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Stryker Voluntary Recall of Hip Replacement, Stryker Lawyers Take Notice

Written by lisaspitzer on . Posted in Class MDL Class Action News

The Stryker ABG II modular-neck stem used for total hip replacement surgery and The Stryker Rejuvinate modular-neck stem hip implant lawyers filing lawsuits for Stryker Hip Replacement recall.

Stryker recalled both of these products on July 4, 2012 because the metal of the neck and stem can corrode, releasing toxic metal ions that can damage tissue and bones around the hip implant.  This can cause severe pain, inflammation, metal poisoning (metallosis from chromium and cobalt), tissue death (necrosis), bone damage, pseudotumers, gait issues, and other serious problems. Revision surgery (to remove and replace the recalled Stryker hip product) may be required.

In July 2012, Stryker Orthopaedics voluntarily recalled its Rejuvenate Modular Hip System. The recall includes both Stryker’s Rejuvenate Modular and ABG II modular-neck hip stems.
Risks

Stryker initiated this voluntary recall due to potential risk associated with modular-neck stems.
 

  •     Fretting and/or corrosion at the modular-neck junction,
  •     Pain and/or swelling.
  •     Need For Revision Surgery
  •     Joint loosening/dislocation
  •     Device wear and tear, such as corrosion and fretting
  •     Excessive metal debris leading to metal ion generation
  •     Inflammation of tissue
  •     Hypersensitivity/allergic response
  •     Broken devices
     

All recipients of these two hip replacements must see their doctor immediately and retain a Stryker Hip replacement lawyer. Do not wait. It is only a matter of time before a new Mutli District Litigation for the Stryker hip Implant becomes T,V news. Lawyers are accepting cases for both of these implants. Contact Class Action Lawyer Network Stryker Hip replacement lawyers today.

Stryker Rejuvenate Hip Implant Lawyers,

Written by lisaspitzer on . Posted in Class MDL Class Action News

Stryker Rejuvenate Hip Implant lawyers accepting cases for stryker Hip replacement
The Stryker Rejuvenate hip replacement device has been linked to an increased risk of metallosis. Although the Stryker Rejuvenate is not a metal-on-metal hip device, it has metal-on-metal components, which are believed to be responsible for the development of metallosis in some patients. According to reports, the Stryker Rejuvenate hip implant device is linked to a high early failure rate, resulting in some patients having revision surgery to replace their hip replacement device. Lawyers are now qccepting cases for the failure of the Syryker Rejuvenate Hip replacement.

Call the new  Stryker Orthopedics Rejuvenate Hip replacement Helplineand speak to a Hip Replacement Lawyer.
Stryker Rejuvenate Hip Implant

The Stryker Rejuvenate hip implant is different from other hip replacement devices in the news recently because it is not a metal-on-metal hip replacement device. Instead, the Rejuvenate hip replacement device, which uses a ceramic component, was meant as an alternative to the metal-on-metal devices. It was marketed to younger patients as a modular hip replacement, meaning the components were custom-made to fit patients better, which was supposed to result in longer-lasting hip replacement devices that offered a better range of motion.

Some patients reportedly developed metallosis after having the Stryker Rejuvenate hip device implanted. Although it was initially believed that such a condition was not possible—because the Stryker Rejuvenate does not have a metal-on-metal ball and socket design—the Stryker hip device has a metal neck piece that can, under some conditions, rub against a metal stem, causing metallic debris to come loose.

Stryker has responded to concerns about the Rejuvenate failure rate by alleging patients did not properly undergo rehabilitation following surgery, or by blaming doctors' implantation techniques. In a Product Correction Bulletin (04/25/12), Stryker officials noted, "Factors such as diabetes and infection may play a role in potential corrosion of an implant as these conditions may affect the pH of the tissue surrounding the implant."

Metallosis is an adverse tissue reaction to heavy metals in the body. It can cause pain, limited mobility, failure of the hip joint, pseudo-tumors, dissolution of the bone, DNA changes and chromosomal aberrations. Patients who have had their Stryker Rejuvenate hip implant device fail may have undergone revision surgery. Typically, hip implants are expected to last 15 to 20 years. In some cases, the Stryker Rejuvenate hips are failing in less than five years. It seems we once again have a failed hip replacement. If you or a loved one has a failed Stryker hip implant or Cobalt or Chromium poisoning call the Stryker Rejuvente Hip Replacement Helpline  today.

New Dangerous Medical Devices, Medical Device Lawsuits

Written by lisaspitzer on . Posted in Medical Device Lawsuits

The Following dangerous medical devices have been added to the list of dangerous devices our lawyers are accepting clients for. These include:

  •     AlloDerm Lawyers,
  •     Bard IVC Filter Lawyers,
  •     Charite Artificial Disc Lawyers,
  •     Metronic Injuse Bone Graft Lawyers,
  •     Mirena IUD lawyers for uterus perforation
  •     Stryker Rejuvenate Lawyers.,
  •     ABG II modular-neck stem Lawyers
  •     Depuy ASR Hip Implant Lawyers, statute of limitations up in many states
  •     Modular-Neck Hip Stems by Stryker Orthopedics Lawyers,
  •     R3 Acetabular System Hip Replacement Lawyers,
  •     Vaginal Mesh Lawyers.
  •     Dow Corning Breast Implant Lawyers

Manufacturers of medical devices are also liable for harm caused by their products. Sometimes these products contain design flaws, were not tested adequately, or were marketed to doctors and patients for uses other than those approved by the U.S. Food and Drug Administration. Examples of medical devices include: defibrillators, breast and other cosmetic implants, orthopedic screws, hip implants, knee implants, heart valves and many other items.

 

J & J Sold Vaginal Mesh Without Approval, Vaginal Mesh Lawyers filing Vaginal Mesh Lawsuits For Injured Women

Written by lisaspitzer on . Posted in Medical Device Lawsuits, Transvaginal mesh

Vaginal Mesh Multi District Litigation lawsuits are being filed by the Vaginal mesh Multi District  litigation division of Class Action Lawyer Network. It appear Johnson and Johnson was selling the vaginal mesh product on it's own initiative.

J&J Sold Vaginal Mesh Implant After Sales Halt Ordered
By DVoreacos and A Nussbaum – Jun 26, 2012 2:23 PM ET

Johnson & Johnson (JNJ), the biggest health-care products maker, continued to sell a vaginal mesh implant for nine months after U.S. regulators told the company to stop marketing the device, according to court records.

The U.S. Food and Drug Administration told J&J in a letter on Aug. 24, 2007, to halt Gynecare Prolift sales until the agency decided whether the device was “substantially equivalent” to other products on the market. The FDA cited the “potential high risk for organ perforation” when surgeons insert the mesh vaginally to support weakened pelvic tissue.
Enlarge image J&J Sold Vaginal Mesh Implant After FDA Ordered Sales Halted

On June 5, J&J said it will stop selling four vaginal mesh implants including the Prolift. Photographer: Daniel Acker/Bloomberg

“You may not market this device until you have provided adequate information” on 16 potential deficiencies and received FDA approval, the agency told New Brunswick, New Jersey-based J&J in the letter. “If you market the device without conforming to these requirements, you will be in violation of the Federal Food, Drug and Cosmetic Act.”

The FDA cleared the device in May 2008 without ordering sanctions, after nine months of negotiations with J&J’s Ethicon unit. The company faces more than 1,400 lawsuits by women who said the mesh caused organ perforation, pain, scarring and nerve damage. Lawyers for the women said the device’s approval history could increase J&J’s cost to resolve the litigation.

J&J began selling the Prolift in 2005 without filing a new application after determining on its own that it was substantially similar to the Gynemesh, a company device already approved by the FDA, said Matthew Johnson, a J&J spokesman, in an e-mail. The device maker relied on FDA guidance for when companies must submit new applications, Johnson said.

The FDA disagreed with J&J’s interpretation and required a new application that prompted questions in the August 2007 letter, Morgan Liscinsky, an agency spokeswoman, said in an e- mail.

J&J faced no sanctions because the FDA determined that the company applied the guidance in good faith and it “promptly complied” when the agency required a new application, Liscinsky said.
Fines, Injunctions

Sanctions for selling products without approval may include fines, injunctions against a company or senior managers and the seizure of illegally marketed devices, Liscinsky said.

The August 2007 letter was “only one part of an extended dialogue with FDA in 2007-08, and it is out of context,” Johnson said in the e-mail. “Throughout this process, our actions were responsible, appropriate and consistent with FDA regulations.”

Henry G. Garrard III, a lawyer who represents women suing in federal court in Charleston, said the FDA’s failure to take additional steps to halt Prolift sales or to sanction J&J raises questions about the agency’s power to protect patients.

“Companies know the FDA has little enforcement ability and scarce resources,” Garrard, of Blasingame, Burch, Garrard & Ashley PC in Athens, Georgia, said in a telephone interview.

“Every woman in America who has been implanted with these devices absolutely should be outraged,” he said. “They should be mad at the company because the company knew they could get away with it.”
‘Water Pistol’

The Prolift negotiations point out “the industry’s ability to shrug off FDA enforcement,” said Erik Gordon, a business professor at the University of Michigan, in an e-mail. “If companies can get away with selling products they aren’t supposed to sell, the FDA is a sheriff packing a water pistol.”

The U.S. Senate is to vote today on changes to the FDA’s device-review system, which has drawn scrutiny for allowing implants like vaginal mesh on the market without human testing.

The bill increases funding for reviews and the FDA’s power to order safety studies after a product is cleared. It doesn’t include powers sought by consumer groups to let the FDA require clinical trials for more implants before they reach the market. The House of Representatives approved the measure last week.
Implants Threaded

Surgeons thread mesh implants through vaginal incisions and use the devices to treat incontinence or pelvic organ prolapse, a condition in which weakened muscles fail to support organs. Almost 300,000 were used in U.S. women in 2010, the FDA estimated last year.

An FDA database of reported malfunctions, deaths and serious injuries shows the agency received 123 complaints about the Prolift from 2005 to May 15, 2008, when the device won clearance. The company said in a September 2007 letter to regulators that reported problems accounted for less than 0.5 percent of sales for both Gynemesh and Prolift.

An agency report in July found a fivefold jump in deaths, injuries or malfunctions tied to prolapse mesh inserted vaginally. In January, the FDA ordered J&J, Murray Hill, New Jersey-based C.R. Bard Inc. (BCR) and other manufacturers to study organ damage and complications related to the products.
Sales Estimates

Manufacturers including J&J sold about $175 million worth of prolapse mesh worldwide and another $295 million for incontinence treatments in 2010, C.R. Bard executives estimated on a conference call that year. Even for top sellers of the devices, the products made up no more than 2 percent of company sales, said Michael Matson, a Mizuho Securities USA analyst in New York.

The numbers declined as lawsuits were filed, he said in a telephone interview.

“The doctors aren’t implanting them,” Matson said. “The patients don’t want them.”

On June 5, J&J said it will stop selling four vaginal mesh implants including the Prolift. The move wasn’t a recall and J&J remains confident in the safety and effectiveness of the devices, Johnson said. The company won’t withdraw the Prolift before its “planned discontinuation” of the mesh products over the next three to nine months, he said.

“Our decision to discontinue these products is based on their commercial viability in light of changing market dynamics,” he said.
Label Update

In letters to state and federal judges, the company said that it will update labeling for one device, the Gynemesh, to allow only abdominal, not vaginal, insertion.

The FDA learned of the Prolift after J&J cited it in an application to sell a related device, the Prolift+M, Liscinsky said. The agency told J&J to file for the Prolift as well, and it combined the review for both devices before the August 2007 letter.

“Due to the complexity of this procedure and potential high risk for organ perforation, bench testing is not sufficient to demonstrate device safety and efficacy,” the FDA said in the letter. Bench testing refers to laboratory testing to determine how a device will function in a person.

In the August 2007 letter, the FDA asked 16 questions about the Gynemesh and Prolift, which are made of the same nonabsorbable polymer. The Prolift kit includes pre-shaped mesh and instruments to help surgeons implant the device.
Complications

One FDA query was about a “significant number” of complications from 2004 to 2007 on the earlier device, the Gynemesh. The agency got 174 such reports, including for infection, abscess and organ perforation. Most of the cases required additional surgery.

The agency’s letter also found that labeling for the Prolift+M device was deficient because it couldn’t support claims that the mesh has “elastic properties that allow adaptation to physiological stresses.” In its response, J&J agreed to remove that claim.

Many of the documents unsealed last month include e-mails between J&J and the FDA over the wording of product labeling about the benefits and risks.

Six days before the FDA cleared the Prolift, J&J agreed in a written response to say in the label that the safety and effectiveness of the device, compared to conventional surgical repair without mesh, “have not been demonstrated in randomized controlled clinical trials.”

Rather, J&J wrote, the substantial equivalence to earlier approved devices had been demonstrated through other tests.

The federal cases are In re Ethicon Inc., Pelvic Repair System Products Liability Litigation, 12-md-02327, U.S. District Court, Southern District of West Virginia (Charleston).

If you have a Gynecare Vaginal mesh and are having complications call us today. We are also accepting cases for Yaz, Yasmin, Mirena IUD, NuvaRing and all drugs and devices harming women.

 

Metronic Infuse Bone Graft Lawyers, Infuse Bone Graft Lawsuits

Written by lisaspitzer on . Posted in Class MDL Class Action News

Lawyers for the victims of the Metronic Infuse Bone Graft are filing lawsuits for victims of off label use of the bone graft.Medtronic Infuse Bone Graft lawsuits  are increasing as more victims come forward
 

Infuse is a bio-engineered bone graft device that is marketed by Medtronic for lumbar surgery. It is intended as a substitute for the traditional surgical procedure involving the taking of a bone graft from the patients hip. The advantage of this product is that no surgery is needed to remove bone from the patient's hip reducing pain and shortening recovery times. However, the introduction of foreign material into the body creates other risks.

The lawsuits allege that Medtronic failed to reveal side effects which Medtronic knew were likely in order to increase sales of the product. These side effects include uncontrolled bone growth called ectopic bone growth that resulted in failures of many surgeries. The active fusion ingredient in the Infuse product is rhBMP-2. The letters BMP stand for Bone Morphogenetic Protein. This ingredient is designed to stimulate bone growth in the spine so that the vertebra will fuse together to relieve back pain.

Injured back surgery patients allege that Medtronic understated the risk of uncontrolled bone growth, inflamatory reactions, retrograde ejaculation, urinary retention, bone reabsorption, implant displacement, sterility, and cancer.

The lawsuits also allege that Medtronic illegally marketed the Infuse product "off-label". Off label marketing means that the company promoted the product for medical uses for which it was not approved by the FDA. Off label use of drugs and medical devices is permissable by medical professionals and can be beneficial to patients but a pharmaceutical drug or device manufacturer is prohibited by the FDA regulations from promoting or marketing products for uses that were not approved by the FDA.

The primary off label use of the products allegedly promoted by Medtronic was for posterior lumbar fusion surgery. Infuse was only approved by the FDA for anterior approach lumbar fusions. This means that Infuse was approved for for spine surgeries with a surgical approach through the abdomen or the front of a person rather than a surgical approach to the spine through the back. It is alleged that Medtronic paid highly respected surgeons it calls "opinion leaders" to influence surgeons to increase off label use of Infuse in posterior spine surgical procedures.

It appears that the Medtronic Infuse bone graft marketing campaign may be yet another incident of a medical device company putting its profits over people.

 

 

Metronic Infuse Bone Graft Lawyers, Metronic Bone Graft Complications

Written by lisaspitzer on . Posted in Medical Device Lawsuits

Lawyers for Medtronic Infuse Bone Graft reviewing cases for major complications for metronic Bone Graft Victims.The Medtronic Infuse bone graft  has been used off-label,  resulting in  serious and potentially life-threatening side effects. and injury to patients.

Medtronic has promoted theri Infuse BMP (Bone Morphogenic Protein) for surgical procedures that have not been properly tested and resulted in inflammatory reactions, breathing problems, severe nerve damage, sterility in men, cancer and wrongful death.The Medtronic Infuse is a new type of bone graft, which uses recombinant human Bone Morphogenetic Protein (rhBMP-2) to stimulate bone growth. It was approved by the FDA in 2002 for the limited use during single-level anterior lumbar fusion surgery, as well treatment of tibia fractures and some oral or dental procedures.
If you or a loved one has had life altering complications from an off label use of this Infunes Bone Graft speak to one of our infuse Bone Graft lawyers today.

Medtronic Infuse Lawyers

TheInfuse Bone graft  lawyers are reviewing  Medtronic Infuse bone graft lawsuits for patients throughout the United States who have experienced inflammatory reactions, nerve damage or other complications following spinal surgery with this bone graft.

Get Your case reviewed by a Metronic infuse bone graft lawyer.

During spine surgery, the Medtronic Infuse bone graft consists of an absorbable collagen sponge that is treated with rhBMP-2, and then placed in a small “cage”, known as the LT-CAGE, to keep the two vertebrae in place and provide the frame for the Infuse BMP.

It was developed as an alternative to traditional bone graft procedures, which involve either the use of bone harvested from the hip or another part of the body, or bone extracted from dead bodies.

The Medtronic Infuse BMP bone graft was promoted as a superior alternative, because it helps avoid pain and problems associated with harvesting bone and removes the risk of the cadaver bone being rejected by the body.

Serious side effects from the Infuse Bone Graft.

  •     Severe Inflammatory Reaction
  •     Airway Compression or Breathing Problems
  •     Nerve Impingement Resulting in Severe Back or Neck Pain
  •     Hospitalization with Treatment in ICU
  •     Need for a Feeding Tube or Tracheotomy
  •     Additional Surgery to Remove Excessive Bone from the Spinal Canal
  •     Death

 Use of  the Medtronic Infuse BMP  has been shown to increase risk of cancer, as well as  sterility.

You must contact us immediately for a case review by Infuse Bone graft lawyers.

NuvaRing Lawyers For NuvaRing Lawsuits,

Written by lisaspitzer on . Posted in Class MDL Class Action News

NuvaRing lawyers filing lawsuits for blood clots and pulmonary embolisms from NuvaRing. Women are alerted to contact a NuvaRing lawyer immediately for review of their potential NuvaRing lawsuit.

on May 30th, 2012, an Iowa woman, Kristina Marie Isaac, filed a lawsuit in New Jersey District Court (case no. 2:2012cv03240) alleging that her NuvaRing caused her an acute pulmonary embolism. NuvaRing is a popular internal birth control device, a vaginal ring placed near the cervix that was approved by the FDA in 2001. A study published on May 10th 2012 in the British Medical Journal revealed that women who used a vaginal ring had a 6.5 times higher risk for developing blood clots. NuvaRing is a dangerous birth control device causing injury.

What is NuvaRing?

NuvaRing is a ring used for birth control that is inserted in a woman’s vagina once a month, releasing a low dose of hormones to prevent pregnancy.

NuvaRing also has risk of more serious side effects.

  • stroke,
  • infarction,
  • blood clot,
  • deep vein thrombosis (DVT),
  • cerebral venous thrombosis
  • pulmonary embolism
  • death.

 The Problem with NuvaRing?                                                                                                                                                           NuvaRing releases the hormones estrogen and progesterone into the patient’s bloodstream.These hormones can cause blood clots and  pulmonary embolisms. Organon failed to provide proper and full information for women regarding these severe side effects.

NuvaRing Lawyers are filing Lawsuits for NuvaRing. If you or a daughter or wife or mother has been injured by NuvaRing contact us immediately.

 

Pradaxa Lawyers Filing Lawsuits for Brain Bleeds, Doctors Concerned as Well

Written by Class Action Lawyer on . Posted in Class Action Articles

Pradaxa Class Action Lawyers for Pradaxa are filing brain hemmorhage lawsuits for Pradaxa death. Concern is for seniors on Pradaxa. Children should be monitoring and contacting a Pradaxa lawyer if there is a Pradaxa wrongful death;

see article below

For millions of heart patients, a pair of new blood thinners have been heralded as the first replacements in 60 years for warfarin, a pill whose hardships and risks have deterred many from using the stroke-prevention medicine.

But growing complaints of risks and deaths tied to the new crop of drugs have made some top U.S. cardiologists hesitant to prescribe them. Some are proposing a more rigorous monitoring regimen for when they are used.

Most concerns revolve around Pradaxa, a twice daily pill from Boehringer Ingelheim that was approved by the U.S. Food and Drug Administration in October 2010 to prevent strokes in patients with an irregular heartbeat called atrial fibrillation. It was the first new oral treatment for that use since warfarin was introduced in the 1950s.

"The good news is you now have an alternative to warfarin," said Dr. Alan Jacobson, director of anti-coagulation services at the Veterans Administration (VA) healthcare system in Loma Linda, California. "The bad news is you can kill a patient as easily with the new drug as you could with the old drug" if it is not handled properly.

"The average patient doesn't understand anything about the new drug, or what the risks are, or what other medicines he can or can't take," said Jacobson, citing interactions with common painkillers and other drugs that can alter Pradaxa blood levels.

Xarelto, a once daily pill that Johnson & Johnson developed with Bayer AG, was approved last November for atrial fibrillation. The condition affects about 3 million Americans, causing blood to pool in a storage chamber of the heart, where it can clot and travel to the brain.

Both new drugs were designed to sidestep risks of warfarin, including brain hemorrhages and other dangerous bleeding, and become mainstays of a new therapeutic market worth at least $10 billion a year. Patients taking warfarin require close monitoring and regular blood tests as well as dietary and lifestyle changes.

Doctors have less data and familiarity with Xarelto, which is still being rolled out.

But Jacobson and another dozen physicians interviewed by Reuters expressed similar concerns about both Pradaxa and Xarelto.

They say that real world use of Pradaxa and Xarelto, which do not require regular blood monitoring or frequent doctor follow-up, raises concerns about the risk of stroke, serious bleeding and blood clots if not taken properly, particularly in patients with poor kidney function.

The nonprofit Institute for Safe Medication Practices estimated last month that 542 reports of deaths associated with Pradaxa were reported to the FDA in 2011, topping all other medicines, including warfarin, with 72 deaths. Adverse event reports on Xarelto were not available.

A case study published in March raised alarm in particular, showing an elderly Utah patient on Pradaxa developed a massive brain hemorrhage and died after a minor fall.

European regulators have instructed Boehringer Ingelheim to add warnings about the bleeding risk to Pradaxa's package insert. Almost two dozen U.S. federal lawsuits have been filed against Boehringer Ingelheim alleging harm from Pradaxa.

Boehringer declined to comment on the lawsuits. The German company also declined to comment about the deaths, but said the number of reports of bleeding with Pradaxa were within Boehringer's expectations, given the incidence of bleeding seen in the drug's largest study.

"Research has shown that the number of reported adverse events for a drug peaks during its first few years on the market," when doctors are most likely to file voluntary reports to regulators and drugmakers, company spokeswoman Emily Baier said.

Dr. Robert Temple, a top official in the FDA's Center for Drug Evaluation and Research, said few doctors notify the agency about incidents from warfarin because its risks are already well known. So the lopsided number of Pradaxa reports compared with warfarin may not indicate an elevated risk, he said.

"We don't necessarily believe it is real," he said. "But we're watching it. We can't help but notice it."

A SHIFT IN PRACTICE

The makers of Pradaxa and Xarelto say it takes time for doctors to get up to speed on new types of treatments and how to best administer them outside the controls of clinical trials.

"This is a shift in medical practice," said Dr. John Smith, senior vice president for clinical development at Boehringer. "Individual physicians have to determine what the follow-up plan will be, to use common medical-sense judgment."

Dr. Peter Wildgoose, a senior director of clinical development at J&J, said the company has not provided special advice on follow-up care for patients on Xarelto.

"There's nothing more than for any other drug that people regularly take," he said, adding that most atrial fibrillation patients probably see their doctors on a regular basis. "These drugs have been tested long term, for several years at a time, with very good outcomes."

Boehringer Ingelheim and Johnson & Johnson officials stressed there was far less evidence in trials of brain bleeding – the most worrisome side effect of anti-coagulants – in patients taking Pradaxa and Xarelto than those taking warfarin.

In the meantime, warfarin is holding its own, with 33 million U.S. prescriptions filled for atrial fibrillation and other uses last year, according to IMS Health, a healthcare information and services company. Some 2.2 million prescriptions were filled for Pradaxa.

About 130,000 U.S. prescriptions were written for Xarelto in the first three months of 2012. Pradaxa and Xarelto each cost about $3,000 a year, versus just $200 for generic warfarin.

Prominent U.S. heart doctors stress that neither new drug has a known antidote for a bleeding emergency, as warfarin does.

They also say that patients using them should undergo testing ahead of time to ensure good kidney function, be carefully taught potential pitfalls of the drugs and be seen by doctors periodically, especially after a switch is made.

"I have received a dozen phone calls from local colleagues in the last couple of months about bleeding on Pradaxa and have yet to find a single case where that bleeding was not related to improper use of the drug," said Dr. Sanjay Kaul, a cardiologist at Cedars-Sinai Medical Center in Los Angeles.

Kaul found that many of the doctors failed to test patient kidney function before prescribing Pradaxa, though 80 percent of the drug is excreted in that organ. Weak kidneys allow the medicine to build to unsafe levels in the bloodstream. About two thirds of Xarelto is eliminated by the kidneys. Other doctors failed to ask patients whether they had a history of gastrointestinal bleeding, which raises the risk for Pradaxa.

"What really compounds the matter is the lack of a specific antidote to reverse life-threatening bleeding" from Pradaxa, said Kaul, who served on independent panels that advised the FDA on both new medications. Kaul said he had written only one prescription for Pradaxa and none for Xarelto.

Boehringer Ingelheim said it is working on an antidote, but declined to elaborate. Johnson & Johnson said it is not developing an antidote, but is monitoring early efforts by other drugmakers to come up with one. Bristol-Myers Squibb Co, which is developing a blood clot drug called Eliquis that is similar to Xarelto, declined to comment on the antidote issue.

HOPES FOR A THIRD NEW DRUG

Warfarin thins the blood by blocking Vitamin K, while Pradaxa directly inhibits thrombin – a protein involved in clotting. Xarelto and Eliquis – which Bristol-Myers is developing with Pfizer Inc – interferes with a protein called Factor Xa.

Richard Purkiss, an analyst with Atlantic Equities, sees the new blood clot drugs reaching combined global annual sales of $10 billion for stroke prevention and other uses, with Eliquis commanding up to a 60 percent market share, based on data showing it was more effective and safer than warfarin, including less bleeding and risk of death from all causes.

Neither Pradaxa nor Xarelto were able to claim both superiority and better safety than warfarin, or reduced risk of death.

Eliquis is eliminated mainly by the liver, which some doctors say could make it more appropriate than Pradaxa or Xarelto for older patients and those with kidney problems. The FDA is expected to make a decision on Eliquis by June 28.

Michael Liss, portfolio manager at American Century Investments, predicts Eliquis will overtake Pradaxa and Xarelto within six months after it is introduced. He expects it to capture peak annual sales of up to $4 billion, with Pradaxa and Xarelto dividing up another $3 billion.

Dr. Kenneth Bauer, head of hematology for the Veterans Administration health system in Boston, said the FDA should never have approved Pradaxa and Xarelto for patients with severe kidney dysfunction, since such patients were excluded from large studies. Nor should the agency have approved an untested 75-milligram half dose of Pradaxa for such patients, he said.

"These are people whose kidneys are already damaged … and even at the smaller dose (of Pradaxa), you risk overdosing yourself," Bauer said.

The FDA said it routinely approves adjusted doses of medicines, and noted that patients with severe liver dysfunction were included in smaller studies of Xarelto and Pradaxa.

Boehringer Ingelheim's Smith said the FDA cleared the lower dose of Pradaxa after conducting its own analysis of how it performs in the bloodstream.

FRAIL ELDERLY 'CANARY IN COAL MINE'

Almost 15 percent of Americans over the age of 80 are believed to have atrial fibrillation and face a fivefold higher risk of stroke if untreated.

Dr. Richard Besdine, director of the Center for Gerontology at Brown University, said he had switched only two of his approximately 100 elderly patients from warfarin. He is unlikely to switch many others for at least a few years.

"If there's an adverse event lurking in the closet for a new drug, it's most likely to come out in patients that are old and frail and taking multiple medications. They're the canary in the coal mine," he said.

Even so, Besdine – like many other doctors now on the sidelines – believes the new drugs may eventually displace warfarin as doctors become familiar with them.

Others note that warfarin's disadvantages have led as many as 70 percent of prospective patients to refuse to take it, leaving plenty of room for the new drugs.

Dr. Robert Califf, a Duke University cardiologist who headed the largest study of Xarelto, noted warfarin is still one of the biggest causes of U.S. emergency room fatalities.

"We shouldn't lose sight of what warfarin is like in the real world," he said.

Mirena IUD and A Perforated Uterus

Written by Class Action Lawyer on . Posted in Class MDL Class Action News

The Mirena IUD along with the vaginal mesh, Yaz, Yasmin are devices and Drugs harming women. Mirena IUD Class Action lawyers are currently reviewing cases for a Mirena IUD Class Action, MDL Lawsuit. If you have a perforated uterus from the Mirena IUD contact us today for a case review.

Birth control drugs and devices  have been the central focus  of lawsuits. Yaz, Yasmin, Beyaz, NuvaRing and the related Vaginal Mesh are just some of the birth control medications, devices and related women problem devices that are causing  injuries, death and destroying lives.
The Mirena IUD is being currently reviewed by our Mirena IUD lawyers. Mirena is manufactured by Bayer ,which also manufacturers Yaz and Beyaz. It is a flexible silicone  intrauterine device that is placed into the uterus through the vagina by a physician. Mirena releases a continuous dose of the hormone levonorgestrel to prevent pregnancy for up to five years.

The first-generation IUD Dalkon Shield was well known for its complications, including :infection, sepsis, miscarriage and even death. Ther Over 300,000 IUD  Dalkon Shield lawsuits were filed.

The problems Mirena IUD  lawyers are accepting  Mirena Silicone  IUD  cases for include puncture of the uterus or the device becoming firmly embedded in the uterus. This can cause bleeding and other serious complications. The device must have moved or gravitated, and can not be located. If you have had the device surgically removed we want to hear from you.

The vaginal mesh lawsuit trials are underway. Lawyers are beginning the depositions of key players. The clock is ticking File you vaginal mesh lawsuit now.

 

Insurance Fraud Lawyers, What is Insurance Fraud, Class Action Lawyer

Written by Class Action Lawyer on . Posted in Class MDL Class Action News

Class action lawyers filing class action insurance Fraud lawsuits. Insurance Fraud, Scam lawyers protect citizens from insurance Fraud.

What is Insurance Fraud?
Fraud occurs when someone knowingly lies to obtain some benefit or advantage to which they are not otherwise entitled or someone knowingly denies some benefit that is due and to which someone is entitled. Depending on the specific issues involved. Insurance Fraud can be handled both civil and criminal. Class action lawyers filer civil negligence suiots against insurance companies for scams.

What is Insurance Fraud?

Any action taken by an individual with the intent to fraudulently obtain payment from an insurer is considered insurance fraud.
Insurance Consumer Tips

Use Caution!

    When receiving phone calls after an accident. It could be someone trying to involve you in a fraud scheme.
    If a life insurance sales pitch comes at a time when there is no apparent need to change insurance coverage, such as a marriage, a new child, or similar life change.
    If an agent offers to replace your old life insurance policy, which has a high cash value, with a new better one. Carefully review the premium schedule, benefits and restrictions on benefits, such as pre-existing conditions

Always!

    Make sure you receive a written policy within sixty (60) days after you have paid your first premium.
    Compare prices and options before purchasing insurance, especially if a price being offered is substantially lower than others.
    Make sure you receive and review your detailed billings for all services.
    When buying or renewing insurance coverage, check with the Office of Insurance Regulation to make sure you are dealing with a licensed agent and a licensed insurance company.
    Protect your insurance identification numbers as you would a credit card number.

Never!

    Write a premium check to an agent. Checks should be written to the insurance company or insurance agency.
    Never sign blank insurance forms.

If you feel you are a victim of insurance fraud you may be able to hire an insurance fraud lawyer and sue for damages as part of a class action lawsuit.