth control, with an estimated 150 million users. In the U.S., the popularity of IUDs is growing, and in 2011, the devices made up about 10.4 percent of the contraceptives issued by doctors, up from 1.4 percent in 2002. The reasons for Mirena’s growth in popularity are simple:

  • Mirena can protect against pregnancy for up to five years and is more than 99 percent effective in controlling pregnancy
  • Mirena is more convenient than most oral contraceptives because once implanted, there is no need to take a daily pill
  • Mirena has a failure rate of less than one percent, while oral contraceptives can have a failure rate as high as 30 percent if they are not taken properly

Mirena Lawsuits 

Plaintiffs pursuing Mirena Lawsuits against the device’s maker, Bayer, allege that Bayer failed to warn of the increased chance of developing papilledema and PTC. The lawsuits also charge that Bayer failed to test Mirena properly to learn of the potential risk and the company failed to notify doctors that patients who have PTC and use levonorgestrel-releasing implants like Mirena should consult with their doctors and have the IUDs removed as soon as possible to avoid further injury.

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Stryker Hip Recall Lawsuits Allege Serious Injuries

August 5th, 2014

Rejuvenate, metal hip implant components manufactured by Stryker Corporation, have been linked to a broad range of debilitating injuries, including organ and tissue damage, inflammation, and metal poisoning.

Stryker Lawsuits Patients-Suing-Over-Recalled-Stryker-Hip-Implant

More than 2,000 Stryker hip lawsuits have been filed in U. S. federal court, designated as multidistrict litigation (MDL), and others have been filed in state courts, including hundreds more in New Jersey that have been consolidated into a multicounty litigation (MCL) in the Superior Court of Bergen County, N.J.

With the 2,000 lawsuits having been consolidated into a multidistrict litigation (MDL) in U.S. District Court in Minnesota, the hope is the recall lawsuits will move faster and resolve more quickly.

The hip recall lawsuits share similar claims, alleging that Stryker:

  • Was negligent in designing the hip implant devices and testing their safety
  • Failed to warn consumers about the dangers of the devices
  • Concealed information about the risk of serious injury and death

The plaintiffs seek compensatory damages including reimbursement of lost wages, costs of revision surgery, other medical expenses and some seek punitive damages. Those who still have the Stryker Rejuvenate and ABG II devices implanted in their bodies are also seeking medical monitoring coverage so any adverse effects can be detected as early as possible.

Mediation began in several Rejuvenate lawsuits in the Fall of 2013 in New Jersey, and a small group of cases, known as bellwether cases, are being prepared for early trial dates in June 2015. These bellwether cases will provide some insight into how juries are likely to respond to some of the evidence and testimony that will be offered in the Stryker MDL.

Some of the factors a jury will likely consider in Stryker lawsuits include:

  • The injuries caused by the implant
  • The effect any complications caused by the implant had on the plaintiff’s overall physical and mental condition
  • Lost wages and diminished earning capacity
  • Past and future pain and suffering related to complications caused by the implant
  • Past and future medical expenses relating to the Rejuvenate surgerystryker

Stryker initiated the recall of Rejuvenate and ABG II modular-neck hip stems after the implants showed signs of corroding and fretting in July of 2012. The company has stated that the recall and lawsuits could cost it as much as $1.3 billion to resolve and settlement in the days ahead. As a leader in the Stryker hip implant litigation, our hip implant recall attorneys continue to review and file new claims on behalf of Stryker victims nationwide. If you have questions or concerns about your potential claim, contact us know to learn how we can help.

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Benicar Produces Symptoms Similar to Celiac Disease

August 4th, 2014

On July 4, 2013, the U.S. Food and Drug administration issued a warning that Benicar causes sprue-like enteropathy. The high blood pressure drug has been linked to more than 60 cases of severe Benicar enteropathy that exhibits symptoms similar to those of Celiac Disease, including:

  • Chronic diarrhea
  • Vomiting
  • Rapid and substantial weight loss
  • Stomach pain and discomfort
  • Dehydration
  • Cardiovascular problems

Benicar-Recall

But unlike Celiac Disease, a gluten-free diet will not improve the symptoms of Benicar enteropathy. The only way to do that is to stop taking Benicar.

What is Benicar?

Benicar is a medication developed by Japanese drug maker Daiichi Sankyo, Inc. to treat high blood pressure. The U.S. Food and Drug Administration originally approved Benicar in 2002, and doctors write more than 11 million prescriptions a year for the medication.

Benicar’s active ingredient, olmesartan medoxomil, lowers blood pressure by helping to keep blood vessels open. It can be taken either as a singular blood pressure treatment or as part of a combination of drugs.

FDA Warning

Despite the popularity of Benicar, research linking the drug to severe gastrointestinal side effects led the FDA in April 2014 to issue a mandate that Benicar carry a warning on its label regarding its association with severe gastrointestinal side effects.

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The Mayo Clinic contacted the FDA in 2012 after their researchers found a connection between specific gastrointestinal symptoms and olmesartan medoxomil. Between 2008 and 2011, Mayo Clinic saw 22 patients with symptoms similar to those associated with Celiac disease. Although tests for Celiac disease returned negative, all the patients took Benicar.

 

Benicar Lawsuits

Some people who took Benicar have suffered physically, financially, and may have undergone long and difficult treatments to ease the severe intestinal complications and other health issues triggered by Benicar. Soon after the 2013 FDA warning, former Benicar users filed the first lawsuits in New Jersey against Daiichi Sankyo, Inc. and the cases were moved to federal court. Those lawsuits and others are still pending today with numerous other new cases being filed on a continual basis.

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FDA: Morcellators May Cause the Spread of Sarcoma in Women

August 1st, 2014

Pending a review by the U.S. Food and Drug Administration, Johnson & Johnson plans to ask doctors to return its laparoscopic power morcellators, surgical tools that may inadvertently spread cancer in women being treating for fibroid tumors. The company’s Ethicon unit suspended sales and distribution of the devices in April 2014.

Morcellators are used in hysterectomies, and also to cut up uterine masses in the uterus so that they can be more easily removed through non-invasive procedures. The problem is that uterine cancers commonly known as sarcomas sometimes appear to be benign fibroids and can’t be reliably detected before surgery. When the blade of the morcellators spins, it potentially spreads the cancer and worsens patient outcomes.

Johnson & Johnson is the world’s largest manufacturer of laparoscopic morcellators, holding an estimated 72 percent of the market in 2011, according to iData Research Inc. Smaller manufacturers, including the German companies Karl Storz GmbH and Rich Wolf GmbH, and Danish company LiNA Medical, haven’t responded to requests for comment regarding the morcellator controversy and their market plans.

The risks of cutting up cancer inside a human body have been known for some time, but the risk that a woman with presumed fibroids actually had cancer was always believed to be extremely small, 1 in 10,000, and most gynecologists did not consider it worth mentioning to patients. But in April 2014, the FDA stated that women undergoing surgery for fibroids actually have a 1 in 350 risk that the growths are cancerous, much greater than originally thought. A new study by Columbia University found that 1 in 368 women undergoing hysterectomies actually have hidden uterine cancer that is capable of being spread by a morcellator.

According to the FDA, the tool was being used in approximately 50,000 hysterectomies per year, and very commonly used to remove uterine fibroids as well.

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GM Concedes 13 Fatalities Related to Faulty Ignitions; Number Likely Much Higher

July 29th, 2014

GM has stated that the company is aware of 13 fatalities tied to the faulty ignition switches that have led to massive recalls of over 25 million vehicles, including:

  • 1997-2005 Chevrolet Malibu  gm-recall2
  • 1998-2002 Oldsmobile Intrigue
  • 1999-2004 Oldsmobile Aero
  • 199-2005 Pontiac Grand Am
  • 2000-2005 Chevrolet Impala
  • 2000-2005 Chevrolet Monte Carlo
  • 2004-2008 Pontiac Grand Prix
  • 2004-2006 Cadillac SRX
  • 2013-2014 Cadillac CTS

Actual Number of Fatalities Hard to Pinpoint

According to one attorney, who represents plaintiffs suing GM, the number of deaths might actually be hundreds, or maybe even thousands. He said at least 100 deaths have already been brought to the attention of plaintiffs’ lawyers involved in the GM cases, and the total number of fatalities could be close to 5000, which includes passengers in other vehicles involved in collisions with GM vehicles with faulty ignition switches. Although the number is subjective and there is no way to prove it definitively, that attorney calculated it using the total number of highway deaths occurring since the defective vehicles became available.

The Center for Auto Safety sent a letter to regulators in March 2014 stating that crash data indicates that 303 deaths were the result of the defective ignition switches, which slip out of position and cause vehicles to stall, putting the driver at risk for a collision. If the engine loses power and an accident subsequently occurs, the airbags will not deploy, seat belts will not work properly, and power steering and power brakes will fail to function.

In June 2014, Reuters conducted an analysis of the Fatality Analysis Reporting System (FARS) a national database of crash information submitted by local law enforcement agencies. According to Reuters, the data suggested that at least 74 people died in faulty ignition related accidents, and also suggested that such accidents happened at a higher rate in GM cars than in competitors’ models.

If you have suffered a GM ignition switch event and experienced injuries as a result we might can help. Contact the attorneys of Childers, Schlueter & Smith for a free case evaluation and consultation to learn more about your legal rights and options. Our experienced product liability injury lawyers will work closely with you and fight to make things right.

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What Went Wrong With GM’s Ignition Switch?

July 25th, 2014

According to a CBS News report, General Motors’ ignition switch defect arose from an effort to change the company’s cars.

In the late 1990s, when GM began developing new small cars, customers voiced their concerns about “cheap feeling” switches that were difficult to turn. So in response, GM redesigned the switches to work more smoothly, leading drivers to believe that the design was superior, according to 2013 deposition testimony of a GM switch engineer. The switches, however, proved to be too loose, were prone to slipping, and led to events that caused more than 50 collisions and the deaths of at least 13 people. Many more events and incidents have since come to light following the awareness of this problem and recall.

The Problem With the GM Ignition Switches

The drawback with the new switches is relatively simple to understand: they can unexpectedly slip from “run” to “accessory” and cause the engine to suddenly stall, which in turn shuts off the power steering and prevents air bags from deploying in the event of an accident. When the switch supplier, Delphi, told GM engineers that that the switches were problematic because they turned too easily, GM ordered the company not to change them because alterations might harm the switch’s electrical performance.

Eventually, the switches were approved, but were well below GM’s specifications for the force required to turn them, resulting instead in a smooth turning key that could easily slip out of position when jarred by the driver’s knee, a bump in the road, a swinging key chain, or even additional weight caused by extra keys on the same ring.

The safety issue has caused big problems for GM: more than 50 collisions and 13 deaths (so far) attributable to the faulty switch. It also led GM to review numerous safety issues, resulting in 54 recalls of 29 million vehicles in 2014 alone, and the year is only half over.

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Update: Xarelto Exceeds Pradaxa in Reported Adverse Events

July 14th, 2014

According to a July 9, 2014 report in the Digital Journal, the anticoagulant drug Xarelto has now surpassed Pradaxa in the number of reported adverse events, including serious bleeding events.

The Institute for Safe Medication Practices’ (ISMP) Quarter Watch publication reported that in 2013, the U.S. Food and Drug Administration received 680 serious adverse event reports from patients who alleged to have suffered adverse events while taking Xarelto, while 528 such events were reported by those taking Pradaxa.

Xarelto is manufactured by Bayer and marketed by Janssen Pharmaceuticals in the U.S., and was approved by the FDA in July 2011 for treatment to reduce the risk of blood clots in patients who undergo hip or knee replacement surgery. In November 2011, the FDA approved Xarelto for use in patients with atrial fibrillation to reduce their risk of stroke, and in 2012, Xarlto’s use was expanded again to include the general treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE).

High Risk Treatment Option

Anticoagulant drugs are considered a high-risk treatment and cause bleeding in approximately 15 percent of those with atrial fibrillation. Nearly one million prescriptions for Xarelto have been dispensed per quarter in the U.S., and by the end of 2013, outnumbered those written for Pradaxa by nearly two to one. The ease of using Xarelto and Pradaxa have made them popular alternatives to warfarin.

According to ISMP, marketing Xarelto for ease of use, rather than providing tools to reduce bleeding risk, is a critical mistake and recommends that the FDA reconsider its decision to prohibit a lower dose of dabigatran that is recommended for older patients in almost all other advanced countries, and establish a therapeutic range so that plasma level tests can identify patients with excessive or less than desirable effects.

If you have suffered uncontrollable bleeding or if your loved one lost life due to bleeding after taking Xarelto we can help. Contact the attorneys of Childers, Schlueter & Smith for a free case evaluation and consultation to learn more about your legal rights and options. Our experienced drug injury lawyers will work closely with you and fight to make things right.

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