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.

Published on:

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..

Published on:

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.

Published on:

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.

Published on:

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.

Published on:

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.

Published on:

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).

Published on:

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 case is heading for an appeal.

3,500 Actos Bladder Cancer Lawsuits in Federal Court

Takeda, tanked another diabetes drug this year when research linked it to liver damage. 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).

Published on:

The U.S. Judicial Panel on Multidistrict Litigation, earlier this week, considered the application for all Cook Celect and Gunther Tulip IVC filter lawsuits filed nationwide in U.S. District Courts. The application was brought by the plaintiffs and they requested that the litigation be centralized before one judge for coordinated pretrial proceedings, as part of an MDL, or Multidistrict Litigation.

Cook Celect Perforation AttorneyCook Medical 27 IVC Filter Lawsuits

Currently, Cook Medical faced at least 27 different IVC filter lawsuits pending in 11 different districts. Plaintiffs have requested that the litigation be transferred to the U.S. District Court for the Southern District of Indiana as part of the MDL.

Cook Medical opposed the transfer, claiming that because the lawsuits involve different device failures with various Cook vena cava filter products, consolidating the cases as part of one MDL was not appropriate. The judges took Cook Medical to task for stating that that these were frivolous lawsuits and had no merit.

According to the manufacturer, informal coordination between the districts could achieve the same goals as an MDL. Still, Cook Medical indicated that it consents to the selection of the Southern District of Indiana as the most appropriate district.

What is Cook IVC Filter?

Blood clots can develop in the legs from various medical conditions, and are known as deep vein thrombosis or DVT. The problem with DVT is that the blood clot can break off from the leg and travel through the heart into the lungs and cause damage, known as a pulmonary embolism. In severe cases death can occur and that’s why DVT and Pulmonary Embolism are considered a serious disease that warrants treatment with oral and intravenous anticoagulants or blood thinners.

In some instances, anticoagulant therapy cannot be used because of bleeding disorders or if not effective and IVC filters, known as inferior vena cava filters, are then used. The inferior vena cava is the main vein that transports deoxygenated blood back to the heart from the lower extremities. The filters are spider-like devices that are implanted into the vena cava to block or trap blood clots that may break off and travel to the lungs.

What are Cook IVC Filter Side Effects?

Plaintiffs have alleged that Cook Celect and Gunther Tulip IVC filters are defectively designed and can cause personal injury. They point to a study was published in the medical journal Cardiovascular Interventional Radiology in April 2012, that found that 100% of Cook Celect and Gunther Tulip IVC filters perforated patients’ venal cava wall within 71 days of being implanted. Furthermore, the study found that 40% of the filters became tilted and out of position.

All of the complaints allege that plaintiffs suffered various vascular and internal organ injuries from Cook IVC filters, including perforation of the vena cava, aorta, bowels, liver, filter tilt or issues where the filters fractured or broke, allowing small pieces to travel to the heart or lungs.

FDA 2010 Warning

In August 2010, the FDA issued a warning about the risk of IVC filter perforation and injury, highlighting that the agency had received hundreds of adverse event reports where filters broke free and traveled to other areas of the body causing injury.

JAMA Study: High Risk and Low Benefit of IVC Filters

According to a study published in the medical journal JAMA Internal Medicine in March 2013, experts questioned the effectiveness of IVC filters, pointing out 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 implementation.

FDA 2014 Removal Warning

In May 2014, the FDA recommended that 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.

Bard Recovery, G2 IVC Filters Under Fire

Similar allegations have been brought against C.R. Bard recently involving 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 complications, including death, but failed to warn doctors and patients.

Many lawsuits have been filed in various federal jurisdictions nationwide, including Texas. According to sources, the number of cases waiting in the wings may eventually exceed 1,000. No MDL has been proposed for the Bard IVC Filter litigation and the company has been quietly settling these severe injury cases around the country.

Published on:

Bayer Healthcare and Johnson & Johnson’s Janssen Pharmaceuticals subsidiary, the manufacturers of the novel oral anticoagulant (NOACS) Xarelto, are exposed to several Xarelto product liability personal injury lawsuits, filed nationwide.

1-Xarelto Bleeding Hemorrhage AttorneyThese have brought by folks who suffered a catastrophic injury or death due to uncontrollable bleeding side effects while on the popular anticoagulant drug.

Illinois Xarelto Wrongful Death Lawsuit

The plaintiffs allege similar claims that the manufacturers failed to provide adequate warnings about the bleeding side effects of Xarelto, and failed to provide information about the lack of a FDA approved reversal agent.

Martha McMunn filed in the U.S. District Court for the Southern District of Illinois on behalf of her husband, Richard McMunn Jr, who passed away from Xarelto bleeding complications last year.

McMunn developed uncontrollable bleeding after using Xarelto for only a week. Xarelto was given following a knee replacement surgery, to prevent blood clots post surgery. McMunn developed life-threatening bleeding and bilateral pulmonary embolism. He died shortly afterwards from bleeding complications.

What is Xarelto?

Xarelto (also known as Rivaroxaban) is a factor Xa (ten) inhibitor which reduces the risk of blood clots and strokes by thinning the blood. Xarelto along with Pradaxa and Elquis are new oral anticoagulants, designed to reduce the risks of strokes, deep vein thrombosis and pulmonary embolisms in certain medical conditions.

The blockbuster drug was approved by the FDA in 2011, and is a joint development by Bayer and Johnson & Johnson’s Janssen subsidiary.

Xarelto: Blockbuster Drug

Bayer and Johnson & Johnson have aggressively touted Xarelto in direct to consumer advertisements as a superior replacement to Coumadin (warfarin). Warfarin was the gold standard of care for oral anticoagulation medication for the past 60 years.

Its biggest selling point for Xarelto, is that patients do not require regular blood monitoring of anticoagulation levels. Warfarin therapy needs to have the medication dosage adjusted on a frequent basis based on blood thinning levels, or protime.

The protime, which is a measure of the efficacy of the anticoagulation had to be kept in a narrow range or 2 to 3 times the INR. If the INR was greater than 3, then the patient would be at risk of major bleed or hemorrhage; if the INR was below 2, then the patient would be at risk to developing blood clots.

Lawsuit Allegations

Lawsuits allege that the Xarelto warning label fails to inform about the risk of uncontrollable bleeding due to the lack of an approved antidote. Warfarin, can be quickly reversed if bleeding occurs, with vitamin K and blood products. Xarelto has no reversal agent to counteract the blood thinning effects of the drug, creating a nightmare scenario for emergency room doctors and first responders.

According to experts, several thousand lawsuits are expected to be filed in the coming months, over the side effects and warning issues surrounding the medication.

 

Published on:

The first federal bellwether trial against Johnson & Johnson’s DePuy subsidiary for its allegedly defective Pinnacle Hip Implant has been underway for the past 3 weeks in Dallas, Texas.

DePuy ASR Metallosis Injury AttorneyThe U.S. District Court for the Northern District of Texas oversaw jury selection on September 2 and over the past three weeks there has been a parade of company executives, paid doctor consultants and defense experts subjected to withering cross examination by the plaintiffs team of lawyers.

DePuy Orthopedics Inc., is facing the first bellwether trial over allegations that the Pinnacle metal-on-metal hip was defectively designed and caused metallosis. According to the plaintiff Kathleen Herlihy-Paoli, the cobalt-and-chromium alloy caused an infection that resulted in the artificial hips to be removed.

Testimony: J&J Knew As Early as 2001 of Pinnacle Problems

According to court testimony, Johnson & Johnson knew as early as 2001 the metal-on-metal version of its Pinnacle artificial hips might generate debris that could cause metal poisoning.

A doctor who consulted with J&J’s DePuy unit on the Pinnacle hip made the company aware in February 2001 that the device would require extensive testing of implant patients to see whether they had metal debris in their bloodstreams.

In an internal memo, DePuy officials said Dr. Thomas Schmalzried warned the potential release of metal ions was a “major issue for metal-on-metal hips.” Schmalzried had said the extent of the metal-hip patient’s tissue damage was “alarming and concerning.” DePuy officials said in the e-mails that they planned to tell colleagues to “keep quiet for now” about the case Schmalzried highlighted.

Smoking Gun Internal Documents

Internal files from 2012 showed DePuy officials found the metal Pinnacle hips had a 15 percent failure rate after five years of use. Company officials had expected a failure rate of 5 percent over that time period. The company failed to warn patients and doctors or the FDA. No recall has been issued for DePuy Pinnacle line of metal on metal

The Hits Keep Coming for Johnson and Johnson (J&J)

Johnson & Johnson 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 allegations that its Pinnacle line of hip implants also were failing prematurely and causing metallosis or metal poisoning.

DePuy ASR SettlementThe J&J’s $2.5 billion settlement of ASR claims, only addressed the ASR line of hips. Here the plaintiffs claimed that its ASR hip devices caused premature hip implant failure, dislocations, pain and required surgical removal because of metallosis.

Metallosis Caused by ASR Implants

In many cases, chromium and cobalt debris from the metal-on-metal grinding between the cup and the ball components of the ASR hips caused local muscle and 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.

DePuy ASR Recall August 2010

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.

Herlihy-Paoli Severe Metallosis

According to Herlihy-Paoli, aged 58, she two Pinnacle hips in 2009 and began to complain of pain from the devices. Blood tests before the 2011 removal surgeries found the “implants had released dangerous levels of cobalt and chromium into her bloodstream. Mrs. Paoli’s cobalt blood serum levels were 85 times higher than normal.”

Once surgeons removed Herlihy-Paoli’s left hip, they “discovered the implant had turned black with metallosis.”

J&J Quits the Metal on Metal Hip Business

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

J&J had advertised the metal-on-metal implants, as a design that would last 20 years and offer greater range of motion.

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