Articles Posted in Medical Malpractice

Published on:

The US Food and Drug Administration (FDA) has announced an investigation of the FDA-approved testosterone products. Recent medical studies have demonstrated that there is increase in the risk of serious adverse cardiovascular outcomes with Testosterone supplements.

The FDA is alarmed by the results of two recent medical studies, that revealed that men taking the testosterone supplements have an increased risk of death, heart attacks (Myocardial Infarction, MI) and ischemic stroke.

Testosterone Use Increases Heart Attacks 36% in first 90 days

In the latest study, men treated with testosterone were more likely to have an MI in the first 90 days after starting the medication. In the three months after the start of testosterone therapy, the risk of MI overall was increased by 36% and was even higher in older men. For those aged 65 years and older, the risk of MI was more than twofold, over 100% higher in the 90 days after filling the prescription.

In the older second study analysis of Veterans Affairs (VA) patients, found that testosterone therapy in men was linked with an increased risk of death, MI, and ischemic stroke.

More Than 50,000 Patients Study

This this study of 55,593 men who received a new prescription for testosterone therapy, and these men were compared with 167, 279 who filled a prescription for phosphodiesterase type 5 (PDE5) inhibitors Viagra and Cialis. The PDE5 inhibitors were selected as a comparator arm because many indications for use are similar to testosterone therapy and these agents are not associated with an increased risk of cardiovascular events.

To assess the effect of testosterone therapy, the researchers compared the rate of MI incidence in the 90-day postprescription interval with the incidence rate in the preprescription interval.

The pre- to postprescription relative risk of MI for all patients was 1.36 (95% CI 1.03–1.81). For men 65 years and older, the relative risk of MI 90 days after starting testosterone therapy was 2.19 (RR 1.27–3.77). For those younger than 65 years, there was only a trend toward a higher risk of MI.

In the comparator arm, those treated with PDE5 inhibitors had similar rates of MI in the period before they filled their prescription, but there was no signal of risk in the postprescription period, even in the older patients.

When investigators stratified patients into two groups—those with existing coronary heart disease and those without—they found testosterone therapy in those aged younger than 65 years was associated with a twofold increased risk of MI. For those of the same age but without heart disease, there was no signal of risk.

In older patients, regardless of heart-disease history, treatment with testosterone increased the risk of MI.

FDA Warns About Non Approved Testosterone Use

The agency states that testosterone products are approved for use in men with low testosterone levels. Low testosterone levels occurs because of testicular failure to produce testosterone from a genetic condition or chemotherapy. Other medical conditions include problems with the hypothalamus or pituitary gland that result in low testosterone levels.

The FDA says that these testosterone therapies are not approved for men with low levels without the associated medical conditions.

Testosterone Sales Pushed

Testosterone therapy, is heavily marketed with direct-to-consumer advertising, the drug branded as “a fountain of youth” to treat low energy levels and improve sexual function in men. As a result, millions of men might be taking testosterone therapy, and yet the long-terms risks, including cardiovascular risks, have never been fully characterized. In 2013 the sales of testosterone exceeded $2 Billion.

Published on:


Injured women who have alleged product liability vaginal mesh lawsuits against Johnson & Johnson subsidiary Ethicon, have also filed a motion for sanctions. This motion claims that the manufacturer has destroyed a massive amount of data that was relevant to the litigation. Allegedly Ethicon destroyed or lost hundreds of thousands of important documents that should have been preserved.

Thousands of Ethicon Vaginal Mesh Claims

Johnson & Johnson is exposed to more than 11,000 Ethicon Gynecare mesh lawsuits in the federal court system, which have been centralized as part of a multidistrict litigation (MDL) before U.S. District Judge Goodwin in the Southern District of West Virginia.

Transvaginal mesh was used for surgical treatment of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI). The women allege that significant design defects led the mesh to erode through the vagina, causing painful injuries and incontinence.

Hundreds of Thousands Crucial Documents Destroyed

The women claim that the documents of more than a dozen corporate executives and marketing personnel were destroyed or simply not saved as required by court order.

Ethicon denied the charges, saying that it had been diligent in saving the key documents, but the company also admitted that some of its employees had not followed its document preservation protocols.

Ethicon Vaginal Mesh Lawsuit Updates

Ethicon is one of six manufacturers that face liability lawsuits, with thousands of claims against C.R. Bard, American Medical Systems (AMS), Boston Scientific, Coloplast Corp. and Cook Medical. The most of the vaginal mesh litigation has been centralized for pretrial proceedings before Judge Goodwin, this consolidation known as Multidistrict Litigation or MDL.

According to the latest U.S. Judicial Panel on Multidistrict Litigation case list released in January, Judge Goodwin is presiding over 11,400 AMS mesh lawsuits, 11,667 cases involving Ethicon mesh, 7,377 Boston Scientific mesh lawsuits, 5,516 Bard Avaulta mesh lawsuits, 1,106 Coloplast mesh lawsuits and 150 Cook Medical mesh lawsuits.

Thousands of cases are filed in various state court systems, with 4,549 Ethicon Gynecare and 915 Bard mesh lawsuits in New Jersey, where the cases have also been centralized for coordinated handling before one state court judge.

In each of the coordinated proceedings involving different manufacturers, a small group of cases are currently being prepared for early trial dates, known as “bellwether” cases.

Plaintiff Mesh Verdicts

Four vaginal mesh cases have already reached trial, in July 2012, a California state court jury awarded $5.5 million in damages against C.R. Bard and a New Jersey state court jury awarded $11.1 million in damages against Ethicon in March 2013.

In July 2013, a federal jury awarded $2 million in damages against Bard, including punitive damages designed to punish the manufacturer for their defective design and sale of vaginal mesh products. A second Bard case settled during the first day of trial for an undisclosed sum.

An Ethicon mesh trial is scheduled to begin on February 10. That trial involves Carolyn Lewis, who has alleged severe injury problems with a Gynecare TVT sling.

Published on:

All Byetta, Januvia, Janumet and Victoza cancer lawsuits are consolidated and centralized as part of an MDL, or Multidistrict Litigation.

These product liability cases involve pancreatic cancer after the use of Byetta, Januvia, Janumet or Victoza as part of the “Incretin Mimetics Product Liability Litigation.”

The product liability cases are centralized before U.S. District Judge Battaglia in the Southern District of California for coordinated handling during pretrial proceedings. The consolidation is beneficial for all parties in complex pharmaceutical litigation, to reduce repetitive discovery and to prevent conflicting rulings from different federal judges.

What are Incretin Mimetics?

Byetta, Januvia, Janumet and Victoza belong to a class of newer diabetic drugs, called incretin mimetics. According to some experts, the side effects of these incretin mimetics have been associated with an increased risk of chronic pancreatitis. Chronic pancreatitis is a known risk factor for the development of pancreatic cancer.

Byetta (exenatide) was approved by the FDA in 2005, and is manufactured by Amylin Pharmaceuticals as a twice daily injection. Januvia (sitagliptin) was approved by the FDA in 2006 and and is manufactured by Merck as an oral medication, and as a combination pill containing Januvia and another diabetic medication metformin, under the brand name Janumet.

Victoza (liraglutide) was approved by the FDA in 2010, and manufactured by Novo Nordisk as a daily injection. Onglyza (saxagliptin) was approved by the FDA in 2009 and is manufactured by Bristol-Myers Squibb and AstraZeneca. Tradjenta (linagliptin) is manufactured by Eli Lilly and Boehringer Ingelheim and approved for sale in 2011.

Incretin Mimetics have blockbuster drug status for treatment of type 2 diabetes, generating billions in annual sales. Merck’s Januvia and Janumet, has over $4 billion in sales last year. Novo Nordisk’s Victoza sales were about $1.8 billion and Amylin Pharmaceuticals’ Byetta earned a reported $149 million last year.

Byetta, Januvia Pancreatic Cancer Allegations

Injured patients allege that the manufacturers of the drugs failed to adequately research the side effects of their products or properly warn consumers and the doctors about the risk of developing pancreatic cancer.

Medical Research of Increased Risk of Pancreatitis

In February, Johns Hopkins medical researchers noted that taking Januvia or Byetta may double the risk of hospitalization due to pancreatitis, which raised concerns about an increased risk of pancreatic cancer.

In March, the risk of pancreatic cancer from Januvia, Byetta and other incretin mimetics was noted in another study published in the medical journal Diabetes. This study found that pancreas tissue from organ donors who took an incretin mimetic were more likely to have increased pancreatic mass and precancerous cells.

Recently, in November Italian researchers found that in a review of 1,169 adverse drug reaction reports, they identified at least 90 cases of users of incretin mimetics suffering from pancreatitis and elevated pancreatic enzymes. Acute or chronic pancreatitis is a risk factor for the development of pancreatic cancer.

Published on:

 

Published on:

Recently, Bard settled the second federal Avaulta bellwether trial over its alleged defective transvaginal mesh devices. The settlement was announced by U.S. District Judge Goodwin, who is supervising the transvaginal mesh product liability lawsuits in Charleston, W.Va.

Bard Avaulta Mesh Injury AttorneyAs previously noted, in the first Bard Avaulta bellwether trial, the jury awarded $2 million to a woman who claimed that Bard failed to warn of defects in its product that caused her mesh side effects. The settlement ended the second trial, brought by a North Carolina woman, Wanda Queen. A third bellwether case goes to trial on October 8 and a fourth on November 4.

Over 20,000 Trans Vaginal Mesh Lawsuits Pending

Over 20,000 lawsuits have been coordinated in multidistrict litigation against Bard and five other manufacturers of transvaginal mesh products used to treat pelvic organ prolapse and stress urinary incontinence. Judge Goodwin is also presiding over five other consolidated MDLs involving vaginal mesh products manufactured by other companies, including American Medical Systems (AMS), Boston Scientific, Johnson & Johnson’s Ethicon subsidiary, Coloplast Corp and Cook Medical.

According to an updated case list released by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on August 15, there are currently 3,407 Bard Avaulta mesh lawsuits, 8,967 American Medical System (AMS) mesh lawsuits, 5,232 Boston Scientific mesh lawsuits, 7,751 Ethicon mesh lawsuits, 435 Coloplast bladder sling lawsuits and about 118 Cook Medical biologic mesh lawsuits.

FDA Warnings

In 2011, the U.S. Food and Drug Administration issued a safety warning that “serious complications associated with surgical mesh for transvaginal repair of [pelvic organ prolapse] are not rare.” The FDA asked manufacturers to submit additional studies of the safety and effectiveness of their products. In response, Bard recalled its Avaulta devices off the market last year.

FDA Flawed 510 (k) Process

Earlier, Goodwin excluded from all the four trials any evidence that Bard’s product had been cleared for sale through the controversial 501(k) approval process. This is a “fast track” process, in which the U.S. Food and Drug Administration allows a company to sell a medical device that is substantially similar to a product already on the market. According to some experts, this process, allows the companies to bypass the rigorous inspection and evaluation process and thereby place in the market untested medical products, to the detriment of patients.

Goodwin also excluded evidence that the FDA never took any enforcement action over the Avaulta device.

Bard New Jersey State Court Actions

In addition to the federal litigation, Bard, faces its first trial in state court coordinated litigation in Atlantic City, N.J., on September 23. Bard lost the first trial in the nation over transvaginal mesh products last year, when a state court jury in Bakersfield, Calif., awarded $5.5 million to a woman and her husband.

 

Published on:

As a Transvaginal Mesh recall attorney and Texas medical doctor, our law firm is fielding many calls from concerned women regarding the complications they are suffering as a result of a defective mesh medical device that has been implanted.

watch the abc news video here

One of the most frustrating things our potential clients tells us is that they do not know what type of device has been implanted. To complicate matters even more, there are about 11 manufacturers of these Vaginal Mesh devices in the United States and also each company has several models and types of vaginal mesh product.

Invariably these women have had redo surgeries with more hardware implanted but they are still symptomatic and experiencing side effects. To make things easier for these potential Trans Vaginal Mesh victims, I have listed here a list of the 5 largest manufacturers and the commonly used mesh devices and the types of product that may have been implicated as being defective or those that have been recalled.

Hopefully this blog will provide a “one stop shop” that folks can review and refer to in their search for vital information and to see if they may have a claim.

In the United States, data from mesh manufacturers reveal that in 2010 approximately 300,000 women underwent surgical procedures to repair Pelvic Organ Prolapse, POP and approximately 260,000 underwent surgical procedures to repair Stress Urinary Incontinence, SUI.

According to mesh manufacturers, approximately one out of three POP surgeries used mesh and three out of four of the mesh POP procedures were done transvaginally. Over 80 percent were done transvaginally with mesh.

Transvaginal Mesh Brands – Johnson & Johnson Ethicon Women’s Health

Several hundred lawsuits are pending in New Jersey state court against Ethicon for injuries allegedly caused by several transvaginal mesh products. Lawsuits claim that Johnson & Johnson knew that Ethicon TVT products were unreasonably dangerous but continued to manufacture and sell them regardless.

Brand names of Johnson & Johnson/Ethicon’s transvaginal mesh patches include:

Ethicon TVT
Gynecare TVT Sling
Gynecare Gynemesh
Gynecare Prolift Mesh
Gynecare Prolene Mesh
Prolene Polypropylene Mesh Patch
Secur
TVT = tension-free vaginal tape

Transvaginal Mesh Brands – C.R. Bard

These cases are consolidated as part of the federal Bard Avaulta litigation, which was centralized last year in West Virginia for coordinated pretrial proceedings.

In October 2010, the U.S. Judicial Panel on Multidistrict litigation ordered that all federal Bard Avaulta pelvic mesh lawsuits be consolidated before U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia as part of an MDL, or multidistrict litigation.

Brand names of Bard’s transvaginal mesh patches:

Avaulta Plus™
BioSynthetic Support System
Avaulta Solo™
Synthetic Support System,
Faslata® Allograft
Align
Pelvicol ® Tissue
PelviSoft® Biomesh
Pelvitex™ Polypropylene Mesh
Pelvilace
Uretex
Ugytex
Transvaginal Mesh Brands – American Medical Systems, Boston Scientific

SPARC® is a type of transvaginal mesh patch produced by American Medical Systems (AMS) designed to treat stress incontinence.

In recent months, a growing number women throughout the United States have filed a transvaginal pelvic mesh lawsuit against Boston Scientific and other manufacturers raising similar allegations. The products, which are commonly used for repair of pelvic organ prolapse (POP) and female stress urinary incontinence (SUI) have been found to erode through the vagina, shrink, cause infection, pain and other complications.

Boston Scientific transvaginal mesh patch brands include:

Advantage™ Sling System
Lynx™ Suprapubic Mid-Urethral Sling System
Obtryx® Curved Single
Obtryx® Mesh Sling
Prefyx Mid U™ Mesh Sling System
Prefyx PPS™ System
All these systems use Advantage® Mesh – The Advantage Mesh is designed to reduce the risks of mesh deformation during tensioning and irritation to the anterior vaginal wall.

American Medical Systems SPARC Transvaginal Mesh Implants

Several different companies, including Minnesota based American Medical Systems, manufacture transvaginal mesh product to treat urinary incontinence and other conditions such as pelvic organ prolapse.

The American Medical Systems SPARC Transvaginal Mesh Approach

The SPARC system is a mesh sling that is put under the urethra to support it during normal daily activities. According to American Medical Systems, most patients regain continence almost immediately after surgery. It is marketed as an outpatient, minimally invasive treatment that can have significant and long term benefits for the patient.

American Medical Systems manufactures numerous products, known as pelvic mesh, vaginal mesh, and bladder slings, designed to treat pelvic organ prolapse and/or stress urinary incontinence. These products include: Apogee, Perigee, Elevate, SPARC, MiniArc, MinArc Precise and Monarc.

Please search this blog for other Vaginal Mesh articles, frequent updates and important information.

Published on:

Vaginal Mesh / Bladder Sling attorneys are currently evaluating and investigating the latest medical device tragedy to be afflicting women of a certain age.

texas_vaginal_mesh_injury_lawyer.jpg

Countless women who had a vaginal mesh or bladder sling medical device implanted to treat pelvic organ prolapse have experienced life altering internal injuries, urinary problems and other significant medical complications as a result of problems with the mesh, which may actually provide no real benefit over other surgical methods of treating pelvic organ prolapse.

Vaginal Mesh Lawsuit Update

Many personal injury cases have been filed throughout the United States by women who experienced complications as a result of the defective and negligent design of a vaginal mesh pelvic support system.

Vaginal mesh, which is also referred to as a pelvic mesh, is a surgical product that is implanted into the vaginal area to prevent pelvic organ prolapse (POP), which can occur in women after childbirth or surgery. Pelvic organ prolapse causes the uterus or womb to fall into the vaginal area, which can also lead to the bladder and bowels slipping out of place and putting pressure on the vagina, causing considerable pain and discomfort, as well as urinary incontinence.

Complaints over vaginal mesh implants claim that negligent designs increase the risk that women may suffer severe complications, physical pain and suffering, deformity and the need for additional corrective surgery. Furthermore, the FDA acknowledged in July 2011 that there is no evidence that vaginal mesh bladder sling surgery provides any greater clinical benefit than non-mesh surgeries.

Vaginal Mesh Injuries

The FDA issued a statement about all vaginal mesh implants in July 2011, indicating that the agency has received thousands of reports of complications after the bladder sling mesh has been implanted, and also warn of an increased risk of organs being punctured during the surgery to implant the devices.

Complications with vaginal sling implants reported by women include:

Infection
Erosion of the mesh into the vagina
Recurrences of prolapse
Urinary problems
Bowel, bladder and blood-vessel perforations
Injury to nearby organs
Pain during sexual intercourse
In many cases, transvaginal sling problems have required multiple surgeries to remove the mesh. Even after surgery, women may be left with permanent and disfiguring injuries.

Published on:

As a Johnson & Johnson Gynecare TVT Trans Vaginal Mesh injury attorney and Texas medical doctor, I am providing this timely update.

texas_vaginal_mesh_injury_lawyer.jpg

Johnson & Johnson (JNJ), the world’s second-biggest health-care products maker, is facing many lawsuits over its Gynecare TVT vaginal implant. The Gynecare TVT implant is based on a similar device pulled from the medical device market more than a decade ago for safety reasons.

The lawsuits are the latest to implicate the shoddy and perfunctory approval process for medical devices at the U.S. Food and Drug Administration, which has cleared faulty hip implants and malfunctioning defibrillators.

In the case of vaginal mesh implants, the FDA continued approving the mesh devices made by J&J and other companies based on their similarity to Boston Scientific Corp’s ProteGen even after it was pulled amid safety complaints. Today, the makers of the entire category of implants face more than 600 lawsuits from women who claim the devices caused serious injury.

The devices treat urinary incontinence and pelvic organ prolapse, in which internal organs slump into the vagina. They were allowed on the market as result of the agency’s approval process, known as 510(k), which relies on the premise that if one device has been cleared by the FDA then similar devices need little if any testing in patients.

In July, the FDA issued a statement saying it is unclear whether prolapse implants provide any benefit over traditional surgery. The statement came three years after the agency first acknowledged a problem in a 2008 report that said mesh complications were serious. An advisory panel of physicians said last month that the FDA should demand more clinical testing of the devices.

According to J&J, its vaginal mesh products are safe and the J&J’s Gynecare TVT was based on the Boston Scientific product.

But according to 510(k) critics, the chain of approvals that began with Boston Scientific’s device highlight a major flaw in the 510(k) process. The system lets manufacturers get clearance for a product by citing its similarity to an already approved device, known as a “predicate.” That second device can be cited as the basis for a third, the third to clear a fourth and so on. And if a first device is recalled, they don’t necessarily look at the second, third or fourth device that are based on that.

The unfortunate Vaginal Mesh story began in 1996, when Boston Scientific gained clearance for ProteGen, the first vaginally implanted mesh designed specifically to treat incontinence. Two years later, J&J won approval for a similar device, called Gynecare TVT. Under the 510(k) system, J&J was not required to conduct human testing because the company claimed its device was “substantially equivalent” to the Boston Scientific device.

A year later, Boston Scientific voluntarily pulled about 20,000 ProteGen meshes, saying it had received 123 reports of problems, including discomfort, pain during sex, and erosion of vaginal tissue. But J&J and at least two other manufacturers, American Medical Systems and Covidien Plc (COV), soon came out with products that traced their design back to ProteGen.

The FDA has said it does not know the number of women who have received the implants since 1998, though it estimates almost 300,000 were used in 2010. All of the devices were approved through the 35-year-old 510(k) system, used by the FDA to review some 90 percent of device applications each year. The same process was used to clear the 93,000 artificial hips pulled by J&J last year due to high failure rates, as well as hundreds of external heart defibrillators recalled since 2005 by Minneapolis-based Medtronic Inc. (MDT)
J&J named ProteGen as a basis for the Gynecare TVT, noting in its application that “technologically, both the new device and predicate device are the same.” By that time, complaints about Boston Scientific’s device were already reaching the FDA. A year after J&J’s TVT won clearance, Boston Scientific voluntarily recalled about 20,000 of its meshes.

J&J’s Gynecare TVT later became a predicate for the IVS Tunneller I, made by Dublin-based Covidien, and the Sparc Sling, made by the American Medical Systems unit of Endo Pharmaceuticals Holdings Inc. (ENDP), based in Chadds Ford, Pennsylvania. Those, in turn, were cited to clear future versions, each said to be “substantially equivalent” to its predecessors, according to FDA records. In 2003, Boston Scientific settled 738 suits over its mesh for an undisclosed sum.

The safety debate has presented a dilemma for manufacturers, who have avoided clinical tests for the devices by calling them similar to one another and now say the products have advanced far beyond the earlier versions.

The FDA advisory panel disagreed. The 17-member group, comprised mostly of pelvic surgeons, recommended at last month’s hearing that some vaginal meshes be reclassified as high-risk devices requiring new studies to stay on the market.

The FDA appears to be inching toward a decision. At the September hearing, Colin Pollard, director of the FDA’s obstetrics and gynecology devices branch, said it may take as long as three years to issue new rules. Until then, current models can stay on the market, he said.

Published on:

According to the concerned women who are calling our offices; they believe that the FDA and other U.S. regulators have failed them by not requiring extensive testing before allowing Johnson & Johnson (JNJ) and other manufacturers to sell the type of surgical mesh implanted in them, to hold their pelvic organs in place. Now many these callers say that they cannot work, sleep through the night, or have sex with their partners due to endless pain.

transvaginal-mesh_lawsuit_attorney.jpg

There are about 270 lawsuits pending against J&J. In all, about 600 suits have been filed against it and other mesh makers, including C.R. Bard, Boston Scientific, and American Medical Systems, acquired in June by Endo Pharmaceuticals Holdings.

The U.S. Food and Drug Administration warned on July 13 of a fivefold increase in women suffering pain and injuries after surgeons inserted mesh through vaginal incisions. Pelvic Organ Prolapse (POP) occurs when the internal structures that support the pelvic organs such as the bladder, uterus and bowel, become so weak or stretched that the organs drop from their normal position and bulge or prolapse into the vagina. While not a life-threatening condition, women with POP often experience pelvic discomfort, disruption of their sexual, urinary, and defecatory functions, and an overall reduction in their quality of life.

Surgery to repair POP can be performed through the abdomen or transvaginally, through the vagina, using stitches, or with the addition of surgical mesh to reinforce the repair and correct the anatomy.

”There are clear risks associated with the transvaginal placement of mesh to treat POP,” said William Maisel, M.D., M.P.H., deputy director and chief scientist of the FDA’s Center for Devices and Radiological Health. “The FDA is asking surgeons to carefully consider all other treatment options and to make sure that their patients are fully informed of potential complications from surgical mesh. Mesh is a permanent implant — complete removal may not be possible and may not result in complete resolution of complications.”
In 2010, there were at least 100,000 POP repairs that used surgical mesh. About 75,000 of these were transvaginal procedures.

The FDA issued a safety communication in 2008 due to increasing concerns about adverse events associated with the transvaginal placement of mesh. Since then, the number of adverse events has continued to climb. From 2008 to 2010, the FDA received 1503 adverse event reports associated with mesh used for POP repair, five times as many as the agency received from 2005 to 2007. The reports don’t always differentiate between transvaginal and abdominal procedures.

The most frequently reported complications from surgical mesh used to repair POP include mesh becoming exposed or protruding out of the vaginal tissue (erosion), pain, infection, bleeding, pain during sexual intercourse, organ perforation from surgical tools used in the mesh placement procedure, and urinary problems. Some reports cited the need for additional surgeries or hospitalization to treat complications or to remove the mesh.

The FDA also conducted a review of scientific literature published between 1996 and 2010 comparing mesh surgeries to non-mesh surgeries. The agency review suggests that many patients who undergo transvaginal POP repair with mesh are exposed to additional risks, compared to patients who undergo POP repair with stitches alone. While mesh often corrected anatomy, there was no evidence that mesh provided any greater clinical benefit than non-mesh surgeries.

FDA recommends that health care providers:

• Recognize that in most cases, POP can be treated successfully without mesh;
• Know that surgical mesh is a permanent implant that can make any future surgical repairs more challenging and can put the patient at risk for additional complications and surgeries;
• Consider that mesh placed abdominally for POP repair may result in lower rates of mesh complications compared to transvaginal POP surgery with mesh; and
• Be sure that patients are aware of the risks and benefits of transvaginal POP repair with mesh, and inform patients if mesh is being used.

The FDA recommends that patients:

• Ask the surgeon before surgery about all POP treatment options, including those that do not involve mesh, and understand why the surgeon may be recommending treatment of POP with mesh;
• Continue with routine check-ups and follow-up care after surgery. Notify the surgeon if complications develop (persistent vaginal bleeding or discharge, pelvic or groin pain during sex); and
• Those who have had POP surgery but don’t know if the surgeon used mesh should find out if mesh was used during their next scheduled visit with their health care provider.

Last week an advisory panel agreed with FDA staff that the agency should reclassify mesh from moderate risk to high risk of harming patients if it fails, and require more studies to determine if they are safe and effective.

Personal injury lawyers say they expect a surge in lawsuits by women because of the dangers of transvaginal mesh for pelvic organ prolapse, POP. POP refers to a condition in which the uterus or bladder bulge, or prolapse, into the vagina.

None of the cases have been tried, and women must prove their claims that mesh makers knew of safety risks and failed to disclose them and that the products were defective. JNJ, Boston Scientific, Bard, and American Medical Systems told the FDA advisory panel that using mesh in transvaginal procedures is safe and effective and serious injuries are rare.

About 300,000 women in the U.S. had pelvic organ prolapse surgeries last year, including more than 70,000 who received vaginal meshes. Between 2008 and 2010, the FDA received 1,503 reports of injuries or malfunction, a fivefold increase from 2005 to 2007.

Bard, which estimated the global prolapse mesh market at $175 million, saw its own pelvic prolapse business fall about 30 percent in 2010 due to what it called “regulatory delays” on product approvals. J&J is the global leader in prolapse mesh, followed by American Medical Systems, Boston Scientific, and Bard. According to experts, the law suits are another high-profile controversy pushing the FDA toward toughening its approval process for devices. As moderate-risk devices, vaginal meshes currently need only show that they are “substantially equivalent” to existing products. A change to a high-risk status would require tests to show efficacy and safety.

Published on:

As a Texas medical doctor and Medical Malpractice attorney, I am providing this case law update and commentary.

fort_worth_medical_malpractice_attorney.jpg

As part of Texas’s tort reform laws, enacted by the Texas legislature in 2003, one of the requirements in order to file a medical malpractice claim, was the furnishing of a medical expert’s report within 120 days of filing the lawsuit.The 5th District Court of Appeals says that the legislation serves the state’s interest in preventing frivolous medical liability lawsuits and related health care system costs. This medical expert report requirement is also known as the Texas’ certificate-of-merit law, and is similar to many other states’ medical malpractice reform.

Recently Texas’ certificate-of-merit law passed another constitutional challenge after the 5th District Court of Appeals validated the requirement for plaintiffs to file an expert report demonstrating the merits of a medical liability case.

The 5th District Court of Appeals rejected arguments that the legislation amounted to an unconstitutional special law that treated medical liability lawsuits differently from other cases. Further, the court said that the provision subjecting plaintiffs who file a deficient report to financial penalties does not violate the constitutional separation powers.

Trial court judges have discretion to determine the amount of monetary sanctions and to inquire whether plaintiffs made a good-faith effort to pursue a medical malpractice or wrongful death case.

The August 12 opinion states that the expert report requirement “rationally relates to the interest of the state to prevent medical practitioners from defending frivolous claims at a high cost to the health care system.”

According to the Texas Medical Association’s statistics, since the 2003 law was enacted as part of a liability reform package that included a $250,000 noneconomic damages cap, Texas has seen a 50% drop in medical negligence cases, a 30% reduction in physicians’ liability insurance rates and more than 20,000 newly licensed doctors.

Critics of the law state that those changes may have happened anyway because of the increase in Texas’ population, which boomed as a result of the oil and gas business and the resulting need for more physicians and that as a function of doctors per capita, Texas is actually less served by the total number of physicians. So the new law is a red herring and an excuse for the insurance companies to be treated as a special interest deemed worthy of protection. Is it any wonder that the shiniest, tallest and the most aesthetically pleasing buildings in Texas are owned by insurance companies? Follow the money trail my friends.

The Texas liability reform package is now being touted as a role model for other states to deny plaintiffs their day in court.

The added expert report requirement means an extra layer of protection for physicians and hospitals. Plaintiffs in medical malpractice claims have to show ahead of discovery that they have a meritorious claim, whereas in any other personal injury claim, for example a car wreck injury case, you can take depositions and exchange discovery to determined what happened. In 2006 the Oklahoma Supreme Court ruled that invalidated the state’s certificate-of-merit statute as a special law.

The Legislature’s imposition of mandatory sanctions, of the defendant’s cost of defense and attorny fees, if the medical expert’s report is considered defective, usurps judiciary’s powers and places an unfair burden on plaintiffs who make a good-faith effort to pursue a case. The cost of defense and attorney fees can be in thousands of dollars that the plaintiffs will have to pay.

This ruling arises from a wrongful death claim Joshua Hightower’s parents filed after their son died from complications of rabies contracted during a kidney transplant at Baylor University Medical Center in 2004. Other patients who received organs from the same donor also died of the disease.

The Hightowers filed two physician expert medical reports supporting their claim that the surgery was risky given the donor’s history of drug use and incarceration, and that the hospital and transplant doctors misrepresented the risks involved.

A trial court found the reports deficient and dismissed the case. The appeals court agreed, saying neither report showed “a connection between the donor’s alleged high-risk status and the rabies virus. … Joshua was injured by rabies, a condition of the donor that no one was aware of at the time of the surgery.”

The judges said that “expert reports need not demonstrate all of a plaintiff’s proof, but they must explain the basis of the expert’s statement to link the conclusions to the facts.”

Having been involved in many medical malpractice cases, I know first hand of the difficulties in obtaining a medical expert’s report that is not conclusory and that adequately addresses the standard of care, the conduct that involves the deviation of the standard of care, the damages that result and the causation ie how the deviations caused the damages.

In other words the doctors who write these reports have to understand complex legal theories and case law in order to write reports that pass muster with the court. Doctors are not lawyers and because of their training they do not understand the legal basis of the claim. They understand the medicine but these reports are not about the medicine but law. You therefore have no medical personnel unless they have a legal background or exposure, being able to write these legal treatises which is basically required to pass the court’s muster.

Meanwhile in California…

State public health officials have fined 12 California hospitals for medical errors that hurt or killed patients, according to a report. Three of the hospitals — L.A. County/USC Medical Center, Torrance Memorial Medical Center and Brotman Medical Center — are in Los Angeles County.

The penalties were issued for errors such as leaving foreign objects in patients’ bodies during surgery and administrating the wrong medication. They occurred in 2009 and 2010. The fines, which hospitals can appeal, range from $50,000 to $75,000 for each mistake.

“Most of these are preventable medical errors,” said Ralph Montano, spokesman for the California Department of Public Health. “Either someone was harmed or killed or likely to be harmed.”

So here you have it folks, the rich get richer and the usual poor plaintiffs get the short end of the stick.