Dallas Fort Worth Injury Lawyer Blog

February 10, 2016

J&J Ethicon Vaginal Mesh Injury Claims Beginning to Settle

According to a recent Bloomberg news article, Johnson & Johnson (J&J) has begun to settle thousands of personal injury and product liability lawsuits filed by women who blame the company’s vaginal-mesh inserts for causing severe injuries.

First of Many Johnson and Johnson Ethicon Settlements

The world’s largest medical-device maker has agreed to pay more than $120 million to settle an initial round of about 3,000 lawsuits where women suffered serious organ damage from erosion of their popular line of vaginal mesh surgical inserts.

February 9, 2016

Xarelto Uncontrollable Brain Bleed Lawsuits Increasing

by Dr. Shezad Malik

Oren Fells from Georgia recently filed a Xarelto uncontrollable intracranial or brain bleeding lawsuit in the U.S. District Court for the Eastern District of Louisiana. The lawsuit was filed against Bayer Healthcare, Johnson & Johnson, and its Janssen subsidiary, the manufacturers of Xarelto.

Catastrophic Xarelto Brain Bleeding Allegations

Fells began taking the newer anticoagulant or blood thinner Xarelto in 2013, for the treatment of atrial fibrillation, a common heart rthym problem. Fells suffered a brain bleed in January, 2014, causing him to develop life long permanent injuries.

February 8, 2016

FDA Launches Uterine Cancer Death Morcellator Investigation

by Dr. Shezad Malik

Michael G. Fitzpatrick, representative of the 8th district of Pennsylvania, has asked the FDA’s Office of Criminal Investigations, to investigate whether three hospitals violated mandatory reporting policies in wrongful deaths related to the use of power morcellators during gynecological surgery.

Brigham and Women’s Hospital (of Boston); Rochester General Hospital; and the University of Rochester Medical Center are implicated in failing to report these surgical deaths, that were likely related to the use of morcellators at the hospital as part of surgical procedures there.

What are Power Morcellators?

February 5, 2016

FDA Ups Transvaginal Mesh Warning Label as “High Risk Devices”

by Dr. Shezad Malik

According to the U.S. Food and Drug Administration (FDA), the popular plastic transvaginal mesh device that has been used to repair pelvic organ prolapse (POP) transvaginally, or through the vagina, will have to undergo rigorous safety studies before being available to be used in patients.

The FDA issued two final orders to vaginal mesh manufacturers and notified the public that the agency is strengthening the medical data requirements for surgical mesh.

FDA Classifies Plastic Vaginal Mesh as High Risk

February 4, 2016

AndroGel Pulmonary Embolism Side Effect Lawsuit Filed

by Dr. Shezad Malik

Timothy Wilkes from Ohio, filed a testosterone drug personal injury and product liability lawsuit in the U.S. District Court for the Northern District of Ohio. According to Wilkes, the side effects of the popular testosterone replacement medication, AndroGel caused a deep vein thrombosis or a blood clot in his legs that traveled to the lung, causing a pulmonary embolism.

AndroGel Used as “Lifestyle” Low T Testosterone Replacement

There are almost 3,500 testosterone lawsuits filed in the federal court system, alleging injuries caused by the side effects of testosterone drugs, including AndroGel, Testim, Axiron, Androderm and other variations of gels, patches, pills and injections.

February 3, 2016

J&J Ethicon Prolift Vaginal Mesh $12.5M Verdict

by Dr. Shezad Malik

Recently, a Philadelphia jury found for the plaintiff Patricia Hammons, who suffered serious internal injuries from the Ethicon Prolift vaginal mesh. Johnson and Johnson, the manufacturer is exposed to at least fifty thousand similar claims, with hundreds of lawsuits fast tracked for early trial in 2016.

$12.5M Verdict and Punitive Damages Awarded

Hammons, was awarded $5.5 million in compensatory damages and $7 million in punitive damages against Johnson & Johnson’s Ethicon subsidiary. Punitive damages are rarely awarded in product liability and personal injury lawsuits, and are designed to punish the company for gross negligence and reckless disregard for the safety of patients.

January 4, 2016

Wright Conserve Metal on Metal Hip Replacement Verdict

by Dr. Shezad Malik

The manufacturers of the Wright Conserve metal on metal hip implant were hammered in a recent personal injury and defective product liability trial. The Georgia federal jury awarded $11 million to Robyn Christiansen, in the first bellwether Wright Conserve hip replacement lawsuit to go to trial.

$10 Million Punitive Damages

The jury awarded $1 million in compensatory damages and $10 million in punitive damages, which is designed to punish the Wright Conserve hip replacement manufacturer for gross negligence for recklessly disregarding the safety of hip patients.

Over 500 Wright Conserve Hip Implant Lawsuits

Wright Conserve hip replacement manufacture is exposed to more than 530 personal injury and product liability lawsuits. Plaintiffs claim that patients suffered serious and catastrophic hip failures from the metal-on-metal design was unreasonably dangerous and defective.

Wright Conserve Hip Lawsuit Allegations

According to the lawsuits, the metal-on-metal hip leads to metallic debris to be released during the grinding action between the metal cup and metal ball, which causes early implant failure. Some complications include premature device failure, loosening, metal poisoning and metallosis and severe pain.

Artificial hip replacements are expected to last at least 15 to 20 years, but Christiansen’s Wright Conserve hip implant failed after only six years, resulting in the need for major revision surgery.

December 30, 2015

Bard G2 IVC Filter Injury Law Suit

by Dr. Shezad Malik

Ava Langford from Missouri, has filed a lawsuit claiming that she developed serious and severe personal injuries when a Bard G2 inferior vena cava (IVC) filter fractured and broke apart.

Langford filed her complaint in the U.S. District Court for the Eastern District of Missouri, alleging that a Bard G2 IVC filter failed and fractured. Langford received the medical device to prevent pulmonary embolism.

Every year, thousands of patients are implanted with a retrieval inferior vena cava filters but they are not warned by doctors about the risk of injury from these temporary devices.

And as time passes, patients tend to forget that they had this device implanted and the first inkling that they had the device, is when they suffer serious injury from a complication.

Experts say that there is a very high failure rate with these devices, which only increases with the duration of the filter in the body, and eventually all of the devices will fail. So 100% failure of the device becomes not a question of “if” but “when.”

According to Langford, the G2 filter is defectively designed, but Bard claims that the IVC filter device had “enhanced fracture resistance” and “increased migration resistance.” Langford claims that Bard failed to perform adequate clinical testing to ensure the filter device was safe and effective.

The filter devices are used when there is a blood clot in the leg known as a deep vein thrombosis and there is a contraindication to using blood thinners, which is the standard therapy for leg blood clots.

These devices are supposed to trap blood clots from traveling from the leg to the lungs and causing a pulmonary embolism, which can be fatal.

These devices unfortunately, have been linked to hundreds of adverse event reports where they puncture the vena cava, tilt out of position or migrate or break apart and cause metallic fragments to travel to the heart or lungs, a condition known as embolization.

2 Major Manufacturers of IVC Filters

There are 2 major manufacturers of IVC filters, Cook Medical and C.R. Bard. The complaints in the Bard and Cook IVC Filter litigation have similar allegations, the injured patients claim that the manufacturers designed and sold retrievable defective devices that were unreasonably dangerous.

FDA Warnings

The FDA in August 2010, announced a warning about the risk of IVC filter injuries, noting that they had received hundreds of adverse event reports where filter devices broke apart and travelled to other areas of the body or caused perforation and migration.

Bard IVC Filter Claims Consolidated in Arizona

All filed Bard Inferior Vena Cava filter injury, perforation and migration lawsuits, are consolidated and centralized in Phoenix, Arizona for coordinated pretrial proceedings.

Existing cases pending throughout the federal court system have been transferred to U.S. District Judge David G. Campbell, who will oversee the multidistrict litigation (MDL) proceedings. Bard Peripheral Vascular is the manufacturer of these Bard IVC filters and is headquartered in Phoenix, Arizona.

This consolidation and centralization of Bard IVC filter cases only applies to cases filed in the federal court system. According to latest court data there are 100 filed Bard Recovery filter and Bard G2 filter lawsuits currently pending in Arizona federal court. As the litigation matures it is expected that the final tally will consist of several thousand injury and defective product liability cases.

Benefits of MDL Consolidation and Centralization

The MDL streamlines the trial process, by preventing duplicative discovery and all the plaintiffs and defendants are gathered before one judge.

Cook IVC Filter Claims Consolidated in Indiana

MDL has been established for all Cook Medical IVC filter lawsuits, involving injuries with the Cook Celect and Gunther Tulip filters. There are more than 200 complaints over those products centralized before U.S. District Judge Richard L. Young in the Southern District of Indiana.

Lawsuits filed against Cook Medical over their defective IVC filters are gaining traction and moving towards trial. U.S. District Judge Young recently announced that a group of 10 Cook Medical IVC filter lawsuits have been chosen for early trial dates that will begin late 2016.

MDL Bellwether IVC Filter Trials

It is common in complex multidistrict ligation involving pharmaceutical and medical device cases, to have mini trials, known as bellwether trials.

A small group of cases will be prepared for early trial dates. The outcome of these trials are designed to aid settlement negotiations, especially if the jury sides with the injured plaintiffs and awards a large damage award or in cases involving gross negligence, awarding punitive damages, which are designed to punish the company for its reckless behavior.

December 29, 2015

Risks of Cancer Spread After Laparoscopic Hysterectomy

by Dr. Shezad Malik

In the United States, Hysterectomy is the second most frequently performed surgical procedure (after cesarean section). The majority of these hysterectomies are performed laparoscopically.

What is Laparoscopic Hysterectomy?

Minimally invasive or laparoscopic removal of the uterus, is know as hysterectomy and typically performed for the treatment of fibroids or benign tumors of the uterus. During the surgery, many doctors remove the uterus in pieces using a mechanical grinding or chopping device known as a power morcellator.

Recently, many personal injury and wrongful death lawsuits being filed against the manufacturers of power morcellators. The injured women claim that patients and doctors should have been warned about the risks associated with use of the medical devices during minimally invasive, laparoscopic hysterectomies.

What Are Power Morcellators?

Power morcellators are medical devices that are used during laparoscopic hysterectomy and myomectomy (fibroid removal) procedures. The device allows the surgeon to grind up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. The medical device is used during minimally invasive surgery, and reduces recovery time, scarring and speeds up recovery time.

How Morcellator Increases the Risk of Uterine Cancer Spread

According to medical experts and the FDA, about one out of every 350 women undergoing a laparoscopic hysterectomy with morcellation may have undiagnosed sarcoma, which doctors are unable to detect before the surgery. Undiagnosed uterine sarcoma is highly malignant and is a lethal form of cancer, with poor life expectancy and treatment options. Most women die shortly after diagnosis and there are no curative treatments.

There is no bullet proof way for doctors to diagnose the uterine cancer before using the morcellator devices. Because of this, the FDA strongly urged doctors to avoid using the devices for laparoscopic hysterectomy or myomectomy procedures in April 2014. The FDA issued a BLACK BOX WARNING against the use of these devices in November 2014.

Power morcellators spread this undiagnosed leiomyosarcoma, endometrial stromal sarcoma or other cancer throughout the pelvis and abdomen during the grinding process, leading to rapid upstaging of the cancer and reducing the risk of long-term survival. As this risk becomes known, many doctors and hospitals have stopped the use of power morcellators over the past year.

Morcellators Approved Under the 510(k) Program

The controversial 510(k) program allows medical devices to be approved without pre-market testing requirements. Under the program, the manufacturer just needs to show that the devices are “substantially equivalent” to devices already on the market. Power morcellators were approved under the 510(k) process without any safety testing.

J&J Ethicon Morcellator Recall

All Ethicon power morcellators were recalled by the manufacturer, in 2014. J&J, acknowledged that the devices pose an unreasonable risk of spreading uterine cancer. Ethicon, a J&J subsidiary requested that hospitals voluntarily return all laparoscopic surgery morcellators. The company, noted that it will no longer sell the devices since there is no way to make them safe.

FDA Morcellator Black Box Warning

The FDA announced November 24, 2014 that it is adding a black box warning to uterine morcellator devices that remain on the market. A BLACK BOX WARNING, is the strongest warning that can be placed on any medical device.

Patients, doctors and hospitals are now on notice of the potential danger of increased uterine cancer spread risk associated with the use of these devices. Furthermore, the FDA announced that power morcellators should not be used with women near menopause or post-menopausal, or in women who could have tissue removed through the vagina or via a small incision.

This contraindication prohibits the use of the devices in the vast majority of women who undergo laparoscopic or vaginal uterine morcellation procedures.

Power Morcellator Litigation Centralized

Many complaints have been filed in the federal court system nationwide. These women were diagnosed with the spread of leiomyosarcoma, endometrial stromal sarcoma or other cancers following uterine fibroid surgery.

The U.S. District Court for the District of Kansas was recently approved for the centralization and consolidation in a multidistrict litigation (MDL) court. This is centralized only against Johnson and Johnson’s subsidiary, Ethicon morcellator manufacturer.

This means that all federal morcellator lawsuits will be consolidated for pre-trial discovery and early bellwether trials in the U.S. District Court for the District of Kansas. Federal courts consolidate lawsuits to MDLs when a large number of plaintiffs claim the same facts against the same defendant. The process allows the courts to operate more efficiently and decreases the costs for all parties involved.

All of the lawsuits filed against manufacturers of these devices claim that hysterectomy morcellators are unreasonably dangerous and that information about the risk of uterine cancer being spread was withheld from the patients and doctors.

December 24, 2015

Xarelto Bleeding Death Lawsuit Filed in Louisiana

by Dr. Shezad Malik

Ashlie Fluitt from Louisiana, filed a wrongful death claim on behalf of her grandmother who died as a result of catastrophic side effects from using Xarelto. Fluitt alleges that Xarelto anticoagulation medication caused severe brain bleeding which caused her grandmother to die.

Fluitt filed her lawsuit in the U.S. District Court for the Eastern District of Louisiana claiming that Hattie Deville-Goodwin’s death was caused by the drug manufacturers’ failure to warn about the uncontrollable bleeding side effects associated with the new-generation anticoagulant or blood thinner Xarelto.

Deville-Goodwin took Xarelto for treatment of deep vein thrombosis or blood clot in her leg. Two months later, Deville-Goodwin developed severe bleeding in the brain, and died shortly afterwards from the deadly intracranial hemorrhage.

Many lawsuits have been filed against Xarelto’s manufacturers, Bayer and Johnson & Johnson and the plaintiffs claim that the companies failed to warn patients and doctors about the risks associated with Xarelto and the lack of an antidote to help stop the bleeding.

Since December 2014, all federal product liability lawsuits filed against Bayer and Johnson & Johnson over the bleeding side effects of Xarelto have been centralized and consolidated before U.S. District Judge Eldon Fallon in the Eastern District of Louisiana as part of an MDL, or multidistrict litigation.

Lawsuits against Bayer and Johnson & Johnson are consolidated in two courts, a multidistrict litigation court in the Eastern District of Louisiana and a mass tort litigation court in Philadelphia.

The MDL in Louisiana contains over 2,400 federal lawsuits, and the mass tort in Philadelphia contains more than 500 state lawsuits.