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.

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TESTOSTERONE MDL 2545 “ANDROGEL” JURY RETURNS $150 MILLION VERDICT IN PUNITIVE DAMAGES FOR “FALSE MARKETING” AGAINST ABBVIE WHILE FINDING NO FAULT IN “HEART ATTACK” CLAIMS

On July 24, a jury in Chicago federal court found in favor of plaintiff Jesse Mitchell, ordering drugmaker AbbVie to pay $150 million in damages for allegedly falsely marketing the benefits of its Androgel testosterone therapy drug, while not holding the company liable for a heart attack suffered by the plaintiff.  This was the second of bellwether trials in a massive class action involving thousands of claims against AbbVie and other drugmakers, including Eli Lilly and GlaxoSmithKline. The thousands of complaints have been consolidated by the country’s federal courts, and are being heard as a multi-district litigation Testosterone MDL 2545 AbbVie “Androgel” Briefcase,  under U.S. District Court Judge Matthew Kennelly in U.S. District Court for the Northern District of Illinois in Chicago.

 

 

 

 

 

 

 

 

 

Lawsuits dating to 2014, allege the testosterone replacement drugs were not only useless, but actually harmful, even though approved by the U.S. Food and Drug Administration to treat testosterone deficiency, the claims allege the companies also falsely marketed the drugs to treat a variety of other conditions, including diabetes, AIDS, cancer, depression and anxiety. The lawsuits further allege the drugmakers invented a nonexistent condition called “andropause” or “low T,” which could be treated by testosterone replacement.

However, plaintiffs claim the drugs are not only ineffective for these off-label uses, but they increase the risk of heart attack, blood clots and stroke.

Judge Kennelly selected eight of the cases to move forward to trial. The first bellwether trial, in which plaintiff Jeffrey Konrad, claimed Androgel caused a heart attack, ended in a mistrial in June.

This trial where Mr. Mitchell, of Oregon, similarly asserted the drug had caused his heart attack, proceeded to the jury in July and after days of testimony and arguments in court, however, the jury refused to find AbbVie responsible for Mitchell’s condition.

The jury did say they believed AbbVie had falsely misrepresented the benefits of its testosterone therapy drug to Mitchell, and ordered the company to pay punitive damages of at least $150 million.

A lawyer for Mitchell did not immediately respond to a request for comment from the Cook County Record on Monday.

In a brief emailed statement, a spokesperson for AbbVie noted “the jury found that Androgel did not cause any damage.”

“We expect the punitive damage award will not stand,” the statement said.

The verdict came over the strong objections of AbbVie, whose lawyers argued in court that they should not be held responsible for Mitchell’s condition or use of the drug.

In a motion for judgment filed July 17, the company noted even a doctor called by Mitchell’s attorneys conceded Mitchell was already at high risk for cardiac disease, without ever taking Androgel, because of his “several cardiac risk factors … including a 34-year smoking history, high blood pressure, high cholesterol, high triglycerides, obesity, a family history of heart disease, and lack of exercise.”

AbbVie also argued the jury could not find it had failed to warn of the risks of Androgel under federal rules and the company claimed the evidence demonstrated Mitchell had never heard of Androgel or any of its alleged “false claims” before his doctor prescribed it for him. And, AbbVie argued, Mitchell’s doctor “relied on his own training, experience and medical judgment, rather than anything said by (AbbVie), when making treatment decisions for Mr. Mitchell.”

“Finally, any suggestion that (Mitchell’s doctor) was somehow deceived or misled by (AbbVie’s) risk information is belied by the fact that he warned Mr. Mitchell of the potential cardiovascular risks,” with Judge Kennelly taking the motion “under advisement” on Friday, July 21 and subsequently denied. Resulting in the 2nd recent verdict against AbbVie, after having been found liable in the Depakote birth defect trial where the Illinois jury awarded $15 million to plaintiff Christine Raquel, after having been prescribed Depakote for bipolar depression.

Jesse Mitchell was represented the firms of Levin Papantonio Thomas Mitchell Rafferty & Proctor, of Pensacola, Fla.; the Alvarez Law Firm, of Coral Gables, Fla.; Seeger Weiss, of New York; Goldberg & Osborne, of Tucson, Ariz.; Heard Robins Cloud, of Santa Monica, Calif.; and Douglas & London, of New York.

AbbVie was defended by the firm of Dechert LLP, of Princeton, N.J.

Organizations Listed:

AbbVie
1 N Waukegan Rd
Lake Bluff, IL 60044

U.S. District Court for the Northern District of Illinois
219 S Dearborn St
Chicago, IL 60604

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JPML Takes a Second Look at Proton Pump Inhibitor MDL 2757 at July 27, 2017 Hearings in Los Angeles

JPML Takes a Second Look at Proton Pump Inhibitor MDL 2757 at July 27, 2017 Hearings in Los Angeles

 The Judicial Panel on Multidistrict Litigation (JPML) has decided to revisit a possible Proton Pump Inhibitor (PPI) MDL consolidation (Nexium, Prevacid, et al) and will hear arguments July 27, 2017 at the Los Angeles Federal court on a new motion to centralize (PPI) drugs in a multidistrict litigation. The case is In Re: Proton-Pump Inhibitor Products Liability Litigation [No. II], MDL Docket No. 2757, JPML, where the case filings have significantly increased since the initial JPML hearing January 26, 2017 in Miami when U.S. District Judge Sarah Vance said at one point during the oral arguments “It just seems to me to be nightmarishly complex” as the primary defense counsel raised concern over the generic makers and related defense issues with so many co-defendants. The JPML ultimately denied the MDL 10 days later to the view that consolidation would be to cumbersome, however due to the large numbers of new suits and the refiling of a Motion to Consolidate, the Los Angeles hearings may have a different outcome.

The drugs at issue include Prilosec, Nexium, Protonix and Dexilant as well as potential the numerous generic manufacturers. The hearing order lists over 163 cases in 28 federal district courts and a decision will likely come in mid-August. Nevertheless, the judges may try to come up with ways to split up the cases into structures that might be simpler and more efficient or combine all parties. Ideas included single-product or single-defendant MDLs, separating out prescription-only users, or separating out patients who had only used products made and sold by AstraZeneca, which its attorney said is currently named in 100 cases.

Kidney injuries

In their May 31 motion, Motion to Consolidate Re: PPI Hearing Los Angeles July 27, 2017, the moving plaintiffs seek centralization before U.S. Judge David R. Herndon of the Southern District of Illinois.

The plaintiffs allege that PPIs cause kidney injuries including acute interstitial nephritis, chronic kidney disease and end-stage renal disease. Concerns that these drugs have harmful side effects for users’ kidneys were brought to the U.S. Food and Drug Administration by consumer advocacy group Public Citizen in 2011, and the agency required warnings about risks of acute interstitial nephritis on labels in 2014, according to the patients’ MDL brief.

More recent research led to stronger findings of a connection, including a scientific study published in January 2016 that said PPI use was independently linked to a 20 to 50 percent higher risk of chronic kidney disease. Plaintiffs have also brought allegations of renal failure being caused by the drugs. To date, more than 5,000 PPI cases are under investigation by Plaintiff’s counsel, and more could be added to that number as awareness of the association between PPI use and kidney damage continues to increase. While the drug class first received FDA approval in 1989, serious side effects prompted the FDA in 2014 to require all PPIs to display a warning label that called out the connection to acute interstitial nephritis. The Plaintiff’s brief also mentions several studies that have made a correlation between PPI use and kidney damage during the past 25 years, including a 1992 study by the University of Arizona Health Sciences Center, a 2006 study conducted at the Yale School of Medicine and a 2016 study from John Hopkins published in the Journal of the American Medical Association (JAMA).

The plaintiffs note that in January, the JPML denied centralization of PPI cases, but say later significant developments “warrant a second look at consolidation.”

The defendants are AstraZeneca Pharmaceuticals LP, Proctor & Gamble Co., McKesson Corp., Takeda Pharmaceuticals USA Inc., Novartis Pharmaceuticals Corp., Pfizer Inc. and Pfizer subsidiary Wyeth.  The defendants’ responses are due June 27.

The plaintiff attorneys are Christopher A. Seeger and Jeffrey Grand of Seeger Weiss in New York.

 

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SCOTUS Bristol-Myers “California-Plavix” Ruling Causes Instant Mistrial in Missouri State Court J&J Talc Trial, But Judge Resets Trial For October 16, 2017

SCOTUS Bristol-Myers “California-Plavix” Ruling Causes Instant Mistrial in Missouri State Court J&J Talc Trial, But Judge Resets Trial For October 16, 2017

July 19, 2017 By Mark York

Is Missouri State Court Still a “J&J Loses Again Venue” or Will the California-Plavix Ruling Change Things?

On June 19, 2017 lawyers in a St. Louis courtroom trial, Estate of Shawn Blaes, et al vs. Johnson & Johnson Case No. 1422-CC09326-01 over Johnson & Johnson’s talcum powder,  were receiving notice of an earlier US Supreme Court decision and were changing trial strategy instantly, scrambling to determine if the Supreme Court decision handed down that morning doomed their case. The ruling was from a California multi-plaintiff drug case, Bristol Myers-Plavix Litigation JCCP Case No. 4748 (San Francisco County Superior Court) where Bristol-Myers had appealed the August 29, 2016 California Supreme Court decision, when the court ruled that “foreign resident plaintiffs were able to remain parties to the Plavix litigation in California State Court” see California Court Opinion Jurisdiction of Non-Resident Plavix Plaintiffs 8.29.2016. Bristol-Myers immediately appealed to the US Supreme Court, where appeal arguments were heard on April 24, 2017 see BMSQ California Plavix SCOTUS Appeal Transcript , which left non-resident plaintiffs in state court cases across the country in limbo, pending the ruling.  On June 19th the 8-1 ruling clarified the non-resident question for many plaintiffs, including the three plaintiffs in the pending trial in front of Judge Rex Burlison, who immediately declared a mistrial, but prior to his ruling the trial attorneys were scrambling to get correct information.

One attorney was still downloading the opinion to his computer as another told the judge “I’m on my cellphone right now trying to learn facts,” according to the trial transcript, Shawn Blaes v. J&J June 19th Trial Transcript of the hearing. Defense counsel aggressively asserted to Judge Burlison that the Supreme Court decision in Bristol-Myers Squibb Co. v. Superior Court, June 19, 2017 California-Plavix SCOTUS Opinion which limited where defendants could be sued, was directly applicable to the case and had disrupted matters so thoroughly that he had to declare a mistrial.

But plaintiffs lawyers had a surprise: A company called “Pharma Tech Industries” was involved, and when W. Wylie Blair of Onder, Shelton, O’Leary & Peterson, was asked to address Bristol-Myers, he introduced the judge to Pharma Tech, a company that was “doing the packaging, labeling and distributing of talc-based body powders right here in Union, Missouri.”

“Roll that again,” Burlison interrupted. “Pharma Tech Industries was doing what?”

Plaintiffs counsel Blair went on to tell him about letters, forms, emails, monthly checks and sales documents showing Pharma Tech’s plant in Missouri had bought raw talc from Imerys Talc America Inc., another defendant in the case, which alleged Johnson & Johnson’s talcum powder caused three women to die from ovarian cancer. Pharma Tech then made products for Johnson & Johnson, and originally the talc products by Pharma Tech had a cancer warning on it, but Pharma Tech, at J&J’s direction, removed it when manufacturing, bottling and labeling its products.

Though intrigued, Burlison decided not to proceed with the trial, as two of the three plaintiffs hadn’t lived in Missouri.  The judge granted Johnson & Johnson’s motion for a mistrial. Going forward, he said, would be like “trying to master a square into a round hole.”

“We do have allegations in this case that would constitute what the Bristol-Myers court refers to as relevant acts, however, we don’t — we do not have pleadings sufficient to anchor those relevant acts to a third party, that being the Pharma Tech Industries here in Missouri,” Burlison said.

The judge has reset the case for trial on Oct. 16, 2017 and permitted plaintiffs attorneys to move forward on discovery over Pharma Tech, a family-owned manufacturer of pharmaceutical powders based in Athens, Georgia. Founded in 1972, Pharma Tech has been run by the same family since 1989, which has a plant in Union, Missouri that provides talc products to Johnson& Johnson.

The Pharma Tech evidence could prove essential to the claims of more than 1,360 other plaintiffs who have cases pending in Missouri, where juries have awarded verdicts of more than $300 million. Pharma Tech has come up in plaintiffs’ motions this month to remand 20 cases back to Missouri. Johnson & Johnson removed them to federal court under Bristol-Myers just before the scheduled depositions and subpoenas on the Pharma Tech evidence. Plaintiffs’ attorneys also want the Missouri Court of Appeals to let them to add the Pharma Tech evidence to a pending appeals of the prior Missouri court verdicts.

Johnson & Johnson declined to comment on the ruling, while co-defendant, Imerys declared:

“None of the cases tried to date have alleged any conduct by Imerys in Missouri, and the vast majority of cases filed against us in St. Louis are by plaintiffs who similarly have no connection to St. Louis or Missouri,” said Imerys spokeswoman Gwen Myers. “We will look to overturn those cases that were already improperly tried in this jurisdiction and will seek to apply this ruling to those that are still pending.”

The defense bar has been emboldened by Bristol-Myers in which the Supreme Court ruled non-resident plaintiffs who sued Bristol-Myers in California had failed to establish specific jurisdiction because there wasn’t enough of a link between their claims and California, where they brought their “mass action.” Most of the 600 plaintiffs didn’t live in California, and Bristol-Myers is based in New York. The court also found that a California distributor, McKesson Corp., didn’t have enough connection to the claims.

 

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Missouri Federal Court Dismisses All Non-Missouri Plaintiffs From Bayer-Essure Birth Control Cases Citing Recent US Supreme Court Bristol-Myers “California Plavix” Ruling “Are Plavix Motions The New Defense Strategy?”

 

faviconOn January 19, 2017, plaintiffs who are residents of states around the country including Missouri, filed a joint complaint against Bayer AG, Bayer-Essure and other Bayer entities over its Essure Birth control implant in the Circuit Court for the City of St Louis, Bayer Essure Missouri Court Litigation, which was removed to Federal Court. The women claim Bayer’s device caused “serious and permanent injuries” and Bayer has been well aware of those risks for years,. The implants, considered “high-risk” at the time of their approval, were taken through the US Food & Drug Administration’s “Pre-Market Approval” process. In 2015 it was learned the FDA has received “nearly 10,000 formal complaints,” of debilitating side effects, that are “related to Essure,” and included an independent medical device expert who reviewed those 10,000 reports. The analysis ultimately turned up 303 reports of fetal death associated with the implants, far more than the 5 events cited in the FDA’s publicly-available documents on Essure. Congressman Brian Fitzpatrick (R-PA) is sponsoring a bill in the US congress that would see Essure recalled entirely from the market. For its part, the FDA recently announced that it would require a “black box” warning on Essure’s packaging, and has begun investigating allegations that clinical trial results were falsified to “silence” patients who experienced side effects after receiving the implants.

These claims are now meritless for the non-Missouri plaintiffs after Judge Carol Jackson, USDC ED Missouri, issued a ruling July 14, 2017 dismissing all claims by plaintiffs who are not residents of Missouri, citing the US Supreme Court in the June 19, 2017 Bristol-Myers v. Superior Court of California (Plavix) ruling where in an 8-1 opinion, the court ruled “California courts lack specific jurisdiction to entertain the nonresidents’ claims” which has subsequently been cited by defense counsel in attempts to get non-resident claims dismissed from numerous state and federal non-Multidistrict Litigation and consolidated court cases across the country, when plaintiffs do not reside in the case venues. Will filing a “Plavix” motion be the “go to” strategy for the short term by defense, to see how many claims they can get removed from pending actions and force parties to refile in courts where the plaintiffs reside. What impact will this have on “State Court” complex litigation dockets such as those in New Jersey and Pennsylvania where large numbers of non-resident plaintiffs have claims pending?

Bayer was able to move away from traditional “Pre-Market approval and other defenses thanks to the “Plavix ruling”, but there were numerous motions, briefings and arguments in the Missouri Essure case as Bayer had originally filed the Bayer Essure Motion to Dismiss Re: Lack of Personal Jurisdiction on March 9, 2017 prior to the Supreme Court Plavix ruling. The cases were originally filed January 19, 2017 in Circuit Court for the City of St, Louis as Laveta Jordan et al vs. Bayer Corp et al (original complaint) Case No. 1722-0000173; The same day Bayer filed the Motion to Dismiss (March 9, 2017), they also filed a Motion to Sever Non-Resident Missouri Plaintiffs, With plaintiffs filing a Motion and Memorandum to Remand back to state court on March 16, 2017. Parties continued aggressive briefing arguments until Plaintiffs filed the final Response on July 13, 2017, just one day before Judge Jackson ruled on all the pending motions.
Judge Jackson ruled as follows on the primary issues raised by Bayer Corp. in its motion.

As to General Jurisdiction:
The question of general jurisdiction is easily disposed of here, as none of the defendants is incorporated in Missouri or has its principal place of business in the state. Moreover, none of the defendants have such substantial and extensive contacts such that they are essentially “at home” in Missouri. Plaintiffs’ allegations that defendants conduct “substantial business activities” in Missouri are insufficient to show that defendants are “at home.”

As to Personal Jurisdiction:
Citing the Plavix Ruling:
“Bristol-Myers Squibb Company v. Superior Court of California, 137 S. Ct. 1773 (2017) is dispositive of the specific personal jurisdiction issue in this case. In Bristol-Myers, out-of-state plaintiffs joined California plaintiffs in state court. Together they alleged a host of state-law claims based on injuries purportedly caused by defendant Bristol-Myers (BMS) prescription drug Plavix. 137 S. Ct. 1773, 1777 (2017). Notably, BMS was not a citizen of California, and the California Supreme Court ultimately concluded that general jurisdiction was lacking. Id. at 1778. But, the California Supreme Court determined that California courts had specific jurisdiction over the claims of the nonresident plaintiffs. Id. The California Supreme Court reasoned that BMS’s extensive contacts with the state and the similarity to the claims of the California residents supported its conclusion, the US Supreme Court reversed”
The Court elaborated that when no such connection exists, “specific jurisdiction is lacking regardless of the extent of a defendant’s unconnected activities in the state.” The exercise of forum activities unrelated to the cause of action – including the operation of research laboratories not connected to Plavix, employment of sales representatives, and the maintenance of a state-government advocacy office–did not affect the analysis. And “BMS did not develop, manufacture, label, package, or work on the regulatory approval or marketing strategy for Plavix in California”.

As to Bayer Contact with Missouri:

Moreover, defendants Bayer, did not develop, manufacture, label, package, or create a marketing strategy for Essure in Missouri. And the general exercise of business activities in the state cannot create an adequate link between the claims and the Missouri forum

As To Plaintiff Diversity:

Of the 94 plaintiffs, seven are citizens of Missouri. One plaintiff is an Illinois citizen who allegedly had the device implanted in Missouri. The remaining plaintiffs are citizens of 25 different states.

On March 9, 2017, defendants Bayer Corporation, Bayer Essure, Inc., Bayer HealthCare LLC, and Bayer HealthCare Pharmaceuticals, Inc., jointly removed the action to this Court on the basis of diversity jurisdiction, 28 U.S.C. § 1332, and federal question jurisdiction, 28 U.S.C. § 1332.1 Bayer Corporation is a citizen of New Jersey and Indiana; Bayer Healthcare LLC is a citizen of Delaware, Pennsylvania, New Jersey, Germany, and the Netherlands; Bayer Essure, Inc. and Bayer Healthcare Pharmaceuticals, Inc., are citizens of Delaware and New Jersey; and Bayer A.G. is a German corporation.2 Some of the plaintiffs are citizens of Delaware, Indiana, and Pennsylvania. Despite the lack of complete diversity on the face of the complaint, defendants argue that they properly removed this case. Specifically, they contend that removal was proper because the diversity-destroying plaintiffs were misjoined, jurisdiction lies under the Class Action Fairness Act, and plaintiffs plead violations of federal law, thus invoking federal question jurisdiction. Plaintiffs counter that all of the claims are properly joined, and the Court lacks subject-matter jurisdiction over this action in the absence of complete diversity of the parties.

Summary of Ruling On All Motions:
Before the Court are defendants’ motion to dismiss pursuant to Federal Rules of Civil Procedure 8, 9(b), 12(b)(2), and 12(b)(6), and defendants’ motion to sever. Also before the Court are plaintiffs’ motions to remand and stay this action. The issues are fully briefed

Bayer’s Motion to dismiss for Lack of Personal Jurisdiction was granted as to all non-Missouri plaintiffs except plaintiff, Jennifer Dischbein, an Illinois resident who had an Essure device implanted in Missouri. FURTHER ORDERED that remaining plaintiffs Laveta Jordan, Jennifer Baggett, Cheryl Denbow, Jennifer Dischbein, Tiffany Queen, Erica Ware, Michelle Weedman, and Lavena Wilkerson shall have until August 1, 2017, to file an amended complaint setting forth their claims against the defendants.

IT IS FURTHER ORDERED that defendants’ motion to dismiss the complaint for failure to state a claim or federal preemption is denied without prejudice. IT IS FURTHER ORDERED that defendants’ motion to sever is denied as moot. IT IS FURTHER ORDERED that plaintiffs’ motion to remand is denied. IT IS FURTHER ORDERED that plaintiffs’ motion to stay is denied as moot.

______________________________________________________
See the Mass Tort Nexus Bayer Essure Missouri Court Litigation briefcase link for additional case related information

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Johnson & Johnson Faces First California State Court Talcum Powder Trial in Los Angeles Superior Court

Talcum Powder Trial

The closely watched first bellwether trial (Eva Echeverria v. Johnson & Johnson, Case No. BC628228), in California state court over claims of cancer caused by Johnson & Johnson’s talc-based products began on Monday July 10th in Los Angeles County Superior Court, in front of Judge Maren Nelson. The trail started following hearings last week over the admissibility of expert witness testimony and the judge’s summary judgment rulings. The first day of trial saw Judge Maren Nelson change her July 5th ruling that J&J talc supplier Imerys Talc America would be included in the trial, where last week she ruled that Imerys reliance on J&J to warn of “talc dangers” was a question of fact for the jury. Prior to the start of the trial on Monday July 10, 2017 Judge Nelson entered a ruling that Imerys is dismissed from the trial. How this ruling impacts J&J’s trial strategy on the first day of trial is unknown, but does direct trial focus entirely onto Johnson & Johnson .

Last week Judge Nelson held “Sargon” hearings, the California equivalent of a “Daubert” hearing where parties argue over which expert witnesses will be permitted to testify at trial and the scope of their testimony. Judge Nelson chose not to exclude any experts or their testimony, but these hearings do reflect the enhanced scrutiny by state court judges, as to expert testimony in talc cases pending in state courts of New Jersey, California, Missouri and Pennsylvania. These pretrial hearings can be as significant as the trials themselves, as proven last October when a New Jersey state court judge canceled the first talc powder trial there after refusing to permit testimony from experts for the plaintiffs over alleged causal links between talc and ovarian cancer. These are the same experts who testified in the recent St. Louis talc trials where verdicts in excess of $300 million have been returned in the last 2 years; however, on June 29th, Judge Rex Burlison (St Louis Circuit Court), granted J&J’s motion for a mistrial, the same day the US Supreme Court ruled on the California State Court Plavix litigation in Bristol-Myers v. Superior Court of California, in an 8-1 opinion, siding with Bristol-Myers and struck down a California Supreme Court ruling allowing out-of-state plaintiffs to join a mass action over the blood thinner Plavix. One of the deceased women in the St. Louis trial was a former Missouri resident, while the other had lived in Texas and Virginia. How the Plavix ruling affects the thousands of other pending cases in the California “JCCP Consolidated Case” docket remains to be seen.

The Bristol-Myers(Plavix) Supreme Court jurisdictional ruling has caused counsel for parties in state court medical device and pharmaceutical cases across the country to change strategy citing to the Plavix opinion as grounds to dismiss thousands of state court cases where plaintiffs are non-residents. The current J&J talc trial in front of Judge Nelson is excluded from the Plavix ruling as Plaintiff, Eva Echeverria is a California resident, who claims she developed ovarian cancer while living in the state after using J&J’s talc products since the 1950’s. Besides being the first state court talc trial outside of Missouri, Echeverria’s case will also highlight a new group of plaintiff attorneys, after the same team represented plaintiffs in each of the previous talc trials.

All the St. Louis talc trials were handled by out-of-state plaintiff firms (Alabama-based Beasley Allen and the Mississippi-based Smith Law Firm), Echeverria’s team consists entirely of local California firms, with Mark P. Robinson Jr. of Robinson Calcagnie as lead counsel and Kiesel Law LLP, Boucher of Boucher LLP, Girardi Keese as liaison counsel. Johnson & Johnson are represented by some of the same firms that represented the companies in St. Louis, like Shook Hardy & Bacon, which is headquartered in Missouri, J&J’s other defense firm, Ohio-based Tucker Ellis, is making its first appearance in a talc trial.

J&J counsel are expected to be extremely aggressive in their attacks on plaintiffs’ experts, the science they rely on and medical treatment testimony, especially in light of the recent J&J defense verdicts in the first 2 Xarelto bellwether trials in the Xarelto MDL 2592 (US District Court Eastern District of Louisiana), where both juries returned defense verdicts within 24 hours of the start of deliberations.

Mass Tort Nexus will be providing ongoing updates to the Echeverria v. Johnson & Johnson trial as the develop.

The consolidated California cases are captioned Johnson & Johnson Talcum Powder Cases, number JCCP4872, and the bellwether case is captioned Eva Echeverria v. Johnson & Johnson, number BC628228, in the Superior Court of California for Los Angeles County.

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