Injured by recalled DePuy ASR and Pinnacle Hips? Metallosis, pain and suffering, hip replacement? Read More Here >>
Injured by recalled Stryker Rejuvenate and ABG II Hips? Metallosis, pain and suffering, hip replacement?Read More Here >>
Injured by Metal on Metal Hips, Biomet M2A Magnum, Smith and Nephew, Wright Conserve? Metallosis, pain and suffering, hip replacement? Read More Here >>
Injured by Trans Vaginal Mesh complications following Pelvic Organ Prolapse and Urinary Incontinence surgery? Pain and suffering, redo surgery, urinary incontinence? Read More Here >>
Injured by Mirena IUD complications? Mirena uterus perforation and uterus imbedment requiring surgery? We can help, Read More Here >>
Injured by Actos Bladder Cancer? We can help, Read More Here >>
Injured by Pradaxa Hemorrhage or Stroke?We can help, Read More Here >>
Injured by NuvaRing Deep Vein Thrombosis, Pulmonary Embolism, Stroke? We can help, Read More Here >>
Injured by Januvia/Byetta/Victoza Pancreatic Cancer?We can help, Read More Here >>
Birth Defects by Zoloft/
SSRI Antidepressants?
We can help, Read More Here >>

Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others. We specialize in Personal Injury trial litigation and focus our energy and efforts on those we represent.

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In the first federal trial involving Boston Scientific Corp., the vaginal mesh manufacturer was ordered by the jury to pay $26.7 million to a group of four women who blamed the company’s vaginal mesh inserts for their personal injuries.

Trans Vaginal Mesh AttorneyJurors in federal court in Miami found that Boston Scientific officials defectively designed their Pinnacle pelvic-organ implants and failed to properly warn doctors and their patients about the device’s risks.

The verdict is the first in a federal case against Boston Scientific over the Pinnacle inserts and the first to combine more than one plaintiff’s claims.

Combined Trial Four Awards

In a first for a federal transvaginal trial, 4 claims were grouped together and tried collectively. Jurors awarded Amal Eghnayem, Margarita Dotres and Mania Nunez more than $6.7 million, and Juana Betancourt, was awarded more than $6.5 million. The panel awarded only compensatory damages.

Boston Scientific company denied that the Pinnacle inserts suffered from design flaws and claimed company officials provided adequate warnings about the implants’ risks.

Allegations: Boston Scientific Did Not Test Vaginal Mesh Products

The women’s lawyers argued that Boston Scientific officials ignored calls for more testing of the pelvic-organ implant and rushed the production of the devices to market without adequate testing.

Thousands of Women Affected with Organ Damage

Doctors inserted more than 70,000 mesh devices in the U.S. in 2010, threading them through incisions in the vagina to strengthen pelvic muscles that failed to support internal organs or to treat urinary incontinence.

Over thirty thousand women nationwide are pursuing Boston Scientific mesh lawsuits after experiencing painful and debilitating complications associated with the use of bladder sling and transvaginal mesh products for repair of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI), including erosion of the mesh through the vagina, infections and other problems.

Boston Scientific Trial Verdicts

In September, a state court jury in Texas ordered Boston Scientific to pay $73 million in damages to a woman who blamed one of its incontinence implants for her constant pain. That verdict was cut to $34.6 million by the trial judge. The company has won other cases that have gone to trial in state court in Massachusetts.

The Massachusetts-based company, is exposed to more than 14,000 suits over its vaginal implants in U.S. federal courts, according to filings with the U.S. Securities and Exchange Commission. Boston Scientific pulled Pinnacle from the U.S. market in 2011.

Many of the cases against Boston Scientific have been consolidated before U.S. District Judge Joseph Goodwin in Charleston, West Virginia. Others have been filed in state courts in Delaware, New Jersey, Missouri, Texas and California. Goodwin, who’s overseeing all the vaginal-mesh suits filed in federal courts against Boston Scientific, presided over the trial of the four women’s claims.

Mesh Materials Not Approved

Women allege that the mesh inserts are made of substandard plastic materials  that erode once they are implanted, causing pain and organ damage, and making sex uncomfortable or impossible. According to evidence presented in the trial, the mesh used in the Pinnacle insert hadn’t been approved for use within the human body by the company that made it.

Vaginal Mesh and Bladder Sling MDL Update

U.S. District Judge Joseph Goodwin is overseeing coordinated discovery and a series of bellwether trials involving seven different manufacturers, which have all be centralized in the Southern District of West Virginia as part of multidistrict litigation.

There are about 70,000 mesh/sling lawsuits in the MDL, as of the latest figures provided by the JPML, with 14,250 Boston Scientific, 10,117 Bard Avaulta, 22,077 Ethicon, 19,170 American Medical Systems (AMS), 1,813 Coloplast, 293 Cook Medical and 84 Neomedic mesh lawsuits.

As part of the coordinated management of the litigation, there are early trial dates set, known as “bellwether” case. The outcome of these trials are only binding on the claims that go before a jury, and they may facilitate vaginal mesh settlement negotiations with the manufacturers.

Boston Scientific is expected to face closing arguments November 17 in another multi-plaintiff trial in federal court in West Virginia.

The Florida case is Eghnayem v. Boston Scientific Corp., 14-cv-24061, U.S. District Court, Southern District of Florida (Miami).

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According to Wisniewski’s attorney, Mike Miller, the jury found Takeda “clearly failed to warn, and it clearly caused her damage. She’s got a life of bladder cancer; it’s a fair verdict,” he added.

Takeda Knew in 2004 of Cancer Link

According to Miller, Takeda knew by 2004 that studies found links between Actos and cancer, and didn’t issue a warning until seven years later to protect billions of dollars in Actos sales.

Takeda Put “Profits Before People”

“Takeda chose to protect profits rather than patients,” Miller said in closing arguments in Wisniewski’s trial. The company’s main goal was “to protect the product,” Miller added.

Actos 7th Bladder Cancer Trial

Wisniewski, a retired accountant who has bladder cancer, is the seventh Actos patient to take her product liability, personal injury claim to trial. In the 6th Actos trial earlier in the year, there was a massive $9 billion verdict handed down in Louisiana against Takeda and Eli Lilly & Co. for hiding the diabetes medicine’s cancer risks. The punitive damage award was reduced by the judge to $37 million, the highest allowable by law. Under the judge’s ruling, Takeda is responsible for paying $27.6 million in punitive damages and Lilly must pay $9.2 million. The jury also awarded Allen $1.5 million in compensatory damages. The case is on appeal.

3,500 Actos Bladder Cancer Lawsuits in Federal Court

More than 3,500 Actos suits have been consolidated before U.S. District Judge Rebecca Doherty in Lafayette, Louisiana, for pretrial discovery, in what is known as Multidistrict Litigation (MDL).

4,500 Actos Bladder Cancer Lawsuits in State Court

The company is exposed to another 4,500 cases in state courts in Illinois, West Virginia, California and Pennsylvania. Can over 8,000 plaintiffs be wrong, with more injured folks waiting the wings?

Actos: Blockbuster Drug Huge Profits
According to Bloomberg, sales of Actos maxed out in March 2011 at $4.5 billion for Takeda and accounted for 27 percent of the company’s revenue. Actos has pumped out more than $16 billion in sales since its 1999 release.

Wisniewski and other users allege that Takeda researchers ignored or downplayed concerns about the Actos bladder cancer links before it went on sale in the U.S. and misled U.S. regulators about the diabetic medication risks.

Key Documents Destroyed

The jury found that the Takeda officials intentionally destroyed documents about the development, marketing and sales of Actos. The company ditched files of 46 former and current employees, including those of top executives in Japan and U.S. sales representatives. “We’ll never know what was in those documents,” Miller said.

Actos Verdicts

In 2013, juries in California and Maryland ordered Takeda to pay a combined $8.2 million in damages. But those verdicts later were tossed out by judges. The company also won defense verdicts recently in two cases in state court in Las Vegas. Takeda faces its next Actos trial in state court in West Virginia starting October 15.

The Pennsylvania case is Wisniewski v. Takeda Pharmaceuticals America Inc., 120702272, Philadelphia County Court of Common Pleas. The consolidated Actos case in Louisiana is In Re Actos (Pioglitazone) Products Liability Litigation, 11-md-02299, U.S. District Court, Western District of Louisiana (Lafayette).

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Stryker Corp. agreed recently this month to pay more than $1 billion to settle lawsuits over thousands of hip implants recalled in 2012 after patients complained of early hip implant failure, pain, and metal debris causing metallosis from the devices.

Stryker Rejuvenate metal hip injury attorney Stryker Settlement Details

Stryker will pay a base amount of $300,000 per case to patients who had the devices surgically removed. The hip implant device manufacturer is exposed to more than 4,000 suits consolidated in New Jersey state court and federal court in Minnesota.

To qualify for the settlement, Stryker patients must show they had their hip implant removed prior to November 3, according to the terms of the settlement.

Patients who suffered extraordinary injuries associated with the hip’s removal, such as multiple surgeries, may qualify for more than $300,000 in compensation.

Stryker Recall July 2012

Stryker recalled their Rejuvenate and ABG II devices in July 2012 after warning surgeons that the implants could damage tissue around the hip and cause other significant health problems.

Stryker settled before facing multiple trials over allegations that their hips had fundamental design defects and that the company failed to warn patients about the devices’ risks.

What is Stryker Rejuvenate Hip?

The Stryker Rejuvenate is a modular metal based hip replacement, and it is subject to fretting, corroding and finally failing shortly after it is implanted.

The Stryker Rejuvenate has two components that fit inside of each other to allow the surgeon to adjust the length of the femoral component based on the patient’s size. This design has been associated to an increased risk of metallosis that occurs from the release of metal debris as the chromium-cobalt neck grinds against the titanium femoral stem.

Usually metal hip implants consist of one component of the metal head and stem. According to experts, approximately 20,000 patients received the metal hip implants. Unfortunately, according to experts it is expected that the Stryker Rejuvenate side effects are going to cause patients to suffer catastrophic failure of their hip replacements the longer the device remains.

Catastrophic hip failure and the need for early replacement is not a question of if, but a question of when.

Stryker Lawsuit Allegations

The lawsuits in the state and federal court litigation have similar claims, alleging that the Stryker Rejuvenate hip implant was defectively designed and unreasonably dangerous, causing patients to develop early hip failure, pseudotumors in the hip joint, pain and suffering and metallosis side effects that resulted in the need for risky revision surgery.

Federal Multidistrict Litigation

Almost 2,000 cases are pending in the federal court system, and consolidated as part of an MDL, or multidistrict litigation. The federal case is In Re Stryker Rejuvenate Hip Implant Products Liability Litigation, 13-mdl-2441, U.S. District Court, District of Minnesota (St. Paul).

New Jersey State Multidistrict Litigation

Consolidated pretrial proceedings have been established in New Jersey state court, since is the corporate state for the hip manufacturer, Howmedica Osteonics. The New Jersey litigation has been centralized before Superior Court Judge Brian R. Martinotti in Bergen County as part of a Multi-County Litigation (MCL). Here also almost 2,000 cases are pending.

The New Jersey case is In Re Stryker Rejuvenate and ABG II Modular Hip Implant Litigation, 296 BER-L-936-13, Bergen County Superior Court (Hackensack).

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Johnson & Johnson was found not liable for personal injuries and product liability by a Texas jury in the first case to go to trial.

DePuy ASR Metallosis Injury AttorneyJury Found For Johnson & Johnson DePuy

The Dallas federal jury ruled unanimously against the plaintiff Kathleen Herlihy-Paoli, who said the two metal-on-metal Pinnacle hips she received in 2009 were defective and that the company failed to warn patients and doctors about the device’s risks.

DePuy had said the implants were improperly positioned, and not to blame for her injuries. Jurors deliberated for two days, after a eight-week trial. The jury found that the ULTAMET artificial hips sold by J&J’s DePuy Orthopaedics unit as part of its Pinnacle line of implants had no design defects and the company properly warned patients and doctors about the devices’ risks.

There are more than 6,000 lawsuit cases over the allegedly defective Pinnacle hip implants that have been consolidated in the Dallas, Northern District of Texas federal court.

Metal on Metal Hip Manufacturers On the Hit Parade

J&J set aside $2.5 billion last year to settle claims that 8,000 of its DePuy ASR hips were defective. The pharmaceutical and medical device giant company  is now exposed to similar allegations that its Pinnacle line of hip implants also were failing prematurely and causing metallosis or metal poisoning.

J&J, the world’s largest health-care company, issued a worldwide recall of 93,000 ASR hip implants in August 2010, saying 12 percent failed within five years. But, according to internal J&J documents unearthed during litigation, 37 percent of ASR hips failed after 4.6 years. In 2012, the failure rate in Australia was 44 percent within seven years.

J&J stopped selling the metal-on-metal version of the Pinnacle hip in August 2013 after the U.S. Food and Drug Administration required device makers to submit new versions of the artificial hips for pre-market approval.

J&J bragged that the Pinnacle metal-on-metal implants, which were approved for sale in the U.S. in 2000, as a design that would last 20 years and offer greater range of motion.

All metal on metal (MoM) hip manufacturers are exposed to similar allegation of premature hip failure and metallosis. In February of this year, Biomet agreed to settle over 1,000 lawsuits over its  MoM M2A Magnum implants. Zimmer has also faced litigation over its Durom MoM device, as has Stryker’s Trident, Rejuvenate and ABG II MoM devices. Smith & Nephew, which started the MoM craze with its Birmingham line of MoM devices is also under the gun as well as Wright’s line of Conserve MoM hip implants.

There are currently more than 4,000 product liability personal injury lawsuits pending nationwide involving the recalled Stryker Rejuvenate or ABG II implants, which were removed from the market in 2012, amid reports that the modular femoral components may be prone to fret, corrode and ultimately fail within a few years.

Metallosis Caused by MoM Implants

In many cases, chromium and cobalt debris from the metal-on-metal grinding between the cup and the ball components of the MoM hips caused local muscle, bone, tissue death and increased Cobalt and Chromium blood levels.

According to medical experts the long term side effects of heavy metal poisoning is unclear, with some stating that it can cause bladder and kidney cancer many years down the road.

The case is Herlihy-Paoli v. DePuy Orthopaedics Inc., 11-cv-3590, U.S. District Court; Northern District of Texas (Dallas).

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The slow moving train wreck that we call the Metal on Metal Hip debacle continues to grind on. For the thousands of patients who were promised the latest and greatest hip technology but instead were sold a pile of scrap metal, and the significant risk of metal poisoning, there maybe light at the end of the tunnel.

DePuy ASR Metallosis Injury AttorneyThere has been some success in resolving the lawsuits involving thousands of defective metal on metal hips. Some of the lawsuits have been settled and thousands more are still pending against the metal hip manufacturers including Zimmer (now the new proud owner of Biomet), DePuy, Stryker, Wright Medical and Smith and Nephew that sold the metal-on-metal hip implants.

The defective hip replacement lawsuits share similar allegations that there is premature catastrophic hip implant failure caused by metal cobalt and chromium release. The artificial hips are made of cobalt chromium alloy and the grinding action of the hip joint in daily activity causing the metal components to rub together, leading to the release of these toxic heavy metal particles.

The release of these metal ions , causing metallosis, an inflammatory condition that damages tissues in the hip joint and muscle and causes elevated blood levels of these heavy metal toxins.

Unfortunately for some folks no amount of money will ever compensate them fully for the pain and suffering that they have endured, the need to be exposed to risky re-do surgery and to undergo lengthy rehabilitation. Until corporate executives start going to jail and forfeiting their salaries/stock options, it will be business as usual and the business is putting profits before people.

Settlements Underway For DePuy ASR

In July 2014, Johnson & Johnson and DePuy Orthopaedics Inc., a subsidiary of J&J, began payments in the $2.5 billion DePuy ASR metal hip implant settlement that was announced in November 2013. The settlement involves approximately 8,000 cases (all of whom were required to have revision surgery before August 13, 2013) with base payments of $250,000 per case. Patients with hip implants older than 5 years, smokers and overweight folks would get less.

DePuy Pinnacle Bellwether Trial: Verdict Expected This Week

As of July 2014, almost 7,000 DePuy Pinnacle lawsuits continue to move forward in U.S. District Court, Northern District of Texas. The first bellwether trial has been underway over the past 8 weeks or so and the case is expected to be handed to the jury this week. Folks hold onto your hats, a verdict may come before the weekend. If as expected the Dallas jury finds for the plaintiff then there maybe a global settlement in the works to resolve these cases.

Zimmer Durom and Biomet Magnum Settlements

In 2010, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated federal Zimmer metal-on-metal Durom Acetabular Cup cases into multidistrict litigation (MDL No. 2158). Zimmer has settled with its Durom Cup with a $400 million payout and plans to continue settling with Zimmer hip replacement patients.

In February 2014, Biomet Inc., which is now owned by Zimmer, agreed to a $56 million settlement for its M2a 38 and Magnum models metal-on-metal hip replacements. The average settlement amount for each Biomet hip case is approximately $200,000. More than 1,600 Biomet hip replacement lawsuits have been filed in the US District Court, Northern District of Indiana. Patients with hip implants older than 5 years, smokers, cases filed after the statute of limitations and overweight folks would get less.

Stryker Rejuvenate/ABG II Hip Settlement

Stryker Corp. recalled its ABG II and Rejuvenate Hip Model Systems in July 2012 and there are 20,000 Stryker hip implanted nationwide. According to some experts, the artificial hip failure rate could be as high as 50 percent.

In the fall of 2013, several Stryker cases began mediation. Either a global settlements will be announced soon or the first bellwether trials could be set. Stryker is exposed to more than 4,000 hip lawsuits in state and federal courts, and 2,000 cases have been designated as MCL in New Jersey.

Wright Medical Technology Inc.

Wright Profemur and Conserve Hip Replacement Implants have not been recalled but a number of lawsuits nationwide have been filed against Wright. No settlements have been announced to date.

Smith and Nephew R3

Smith and Nephew Implants have not been recalled, except for a limited number of R3 models and a number of lawsuits nationwide have been filed against Smith and Nephew. Smith & Nephew initiated a worldwide recall of the metal liner in its R3 Acetabular System in 2012, after reports of loosening, pain, device failure, infection, metal sensitivity and dislocation. Almost 4,000 of the metal liners were used in the United States between 2009 and the recall.

No settlements have been announced to date, although according to confidential sources, settlement talks are at an advanced stage..

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Johnson & Johnson faces the first product liability personal injury lawsuit over side effects of Levaquin that caused peripheral neuropathy for Karyn Grossman, from Maryland. According to Grossman, she developed the severe and often permanent form of nerve damage after using the popular antibiotic.

1-Levaquin Peripheral Neuropathy AttorneyThe lawsuit was filed in September in the U.S. District Court for the Northern District of California, against Johnson & Johnson, Ortho-McNeil-Janssen Pharmaceuticals subsidiary and the drug distributor, McKesson Corp. as defendants.

FDA 2013 Warnings

In 2013, the FDA required new warnings about the risk of nerve damage and peripheral neuropathy associated with the fluoroquinolones class of antibiotics including Cipro, Avelox and others.

According to the FDA, peripheral neuropathy could occur at any time during treatment with the popular antibiotics and may continue for months or even years after use of the medications is stopped.

What is Peripheral Neuropathy?

Peripheral neuropathy occurs because of damage to the nerves, which reduces sensation and movement. Symptoms which can be severe and debilitating include pain, burning, tingling, numbness, weakness, and sensitivity to light touches, temperature and motion in the arms and legs. The disease can be very difficult to treat and include antidepressants, vitamins and physical aides such as walking sticks and in catastrophic cases folks are wheel chair bound.

Plaintiff Levaquin Side Effect Allegations

According to Grossman, Johnson & Johnson ignored information about the link between Levaquin and peripheral neuropathy for years, failed to adequately warn patients and doctors about the risk of permanent and long-lasting nerve damage.

Grossman claims that, “The warning label for Levaquin during the period from September 2004 through August 2013 misled Plaintiff and her treating physician by incorrectly advising patients and physicians that peripheral neuropathy associated with Levaquin was ‘rare’ and in any case could be avoided by discontinuing the drug upon the onset of certain symptoms. The truth, however, is that the onset of irreversible peripheral neuropathy is often rapid and discontinuation of the drug will not ensure that the peripheral neuropathy is reversible.”

Levaquin Nerve Damage Side Effect Risk

Levaquin is one of the most widely used antibiotics in the world, and is part of the popular class of medications known as fluoroquinolones, which have previously been linked to a number of serious health issues, including a risk of tendon ruptures, retinal detachment and kidney problems. Other drugs in the same class include Cipro, Avelox, Noroxin, Floxin and Factive.

Levaquin is used to tackle bacterial pneumonia, bacterial chronic bronchitis, life-threatening bacterial infections such as meningitis, symptoms caused by multiple, concurrent bacterial infections and bacterial infections that are resistant to other antibiotics. Women are sometimes prescribed Levaquin for routine bacterial urinary tract infections.

Levaquin Blockbuster Drug

Levaquin is a blockbuster drug, and a tremendous cash cow for Johnson and Johnson. About 23.1 million patients received a prescription for an oral fluoroquinolone in 2011. Cipro dominated the market, comprising 70% of those prescriptions, followed by Levaquin or a generic equivalent, which was used by 28%.

Another 3.8 million patients received injections in 2011, with Levaquin or a generic equivalent making up 63% of those, followed by Cipro at 28%. According to IMS Health, which tracks prescription drugs sales, Levaquin was the best-selling antibiotic drug in the United States in 2010, with sales of about $1.5 billion.

Johnson & Johnson “knew or should have known”

Plaintiffs have alleged that Johnson & Johnson knew or should have known about the risk of peripheral neuropathy from Levaquin and other fluoroquinolones as early as 1992, when a case report was published in the British medical journal, The Lancet.

Other studies were published in 1996 and 2001, highlighting cases where users of fluoroquinolone antibiotics experienced symptoms of peripheral nerve damage, including numbness, pain and muscle weakness.

Researchers found that over half of patients experienced symptoms lasting more than a year, and 80% characterized the nerve problems as severe.

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According to the U.S. Judicial Panel on Multidistrict Litigation (JPML), all pending federally filed Cook inferior vena cava (IVC) filter lawsuits will be consolidated and centralized before U.S. District Judge Richard L. Young in the Southern District of Indiana, for coordinated pretrial proceedings.

Bard IVC FILTER Injury AttorneyThis order by the JPML establishes a nationwide federal Multidistrict Litigation (MDL) in one courthouse. This MDL will include all product liability and personal injury lawsuits involving side effect complications with Cook IVC filters.

What are Cook IVC Filters?

Cook IVC Filters are small metallic spider-like devices implanted by doctors to prevent blood clots from traveling from the leg (known as a deep vein thrombosis) to the lungs and causing a pulmonary embolism (blood clot in the lung). There are two main models, the Cook Celect and Gunther Tulip filters. The devices are commonly used when anticoagulant therapy is contraindicated because of bleeding risks or has not been effective.

Status of Cook IVC Filter Litigation

There are currently 32 complaints filed across the U.S. in various federal courts, alleging that design defects with Cook Celect and Gunther Tulip filters make the devices subject to fracture, migrate, tilt or perforate the inferior vena cava, aorta or other vital organs.

‘Damning’ Medical Studies

According to an April 2012 study in the Cardiovascular Interventional Radiology, researchers found that 100% of Cook Celect and Gunther Tulip IVC filters perforated patients’ venal cava wall within 71 days of implantation. The study also revealed that 40% of the filters became tilted and out of position.

A study published in the medical journal JAMA Internal Medicine in March 2013 questioned the effectiveness of IVC filters, finding that less than 10% of filters evaluated in the study were successfully removed from patients and 8% of recipients of IVC filters suffered a pulmonary embolism despite the device’s presence.

FDA Warnings

In August 2010, the FDA issued a warning about the risk of IVC filter side effects, warning that the agency had received hundreds of adverse event reports where filters broke free and migrated to other areas of the body or caused perforation types of injury in organs and blood vessels.

In May 2014, the FDA urged doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has passed, highlighting that many doctors were not adequately warned about the importance of retrieving the devices.

Benefits of Cook IVC Filter MDL

In complex product liability litigation involving either defective pharmaceutical or medical product devices, it is common for MDL proceedings to be established to reduce discovery, avoid conflicting rulings from different Courts and to serve the convenience of the parties.

Bellwether Trials

After the MDL is up and running, Judge Young will order a group of cases in the MDL for early trial dates. The 10 to 12 cases will be picked by the defendants and plaintiffs and be set up for specific discovery. These early trials are known as “bellwether” trials and they are designed to help the parties determine how juries may respond to similar evidence and testimony that is repeated throughout the litigation.

Bard Recovery and G2 IVC Filters Litigation

Another major manufacturer, C.R. Bard, of these IVC devices has been exposed to several hundred lawsuits.  Similar claims have been filed against C.R. Bard in recent years involving side effect problems with their Bard Recovery IVC Filter and Bard G2 IVC Filters. According to the complaints, Bard knew for years that their IVC filters were prone to fracture, which can cause severe side effect complications, including death, but failed to warn doctors and patients.

These cases were never consolidated in a MDL, and Bard has been recently quietly settling these personal injury and product liability cases nationwide.

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xarelto side effects attorneyThe medications reduce the incidence of blood clots and reduce the rate of strokes as in the case of atrial fibrillation and to prevent catastrophic injuries from pulmonary embolism including death.

Untreated deep vein thrombosis (blood clot in the leg) can result in a pulmonary embolism when the blood clot in the leg breaks off and travels in the venous system to the lung.

All anticoagulants have a narrow therapeutic index; too little blood thinning and the patient has injury from strokes or embolism, too much and the patient develops bleeding and can even die.

New Drug Xarelto (Rivaroxaban)

Until recently there was only one option for an oral anticoagulant, Coumadin also known as Warfarin. Coumadin has been around for 60 years although not perfect, it was the best that we had. The problem with Coumadin was the need for frequent regular blood tests to measure the amount of blood thinning and avoidance of certain foods. We know it reduces the risk of strokes and pulmonary embolism and if the blood was too thin we could reverse it with vitamin K and blood products.

Recently new anticoagulation drugs have been approved for sale, the first being Pradaxa, followed by Xarelto and most recently Elquis. These medications act on a different blood thinning pathway to Coumadin and are known as direct Factor Xa (ten) inhibitors or thrombin inhibitors. Doctors prescribe Bayer’s billion-dollar blood thinner Xarelto to prevent blood clots and protect patients from strokes, deep vein thrombosis and pulmonary embolism. Xarelto may cause irreversible internal bleeding that can lead to hospitalization and death.

Institute of Safe Medication Practices Report

According to an industry consumer watchdog, the Institute of Safe Medication Practices (ISMP), noted that the number of serious adverse events with Xarelto bleeding side-effects is significant and worse that for another new blood thinner, Pradaxa. Xarelto prescriptions increased to nearly 1 million prescriptions per quarter, according to ISMP. ISMP monitors and analyzes serious adverse drug events reported to the U.S. Food & Drug Administration (FDA).

Xarelto Increasd Adverse Reports

As the usage of Xarelto increases in the United States, many Xarelto uncontrollable bleeding lawsuits are being filed against Bayer AG, and Johnson and Johnson, the manufacturers and distributors of Xarelto. In the first quarter of 2013, ISMP found 680 serious adverse event reports associated with Xarelto, compared to 528 complaints for Pradaxa. According to ISMP the trend is mostly due to doctors changing prescriptions for their patients from Pradaxa to Xarelto.

Xarelto and Pradaxa: No Antidote

Warfarin, the traditional go to blodd thinner drug, was approved by the FDA in 1954 and marketed under the brand names of Coumadin. There is no approved antidote for oral anticoagulants, such as Xarelto and Pradaxa. If significant bleeding should occur in patients taking the blood thinners then this lack of an antidote means that patients who suffer seemingly minor injuries are at risk of uncontrolled bleeding that could be fatal.

Xarelto History

Xarelto is a Bayer drug that is marketed in the US by Johnson & Johnson and its subsidiary, Janssen Ortho LLC. Xarelto was initially approved by the FDA in July 2011 to reduce deep vein thrombosis and pulmonary embolism in patients who had knee or hip replacement surgery (preventive use). Xarelto use was expanded in November 2011 to reduce stroke and blood clot risks in patients with atrial fibrillation. Xarelto received FDA approval again in November 2013 to treat deep vein thrombosis and pulmonary embolism.

Xarelto Lawsuits

Hundreds of adverse event reports have been submitted to the FDA suggesting a link between Xarelto and bleeding injuries or death. Similar allegations have been raised in lawsuits, that the drug makers failed to adequately warn about the bleeding risk or lack of an effective Xarelto reversal agent. Xarelto was heavily marketed as superior to warfarin because it is easier to take and require no monitoring to maintain the correct dosage.

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According to a new Columbia University medical study, one in about 370 women who have the morcellation procedure to remove uterine fibroids have undiagnosed and unrecognized sarcoma cancer.

J&J Ethicon Morcellator Cancer AttorneyThis hidden danger can be spread throughout the body during the invasive procedure, leading the cancer staging to be upgraded from stage 1 (local) to stage 4 (metastastic spread). The study was published in the Journal of the American Medical Association (JAMA) on September 24.

What Are Power Morcellators?

Power morcellators are surgical tools that gynecological doctors use to perform uterine fibroid surgery in a minimally invasive or laparoscopic procedure.

In a laparoscopic hysterectomy or myomectomy surgery, power morcellators can be used to grind up the uterus or uterine fibroids into very small pieces, allowing doctors to remove the material through a small incision.

The device was designed to reduce the surgery time, incision and recovery time for women undergoing these popular procedures. But, this convenience comes at a huge risk for women with undiagnosed uterine sarcoma cancer, power morcellation spreads cancerous uterine tissue throughout the pelvis, abdomen and body.

FDA Warning: Hysterectomy Morcellation and Uterine Sarcoma Cancer Spread

Earlier in the year, the FDA issued strong warnings asking doctors to stop using power morcellators due to the increased cancer spreading risks, there is no way for doctors to accurately detect which women may have undiagnosed sarcoma.

According to the FDA, one out of every 350 women undergoing surgery with morcellation may have the undiagnosed uterine cancer, and the findings of this latest research confirms those findings.

Healthcare Insurance Carriers: No Coverage for Morcellation Procedures

The findings raise concerns that have led a number of hospitals nationwide to declare that they will no longer use power morcellators during uterine fibroid removal surgery.

Some health insurance carriers have followed suit and stopped covering these procedures. The insurers started dropping health insurance payments after health experts and law makers called for power morcellator recalls. Also there are a growing number of hysterectomy morcellation lawsuits that have been filed on behalf of women diagnosed with the spread of leiomyosarcoma, endometrial stromal sarcoma and other uterine cancers that were contained prior to the procedure.

Johnson & Johnson’s Ethicon Morcellator Recall

Health care giant, Johnson & Johnson’s Ethicon unit, which had cornered more than 70% of the market, has announced a power morcellator recall recently. According to Ethicon, the devices were too great a cancer risk and that there was currently no way to make them safe.

According to medical experts, many women are exposed to an unnecessary risk of spreading cancer from morcellation, because some gynecologists have not disclosed the cancer risks to their patients.

Growing Hysterectomy Morcellator Cancer Lawsuits

As the public learns that aggressive uterine cancer cases can follow a laparoscopic hysterectomy or myomectomy morcellation procedures, more lawsuits are being filed nationwide. The lawsuits have similar allegations that there were inadequate warnings and the manufacturers failed to make the devices safe.

Furthermore, women claim that are many safer alternative treatment options are available for symptomatic uterine fibroids, including traditional surgical hysterectomy, catheter-based blocking of the uterine artery, and laparoscopic hysterectomy or myomectomy without use of morcellation.

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Trans Vaginal Mesh AttorneyAccording to Endo, they settled “substantially all” the remaining U.S. lawsuits against its American Medical Systems Holdings unit over the Perigee, Apogee and Elevate mesh implants. Endo announced that the company was adding $400 million to its $1.2 billion liability reserve for the devices. These vaginal mesh devices were designed to support pelvic muscles and treat incontinence.

The deal settles more than 10,000 lawsuits. Endo agreed earlier this year to pay about $830 million to settle an additional 20,000 suits over the implants. That settlement was announced after the U.S. Food and Drug Administration said vaginal-mesh inserts should be subject to stricter safety requirements because they are high-risk devices.

In Endo’s first set of vaginal mesh settlements, the company paid $54.4 million to resolve an undisclosed number of suits over the devices in June 2013. The company has now agreed to pay almost $1.3 billion to resolve suits over the implants.

Thousands of Women Affected with Organ Damage

Doctors inserted more than 70,000 mesh devices in the U.S. in 2010, threading them through incisions in the vagina to strengthen pelvic muscles that failed to support internal organs or to treat urinary incontinence. Over thirty thousand women nationwide were pursuing AMS mesh lawsuits after experiencing painful and debilitating complications associated with the use of bladder sling and transvaginal mesh products for repair of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI), including erosion of the mesh through the vagina, infections and other problems.

J&J, a global giant and the world’s biggest maker of health-care products, has pulled four lines of vaginal implants off the global market. Endo is still exposed to about 5,000 suits over the mesh implants.

Mesh Dominoes Beginning to Fall

The majority of mesh cases have been consolidated in Charleston, West Virginia, before U.S. District Judge Joseph Goodwin, who is overseeing discovery exchanges and bellwether trials. At last count on September 15, there was close to 20,000 AMS mesh lawsuits consolidated in West Virginia federal court.

According to confidential sources, other manufacturers including Boston Scientific Corp., Bard, and Coloplast A/S are engaged in settlement talks.

Coloplast Settlement Details

Coloplast, based in Humlebaek, Denmark, agreed in March to pay about $16 million to resolve 400 claims that its inserts harmed women. Women in those cases are receiving an average of $40,000 each.

Endo is scheduled for its first trial early next year in Texas state court on claims that it defectively designed the vaginal-mesh implants.

Texas Jury Hammers Boston Scientific $75 M

Last month, a Texas jury ordered Boston Scientific to pay $73 million in damages to a woman who injured by a defectively designed implant, which left her in constant pain.
The consolidated AMS cases are In re American Medical Systems Inc. Pelvic Repair Systems Products Liability Litigation, 12-md-02325, U.S. District Court, Southern District of West Virginia (Charleston).