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/
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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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An Illinois woman has filed a lawsuit against Johnson & Johnson over their talcum powder products. Lynne Cebulske alleges that she developed ovarian cancer after using Johnson’s Baby Powder and Shower to Shower body powder for feminine hygiene purposes.

J&J Talcum Powder Ovarian Cancer attorneyCebulske filed the complaint in St. Clair County Court in Illinois on May 14. Throughout the United States there are a growing number of talcum baby and body powder lawsuits filed by women who allege that Johnson & Johnson failed to warn about the ovarian cancer risk associated with the talcum products.

Cebulske was diagnosed with ovarian cancer on May 14, 2012, after using Johnson & Johnson’s talcum powder products since 1992.

What is Johnson’s Baby Powder and Shower-to-Shower?

Johnson’s Baby Powder and Shower-to-Shower are talcum-based products that have been promoted for female hygiene. Recent medical studies have indicated that use of the powders as a female hygiene product may cause talc particles to migrate through the vagina to the uterus, fallopian tubes and ovaries causing ovarian tumors.

Medical Studies: Link between Talc Genital Use and Ovarian Cancer

In June 2013, a study published in the medical journal Cancer Prevention Research found that women who used talc genital powder may face a 20% to 30% higher risk of ovarian cancer than those who do not.

The International Agency for Research on Cancer, has classified genital use of talc powder as a “possible carcinogen,” and the American Cancer Society has indicated women concerned about the talcum powder cancer risk may want to avoid these products.

Talc Ovarian Cancer Lawsuits

In April 2014, a talcum powder class action lawsuit was filed against Johnson & Johnson, alleging that the company failed to adequately warn consumers about the potential risk of ovarian cancer from Johnson’s Baby Powder. Plaintiffs in that case maintain that talcum baby powder is not safe for use as a feminine hygiene product, and that Johnson & Johnson has withheld information about the link to ovarian cancer for decades.

In October 2013, a South Dakota jury found that Johnson & Johnson failed to adequately warn about the risk of ovarian cancer from talcum powder products. The woman was diagnosed with cancer in 2006 after using Shower-to-Shower body powder for 30 years.

Cebulske raises similar allegations to those brought by other women, pursuing claims for failure to warn, negligence, breach of warranty, and civil conspiracy. She is seeking compensatory damages in excess of $350,000.

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David Lyon from Texas recently filed a product liability personal injury lawsuit against the makers of Androgel. Lyon alleges that testosterone gel side effects caused a myocardial infarction or heart attack and that the manufacturer mislead consumers that the drug was safe.

Testosterone Androgel Lawsuit

Lyon filed his lawsuit in the U.S. District Court for the Northern District of Illinois on June 2. Lyon claims that AbbVie, Inc. and Abbott Laboratories withheld important information from patients and doctors about the risk of heart attacks and other blood clot injuries from Androgel use.

According to Lyon, he was prescribed Androgel in January 2005, for low testosterone symptoms. He claims that he had no prior history of cardiac problems until he suffered a significant myocardial infarction from Androgel in November 2005.

Hundreds of Testosterone Lawsuits Filed

Many Androgel lawsuits have been filed by men nationwide who have suffered heart attacks, strokes, blood clots including life-threatening pulmonary embolism and deep vein thrombosis injuries that were allegedly caused by the popular testosterone gel.

Plaintiff Claims Fraud

Lyon accuses AbbVie of duping men with a manufactured disease that they called “Low-T.” As men age, the side effects of aging, like fatigue and lowered libido and reduced testosterone levels are common place. Testosterone supplements are only indicated for a medical condition known as hypogonadism, which causes abnormally low testosterone levels.

Lyon is pursuing claims for failure to warn, breach of warranty, negligence, fraud, negligent misrepresentation, and seeks compensatory and punitive damages.

Testosterone Litigation

Many testosterone lawsuits have been filed in recent months against AbbVie and makers of other similar drugs, after a series of studies revealed the link between testosterone and cardiovascular risks.

In November 2013, a study published in JAMA demonstrated that side effects of low T drugs may increase the risk of heart attacks, strokes, and death among older men with certain pre-existing heart problems.

A study published in the medical journal PLOSOne in January 2014, found that low T treatments may double the risk of heart attack for younger men with heart disease and men over the age of 65, regardless of their prior heart conditions.

FDA Warning and Investigation

The FDA launched a safety review of all testosterone replacement therapy on January 31. Most of the lawsuits filed to date have involved injuries associated with the use of AndroGel, which is a testosterone gel spray manufactured and sold by AbbVie.

Other cases are being filed by men who suffered BLOOD CLOT injuries following use Axiron and other testosterone products, including Testim, Foresta, AndroDerm and others.

Testosterone Multidistrict Litigation, MDL

In May a motion was filed for all testosterone drug lawsuits to be centralized as part of one consolidated proceeding during pretrial litigation. Known as multidistrict litigation or MDL, this process reduces duplicative discovery and avoids conflicting rulings from different judges.

The U.S. Judicial Panel on Multidistrict Litigation (JPML), which oversees MDL consolidations, heard oral arguments over the AndroGel consolidation motion on May 29. It is expected to issue a ruling in the near future.

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Boston Scientific is exposed to more than 10,000 federal product liability lawsuits filed by women who experienced injuries from transvaginal mesh products implanted for repair of pelvic organ prolapse (POP) or female stress urinary incontinence (SUI).

U.S. federal Judge Joseph R. Goodwin, is presiding over six federal multidistrict litigation for vaginal mesh claims brought against different manufacturers. According to the court, the first bellwether trial involving eleven Boston Scientific cases will begin on October 14, 2014.

Another 200 cases are now also being prepared for early trial dates. Over the remainder of this year, case-specific discovery will move forward in this second round of bellwether cases, with the first lawsuits expected to be trial-ready by January 30, 2015.

The parties have been directed to meet and confer over the coming weeks to determine the appropriate venue for these bellwether cases by July 25, 2014. Following conclusion of pretrial proceedings, Judge Goodwin indicates he will begin remanding cases back to the various U.S. District Courts nationwide for individual trial dates.

Vaginal Mesh Litigation and Bellwether Trials

Judge Goodwin currently presides over more than 50,000 cases that filed against various different manufacturers, which are centralized in the Southern District of West Virginia.

In addition to Boston Scientific mesh lawsuits, the latest update provided by the Court indicates that there are 17,293 AMS, 17,638 Ethicon Gynecare, 7,783 Bard Avaulta, 1,325 Coloplast, 184 Cook Medical and about 28 Neomedic Pelvic mesh lawsuits.

In several of the proceedings, a series of bellwether trials or mini trials, have been set to help the parties determine how juries may respond to certain evidence and testimony. The outcomes of these early trial dates are designed to facilitate possible vaginal mesh settlement agreements that may resolve a large portion of the litigation.

Mesh Trial Verdicts

The first federal vaginal mesh trial began in July 2013, against C.R. Bard involving their Avaulta mesh product. That case resulted in a $2 million damage verdict, including $1.5 million in punitive damages designed to punish the manufacturer for their bad acts involving the design and sale of the product.

Since that verdict, Bard has settled at least two federal cases shortly before trial. Another 200 Bard Avaulta mesh lawsuits are being prepared for trial dates early next year.

In May, Endo Health Solutions settled AMS mesh lawsuits for an estimated $830 million to avoid a series of bellwether trials set to begin over this summer.

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Endo Health Solutions Inc., said it will pay about $830 million to settle most transvaginal lawsuits. Thousands of injured women allege that its vaginal-mesh implants eroded, left them incontinent and made sex painful.

Endo’s American Medical Systems Inc. unit reported that it’s settling about 20,000 law suit product liability injury claims over the medical devices, which include the Perigee, Apogee and Elevate implants. Endo, a medical device company based in Ireland, is still exposed to at least 5,000 injury claims against AMS, including some that have been consolidated for pretrial proceedings in West Virginia.

FDA Strict Safety Requirements for Mesh

The settlement announcement comes hot on the heels of the U.S. Food and Drug Administration announcement that vaginal-mesh inserts should be subject to stricter safety requirements since they are high-risk devices. Endo said it has insurance that may cover all or part of the costs of resolving the implant cases. Last year, Endo agreed to pay more than $54 million to resolve an unidentified number of vaginal-mesh suits.

FDA Order

The FDA had ordered Endo, Johnson & Johnson, C.R. Bard Inc. and 31 other vaginal-implant companies to study rates of organ damage and complications linked to the implants after manufacturers were sued over the devices.

Doctors inserted more than 70,000 mesh devices in the U.S. in 2010 alone, to strengthen pelvic muscles that failed to support internal organs or to treat incontinence. JNJ halted of its lines of vaginal implant devices last year after facing a barrage of law suits.

Details: $40,000 Settlement Case Average

Endo’s settlement, offers women who claim that they were injured by the implants an average of $40,000 per case based on the $800 million settlement. The settlement allows women to seek more for their damages if the devices caused devastating injuries and forced them to undergo multiple surgeries to have the mesh removed.

Mesh Manufacturers Under Pressure to Settle

Endo still faces vaginal-mesh suits consolidated before U.S. District Judge Joseph Goodwin in Charleston, West Virginia. Bard, Boston Scientific Corp. and Coloplast A/S also are involved in settlement talks.

Coloplast announced in March, that it would pay about $16 million to settle 400 injury claims that its mesh inserts damaged women. Women in those Coloplast cases also are receiving an average of $40,000 each.

Other vaginal-mesh manufacturers may settle after the FDA’s announcement that regulators are tightening safety standards for the devices. If the inserts are designated high-risk devices, manufacturers would be forced to conduct studies showing their products are safe and effective.

Now manufacturers get approval based on comparing their mesh to similar products that are already on the market rather than study results. This is the so called 510(k) approval method, an extremely controversial FDA approval process. According to some experts, this approval process has led to this debacle involving mesh injuries, damages in metal on metal hips and other complex medical devices. This is because the process allows for a short cut which the manufacturers exploited in their rush to garner market share in their production of “me too” devices.

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).

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Medtronic, Inc., announced that it has agreed to settle 950 of its BMP Infuse Bone Graft product liability injury cases.

medtronic bone graft injury attorneyMedtronic warned that the initial settlement of $22 million is likely be the tip of the settlement iceberg. The medical device manufacturing giant plans to record a fourth-quarter charge of up to $140 million to cover its initial settlement and the estimated cost of additional settlements.

What is BMP Infuse?

Infuse is a genetically modified bio-engineered bone graft product, a  version of a naturally occurring protein that promotes bone growth. The U.S. Food and Drug Administration in 2002 approved the product for spinal fusion involving the anterior approach for back spinal surgery.

The product is applied to an absorbable collagen sponge that is placed within an “LT-Cage” that is implanted to encourage bone growth and fuse the gaps between the vertebrae.

BMP Infuse Side Effects

Infuse side effects can cause unwanted bone growth, leading to severe pain, reduced mobility and nerve damage in some patients. In 2011, The Spine Journal, a medical publication, reported that the Infuse’s side effects were not reported in clinical research.

Medtronic Infuse has been touted as a cutting edge alternative to traditional spinal fusions. In the older procedure, bone is harvested from another area of the body usually the pelvis or used from a cadaver.

Medtronic Lawsuit Allegations

Medtronic has been accused of manipulating Infuse studies and using deceptive marketing practices to promote off label use by physicians in other types of orthopedic procedures not approved by the FDA. According to the Medtronic Infuse bone graft lawsuits, plaintiffs have suffered severe nerve damage, airway compression and other complications associated with uncontrollable bone growth after the device was used off-label, such as in the cervical spine, at multiple levels or through a non-anterior approach.

Medtronic: No admission of Liability or Wrongdoing

Medtronic reported that, “subject to certain conditions,” to pay roughly $22 million to resolve the claims of about 950 claimants. The company described the settlement as “a compromise of disputed claims” and said it is “not in any way an admission of liability or validity of any defense in the litigation by Medtronic.”

The product remains on the market, and Medtronic said it will “vigorously defend the product and company actions in the remaining cases.”

Still pending, however, are roughly 750 cases filed by about 1,200 individuals. Medtronic noted that the pending cases are “still in the early procedural stages and none have resulted in a finding of liability against Medtronic.”

Medtronic Liability

Medtronic expects to record a charge of between $120 million and $140 million in its recently completed fourth quarter—a charge that accounts for not only the latest $22 million settlement but also the estimated costs of settling the 1,200 pending claims and the 2,600 that have yet to be filed.

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Wolf Power Morcellator manufacturing company has been sued by a California woman. The woman filed a product liability lawsuit alleging that during a laparoscopic hysterectomy she developed metastatic leiomyosarcoma cancer.

J&J Ethicon Morcellator Cancer AttorneySarah Salem-Robinson and her husband, filed their claim in U.S. District Court for the Northern District of California on May 13, against Richard Wolf Medical Instruments Corporation.

Hysterectomy, Fibroids and Morcellators

Several hysterectomy cancer lawsuits have been recently filed against the manufacturers of power morcellators. These medical devices are used during laparoscopic procedures to cut the uterus into tiny pieces that can be removed through minimally invasive surgery.

Unfortunately power morcellators can cause devastating injuries, if there is an undiagnosed sarcoma in the uterus, the device could cause the cancer to be spread throughout the abdomen, pelvis and other organs including the liver, lungs and brain.

Plaintiff Allegations: Leiomyosarcoma Metastatic Cancer

According to Salem-Robinson, a Wolf Power Morcellator was used during her hysterectomy in 2012. Her doctors did not know that her uterus contained leiomyosarcoma (LMS), which was spread through her abdominal cavity by the use of the morcellator.

After the hysterectomy, Salem-Robinson was diagnosed with metastatic LMS cancer, and she is suing Wolf for negligence, strict products liability, breach of warranty, and fraud.

FDA: Morcellation Hysterectomy Cancer Risks

Laparoscopy-assisted hysterectomy (LASH) is a gynecological procedure for removal of uterine fibroids. The minimallly invasive procedures require use of power morcellators to cut the uterus and fibroids into very small pieces.

In April, the FDA issued a public safety communication that urged doctors to avoid using power morcellators for fibroid removal. This warning came after reports of patients diagnosed with leiomyosarcoma and other uterine cancers during laparoscopic hysterectomy procedures.

The FDA reported that one out of every 350 women who undergo laparoscopic hysterectomy or uterine fibroid removal has undiagnosed cancerous sarcoma cells. The agency warned that use of power morcellators carries an unreasonable risk of spreading the cancer and reducing the long-term survival.

Morcellator Manufacturers Knew or Should Have Known of Cancer Risks

The women affected with advanced uterine cancers claim that adequate warnings were not provided and Wolf and other manufacturers including Johnson and Johnson Ethicon failed to make the devices safe.

Salem-Robinson alleges that Wolf Corporation failed to conduct adequate testing on the risk of power morcellators spreading uterine cancer, claiming that information was concealed from the FDA, National Institutes of Health and the doctors.

Following the FDA warnings last month, Johnson & Johnson’s Ethicon subsidiary announced that it has halted sales of morcellators until it can determine if there is a safe way to use them for uterine fibroid removal.

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Johnson & Johnson and its Ethicon subsidiary are exposed to more than 17,500 Ethicon pelvic mesh lawsuits in the federal court system.

Trans Vaginal Mesh AttorneyThousands of injured women have filed Ethicon Gynecare mesh product liability lawsuits for transvaginal repair, pelvic organ prolapse (POP) and female stress urinary incontinence (SUI) damage symptoms after the mesh surgeries.

The Ethicon Gynecare pelvic mesh and bladder sling products have been under fire for causing severe and debilitating injuries when the mesh erodes through the vagina, causing serious infections and the need for revision surgeries.

Ethicon Gynecare Multidistrict Litigation

The cases have been consolidated as part of an MDL, known as multidistrict litigation, before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia for coordinated pretrial management of the lawsuits.

Some lawsuit cases have been chosen for early trial dates, known as “bellwether” cases. In February, the first Ethicon bellwether trial took place involving a lawsuit brought by Carolyn Lewis. Lewis’s case ended in a defense verdict after Judge Goodwin found that a jury could not find that she had met her burden of proof.

Jury selection in the second Ethicon pelvic mesh trial is now set to begin on August 22, with trial set to commence on August 25, brought by Jo Huskey.

Trans Vaginal Mesh Lawsuits

Judge Goodwin is also overseeing six other consolidated proceedings involving pelvic mesh products made by American Medical Systems (AMS), Boston Scientific, C.R. Bard, Coloplast Corp, Cook Medical and Neomedic.

According to the latest case list, there are currently more than 17,293 AMS mesh, 10,800 Boston Scientific mesh, 7,783 Bard Avaulta mesh, 1,325 Coloplast mesh, 184 Cook Medical mesh and 28 Neomedic Pelvic mesh lawsuits.

These lawsuits allege that transvaginal mesh and bladder sling products were defective and unreasonably dangerous, causing women to experience complications where the mesh eroded through the vagina, causing infections and the need for revision surgeries.

A series of bellwether cases are being prepared for early trial dates involving pelvic mesh products made by C.R. Bard and Boston Scientific.

Trans Vaginal Mesh Verdicts

In July 2013, a federal jury awarded $2 million in damages against Bard, including punitive damages. A second Bard case settled during the first day of trial for a confidential amount, and a third bellwether trial against Bard settled in April.

Three other vaginal mesh cases have gone before state court juries, in July 2012, a California jury awarded $5.5 million in damages against C.R. Bard. A New Jersey jury awarded $11.1 million in damages against Ethicon in March 2013, and a Texas jury awarded $1.2 million in an Ethicon TVT-O mesh lawsuit in April.

Endo Health Solutions, the owner of AMS, has agreed to pay $830 million to settle AMS mesh lawsuits filed by about 20,000 women. As a result, Judge Goodwin issued an order canceling AMS bellwether trial dates set for June 2, July 7 and August 19.

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Germany based Boehringer Ingelheim, the manufacturer of the anticoagulant medication Pradaxa has agreed to pay $650 million to settle Pradaxa injury lawsuits. There are 4,000 lawsuits on file by folks who allege that the company failed to warn about the risk of severe and deadly bleeding problems with the anticoagulant drug use.

Pradaxa Wrongful Death AttorneyPradaxa, has been linked to more than 500 patient deaths. The settlement comes about week after the drugmaker  said a new analysis of a company-funded study used to win approval of the Pradaxa found 22 serious bleeding events that weren’t included in the original report.

What is Pradaxa?

Pradaxa (dabigatran) was approved by the FDA in October 2010 for the prevention of strokes for patients with atrial fibrillation. Atrial fibrillation is one of the most common heart rhythm abnormality. Pradaxa and other similar drugs are a new class of blood thinners designed to replace warfarin, which had been around for some 60 years.

Pradaxa Bleeding No Antidote

Unfortunately Pradaxa use lead to an inordinate number of adverse event complaints by doctors and patients. Warfarin anticoagulant effects can be reversed using vitamin K, Pradaxa had no reversal agent. There have been thousands of reports of injuries and hundreds of deaths associated with Pradaxa use.

4,000 Pradaxa Lawsuits

About 4,000 Pradaxa product liability lawsuits have been filed in both state and federal courts. According to documents made public during litigation, Boehringer officials didn’t disclose to the FDA a data analysis that indicated the blood-thinning drug may have caused more fatal bleeding after it was cleared for sale than in a study used to win approval.

Federally, more than 2,350 of the Pradaxa cases have been consolidated as part of an MDL, or multidistrict litigation, which is centralized before U.S. District Judge David R. Herndon in the Southern District of Illinois.

The complaints allege that Boehringer Ingelheim failed to provide adequate warnings about the risk of serious and deadly Pradaxa bleeding and the lack of an effective antidote. Without an effective antidote, there have been instances of unstoppable bleeding, the doctors had to stand by helplessly while the patients bled to death.

FDA Bleeding Risk Findings

FDA officials said they received reports of 542 deaths and 3,781 side-effect incidents tied to the drug in 2011. According to the FDA, Pradaxa was found to increase the risk of certain bleeding events when compared to warfarin. Pradaxa decreased the risk of stroke and brain bleeds, but the FDA noted that Pradaxa increased the risk of gastrointestinal bleeding.

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Johnson & Johnson’s Ethicon subsidiary has announced that it will stop selling its power morcellators used for uterine fibroid removal surgery. Medical research has shown that use of the devices during minimally invasive laparoscopic hysterectomy and myomectomy procedures may carry a risk of spreading sarcoma cancer.

Medtronic Infuse BMP attorneyJohnson & Johnson Ethicon: No Recall

The company, which manufactured and sold uterine fibroid surgery morcellators since 1998, has stopped sales, promotion and distributing the medical devices after an April 17 FDA warning. The FDA warned doctors to avoid the devices because of the risk of spreading preexisting uterine sarcomas.

Many hospitals have announced that they will no longer be performing laparoscopic hysterectomy or fibroid removal surgery with morcellators, Johnson & Johnson has not announced a recall the devices at this time.

Johnson & Johnson morcellator devices included the Gynecare Morcellex, Morcellex Sigma, and Gynecare X-Tract. The company is the world’s largest morcellator manufacturer, with nearly three quarters market share in 2011.

FDA Warning

The FDA has warned that use of the devices carries an unreasonable risk, since an estimated 1 out of every 350 women who undergo a laparoscopic hysterectomy or myomectomy may have unsuspected uterine sarcoma, and there is no reliable way of discovering the uterine sarcoma cancer prior to the fibroid surgery.

What is a Power Morcellator?

Power morcellators cut tissue into smaller pieces, which allow doctors to remove the uterus or fibroid tumors through a port incision during minimally invasive laparoscopic surgery. Women with undiagnosed uterine sarcomas, the morcellators may spread the aggressive cancer throughout the body, greatly reducing the chances for long-term survival.

Lawsuits Over Fibroid Surgery Morcellators

As women learn that cases of stage 4 leiomyosarcoma or other uterine cancers diagnosed following a hysterectomy or myomectomy may have been caused by the use of morcellators, questions are being raised about why adequate warnings were not provided and whether Johnson & Johnson and other manufacturers failed to make the devices as safe as they could have been.

Along with Johnson & Johnson’s Ethicon unit, the equipment for the process is manufacturers by closely-held companies including Karl Storz GmbH & Co., Richard Wolf Medical Instruments Corp., LiNA Medical and Blue Endo.

According to the Wall Street Journal, J&J purchased FemRx and its “Diva” morcellator in 1998. By 2011, they owned a owned a 72% share of the power morcellator market.

Ethicon is facing at least one lawsuit filed by a woman who died of metastatic leiomyosarcoma at the age of 53, one year after undergoing a hysterectomy with a power morcellator.

 

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The U.S. Food and Drug Administration today issued two proposed orders to address the health risks associated with surgical mesh used for transvaginal repair of pelvic organ prolapse (POP). If finalized, the orders would reclassify surgical mesh for transvaginal POP from a moderate-risk device (class II) to a high-risk device (class III) and require manufacturers to submit a premarket approval (PMA) application for the agency to evaluate safety and effectiveness.

What is Pelvic Organ Prolapse?

POP occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak, stretched, or broken that the organs drop from their normal position and bulge (prolapse) into the vagina. Women affected by POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

FDA takes a Stand

According to William Maisel, M.D., M.P.H., deputy director of science and chief scientist at the FDA’s Center for Devices and Radiological Health, “the FDA has identified clear risks associated with surgical mesh for the transvaginal repair of pelvic organ prolapse and is now proposing to address those risks for more safe and effective products. If these proposals are finalized, we will require manufacturers to provide premarket clinical data to demonstrate a reasonable assurance of safety and effectiveness for surgical mesh used to treat transvaginal POP repair.”

Vaginal Mesh Litigation

The cases have been centralized before Judge Goodwin for coordinated pretrial proceedings in the U.S. District Court for the Southern District of West Virginia.

Judge Goodwin currently presides over seven different federal multidistrict litigations (MDLs), which have been established for cases filed against different manufacturers of vaginal mesh and bladder sling products. These complaints allege that women face an unreasonable risk of vaginal mesh complications following surgery.

According to an updated court case list released on April 15, Judge Goodwin currently presides over 14,679 Ethicon mesh lawsuits against Johnson & Johnson, as well as 16,515 AMS mesh lawsuits, 9,776 Boston Scientific mesh lawsuits, 7,096 Bard Avaulta mesh lawsuits, 1,267 Coloplast mesh lawsuits, 173 Cook Medical mesh lawsuits and about 25 Neomedic Pelvic mesh lawsuits.

What is Trans Vaginal Mesh?

Surgical mesh is a medical device made from polypropylene plastic that is used to provide additional support when repairing weakened or damaged tissue.

Beginning in January 2012, the FDA issued orders to manufacturers of urogynecologic surgical mesh devices to conduct postmarket surveillance studies (522 studies) to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP.

In Sept. 2011, the FDA’s Obstetrics and Gynecology Devices Panel recommended that surgical mesh for transvaginal POP be reclassified from class II to class III and require PMAs.

In July 2011, the FDA provided an updated safety communication about serious complications associated with transvaginal placement of surgical mesh used to treat POP. At that time, the FDA also released a review of urogynecologic surgical mesh adverse events and peer-reviewed scientific literature that identified serious safety and effectiveness concerns. The FDA previously communicated about serious complications associated with transvaginal placement of surgical mesh to treat POP and stress urinary incontinence (SUI) in an October 2008 FDA Public Health Notification.