C. R. Bard, Inc., Hit With Multimillion Dollar IVC Filter Jury Verdict in Arizona Federal Court

Plaintiff Wins the First Bellwether Trial in Bard IVC Filters Products Liability Litigation MDL 2641

By Mark A. York (March 30, 2018)

Bard G2 Inferior Vena Cava Filter

 

 

 

 

 

 

 

 

 

 

 

 

(Mass Tort Nexus Media)  A Phoenix federal jury awarded $2 million in compensatory damages on Friday to plaintiff Sherr-Una Booker, in the first bellwether trial against IVC filter maker Bard, Inc. and affiliate company Bard Peripheral Vascular, Inc. finding that the clot-stopping vein filter known as a G2 model IVC filter, (an Inferior Vena Cava filter) manufactured by Bard broke apart in her body, and returned a verdict citing that the device maker was responsible for 80 percent of the harm. They also said that Bard is liable for punitive damages in addition to the $2 million in actual damages award, with the hearing on punitive damages taking place right after the initial verdict announcement.

The punitive damages phase of the first bellwether over the IVC device began immediately after the early Friday verdict in the Sherr-Una Booker v. C.R. Bard, Inc et al, Case No. 16-CV-0474-PHX-DCG litigation, US District Court of Arizona in front of Judge David G. Campbell.  The Booker trial is the first “bellwether trial” in the more than 3,500 other IVC filter lawsuits pending in the Bard IVC Filters Litigation MDL 2641, before Judge Campbell. The verdict came fairly quickly after just six-and-a-half hours of deliberations that started Thursday. The jury said Bard was not liable for strict liability, which will probably be appealed by Ms. Bookers counsel. We will update this article with the results of the punitive damage hearing as soon as they become available.

BARD IVC FILTER PROBLEMS

Bard’s IVC filters, including its Recovery, G2, Meridian, and Denali product lines, are the target of over 3,500 injury claims in the Bard IVC Filters Products Liability Litigation MDL 2641 currently pending before the court in the District of Arizona. The thousands of lawsuits  filed against the two Bard companies claim they concealed dangerous side effects associated with their retrievable IVC filters – including filter migration, fracture, organ perforation, embolization, and inferior vena cava punctures – and failed to warn doctors and patients about these risks. In addition to the Bard MDL 2641 cases, there is other litigation against smaller IVC manufacturers, Cordis Corporation Rex Medical, Argon Medical, and B. Braun who are all facing  IVC lawsuits in state and federal courts across the country.

BARD FAILURE TO WARN

IVC filters are implanted into the inferior vena cava – the body’s largest blood vessel – to intercept blood clots before they can travel to the heart and lungs. The devices are indicated for patients at risk for pulmonary embolism, and who are unable to use standard blood-thinning medications. The filters involved in the C.R. Bard and Cook Medical litigations are retrievable, and are intended to be removed once a patient is no longer at risk for pulmonary embolism.

Plaintiffs pursuing IVC filter lawsuits against C.R. Bard and Cook Medical claim that the companies failed to provide doctors with adequate warnings and instructions for removal. They also claim that the devices are defectively designed, and accuse the two companies of concealing the risks associated with their blood clot filters.

The FDA has issued two safety alerts about using retrievable IVC filters.

  • The first was released in August 2010, after the devices were linked to hundreds of adverse events, including reports of filters fracturing and migrating to other areas of the body. In other cases, pieces of the filters perforated organs and blood vessels.
  • The FDA issued a second alert in May 2014 to remind doctors of the importance of IVC filter retrieval. A year earlier, a paper published in JAMA Internal Medicine found only 8.5% of retrievable IVC filters were successfully removed.

“In conclusion, our research suggests that the frequent use of IVC filters for VTE treatment and prophylaxis, combined with a low retrieval rate and inconsistent use of anticoagulant therapy, results in suboptimal outcomes, such as mechanical filter failure and high rates of VTE,” the authors of the report concluded. “More comprehensive longitudinal data would likely identify additional complications.”

Additional research has shown in the last 30 years an estimated 30,000 IVC filters have been implanted. But it wasn’t until 2010, after they’d received thousands of adverse event reports, that the FDA finally issued a warning citing the risk of retrievable filter injuries. It took another four years for the FDA to strengthen the warning when in 2014 they implored doctors to remove IVC filters within about one to two months after the risk of a pulmonary embolism has lessened.

BARD KNEW OF DANGERS

In 2015 after the FDA issued the second IVC warning, a bombshell media report claimed C.R. Bard continued to market and sell their inferior vena cava (IVC) filters even after the company became aware the filters were failing and causing serious injuries and even death. The report went on to link at least 27 deaths and more than 300 injuries to failures associated with C.R. Bards Recovery Model IVC filters. The investigative report also uncovered that IVC devices made by C.R. Bard and Cook Medical had been linked to hundreds of adverse event reports where they punctured the vena cava, tilted out of position or migrated or broke apart and caused metallic fragments to travel to the heart or lungs – a condition known as embolization. Even after C.R. Bard was warned about the problems, they continued to sell the devices, without warning the doctors of the defects and injuries.

With 3,500 additional cases remaining the the Bard IVC Filter litigation docket, it seems that the Bard entities may need to prepare for a long and protracted legal fight, unless they determine settlement discussions are the best legal strategy to prevent future plaintiff wins.

 

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Johnson & Johnson Hit With $35 Million Surgical Mesh Implant Verdict

$35 Million Verdict For Plaintiff In Ethicon Prolift Mesh Implant Trial Including $25 Million In Punitive Damages

ETHICON PROLIFT SURGICAL MESH

 

 

 

 

 

 

 

 

 

A jury trial in the US District Court of Northern Indiana returned a verdict against Johnson & Johnson and its Ethicon division, that included $25 million in punitive and $10 million in compensatory damages. The jury found that that Ethicon was negligent in the design of the Prolift surgical mesh implant device, as an unreasonably dangerous product, resulting in post-implant injuries to plaintiff  Barbara Kaiser of Valparaiso, Indiana.

This verdict is the latest plaintiff trial win in the ongoing Ethicon Pelvic Mesh MDL 2327 litigation (See Ethicon MDL 2327 Litigation Briefcase), which includes the overall master docket data which guided the Barbara Kaiser case, prior to being remanded back to the Indiana court for trial by Judge Joseph Goodwin, from the US District Court of West Virginia, where the Ethicon Pelvic Mesh MDL cases are docketed. The Ethicon pelvic mesh litigation still has thousands of remaining cases, where plaintiffs have asserted claims against Ethicon and J&J over their surgical mesh line of products.

The trial took place in the United States District Court for the Northern District of Indiana, where a nine-person jury returned a verdict against Johnson & Johnson et al., the industry leader in  pharmaceuticals and medical devices, after finding that Johnson & Johnson marketed, sold, and recruited physicians worldwide to implant the controversial “Ethicon Prolift” mesh device for Pelvic Floor Repair in women that suffered from pelvic prolapse.

The verdict was handed down after nearly a two-week jury trial that began on Monday, February 26th, concluding on March 8th, 2018.

The verdict confirmed claims that Johnson & Johnson and Ethicon are  liable for its defective product line, designed for use in surgical procedures where the Pelvic organ prolapse repair is used, confirming primary plaintiff claims that the Defendants were negligent in the design of Prolift as an unreasonably dangerous product, resulting in long term injuries to Mrs. Barbara Kaiser of Valparaiso, Indiana as a result of the surgical implant of the Prolift device. The jury found Ethicon deliberately failed to warn of the risks to Prolapse patients prior to consenting to the Prolift mesh implant surgery and sold a Prolift product in a defective and unreasonably dangerous condition.

“The $35 million verdict is one of the largest verdicts in the country,” said lead trial counsel Thomas Plouff, further stating “Ethicon defended an indefensible product and the jury stood up for Barb Kaiser. They were asked to send a message to Ethicon to deter future wrong doing and they certainly did, a company that sold a medical device without doing any clinical testing and caused thousands of women to suffer painful complications from mesh in their pelvic area.”

The trial in front of the Honorable Judge Philip P. Simon, in Northwest Indiana, in what is known as a fairly conservative court venue for plaintiffs seeking damages against manufacturers of products, with Northwest Indiana being a major manufacturing center and not being known for massive verdicts such as the Kaiser mesh award. The verdict requires the Johnson & Johnson corporate conglomerate to pay $35 million, which is $10 million for compensatory damages (for Mrs. Barb Kaiser’s dyspareunia, pelvic pain, levator myalgia, painful bladder spasms, and groin pain), and $25 million in punitive damages. The high punitive damage figure would seem to send a clear message to J&J that their conduct related to the design and marketing of the Prolift product was wrong and intentional, resulting in the very large punitive award.

The Kaiser mesh lawsuit is part of an ongoing legal battle between plaintiffs and surgical mesh makers across the country regarding the many thousands of injuries resulting from various mesh products being surgically implanted. The Ethicon Pelvic Repair MDL 2327 has been in existence since 2012 and the judge is moving toward resolution of those 40 thousand plus claims against many of the largest medical device manufacturers in the world. However, the currently evolving “hernia mesh” legal and medical issue are outline below.

 Hernia Mesh Injuries and 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 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.

         SURGICAL MESH ISSUES

  • 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.
  • 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:
  • Parietex ProGrip/Plug and Patch System
  • 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.
  • The Parietex ProGripand 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.
  • 3d Max
  • 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 Plugis 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 (Supramesh)
  • 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 SThernia 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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More Doctors Charged With Taking Opiate Rx Kickbacks From Insys Therapeutics, Inc.

“MD’s Paid To Write Fentanyl Based Subsys Prescriptions”

Subsys, a fast acting fentanyl spray

 

 

 

 

 

 

 

 

 

 

 

(Mass Tort Nexus Media) Following the indictments of the entire Insys Therapeutics, Inc. Board of Directors in late 2016, and then criminal charges against company founder John Shapoor in October 2017,  the US Attorney’s office in New York has brought federal charges against five New York doctors who accepted kickbacks from Insys in exchange for prescribing the company’s fentanyl-based cancer pain medication.

The multi-count indictment filed last week in Manhattan federal court charged physicians Gordon Freedman, Jeffrey Goldstein, Todd Schlifstein, Dialecti Voudouris and Alexandru Burducea with receiving payment from Insys to participate as speakers, in order to enable illegal fees paid for writing fentanyl based prescriptions. Under the guise of “educational events”, the speaking fees were simply a mechanism to pay the doctors, as Insysy has done across the country since mid 2015.

As far as how this “pay to prescribe Subsys” policy came about, here’s a look at what’s taken place at the Insys Therapeutics, Inc. executive level.

INSYS EXECUTIVES INDICTED

December 2016 saw Insys Therpaeutics CEO Michael Babich and five other senior executives indicted on criminal charges for paying kickbacks and bribes to medical professionals and committing fraud against insurance companies across the country for offering a highly addictive Fentanyl prescription product “Subsys” to the masses. The Insys boardroom was indicted in the US District Court of Massachusetts, where the entire team has engaged a stable of top national law firms to defend the indictments. The “Subsys” sales teams were charged in federal indictments across the country, including Arkansas, Connecticut, Alaska and New York and the indictments will only increase as these cases proceed and “cooperating witnesses” decide that prison isn’t an option.

To compound further harsh scrutiny for Insys, it’s new CEO Saeed Motahari, moved over from Purdue Pharmaceuticals, the Oxycontin maker, who’s also a major target of criminal and civil investigations across the country by local state and federal agencies. Purdue is charged with false marketing, off-label use and ignoring the Oxycontin highly addictive dangers for years, while bringing in literally billions of dollars in profits.

PRIOR DOCTOR INDICTMENTS

Doctors who’ve written massive numbers of Subsys prescription, under the “fee to speak” program have been indicted and they include pain clinics, medical centers and other healthcare facilities who now face federal criminal charges for fraudulent prescription writing, submitting false claims to insurance companies and numerous other federal charges and all face a minimum of 20 to 50 years in federal prison. Two of the busiest “Subsys” prescription writers in the country were Alabama doctors, John Couch and Xiulu Ruan, who earned over $40 million from Insys, and were charged with running a pill mill between 2013 and 2015, have been convicted and sentenced to 20 years each in federal prison.

The top “Subsys” prescriber of all, Dr. Gavin Awerbach, of Saginaw, MI pled guilty to defrauding Medicare and Blue Cross out of $3.1 million in improper Subsys prescriptions, his criminal sentence is pending. To show the far reach of Insys and its corporate plans to saturate the US market with opioids, in Anchorage, Alaska Dr. Mahmood Ahmad, was charged with a massive Subsys prescribing operation, which he denies, but immediately surrendered his Alaska medical license which caused the revocation of his license Arkansas.

THE OFF LABEL CAMPAIGN

The only people who are supposed to be taking Subsys are adult cancer patients, according to the FDA “Subsys” approval files, anything other than that is an “off label” indication. Now you can take a drug to treat something off label if you want to, but you have to get your doctor to get pass a prior authorization.

Anthem alleges that Insys has an entire unit to get around this requirement — it’s titled the “reimbursement unit.” Investigative journalists exposed this fraud initially as far back as 2015 on behalf of the Southern Investigative Reporting Foundation, see Insys Therapeutics “Subsys” Off Label Rx Fraud.

The Reimbursement Unit claim was basically the company’s fraudulent prescription approval factory, which helped participating doctors process claims (the doctors had so many they couldn’t handle them all). The unit falsified records to show patients had cancer and called insurers, pretending to be patients or other medical professionals, to facilitate approval of payment for off-label treatment.

This is the Unit’s script for obtaining off-label approval (taken from the Anthem suit):

The script read: “The physician is aware that the medication is intended for the management of breakthrough pain in cancer patients. The physician is treating the patient for their pain (or breakthrough pain, whichever is applicable).” The script deliberately omitted the word “cancer as applied to the patient treatment under discussion.”

Prosecutors also said that two former Insys employees who were first charged in 2016 in connection with the scheme, Jonathan Roper and Fernando Serrano, had secretly pleaded guilty and become cooperating witnesses. The five doctors were arrested last Friday morning and face charges including that they violated the federal anti-kickback law and conspired to commit fraud.

INSYS RX ABUSES WERE BLATANT

The case is the latest in a series of medical practitioners and former Insys executives and employees facing criminal charges related to Subsys, the company’s potentially addictive fentanyl-based spray.

Federal prosecutors in Boston are moving forward aggressively against the seven former Insys executives and managers as well billionaire founder John Kapoor, all accused of actively designing and participating in the scheme to bribe doctors to prescribe Subsys and to defraud insurers into paying for it. Insys has said it may need to pay at least $150 million towards part of a settlement with the U.S. Justice Department as well as numerous other state investigations around the country, not to mention the civil complaints filed against the company in the Opiate Prescription MDL 2804, see OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION, where the Insys sales and marketing tactics are listed as prime examples of boardroom designed “profits over patients” policies are cited.

 

Insys is joined in the massive Federal Opioid MDL 2804, by other Big Pharma defendants including Purdue Pharmaceuticals, Endo Health, J&J’s Janssen Pharmaceutical and other opioid manufacturers who were allowed to place profits over patients for more than 15 years, while earning billions in profits.

UNETHICAL SALES TACTICS

According to the most recent and prior doctor indictments, the physicians have participated in Insys’ speaker programs, which were in reality social gatherings at high-end restaurants. They earned kickbacks ranging from $68,000 and $308,000 and were among the top 20 prescribers of Subsys nationwide at some point during the marketing campaign. A few doctors indicted as far back as late 2016 have already been sentenced to federal prison terms up to 20 years and forfeit of millions of dollars in assets. The Insys marketing tactics included trips with doctors to strip clubs with Insys sales managers; and often with Insys executives, where they covered lap dances and drinks which on one trip ran up a tab of over $4,100 which was apparently enough to convince physicians to write massive numbers of off-label fentanyl prescriptions.

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Why Are Opiate Prescription Overdoses Still Rising? The Statistics Are Telling The Story

The Emergency Room Statistics Tell The Story

 Why Is The Midwest USA Still Seeing Opioid OD’s Rise Every Year? 

By Mark York (March 9, 2018) 

  

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) According to sources at all levels from police and fire first responders to emergency room physicians across the country and analysts at the CDC, there’s been no slowdown in opiate based medical emergencies in the US over the last 2 years. Emergency response and ER visits for opioid overdoses went way up, with a 30 percent increase in the single year period of June of 2016 to June of 2017, according to the Centers for Disease Control and Prevention. 

The increased emergency room visits also include more young children aged three to fourteen years old, which truly reflects on the unknown number still available opiates that are readily accessible to anyone who has an interest in getting them, and often with an inadvertent and tragic risk to younger victims who somehow are exposed and now being swept up in the opioid crisis.  

Center for Disease Control’s Acting Director Dr. Anne Schuchat said overall the most dramatic increases were in the Midwest, where emergency visits went up 70 percent in all ages over 25. This is a figure that’s is comparative to prior medical emergency spikes during pandemic healthcare  

WHY THE HUGE INCREASE IN THE MIDWEST

ER visits for opioid-related emergencies more than doubled in two states. Wisconsin saw the biggest increase, 109 percent and Delaware saw a 105 percent increase. In Pennsylvania, ER visits were up 81 percent. 

“We’re seeing the highest ever death rates in the US,” Schuchat said. She pointed to national statistics that out of 63,000 overdose deaths in 2016, 42,000 of them involved opioids. 

“[This] means 115 people die each day from opioid overdose,” she said. This number has been at are above 100 for most of the last 3 years, with no end in sight and with so many different regions affected it may require more grassroots focus and demands made to elected officials to move faster on a long term solution.  

There were some decreases reported in the East, with the largest being a 15 percent reduction in Kentucky, which could reflect fluctuation in drug supplies or interventions. 

However, hospital visits in cities of all types increased steadily in each quarter by 51 percent. Schuchat emphasized, “Bottom line — no area of the US is exempt from this epidemic.” Looking closer at causation and access to opiates across the country is required. How are unlimited numbers of federally controlled substances still so readily accessible to so many?   

US Surgeon General James Adams was also present during the briefing and mentioned how he witnessed first-hand his own young brother’s struggle with opioid addiction. 

“Science is clear: Addiction is a chronic disease and not a moral failing,” the doctor said. Adams outlined that a coordinated effort is necessary to prevent opioid addiction. “To successfully combat this epidemic, everyone must play a role,” he noted. 

The Surgeon General explained how health departments, along with public safety and law enforcement officials, have to work together to deal with local opioid-related emergencies. 

He stressed the need to make naloxone, a life-saving drug that can reverse the effects of an overdose, more accessible in emergency situations. 

 CHILDREN ARE OPIOID VICTIMS TOO 

Opioid poisonings and overdoses are sending increasing numbers of U.S. children and teens to the hospital, according to additional studies showing a substantial rise in young patients needing critical care. The study included accidental poisonings along with overdoses from intentional use. Prescription painkillers were most commonly involved, but heroin, methadone and other opioid drugs also were used. 

Hospitalizations were most common among kids aged 12-17 and those aged 1 to 5. The youngest kids typically found parents’ medications or illicit drugs and used them out of curiosity, said Dr. Jason Kane, the lead author and an associate pediatrics professor at the University of Chicago and Comer Children’s Hospital. 

Reasons for the increases are unclear but it could be that drugs became more widely available and potent during the study years, Kane said. Finding a solution is something that is often discussed yet there seems to be limited ability to slow or control access to opiates.  

“Opioids can depress your drive to breathe,” Kane said, and they also may cause blood pressure to plummet to dangerously low levels. Treatment for these symptoms includes ventilators and powerful drugs that constrict blood vessels. Naloxone, the “rescue’ drug used that can revive overdose patients who’ve stopped breathing, was used in nearly one-third of cases during the 2004-15 study. 

The study was published March 2018 American Association of Pediatrics, see Pediatrics Journal study results. The study involved 31 children’s hospitals, or about 20 percent of U.S. children’s hospitals. Opioid-related stays increased from almost 800 to 1,500 during the study. The results echo research published last year that found the annual rate of hospitalizations for opioid poisonings in kids nearly doubled from 1997-2012 

The new study found a similar increase in patients requiring intensive treatment, rising from 367 to 643 in the final years.A small fraction of the nearly 4.2 million hospitalizations of children during the study involved opioids, but 43 percent of these opioid-related stays required intensive treatment. Annual deaths dropped from almost 3 percent to just over 1 percent of kids hospitalized for opioid reactions. 

The number of children admitted to peditriac hospital intensive care units for opioid poisoning nearly doubled over a decade, according to a new study. 

“Current efforts to reduce prescription opioid use in adults have not curtailed the incidence of pediatric opioid ingestion, and additional efforts are needed to reduce preventable opioid exposure in children,” authors wrote in the study “Opioid-Related Critical Care Resource Utilization in U.S. Children’s Hospitals” (Kane JM, et al. Pediatrics. March 5, 2018, https://doi.org/10.1542/peds.2017-3335). 

Researchers analyzed 2004-’15 data from the Pediatric Health Information System and found 3,647 opioid-related hospitalizations across 31 children’s hospitals. They rose from 797 in 2004-’07 to 1,504 in 2012-’15 and were highest among children ages 12-17 (61%) followed by ages 1-5 (34.2%) and ages 6-11 (4.8%). With nearly 20% of children in the youngest age group were admitted for methadone ingestion, which tends to show that the drug access is often affiliated with a person undergoing opioid addiction treatment 

THE OFTEN OVERLOOKED VCTIMS

“These kids are really the secondary victims of this adult opioid epidemic,” Kane said. He said the results emphasize how crucial it is to store medications and other drugs locked, hidden and out of children’s reach. 

The Pediatrics Journal editorial notes that several treatment programs for drugs including opioids have been shown to reduce teen and young adult use. The new findings highlight the need for pediatricians to get involved “to combat the ongoing opioid crisis in our country,” the editorial said. Perhaps speaking to and letting young children know the dangers of opiates at an early age would be advisable, just as the “drunk driving” campaigns has been ingrained into our society from a young age, resulting in a net reduction in drunk driving fatalities.   

Treating the opioid crisis and abuse of prescription opiates as a disease or referring to it as a formally recognized medical condition requiring medical professional intervention as an inclusive part of the solution will be a mandatory part of any long term viable solution to the opiate crisis.     

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