Defense Wins 3rd Xarelto Mass Tort Bellwether in a Row

XareltoA jury in federal court in Missouri returned the third verdict in favor of Janssen Pharmaceuticals and Bayer in a bellwether trial over the blood-thinner Xarelto. The companies are facing 18,000 similar lawsuits charging that the drug causes uncontrollable bleeding.

Juries in the multidistrict litigation docket, MDL 2592 before U.S. District Judge Eldon E. Fallon in the Eastern District of Lousiana, also returned defense verdicts on May 3 and June 12 this year.

The plaintiff Dora Mingo of Summit, Mississippi, alleged under Miss. Code Ann. Sec. 11-1-63 that Xarelto was defectively designed because there is no antidote and that it is unreasonably dangerous because of an inadequate warning to physicians about uncontrollable bleeding.

Mingo, a 69-year-old retired schoolteacher, suffered acute gastrointestinal bleeding and severe blood loss after taking Xarelto for a month in 2015 to prevent blood clotting after surgery. Plaintiff attorney Andy Birchfield of Beasley, Allen, Crow, Methvin, Portis & Miles of Montgomery, AL, said the companies should have instructed doctors to conduct a simple Prothrombin Time (PT) blood test, to assess a patient’s risk of bleeding.

As in the previous trials, the jury returned the verdict after a few hours of deliberation.

Xarelto is Bayer’s best-selling drug and in 2016 it generated $3.41 billion in revenues to the German company. Johnson & Johnson, the parent company of Janssen, reported $2.2 billion in revenues from Xarelto.

The FDA approved the drug in 2011 for patients with a heart rhythm disorder known as atrial fibrillation and to treat the risk of deep vein thrombosis and pulmonary embolisms.

Representing Janssen was Richard Sarver of Barrasso Usdin Kupperman Freeman & Sarver in New Orleans, who was involved in the first Xarelto trial. Bayer was represented by Lyn Pruitt of Mitchell Williams in Little Rock, Arkansas, and Walter T. Johnson at Watkins & Eager in Jackson, Mississippi.

Nexium, Priosec and PrevAcid Mass Tort Litigation Consolidated in New Jersey

The US Judicial Panel on Multidistrict Litigation consolidated 161 proton-pump inhibitor (PPI) products liability lawsuits into new federal MDL No. 2789 in federal court in New Jersey.

It was the second, successful try by the plaintiffs. In January, the Panel denied a motion that also sought centralization of the claims. At the time, it cited the small number of filings (only 15), the differing heartburn drugs involved and the need to protect trade secrets among the various defendants.

Since then, the size of the litigation has grown. Further, two defendants, AstraZeneca and Pfizer, had also changed course, and now supported consolidation. There are 34 tag-along actions in addition to the 161 cases consolidated by the Panel.

US District Judge Claire C. Cecchi, who is already managing PPI cases in the district, will oversee the MDL litigation. Heartburn drugs in the MDL:

  • Nexium
  • Nexium 24HR
  • Prilosec
  • Prilosec OTC
  • PrevAcid
  • PrevAcid 24HR
  • Dexilant
  • Protonix

Causes kidney damage

The defendants are AstraZeneca Pharmaceuticals LP, Pfizer, Inc., Wyeth Pharmaceuticals Inc., Wyeth LLC, Wyeth-Ayerst Laboratories, Procter & Gamble Company, Takeda, Novartis Consumer Health, Inc., Novartis Pharmaceuticals Corporation, Novartis Vaccines and Diagnostics, Inc. and Novartis Institute for Biomedical Research Inc.

In the 161 personal injury and wrongful death actions, plaintiffs allege that as a result of taking one or more proton-pump inhibitors (PPIs), they or their decedents suffered kidney injury (e.g., chronic kidney disease (CKD), acute interstitial nephritis, end stage renal disease, or kidney failure). Plaintiffs allege that defendants failed to adequately warn of the negative effects and risks associated with PPIs.

“Although several of the grounds on which we denied centralization in Proton-Pump I remain largely valid, we find that the significantly larger number 6 of involved actions, districts, and counsel, the concomitant increase in burden on party and judicial resources, and the opportunity for federal-state coordination, coupled with most defendants’ change in position to now support centralization, tip the balance in favor of creating an MDL,” the Panel said. “Centralization will facilitate a uniform and efficient pretrial approach to this litigation, eliminate duplicative discovery, prevent inconsistent rulings on Daubert and other pretrial issues, and conserve the resources of the parties, their counsel, and the judiciary,” the Panel said.

New On-Demand Webinar: Summer 2017 Mass Torts Update

Overview:

  • US Supreme Court decision limiting personal jurisdiction for mass torts in state courts. SCOTUS kicks out 592 non-resident plaintiffs.
  • The best path forward for mass tort plaintiffs.
  • 3 Mass torts heading for settlement:
    • Taxotere: 1,272 cases filed before Chief US District Court Judge Kurt D. Engelhardt, in the Eastern District of Louisiana, MDL 2740.
    • IVC filter: 2,342 cases before Chief US District Court Judge Richard L. Young, in the Southern District of Indiana, MDL 2570.
    • Fluoroquinolones (FLQs): 752 cases before Chief US District Court Judge John R. Tunheim in the District of Minnesota, MDL 2642.
  • Case to watch – Xarelto: 17,593 cases filed before US District Judge Eldon E. Fallon, Eastern District of Louisiana, MDL 2592, In re: Xarelto (Rivaroxaban) Products Liability Litigation
  • Using the 5 W’s to generate new business online
    Watch 20now
  • Watch now. It’s free. No registration required.

$300 Million Settlement for Benicar Blood-Pressure Drug

Daiichi Sankyo Company announced a $300 million settlement related to its blood pressure drug Benicar. Despite this, the company admitted no liability for any wrongdoing.

Patients who have been injured by Benicar can take part in the $300 million settlement if they have a retainer in place with a qualified Benicar attorney by August 23, 2017.


See our earlier report Picking 6 Winners in Mass Torts Litigation.


A total of 1,942 lawsuits have been filed in MDL 2606, IN RE: Benicar (Olmesartan) Products Liability Litigation, before US District Judge Robert B. Kugler in New Jersey as of July 15.

Benicar, Benicar HCT, Azor, and Tribenzor are angiotensin II receptor blockers that lower blood pressure associated with hypertension. It is also linked to severe gastrointestinal injuries, including:

  • Sprue-like enteropathy, which has symptoms similar to those of celiac disease.
  • Lymphocytic colitis, microscopic colitis, and collagenous colitis.
  • Patients may suffer from chronic diarrhea, vomiting, nausea, abdominal pain, kidney failure, and significant weight loss.

Starting in January 2014, plaintiffs began filing Benicar-related injury lawsuits, and in March 2015, the Judicial Panel on Multidistrict Litigation created the Benicar MDL. On August 1, 2017, Judge Kugler approved the $300 million settlement.

Patients who experienced Benicar-related side effects can still take part in the settlement, but only if they are represented by a Benicar attorney by the August 23, 2017, deadline.

According to the master settlement agreement, the fund will start to be paid out when 95 percent of all eligible litigants and claimants opt into the settlement under various conditions. Once the thresholds are met, claimants who meet specified criteria will receive compensation from the settlement fund.

Endo Settles ‘Virtually All Known’ Mesh Suits for $775 Million

law news, legal news, jury verdict, case settlement

Endo International Plc announced that it has reached agreements to resolve virtually all known U.S. vaginal-mesh implants product liability claims for $775 million. Women suing the company accuse it of selling defective devices that caused injuries such as chronic pain, incontinence, bleeding and infection.

The Dublin-based company said it is engaged in discussions to resolve the known remaining U.S. claims at reasonable values. Under the agreements, Endo will make installment payments beginning in the fourth quarter of 2017 and continuing through the fourth quarter of 2019.

Endo’s settlement of the remaining 22,000 mesh suits means the company has now set aside more than $2.6 billion to wipe out cases over the flawed medical devices, according to filings with the U.S. Securities and Exchange Commission.

As part of its second quarter 2017 results, the company intends to increase its mesh product liability accrual by $775 million, which is expected to cover approximately 22,000 U.S. mesh claims, as well as all known international mesh product liability claims and other mesh-related matters.

Endo said it is unaware of any mesh-related matters not covered by the foregoing accrual increase.

“Beginning in the second quarter of 2017, we aggressively executed a settlement strategy in connection with Endo’s mesh litigation. We believe it is a very important milestone for Endo to have reached agreements to resolve virtually all known U.S. mesh product liability claims,” said Paul Campanelli, Endo’s President and Chief Executive Officer. “While it remains possible that additional claims will be filed, we believe today’s announcement will assist most mesh claimants to move forward with their lives and will permit Endo to move forward with an even greater focus on executing against our core strategic priorities,” he added.

Meanwhile, Johnson & Johnson said in SEC filings in February that it was defending 54,800 cases over its pelvic mesh inserts while Boston Scientific said that same month it faced 43,000 mesh claims. Both companies have settled some mesh suits.

Xarelto Trial Starts Today as More than 15,000 Adverse Events Linked to Blood Thinner

XareltoAs the number of lawsuits against the blood thinner Xarelto continues to climb, so do reports of injuries and deaths caused by the controversial anticoagulant, according to a recent study by the Institute for Safe Medication Practices (ISMP).

A total of 17,593 cases are filed before US District Judge Eldon E. Fallon in MDL 2592, IN RE: Xarelto (Rivaroxaban) Products Liability Litigation. The next bellwether trial is scheduled to begin August 7 in Jackson, Mississippi.

According to ISMP, the U.S. Food and Drug Administration received 15,043 reports of serious injury or death linked to Xarelto last year — a 41 percent increase over the previous year.

ISMP, a non-profit organization that monitors and analyzes adverse drug events reported to the government, published the findings in its annual edition of QuarterWatch.

3,018 deaths

Oral blood thinners such as Xarelto caused more emergency room visits in 2016 than any other class of drugs, ISMP found. The group said it identified nearly 22,000 reports of severe injury, including 3,018 deaths. Nearly all of the injuries were from internal bleeding, the report states. Of the five anticoagulants implicated, rivaroxaban, sold under the brand name Xarelto, accounted for 68.4 percent of all adverse events in 2016, according to ISMP.

The report comes as the first trials in litigation against Xarelto get underway. More than 18,000 lawsuits against the makers of Xarelto have been centralized under the federal multidistrict litigation (MDL) process that uses “bellwether” trials to establish evidence and determine any settlement value for similar plaintiff claims.

“These injury findings are disheartening, but unfortunately not all that surprising,” said Andy Birchfield of the Beasley Allen law firm and co-lead counsel of the plaintiffs’ steering committee for the Xarelto MDL. “The statistics are a testament that Xarelto is one of the most high-risk drug treatments in medicine today, and the reason we are pursuing justice for the victims of this potentially deadly medication.”

Johnson & Johnson, Janssen Pharmaceuticals, and Bayer Healthcare are accused of downplaying the risks of taking Xarelto and aggressively marketing the drug as an alternative for warfarin in patients needing blood thinners to reduce the risk of dangerous clots. The companies positioned the drug as more convenient, calling for a once-a-day dose and eliminating the need for regular monitoring of a patient’s blood. However, the lawsuits charge that doctors and patients were not fully informed of the risks.

Johnson & Johnson Talcum Powder Lawsuit Trial Starts in California

The trial of the first of more than 300 ovarian cancer lawsuits involving Johnson & Johnson’s talcum powder products started on July 10 in Los Angeles Superior Court.

The case was filed by 63-year-old Eva Echeverria, a California resident, who claims she developed ovarian cancer in 2007 after using J&J’s talc products since the 1950s.

The case is Eva Echeverria v. Johnson & Johnson, Case No. BC628228 and the coordinated proceeding is Johnson & Johnson Talcum Powder Cases, Case No.  JCCP4872, in the Superior Court of the State of California, County of Los Angeles.

Mark P. Robinson Jr. and Kevin F. Calcagnie of Robinson Calcagnie Inc.
are representing Echeverria.

“This trial is vitally important, as it is considered a bellwether case. The verdict in this lawsuit could provide insight into how juries might decide similar claims pending in California’s talcum powder litigation,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective medical devices, drugs and consumer products.

Nationwide Talcum Powder Litigation

Johnson & Johnson has been named a defendant in more than 3,000 talcum powder lawsuits currently pending in courts around the country, all of which were filed by women who allegedly developed ovarian cancer after the regular use of the company’s talc-based powders for feminine hygiene purposes. Plaintiffs claim that Johnson & Johnson officials were aware of research published as early the 1970s that suggested such a link, yet failed to warn the public to protect it profits derived from its Baby Powder and Shower-to-Shower product lines.

In federal mass tort litigation, J&J is facing 415 lawsuits in MDL 2738 in New Jersey, supervised by US District Judge Freda L. Wolfson, IN RE: Johnson & Johnson Talcum Powder Products Marketing, Sales Practices and Products Liability Litigation.

The California trial will be the first convened outside of Missouri’s 22nd Circuit Court in St. Louis, where one of the nation’s largest talcum powder litigations is currently underway. So far, only one Missouri jury has rendered a verdict in favor of Johnson & Johnson. Plaintiffs in four cases have been awarded compensatory and punitive damages amounting to $110 million, $70 million, $72 million and $55 million. A mistrial was declared in the state’s sixth trial just last month. (Case No. 1422-CC09326-01).

Transvaginal Mesh Lawsuit Plaintiff Recovers $2.1 Million from Johnson & Johnson

Ethicon, Inc.’s Gynecare Prolift mesh

Ethicon, Inc.’s Gynecare Prolift mesh

A Pennsylvania jury awarded $2.1 million to a woman who suffered serious complications after Ethicon, Inc.’s Gynecare Prolift mesh deteriorated in her body.

The May 26 verdict in the Philadelphia Court of Common Pleas, marks the fourth consecutive defeat for Johnson & Johnson and its Ethicon division in a Pennsylvania transvaginal mesh lawsuit. (Case No. 130603835)

“Thousands of women across the country, including many of our own clients, are pursuing similar pelvic mesh claims against Johnson & Johnson and Ethicon. We are pleased with the jury’s finding, and will continue to monitor upcoming trials,” says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices.

J&J TVM litigation

This latest trial involved a woman who was implanted with Prolift mesh in 2006 to treat stress urinary incontinence and pelvic organ prolapse. According to her complaint, erosion of the mesh into her vagina and bladder resulted in permanent complications, including constant pelvic pain, incontinence, urinary tract infections, and severe pain with sexual intercourse. The jury deliberated for just nine hours before delivering its decision last Friday.

Last week’s verdict came just a month after another Pennsylvania jury ordered Johnson & Johnson and Ethicon to pay $20 million in punitive and compensatory damages to a woman who suffered complications related to Ethicon’s Gynecare TVT-Secur implant. Philadelphia juries have awarded $12.5 million and $13.5 million to two other transvaginal mesh plaintiffs.

Transvaginal mesh lawsuits involving Johnson & Johnson and other device makers began to mount in U.S. courts after the issuance of a 2008 U.S. Food & Drug Administration (FDA) alert warning that the devices had been linked to at least 1,000 reports of serious injuries over a three year period. The agency updated its warning July 2011, after the number of reported transvaginal mesh complications related to prolapse repair tripled. Among other things, the FDA modified its previous stance that such injuries were rare.

In 2012, Ethicon announced it would stop selling four pelvic mesh devices, including Gynecare TVT Secur, Gynecare Prosima, Gynecare Prolift and Gynecare Prolift+M. The company attributed its decision to commercial concerns and maintained that the products were safe. However, the FDA had recently ordered Ethicon and 20 other vaginal mesh manufacturers to conduct further research into the risks associated with their implants.

Legal Implications of a Deregulated FDA

President Trump, who has stated that 75% to 80% of all governmental regulations are unnecessary.

This article is reprinted from the Spring 2017 issue of The Trial Lawyer, which can be read online here.

By Joseph DiNardo, Esq. and Erin Delaney, Esq.

There is much uncertainty throughout the pharmaceutical industry as a new U.S. Food and Drug Administration (FDA) Commissioner is chosen and steps are taken to deregulate government agencies.

President Donald Trump has stated one of his goals is to speed up the drug approval process to lower drug prices, promote competition, benefit small start-ups and bring innovative new treatments to market faster.

However, many industry leaders are concerned that dramatically speeding up the current approval process could put patients at risk. This, in turn, could subject manufacturers to costly litigations.

CEO of Pfizer favors deregulation

The high cost of obtaining approval for a new drug, estimated at $2.6 billion, has been blamed for hindering pharmaceutical start-ups from entering the market. As a result, certain pharmaceutical executives, like the CEO of Pfizer Inc., have publicly favored deregulation, claiming it will help create more competition and lower drug prices.

Others in the pharmaceutical industry disagree, opining that current FDA rules and regulations provide a level playing field for both small and large companies. Lowering the bar for drug approvals, they contend, would allow the wealthiest pharmaceutical companies to inundate the market with countless new drugs and associated advertising, eclipsing any potential advances of smaller companies.

President Trump, who has stated that 75% to 80% of all governmental regulations are unnecessary, issued an executive order on January 30, 2017, aimed at significantly reducing them. The order requires all executive government agencies identify at least two regulations to be repealed for each newly-proposed regulation.

FDA may not be affected

While not immune to the executive order, the FDA, which regulates food, drugs, medical devices, blood donations, vaccines, biologic products, animal and veterinary products, cosmetics and tobacco products, may not be markedly affected by it. Many FDA regulations deal with process and merely codify or interpret the law. Accordingly, even if certain agency regulations were repealed, congressional mandates, including statutory safety and efficacy standards under the Food, Drug and Cosmetic Act (FDCA), would not change.

Further, a number of regulations are no longer applicable and could be repealed without consequence. Arguably, some existing regulations could even increase protection and transparency for the public if rescinded.

It is not the executive order that has the industry buzzing, however, but rather the potential actions of the new FDA commissioner under the Trump administration, who is likely to share the President’s goal of streamlining the FDA’s drug approval process to decrease the amount of time it takes for new drugs and medical devices to get to market. In an attempt to restructure and quicken the process, the commissioner may choose to institute various levels of approvals, focusing on biomarkers and short-term surrogate endpoints.

Although legislation is in place that requires substantial evidence of a drug’s efficacy prior to it being sold in the marketplace, some suggest if the new commissioner were so inclined, the commissioner need only to interpret existing regulations loosely to weaken the efficacy standard.

12 years from lab to patient

Under the current system, it takes a new drug, on average, 12 years to make it from a research lab to the patient. The FDA’s role is minimal throughout the preclinical research stage, which can take one to six years, but increases if the drug is successful and the FDA approves the commencement of human trials.

Phase one allows researchers to test the drug for the first time in a small group of healthy volunteers, identifying side effects and basic product characteristics, adjusting dosages and evaluating safety. Phase two involves evaluating

Phase two involves evaluating efficacy and short-term side effects for different dosages within a larger randomized or controlled group of people, often measuring biomarkers or laboratory results rather than clinical outcomes. Phase three, a large clinical trial, uses a group of people more similar to those to whom the product would be marketed to determine a risk/benefit ratio. Each phase takes about one to two-and-a-half years.

Ninety percent of the drugs and biologics that proceed through clinical trials fail, whether it’s due to safety or efficacy. If a drug completes phase three of the trials, the manufacturer will file a New Drug Application with the FDA, getting a response, on average, in about 12 months for standard review and eight months for priority review.

Nevertheless, according to 2016 data, the majority of new drugs are approved through an expedited approval process. The approval process has also already been shortened for certain drugs and medical devices by the 21st Century Cures Act, which was signed by President Barack Obama last year.

Safety and efficacy

Some experts argue that safety and efficacy go hand-in-hand; side effects that would never be approved for an over-the-counter drug may be approved for a drug that treats a life-threatening illness if it were proven to be an effective treatment. The type, nature, length and size of clinical trials are already becoming increasingly flexible, allowing deviations from the typical structure on a case-by-case basis in consideration of factors such as whether the condition is widespread, rare, chronic, short-term or life-threatening, the frequency of the symptoms, and the toxicity of the drug on test subjects. For instance, the FDA may approve orphan drugs, which treat diseases that typically affect less than 200,000 people, based on only one positive clinical trial and/or on surrogate endpoints, while mass-market drugs typically require two to three trials to prove safety and efficacy. In doing so, the FDA provides patients access to a drug, often where there was a previously unmet medical need, while the company continues to study its clinical benefits.

Even so, the FDA maintains that “a randomized, controlled, clinical trial… of a size and duration that reflect the product and target condition remains the gold standard for determining whether there is an acceptable benefit/ risk profile for drugs and biologics.” A neurologist at the Mayo Clinic told Business Insider he commends the idea of speeding up the development of new treatments, but worries that in doing so patients could be exposed to “costly, ineffective and potentially dangerous drugs.” Likewise, the CEO of Ovid Therapeutics Inc., a pharmaceutical company that develops drugs for rare diseases, told Reuters, “any change at the FDA that allows drugs to be tried out on patients without clinical evidence is a damaging approach.”

In a January 2017 FDA evaluation of 22 case studies with divergent results, early clinical studies were promising. Should the commissioner decide to base approval on initial safety reports or on surrogate endpoints, these drugs could have been approved. However, “[p]hase 3 studies did not confirm phase 2 findings of effectiveness in 14 cases, safety in 1 case, and both safety and effectiveness in 7 cases… In two cases, the phase 3 studies showed that the experimental product increased the frequency of the problem it intended to prevent.” The side effects of these drugs in phase three trials ranged from mere uselessness to serious adverse events, including death.

Testing requirement

Further, removing the requirement of extensive clinical testing could mean that courts will see more lawsuits and multidistrict litigations similar to those currently filed against 3M involving its Bair Hugger Forced Air Warming device. In that litigation, it is alleged that the company knew of the threat of contaminants due to the device, and the risk of infection, but failed to warn of the risk. The plaintiffs further allege that 3M continued to market its product as safe for use during surgeries and attempted to “conceal and discredit peer-reviewed scientific studies that undermined their ability to market the Bair Hugger.” Notably, the FDA approved the Bair Hugger device for use in 1987 under Section 510(k) of the FDCA, which is an expedited process that allows for less clinical testing if a substantially similar device is already on the market.

It is also unclear how rules and regulations that promote a quicker approval process will affect the doctrine of federal preemption. Just like Bayer Corp. has done with some success in suits alleging injuries sustained from the implantation of Essure Permanent Birth Control, a manufacturer’s defense often rests on the fact that the FDA approved the drug or device’s design, manufacturing method, labels, warnings and instructions for use prior to its release into the market.

This defense has held up in the past, especially for devices approved in the premarket approval process, based on the FDCA’s statutory requirements for safety and effectiveness, with defendants arguing the FDA subjected their product to the “highest level of scrutiny that exists in the federal regulatory system.” If the statutory requirements for a new drug’s approval are weakened, this defense may prove futile for pharmaceutical companies in future litigations to the advantage of plaintiffs.

40 MDLs

Congruently, there are currently 40 multidistrict litigations pending with the Judicial Panel on Multidistrict Litigation in which plaintiffs allege the defendants engaged in false and misleading marketing and sales practices, including those for Vioxx, Tylenol, Celexa, Lipitor, Avandia and Plavix, to name a few. Allowing a pharmaceutical company to advertise a drug for potentially ineffective uses without proper testing could open the floodgates of similar litigation should the drug fail to work, or worse, cause fatalities, while costing patients hundreds of thousands of dollars per year. For example, Sarepta Therapeutic’s orphan drug, Exondys 51, which the FDA approved for use in September 2016 based on surrogate endpoints, runs patients about $300,000 per year with little to no insurance coverage, but it has not yet been proven effective.

Industry heads such as the CEO of Alnylam Pharma and the head of research and development at Merck and Co Inc. have also expressed concern about how a manufacturer must be able to show insurers and physicians alike through a risk/benefit profile that their drug has value, rather than leaving them to make such a determination on their own. Further, even if deregulation lowers costs to pharmaceutical companies, there have been no assurances that these reduced costs will be passed on to patients. A first-to-market advantage will not do pharmaceutical companies much good if the product is too expensive for patients to afford and insurance companies are not willing to cover the cost.

If current pre-market clinical requirements are reduced, it could arguably endanger patients, who are often the most vulnerable. It may also make it more difficult for pharmaceutical companies to differentiate effective products from new, less effective — or ineffective — treatments flooding an easy-to-enter market. On the other hand, greater flexibility could allow for innovative new products to enter the market faster and reach those waiting on new therapies or a cure. Until the right balance has been struck, the industry may be in for a bumpy, litigation-filled ride.

Mass Torts: How To Add or Expand a Hernia Mesh Litigation Practice

By Larry Bodine and Victoria Blute.

If you’re a plaintiff lawyer who’s starting or expanding a practice in mass torts, you may want to think about a hernia mesh practice.

As many attorneys know, mass torts are product liability lawsuits against drug companies and device makers over dangerous drugs and devices.

Frequently, there are thousands of plaintiffs, and their cases are ordinarily consolidated into a single court. In this blog post, we’ll talk about defective surgical mesh commonly used to repair hernias.


Learn How To Effectively Market A Hernia Mesh Practice Online

If you’re interested to learn more about marketing a hernia mesh practice, you can watch our free hernia mesh webinar.


The Problems With C-Qur Hernia Mesh

The C-Qur (pronounced “secure”) Hernia Mesh is made by Atrium is headquartered in Hudson, NH. Atrium is a subsidiary of an enormous German holding company called Maquet Getinge.

  • The first problem with this mesh is that it’s made with polypropylene plastic that causes a rejection response when placed in the body. It causes the mesh to bind beyond the muscle wall and bind to the intestines and other organs.
  • The second problem with this mesh is that it contains a flexible metal ring that holds the mesh in a circle, and the ring is prone to breaking.
  • The third problem is that this mesh is that it’s associated with a high rate of infections.

Timing To Start A Practice

It’s still early in this litigation involving the C-Qur Hernia Mesh. If you’re an attorney thinking of starting a practice in this area, it’s very inexpensive to sign up clients right now.

There are many potential plaintiffs. There are an estimated one million hernia operations conducted each year, and statistically, they occur in a little under 2 percent of all men.

The defendants have deep pockets. Maquet Getinge, which owns Atrium, has annual sales of $3.3 billion worldwide. Based on previous cases, a mass settlement, when one takes place, could range somewhere in the area of $70,000. In one case that actually went to trial over surgiccal mesh, the plaintiff recovered $1.5 million.

Litigation Overview

Currently, the cases are consolidated into a multi-district litigation docket before US District Judge Landya McCafferty in New Hampshire, under MDL 2753. This was created last December in 2016 and so far, there are about 24 cases filed.

In this litigation, the plaintiffs allege that the C-Qur mesh was:

  • Defectively designed or manufactured
  • The defendants knew (or should have known) about the allergic or inflammatory response
  • Defendants failed to provide adequate instructions and warnings.

Injuries and Complications Related To C-Qur Hernia Mesh

Here are some of the complications that arise from the mesh’s placement:

Foreign body response. The polypropylene mesh causes inflammation and encapsulation of the foreign body with scar tissue; the body rejects it. There’s a very high rate of rejection.

There’s also a high rate of infection because the coating of the hernia mesh prevents fluid from escaping. It allows fluid to pool and remain dormant for months, becoming a breeding ground for bacteria.

The mesh is known to perforate organs. A hole can form in an organ such as the intestines when coming in contact with parts of the hernia mesh. This causes chronic, intense pain until the mesh has been removed. It can require additional surgeries — many patients who have had this mesh implanted require revision surgery.

It can also cause bowel obstruction. The mesh can cause dense adhesions that connect to the hernia mesh and interfere with proper bowel function.

Key Points Of Liability: C-Qur Hernia Mesh

The C-Qur Hernia Mesh was never tested for safety of efficacy by the FDA.

The FDA gave it a 510(k) approval in March of 2006. The approval was based on the fact that it was “similar” to an earlier version of the mesh, meaning that the FDA never tested it.

There were a series of warnings and recalls that increased the liability.

The first warning came in 2012 when the FDA issued a warning letter to Atrium, saying their sterilization process was defective. The FDA found 35 separate complaints of human hair being embedded into the mesh. There were multiple instances of C-Qur infections that the company failed to report.

There was a recall that took place on August 9, 2013. Atrium Medical recalled 95,286 units because the coated mesh could adhere to the inner packaging when exposed to high humidity.

In reality, however, no actual products were pulled from the market.

Atrium simply wrote a letter to doctors notifying them of the “stickiness” problem.

Finally, there was a FDA injunction against the company stopping them from producing the mesh, and that took place on Feb 4, 2015. It was followed up by more than 10 inspections by FDA investigators, who found major violations in the quality system regulation, the medical device reporting regulation, and the correction and removal regulation.

There are lots of examples here of failure to test the product and bad activity by the manufacturer.

Finally, there were numerous scientific articles dating back to 2009 (just three years after the mesh was on the market) all the way up to February of 2016, that finds the mesh causes an increase in adhesions. Additionally, these articles found that the C-Qur hernia mesh causes more infections than all the other brands combined.

Previous Hernia Mesh Litigation: Kugel Hernia Patch

What is the settlement value of a hernia mesh case? For guidance, we should look to previous hernia mesh litigation involving the Kugel hernia patch.

Back in 2010, CR Bard and its subsidiary, Davol, Inc. settled 2,600 cases involving the Composix Kugel hernia patch for a total mass settlement of $184 million dollars. That comes down to roughly $70,000 per case.

This took place after a federal court jury found that the Kugel mesh was defective and awarded $1.5 million to the plaintiff, Christopher Thorpe, in 2010.

Similarly to the C-Qur mesh, the patients with Kugel mesh charged that it caused dangerous side effects like bowel obstruction and perforation, adhesions and infections due to a metal ring inside the patch that was prone to breaking.

Just like the C-Qur mesh, the Kugel mesh also received the shortcut 510(k) approval from the FDA. It was never tested for efficacy or safety. When the FDA approved it in 2006, they simply said that it was substantially equivalent to a previously approved mesh.

Key Point: Kugel Hernia Patch Recalls

Another key point in liability is recalls.

Before litigation began against the Kugel mesh, there were a wave of recalls in 2005 and 2006. There was a second wave in 2007. In that year, on June 22, all the federal cases were consolidated into the Rhode Island Federal Court in MDL 1842 before Senior US District Judge Mary M. Lisi. Out of some 3,000 cases, only six remain in the MDL.

Attorneys Should Keep Their Eyes On Ethicon Physiomesh

A third type of mesh to keep on the horizon: the Ethicon Physiomesh flexible composite mesh.

There are already dozens of lawsuits filed against Ethicon, a division of Johnson & Johnson. There’s been a motion filed to create a multi-district litigation docket, and that was filed in March. There’s no decision on whether to create it yet.

In any event, Ethicon issued an urgent field safety notice and withdrew their product from the market in May 2016. The notice included a recall of all existing stock held by healthcare facilities for all variations of the Physiomesh product line.

On the same day, Health Canada issued a recall for Physiomesh products.

The Australian Therapeutic Goods administration issued a hazard alert in June.

The recall of the on-the-shelf products should serve to prevent future hernia repair patients from being implanted with the mesh. However, that recall doesn’t help those who were already implanted with it.

It’s estimated that as many as 300,000 people have been implanted with Physiomesh since the product was approved in 2010.

Hernia Mesh: Where Do Attorneys Go From Here?

There are two kinds of hernia mesh to look at: C-Qur Mesh and Ethicon Physiomesh.

In both cases there are many potential plaintiffs and well-funded defendants.

There’s a history of settlements involving the Kugel mesh patch and in both cases, a long history of bad behavior by the companies involving recalls and even a court order to stop manufacturing.

The science backs up the danger of the mesh, and of course, there was a lack of safety testing by the FDA. The C-Qur mesh and Ethicon Physiomesh are two good places to start if you want to grow or begin a hernia mesh mass torts practice.

How do you get more clients?

Now that you know about the history of defective hernia mesh and how straightforward the litigation can be, what it comes down to is this:

To learn about attracting potential clients for hernia mesh cases, watch our webinar on hernia mesh from our Mass Torts Marketing series.

Do you have questions about marketing a mass torts practice? LawLytics can help. Call us at 800-713-0161 or schedule our call.


Larry Bodine, Esq., is the Editor of the National Trial Lawyers website. Victoria Blute is the Community Manager of LawLytics Marketing Suite.