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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The epidemic of premature metal on metal hip implant failure continues surge at an alarming rate. DePuy ASR, DePuy Pinnacle, Biomet Magnum, Smith and Nephew, Wright Conserve, Zimmer Durom cup and Stryker Rejuvenate and ABG II, are among hip replacements that continue to fail prematurely and require painful and risky revision surgery.

DePuy ASR Metallosis Injury AttorneyTotal Number of DePuy ASR Settlements Exceeds 9,400 Cases

Johnson and Johnson (J&J) and its subsidiary DePuy Orthopaedics, has agreed to add another 1,400 hip injury claims to a settlement agreement reached in 2013. This new agreement extends the deal to include recalled ASR implants that were revised as of January 31, 2015.

J&J had initially agreed to settle about 8,000 ASR lawsuit cases, that folks brought when their hip replacement failed and had to be removed prior to August 31, 2013. The initial agreement left several thousand DePuy ASR hip lawsuits in limbo.

Settlement Extended to Cover J&J DePuy ASR Revisions as of January 31, 2015

On February 20, the U.S. District Judge presiding over the federal litigation was notified that an agreement has been reached that extended the settlement program to include U.S. citizens or residents who received an ASR hip and had revision surgery on or before January 31, 2015.

J&J DePuy ASR Settlement Details

Under terms of the original agreement, plaintiffs will receive an average payment of $250,000 for pain and suffering, with the age of the plaintiff, the length of time the implant was in place, the weight of the plaintiff, whether they were a smoker, will be considered prior to a final award.

Patients who developed “extraordinary injuries”, and complications associated with the revision surgery, can also obtain additional compensation and all medical expenses will be covered by the manufacturer.

Thousands of Defective J&J ASR Hips in Americans

Despite the settlements, there are thousands of people throughout the U.S. who still have a defective implanted DePuy ASR hip. It is estimated that as many as 30,000 ASR hips were implanted in the U.S. prior to the world wide recall.

August 2010 J&J ASR Recall

The metal-on-metal implant was recalled in August 2010, because of a high rate of failures associated with the flawed design. This defective hip released cobalt and chromium metallic debris into the body and the hip joint as the components grind against each other during normal use. This accumulation of heavy metals is known as metallosis.

DePuy ASR Hip Failure Rate

The metal-on-metal hip replacement system was recalled from the market after medical data found that about one out of every eight would fail within five years. More recent data has suggested that the DePuy hip failure rate may be substantially higher, ending up in the 35% to 45% range.

Latest $2.5M Oklahoma Jury Verdict

Andrea Smith, from Oklahoma has been awarded $2.5 million after suffering metal blood poisoning from DePuy ASR hip replacements. The state court jury found the DePuy ASR hip to be defective and unreasonably dangerous.

Smith, received ASR hip implants on each side in October 2006 and February 2007. According to Smith, she had to undergo revision surgery to have the implants removed in 2011 and 2012, after high levels of Cobalt and Chromium metal ions were found in her blood.

More Than 7,700 J&J DePuy Pinnacle Hip Lawsuits

J&J is continues to deny, delay and defend thousands of cases involving similar metallosis and premature failure problems from the DePuy Pinnacle hip. The DePuy Pinnacle is an older model that features a substantially similar metal-on-metal design.

There are currently more than 7,700 DePuy Pinnacle hip lawsuits pending throughout the U.S. In the federal court system, as of 7/15/2015, all complaints involving problems with DePuy Pinnacle implants are centralized in the U.S. District Court for the Northern District of Texas under U.S. District Judge Ed Kinkeade as part of a multidistrict lawsuit (MDL).

DePuy Pinnacle Bellwether Trials

The Dallas court has identified ten different cases that have been selected to be prepared for early trial dates. These early trials are known as “bellwether” cases. The trials help the parties gauge how juries may respond to similar evidence and testimony that is repeated throughout the litigation.

The consolidated federal case is In re DePuy Orthopedics Inc., ASR Hip Implant Products Liability Litigation, 10-MD-2197, U.S. District Court, Northern District of Ohio (Toledo).

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Power morcellators are medical devices used to allow surgeons to cut up and remove fibroids through a minimally invasive incision in the abdomen. Over the past 2 years, medical experts have questioned the safety of the devices, since some women may have undiagnosed cancers contained within the uterus, which the devices may rapidly spread throughout the body, during the grinding and cutting process.

J&J Ethicon Morcellator Cancer AttorneyFDA Black Box Warning for Power Morcellators

The FDA has hammered the laparoscopic power morcellator devices with the strongest warning possible, requiring the morcellators to have a black box warning concerning the risk of cancer spread.

FDA Notes Increased Risk of Uterine Cancer Spread

According to the FDA, most women should not undergo a laparoscopic power morcellation hysterectomy because of the risk of spreading undiagnosed uterine cancer.

The FDA issued the black box warning in November 2014, alerting patients, doctors and hospitals about the risk of spreading unsuspected uterine cancer, which can sharply reduce the affected patient’s survival chances.

FDA: Power Morcellator Hysterectomy Contraindications

Contraindications were also included on the warning label, including that the laparoscopic power morcellator should not be used in women who are peri- or post-menopausal or who could have the uterus tissue removed intact, and those women in which the uterus tissue being morcellated is known or suspected to be cancerous.

The FDA stated, “Based on a quantitative analysis of currently available data, the FDA estimated that approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma.

If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”

What is Power Morcellator Hysterectomy?

Power morcellator devices are used in minimally invasive laparoscopic procedures to remove fibroids, benign uterine tumors and during hysterectomies.

What is the problem with Power Morcellator Hysterectomy?

The major problem is that benign fibroids may harbor hidden or undiagnosed uterine sarcoma (a cancer). Morcellators grinds the uterine tissue with powerful blades, so it can be removed. But in that grinding process, the cancerous uterine tissue may spread through the abdomen.

In the case of uterine sarcoma, which cannot be diagnosed prior to surgery, the uterine tissue is a very aggressive cancer, resulting in a spreading of the cancer, which had been previously localized.

The FDA stopped short of an outright ban. The FDA noted that there are other options for women with uterine fibroids, including traditional surgery, laparoscopic hysterectomy and myomectomy without morcellation.

Power Morcellator Litigation Update

Many injured women and their families are now pursuing power morcellator lawsuits against manufacturers of the devices after women were diagnosed with the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers following use of the medical device.

There are at least 22 lawsuits pending across 16 federal courts, alleging personal injury, wrongful death and product liability complaints against several manufacturers of power morcellators. All the plaintiffs claim that the devices caused the spread of uterine cancers during a laparoscopic hysterectomy or myomectomy, removal of benign fibroids.

Plaintiffs are requesting to centralize cases brought in the federal court system before U.S. District Judge Kathryn H. Vratil in the District of Kansas. The major manufacturers all oppose centralization of the litigation into a multidistrict litigation, stating that it would be impracticable and that there are not enough cases to justify it. A hearing is set for October, over whether to grant a power morcellator MDL.

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Laparoscopic morcellator lawsuits are increasing slowly but surely, filed by injured women who had undiagnosed uterine cancer spread during a minimally invasive hysterectomy. Recently, according to the Wall Street Journal, a settlement has been reached in one of the first federal lawsuits.

Medtronic Infuse BMP attorneyLina Medical reportedly has agreed to settle Scott Burkhart’s wrongful death claim of his wife, who had undiagnosed leiomyoscarcoma spread throughout her body by a Lina power morcellator.

Burkhart’s case was the first of several hysterectomy morcellation lawsuits, which allege that several different medical device manufacturers sold a defective and unreasonably dangerous product, and failed to warn about the serious risk of cancer women may face if the morcellator is used during a minimally invasive surgery.

There is no sure fire way for doctors to determine which women may have unsuspected sarcoma contained within the uterus.

What is Power Morcellator?

Power morcellators are medical devices used during minimally invasive laparoscopic hysterectomy and fibroid removal procedures. The device grinds up the uterus and uterine fibroids, allowing the easy removal of the tissues through a small incision in the abdomen.

Morcellator use has been curtailed over the past year, because of the risk that the devices may cause the spread of aggressive uterine cancers that were undiagnosed in the uterus.

2014 FDA Strong Cancer Risk Warning

In April 2014, the FDA issued a strong warning about the risk of power morcellation cancer, noting that one out of every 350 women undergoing surgery for uterine fibroids may actually have undiagnosed sarcoma.

An FDA advisory panel determined that there is no way to make power morcellators safer. The panel was unsure whether to recommend morcellators be recalled or that stronger warnings be placed on the devices.

Late last year, the FDA announced that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer.

Many hospitals have announced that they will no longer allow morcellation hysterectomy to be performed and some health care insurances will no longer cover the procedure.

How does Power Morcellator Increase Cancer Risk?

The grinding action of a power morcellator may cause widespread dissemination or spread of cancer cells throughout the abdomen and pelvis. This metastatic cancer spread significantly reduces long-term survival.

Morcellator Lawsuits

To date, about 20 power morcellator cancer cases have been filed in various federal and state courts through out the country.

All of the complaints shared similar allegations that morcellator use caused widespread leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers diagnosed following a laparoscopic hysterectomy or fibroid removal surgery.

According to plaintiffs, the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have not occurred if alternative treatment options had been used, including traditional surgical hysterectomy performed vaginally or abdominally.

Federal Multidistrict Litigation Pending

In June, the U.S. Judicial Panel on Multidistrict Litigation (JPML) received notice seeking to transfer complaints filed in U.S. District Courts to one judge for coordinated handling during pretrial proceedings.

This is known as an MDL, or multidistrict litigation, and the centralizations of the lawsuits are designed to speed up the trials.

The plaintiffs are requesting that Lina Medical and other manufacturers of power morcellators be held with U.S. District Judge Kathryn H. Vratil in the District of Kansas.

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According to the FDA recent warning, there are serious issues and side effects with the new class of medications used to treat type 2 diabetes.

Invokana Diabetic Ketoacidosis AttorneyWhat is Invokana?

Johnson & Johnson’s Janssen Pharmaceuticals unit manufactures and distributes Invokana (canagliflozin), for patients with type-2 diabetes, to control their blood-sugar levels. The drug has achieved blockbuster status, in that it is set to blow past a billion dollars in sales in 2015.

Invokana Mechanism of Action

The FDA approved Invokana in 2013, and Invokana was the first medication in a new class known as sodium-glucose cotransporter-2 (SGLT2) inhibitors. Other members of this class include Farxiga, Invokamet, Glyxambi, Jardiance, and Xigduo XR. AstraZeneca manufactures Farxiga and Xigduo, Jardiance and Glyxambi is made by Lilly and Boehringer Ingelheim. J&J also combines Invokana with metformin and markets it as Invokamet.

Invokana is the most widely used of the class. These medications prevent hyperglycemia (high blood-sugar levels) by allowing the kidneys remove excess blood sugar via the urine.

What is the problem with Invokana?

According to a report from the Institute for Safe Medication Practices (ISMP), Invokana has been linked to hundreds of severe adverse events.  The FDA has received over 457 adverse events for Invokana in its first 12 months on the market, including:

  •     Kidney failure or damage
  •     Kidney stones
  •     Fluid/electrolyte problems
  •     Urinary tract infections

FDA Warning: Invokana Linked to Diabetic Ketoacidosis

In May 2015, the FDA issued a Safety Communication for all drugs in the SGLT2 inhibitor class, including Invokana, after receiving 20 reports of patients who developed diabetic ketoacidosis.

All of the victims were hospitalized between March 2013 and June 2014. The FDA has continued to receive more reports of this potentially lethal side effect. According to the FDA, “Healthcare professionals should evaluate for the presence of acidosis, including ketoacidosis, in patients experiencing these signs or symptoms; discontinue SGLT2 inhibitors if acidosis is confirmed; and take appropriate measures to correct the acidosis and monitor sugar levels.”

New warning labels will be required for Invokana, Invokamet, Farxiga, Glyxambi, Jardiance, and Xigduo XR, which urge patients to look for signs of the DKA condition and to seek immediate medical attention if symptoms are present.

EMA Warning: 101 Cases of Ketoacidosis Reported Worldwide

According to the European Medicines Agency (EMA) warning issued in June 2015, SLGT2 inhibitor diabetes drugs have been associated with 101 cases of diabetic ketoacidosis worldwide.

What is Diabetic Ketoacidosis?

Diabetic ketoacidosis (DKA) is a serious complication of diabetes that occurs when the body produces high levels of blood ketones. DKA develops when the body is unable to produce enough insulin. Insulin plays a key role in helping sugar (glucose) — a major source of energy for the muscles and other tissues — enter the cells.

Without enough insulin, the body begins to break down fat as an alternate fuel source. This process produces a buildup of toxic acids in the bloodstream called ketones, eventually leading to diabetic ketoacidosis if untreated.

What are Diabetic Ketoacidosis Symptoms?

Decreased alertness
Deep, rapid breathing
Dry skin and mouth
Flushed face
Frequent urination or thirst that lasts a day or more
Fruity-smelling breath
Headache
Muscle stiffness or aches
Nausea and vomiting
Stomach pain

Take Home Message

With the serious safety concerns and lack of safety studies of this new class of diabetes drug, a detailed investigation is underway to determine is there is grounds for a defective drug product liability claim with an Invokana lawsuit or Farxiga lawsuit as a result of the drug makers’ failure to adequately research the potential risks and warn about the side effects.

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There have been many reports of loosening and other failure problems with the Zimmer Persona artificial knee replacements.

Dallas Defective Medical Device attorneyAccording to sources, more than 11,600 of the “personalized” artificial knee components have been recalled less than three years after the novel design was introduced.

FDA Warning and Class 2 Recall

The FDA on March 12 announced a Zimmer Persona knee recall, involving all lots and sizes of the Persona Trabecular Metal Tibial Plate used during knee replacement procedures throughout the United States between November 2012 and early 2015.

Zimmer sent an Urgent Medical Device Recall notice in late February, warning surgeons and hospitals about an increase in complaints involving radiolucent lines and loosening among patients who received a Zimmer Persona knee.

Recently, the FDA categorized this action as a Class 2 recall. According to Zimmer, the current complaint rate is higher than similar artificial knee devices, and noted that six out of every 1,000 implants may fail. But according to some medical experts, the risk of Zimmer Persona knee failure may be much higher with time.

What is the Zimmer Persona Knee?

The Zimmer Persona knee replacement system was introduced in late 2012, marketed by Zimmer as having “[a]natomically accurate components available for a new level of fit tailored to each patient’s unique anatomy.”

The “Personalized Knee” system was designed to provide a high degree of accuracy in it’s fit. But, the Zimmer knee faulty design increases the risk of loosening, pain and ultimately failure, leading to re-do knee revision surgery.

According to Zimmer, patients may note problems with initial fixation, causing knee pain and discomfort. This leads to complications where the knee replacement never achieves correct fixation, and some patients may require additional knee replacements or removal of the artificial knee device.

Zimmer Notification Letter to Hospitals

Zimmer notified hospitals recently that, “Out of the complaints received, 36% identified symptomatic radiolucent lines or were revised for loosening, 28% identified asymptomatic radiolucencies, 8% subsided, and 28% were inconclusive. Aseptic loosening of cementless tibial implant components is one of the most prevalent causes for revision in total knee arthroplasty and a number of factors may contribute to the loosening failure mode, including patient characteristics, rehabilitation protocol and compliance, surgical technique, and product features.”

Zimmer Persona Nationwide Recall

The recall affects all lots and sizes C-J, both left and right, of the Persona Trabecular Metal Tibial Plate. According to the FDA, about 11,658 units are affected by the recall.

Surgeons and hospitals have been made aware of the problem, and all of the recalled Zimmer Persona knee implants have been returned to the manufacturer. It is unclear whether patients with a defective Zimmer Persona knee have been notified of the recall or provided instructions about the need for further medical monitoring.

Zimmer Persona Knee Lawsuits

Zimmer Persona knee lawsuits are being filed against the manufacturer, alleging that the company failed to adequately research and test the design before aggressively marketing the Persona Knee system to doctors throughout the United States.

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The massive transvaginal mesh injury lawsuits has been slowly winding its way through both the federal and state court system, over the past 4-5 years. The unwieldy personal injury and defective product liability litigation, which now by some estimates tops 100,000 filed lawsuits by injured and affected women, has been painstakingly slow.

Trans Vaginal Mesh AttorneyThe is a silver lining to the litigation. Recently, Medtronic’s Covidien unit agreed to settle more than 11,000 transvaginal mesh lawsuits filed by women who experienced serious and severe complications with the products.

What is Transvaginal Mesh and why is it Dangerous?

Covidien manufactured transvaginal mesh and bladder sling products sold by other companies. The devices are used for surgical repair of pelvic organ prolapse and female stress urinary incontinence. Serious side effects have reported including severe and debilitating problems due to erosion of the mesh through the vagina, infection, urinary incontinence and other significant complications, often leading to multiple painful revision surgeries.

Covidien Settlement Details

According to U.S. District Judge Joseph Goodwin, who is overseeing the multidistrict consolidated trials in West Virginia, Covidien has entered into a Confidential Master Settlement Agreement to settle claims related to it’s pelvic repair products.

Medtronic, which acquired Covidien in early 2015, indicated that the settlement was reached on June 1 and may resolve 11,300 lawsuits.

Federal Multidistrict Mesh Litigation

Judge Goodwin oversees more than 80,000 transvaginal mesh and bladder sling lawsuits centralized as part of seven different federal MDLs established for cases brough against different manufacturers, including C.R. Bard, Ethicon, Boston Scientific, American Medical Systems (AMS), Coloplast, Cook Medical and Neomedic.

Multidistrict litigation is a consolidation of lawsuits transferred from around the country to a single United States District Court to streamline the trial processes. Here, the plaintiffs and defendants are under one roof, the trials are being processed by one judge, and this leads to speedier outcomes.

After several bellwether trials for plaintiffs, Judge Goodwin has been urging the parties to enter good faith settlement negotiations to avoid the need for tens of thousands of individual trials throughout the U.S.

These early trials were held nationwide, with many of them resulting in multi-million dollar damage awards for women who experienced severe injuries after receiving transvaginal mesh.

Ethicon Trial Coming Up

Since Johnson & Johnson’s Ethicon subsidiary did not agreed to settle the claims against them, Judge Goodwin scheduled a consolidated trial, involving 26 different injured women going before the same jury in November 2015. Those lawsuits involve West Virginia plaintiffs who had surgery in the state to implant Ethicon’s TVT product used to treat stress urinary incontinence, according to the ruling.

To date, Ethicon has faced only two trials involving its TVT Obturator product. In September 2014, a federal jury in West Virginia awarded $3.27 million against Ethicon in a case involving the TVT Obturator product.

In April 2014, a Texas state court jury awarded $1.2 million to a woman who suffered severe injuries.

In 2013, an Atlantic County, N.J., jury awarded $11.1 million in damages against Ethicon, including punitive damages as a result of Ethicon’s actions surrounding the manufacture and sale of the Prolift product, a product used in the treatment of pelvic organ prolapse.

American Medical System Settlement (AMS)

AMS is the only major manufacturer to settle the claims involving their mesh and bladder sling products. Endo International announced in October 2014 that it has agreed to pay about $1.6 billion to resolve “substantially all” of the 20,000 mesh lawsuits pending against it’s AMS subsidiary.

Boston Scientific Mesh Verdicts

Recently in May, a Delaware jury awarded Plaintiff Deborah Barba $100 million following a trial against defendant-manufacturer Boston Scientific. The verdict consisted of $25 million in compensatory damages and $75 million in punitive damages, designed to punish the company for its wrongful behavior.

Ms. Barba was implanted with Boston Scientific Pinnacle and Advantage Fit mesh products in 2009 to treat pelvic organ prolapse and stress urinary incontinence. She underwent two corrective surgeries due to complications caused by the products. Ms. Barba continues to experience severe pelvic pain and other gynecological symptoms to this day.

This latest jury verdict is the sixth Plaintiffs’ victory against Boston Scientific, which include a $73.4 million verdict (subsequently reduced to comply with Texas damage caps) from a Texas court, a $26.7 million verdict to four women in Florida, and an $18.5 million verdict to a group of women in West Virginia.

Serious settlement negotiations are underway with Boston Scientific to settle the remainder of the some 20,000 claims.

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Many product liability 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.

Ethicon Morcellator Cancer AttorneyWhat Are Power Morcellators?

Power morcellators are medical devices that are used during laparoscopic hysterectomy and myomectomy 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.

Morcellator Uterine Cancer Spreading Risk
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.There is no bullet proof way for doctors to diagnose the uterine cancer before using the morcellator devices to grind up the uterus or remove the uterine fibroids, which is also known as myomectomy procedure. Because of this, the FDA strongly urged doctors to avoid using the devices for laparoscopic hysterectomy or myomectomy procedures in April 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 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.

Ethicon Morcellator Recall

All Ethicon power morcellators were recalled by the manufacturer, earlier last year. J&J, acknowledged that the devices pose an unreasonable risk of disseminating 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.

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 Morcellators Under the Gun

Power morcellators have been under under fire since the well-publicized case of anesthesiologist Amy Reed, who underwent a hysterectomy, for fibroid removal in October 2013. Dr Reed, then discovered that power morcellation had spread an undiagnosed uterine leiomyosarcoma.

The FDA’s warnings last year triggered a widescale retreat from tissue morcellation. Johnson & Johnson voluntarily withdrew its morcellators from the market because of cancer “uncertainty.”

The hospital chain HCA Holdings prohibited their use at its facilities for removing uterine fibroids.

Highmark, a health insurer in the eastern United States, stopped paying for laparoscopic power morcellation in gynecologic procedures.

In February 2015, United Healthcare announced that, it would require preauthorization for all hysterectomies other than vaginal procedures performed on an outpatient basis.

Most recently, health insurer Aetna announced that it will no longer cover most hysterectomies and myomectomies that utilize power morcellators to remove uterine fibroid tumors “because the safety and efficacy of this approach has not been demonstrated.”

Power Morcellator Cancer Litigation

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.

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.

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It is official folks, Takeda Pharmaceutical Co. has announced this week, that it will pay more than $2.4 billion to settle the pending Actos lawsuits over bladder cancer claims. Asia’s largest drugmaker agrees to settle more than 9,000  Actos bladder cancer lawsuits in federal and state courts in the U.S.

The settlement deal would average about $275,000 for each case, and would be the first settlement in the four year old litigation over the type 2 diabetes drug.

Actos Settlement Details

As is common in complex pharmaceutical ligation, a grid settlement matrix will be applied to the bladder cancer cases. Folks will be awarded points for their injury as a baseline, points will be deducted for pre-existing risk factors such as smoking, exposure to toxins known to cause bladder cancer and low cumulative dose of Actos.

Folks with a higher cumulative dose will get more settlement than folks who took Actos for less than a year. Folks who had pre-existing bladder cancer will get less than folks who developed bladder cancer while on Actos.

Plaintiffs who developed severe metastatic spread of the disease or died as a result of the cancer, will get the highest settlement. The exact amount payable is still being worked out, and plaintiffs can expect their settlement checks a year from now.

It just takes that much time to enroll the 9,000 plaintiffs into the settlement, review each person’s medical records and negotiate the amount to be paid back to the insurance companies, including Medicare and Medicaid to pay back the medical expenses incurred as a result of the cancer.

Important Dates and Deadlines

Plaintiffs must accept and opt in the settlement by July 15, 2015,  so time is of the essence to return and complete the opt in forms. Plaintiffs must have taken Actos before December 2011 and diagnosed with bladder cancer after the use of Actos.

Actos Bladder Cancer Lawsuits Continue to Increase

There are more than 4,000 federal personal injury, product liability lawsuits pending against Takeda Pharmaceuticals and Eli Lilly. The claims blame the companies for providing inadequate warnings about the risk of bladder cancer from Actos, a blockbuster type 2 diabetes drug.

Louisiana Federal Multi-district Litigation

Since December 2011, federal lawsuits have been centralized before U.S. District Judge Rebecca F. Doherty in the Western District of Louisiana, as part of an MDL, or Multi-District Litigation.

The first federal Actos trial ended in a record breaking $9 billion jury verdict last year. The jury found evidence that the drug makers deliberately destroyed documents about Actos and bladder cancer link. Takeda also deleted the files of 46 former and current employees, including those of top executives in Japan and U.S. sales representatives.

Judge Doherty post verdict, reduced the punitive damage award in the case to $37 million. The case is on appeal.

8,000 Actos Bladder Cancer Lawsuits Cannot Be Wrong

More than 4,000 Actos suits have been consolidated before a federal judge in Louisiana for pretrial information exchanges. According to court documents, Takeda is exposed to another 4,500 claims in state courts in Illinois, West Virginia and Pennsylvania.

Takeda is blamed for not disclosing that that Actos use can lead to bladder cancer. All of the lawsuits allege that Takeda knew or should have know about the increased risk of bladder cancer and yet failed to alert patients, doctors and the FDA. The Japan-based drugmaker agreed to the settlement thinking that it could avoid more huge verdicts and to put this litigation behind them.

The consolidated Actos cases in Louisiana are In Re Actos (Pioglitazone) Products Liability Litigation, 11-md-02299, U.S. District Court, Western District of Louisiana (Lafayette).