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

Boston Scientific Pelvic Mesh Cases Removed From Philadelphia Court of Common Pleas Based on SCOTUS “Plavix” Ruling

Boston Scientific Mass Tort Mesh Cases Removed From Philadelphia Court of Common Pleas Based On Recent Supreme Court  June 2017, Bristol Myers vs. California Superior Court “Plavix” Ruling

 

 

 

 

 

 

Boston Scientific, Marlborough, MA

By Mark A. York (September 7, 2017)

Plaintiffs who filed suit against Boston Scientific in a Philadelphia court over allegedly defective pelvic mesh, have agreed to have their cases removed from the Pennsylvania Court to other venues based on the June 2017 “Bristol-Myers California Plavix” U.S. Supreme Court opinion.  The Plavix ruling has thrown thousands of non-resident drug and medical device state court cases across the country into turmoil, as the non-resident plaintiffs cannot continue their cases in state courts where they do not reside or the defendant companies are not corporate residents.  This was based on the Supreme Court ruling that stated Bristol-Myers R&D and sales activity in the State of California related to it’s Plavix blood thinner, (see Mass Tort Nexus “Plavix” CA State Court Briefcase) was not enough of a corporate presence to subject them to California state court jurisdiction, resulting in jurisdictional issue across the country for plaintiff firms.

Last month, Boston Scientific filed motions asking the court to remove any cases pending against it in the Philadelphia Court of Common Pleas, citing the Supreme Court’s both the “Bristol-Myers Squibb v. Superior Court of California”, see US Supreme Court Strikes Down State Court Jurisdiction and “BNSF Railway v. Tyrrell”, see SCOTUS Limits What State Court A Corporate Defendant Can Be Sued In.

According to one of the lead attorneys, the parties have agreed to litigate the cases in either Massachusetts, where Boston Scientific has its principal place of business, or in Delaware, it’s state of incorporation.

Kline & Specter attorney Shanin Specter said. “An agreement was reached with Boston Scientific to have the cases heard in a courtroom other than the Philadelphia Court of Common Pleas, so the cases can move forward and litigate without the jurisdictional issue creating legal issues. Although Boston Scientific’s motion last month sought to remove 94 cases, Specter said only three cases had been moving forward against Boston Scientific with calls placed to Boston Scientific defense counsel Shook, Hardy & Bacon and attorney Joseph Blum seeking comment have not been returned.

Judge New Asked to Reconsider

Last month, Boston Scientific had filed a motion requesting Philadelphia Court of Common Pleas Judge Arnold New reconsider his March 2015 decision that the state court had jurisdiction over the mesh cases.  New, who is the supervising judge of Philadelphia’s Complex Litigation Center, issued a one-page order saying Boston Scientific’s motion was moot.

As part of the motion, Boston Scientific had sought to have New’s 2015 ruling vacated to allow for additional arguments on the issue, and allowing defense counsel to begin pleading the removal of thousands of other non-resident plaintiff cases currently in in the court’s complex litigation docket.

Ethicon Mesh Motion for Removal

Another major defendant in over one thousand pelvic mesh mass cases , Johnson & Johnson subsidiary Ethicon, has also filed motions recently seeking to have the cases dismissed based the Supreme Court’s recent decisions. Plaintiffs, however, have requested Judge New pend any rulings on these issues, based on the Pennsylvania Superior Court has agreed to consider the matter in a case that is pending before the intermediate court on appeal.

The Supreme Court’s ruling from June 19, 2017 in Bristol-Myers vs. Superior Court of California (see US Supreme Court Denies California State Court Jurisdiction) now seen as the defining game-changing decision, for mass torts in state courts, that has promised to reshape the geography of mass tort litigation across the country. In the ruling, a majority of the Supreme Court determined that plaintiffs suing Bristol-Myers Squibb in California who were not California residents had failed to establish specific jurisdiction over the pharmaceutical giant, since there was no significant link between the claims and Bristol-Myers’ conduct in California. The ruling, according to observers, makes clear that out-of-state plaintiffs can’t sue companies in states where the defendants aren’t considered to be “at home,” or haven’t conducted business directly linked to the claimed injury.

Johnson & Johnson Files For Missouri Removals

Earlier this month, J&J filed a motion in Missouri seeking to dismiss more than 1,300 lawsuits against it over talcum powder, claiming the lawyers had engaged in “blatant forum shopping on a grand scale.” On June 19, 2017 St Louis City Court Judge Rex Burlison declared a mistrial in the fifth talcum powder cancer trial being heard there, which was the afternoon of the SCOTUS “Plavix” ruling, declaring that the opinion earlier that day prevented the trial from moving forward. The trial was reset for October 2017, and the parties are currently arguing the jurisdictional issues of resuming the trial in front of Judge Burlison, see Mistrial Declared in J&J Talc Trial Due to SCOTUS Ruling.

Boston Scientific Argument

In requesting reconsideration regarding the recent Supreme Court decisions, Boston Scientific contends that Pennsylvania state courts no longer have jurisdiction over it. Specifically, the motion said Boston Scientific is a Delaware corporation with its principal place of business in Massachusetts, it does not have sufficient ties to Pennsylvania to render it “at home” in the state, and the plaintiffs are not Pennsylvania residents. The company further says that finding Pennsylvania has jurisdiction simply because the company complies with the state’s business registration statute violates the due process clause of the U.S. Constitution and the now precedent “California Plavix” decision, .

“It is undisputed that Boston Scientific’s principal place of business is Massachusetts while its place of incorporation is Delaware,” the motion said. “Those are the only two jurisdictions where Boston Scientific is so heavily engaged in activity as to render it ‘at home.”

State Court Removal and Refiling Across The Country

The Philadelphia Court of Common Please Complex Litigation Docket appears to be preparing for a departure of many of the thousands of product liability cases, which prior to June 19, 2017 were moving along quite well in the under the direction of Judge Arnold New. State court dockets across the country are now forced to consider the removal of many cases as well as the potential refiling of thousands of cases in the state of incorporation for the medical device and pharmaceutical manufacturers.

Read More

Endo International Agrees To An Additional $775 Million to Settle Remaining Mesh Lawsuits For A Total of $2.6 Billion

 

Endo International Plc has agreed as of August 7, 2017 to set aside an additional $775 million to resolve the remaining lawsuits alleging the company’s vaginal-mesh implants eroded in some women, leaving them incontinent and in pain related to the Transvaginal Mesh Multidistrict Litigation pending in the US District Court of West Virginia, see the Mass Tort Nexus briefcase, American Medical Systems MDL 2325 TVM Litigation Link, a subsidiary of Endo sold to Boston Scientific in 2015.

The agreement to fund settlement of the remaining 22,000 mesh suits means the company has now set aside more than $2.6 billion to finalize the litigation claims related to the American Medical Systems flawed medical devices, according to document filed with the U.S. Securities and Exchange Commission.

This comes a year after Dublin-based Endo shut down one of its units that makes mesh implants, used to support internal organs or treat incontinence, after being hit with many thousands of complaints over the devices.

“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,” Paul Campanelli, Endo’s president and chief executive officer, said Monday in a statement.

Other mesh-insert makers, including Johnson & Johnson and Boston Scientific Corp., still face thousands of claims in the U.S. and worldwide from women who blame the devices for injuring them. More than 100,000 transvaginal mesh lawsuits have been filed, making it one of the largest mass torts in history. About 75% of mesh lawsuits are consolidated in West Virginia federal court through seven multi-district litigation (MDL) cases. The rest are contained in state courts, including those in Pennsylvania and West Virginia.

J&J, based in New Brunswick, New Jersey, said in SEC filings in February that it was defending 54,800 cases over its inserts while Marlborough, Massachusetts-based Boston Scientific said that same month it faced 43,000 mesh claims. Both companies have settled some mesh suits. The U.S. Food and Drug Administration increased regulatory restrictions on the mesh inserts after concluding in 2014 they were high-risk. The agency ordered Endo’s American Medical Systems unit, J&J and other mesh makers to study organ-damage rates linked to the devices. J&J dropped some of its mesh lines in 2012.

The consolidated AMS cases are In re American Medical Systems Inc. Pelvic Repair Systems Products Liability Litigation, 12-md-02325, U.S. District Court, Southern District of West Virginia (Charleston). Endo paid $150 million in legal settlements related to its vaginal mesh in the 4th quarter of 2016 and now more payments are on the way. The company recorded a $834 million pretax charge to increase the estimated product liability accrual. It had already set aside $1.4 billion to cover the legal costs at the end of the previous settlements.

In 2015 Endo sold the men’s health portion of its American Medical Systems device unit to Boston Scientific for $1.6 billion, and renamed the remaining portion Astora Women’s Health. Endo had acquired AMS for $2.9 billion in 2011, making the purchase a significant misjudgment of corporate strategy in what was even then a highly litigated medical device area, as TVM was widely known as a product that was prone to high numbers of adverse events and regulatory scrutiny.

Endo International/American Medical Systems Settlement History

Endo International plc (Endo) acquired device maker American Medical Systems Holdings, Inc. (AMS) in 2011. Endo has agreed to pay out roughly $2.6 billion to settle cases claiming injuries from its vaginal mesh devices, which include the Perigee, Apogee and Elevate implants. The company has previously ceased production of AMS transvaginal mesh.

The following settlements amounts were agreed to by Endo in attempts to resolve mesh implants made by AMS:

$775 million settlement to resolve 22,000 mesh lawsuits in August 2017. This settlement resolves the remaining lawsuits against AMS mesh implants.

Approximately 450 mesh lawsuits resolved through two separate settlements in April and May 2015.

$400+ million to settle more than 10,000 mesh lawsuits (~$48,000 per case) in October 2014. With the move, Endo said that it resolved “substantially all” the remaining lawsuits against its AMS unit. The $400 million was in addition to $1.2 billion already pledged by Endo to cover mesh litigation.

$830 million settlement to resolve around 20,000 mesh lawsuits (~40,000 per case) in May 2014. The settlement came a day after the FDA said transvaginal mesh should be reclassified as a high-risk medical device and subject to stronger regulatory scrutiny. “The settlements, once final, will resolve a substantial majority of the AMS vaginal mesh-related claims,” Endo said in a statement at the time.

$55 million paid in June 2013 to settle an undisclosed number of lawsuits, according to a filing with the U.S. Securities and Exchange Commission.

 

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

C.R. Bard Settles 75 Transvaginal Mesh Lawsuits

C.R. Bard, Inc. has reportedly settled another batch of transvaginal mesh lawsuits that were part of the federal multidistrict litigation underway in West Virginia federal court. Terms of this agreement remain confidential.

Some 5,700 product liability claims are pending against C.R. Bard in the U.S. District Court, Southern District of Western Virginia, where federal lawsuits involving the company’s transvaginal mesh devices are before U.S. District Judge Joseph R. Goodwin. Judge Goodwin is also presiding over multidistrict litigation involving pelvic mesh devices manufactured by:

  • American Medical Systems, Inc.
  • Ethicon, Inc.,
  • Boston Scientific Corp.,
  • Cook Medical, Inc.
  • and Coloplast Corp.

Judge Goodwin dismissed 75 C.R. Bard vaginal mesh lawsuits on Monday, all with prejudice.  Court records show that the dismissed cases have been “compromised and settled” for an undisclosed amount, according to Law360.com.

This is just the most recent transvaginal mesh settlement reported in the C.R. Bard litigation. In April, Judge Goodwin dismissed 149 cases that were also compromised and settled for undisclosed amounts.

Bloomberg News reported in July 2015 that C.R. Bard had spent $200 million to resolve 3,000 transvaginal mesh lawsuits. Plaintiffs involved in that accord each reportedly received $67,000. A smaller group of cases had been settled the previous year for about $43,000 per plaintiff.

TVM Dangers

Transvaginal mesh is used to surgically treat women suffering from pelvic organ prolapse and stress urinary incontinence.  In 2008, the  U.S. Food & Drug Administration (FDA) warned that such devices had been implicated in more than 1,000 serious injury reports during the previous three-year period.

In July 2011, the agency disclosed that it had received more than 2,800 more adverse event reports related to the products, including cases of injury, death, and malfunction. Over 1,500 incidents were associated with pelvic organ prolapse repairs, while 1,371 were associated with stress urinary incontinence repairs.

The FDA’s 2011 alert also noted that the agency no longer considered transvaginal mesh complications following prolapse repair to be rare, the reverse of its previous position. The FDA also expressed doubt that prolapse repair with transvaginal mesh offered any added benefits compared to traditional non-mesh repair.

Just last year, the FDA issued new rules that, among other things, made transvaginal mesh implants ineligible for the agency’s 510(k) clearance program. This program allows a medical device to come to market in the absence of human clinical trials when a manufacturer can show a device is “substantially equivalent” to another product previously approved by the FDA.

For more info click here.

Read More

Transvaginal Mesh Lawsuit Plaintiff Recovers $2.1 Million, as Johnson & Johnson Loses 4th Pennsylvania Trial

Ethicon polypropylene pelvic mesh
Ethicon polypropylene pelvic 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 following 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.

 

Read More

Australian Survey Finds that 58% were Injured by Pelvic Mesh Implant

HIC CEO, Danny Vadasz
HIC CEO, Danny Vadasz says “This is a significant public health problem which has been grossly underestimated — in terms of numbers of women as well as the severity of resultant health problems.”

Problems caused by transvaginal mesh have been grossly under-estimated, according to a new survey by an Australian Health Issue Center.

  • Of these, a shocking 58% say they have been adversely impacted, citing problems such as chronic incontinence, abdominal pain, and pain during intercourse. Sadly, for a quarter of these women, the impact of the implants has led to a breakdown of their marriages or personal relationships.
  • Just 38% of the respondents believe they made an informed choice to have the procedure.
  • Of the women who sought remedial medical help, slightly over 10% reported this made things better while 40% reported it made no difference and 11%, that it made matters worse.
  • The remaining 39% were told that nothing could be done for them.

In just three weeks, 1,250 women completed the online Facebook survey targeting the thousands of women nationwide who have undergone pelvic mesh implants to treat stress urinary incontinence and pelvic organ prolapse.

In the US, there are 80,000 lawsuits against the manufacturers or transvaginal mesh in eight MDLS:

A catastrophic failure

Commenting on the overwhelming response to the survey, HIC CEO, Danny Vadasz, says he has no idea ‘how much of the iceberg has been revealed’ so far but believes there could be considerably more given that HIC is currently averaging over 100 survey responses per day.

“Even if we were to receive no further responses, I think we have already demonstrated that this is a significant public health problem which has been grossly under-estimated — in terms of numbers of women as well as the severity of resultant health problems.

HIC is a not for profit consumer health advocate based in Victoria, Australia, which encourages better health outcomes by encouraging consumers to become involved in their own health care and ensuring the health system is responsive to their needs.

“What we are seeing is a catastrophic failure at all levels of the health system to protect the well-being of thousands of women – the lack of due diligence by the TGA in approving the device given the risks; culpability of manufacturers who despite plenty of evidence of adverse reactions overseas, continue marketing their products; the government which does not have a central register of how many procedures have occurred and how many products have been sold and finally, those surgeons who continue to practise the procedure without informing their patients of the risks and the irreversibility of the implant.

“Clearly a lot of questions need to be asked!”

Vadasz says while transvaginal mesh has been seen by the medical fraternity as having ‘revolutionised’ surgical options for women with stress urinary incontinence and pelvic organ prolapse, the collateral damage for women when it goes wrong, is just too high. “We are calling for the classification of mesh to treat either of the conditions to be upgraded to a higher risk status so the patient consent process reflects the consequences when there are complications.”

Unaware that mesh caused injuries

Despite the number of women coming forward, Vadasz believes that the problem will continue to go underreported given that many women do not associate their symptoms with their mesh implants. On top of this, many have been told by doctors there is no causal relationship.

“This has been borne out by the significant number of survey respondents who told us they were unaware that the pain and problems they had suffered for many years could be linked to their mesh implant. Some have cried at the realization with one woman declaring, ‘Now I know I’m not crazy’.”

Here are some of the more harrowing comments on the HIC Facebook page:

“My specialist told me it was all in my head. He got angry with me and said: “I suggest you stop focussing on the vagina, and get on with your life” in a dismissive and irritated tone. Doctors I have seen since have not been forthcoming on what they can see, it is like they are trying to protect the medical fraternity by not telling me fully what is going on or helping me fine treatment.”

“I was told the mesh cannot be removed. I had complications from the moment I came out of theater. I needed a complete reconstruction but was refused and offered the TVT as part of a study or to put up with consequences of a grossly oversized baby that was a face presentation and a complete episiotomy after he became stuck. I now suffer urge incontinence and a partial vaginal prolapse. I wish I’d never had the TVT done!”

 Vadasz is calling on women who have had an implant (or believe they may have) to complete the HIC survey: https://www.facebook.com/pg/UnderstandingPelvicMesh/about/

About the survey

The Health Issues Centre is one of several organizations invited to give input into the senate inquiry into the extent and impact of Transvaginal Mesh Implants (TVM) across Australia. Currently there is little information about the number of women who have undertaken the procedure and less about those who have suffered from side-effects. In order to understand the size of the problem and gain insight into the impact on these women, the consumer health advocacy conducted a highly targeted nationwide survey.

Using the center’s Facebook page to create interest and an online survey, the survey targeted 14,000 women nationally. The questions are as follows:

·       Have you undergone a transvaginal mesh, tape or sling implant as treatment for urinary incontinence or pelvic organ prolapse?

·       Do you continue to have undiagnosed symptoms of chronic abdominal pain or urinary incontinence?

·       Do you feel you were fully informed before agreeing to the procedure?

·       Did the procedure satisfactorily resolve your health concerns?

·       Could you specify any adverse impacts you may have experienced?

·       How would you rate this adverse impact – discomforting, severe, debilitating, unendurable, none of these.

·       Have you sought medical assistance to rectify the problem?

·       Did your doctor/specialist confirm a causal relationship between your symptoms and the mesh implant?

·       If you were offered remedial treatment, did it change your condition?

While launched only three weeks ago, 20,000 have engaged with the survey and 1,250 surveys have been completed. Over 14,000 people have viewed the Facebook video.

 

 

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

Bellwether Cases Chosen for NJ Mesh Litigation Against Bard and Ethicon

C.R. Bard has selected three additional cases for bellwether trials in consolidated litigation in the New Jersey Superior Court, now in Bergen County. Bard and Johnson & Johnson’s Ethicon subsidiary face 8,700 lawsuits in the state and federal MDLs.

Judge James J. DeLuca has docketed a total of eight bellwether cases, now including Angela Best v. CR Bard, Case No. 005140-15, Beverly Lewis v. CR Bard, Case No. 007558-15, and Lisa Moore v. CR Bard, Case No. 017575-14.

The next case management conference is scheduled on March 30, Docket No. BER-L-017610-14,
Master Case No. BER-L-17717-14, Civil Action Bard Litigation, Case No. 292.

Settlement and verdict

The state supreme court transferred the 355-case docket from Atlantic County in January.

  • In September 2015 Johnson & Johnson agreed to pay $5 million to settle the pelvic mesh lawsuit of Pamela Wicker, who required multiple surgeries to remove the material.
  • In February 2013 a jury awarded $11.1 million in the first bellwether trial in Gross v. Gynecare Inc., Superior Court of New Jersey, Law Division, Atlantic County, Docket No.: ATL-6966-10. The plaintiff, Linda Gross, a South Dakota nurse who complained of constant pain, underwent 18 operations after J&J’s Gynecare Prolift was implanted to shore up weakened pelvic muscles. The case was prosecuted by Mazie Slater Katz & Freeman of Roseland, NJ.

Bard faces 8,291 lawsuits MDL 2187 before in U.S. District Judge Joseph R. Goodwin in the Southern District of West Virginia. Ethicon faces 31,957 lawsuits in MDL 2327, also before Judge Goodwin.

In New Jersey, attorney Jeffrey S. Grand of Bernstein Liebhard LLP, is the Co-Plaintiffs’ Liaison Counsel. He serves with Co-Plaintiffs’ Liaison Counsel Fidelma L. Fitzpatrick and Jonathan D. Orent, Esquire, of Motley Rice LLC.

Transvaginal Mesh Side Effects

Pelvic mesh devices are surgically implanted for the correction of pelvic organ prolapse (POP) or stress urinary incontinence (SUI). Among the potential injuries or side effects associated with defective pelvic mesh products are:

  • Chronic vaginal drainage
  • Erosion of the vaginal tissue
  • Feeling as though something is protruding from the vagina
  • Lower back pain
  • Mesh trim or removal in doctor’s office
  • One or more surgeries to repair or remove mesh
  • Pain during intercourse
  • Perforations of the bowel, bladder or blood vessels
  • Pressure or feeling of “fullness” in the lower abdomen
  • Reoccurrence of POP or SUI
  • Urinary problems
  • Vaginal bleeding
  • Vaginal infections
  • Vaginal pain not related to intercourse
  • Vaginal scarring

Read More

Judge Approves $12.5 Million Settlement for 4,000 Caldera Pelvic Mesh Claims

vaginal-mesh-TVM-US District Judge Stephen V. Wilson in California approved a meager $12.5 million settlement to be shared pro rata by 4,000 plaintiffs suing over Caldera Medical Inc.’s defective transvaginal pelvic mesh, because that’s all that is available for the company’s insurance policies.

The plaintiff attorneys recovered only $670,020 in fees, less than 6% of the settlement fund.

The claims being settled relate to injuries caused by transvaginal mesh (“TVM”) devices manufactured by Caldera under the following trade names: T-Sling®, Desara®, Ascend®, Hydrix®, POPmesh®, and Vertessa®. The products caused extreme pain, erosion of internal bodily tissue, dyspareunia, painful scarring, and other injuries.

Liability estimated at $100 million

The judge said that Caldera’s liability was estimated at $100 million, but that its insurer had no current income and a negative liquidation value that would not provide more money for the plaintiffs.  Federal Insurance Company v. Caldera Medical, Inc., U.S.D.C., Central District of California Case No. 2:15-cv-00393.

Although Caldera initially had $20 million in coverage, after defense costs, only $12.5 million was left over. Further, $1 million will be held back for costs of the class notice and settlement administration.

The July 2015 settlement is intended to resolve all known TVM claims relating to Caldera’s TVM products. It was reached after unsuccessful mediation sessions in November 2014 and January 2015. Fo1iy-six class members (1.15% of the class) objected to the settlement. The issue was whether there was any way to get more funds to contribute to the settlement.

Caldera’s records demonstrated that it had no net profits or liquid funds to contribute to a settlement and that it also had significant debt secured by its assets, which prevented borrowing. The parties submitted the liquidation analysis of an expert, Dr. Joseph Tanimura, who concluded that the liquidation of Caldera would not raise any additional money.

Caldera’s current liabilities totaled $3.6 million, and the book value of its assets was only $2.9 million, most of which would sell for far less in a forced liquidation. After deducting transaction costs, Dr. Tanimura concluded that a liquidation of Caldera would produce a value of negative $3 million.

On January 25, 2016, the Court granted the parties’ motion for preliminary settlement approval, preliminary class
certification, and class notice. The plaintiffs are represented by Gordon Renneisen of the Cornerstone Law Group in San Franciso and David Bricker of Waters Kraus & Paul in El Segundo, CA.

Read More