The FDA 510(k) System Overhaul -Process For Medical Device Approval: Is this a win for Big Pharma?

 

IS BIG PHARMA LOBBYING DICTATING FEDERAL REGULATORY POLICY IN WASHINGTON D.C. NOW?

By Mark A. York (December 5, 2018)

 

 

 

 

 

 

 

Official FDA announcement: FDA changes 510(k) program for approval and review of medical devices Nov. 26, 2018

(MASS TORT NEXUS MEDIA) On November 26, 2018 the FDA announced an overhaul of the 510(k) system that is meant to prompt manufacturers to base new products on technologies that are 10 years old or less. Almost 20% of the products currently cleared by the system were based on devices older than 10 years. For consumer safety, the FDA is considering whether to publicize the manufacturers and their devices that are based on older products.

The FDA is supposed to protect the interests of the general public and ensure that new devices, as well as existing ones are functioning as designed. More often that is not the case, as the FDA either fails to review medical device failures or simply ignores them.

The FDA has a reporting and tracking database that permits the public to review and see what devices are unsafe or causing adverse events, see FDA Medical Device Adverse Event Report Database.

Now there seems to be an effort by the FDA to pull back on the reporting functions in their official oversight duties. This includes the reporting requirements for problematic medical devices.

But earlier this year, the FDA made a rule change that could curtail that database, which was already considered to be of limited scope by medical researchers and the FDA itself.

For the FDA Medical Device Reporting Program (MDR): FDA.gov/MedicalDevices/Safety/ReportaProblem

BIG PHARMA LOBBYING INFLUENCE

Pharmaceutical companies and medical device makers, collectively Big Pharma, spend far more than any other industry to influence politicians. Big Pharma has poured close to $2.5 billion into lobbying and funding members of Congress over the past decade.

Hundreds of millions of dollars flow to lobbyists and politicians on Capitol Hill each year to shape laws and policies that keep drug company profits growing. The pharmaceutical industry, which has about two lobbyists for every member of Congress, spent $152 million on influencing legislation in 2016, according to the Center for Responsive Politics. Drug companies also contributed more than $20m directly to political campaigns last year. About 60% went to Republicans. Paul Ryan, the former speaker of the House of Representatives was the single largest beneficiary, with donations from the industry totaling $228,670.

Over the past decade, manufacturers have also paid out at least $1.6 billion to settle charges of regulatory violations, including corruption and fraud, around the world, according to the consortium, which published its report findings on November 26, 2018.

The new FDA rule, which had been sought by medical device manufacturers, opens the door for a decrease in reported information for nearly 9 out of 10 device categories, a recent review found. It could allow manufacturers to submit quarterly summarized reports for similar incidents, rather than individual reports every time malfunctions occur, meaning there will be much less detail about individual cases.

As part of the worldwide scrutiny of medical devices and at times, the  affiliated dangers, a massive investigation known as “The Implant Files” was undertaken by a group of journalists around the world.  Led by editors and reporters from the International Consortium of Investigative Journalists, it took a year to plan and another year to complete

ICIJ partnered with more than 250 journalists in 36 countries to examine how devices are tested, approved, marketed and monitored. This included an analysis of more than 8 million device-related health records, including death and injury reports and recalls.

The Implant Files review encompassed more than 1.7 million injuries and nearly 83,000 deaths suspected of being linked to medical devices over 10 years, and reported to the U.S. alone.

Like the rest of Big Pharma, the medical device manufacturers have created an intricate web of corporate and political influence including at the Federal Drug Administration, where the FDA is charged with oversight of medical devices.

The new rule is one of several regulatory changes favoring the medical device industry that have been proposed and enacted since the beginning of the Trump administration. They are part of a decades-long campaign to decrease U.S. regulation of the pharmaceutical and medical device industry, which is a massive global business that has existed for years with minimal international scrutiny.

A recent analysis of the 10 largest publicly traded medical device companies in the U.S. found that since the start of the Trump administration, the companies have spent more than $36.5 million on efforts to influence rules and legislation. Some of these companies manufacture a variety of medical products, including pharmaceuticals and lab equipment, but four of the 10 exclusively manufacture devices and lobbying disclosures for all 10 emphasize efforts to influence policy around devices.

BUYING A PRESENCE IN WASHINGTON

The medical device industry was worth $405 billion worldwide in 2017, according to an Accenture market analysis. Despite its size, the medical device industry has only a patchwork of international oversight, even though when things go wrong with a device, the consequences can be serious.

But the single largest medical device market in the world is the U.S., worth an estimated $156 billion in 2017, according to the U.S. Department of Commerce. As the medical device market has boomed over the past several decades, the industry has built a sizable presence in Washington, D.C.

Many medical device companies have built sophisticated lobbying arms, often employing their own team of lobbyists in addition to hiring outside firms for specific issues. Several of the largest companies used between 15 and 50 lobbyists in 2017 alone, an analysis by the Center for Responsive Politics (CRP) found.

There are also two main trade groups for the industry to which device makers contribute membership fees to, both of which pack a hefty lobbying punch on their own. Since the start of 2017, the Advanced Medical Technology Association (AdvaMed), the older and larger group, has spent more than $6 million and the Medical Device Manufacturers Association (MDMA) has spent nearly $2.6 million. The groups’ policy goals echo those that individual companies list on their lobbying disclosures, among them: decreasing taxes on devices, increasing insurance coverage and reimbursement and the FDA’s approval process for bringing a device to market.

The medical device lobbying effort is vast, with lobbyists seeking to be heard on Medicare and Medicaid reimbursement codes, device purchasing policies at the Veterans Administration, even cybersecurity and trade issues. Companies regularly lobby Congress and target agencies and offices across the executive branches in D.C., from the FDA to the Center for Medicare and Medicaid and the National Security Council.

Altogether, the industry has spent more than $20 million per year for the past five years lobbying the federal government, according to an analysis of campaign finance and lobbying data from CRP.

With the change in administration in 2017, that spending increased to more than $26 million, $2.2 million more than its highest level in any of the previous four years. Based on disclosures from the first three quarters of the year, medical device lobbying in 2018 is on pace to exceed 2017 levels.

An industry spokesperson noted that the U.S. pharmaceutical industry spends more heavily on lobbying than the device industry. Big Pharma-pharmaceuticals, which was worth more than $453 billion in the U.S. in 2017, spent more than $171 million the same year, more than six times as much as the device industry, according to a Statista market analysis.

The lobbying resources of the device industry far outweigh those of consumer and patient advocates, which are often on the other side of regulatory debates on Capitol Hill.

Very few advocacy groups spend time lobbying on devices, said Dr. Diana Zuckerman, a former HHS official under Obama and president of the National Center for Health Research, a nonprofit advocacy organization based in Washington.

“When we’ve talked to congressional staff about this,” she said, “they say things like, ‘Well, we’re getting calls every day, all day long from various device companies or their lawyers,’ and the nonprofits are basically going to the Hill for visits a few hours a year.”

Zuckerman’s group is one of about a half dozen to lobby on devices over the past few years. Each of the largest spends no more than a few-hundred-thousand dollars annually to lobby on devices and all other consumer issues, according to their federal lobbying disclosures.

Trial lawyer groups, which the device industry spokesperson noted often sue device makers, also spent less than one third of what the device industry did in 2017, a CRP analysis found.

Three companies that spent the most on lobbying in the past five years were  ask about their lobbying efforts. Baxter International and Abbott Laboratories did not comment. Medtronic said, “Despite the company nearly doubling in size, our lobbying-related efforts over the last 10 years have remained relatively stable.”

Previously, Abbott, Medtronic and a half-dozen other international device makers told the International Consortium of Investigative Journalists that they conduct business with the highest ethical standards, adhere to all laws and have rigorous programs to prevent employee misconduct.

In a statement, Mark Leahey, president of MDMA, said, “As millions of Americans benefit daily from the more than 190,000 different medical devices available and in use in the United States, our members continue to work with patient groups and policy makers to advance policies that promote improved access for patients and providers. This dynamic innovation ecosystem remains committed to developing the cures and therapies of tomorrow, while reducing adverse events and learning from ongoing research and each patient’s experience.”

OBAMA – TRUMP COMPARISON

During its eight-year tenure, the Obama administration permitted some deregulation but also instituted the first FDA product ban since the 1980s.

Beginning in 2014, warning letters to industry began to drop steeply and approval of new devices to rise. By 2017, the number of FDA warning letters to device manufacturers about product safety had dropped to nearly 80 percent less than those issued in 2010, while approval numbers for new devices were more than three times as high as at the beginning of the decade. The FDA says the decrease in warning letters is due to a more interactive approach to working with violative companies, and the uptick in approvals is due to an increase in staffing and efficiency.

Under Obama, some FDA regulators responsible for overseeing the device industry pushed for deregulation. Administrators largely kept it in check, said Peter Lurie, an FDA associate commissioner during the Obama administration.

“It was accompanied by very heavy lobbying on Capitol Hill as well,” said Lurie. Priorities included faster device approval times and decreasing taxes.

During Obama’s final year in office, the FDA banned its first device in more than 30 years, a type of surgical glove and proposed a ban on a home shock collar for behavior modification. That ban is still pending.

The industry successfully pushed for changes in a proposed regulation on unique device identifiers, the identification codes for individual devices, similar to automotive vehicle identification numbers, and won the suspension of a tax on medical devices created to help fund the Affordable Care Act.

“Now with the advent of the Trump administration,” said Lurie, “the deregulatory gloves are off and we’re seeing a number of the device industry’s most desired objectives come to fruition.”

President Trump vowed to cut regulations across the government by 75 percent when he came into office.

In 2002, Congress instituted a program in which the device industry pays “user fees” to fund the FDA office that oversees it, amounts which are agreed upon in negotiations between industry and the regulator every five years. In its first year, the fees provided 10 percent of funding for the device center, but by 2018, the fees brought in more than $153 million, providing more than 35 percent of the center’s budget.

“It’s carefully negotiated for weeks and months at a time,” said Jack Mitchell, former director of Special Investigations for the FDA. “And there’s a laundry list of things that the industry gets FDA to agree to and that they’re paying for.”

If the most recent agreement, negotiated in 2017, had not gone through by the deadline, the agency would have legally been required to temporarily layoff at least one third of its device center staff. The final agreement included a decrease in approval time for certain devices.

“We do not believe user fee funding has influenced our decision making,” the FDA said in a statement, noting that other parts of the FDA are also funded by user fees.

The agency also noted that it held meetings with patient stakeholders in addition to industry when negotiating the user fee agreement, saying, “Patients are a critical part of the user fee process.”

The FDA emphasized that it does not always agree with the industry, citing as examples its support of legislation that makers of reusable devices provide instruction on how to prevent bacterial contamination, and including device identifier codes in insurance claims forms.

MAKING FDA APPROVAL EASIER FOR BIG PHARMA

The changes to how adverse events are reported was seen as an overwhelming industry success.

The FDA database in which surgical complications are entered is known as the Manufacturer and User Facility Device Experience Database (MAUDE), which includes more than 750,000 incidents per year. The adverse events range from minor malfunctions to patient deaths linked to products being used around the world.

Despite its size, it’s widely accepted that the database is only a rather limited record of the full scale of medical device complications and adverse events.

The rule went into effect in August. The FDA said in a statement in November that though the reports are valuable, they were never meant to be sole source for determining if a device is causing harm.

“This type of reporting system has notable limitations,” said the FDA, “including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data.”

Patients are able to report adverse events to the database themselves, but few know to do so. Companies are required to report the events, once they are notified., which they don’t always do. The FDA said thirty-three percent (33%)  of all FDA warning letters to device makers were to companies that failed to meet rules for reporting complications with devices.

The more companies that fail to file properly, the less the database accurately reflects what is happening to patients with devices.

Under the rule change, companies could be allowed to submit quarterly summarized reports for similar incidents, rather than individual reports each time malfunctions occur. Previously, qualified manufacturers could submit summarized reports if they filed a request with the agency. Now they can do so without making a request.

“[The database] is the way we’ve learned about some very serious health issues,” said Rita Redberg, a cardiologist at the University of San Francisco who studies adverse events like Hershey’s. “It’s the most widespread and publicly available database for adverse events, which is extremely important for patient safety.”

In a public comment in support of the rule change, AdvaMed called the change a “commonsense approach” that will reduce the volume of reports manufacturers need to submit to the FDA and streamline the information the FDA receives about malfunctions.

“This process will actually make it easier for third parties to assess the malfunction data in [the database],” said Greg Crist, a spokesperson for AdvaMed. “Comparing the old alternative summary reporting program to this new initiative is comparing apples to oranges.”

In response to public comments that critical report information would be lost with the change in reporting, the FDA wrote in the published rule that, “We do not believe there will be an adverse impact on the content of information provided to FDA.”

In a statement, the agency said the new program “streamlines the process for reporting of device malfunctions and allows us to more efficiently detect potential safety issues and identify trends. It also frees up resources to better focus on addressing the highest risks.”

But Redberg, is worried that the new rule change will make searching an already unwieldy database more difficult, decreasing the ability of researchers and the public to search for misfiled reports or see accurate numbers of adverse events.

“It makes things easier for industry, it makes things worse for patients,” she said. “I really think it’s a public health crisis. We have more and more devices in use, and for many of them we really have no idea how safe they are because we don’t have accurate reporting.”

How these changes are affecting medical care in the US, and more importantly the publics right to be informed of adverse events and problems with medical devices, their approval process and who’s lobbying who and for what in the FDA should be open and transparent.  

(Certain images and text excerpts in this article were reprinted from third party media sources)

Read More

BARD HERNIA MESH MDL 2846: WHAT YOU NEED TO KNOW TO GET INVOLVED

IS YOUR FIRM LOOKING AT THE BARD HERNIA MESH LITIGATION?

By Mark A. York (October 9, 2018)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) One of the fastest growing emerging mass torts is the C.R. Bard/ Davol, Polypropylene Hernia Mesh Products Liability Litigation, MDL No. 2846, (Judge Edmund A. Sargus, US District Court, Southern District of Ohio). Bard/Davol controls close to 70 percent of the hernia mesh implant market in the United States and have for close to 10 years, and by simply doing the math you can calculate the number of cases that will be filed into the MDL.

With more than 300,000 surgical mesh implant procedures per year, and a conservative failure rate of 20% and Bard’s 70% market share, the numbers for just the last 5 years would exceed 200,000 potential cases. Using the same figures reflects over 42,000 potentially new failures per year, and accordingly the number of potential cases.

For real time case docket information see the Mass Tort Nexus briefcase: BARD-DAVOL-Hernia-Mesh-MDL-2846-(Polypropylene-Mesh)-USDC-Southern-District-of-Ohio

The U.S. National Library of Medicine reports that incisional hernia repair involving mesh has a recurrence rate of 20-45%. Overall, patients with complex ventral hernias (a bulge in the abdominal wall which can include incisional hernias) have a recurrence rate of approximately 30-40% nationally.

Additional synthetic mesh failure data: “Hernia Reoperation Rate Underestimates Real Recurrence Numbers”. American College of Surgeons, Oct. 24, 2017

http://www.mdedge.com/acssurgerynews/article/55911/general-surgery/hernia-reoperation-rate-underestimates-real-recurrence

Discussions on the Bard Hernia Mesh MDL 2846 took place with Kelsey L. Stokes of Fleming, Nolen & Jez, L.L.P., Houston, Texas, co-lead counsel, who commented “We represent hundreds of clients that have been seriously injured by hernia mesh products manufactured by Davol/C.R. Bard.  We have observed that these devastating injuries are occurring all across the United States.

For additional case related information or potential case referrals, please contact Kelsey Stokes at Kelsey_Stokes@fleming-law.com.

MESH WARNINGS OFFERED LONG AGO

The history of synthetic mesh failures and formal warnings being raised can be traced back more than 20 years, after news broke that mesh firms were warned 21 years ago about the risks of the device’s material. Court filings and other sources reveal that manufacturers were warned decades ago that plastic should not be used to make implants.

CR Bard and its subsidiary Davol were allegedly warned that they should discontinue their use of polypropylene resin back in 1997.

Marlex, the Bard supplier of the synthetics resins,  said repeatedly that they were afraid of being sued if the product was used in implants. In 2004, formal warning notices were sent stating that Marlex was “not for human implantation” and told medical mesh companies that they did not want their custom mesh products used “at any price.”

In an email, CR Bard vice president Roger Darois said “We purchase our polypropylene monofilament from an extrusion supplier who purchases the resin directly from the resin manufacturers,” he said. “Thus, it is likely that they do not know of our implant application. Please do NOT mention Davol’s name in any discussions with these manufacturers. In fact, I would advise purchasing the resign through a third party, not the resin supplier, to avoid a supply issue once the medical application is discovered”

 Different Types Of Mesh Placement

  • Overlay– The hernia mesh is placed between the skin/subcutaneous tissue and the rectus abdominis. Mesh is easiest to remove when it is placed in the overlay position.
  • Inlay– The hernia mesh is placed between layers of the rectus abdominis.
  • Underlay– The hernia mesh is placed between the rectus abdominis and the peritoneum. The hernia mesh has a higher chance of attaching to the patients underlying organs when placed in the underlay position.

THE BARD MDL 2846 POLYPROPYLENE HERNIA MESH PRODUCTS

  • Composix
  • Composix E/X
  • Composix L/P
  • Ventralight
  • Spermatex
  • Sepramesh
  • Ventralex
  • Ventralex ST
  • Kugel Patch
  • Composix Kugel
  • Ventrio
  • Visilex
  • Ventrio ST
  • Marlex (AKA Flat Mesh; Bard Mesh)
  • Perfix Plug
  • Perfix Light Plug
  • 3D Max-Lite
  • 3D Max

 

FDA Hernia Surgical Mesh Implants Information and Links

FDA describes hernias, the different treatment options to repair hernias and recommendations for patients that are considering surgery for their hernias. The FDA wants to help patients make informed decisions about their health care and to facilitate a discussion between patients and their surgeons

Official FDA Links: Hernia Surgical Mesh

htts://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/ucm317438.htmsurgeons.

 https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/ucm317440.htm

 https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/ImplantsandProsthetics/HerniaSurgicalMesh/ucm317438.htm

 Hernia Surgical Mesh Implants- Reporting of Adverse Events to the FDA

(Review these sources and checklists for case evaluation and product identification)

Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. If you suspect a problem with surgical mesh, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Health care personnel employed by facilities that are subject to the FDA’s user facility reporting requirements should follow the reporting procedures established by their facilities. Device manufacturers must comply with the Medical Device Reporting (MDR) regulations.

FDA Related Hernia Mesh Information:

Hernia mesh specifics:

  • Manufacturer’s name
  • Product name (brand name)
  • Catalog number
  • Lot number
  • Size
  • Date of implant
  • Date of explant (if mesh was removed)

Hernia repair involving surgical mesh operation specifics:

  • Preoperative diagnosis, postoperative diagnosis and operative procedure
  • Hernia description including size, location, and status (e.g. reducible, sliding, nonreducible, strangulated)
  • Mesh placement (e.g. onlay, underlay, bridging, extent of fascial overlap, fixation method)

Adverse event specifics:

  • Description of the problem including time of onset, inciting factors and severity,
  • Time to resolution
  • Detailed description of the medical and/or surgical interventions (if required) undertaken in response to the adverse event

What is a Hernia?

A hernia occurs when an organ, intestine or fatty tissue squeezes through a hole or a weak spot in the surrounding muscle or connective tissue. Hernias often occur at the abdominal wall.  Sometimes a hernia can be visible as an external bulge particularly when straining or bearing down.

Types of Hernias

The most common types of hernias are:

  • Inguinal:occurs in the inner groin
  • Femoral:occurs in the upper thigh/outer groin
  • Incisional:occurs through an incision or scar in the abdomen
  • Ventral:occurs in the general abdominal/ventral wall
  • Umbilical:occurs at the belly button
  • Hiatal:occurs inside the abdomen, along the upper stomach/diaphragm

Causes of Hernias

Most hernias are caused by a combination of pressure and an opening or weakness of muscle or connective tissue. The pressure pushes an organ or tissue through the opening or weak spot. Sometimes the muscle weakness is present at birth but more often it occurs later in life. Anything that causes an increase in abdominal pressure can cause a hernia, including obesity, lifting heavy objects, diarrhea or constipation, or persistent coughing or sneezing. Poor nutrition, smoking, and overexertion can weaken muscles and contribute to the likelihood of a hernia.

Treatment Options for Hernias

Hernia repairs are common—more than one million hernia repairs are performed each year in the U.S. Approximately 800,000 are to repair inguinal hernias and the rest are for other types of hernias.1

  • Non-Surgical
    • Watchful Waiting– Your surgeon will watch the hernia and make sure that it is not getting larger or causing problems. Although surgery is the only treatment that can repair hernias, many surgical procedures are elective for adult inguinal hernias. Watchful waiting is an option for people who do not have complications or symptoms with their hernias, and if recommended by their surgeon.
  • Surgical
    • Laparoscopic– The surgeon makes several small incisions in the abdomen that allow surgical tools into the openings to repair the hernia. Laparoscopic surgery can be performed with or without surgical mesh.
    • Open Repair– The surgeon makes an incision near the hernia and the weak muscle area is repaired. Open repair can be done with or without surgical mesh. Open repair that uses sutures without mesh is referred to as primary closure. Primary closure is used to repair inguinal hernias in infants, small hernias, strangulated or infected hernias.

Hernias have a high rate of recurrence, and surgeons often use surgical mesh to strengthen the hernia repair and reduce the rate of recurrence. Since the 1980s, there has been an increase in mesh-based hernia repairs—by 2000, non-mesh repairs represented less than 10% of groin hernia repair techniques.

The use of surgical mesh may also improve patient outcomes through decreased operative time and minimized recovery time. However, recovery time depends on the type of hernia, the surgical approach, and the patient’s condition both before and after surgery.

Information found in medical literature has consistently demonstrated a reduced hernia recurrence rate when surgical mesh is used to repair the hernia compared to hernia repair without surgical mesh. For example, inguinal hernia recurrence is higher with open repair using sutures (primary closure) than with mesh repair2.

Despite reduced rates of recurrence, there are situations where the use of surgical mesh for hernia repair may not be recommended. Patients should talk to their surgeons about their specific circumstances and their best options and alternatives for hernia repair.

 What is Surgical Mesh

Surgical mesh is a medical device that is used to provide additional support to weakened or damaged tissue. The majority of surgical mesh devices currently available for use are constructed from synthetic materials or animal tissue.

Surgical mesh made of synthetic materials can be found in knitted mesh or non-knitted sheet forms. The synthetic materials used can be absorbable, non-absorbable or a combination of absorbable and non-absorbable materials.

Animal-derived mesh are made of animal tissue, such as intestine or skin, that has been processed and disinfected to be suitable for use as an implanted device. These animal-derived mesh are absorbable. The majority of tissue used to produce these mesh implants are from a pig (porcine) or cow (bovine) source.

Non-absorbable mesh will remain in the body indefinitely and is considered a permanent implant. It is used to provide permanent reinforcement to the repaired hernia. Absorbable mesh will degrade and lose strength over time. It is not intended to provide long-term reinforcement to the repair site. As the material degrades, new tissue growth is intended to provide strength to the repair.

Hernia Repair Surgery Complications

Based on FDA’s analysis of medical device adverse event reports and of peer-reviewed, scientific literature, the most common adverse events for all surgical repair of hernias—with or without mesh—are pain, infection, hernia recurrence, scar-like tissue that sticks tissues together (adhesion), blockage of the large or small intestine (obstruction), bleeding, abnormal connection between organs, vessels, or intestines (fistula), fluid build-up at the surgical site (seroma), and a hole in neighboring tissues or organs (perforation).

The most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction).

Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.

Please refer to the recall notices here for more information if you have recalled mesh. For more information on the recalled products, please visit the FDA Medical Device Recall website. Please visit the Medical & Radiation Emitting Device Database to search a specific type of surgical mesh.

If you are unsure about the specific mesh manufacturer and brand used in your surgery and have questions about your hernia repair, contact your surgeon or the facility where your surgery was performed to obtain the information from your medical record.

The FDA approved most Bard hernia mesh devices for use in hernia repair surgical procedures through the FDA 510(k) process.  The 510k process does not require a manufacturer to prove that a product is safe for its intended use, but merely requires a showing that a device is a “substantive equivalent” to a product or products already approved by the FDA.  In fact, post-approval, the FDA has advised consumers that adverse events as a result of hernia mesh devices are possible.  The FDA did so as a result of receiving a number of complaints about hernia mesh devices in general.(2)

According to the FDA, “[t]he most common adverse events following hernia repair with mesh are pain, infection, hernia recurrence, adhesion, and bowel obstruction. Some other potential adverse events that can occur following hernia repair with mesh are mesh migration and mesh shrinkage (contraction).” (3)

Hernia Mesh Injuries And Complications

Hernia mesh is used to repair both ventral hernias and inguinal hernias. Various injuries and complications can occur depending on what part of the body the mesh is placed. A coated hernia mesh is also more likely to cause injuries such as infection than a non-coated hernia mesh. The follow is a list of the array of complications we observed:

  • Infection, including sepsis. An infected mesh almost always requires removal.
  • Adhesions form to connect the bowel to the hernia mesh. Adhesions frequently form when ventral hernias are repaired with a coated mesh.
  • Bowel Obstruction caused by adhesion formation. Evidenced by a change in bowel habits or the inability to defecate.
  • Abdominal Pain is a sign of possible adhesion formation, a bowel obstruction, infection, or nerve damage.
  • Rashes are commonly observed in association with hernia meshes such as the C-Qur V-Patch and Ventralex ST.
  • Leg, Groin, and Testicular Pain are all common to inguinal hernias repaired with mesh. This pain can be debilitating.
  • Pain with Sex (Dyspareunia) caused from the mesh used to repair an inguinal hernia attaching to the spermatic cord.
  • Testicle Removal may be necessary if the mesh erodes far enough into the spermatic cord.
  • Diarrhea can be an early symptom of the mesh attaching to the bowel.
  • Constipation can be a sign of a bowel obstruction. You should consult a doctor if your constipation persist for several days.
  • Nausea can be an additional sign of adhesions to the bowel and stomach.
  • Seroma is a fluid capsule surrounding the mesh. Seromas can be present with and without infection.
  • Fistula. An abnormal tunnel between two structures. Our attorneys observe many fistulas connecting to the bowel, which are associated with infections.
  • Dental Problems. Medical reviewers have observed a large number of patients who have lost their teeth after a hernia mesh infection.
  • Autoimmune Disorders. An alarming number of our patients have developed autoimmune disorders after being implanted with a pelvic or hernia mesh.
  • Neurological Changes. Several different patients that have been implanted with the same type of mesh have been diagnosed with unexplained neurological changes on a CT scan.
  • Severe Headache. Typically a sign of a larger problem, such as an infection.
  • Fever. Associated with both an autoimmune response to the mesh and infection.
  • Renal Failure has been observed in those implanted with large coated meshes. The coatings are absorbable and put a great deal of strain on the kidneys.
  • Liver Abnormalities have also been documented in those implanted with coated hernia meshes. The liver is also responsible for cleansing the body.
  • Joint Aches and Pain can be caused by increased systemic inflammation due to infection and an autoimmune reaction to the mesh.
  • Abnormal Sweating can be related to an autoimmune response or to an infection.
  • Meshoma is the migration, contracture, or bunching-up of an artificial mesh. Meshomas become hard, tumor-like bodies.

In addition to the Bard MDL 2846, there is other hernia mesh litigation in courts across the country, including the Ethicon Physiomesh MDL 2782, Judge Richard W. Story, US District Court-Northern District of Georgia. For current information on MDL 2782, see the Mass Tort Nexus briefcase Ethicon-MDL-2782-Physiomesh-Hernia-Mesh-Litigation for all up to date docket and case filing information.

There is also the Ethicon Physiomesh New Jersey State Court Multi-county litigation, see Ethicon Physiomesh MCL Designation to Superior Court Atlantic County Notice (New Jersey Supreme Court Aug 15, 2018), for information and to discuss potential referrals in the New Jersey Ethicon Physiomesh litigation contact, Joshua S. Kincannon, at JKincannon@lomurrofirm.com, where Josh is the head of the LoMurro Firm mass tort practice group in Freehold, NJ.

Meet The Hernia Mesh Lead Counsel in November
Kelsey Stokes, lead counsel in the Bard MDL 2846 from the Fleming, Nolen & Jez firm and Joshua Kincannon, lead counsel on the New Jersey Ethicon Physiomesh litigation from the LoMurro Firm will both be speaking at the upcoming Mass Tort Nexus “CLE Immersion Course” November 9 -12, 2018 at The Riverside Hotel in Fort Lauderdale , FL.  
For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.
For the most up to date information on all MDL dockets and related mass torts visit www.masstortnexus.comand review our mass tort briefcases and professional site MDL briefcases.
To obtain our free newsletters that contain real time mass tort updates, visit www.masstortnexus.com/news and sign up for free access.  

 

 

Read More

Abilify, Taxotere and Ethicon Multi-Layered Hernia Mesh Lawsuits Being Consolidated in New Jersey State Court

New Jersey State Court MCL Designations: Is NJ the emerging state court mass tort venue for lawsuits against Big Pharma?

By Mark A. York (May 11, 2018)

(Mass Tort Nexus Media) In late 2017 plaintiffs and defendants in the Abilify litigation in New Jersey state court moved to have the litigation designated as a multicounty litigation (MCL) on December 27, 2017 and which was approved as an MCL on May 9, 2018, see links below for both court filings.

Abilify New Jersey State Court MCL Notice to the Bar December 27, 2017

Abilify New Jersey MCL Designation – Atlantic County May 9, 2018

 

 

 

 

 

 

 

The  New Jersey judiciary site provides multicounty litigation docket information where you will see there are more MCL dockets that parallel existing federal MDL’s being brought in Big Pharma’s backyard. These multicounty litigations involve large numbers of claims that are associated with pharmaceuticals and medical devices based in New Jersey, and there appears to be an emerging consensus that confronting J&J, Sanofi and others in their home state venue is now a very viable litigation option for mass tort firms across the country. The recently consolidated Abilify MCL is a prime example, as is the pending Taxotere MCL application.

There were nearly 50 Abilify cases filed in Bergen County in New Jersey Superior Court, with that number expected to rise over the next few months, with Superior Court Judge James DeLuca having been the initial judge handling the docket, both plaintiff and defense had agreed that the cases should remain with Judge DeLuca. However, the May 7, 2018 order designated Superior court Judge Nelson C. Johnson and the Atlantic county court as the Abilify New Jersey MCL venue, Abilify New Jersey MCL Designation Atlantic County May 7, 2018.

The motion for MCL designation was filed to ensure that any Abilify case filed in New Jersey will be transferred into the designated state court venue and remain there. There is already a multidistrict litigation (MDL) designation in the Abilify federal litigation, which is consolidated in Northern District of Florida, where the three upcoming bellwether trial were just settled, as well as pending “global settlement order, see Abilify MDL 2734 Global Settlement Order, where Judge Casey Rodgers ordered the parties to reach an agreement within 120 days of the May 1, 2018 order entry date.  The MDL for Abilify was consolidated in October 2016, before U.S. District Judge M. Casey Rodgers.

NEW JERSEY STATE COURT ETHICON MESH CONSOLIDATION

Ethicon now faces a home state hernia mesh legal battle as the New Jersey Supreme Court posted the Application for Multicounty Litigation (MCL) status on April 11, 2018 regarding the emerging Ethicon/J&J multi-layered hernia mesh products litigation pending in New Jersey state courts, Ethicon Hernia Mesh Litigation MCL Notice – New Jersey State Court April 11, 2018. The filing requests the Ethicon hernia mesh cases be consolidated in Bergen County in front of Judge Rachell Harz, over litigation related to Ethicon’s Proceed, Physiomesh and Prolene synthetic hernia mesh products. For information regarding the New Jersey Ethicon Hernia Mesh Litigation see Mass Tort Nexus Briefcase Re: Ethicon Hernia Mesh New Jersey State Court Consolidation, adding another docket of mesh cases to the ever growing J&J/Ethicon defense of its synthetic surgical mesh products.

 

 

 

 

 

As a growing number of hernia mesh lawsuits continue to be filed against Johnson & Johnson and it’s Ethicon subsidiary in New Jersey state court, each involving complications allegedly caused by the design of multi-layered patch products sold in recent years, a request has been filed to centralize the litigation before one judge for coordinated pretrial proceedings.

On April 11, Glenn A. Grant, acting administrative director of New Jersey state courts, issued a Notice To The Bar (PDF), indicating that the state Supreme Court has received an application to create a multicounty litigation (MCL) for all product liability lawsuits over Ethicon multi-layered hernia mesh.

TAXOTERE EMERGING MCL

The most recent MCL application to be filed and listed by the New Jersey Courts is the Taxotere (docetaxel) cancer chemotherapy drug litigation against Sanofi-Aventis US, Sandoz, Inc. and Actavis, Inc with the MCL Notice posted on April 11, 2018 see Taxotere New Jersey MCL Notice To The Bar April 11, 2018.

There is already an existing Taxotere MDL 2740 in the US District Court ED Louisiana see Mass Tort Nexus Briefcase TAXOTERE-MDL-2740-(US-District-Court-Eastern-District-of-Louisiana, where there are more than 5,000 claims pending in front of the very soon to depart Chief Judge Kurt D. Englehardt, who recently received full US Senate approval to move up to the Forth Circuit Court of Appeals, replaced by sitting US District Court Judge, Jane Triche Milazzo.

 

 

 

 

 

How the New Jersey state court Taxotere MCL compares to the Taxotere MDL 2740 remains to be seen, but the New Jersey based pharmaceutical giants are now being forced to address mass torts more and more often in their home state courts, which previously was perceived as a venue of last resort for many plaintiff firms across the country.

With these three newest mass torts emerging in New Jersey state courts, along with the many pre-existing MCL’s that have been very successful there, will New Jersey now be considered the “go to” venue for filing litigation against Big PharMa?

 

 

 

Read More

Johnson & Johnson’s Ethicon Files Appeal in Court Ruling Where Defense Verdict in Mesh Trial Sidestepped By Judge

Plaintiffs Gets a Second Chance After Defense Trial Verdict

 

 

 

 

 

 

 

 

In another legal slam against Johnson & Johnson and their Ethicon mesh division, plaintiff Kimberly Adkins, who’s trial in June 2017 ended in a defense verdict, has been granted new life. In post trial pleadings, the judge granted the plaintiff’s petition for a hearing on damages, after determining that the jury findings had found the mesh was designed defectively, even though they entered a defense verdict. The manufacturer of the pelvic mesh involved, Ethicon Inc. (Ethicon), has appealed the judge’s ruling, when he ruled the matter can proceed to a damages hearing. In so doing, Ms. Adkins’ lawsuit, related to a TVT Secur mesh implant surgical deveice, has been revived, at least for the time being.
The primary defendant in the surgical mesh side effects lawsuit is Ethicon, a subsidiary of Johnson & Johnson, is now facing more than 100 lawsuits in the pelvic mesh mass torts currently consolidated in the Philadelphia Court of Common Pleas, Philadelphia. In what was the fifth case in the mass torts docket to go to trial, the jury on June 9 delivered for Ethicon, with what was  defendant’s first win in the 5 cases heard to date. Ethicon faces many thousands of other mesh lawsuits in federal and state courts across the country, and to date, have mounted vigorous defense in all cases.

Shortly after the defense verdict, Ms. Adkins’ trial team responded with a post-trial motion asserting that the jury’s findings were inconsistent with regard to the issue of whether or not a design defect, alleged in the surgical mesh complications lawsuit (a defect acknowledged by the jury) had been the cause of injuries to Adkins. They also stated that she was entitled to a review of the claim for damages based on the jury design defect determination.

The focus by plaintiffs is, that the jury had determined the Ethicon TVT-Secur mesh implanted in Adkins had, indeed been designed with certain defects. But in their verdict determination, by failing to identify that the product that may have caused Adkins’ injuries went against the weight of the evidence.

Adkins’ post-trial petition found merit with the judge in the Philadelphia Court, who revived the surgical mesh lawsuit in July and directed that the case be set for a hearing related to damages.

Ethicon promptly filed an appeal of the judge’s ruling with the Pennsylvania Superior Court. A spokesperson for Ethicon, Kristen Wallace, said in a statement that the trial jury in the Philadelphia Court of Common Pleas had, indeed determined that the Ethicon surgical mesh had not been the cause of the plaintiff’s injuries.

“We have filed an appeal to the Superior Court solely regarding the court granting a new hearing on damages, because we believe that it was not right to set aside what the jury decided,” Wallace said.

Adkins’ legal team announced it would be opposing the appeal, noting that any further delays incurred by Ethicon’s now standard legal strategy of appealing all rulings to delay final determination, will only delay the final determination of damages being awarded to the plaintiff, for the harm, and suffering experienced after she received the Ethicon TVT Secur mesh implant.

The primary plaintiff claims are that Adkins suffered extensive post-surgical injuries, when the Ethicon TVT Secur implant eroded into the plaintiff’s vaginal canal, causing Adkins severe and ongoing pain, after a portion of the surgical mesh was removed by way of follow up surgical procedure in September, 2012 – however the pain continued. even in the aftermath of the revision surgery. The plaintiff has been unable to return to the pre-implant active lifestyle she enjoyed including being unable to enjoy normal sexual relations with her partner of 20 years.

Ms. Adkins initially filed her complaint related to surgical mesh complications in July, 2013. The case is Kimberly Adkins v. Ethicon Inc. et al., Case No. 130700919, in the Court of Common Pleas of Philadelphia County, Pennsylvania.

Read More

HERNIA MESH AND THE FDA “ARE THEY DOING ENOUGH OR DOING JUST ENOUGH TO JUSTIFY THEIR ROLE?”

 A Guide to Who’s Who in Hernia Mesh and the Documented Problems With Mesh in the USA

Hernia Hernia Mesh ProductsMesh Litigation: Who is the FDA Protecting?

Hernia mesh lawsuits are being filed across the country in state and federal courts. While reviewing pelvic mesh and bladder sling adverse events from thousands of incidents where severe hernia mesh complications have resulted in injuries up to and including death. Patterns began to appear, linking specific injuries with certain hernia mesh products. The investigation uncovered design defects in a large number of hernia mesh products currently on the market.

Over the course of the investigation, and immense amount of information and scientific studies were FDA reports as well as published major medical reviews. A brief, general summary for each hernia mesh study is provided. Links to the full study are also provided for further research; however, due to copyright laws, often only the abstract of the study is available publicly.

Why Learning About Hernia Mesh is Important

The FDA continues to quickly approve untested hernia mesh products, which benefits the medical device manufacturers and hurts the general public. When a product is then shown to be defective, severely injuring thousands nationwide, the FDA is slow to take any action. The manufacturers of hernia mesh know of the life-threatening complications their products can cause, but they don’t warn the public or surgeons. Educate yourself on the dangers of hernia mesh and warn those you know.

There are over 100,000 hernia meshes implanted every year in the United States. Many of the most dangerous hernia meshes remain on the market and have not been recalled by the FDA. Bowel obstructions and severe infections are common complications related to hernia mesh.

What is the FDA’s Opinion on Hernia Mesh?

In April of 2016 the FDA put out an article on hernia surgical mesh implants. The following excerpt demonstrates just how out of touch the FDA is with how dangerous current hernia mesh products are.

“Many complications related to hernia repair with surgical mesh that have been reported to the FDA have been associated with recalled mesh products that are no longer on the market. Pain, infection, recurrence, adhesion, obstruction, and perforation are the most common complications associated with recalled mesh. In the FDA’s analysis of medical adverse event reports to the FDA, recalled mesh products were the main cause of bowel perforation and obstruction complications.”

Just one month later, the manufacturer of the Physiomesh, Ethicon a subsidiary of Johnson and Johnson, removed the hernia mesh due to high rates of complications. Currently, the FDA’s website still has no information on the Physiomesh recall. Ethicon continues to deny that the Physiomesh was subject to a hernia mesh recall, but does admit that they withdrew the product from the market. To date, there have been very few hernia mesh products actually recalled. The majority of complaints that were reviewed are products that have not yet been recalled, or have simply been “pulled from the market.”

Is the FDA Turning a Blind Eye to the Complications Caused by Defective Hernia Meshes?

It seems like an outrageous proposition, until you read some of the adverse event reports that physicians and medical device sales representatives have reported to the FDA. Repeatedly, the FDA has been alerted to various defects related to specific hernia meshes that are resulting in life-changing complications, yet no action has been taken. To highlight how absurd it is that the FDA hasn’t taken action on various hernia mesh products, the Hollis Law Firm created a Parietex ProGrip lawsuit page and a Parietex Composite lawsuit page. Both pages highlight FDA adverse event reports that should have made it obvious to the FDA why patients were experiencing specific complications with certain hernia mesh products. Shortly after the two pages went live, the FDA’s entire online adverse event database went down. We’re just getting started though. Now that the FDA’s online adverse event database is back up, we will be making similar updates to every hernia mesh subpage

Why Does Hernia Mesh Cause So Many Complications?

Polypropylene before implantation

What causes the complications can vary depending on the hernia mesh product. Many hernia mesh products contain a type of plastic known as polypropylene, the same material that is used to make many types of pelvic mesh and bladder slings. Polypropylene is also used to make a wide variety of non-medical devices, such as fishing line and soda bottles. Polypropylene is utilized to make so many commercial products for one main reason, it’s dirt cheap. Here is a Polypropylene Material Safety Data Sheet (MSDS) for a type of polypropylene used in many hernia mesh products. The MSDS notes “Prohibited Uses: Applications involving permanent implantation into the body.” However, the manufacturers of many hernia mesh products continue to use polypropylene and deny that polypropylene degrades and contracts.

Polypropylene 18 months after implantation

Should Hernia Mesh Ever Be Used?

Yes, there are times when mesh needs to be utilized to repair a hernia. The larger a hernia is, the more likely a mesh is needed. If a mesh is required to repair the hernia, there are more than 50 different hernia mesh products to choose from. Various manufacturers utilize a wide range of materials to make their hernia meshes. These materials range from plastics to gels to pig skins. Later in this article, we will cover some of the most dangerous types of hernia mesh. Additionally, certain hernias are easier to fix without using mesh. Inguinal hernias are typically smaller and can be repaired without mesh by a skilled surgeon. The unnecessary use of hernia mesh to repair inguinal hernias has resulted in thousands of patients developing debilitating pain.

Alternatives to Hernia Mesh

  • Shouldice Repair: A two layer suture only hernia repair utilizing the patient’s fascia and tendon.
  • McVay Repair: Abdominal tendons are sutured to the inguinal ligament.
  • Bassini Repair: A suture inguinal hernia repair that preserves the spermatic cord.
  • Desarda Repair: A suture only repair using multiple layers of fascia.

Shouldice Repair

Long before hernia mesh was utilized to repair hernias, surgeons used the shouldice technique to repair hernias. The shouldice technique originated from the Shouldice Hospital in Ontario, Canada, where the technique is still favored to this day. For over 70 years, the Shouldice Hospital has maintained a success rate of 99.5% on primary inguinal hernia repairs. In most cases, general anesthesia is not even necessary to perform the shouldice repair. Typically local anesthetics, pain medication, sutures and a sedative is all that is required. Not having to rely on general anesthesia greatly reduces the risk associated with any surgery. It is time for the surgeons in the United States to start learning the Shouldice technique again while in residency.

When Should Hernia Mesh Never Be Used?

Smaller hernias, such as hernias caused by laparoscopic surgery, don’t require mesh to repair. Small hernias can easily be repaired with sutures by an experienced surgeon. The difficulty with hernias is they are very difficult to permanently repair. There is a high rate of hernia recurrence, both with sutures and with mesh. When sutures fail and the hernia comes back, the surgeon can usually try to stitch the hernia back up. When a mesh fails and the hernia comes back, many severe complications can occur. Also, the hernia is usually much larger after mesh failure. Abdominal tissue and muscle typically adheres to the mesh and must be removed with it.

Types of Hernias

  • Incisional: At an old surgical incision.
  • Umbilical: Near the belly button.
  • Inguinal: Groin.
  • Femoral: High in the thigh.
  • Recurrent: Previous hernia site.
  • Bilateral: Both left and right sides

How do the Manufacturers Convince Surgeons to Use Hernia Mesh?

The manufacturers of hernia mesh products funded studies to demonstrate that there was a lower rate of hernia recurrence when hernia mesh was utilized. These studies were lacking in many ways, such as the length of time that patients were monitored after mesh implantation and what were considered “normal complications.”  Researchers have frequently talked to victims that were implanted with mesh 10 or 15 years ago and have just recently suffered from the mesh eroding into their bowels. Hernia recurrences and complications that happen 10 years later aren’t captured by the studies.

How Bad are Hernia Mesh Complications?

Unlike sutures, which have relatively few and minor possible complications, hernia mesh frequently causes life-threatening complications. Hernia mesh can erode into the bowel, requiring multiple additional surgeries, weeks of hospitalization, partial bowel removal, colostomies, and more. The mesh failure frequently causes patients to experience a systemic infection. We recently observed high rates of dental infections associated with mesh failure. Many victims report all of their teeth suddenly rotting out. Even if there is a slightly lower rate of hernia recurrence when mesh is used, it doesn’t justify the risk of life-threatening complications.

 Hernia Mesh Injuries and Complications

Hernia mesh is used to repair both ventral hernias and inguinal hernias. Various injuries and complications can occur depending on what part of the body the mesh is placed. A coated hernia mesh is also more likely to cause injuries such as infection than a non-coated hernia mesh. The follow is a list of the array of complications we observed:

  • Infection, including sepsis. An infected hernia mesh almost always requires removal.
  • Adhesions form to connect the bowel to the hernia mesh. Adhesions frequently form when ventral hernias are repaired with a coated mesh.
  • Bowel Obstruction caused by adhesion formation. Evidenced by a change in bowel habits or the inability to defecate.
  • Abdominal Pain is a sign of possible adhesion formation, a bowel obstruction, infection, or nerve damage.
  • Rashes are commonly observed in association with hernia meshes such as the C-Qur V-Patch and Ventralex ST.
  • Leg, Groin, and Testicular Pain are all common to inguinal hernias repaired with mesh. This pain can be debilitating.
  • Pain with Sex (Dyspareunia) caused from the mesh used to repair an inguinal hernia attaching to the spermatic cord.
  • Testicle Removal may be necessary if the mesh erodes far enough into the spermatic cord.
  • Diarrhea can be an early symptom of the mesh attaching to the bowel.
  • Constipation can be a sign of a bowel obstruction. You should consult a doctor if your constipation persist for several days.
  • Nausea can be an additional sign of adhesions to the bowel and stomach.
  • Seroma is a fluid capsule surrounding the mesh. Seromas can be present with and without infection.
  • Fistula. An abnormal tunnel between two structures. Our attorneys observe many fistulas connecting to the bowel, which are associated with infections.
  • Dental Problems. Medical reviewers have observed a large number of patients who have lost their teeth after a hernia mesh infection.
  • Autoimmune Disorders. An alarming number of our patients have developed autoimmune disorders after being implanted with a pelvic or hernia mesh.
  • Neurological Changes. Several different patients that have been implanted with the same type of mesh have been diagnosed with unexplained neurological changes on a CT scan.
  • Severe Headache. Typically a sign of a larger problem, such as an infection.
  • Fever. Associated with both an autoimmune response to the mesh and infection.
  • Renal Failure has been observed in those implanted with large coated meshes. The coatings are absorbable and put a great deal of strain on the kidneys.
  • Liver Abnormalities have also been documented in those implanted with coated hernia meshes. The liver is also responsible for cleansing the body.
  • Joint Aches and Pain can be caused by increased systemic inflammation due to infection and an autoimmune reaction to the mesh.
  • Abnormal Sweating can be related to an autoimmune response or to an infection.
  • Meshoma is the migration, contracture, or bunching-up of an artificial mesh. Meshomas become hard, tumor-like bodies.

Too Many Lawyers and Surgeons Rely on Out of Date Hernia Mesh Studies

Polypropylene can cause damage to the surface of any organ it is touching. Old literature and scientific studies found that polypropylene was safe for hernia repair, and only caused severe complications when used as a pelvic mesh. This is why most attorneys have, and still refuse to take hernia mesh cases. The old literature and scientific studies are no longer valid though. Over time, surgeons began to insert and secure hernia mesh via laparoscopic procedures. When a hernia is repaired with mesh laparoscopically, some surgeons insert the mesh deeper into the abdominal cavity, which causes the mesh to come in contact with the bowel. When polypropylene comes in direct contact with the bowels, severe complications typically arise. Due to the now widespread utilization of laparoscopic intraperitoneal hernia repair with mesh, the old scientific studies are no longer valid.

Why Do So Many Hernia Mesh Products Have Coatings Now?

As intraperitoneal laparoscopic hernia repair surgeries with mesh increased, so did the severe complications. The hernia mesh manufacturers scrambled to create a new hernia mesh that would fix the problem polypropylene was causing. However, any material other than polypropylene would have to undergo FDA Pre-Market Approval (PMA). In order to gain PMA status (which also makes the company immune from lawsuits), the company would have to conduct pre-clinical studies to prove that the hernia mesh was safe. Instead, the manufacturers began to apply various types of coatings to the mesh. The idea was that the coating would create a layer between the bowel and the polypropylene. Most of these coatings are intended to be absorbed by the body over a period of months to years.

Differences in Mesh Placement

  • Overlay– The hernia mesh is placed between the skin/subcutaneous tissue and the rectus abdominis. Mesh is easiest to remove when it is placed in the overlay position.
  • Inlay– The hernia mesh is placed between layers of the rectus abdominis.
  • Underlay– The hernia mesh is placed between the rectus abdominis and the peritoneum. The hernia mesh has a higher chance of attaching to the patients underlying organs when placed in the underlay position.

Composite Mesh: The Most Dangerous Type of Hernia Mesh

Any mesh with a coating is known as a composite mesh. Most of the manufacturers promote the meshes coating as a “barrier” and instruct surgeons to use the coating as a barrier. The FDA requires any “barrier” type of medical device to undergo Pre-Market Approval and pre-clinical studies to ensure the device’s safety. Instead of conducting safety studies, companies just told the FDA that they wouldn’t promote their hernia mesh as a “barrier.” A majority of the meshes currently being used in hernia repair are untested composite meshes that have only been on the market for a few years. There is currently no reliable data on these hernia mesh products. Medical reviewers are currently noticing a very high rate of complications associated with hernia meshes that are coated.

Big Profits Making Composite Mesh

Due to the complications that polypropylene was causing when it came in direct contact with the bowel, the demand for composite hernia mesh skyrocketed. Any company with a composite mesh could rapidly increase its nationwide market share. Mesh products were already one of the most profitable medical devices a company could manufacture, many making over $100,000,000 a year! A composite mesh also sells for approximately 15 – 20 times more than an uncoated polypropylene mesh. Suddenly, every device manufacturer rushed to get a composite mesh on the market. Many companies created and sold several different types of composite hernia mesh at the same time. If one type of composite mesh caused too many side effects, the company would simply quit manufacturing that particular composite mesh. There are currently over 350,000 hernia repairs in the United States each year.

Current Hernia Mesh Lawsuits and Investigations

There are many different hernia mesh products available, many of which are manufactured by different medical device companies. The strengths and weaknesses of a hernia mesh lawsuit are in part determined by which company manufactured the hernia mesh and the exact mesh that was utilized. Below is a list of products that have received a large number of complaints. Bookmark this page and check back soon, this list is growing and we continue to add more unique content every week!

Ethicon – Johnson & Johnson

Proceed Hernia Mesh

The Proceed hernia mesh came to market in 2003. The Proceed is a light-weight hernia mesh with an Oxidized Regenerated Cellulose (ORC) fabric covering the polypropylene. The cellulose is adhered to the polypropylene with polydioxanone (PDS). Ethicon touts the Proceed’s barrier as supporting “safe and comfortable healing.” Ethicon has previously issued limited recalls on the Proceed hernia mesh, because of the cellulose layer separating from the polypropylene and increasing the risk of bowel complications. The Proceed hernia mesh continues to delaminate and should be permanently recalled. Physicians have submitted 100’s of adverse event reports to the FDA and Johnson & Johnson regarding the Proceed hernia mesh being defective and injuring patients.

Physiomesh

The Physiomesh was withdrawn from the market in May of 2016. Ethicon maintains that they did not recall the Physiomesh. The Physiomesh was a composite hernia mesh. Multiple studies revealed that Ethicon’s Physiomesh had high rates of complications, including subsequent hernias and additional surgeries. Ethicon admitted that they’re unable to determine why the Physiomesh is defective, or how to decrease complications for those who had a Physiomesh implanted. Part of the problem was likely that the Physiomesh had a coating on each side of the mesh. The coating prevented the Physiomesh from properly incorporating with the host tissue. Prior to removing (not recalling) the Physiomesh from the market, Ethicon created a new hernia mesh called Physiomesh Open.

Prolene Hernia System

The Prolene Hernia System (PHS) was introduced to the market in 1997. The Prolene Hernia System is similar to polypropylene mesh plugs with a polypropylene onlay. In fact, the Prolene Hernia System cites Bard’s Perfix plug as a predicate device. Our hernia mesh lawyers have observed similar complications associated with the Prolene Hernia System and the Perfix plug. The Prolene Hernia System utilizes heavy-weight polypropylene. In 2007, Ethicon came out with the Ultrapro Hernia System, a light-weight version of the Prolene Hernia System. Light-weight polypropylene was believed to cause less complications than heavy-weight polypropylene. Injuries associated with the PHS include debilitating pain, nerve damage, and sexual dysfunction necessitating testicle removal.

Covidien – Medtronic

Parietex

The Parietex hernia mesh was Covidien’s first polyester hernia mesh. The Parietex originally came to the market in 1999 as a heavy-weight polyester mesh. The original Parietex caused many problems similar to polypropylene based hernia meshes, such as adhesions, infections, and bowel complications. Like polypropylene, polyester also shrinks and contracts to a significant degree after it is implanted in the body. As the Parietex contracts, tension increases and the mesh has a tendency to tear where the tacks or sutures were used to secure it. Severe pain and a recurrence of the hernia typically result when the Parietex mesh rips apart. After the Parietex detaches it can migrate to other parts of the body.

Parietex Composite Mesh

The Parietex Composite (PCO) mesh is composed of a polyester base with a resorbable collagen barrier. The resorbable collagen barrier is intended to prevent the polyester base from adhering to the patient’s bowel. Covidien touts the Parietex as a unique material that “works with the body’s natural systems.” However, many of our clients would disagree. The collagen layer of the Parietex Composite hernia mesh is very thin and delicate. The collagen layer disappears quickly after implantation and does little to nothing to protect the bowel and underlying organs from the polyester base. Recently, Covidien came out with the Parietex Optimized Composite Mesh in an attempt to fix the problems associated with the collagen layer. The hernia mesh lawyers at the Hollis Law Firm frequently see severe adhesions, bowel obstructions, and infections associated with the Parietex Composite hernia mesh. Additionally, like the original Parietex, the Parietex Composite tears easily on sutures or tacks as it begins to contract post implantation.

Parietex ProGrip / Parietex Plug and Patch System

The Parietex ProGrip and the Parietex Plug and Patch System are made from polyester weaved together with a partially semi-resorbable polylactic acid (PLA) layer. The Parietex ProGrip is a “self-fixating” mesh because it has thousands of hooks that are intended to keep the mesh in place. However, the thousands of hooks also cause patients to experience severe pain and make the hernia mesh nearly impossible to remove. When the Parietex ProGrip fails and complications result, multiple surgeries are usually required to remove the underlying problem: the defective Parietex ProGrip hernia mesh. Covidien was recently acquired by Medtronic for nearly $50 billion. Covidien is also one of many defendant mesh manufacturers in the pelvic mesh litigation

Atrium – Maquet – Getinge Group

C-Qur Hernia Mesh

The C-Qur is a composite hernia mesh that came to market in 2006, and was initially marketed by Atrium Medical Corporation. Maquet, a subsidiary of the Getinge Group, acquired Atrium in 2011 and now manufactures the C-Qur hernia mesh. The FDA has issued several warnings letters and even sued Atrium Medical Corporation for violations. Recently, the FDA shut down one of Atrium’s facilities that manufactured the C-Qur hernia mesh. Atrium has only issued recalls on the C-Qur’s packaging, not on the actual C-Qur hernia mesh itself.

The C-Qur hernia mesh has an Omega-3 Fatty Acid coating that causes severe allergic reactions. The C-Qur hernia mesh is also associated with life-threatening systemic infections. Removing the C-Qur mesh is extremely difficult and can result in further injury. The C-Qur hernia mesh remains on the market, even as lawsuits continue to mount. Our hernia mesh recall lawyers continue to receive frequent complaints related to the C-Qur hernia mesh.

Davol – C.R. Bard

Kugel Hernia Mesh

The Kugel hernia mesh was one of first and most well known hernia meshes to be recalled. C.R. Bard recalled several lots of the Kugel hernia patch in 2005, 2006 and 2007. The Kugel hernia mesh patch has a ring in the middle of the mesh to help it keep it’s shape. Multiple lots of the Kugel hernia mesh were recalled due to a large number of reported ring breaks. Many patients have suffered bowel perforations as a result of the inner ring of the Kugel hernia patch breaking. Davol only recalled limited lots of the Kugel, claiming that certain lots had defective rings. Davol continues selling the Kugel hernia mesh to this day. The real problem with the Kugel hernia mesh is that it’s made of polypropylene, which shrinks over time. As the polypropylene mesh shrinks, more and more force is applied to the ring. Eventually, the ring breaks due to the shrinkage of the polypropylene.

3DMax

The 3DMax is a bare heavy-weight polypropylene mesh used to treat inguinal hernias. In 2008, Bard released a light-weight version of the 3DMax called the 3DMax light. Patients nationwide have experienced severe, debilitating pain after being implanted with the Bard 3DMax mesh. The 3DMax mesh can erode through soft tissue and then attach to the spermatic cord in men, causing severe sexual dysfunction and testicle pain. Once the mesh is attached to the spermatic cord, there is a risk of losing the testicle when removing the mesh. The 3DMax is curved, and is intended to be implanted without any sutures or tacks. Our hernia mesh attorneys have identified many cases where the Bard 3DMax has folded over upon itself and migrated inside the patient. As can be seen in the picture, the outer sealed edge of the 3DMax also has a tendency to easily break and tear. The sealed edge is intended to help the 3DMax maintain its shape. Bard’s 3DMax simply is not fit for permanent, life-long human implantation.

PerFix Plug

The PerFix Plug is a bare polypropylene mesh used to treat inguinal hernias. The PerFix Plug looks like a double layer dart with an overlay patch. The polypropylene of the PerFix Plug has been observed to come unwoven over time. Many experience severe pain and difficultly exercising and even walking after being implanted with the Bard PerFix Plug. The PerFix Plug is another hernia mesh that has caused many men to loose a testicle. The PerFix Plug is not necessary to repair an inguinal hernia.

Ventralex ST Hernia Mesh (Sepramesh)

In 2007, Bard bought the license to Sepramesh from Sanofi Genzyme. The Sepramesh was intended to “Separate the polypropylene from the bowel.” Bard then created the Ventralex ST hernia mesh by combining the Sepramesh and the Kugel mesh. Bard recalled several lots of the Kugel hernia mesh approximately a decade ago. Bard has yet to issue a recall on any lot of the Ventralex ST hernia mesh.Bard also claims that the Ventralex ST hernia mesh’s coating is similar to the coating used on the C-Qur hernia mesh. Like with the C-Qur, researchers are seeing severe inflammatory reactions, infections, and adhesions related to the Ventralex ST. Please note that Sepramesh, Ventrio ST and Ventralight ST are also included in the Ventralex ST lawsuit.

Scientific Articles on Hernia Mesh

The below articles are on hernia mesh in general. Each hernia mesh subpage also contains additional case specific scientific articles.

August 2016: Evaluation of Long-Term Surgical Site Occurrences in Ventral Hernia Repair: Implications of Preoperative Site Independent MRSA Infection.

632 patients were studied for two years after being implanted with hernia mesh. 31% experienced complications within just two years. Complications included cellulitis, necrosis, nonhealing wound, seroma, hematoma, dehiscence, and fistula. Patients with a preoperative MRSA+ infection from any site (urine, blood, surgical site), might be at an elevated risk for hernia mesh complications.

August 2016: Oral, Intestinal, and Skin Bacteria in Ventral Hernia Mesh Implants.

36 patients with failed hernia mesh were studied. All participants were found to have gingivitis and 33% had infected gums and teeth. Oral bacteria was discovered on 43% of explanted hernia mesh. The study discusses the difficulty in knowing the real rate of hernia mesh infections, due to lack of standardized criteria to define infection, lack of follow-up exams, and lack of intervention when complications arise. It notes that hernia mesh infection is the most common reason for mesh removal.

June 2016: Sepramesh and Postoperative Peritoneal Adhesions in a Rat Model.

The study notes that “postoperative peritoneal adhesions occurred at the extremities of the mesh, where there was close contact between the polypropylene and viscera, or where the fixation suture was placed.”

August 2015: Previous Methicillin-Resistant Staphylococcus Aureus Infection Independent of Body Site Increases Odds of Surgical Site Infection after Ventral Hernia Repair.

768 patients underwent hernia repair. 10% experienced a hernia mesh infection. 33% of patients with a preoperative MRSA+ infection experienced a hernia mesh infection.

May 2014: Comparison of Outcomes of Synthetic Mesh vs Suture Repair of Elective Primary Ventral Herniorrhaphy: A Systematic Review and Meta-Analysis.

637 hernia mesh repairs and 1145 suture repairs were compared. Hernia mesh repair was associated with a slightly lower rate of recurrence, but a higher rate of severe complications. The authors admit that “further high-quality studies are necessary to determine whether suture or mesh repair leads to improved outcomes for primary ventral hernias.”

November 2013: Coated Meshes for Hernia Repair Provide Comparable Intraperitoneal Adhesion Prevention.

Uncoated polypropylene was compared to various types of coated polypropylene placed intraperitonally via laparoscopic procedure. The uncoated polypropylene hernia mesh resulted in significantly more adhesions.

October 2013: Biologic Meshes are Not Superior to Synthetic Meshes in Ventral Hernia Repair: An Experimental Study with Long-Term Follow-Up Evaluation.

The study notes that “In laparoscopic incisional hernia repair, direct contact between the prosthesis and the abdominal viscera is inevitable, which may lead to an inflammatory reaction resulting in abdominal adhesion formation.” The authors advise additional research is necessary, and to be wary of short-term experimental results on laparoscopically placed hernia mesh.

October 2013: Intra Peritoneal Polypropylene Mesh and Newer Meshes in Ventral Hernia Repair: What EBM Says?

The authors are concerned about using polypropylene mesh (PPM) for laparoscopic hernia repair. They question if paying 15-20 times more for a composite mesh is worth it. The study notes “Complications of intraperitoneal PPM (adhesions, infection, intestinal fistulization, sinus formation, seroma and recurrence) can occur with the newer mesh also. There is no statistically significant difference in the incidence of these complications between these meshes.”

August 2012: Ventral Hernia Repair with Synthetic, Composite, and Biologic Mesh: Characteristics, Indications, and Infection Profile.

The study notes that polypropylene “is unsuitable for intra-abdominal placement because of its tendency to induce bowel adhesions.”

August 2011:  Complications of Mesh Devices for Intraperitoneal Umbilical Hernia Repair: A Word of Caution.

The surgeons note experiencing serious complications in several patients implanted with a composite mesh. Injuries included small bowel resections and mesh removal. The study notes “We think that, if preperitoneal deployment of such mesh devices is possible, this should be the preferred position, notwithstanding the fact that these meshes have a dual layer. There is a complete lack of convincing data on these mesh devices in the medical literature. No long-term data have been published, and, for three of the four mesh devices available, no publications on their use in humans were found.”

July 2011: Mesh Infection in Ventral Incisional Hernia Repair: Incidence, Contributing Factors, and Treatment.

The study discusses the need for a better identification, classification and reporting systems for hernia mesh infections. It notes part of the difficulty is that hernia mesh implants have a tendency to remain dormant for long periods of time. It can take years before a hernia mesh infection is identified.

January 2010: Oral Biofilms: Emerging Concepts in Microbial Ecology.

The overall health and biology of an individual is closely linked to which oral biofilms develop.

June 2009: The Problem of Mesh Shrinkage in Laparoscopic Incisional Hernia Repair. 

Laparoscopic hernia repair requires expanding the abdomen with approximately 3 liters of gas. The surface area of the abdominal wall is stretched by about 80% during laparoscopic repair. Surgeons must anticipate significant mesh shrinkage in laparoscopic hernia repair. Mesh shrinkage remains one of the unsolved problems of laparoscopic incisional hernia repair.

How Does the FDA Learn About Hernia Mesh Complications?

If a hernia mesh fails within a few years and the same surgeon that implanted the mesh removes the mesh, the surgeon will sometimes report the complication to the manufacturer. It is then the manufacturers duty to determine if the complication warrants notifying the FDA. Through our investigations, we uncovered that many manufacturers fail to report adverse events related to hernia mesh to the FDA. Surgeons will also occasionally file adverse event reports directly to the FDA, but the process is very time consuming. As a result, the FDA is only aware of a very small percentage of total hernia mesh complications. The manufacturers of hernia mesh then cite to low rates of hernia mesh complications reported to the FDA as evidence that hernia mesh is safe!

Are There Other Ways to Report Hernia Mesh Complications to the FDA?

If you have suffered hernia mesh complications, you can alert the FDA through a MedWatch Report. You can also alert the FDA by filing a hernia mesh lawsuit against the manufacturer of the mesh. When a manufacturer is notified of a pending hernia mesh lawsuit, the manufacturer must report the basis of the hernia mesh lawsuit to the FDA. Medical device companies are allowed too much discretion on if they have to notify the FDA when a surgeon reports a hernia mesh adverse event. The medical device companies do not have discretion on reporting a hernia mesh lawsuit to the FDA. The companies must report every single hernia mesh lawsuit to the FDA.

Read More

67 Ethicon Physiomesh Lawsuits Consolidated into MDL in Atlanta

Ethicon hernia mesh physiomesh
The lawsuits charge that the devices implanted in their bodies were defectively designed or manufactured, and that the defendants failed to give appropriate warnings and instructions about the dangers posed by these devices.

The JPMDL consolidated all Ethicon Physiomesh Flexible Composite Hernia Mesh litigation in the federal courts before Judge Richard W. Story in the Northern District of Georgia.

About 70 actions were pending in 36 district courts, and dozens of law firms are involved in this litigation. The docket will be in MDL No. 2782.

The JPMDL (Judicial Panel on Multidistrict Litigation) ruled that all the actions share common factual questions about defects in defendants’ Physiomesh hernia mesh, which can lead to complications when implanted in patients, including herniation through the mesh, recurrent hernia formation and/or rupture, and deformation of the mesh.

Many plaintiffs charge that the multi-layer coating in Physiomesh prevented adequate incorporation of the mesh into the human body, and caused to a variety of serious complications and that the polypropylene mesh part of the Physiomesh was insufficient to withstand normal abdominal forces.

Ethicon argued unsuccessfully that individual factual issues will predominate about the wide variety of alleged injuries, causation, and the timing of each plaintiff’s injury as it relates to the warnings
given with the product and the applicable statute of limitations. The JPMDL has rejected the argument
that products liability actions must allege identical injuries to call for centralization. See, for example, In
re: Cook Medical, Inc., IVC Filters Mktg., Sales Practices & Prods. Liab. Litig., 53 F. Supp. 3d
1379, 1381 (J.P.M.L. 2014).

 

Read More

Philadelphia Jury Awards $20 Million against Johnson & Johnson in Vaginal Mesh Case

Tension-free vaginal tape (TVT)
Tension-free vaginal tape (TVT)

A Philadelphia Court of Common Pleas jury returned a $20 million verdict against Johnson & Johnson for injuries suffered by a New Jersey woman after receiving a vaginal mesh device.

The verdict was the third consecutive eight-figure award against J&J in a mesh case in the Philadelphia courts.

The award—$2.5 million in compensatory and $17.5 million in punitive damages—was recovered by Peggy Engleman, 56, of Cinnaminson, PA. She charged that the Ethicon TVT-Secur medical device was defective and that the company failed to warn of its risks, and continued to market the device while they knew about the damage it caused to patients.

In related litigation:

Polypropylene mesh erodes

Doctors implanted the device into Engleman in 2007 to relieve stress urinary incontinence, a leakage caused by exercise or coughing. But within a month the TVT-Secur failed and Engleman’s stress urinary incontinence returned.

She began to suffer pain and discomfort when the polypropylene mesh started to erode inside her body. Doctors were unable to remove it all even after three more surgeries. As a result, Engleman now suffers chronic vaginal pain and pelvic floor spasms. She also developed permanent urinary dysfunction.

The TVT-Secur vaginal mesh product was introduced in September 2006 but J&J had already had many reports of high failure rates from countries all over the world.

“This jury sent a strong message today to Johnson & Johnson that they continue to hear in courtrooms across the country—our communities deserve better than these dangerous mesh devices and putting profits before safety will not be tolerated,” lead plaintiff’s counsel Benjamin Anderson told Fox 29.

Read More

Woman Sues Ethicon After Intestines Push Through Hernia Mesh

Ethicon PhysiomeshA Georgia woman filed a products liability suit against Johnson & Johnson and Ethicon when loops of her intestines protruded through multi-layer Physiomesh hernia mesh, causing an intestinal obstruction and severe pain.

She and her husband charge the companies with defective design, failure to warn, negligence and loss of consortium in Connie Franklin and Marvin Franklin v. Johnson & Johnson, No. 4:17-cv-00031, Feb. 2, 2017, US District Court, Middle District of Georgia

As many as 300,000 people may have been implanted with Physiomesh since the FDA approved the product via the 510(k) process in 2010. Ethicon issued an urgent field safety notice on May 25, 2016 related to its hernia repair product Ethicon Physiomesh Flexible Composite Mesh.

  • On the same day, Health Canada, (the Canadian FDA) issued a recall of the Physiomesh products as well.
  • The Australian Therapeutic Goods administration followed suit in June issuing a hazard alert.

See MDL Motion Expected in Ethicon Physiomesh Hernia Repair Product Litigation

Cannot remove Physiomesh

Connie Franklin was implanted with a 20 cm by 25 cm section of Physiomesh to repair an incisional hernia. After suffering pain, nausea and vomiting, she had surgery again on August 1, 2016 for a hernia recurrence.

“The central portion of the Physiomesh device was not incorporated into the abdominal wall and loops of Ms. Franklin’s intestines were protruding through the ruptured central portion of the mesh, and she suffered an intestinal obstruction. The mesh was densely adhered to the loops of Ms. Franklin’s intestines,” the complaint says.

“Ms. Franklin underwent a prolonged surgical procedure to attempt to remove the Physiomesh from her intestines and to remove the mesh that failed to incorporate into the abdominal facsia. Portions of the Physiomesh could not be removed, and remain in Ms. Franklin’s body.”

Physiomesh has a unique design incorporating five distinct layers: two layers of polyglecaprone-25 (“Monocryl”) film covering two underlying layers of polydioxanone film (“PDS”), which in turn coat a polypropylene mesh. This design is not used in any other hernia repair product sold in the United States.

“The multi-layer coating was represented and promoted by the Defendants to prevent or minimize adhesion and inflammation and to facilitate incorporation of the mesh into the body, but it did not,” the complaint says.

The defective design causes delayed wound healing, inflammation, foreign body response, rejection, infection, and other complications. When the Physiomesh degrades, the polypropylene mesh is exposed to the adjoining tissue and becomes adhered to organs, causing bowel perforation or erosion, fistula formation, bowel strangulation, hernia incarceration and other injuries.

The plaintiffs argue that neither they nor their physician was adequately warned about the defective and dangerous condition of the product.

Attorneys for the plaintiffs are Henry G. Garrard, III, James B. Matthews, III, Andrew J. Hill III, Josh B. Wages and Patrick H. Garrard of Blasingame, Burch, Garrard & Ashley in Athens, GA.

Read More

4th Circuit Finds Evidence Sufficient to Uphold $3.27M Ethicon Pelvic Mesh Verdict

Ethicon polypropylene pelvic mesh
Ethicon polypropylene pelvic mesh

The Fourth US Circuit Court of Appeals upheld a $3.27 million jury verdict in the second Ethicon pelvic mesh bellwether trial, dismissing defense arguments that the FDA’s 510(k) shortcut approval process shielded them from liability. The court ruled that the plaintiffs offered sufficient evidence and that the trial judge committed no reversible error.

The case is Jo and Allen Huskey v. Ethicon, Inc. and Johnson & Johnson, No. 15-2118, 4th Cir.; 2017 U.S. App. LEXIS 1402. It is one of 31,676 lawsuits filed in Ethicon, Inc., Pelvic Repair System Products Liability Litigation in MDL 2327 supervised by US District Judge Joseph R. Goodwin in the Southern District of West Virginia in Charleston.

In 2014 a jury found Ethicon liable for design defect, failure to warn and loss of consortium claims. “The Huskeys offered sufficient evidence to sustain the jury’s verdict and the district court committed no reversible error. Accordingly, we affirm,” the appeals court said.

On appeal, Ethicon argued that:

  1. The Huskeys failed to prove a specific flaw in the TVT-O’s design — as opposed to a general complication flowing from implantation.
  2. Comment k of the Restatement (Second) of Torts § 402A shielded it from liability.
  3. It was error to exclude evidence about the FDA 510(k) approval of the TVR-O and a study about pelvic mesh by an FDA advisory committee.

Flaws in TVT-O’s design

The first design flaw was making the TVT-O out of polypropylene. Dr. Scott Guelcher, an associate professor of chemical engineering at Vanderbilt University and one of the Huskeys’ expert witnesses, testified that “the body recognizes [the polypropylene mesh] as a foreign material, and . . . will continue to attack it in this way until it’s removed or destroyed or it’s gone.”

The second flaw was using heavy-weight mesh, which also causes a foreign body response. Dr. Brigitte Hellhammer, a former Ethicon employee, testified that lightweight mesh “would help in reducing a foreign body response, inflammatory response, and would reduce the potentiation for scar plating.”

“A reasonable jury could conclude from this expert testimony that Ethicon’s use of a heavyweight quantity of polypropylene mesh in the TVT-O constituted a design defect,” the court ruled.

Ethicon argued that Comment K of the Restatements shielded it from strict liability because “some products…are quite incapable of being made safe for their intended and ordinary use.” The appeals court rejected the argument because “the expert testimony allowed the jury to infer that Ethicon could have designed the TVT-O with lightweight mesh without sacrificing any performance. Consequently, the jury could reasonably conclude that the TVT-O was not unavoidably unsafe.”

No error excluding FDA evidence

Ethicon argued that the district erred in excluding evidence of the TVT-O’s compliance with the FDA’s Section 510(k) evaluation process, and that a 2011 FDA Advisory Committee deemed mesh slings, including the TVT-O, safe and effective.

In 2003 Ethicon received FDA clearance under the 510(k) shortcut to market the TVT-O because it was substantially equivalent to a pre-existing device, the Gynecare TVT. The appeals court ruled that excluding this was correct, because “the 510(k) process focuses mostly on the equivalence between the product in question and an older one, and only “tangentially” examines the safety of the product going through the process.

It was also correct to exclude a 2011 review by an FDA Obstetrics and Gynecology Devices Advisory Committee of published literature about pelvic mesh treatment. “While the district court did not permit Ethicon to present evidence as to the FDA’s view of the underlying studies, it did permit Ethicon to introduce those studies themselves. The FDA did not use its own analysis of the TVT-O to reach a conclusion regarding the device’s safety and efficacy. Rather, it simply opined on the work others had done,” the court said.

Three unsuccessful surgeries

Jo Huskey of Illinois had the Tension-Free Vaginal Tape-Obturator (“TVT-O”) implanted in 2011 to treat stress urinary incontinence. It is a sling made of polypropylene in a heavy-weight laser-cut mesh. A few weeks later the surgeon discovered that the mesh had eroded, causing her to experience pelvic pain. On June 29, 2011 he had a second surgery to cover the exposed mesh, but it did not relieve the pain. She had a third surgery on November 18, 2011, revealing an infection the complete erosion of the right side of the mesh.

She and her husband filed suit in 2012. In 2014 the jury awarded Mrs. Huskey $3.07 million in total damages, allocated between past expenses for medical care, previous pain and suffering, and future pain and suffering. The jury awarded Mr. Huskey an additional $200,000 for his loss of consortium.

“To this day, the remaining mesh and scar tissue from her operations cause Mrs. Huskey to experience severe pain, particularly when engaging in physical activity and sexual intercourse. Additionally, her SUI symptoms have returned. For the rest of her life, she will require medication for pain management; no surgical intervention can permanently cure her,” the Fourth Circuit said.

Read More

MDL Motion Expected in Ethicon Physiomesh Hernia Repair Product Litigation

Ethicon PhysiomeshEthicon, a division of Johnson and Johnson, issued an urgent field safety notice on May 25, 2016 related to its hernia repair product Ethicon Physiomesh Flexible Composite Mesh.

The notice included a recall of existing stock currently held by health care facilities for all variations (product codes) of the Physiomesh Product Line.

  • On the same day, Health Canada, (the Canadian FDA) issued a recall of the Physiomesh products as well.
  • The Australian Therapeutic Goods administration followed suit in June issuing a hazard alert.

The recall of “on the shelf” products should serve to prevent future hernia repair patients from being implanted with Physiomesh however, this recall does not help those already implanted with the defective hernia mesh product.

We estimate that as many as 300,000 individuals may have been implanted with Physiomesh since the product was approved by the FDA via the 510k process in 2010.

MDL Motion Expected

A large number of lawsuits are expected to be filed resulting from injuries alleged to be caused by Ethicon Physiomesh. It is probable that, as more cases are filed, a motion to consolidate will be filed before the Judicial Panel on Multidistrict Litigation (JPML). Given the fact that Ethicon has recalled the Physiomesh product line, this litigation may move rapidly.  It is possible that an MDL could be formed as early as 2017.

The emerging litigation related to injuries caused by Physiomesh will be discussed in the November 11th – November 14th Four Days to Mass Tort Success Course  in Fort Lauderdale. We will continue to update our subscribers on this emerging litigation. If you are not already a subscriber to the Mass Tort Nexus App, please sign up today at this link: Sign Up

Current litigation

Matthew Huff filed a complaint (See Huff vs Ethicon) in the Southern District of Illinois in April 2016.  The Huff complaint alleges that after being implanted with Physiomesh he was hospitalized beause of an infection in and around the mesh, which caused two abdominal abscesses and an intestinal fistula. These complications from the Physiomesh implant required extensive surgery.

Joanne Quinn filed a complaint (See Quinn vs Ethicon) in the Middle District of Florida in September 2016. The Quinn complaint alleges that the implanted Physiomesh did not improve her condition and in fact resulted in further complications including bowel obstruction. Quinn alleges that due to complications related to Physiomesh she was required to undergo a significant surgical procedure in an attempt to correct the complications allegedly caused by Phsyiomesh.

Shortly after the FDA approved Physiomesh, surgeons and other medical providers began filing adverse event reports, by the end of 2012 an estimated 90 adverse event reports had been filed related to Physiomesh. Today an estimated 650 Adverse Event Reports have been filed in the FDA’s Maude Adverse event reporting System since Physiomesh Composite Mesh was approved by the FDA in 2010 via the 510k market approval pathway. Despite this alarming number of adverse event reports, the FDA took no action prior to the manufacturer’s recall of all Physiomesh Products in May.

Read More