Category: MDL

Xarelto Manufacturers Cherry Picked Early Trial Venues

By Emily Cox
Xarelto Manufacturers Cherry Picked Early Trials
Flickr/Mihir

It appears that Xarelto manufacturers may have stacked the deck against early trial plaintiffs in the multidistrict litigation (MDL) over the companies’ failure to adequately warn about the blood thinner’s dangerous bleeding risks.

Xarelto manufacturers first sought to centralize the litigation on home turf in corporate-friendly New Jersey. However, the Judicial Panel on Multidistrict Litigation (JPML) chose to consolidate federal Xarelto lawsuits in Louisiana instead. Following this decision, Xarelto manufacturers quickly devised a way to regain the upper hand in the litigation, while limiting its scope.

Lexecon v. Milberg Weiss, 523 U.S. 26 (1998), holds that MDL district judges lack the authority to try cases that originate outside of the transferee court. However, this ruling strikes at the very judicial efficiency that is at the heart of MDL formulation and the bellwether trial process. Consequently, the ruling also provides for Lexecon waivers that must be signed by both plaintiffs and defendants so that the bellwethers represent patients across the country rather than just the MDL district. Generally, these waivers are signed with little fanfare. But, they are not compulsory. Consequently, Xarelto manufacturers Johnson & Johnson and its Janssen unit used these waivers to choose their battlefields for the bellwether trial process.

Xarelto Manufacturers Refuse to Sign Lexecon Waivers

Refusing to sign the Lexecon waivers was a calculated move to limit the scope of the early trial process. According to the Lexecon ruling, Xarelto manufacturers could have hypothetically limited the litigation to only Louisiana cases. However, in an effort to keep the court’s favor, the drug makers consented to allowing plaintiffs from the entire 5th circuit. This consists of Louisiana, Mississippi, and Texas. Judge Fallon noted this concession during oral arguments on limiting the bellwether trial pool so severely.

The associated case management order also indicated that plaintiff attorneys were free to choose seven plaintiffs from states of their choosing. However, this was more of a symbolic gesture. Without the defendants signing off on Lexecon, cases outside of the 5th circuit were inherently illegible for the bellwether process regardless. Judge Fallon indicated as much during the hearing. He indicated that he would simply wash his hands of these cases, remanding them back to their original courts.

“If they [Xarelto manufacturers] don’t agree, it doesn’t matter whether or not you should try a case filed in New York or whatever,” Judge Fallon said.

“I’m going to just send them back to wherever they came from, and let you try them.”

This put plaintiff attorneys between the proverbial rock and a hard place by essentially limiting their trial picks to the 5th circuit’s three states. Their only chance for success was to pick the best defendants from those states, rather than the best overall cases. Furthermore, in conceding to accept Texas and Mississippi cases, Xarelto manufacturers not only appeased the court enough to reject plaintiff attorney objections. They also ensured these cases landed in courts that may provide some of the more favorable outcomes for the defendants in the nation.

Xarelto Manufacturers Steered MDL Litigation Toward Favorable Outcomes

Allowing Mississippi and Texas cases into the bellwether process was by no means a gesture of goodwill. All three states in the 5th circuit have provisions that could ensure that the bellwether process goes smoothly for the drug makers.

The Louisiana Learned Intermediary Doctrine absolutely annihilated the first two bellwether trials. The doctrine holds drug makers only need to inform doctors of risks, negating labeling issues. Unfortunately, plaintiff doctors vigorously defended the Xarelto manufacturers rather than their patients. Testimony depositions from the doctors in both trials read like primers for “How a prescribing physician should testify to support a learned intermediary doctrine defense.” Doesn’t sound like the drug makers had a hand in that at all

In August, the MDL moves to Mississippi. While plaintiff attorneys stand a better chance at winning here, the victory will be marginal. Mississippi imposes a $1 million cap on noneconomic damages. Most of the plaintiffs are elderly and do not work. Consequently, noneconomic damages pretty much encapsulate the entirety of their compensation. Furthermore, these early trials help establish future settlement amounts. A Mississippi victory will undoubtedly lower the potential value of these settlements.

The final bellwether trial will take place in Texas. Unfortunately, the state requires evidence of FDA fraud to bring failure to warn claims. Granted, this is a product liability litigation. However, Xarelto manufacturers’ failure to warn is the very basis of the litigation.

Consequently, due to the drug makers’ maneuvers, the Xarelto bellwethers could very well paint a bleak, if incomplete, picture of the litigation’s potential.  Plaintiffs and attorneys would do well to remember that, regardless of the bellwether outcomes, they are only a fraction of the bigger picture.

Lawsuits Against Xarelto Manufacturers

The FDA approved Xarelto in 2011 to treat atrial fibrillation and reduce blood clot risks. The agency has expanded the drug’s indications several times since then despite the fact that the drug has no reversal agent to stop emergency bleeding. Other anticoagulants, like Coumadin (warfarin) have antidotes to reverse their blood thinning effects in emergency situations. However, patients were never warned of these life-threatening risks. Regardless, Xarelto still quickly became one of the drug makers’ star performers.

Xarelto made $582 million in sales during its first full year on the market. In 2013, this figure rose to $2 billion for the fiscal year. Xarelto is now Bayer’s top-selling product. It brought in $2.5 billion in sales in 2015 and $3.24 billion in 2016. It is third on Johnson & Johnson’s product roster, generating $2.29 billion for the company in 2016. Like many meteoric climbs to come before it, sacrifices were made. Unfortunately, these sacrifices may have been the health of the very patients Xarelto was purportedly designed to help.

More than 18,000 individuals have filed product liability lawsuits against Xarelto manufacturers after suffering from uncontrollable, life-threatening bleeding. They allege that the drug makers knew about the substantial risks of the anticoagulant but never warned patients. Instead, the companies downplayed the risks to boost sales.

Benicar Lawsuits Filed by Almost 2,000 Over Gastrointestinal Problems

By Emily Cox
Benicar Lawsuits
Benicar Litigation Continues to Grow. (Flickr/Martin Bowling)

Almost 2,000 Benicar lawsuits are now pending against Daiichi Sankyo and Forest Laboratories over the drug makers’ failure to warn the medical community, patients, and federal regulators about the popular blood pressure drug’s risk of chronic diarrhea and gastrointestinal problems.

According to this week’s docket update, there are now 1,942 Benicar lawsuits pending in the multidistrict litigation (MDL). However, historically, there have been 2,254 lawsuits against the drug manufacturers, and lawsuits continue to mount. These lawsuits all indicate that the drug makers knew about the connection between Benicar and gastrointestinal distress, including debilitating diarrhea. However, these companies concealed this risk for years in order to maximize profits at the expense of patients who might not have wished to incorporate uncontrollable diarrhea into their daily blood pressure regulation regimen.

Some plaintiffs allege that Benicar caused them to have 10 to 20 diarrhea attacks per day. Therefor, this led to malnutrition and the loss of up to 100 pounds. As a result, others experienced malnutrition complications such as cataracts and infections. A few have even died from the severity of their gastrointestinal issues and related complications.

Furthermore, gastrointestinal issues from Benicar may not surface immediately. It could take months, or even years, after patients start taking the drug. Consequently, many doctors didn’t recognize that Benicar was causing these issues. So, patients remained on the drug, increasing the risk of permanent intestinal damage, known as villous atrophy.

Benicar Lawsuits Litigation

Finally, in July 2013, the FDA mandated the drug manufacturers update Benicar warnings. The agency indicated that there was unmistakable evidence that the drug may cause severe diarrhea problems. As patients began to realize that Benicar was causing their gastrointestinal issues, they began seeking retribution for the harm these companies inflicted willfully on them for financial gain. In 2015, the Judicial Panel on Multidistrict Litigation (JPML) centralized all federal Benicar lawsuits in the District of New Jersey. District Judge Robert Kugler is presiding over the litigation.

The MDL presses forward this week with Daubert hearings to establish scientific grounds for plaintiff claims. Depending on the outcome of these hearings, the court will schedule a series of bellwether trials. These early trials will help gauge how future juries will likely react to evidence that is central to the litigation.

 

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’.

 

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.

Prolift Pelvic Mesh Released Without FDA Clearance

By Emily Cox
Prolift Released Without FDA Clearance Despite Poor Clinical Trial Results
Ethicon can’t be bothered by trivial details like FDA clearance and clinical trial results (Flickr/Mick Licht)

Expert testimony from the latest pelvic mesh trial indicates that the FDA wasn’t even aware of the Prolift device’s existence before Ethicon unleashed the defective product on unsuspecting patients despite poor clinical trial results.

In late May, a Philadelphia jury awarded Sharon Beltz $2.16 million for the pain and suffering that she will have to endure for the rest of her life as a result of the Prolift mesh. Surgeons are not even able to remove the defective mesh to address her corresponding injuries.

“Mrs. Beltz’s problems are thus permanent. She may elect to undergo further pain injections, resection of the mesh, or start taking pain medications regularly, but these options at best will only mitigate her symptoms. Mrs. Beltz has to live the remainder of her life with constant pelvic pain, a sensation her bladder is pulling, urinary incontinence and retention, lower flank pain, urinary tract infections, and severe pain with sex that lingers days after she has intercourse,” court papers said.

“She will be at risk for exposure of the mesh in her vagina and erosion of the mesh into her bladder, urethra, or other organs for the remainder of her life.”

In 2012, Ethicon withdrew four of its transvaginal mesh devices, including the Prolift device, from the market. However, the company maintains that this decision was the result of “changing market dynamics” rather than liability concerns. This isn’t an entirely inaccurate characterization. More than 54,000 pelvic mesh injury lawsuits against Johnson & Johnson and Ethicon is quite the  “changing market dynamic” indeed.

FDA Wasn’t Notified of the Prolift Mesh’s Existence

Expert witness Dr. Peggy Pence produced a report heard at the trial, indicating that Johnson & Johnson and its Ethicon unit never applied for premarket clearance or even notified the FDA of the Prolift device’s existence before launching it in 2005. In her report, Dr. Pence claimed that the manufacturers misbranded and adulterated Prolift due to inadequate 510(k) premarket clearance. 510(k) is a premarket submission made to the FDA to demonstrate that a device is at last as safe and effective, or substantially equal, to a device that the agency has already approved.

According to court documents, the FDA approved another Ethicon product, the Gynecare Gynemesh PS, under 510(k) guidelines. This means that Gynemash was substantially equivalent to a product already on the market and performing satisfactorily. However, manufacturers never applied for 510(k) clearance for the Gynecare Prolift Pelvic Floor Repair System even though the companies characterized it as a line extension of the Gynecare Gynemesh PS. Consequently, Dr. Pence alleged that the FDA wasn’t notified of the Prolift’s existence. This eliminated the agency’s ability to regulate the device to ensure patient safety.

Ethicon Released Prolift Despite Dismal Premarket Study Results

Given the device’s performance in Ethicon’s premarket studies, it’s no wonder that the manufacturers didn’t seek FDA clearance. The agency never would have granted approval based on performance.

Ethicon performed two, non-randomized and non-controlled studies the year before it launched Prolift. The company conducted these studies at eight sites in France and three sites in the U.S. Twenty percent of the French study participants experienced painful intercourse after receiving the mesh implant. Overall, 25.6 percent participants in the French study experienced transvaginal mesh complications, and 65.9 percent of U.S. patients experienced similar adverse events.

Even knowing the high likelihood of complications from these studies, Ethicon Prolift entered the market in 2005 without FDA 510(k) clearance. Court records note that Ethicon tried to claim that Prolift pelvic mesh was a custom device and, therefore, exempt from 510(k) premarket clearance. However, Pence took exception to this characterization. She stated that neither the Prolift device, or instruments designed for Prolift implantation, were custom. Consequently, the device required 510(k) notification to enter the market.

“Ethicon marketed a product that violated safety and ethical standards,” she concluded.

Prolift and Other Pelvic Mesh Lawsuit Background

Pelvic mesh products treat female pelvic organ prolapse and/or stress urinary incontinence. In 2008, the FDA issued an alert that the devices were connected to at least 1,000 serious injury reports during a three-year period. These injuries include erosion, scarring, adhesions, infections, vaginal bleeding, organ perforation, and recurrent of prolapse or incontinence. And, this was just the beginning.

In 2011, the FDA reported that there were now more than 2,800 reports related to pelvic mesh. These reports included injury, death, and malfunction. The agency also indicated that there was little evidence that transvaginal mesh was more effective than non-mesh repair. Furthermore more, the products may expose women to unnecessarily to harm.

Since then, the FDA has strengthened transvaginal mesh requirements for pelvic organ prolapse repair. Among other safeguards, these devices are no longer eligible for the agency’s 510(k) clearance program.

 

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