Category: Defective Products

Bard Mesh Manufacturers Paid Doctors to Promote Defective Products

By Emily Cox
Bard Mesh Money
Flickr/Megan

According to a new lawsuit, manufacturers knew that heavyweight Bard mesh product lines, Composix E/X (CEX) Mesh and Ventrio Patch, were unreasonably dangerous but continued promoting them regardless, going so far as to pay off members of the medical community to recommend and use the defective devices.

Maureen Lumby filed the complaint earlier this month in the Western District of Missouri. She named C.R. Bard, its Davol, Inc. unit, and Red Oak Sales, Inc. as defendants.

Lumby underwent hernia repair surgery in March 2006, receiving a Bard CEX patch. However, the Bard mesh inevitably failed due to inconsistent constriction of the CEX’s two materials. This caused the mesh to fold and pull away from the implant site. Consequently, Lumby had to undergo another invasive surgery to remove it in July 2012.

Doctors replaced the defective mesh with another Bard mesh product, the Ventrio Patch. The heavyweight mesh failed just as surely as its predecessor. Again, the Bard mesh had folded. However, this time it became adhered to her small bowel. Due to this, she had to undergo extensive surgery in October 2014 to “strip the bowel off the mesh.”

Bard Mesh Manufacturers Knew Products Were Defective

Lumby’s claim indicates that the Bard mesh manufacturers and distributor knew that these products had substantial risks due to their heavyweight designs and substantially smaller pore size than other mesh products. Consequently, these factors caused the mesh material to harbor infections, degrade, react with human tissues, move out of position, and erode into nearby organs and tissues. Furthermore, the products regularly failed, causing recurring hernias and the need for additional surgery. Despite these dangers, Bard and its distributor turned a blind eye to patients’ health, keeping their sights on their mutual bottom lines.

“Defendants provided incomplete, insufficient, and misleading information to physicians in order to increase the number of physicians using the CEX and Ventrio and therefore increase its sales,” the lawsuit states.

Furthermore, the lawsuit alleges that the Bard mesh manufacturers and distributor “paid doctors, surgeons, physicians, and/or clinicians to promote CEX and Ventrio.”

And, they didn’t stop with the medical community. They also concealed adverse event reports from the FDA and other regulatory agencies worldwide. The Bard mesh manufacturers even “manipulated, altered, skewed, slanted, misrepresented, and/or falsified pre-clinical studies to bolster the perceived performance of the CEX and Ventrio.”

Bard publicly concealed and denied the dangers of the mesh products’ heavyweight designs. However, despite these assertions, they have now changed all of its heavyweight mesh designs to lightweight mesh. Bard’s internal data also confirms that these modified devices are substantially safer.

Lumby’s Bard mesh case joins a growing number of hernia mesh lawsuits over dangerous design defects. Most of the cases involve Atrium C-Qur mesh and Ethicon Physiomesh. However, Lumby’s claim indicates that the size and scope of the hernia mesh litigation continues to grow.

 

Essure Birth Control Implant Withdrawn from Canadian Market

By Emily Cox
Birth Control Implant Withdrawn from Canada
Flickr/Alex Indigo

As safety concerns mount across the globe, Bayer has suspended Canadian sales of its controversial birth control implant in the face of plummeting sales after warning labels were added to the product to warn of Essure’s substantial health risks.

Bayer Healthcare released the statement to the Toronto Star this week. The healthcare conglomerate indicated that it was voluntarily withdrawing Essure from the Canadian market due to a fall in patient demand. Bayer adamantly denies that this market withdrawal has anything to do with Essure safety concerns. The company insists that its purely market dynamics. However, several thousand lawsuits throughout North America and a potential Canadian class action, alleging irreparable harm from the birth control implant probably influenced this market dynamic substantially.

Essure Birth Control Implant Complications

Essure sterilization involves the placement of metal coils in the fallopian tubes. These coils create a scar tissue barrier, preventing pregnancy. However, thousands of women have reported substantial, lasting problems with the device. These include chronic pain, allergic reaction, heavy bleeding, tissue perforation, the coils moving out of place, and even death, as well as unintended and ectopic pregnancies.

Essure implantation is an outpatient procedure. However, removing the coils is another story altogether. Most doctors don’t have the necessary training to safely remove only the coils. It’s a costly, specialized procedure that insurance deems elective and will not cover. Consequently, the majority of women must undergo a hysterectomy to treat Essure complications.

As reports of serious injuries continued to mount, independent experts began demanding for additional warnings on the birth control implant. Consequently, the FDA launched its own investigation and found that these reports had substantial merit. In November 2016, the FDA added a black box warning to Essure implants. This is the strongest warning the agency employs. Canada added a similar warning to the birth control implant in May 2016. Potential Essure recipients in U.S. now also must also complete a patient checklist to ensure that they fully understand the severity of the risks associated with the device and that there are safer alternatives.

Birth Control Implant Lawsuits

A potential Essure class action, several hundred women strong, is currently pending in Canada. Meanwhile, in the U.S., Bayer faces several thousand Essure lawsuits throughout the country. These women allege that Bayer knew about the serious problems with the device for years. However, the conglomerate elected to conceal this information from consumers, doctors, and federal regulators to the detriment of women around the world.

Bayer estimates that 750,000 women have received the birth control implant with 70 percent of those in the U.S. However, this number is likely much higher. Conceptus projected the same figure in 2013 when Bayer acquired the company. Falling sales are still sales…and implantations. Consequently, experts expect thousands of additional women to come forward to take Bayer to task for its greed and negligence.

 

 

Roundup Regulatory Collusion Unraveling on Both Sides of the Pond

By Emily Cox
Roundup Regulatory Collusion
Flickr/OccupyReno MediaCommittee

Prompted by allegations of Roundup regulatory collusion in the U.S., European Parliament members are requesting access to documents and deposition transcripts in the current Roundup cancer litigation that indicate Monsanto falsified scientific studies and colluded with regulators to hide the weed killer’s substantial health risks.

European legislators Bart Staes, Heidi Hautala, Benedek Javor, and Michel Rivasi sent the request for Roundup regulatory collusion evidence to District Judge Vince Chambria earlier this month. It appeared on the court docket late last week.

The European Union’s (EU) glyphosate authorization expires December 31, 2017. As reauthorization looms, lawmakers are struggling to decipher real science from research bought and paid for by the herbicide’s manufacturer. European legislators suspect the agrochemical giant Monsanto may be responsible for vastly contradictory scientific findings on Roundup’s safety.

In November 2015, the European Food Safety Authority (EFSA) concluded that Roundup’s main ingredient, glyphosate, was unlikely to cause cancer. However, the World Health Organization’s (WHO) classified the chemical as a probable carcinogen earlier that year. These opposing findings have cast a shadow of doubt over the assessments of the EFSA and other EU agencies. The EFSA, in particular, relied on industry-based data and sealed scientific reports from Monsanto to assess glyphosate’s safety. Recent reports also show that the pesticide industry had advance access to the EFSA’s safety assessment of glyphosate. In fact, industry representatives were even asked to file redaction requests and edit the documents until the very last minute.

“Monsanto Papers” Reveal Roundup Regulatory Collusion

After discovering the pesticide industry’s substantial influence with its own regulatory agencies, European lawmakers turned a keen eye to the Roundup product liability litigation when the court uncovered documents indicating Monsanto ghostwrote scientific studies and engaged in Roundup regulatory collusion. Monsanto even paid researchers to put their names on its bogus studies that downplayed glyphosate’s risks. EU agencies relied on these studies to determine the chemical’s safety. European lawmakers hope that U.S. court documents will reveal how much of Roundup’s safety was determined solely by the manufacturer.

Evidence of Roundup regulatory collusion with former EPA-expert Jess Rowlands has significantly heightened European lawmaker concerns. The Roundup litigation unearthed documents that suggest Rowland reassured Monsanto that he had squashed glyphosate’s pesticide review. Reportedly, he even wrote that he “should get a medal” for protecting Roundup.

Furthermore, Rowlands actively intervened in EFSA’s glyphosate assessment. He even directed the EFSA to discard the conclusions of a key study showing cancer in mice exposed to the chemical.

The ongoing investigations and discovery process on both sides of the Atlantic raise serious questions about the integrity of the most influential environmental regulatory agencies in the world.

Roundup Cancer Lawsuits

Judge Chhabria is currently presiding over all federal Roundup cancer lawsuits. Farmers, landscapers, and other agricultural workers claim that regular Roundup exposure caused non-Hodgkin’s lymphoma and other cancers. They claim that Monsanto failed to provide warnings and safety recommendations that could have prevented their cancers. While Monsanto continues to claim that glyphosate’s carcinogenic classifications are based on junk science, it appears the company may have fabricated any and all evidence to the contrary.

Judge Chhabria has agreed to Monsanto’s proposal to bifurcate the federal Roundup litigation. Consequently, the court will first address issues of general causation over the link between Roundup and non-Hodgkins lymphoma. The court will then move on to case-specific issues to determine if Roundup caused the cancer of specific plaintiffs. As a result of this process, it is possible that the first state court trials will begin far ahead of the federal trials.

Following the initial causation phase, Judge Chhabri will most likely move to select a small group of representative cases for early trials next year. These trials will demonstrate how juries will likely respond to certain evidence and testimony that appears throughout the litigation.

Jurisdiction Ruling Begins its Chokehold on Product Liability Mass Torts

By Emily Cox
Jurisdiction Ruling
Flickr/Matt Wade

The full implications of last month’s Supreme Court jurisdiction ruling, limiting state authority on product liability mass torts, are still in their infancy, but the waves are beginning to rock plaintiff-friendly courts.

A Missouri judge said Friday that most women suing Bayer over allegedly hiding safety concerns for its Essure birth control device couldn’t sue in Missouri federal court as they no longer meet the requirements of the new jurisdiction ruling.

Plavix Jurisdiction Ruling

In an 8-1 ruling, the Supreme Court set tighter perimeters for state jurisdiction over product liability cases last month. The high court decided that nonresident plaintiffs cannot sue Plavix manufacturer Bristol-Myers Squibb (BMS) in California state court. The opinion held that California had not identified an “adequate link between the state and nonresidents’ claims.”

Nationwide marketing, substantial corporate activity in the state, and similar injuries as residents have long held as substantial connections to attach nonresident claims on mass tort lawsuits in plaintiff-friendly states. Corporations have practically inexhaustible resources, and injured plaintiffs need any edge they can get. Consequently, product liability plaintiffs flock to safe havens like California and Missouri, seeking more favorable outcomes. Much of the Supreme Court’s jurisdiction ruling seems to hinge on the fact that none of the nonresident plaintiffs were prescribed Plavix, injured, or received treatment in California. And, at least one district court has interpreted this as being the line in the sand.

Jurisdiction Ruling Enacted to Toss Essure Cases

District Judge Carol E. Jackson ruled that only eight of the 94 women bringing suit against Bayer for substantial injuries incurred from the Essure device could proceed in Missouri federal court. Seven of these are residents. The judge also granted one Illinois woman, who had the device implanted in Missouri, jurisdiction. She dismissed the rest from the lawsuit, along with a bid to send the litigation back to state court.

“With one exception in this case, the non-Missouri plaintiffs do not allege that they acquired the Essure device from a Missouri source or that they were injured or treated in Missouri,” Judge Jackson said. “Moreover, defendants 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.”

Comparatively, a Missouri talcum powder case was declared a mistrial before the ink used to pen the jurisdiction ruling even dried. However, nonresident claims are going forward as defendant Johnson & Johnson uses a Missouri-based company to package and label talc products.

Lawyers for the plaintiffs argue that, during development, Essure manufacturers had “extensive contacts” in the state and a marketing strategy targeting it. They also said that the company conducted several studies in the state to receive FDA approval. This means that the company used Missouri hospital and Missouri physicians for this very approval. They remain hopeful that these facts can overturn the jurisdiction ruling.

The Essure Case Demolished by Jurisdiction Ruling

Originally, these women sued Bayer in St. Louis in January. Bayer removed the case to federal court in March as the women involved came from more than 25 states. They claim that Essure’s original manufacturer, a company in serious financial trouble named Conceptus, lied about the device’s safety for profit.

“By the time the FDA approved Essure for sale in 2002, it was Conceptus’ only commercial product,” the complaint states. “Conceptus relied entirely on the success of Essure to solve its massive debt problems and achieve profitability. To promote the perceived safety of the device and gain market acceptance, Conceptus devised and implemented a scheme to defraud physicians and patients, by means of false and fraudulent pretenses, representations and concealment of material facts.”

When Bayer bought Conceptus in 2013 for about $1.1, Bayer continued this path of deceit, exposing women to harm for financial gain. According to the suit, Bayer also manipulated FDA reports and provided false or misleading information about the device’s safety.

The complaint also cites a study of New York women with Essure. It found that these women were 10 times more likely to need corrective reoperation than those with tied tubes.

Essure Overview

Essure is a permanent birth control system. It consists of two coils that a doctor can implant in a woman’s fallopian tubes in an outpatient setting. The coils cause scar tissue to form, creating a barrier to prevent pregnancy. However, there are many reports of serious adverse reactions. These include heavy bleeding, chronic pain, unwanted pregnancy, ectopic pregnancy, allergic reaction, and even death. Unfortunately, not many doctors are trained to operate on the fallopian tubes to remove just the coils. Consequently, women who endeavor to alleviate their symptoms often must undergo a hysterectomy. As a result, the FDA added a black box warning to the device. The agency also mandated that prospective patients complete a checklist to ensure that they were aware of the serious risks.

 

 

 

IVC Filter Complications Quickly Result in a Man’s Death

By Emily Cox
Are These Spider-Like Devices a Death Trap? (Flickr/Julie Falk)

IVC filter complications are generally serious and can even be life-threatening, but they also usually take time to develop. However, for one Alabama man, his IVC filter complications presented immediately and quickly turned deadly, taking his life little more than two weeks after receiving the filter that was supposed to save it.

Velvet Rodgers’ wife, Effie Rodgers, filed the complaint this past Wednesday. She alleges that serious injuries from her late husband’s IVC filter complications caused his untimely death. Rodgers claims that the filter’s manufacturers C.R. Bard and Bard Peripheral Vascular Inc. knew and concealed the filter’s substantial defects, representing the device as safe to protect their vested interests.

Her husband underwent Denali® IVC Filer implantation on December 7, 2015, to treat venous thromboembolism (VTE). VTE is the formation of blood clots in veins. These blood clots can break loose and travel to the lungs or heart, causing pulmonary embolism and even death. Consequently, physicians may elect to implant one of these metal, spider-like filters in the inferior vena cava vein to catch these blood clots before they can do irreparable harm. Unfortunately for Rodgers, the device meant to save his life took it instead. IVC filter complications developed immediately and progressed at breakneck speed, claiming his life on December 24, 2015.

IVC Filter Complications

The Denali is one of Bard’s newest generations of IVC filters. However, it has been connected to many of the same serious health risks as previous models. The metal legs are particularly prone to breaking. These broken pieces can move through the bloodstream, eventually puncturing the lungs or heart and can cause sudden death.

In January 2015, Elsevier published a case report on a 46-year-old woman who almost died from Denali IVC filter complications. The filter fractured within six months of implantation, sending filter fragments into her vein. Eventually, one of these fragments pierced her heart, causing a life-threatening heart condition called cardiac tamponade.

The broken pieces of the filter required emergency open-heart surgery to remove. Researchers found the filter’s fragile design at fault.

“Electron microscopic fragment analysis revealed high-cycle metal fatigue indicating the filter design failed to withstand this patient’s natural inferior vena cava biomechanical motions,” they concluded.

IVC Filter Complication Lawsuits

Rodgers joins a growing number of individuals taking Bard to task for negligently and knowingly selling dangerous, defective devices. Currently, Bard is facing almost 2,300 lawsuits over its retrievable vena cava filters. This also includes Bard’s G2 filter and Recovery filter.

In August 2015, the Judicial Panel on Multidistrict Litigation (JPML) centralized the litigation in the District of Arizona to coordinate pretrial proceedings. Judge David G. Campbell is overseeing the multidistrict litigation.

On August 11, Judge Campbell will hear oral arguments to determine whether to certify a Bard IVC filter class action to protect patients from future IVC filter complications as much as possible. If he grants certification, the class action would make Bard pay for all future medical monitoring of its retrievable filters to catch dangerous complications before they before they endanger and take more lives like Rodgers’.

 

Asbestos Fibers Found in Makeup Sold at Popular Tween Clothing Store

By Emily Cox
Asbestos Fibers Found in Tween Clothing Store Makeup
Asbestos Fibers for that Youthful Glow (Flickr/Mike Mozart)

A recent investigation found asbestos fibers in makeup marketed and sold by tween megachain Justice, formerly the Limited Too.

WTVD in Durham, North Carolina, launched the investigation with the Scientific Analytical Institute (SAI) in Greensboro, North Carolina. They found that the “Just Shine Shimmer Powder” contained asbestos fibers and traces of other dangerous heavy metals.

When it comes to the powder, Sean Fitzgerald, SAI’s director of research and analytical services said, “I would treat it like a deadly poison, because it is.”

In Your Face, Asbestos Fibers

Usually, when you think of asbestos, cordoned-off old elementary schools and government buildings bedazzled with “Danger” signs come to mind. Teenage beauty powder displayed next to bedazzled jeans…not so much. However, that’s exactly what this investigative team found after testing the popular chain’s makeup.

Manufacturers once used asbestos in countless applications due to its resistance to heat, fire, chemicals, and electricity. However, the minuscule asbestos fibers easily separate, making them a breeze to breath. These fibers can build up in your longs and cause a variety of serious health issues. Breathing in asbestos fibers over long periods of time increases the risk for diseases like lung cancer and mesothelioma. But, surely, there isn’t any danger of breathing in these particles while dusting a loose powder on your face by your mouth. You know, where you breath.

“Fibers like this get into your breathing zone, and when you inhale, these fibers can get into the lung and go to the very bottom of the lung and that is exactly where you have the greatest likelihood of asbestos to cause disease,” Fitzgerald said.

“In this powder designed for children, they could die an untimely death in their thirties or forties because of the exposure to asbestos in this product,” he cautions. “Children should not be allowed to breathe it. If a 10-year-old inhaled this fiber today, when he’s 50 years old, it’s still there.”

Nothing Says a Youthful Glow Like Asbestos Fibers, Lead, and Barium

Asbestos fibers aren’t the only frightening thing found in Just Shine Shimmer Powder. SAI also found heavy metals in the product. Lead, barium, chromium, and selenium capped off this delightful chemical concoction for kids. Children are particularly vulnerable to lead’s toxicity. They can suffer profound and permanent adverse health problems, particularly when it comes to the brain and nervous system. At least, Justice may have accomplished one thing. It could do away with the stereotype of fashion-minded young women as being vapid, airheads by making them actually brain damaged.

“The more lead you have in your system, the more negative health effects you’re going to have. Any amount of lead can be absorbed through the skin and go into your blood, and contribute to your overall poisoning of your blood,” Fitzgerald said.

Asbestos Fibers and Lead Contamination

Fitzgerald suggests that the manufacturer wasn’t intentionally using these ingredients to beautify our youth. Rather, talc, a mineral found in many products, is to blame. Talc is a mineral that forms in the other along with other minerals, including…you guessed it – asbestos.

“What we have here is a talc that was contaminated with asbestos that was used to manufacture a product unfortunately aimed at young children,” Fitzgerald said.

However, the FDA requires cosmetic talc to be asbestos-free, and manufacturers are resoundingly compliant. In 2009 and 2010, the agency did test samples of talc from four suppliers along with 34 makeup samples and found absolutely no asbestos fibers.

“The problem is, it’s not necessarily the manufacturer, there was no intent to put this in the talc, but they shouldn’t have been using that reserve, because they should’ve tested it and known that that talc source was contaminated with asbestos,” Fitzgerald said.

Justice has already pulled Justice Shine Shimmer Powder from shelves. The clothing company is current beginning its own investigation into asbestos fibers contaminating the product.

Hernia Mesh Pain Burns Away at Woman’s Life, Incinerating Capacity and Enjoyment

By Emily Cox
Hernia Mesh Pain
Flickr/Soreen D

If at first the mesh doesn’t succeed, try, try again. According to a new lawsuit, that’s exactly what doctors did to a Texas woman, implanting her with fresh Physiomesh each time the previous one failed, leaving her with lasting severe hernia mesh pain that limits her ability to work and even perform daily activities. Maybe doctors should have taken another old adage to heart – Albert Einstein’s definition of insanity.

Lydia Edwards filed the complaint on June 6 in the Northern District of Texas. She names Physiomesh manufacturers Johnson & Johnson and Ethicon as responsible for causing her hernia mesh pain through their greed and negligence. According to Edwards, she underwent surgery in February 2014 to repair a recurrent hernia despite previous Physiomesh placement. Surgeons discovered the hernia mesh had failed and replaced it with new Physiomesh. In July 2015, Edwards was back on the operating table again for the same hernia. Surgeons found the hernia had incarcerated several loops of her small intestines and colon. Despite the hernia mesh obviously not performing its specific function, doctors decided against removing the polypropylene product from her body. Instead, they opted to add to it, reinforcing it with another Physiomesh.

Surprisingly, adding more of the defective product inside her body didn’t fix, well, anything. Years later, Edwards continues to suffer horrendous hernia mesh pain that limits her ability of work, perform daily activities, or even find enjoyment in her life. And, there’s no end in sight. The damage and hernia mesh pain may be permanent. Consequently, Edwards now suffers from anxiety and depression. This only adds to the physical anguish that plagues her days.

Hernia Mesh Pain and Injury Lawsuits

Edwards joins a growing number of people taking Johnson & Johnson and Ethicon to task for gaining financially at patients’ expense. They allege that the manufacturers knew the mesh’s substantial defects had a high probability of causing irreparable harm but continued to sell the product anyway due to its substantially higher profit margin compared to other hernia mesh products. As adverse reports began to stack up, the companies, with their appetites sated, made off like thieves in the night, quietly removing the products from shelves in a worldwide market withdrawal.

In June, the Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal Physiomesh cases. District Judge Richard W. Story is now presiding over them all in the Northern District of Georgia for pretrial proceedings. It’s early days yet in the multidistrict litigation. However, experts agree that the litigation could ultimately swell to several thousand strong.

IVC Filter Class Action Might Be on the Horizon

By Emily Cox
VC Class Action on the Horizon
A New Dawn in the IVC Filter Litigation (Flickr/frankieleon)

Parties involved in the federal Bard IVC filter litigation will present oral arguments next month to determine whether to certify an IVC filter class action to protect filter patients from future complications as much as possible.

The Court released a joint status report this past week, indicating that a hearing on August 11 will consider certification of the IVC class action status. The July 13 status conference will further determine how this hearing will be conducted. The parties also indicated that they need to know if the Court expects them to produce facts and expert witnesses at the August IVC filter class action hearing.

The IVC filter class action lawsuit seeks to protect individuals facing substantial injury risks in the future due to high IVC complication rates. If successful, the lawsuit would make C.R. Bard pay for all future medical monitoring of its retrievable filters to catch dangerous complications as early as possible. Some of these complications include the filters moving out of position, breaking, and puncturing other organs, such as the heart and lungs.

The Massive Litigation that Produced the IVC Filter Class Action

There are currently almost 2,300 Bard G2 and Recovery filter lawsuits and other claims against C.R. Bard over problems with the company’s retrievable vena cava filters. Surgeons implant these small, wire, spider-like devices prevent blood clots from traveling to the lungs and causing pulmonary embolism. Plaintiffs allege that the blood clot filter’s design defects make these devices exceptionally dangerous. They are prone to move out of position and fracture, sending small pieces throughout the body via the blood stream. Both of these complications can cause the filter to puncture internal organs, usually the heart, lungs, and vena cava vein itself.

In August 2015, the Judicial Panel on Multidistrict Litigation (JPML) centralized the litigation. District Judge David G. Campbell is overseeing the multidistrict litigation (MDL) in the District of Arizona to coordinate pretrial proceedings. This reduces duplicative discovery and avoids conflicting rulings from different courts, serving judicial efficiency. Judge Campbell has already established a bellwether trial plan. Consequently, the first bellwether trials over Bard IVC complications should begin later this year. These early trials help gauge how juries may react to evidence and testimony that appears throughout the litigation. These early trial outcomes will not directly affect other cases. However, they may be exceptionally influential for eventual IVC filter settlements in the future.

The MDL will hold a Science Day on August 10. Each side will have two hours to make non-adversarial presentations about the scientific issues related to the litigation.

Hundreds of similar Cook and Cordis IVC filter lawsuits are also pending against the manufacturers. Cook bellwether trials will commence in October 2017.

 

Hernia Mesh Failures Result in Serious Injuries

By Emily Cox
Hernia Mesh Failures Results in Additional Surgery
Hernia Mesh Failures Results in Additional Surgery (Flick/Sgt. Lesley Waters)

According to a new lawsuit, three hernia mesh failures led to a series of serious injuries over the course of a year, requiring additional surgeries and explantation of defective Physiomesh within months of it being surgically placed in a Florida woman.

Sheri Ann James and her husband, Alfred George James, filed the complaint late last month. James named Johnson & Johnson and its Ethicon unit as defendants.

During a nightmarish year, James experienced three separate hernia mesh failures, requiring surgical interventions. Two of these defective devices were Ethicon Physiomesh that both failed within months of implantation. In May 2012, James received a 15 x 25 cm Physiomesh device to replace another failed synthetic hernia mesh. The new hernia mesh failures became painfully apparent soon afterward. She began to experience pelvic pain and frequent urination. A cystoscopy confirmed fistula formation as well.

That December, James underwent an extensive surgery, lasting more than three hours, to address her serious injuries. In addition to repairing the damage from the defective surgical mesh, surgeons implanted a new Physiomesh to address the previous device’s failures.

By July 2013, the new hernia mesh had failed as well, causing damage to her bladder. Surgeons were forced to explant bits of the defective mesh before it caused even more damage. Doctors indicate that James may have to undergo additional surgical procedures to repair adhesions and scarification.

Hernia Mesh Failures, Withdrawals, and Lawsuits

Even in the face of exceedingly high rates of hernia mesh failures, causing extensive problems and revision surgeries in their wake, Ethicon refused to issue a Physiomesh recall. The defective hernia mesh continued to gather its victims in increasing numbers until June 2016. As reports of serious injuries became overwhelming, Ethicon quietly removed Physiomesh products from the market with little fanfare. While Ethicon classified it as a voluntary market withdrawal, the company asked the medical community to return all unused implants and indicated that it would not return these products to the market.

James joins a growing number of individuals in the Ethicon Physiomesh multidistrict litigation (MDL). They all raise similar allegations that the hernia mesh’s defects posed an unreasonable risk to patients. They also claim that Ethicon knew about these defects but continued to sell the device in order to protect its bottom line. Experts expect the litigation to ultimately swell to several thousand strong.

 

Monsanto Tried to Use EPA Collusion Allegations to Venue Shop for Roundup Cancer Lawsuits

by Emily Cox
Roundup Cancer Lawsuits
Federal Judge Warns Monsanto to Stop with Inane Transfer Theories (Flickr/Donna Cleveland)

In a bizarre move, Monsanto tried to use EPA collusion allegations to move state-level Roundup cancer lawsuits to more corporate-defendant friendly federal court, claiming that this collusion transforms the corporation into a federal officer despite the company’s contradictory denial of this very collusion.

The District Judge overseeing all federal Roundup cancer lawsuits slammed Monsanto’s attempt to venue shop, indicating that the company may face penalties if it continues to file “flimsy theories of removal in the future.”

Overwhelmingly, companies perceive federal courts as more corporate-defendant friendly. Consequently, it’s no surprise that Monsanto filed a notice of removal earlier this year to send a California complaint representing more than 40 people to the federal litigation. The Judicial Panel on Multidistrict Litigation (JPML) centralized the federal litigation in the Northern District of California this past October. Judge Vince Chhabri is presiding over these discovery and pretrial proceedings.

However, Monsanto also faces large numbers of Roundup cancer lawsuits in various state courts where the agrochemical giant has adequate contracts to establish local jurisdiction. Some of these states like California and Missouri are notoriously plaintiff-friendly. In fact, California and Missouri top the American Tort Reform Association’s list of “Judicial Hellholes” for tending to side with injured plaintiffs rather than corporate America. These associations have made Monsanto desperate to move these claims to friendlier federal ground.

Monsanto’s Strange Move to Transfer Roundup Cancer Lawsuits to Federal Court

In a perverse twist, Monsanto even tried to use serious allegations against itself to help its cause. Grasping at litigious straws, the weed killer’s manufacturer tried to claim federal jurisdiction based on plaintiff allegations of EPA collusion to influence the regulation of Roundup. Monsanto went so far as to claim that EPA collusion allegations somehow convert the corporation into a federal officer. Unsurprisingly, Roundup cancer lawsuit plaintiffs struck back, contending that Monsanto had no grounds to transfer the case to federal court.

Judge Chhabria agreed wholeheartedly with the plaintiffs and reprimanded Monsanto’s behavior. He issued a caustic order this past week, renouncing Monsanto’s federal jurisdiction theory as “baseless.” He pointed to the absurdity of Monsanto trying to claim federal officer status based on a relationship with the federal government that the company denies even exists. If the courts permitted this, then Monsanto is blatantly admitting to collusion. The judge went on to warn that the Court may consider fee shifting if the company continues with similar transfers.

“To be sure, evidence that Monsanto influenced the EPA may be indirectly relevant to the [question about the cancer risk with Roundup], as collusion could undermine the value of the EPA’s scientific conclusions,” wrote Judge Chhabri in the order. “But an issue is not ‘necessary’ to resolve for the purposes of federal-question jurisdiction simply because it has relevance. In this case, collusion is, at most, a means for the plaintiffs to impeach certain evidence they disagree with.”

The order and its tone may have wide-reaching implications for hundreds of Roundup cancer lawsuits currently pending in state courts. Consequently, Monsanto may have to face state court juries far before the federal litigation’s own bellwether trials.

Roundup Cancer Lawsuits

In 2015, the International Agency for Research on Cancer (IARC) classified Roundup’s main ingredient, glyphosate, as a probable carcinogen. After this announcement, lawsuits over the Roundup cancer risk began to emerge. Many agricultural workers assert that the chemical caused non-Hodgkin’s lymphoma. Furthermore, Monsanto allegedly went to great lengths to hide Roundup’s risks.

Monsanto continues to defend the safety of Roundup. The company goes as far as to assert that the chemical is “safer than table salt.”

However, worldwide experts are investigating the effects of glyphosate-based herbicides, questioning Roundup’s lack of safety warnings. In fact, earlier this month California regulators moved to require a Roundup cancer warning label as soon as next year.

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