Pelvic Mesh Products Approved with No Clinical Trials in U.S.

By Emily Cox
Pelvic mesh products
Flickr/StickerGiant

New research indicates that stronger regulatory oversight could have prevented hundreds of thousands permanent, painful, and debilitating injuries from pelvic mesh products that the FDA approved with little research and no clinical trial data.

Oxford University researchers published their findings in The BMJ Open medical journal on December 6. The study suggests that the FDA approved more than 60 pelvic mesh products with little to no research to establish safety or effectiveness. Consequently, researchers indicate that regulatory failures are partially to blame for the vaginal mesh problems and injuries that have ruined thousands of lives.

The study looked at data on 61 devices the FDA approved through its controversial 510(k) “fast-track” approval program. The program only requires manufacturers show that devices are “substantially equivalent” to products the agency has previously approved. Researchers found that all the devices received approval by tracing their lineage back to a mere two devices. The Ethicon Mersilene Mesh received traditional approval back in 1985. The FDA approved the Boston Scientific ProteGen Sling in 1996.

However, researchers note that there is no logical basis for establishing equivalency with these older devices. The newer pelvic mesh products used new technology, materials, and designs. Consequently, the fact that these devices were drastically different in pretty much everything other than function should have raised red flags among regulators.

No Pelvic Mesh Products Underwent Clinical Trials

The study also found no clinical trials evidence for any of the 61 devices that showed they worked or were even safe before the FDA approved them. Furthermore, the researchers also found that the FDA later called for clinical trials in 119 cases. In those cases, 66 percent of manufacturers immediately yanked the device from the market, and 22 percent changed the device’s indication instead of subjecting it to intense scientific study.

Out of all these cases, only seven studies went as far as the recruitment process. However, none ever actually reported their outcomes.

“Transvaginal mesh products for pelvic organ prolapse have been approved on the basis of weak evidence over the last 20 years,” the researchers concluded. “Devices have inherited approval status from a few products. A publicly accessible registry of licensed invasive devices, with details of marketing status and linked evidence, should be created and maintained at the time of approval.”

Pelvic Mesh Products Lawsuits

Due to these regulatory failings, these devices have permanently maimed hundreds of thousands of women. Consequently, a tidal wave of transvaginal mesh lawsuits has come crashing through America’s court system. With little to no safety research or studies, substantial design defects slipped through cracks. These defects have left women with serious, often permanent complications. These include chronic pain, nerve damage, infection and loss of sexual function, as well as organ erosion and perforation. Erosion and perforation also can prevent the complete retrieval of the device, leaving toxic plastic behind in the damaged tissue.

Also, there’s evidence that these regulatory issues are not exclusive to the US. There appears to be a worldwide phenomenon of these agencies failing the citizens they’ve sworn to protect. These failings have only served to further corporate interests and profits. As a result, the pelvic mesh products litigation is one of the largest mass torts in recent years.

Currently, the most recent U.S. vaginal mesh trial is underway in New Jersey. The plaintiff rested her case this past Thursday, and defendants Johnson & Johnson and its Ethicon unit are expected to present their case throughout this week. Most expect a jury verdict sometime next week. So far, U.S. juries have found overwhelmingly for pelvic mesh plaintiffs, awarding multi-million dollar verdicts. Jurors have almost unanimously found that the manufacturers knowingly marketed these dangerous devices for financial gain.

Vaginal Mesh Investigation Set to Blow Lid Off J&J Implant Scandal

By Emily Cox
Vaginal Mesh Investigation
Flickr/Balint Földesi

A BBC Panorama vaginal mesh investigation is set to reveal that Johnson & Johnson subsidiary Ethicon failed to tell doctors about the implant’s permanent, painful, and debilitating side effects.

Panorama is the world’s longest running investigative current affairs documentary program. The findings of its vaginal mesh investigation will air Monday night. The program documents substantial conflicts of interest, negligent clinical trials, and weak regulatory systems that led to thousands of women to receiving a patently unsafe and dangerous implant. Furthermore, as Ethicon became increasingly aware of serious complications, the medical giant didn’t update doctors about the extent of the risks for its leading mesh device, Gynecare TVT.

The vaginal mesh investigation also discovered a shocking lack of clinical testing for the device. Ethicon launched the implant after only testing it on 31 women for five weeks and in sheep. Ethicon quietly withdrew the dangerous device from the market in 2012. However, not before thousands of women were already experiencing chronic pain and permanently debilitating conditions from the defective device.

Since the late 1990s, surgeons have used these implants to treat minor incontinence and prolapse in women. The insertion procedure for the net-like devices is non-invasive and quick, but the complications are anything but.

The program is airing just more than a week after Christina Brajcic, 42, of Ontario, Canada, lost her fight to mesh complications. Brajcic was the first woman to officially die from the dangerous implants. But, hundreds of thousands more women are now unable to walk, work, or even sit down from device complications. These include chronic pain, nerve damage, and loss of sexual function, as well as organ erosion and perforation. Consequently, some of these women even report feeling suicidal.

Vaginal Mesh Investigation Into Instructions for Use Leaflet

Panorama found that an associate medical director at Ethicon warned that the instructions for use (IFU) leaflet for Gynecare was insufficient. The IFUs were designed to teach doctors how to insert the implants. They also detailed the implant’s risks so that doctors could explain these to patients.

At the time, the leaflet indicated that the side effects were “transitory,” but countless women continue to experience permanent complications.

“From what I see each day, these patient experiences are not ‘transitory’ at all,” the associate medical director wrote in an email.

Ethicon took this under advisement. But, the company ultimately decided not to warn that the complications could be permanent. Rather, Ethicon decided the leaflet wording, including the word “transitory,” was “appropriate for the intended users – trained pelvic floor surgeons” after reviewing complaints. Consequently, surgeons continued to remain in the dark as to the permanency and severity of Gynecare’s complications.

BBC Panorama interviewed Dr. Wael Agur, a consultant urogynaecologist, to determine how much surgeons rely on the information for use leaflet.

“It’s so important for me as a surgeon to understand full the risks of a medical device I’m about to implant during a surgical procedure, and my first resource would be the instructions for use,” he said.

“I would expect the manufacturer to have a comprehensive list of the adverse events and the risks within the instructions for use, so I fully understand these and communicate them.”

Vaginal Mesh Investigation Puts a Face to U.S. Pelvic Mesh Litigation

Back in September 2017, a Pennsylvania jury ordered Ethicon to pay Ella Ebaugh $57 million for her lifelong sentence to constant, excruciating pain from its Gynecare TVT device. However, Ethicon is still trying to dodge accountability for maiming thousands of women worldwide and is appealing the verdict.

Ebaugh received the vaginal tape in May 2007 to help cure mild incontinence. When her condition didn’t improve, physicians implanted a second TVT device. By 2011, she was in severe pelvic pain and having sudden urinary urges. Physicians found that the mesh had eroded into her urethra, literally mangling it. Ebaugh underwent a series of extensive surgical interventions. However, doctors were unable to repair all the mesh’s damage or even remove all the polypropylene materials from her body. As a result, Ebaugh’s continued chronic pain has left her needing a walking stick and mobility scooter.

“If I was told that I would need a wheelchair to get around, if I was told that I was going to live with permanent disabilities for the rest of my life, I wouldn’t have had a surgery for a simple stress urinary incontinence problem,” Ebaugh told Panorama in her first UK interview.

“The pain that I have I will have to live with for the rest of my life. There’s nothing they can do to help me,” she added.

Ebaugh’s verdict is the largest to come out of Pennsylvania’s mass tort pelvic mesh program so far. However, the latest trial launched Nov. 27 in New Jersey and should last until Christmas. This trial is also focusing on claims that Johnson & Johnson and Ethicon knew their vaginal mesh products were unreasonably dangerous but pushed them on unsuspecting women anyway to line their already considerable coffers.

Veterans’ Opioid Lawsuits Could Be Among Strongest in Litigation

By Emily Cox
veterans opioid lawsuits
Flickr/Beverly

Opioid litigation insiders are already projecting that veterans’ opioid lawsuits will have a lot of traction when individual cases begin transferring into the newly established multidistrict litigation (MDL).

The Judicial Panel on Multidistrict Litigation (JPML) centralized all local government opioid lawsuits Dec. 5 before Judge Dan Polster in the Northern District of Ohio. So far, all 155 cases are from government entities. However, the panel acknowledged that far more cases from a wide variety of plaintiffs and defendants will probably come forward in the future to join the litigation. It is likely that Judge Polster will establish different tracks within the MDL to separate different claims and parties. Individuals coming forward to take opioid manufacturers and distributors to task for profiting from addiction will undoubtedly be one of these tracks. And, veterans’ opioid lawsuits could be among the strongest among these cases. The predatory practices of the manufacturers who egregiously exploited veteran vulnerabilities for financial gain coupled with negligence from the VA irrefutably put veterans at significantly higher risk for opioid addiction than the general population.

Veterans’ Opioid Lawsuits

Recently, the VA has come under fire for its role in fueling the veteran opioid epidemic that is killing our soldiers after they come home from action. Newsweek reports that the VA recklessly overprescribed opiates for more than a decade. By 2011, veterans were twice as likely to die from an accidental opioid overdose as their civilian counterparts. To address the issue, the VA began frantically instituting mandatory opiate cutoffs for veterans with chronic pain. This initiative has also faced scrutiny for being a potentially unsafe approach, and vets are still dying from overdoses. In October, parties reached a $2.3 million settlement for an opioid overdosing at a VA medical center that resulted in the death of a former Marine. The VA has been the primary target in veterans’ opioid lawsuits so far. But, it’s only part of the story behind the veteran opioid crisis.

Pharmaceutical Companies’ Role in Veterans’ Opioid Lawsuits

Purdue Pharma played a key role in spreading opiate use among veterans. The OxyContin manufacturer gave $200,000 to the VA pain management team to essentially create propaganda. Their efforts resulted in the initial VA – Department of Defense guideline material that concluded opiates “rarely” cause addiction. Purdue’s 2001 marketing budget plan also praised that “additional corporate initiatives and partnering efforts were very successful Veterans Administration.”  The plan also praised other major health organizations for promoting the fraudulent “Pain: The 5th Vital Sign” campaign. However, targeting the VA was not a novel initiative on Purdue’s part.

In October, the City of Paterson filed a lawsuit against some of the country’s largest drug companies. Paterson lists Purdue Pharma, Teva Pharmaceuticals, Johnson & Johnson, Janssen Pharmaceuticals, Endo Pharmaceuticals, and Insys Therapeutics as defendants. The claim alleges that these opioid manufacturers targeted veterans with chronic pain due to their specific susceptibility to opiate dependency.

Pharmaceutical Companies Preyed on Veterans’ Underlying Issues

Sixty percent of veterans who fought in the Middle East and 50 percent of older veterans have chronic pain. Veterans with chronic pain have much higher rates of compounding conditions like post-traumatic stress and traumatic pain injury. These conditions contribute significantly to pain-management challenges. Furthermore, their pain is generally connected to traumatic events. This trauma can affect one’s ability to cope with physical discomfort and manage pain. If the trauma is not well-managed, then chemical dependency can become an issue.

“The opioids help ameliorate that anxiety,” Dr. Peter Abaci, the medical director of Bay Area Pain and Wellness Center in Los Gatos, Calif., and author of Conquer Your Chronic Pain: A Life-Changing Drug-Free Approach for Relief, Recovery, and Restoration said. “It takes over everything – the decision making and how they feel – and they latch onto that. It’s the only thing to calm them down, and they can potentially develop addiction from there.”

Consequently, it’s imperative to treat also these underlying conditions before addiction can take hold. However, VA medical centers often don’t have the resources to bring in counselors, psychologists, dieticians, physical therapists, and other professionals to supplement patients’ treatment protocol. Pharmaceutical companies were more than happy to exploit this, swooping in with a solution that saved the VA tons of time and money, while endangering millions of those injured while defending our country. Opioid manufacturers knew that there was a tendency towards chemical dependency if veterans’ underlying issues remained untreated while taking these highly addictive pain medications. And, these reprehensible companies squeezed every dollar they could out of it. Now, exploited veterans will get a chance to squeeze back. After all these heroes have sacrificed, they deserved far better and hopefully they’ll get it.

 

 

 

 

 

 

 

Non-Hodgkins Lymphoma Claims Against Monsanto Continue to Mount

By Emily Cox
non-hodgkins lymphoma
Flickr/Mike Mozart

On the heels of the European Union approving the use of the controversial weed killer glyphosate for the next five years, individuals continue to surge forward with claims that the herbicide causes non-Hodgkins lymphoma.

Patricia Lashock filed the most recent of these claims Thursday, claiming severe and permanent harm from the weed killer. She alleges that she developed non-Hodgkins lymphoma after using glyphosate-containing products, including the Roundup, from 1977 to 2010. Lashock joins hundreds of other individuals asserting that Monsanto falsified scientific studies and colluded with worldwide regulators to hide glyphosate’s substantial health risks. Furthermore, internal Monsanto documents indicate that the manufacturer knew Roundup could cause cancer and non-Hodgkins lymphoma.

“If somebody came to me and said they wanted to test Roundup I know how I would react – with serious concern,” a Monsanto scientist confided in a 2001 internal email.

Glyphosate is the primary ingredient in Roundup and the best-selling herbicide in the world. However, this should come as no surprise. Monsanto essentially owns the global seed market. It has made sure that the majority of its seeds are glyphosate dependent, making worldwide agriculture Monsanto dependent.

Consequently, despite substantial indications that glyphosate causes non-Hodgkins lymphoma and even an official carcinogenic classification from the World Health Organization, the EU bowed to this dependency this past week when it voted to extend its authorization for glyphosate for an abbreviated five-year period. However, the deliberations over the extension were unusually lengthy and combative. Monsanto’s tainting of glyphosate scientific reviews with its meddling was a particular point of contention.

France led the opposition to allowing the use of glyphosate to continue. French President Emmanuel Macron announced after the vote that he had requested government officials to come up with a plan to ban the herbicide in his country within three years.

Round-up Non-Hodgkins Lymphoma Federal Litigation

Lashock’s case will join hundreds of other similar cases pending in the federal multidistrict litigation (MDL).  In October 2016, the Judicial Panel on Multidistrict Litigation (JPML) consolidated all Roundup non-Hodgkins lymphoma lawsuits. Judge Vince Chhabria is presiding over the litigation in the Northern District of California. Due the complexity of the litigation and number of plaintiffs, the panel felt that judicial efficiency would be best served through centralization. This reduces duplicate discovery and conflicting rulings that can further bog down these already complicated proceedings.

Judge Chhabria previously 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. Expert testimony for this portion of the pretrial process begins March 5, 2018. The court will then move on to case-specific issues to determine if Roundup caused the cancer of specific plaintiffs. As a result, it is possible that the first state court trials will begin ahead of the federal trials.

 

 

 

 

Opioid Lawsuits Receive Centralization in Northern Ohio

By Emily Cox
Opioid lawsuits
Flickr/Cindy Shebley

As the opioid crisis continues to ravage the country, the Judicial Panel on Multidistrict Litigation (JPML) has elected to centralize the corresponding torrent of opioid lawsuits filed by various local governments.

Five days after the panel heard arguments on consolidation in St. Louis, the JPML reached its decision Tuesday. The panel has centralized the landmark litigation before Judge Dan Polster in the Northern District of Ohio. The transfer order effects 155 cases from 25 different courts.

The panel indicated that, although individual issues may still arise, they don’t negate the efficiency inherent to centralization at this early stage. Furthermore, the opioid lawsuits all implicate questions of common fact that these pharmaceutical companies engaged in substantially harmful marketing practices and widespread diversion. The panel acknowledged that far more suits with a wide variety of plaintiffs and defendants were likely to come forward. Consequently, the JPML suggested Judge Polster should consider establishing different tracks within the multidistrict litigation (MDL) to separate out different claims and parties.

“All of the actions can be expected to implicate common fact questions as to the allegedly improper marketing and widespread diversion of prescription opiates into states, counties and cities across the nation, and discovery likely will be voluminous,” the panel said. “In our opinion, centralization will substantially reduce the risk of duplicative discovery, minimize the possibility of inconsistent pretrial obligations, and prevent conflicting rulings on pretrial motions.”

The JPML chose the MDL’s venue in part due to Ohio’s substantial number of opioid-related overdoses and the state’s expenditures of massive sums to deal with the crisis. Furthermore, the district is geographically central and relatively close to defendants’ headquarters. Also, Polster’s previous MDL experience in managing several hundred cases over gadolinium contrast dyes further recommended his court going forward with the opioid lawsuits.

Opioid Lawsuits

The MDL’s lawsuits assert that opioid manufacturers grossly overstated the drugs’ benefits while downplaying their substantial risks to essentially saturate the entire country with their highly addictive pain pills. Some government entities are also pointing the finger at distributors. They claim distributors cashed in on Big Pharma’s depraved marketing scheme by consciously failing to report, or even monitor, suspicious drug orders.

Many believe that the opioid crisis litigation mirrors the tobacco lawsuits of the 1990s. Just like Big Tobacco, Big Pharma allegedly began pushing fraudulent research to show their products were not addictive to massively expand market share. Others are also criticizing the federal government’s inaction to address a problem that could take down the U.S. as a major world power. Addict care and law enforcement efforts come down primarily on local governments and taxpayers. So, it’s finally come to the point of the quintessential straw that breaks the camel’s back. Resources to address the crisis are being stretched to the max. Consequently, lawsuits will have to take up the slack to bring these drug companies to heel.

“If I’m right, that this was a massive fraud, we should not be the ones who are bearing [the cost],” a leading opioid attorney said.

“It ought to be Big Pharma.”

Consequently, he was reluctant to escribe “epidemic” to the opioid problem as the situation was purposefully devised by the pharmaceutical industry to create it.

These are “large companies pouring large amounts of money to lie to people,” he continued. However, he remains optimistic that an opioid MDL may lead the way to a brighter tomorrow.

“It is an incredible thing to witness,” he said. “Everybody is collaborating to come together to find a solution.”

Overdoses Behind the Opioid Lawsuits

In 2016, more than 60,000 Americans lost their lives to drug overdoses. Also, from 2013 to 2016, there was a five-fold increase in prescription painkiller drug deaths. In 2013, the death toll was 3,105. By 2016, prescription pain pill killer deaths had skyrocketed to 20,101 people in the U.S. That’s more than the total casualties from 9/11, and the Iraq and Afghanistan wars combined. …And, it’s turned into an annual thing. The Centers for Disease Control Prevention reports that 145 Americans are dying daily from opioid overdoses.

While you can’t put a price on human lives, the Medical Care Journal did in October 2016. Its study put the economic cost of opioid abuse, dependency, and overdose at $78.5 billion. Most of these costs are on the shoulders of taxpayers and local government entities. Furthermore, the Council of Economic Advisers released a report this month. They indicate that the total toll of the opioid crisis cost the American economy $504 billion in 2015. This is equivalent to 2.8 percent of gross domestic product for that year.

Disputes in the Opioid Lawsuits MDL

While most parties involved in the litigation pushed for centralization, there were some disagreements on the venue. Approximately 40 claims requested various courts across the nation. Meanwhile, 46 of the lawsuits argued that the MDL should be in either the Southern District of Ohio or the Southern District of Illinois.

The bulk of defendants also sought consolidation. The three major opioid distributors facing lawsuits, AmerisourceBergen Corp., McKesson Corp., and Cardinal Health, sought centralization in the Southern District of West Virginia. Meanwhile, several of the manufacturers were looking toward the Northern District of Illinois or the Southern District of New York.

Phizer Inc. argued that the panel should be exclude it altogether from any MDL. The Big Pharma giant based its reasoning on the fact that it has beat all five of the government suits it has faced. However, since the company has no pending cases, the panel didn’t address its concerns.

About 15 additional plaintiffs argued against consolidation or just that their suits be left out of the MDL. Among these was the city of Chicago. In 2014, Chicago was the first to sue over opioids.  Counsel for Chicago expressed concerns that it would have to revisit “painfully negotiated” issues. At the least, the city requested that it could complete document discovery before sending a case into the MDL. But, the JPML has denied this request.

Everett, Washington also opposed centralization. The city sued drug makers earlier this year. Counsel for the city said that the crisis was too dangerous to test the limits of the MDL construct.

“This is not a case to test these waters,” he said during oral arguments. “People are dying every day.”

 

 

1st Xarelto Loss Slams J&J and Bayer with $29M Verdict

By Emily Cox

Xarelto Loss

The Philadelphia Xarelto trial was the first of its kind and could prove to be a significant turning point in the litigation. It was not only the first to go before a jury outside of the ongoing federal multidistrict litigation (MDL). It’s now also the first to successfully take Johnson & Johnson and Bayer to task for actively hiding life-threatening bleeding risks associated with their billion-dollar blood thinner. In the first Xarelto loss, the jury awarded $29 million in damages for the manufacturers risking patients’ lives for financial gain.

The verdict substantiates an Indiana woman’s claims that she suffered serious gastrointestinal bleeding due to the medication. However, three previous juries in the ongoing MDL sided with the companies earlier this year over these same types of risks.

Plaintiff Lynn Hartman alleges she had to undergo four blood transfusions to counteract Xarelto’s dangerous bleed-out effects. Furthermore, these bleeding issues completely resolved when she switched to another blood thinner.

Hartman is only one of 1,500 individuals with cases pending in Philadelphia Court of Common Pleas’ mass tort program. These cases allege that J&J and Bayer consciously hid Xarelto’s significant bleeding risks. These subversive marketing tactics skyrocketed the blood thinner to the tops of their mutual pharmaceutical rosters. However, time and again federal juries have failed to make these companies take responsibility for their reprehensible actions. Consequently, the Pennsylvania program has taken matters into its own hands to consolidate Xarelto claims outside of the decidedly defense-favoring MDL.

Xarelto Loss Trial

Hartman’s trial focused on claims that J&J subsidiary Janssen Pharmaceuticals and Bayer intentionally mishandled and misrepresented clinical trial results to promote the blockbuster blood thinner. During opening arguments, attorneys focused on the companies rigging a clinical trial. The clinical trial compared the drug’s efficacy and safety to warfarin. Warfarin (Coumadin) has been anticoagulant go-to for decades. Janssen and Bayer were aggressively seeking to dethrone the traditional blood thinner. So, the companies loaded the trial with Eastern Europe patients where physicians more frequently mishandle warfarin dosing.

“They made sure the warfarin patients did not receive the right amount of medicine, and they did it on purpose,” attorney Ned McWilliams said.

Consequently, warfarin users appeared to suffer similar rates of bleeding incidents and strokes as Xarelto users. But, when North American data was isolated, Xarelto users who experienced serious adverse effects were significantly higher than warfarin patients. The rate among U.S. participants was 8.1 percent annually versus 3.6 percent annually among global participants. Despite knowing that Xarelto was considerably more dangerous than warfarin, the companies continued to conceal this information, sacrificing patients for profits.

“They intentionally rigged a clinical trial, so they could make billions of dollars,” McWilliams said.

The correct data would not appear on Xarelto’s label until September 2015. As a result, doctors were unaware of Xarelto’s comparative risks when prescribing the medication.

Further Condemning Evidence in Xarelto Loss

Hartman’s attorneys indicated that the companies failed to warn about the significantly higher risk of bleeding when using Xarelto with aspirin. They also didn’t inform doctors that some patients end up with significantly higher blood levels of the medication than others. Instead, J&J and Bayer continued to insist that blood testing was unnecessary to make Xarelto appear more convenient than warfarin. Warfarin requires regular blood testing to ensure safe dosages. However, J&J and Bayer forewent these safety measures for the sake of a successful marketing campaign.

Furthermore, attorneys claim Xarelto’s risks are significantly higher than Eliquis and Pradaxa. These are other popular new generation anticoagulants.

“Xarelto is the worst in class of the new blood thinners,” said an attorney for Hartman. “The serious health complications suffered by thousands of patients could have been avoided if physicians were properly instructed about the risks, and if patients were given the choice to switch to Eliquis and Pradaxa, which are safer and far more effective.”

Former FDA chief David Kessler added yet more fuel to the fire during his trial testimony. Kessler told jurors that Xarelto’s warning label lacked critical information about the severity of the drug’s potential bleeding risks.

Xarelto Loss Going Forward

As a result of the overwhelming evidence, the Philadelphia jury ordered J&J and Bayer to pay $1.8 million in actual damages and $26 in punitive damages. The jury levied these punitive damages to punish J&J and Bayer for exploiting patients and physicians to further their own financial interests. Xarelto is now Bayer’s top-selling product. It generated $3.2 billion in sales last year alone. Xarelto is J&J’s third-biggest seller, bringing in $2.3 billion in 2016. This goes a long way to replace J&J’s profits from its Remicade arthritis treatment, which lost patent protection a year ago. These lost profits are a large part of J&J’s devious mechanizations to fraudulently market Xarelto.

The companies announced Tuesday that they plan to appeal the Xarelto loss. However, many are speculating that this could be a turning point in the litigation. And, the companies still face more than 20,000 cases pending in the federal proceedings and 1,500 in Pennsylvania state court.

 

 

Toxic Mesh Deemed Unreasonably Dangerous

By Emily Cox
Toxic Mesh
Flickr/Eek the Cat

A new product liability lawsuit over substantial defects with Bard Perfix hernia mesh alleges the toxic mesh caused severe complications and inflammation. Ultimately, additional risky and painful surgical procedures were necessary to remove the dangerous mesh.

Bruce C. Baptist filed the complaint on November 17 in the Eastern District of Louisiana. Baptist indicates that C.R. Bard and Davol knew that the Bard Perfix mesh was unreasonably dangerous and toxic. Consequently, the hernia mesh poses serious health risks following implantation that require additional invasive surgeries to address.

Surgeons implanted the toxic mesh into Baptist’s body during hernia repair surgery in November 2015. According to his lawsuit, the human body attacks the hernia mesh as a foreign substance. The sterilization process further damages the already defective mesh, causing it to degrade and weaken. Consequently, the toxic mesh releases a number of harmful chemicals into the body.

“Defendants’ polypropylene surgical mesh is made of woven polypropylene which is a cheap plastic that degrades and erodes through tissue once implanted,” the lawsuit states. “The woven design of polypropylene surgical mesh creates small pores or holes. Nerves grow into the small pores or holes and attach to polypropylene surgical mesh soon after implant. As polypropylene surgical mesh erodes, polypropylene surgical mesh pulls and stretches the attached nerves causing debilitating pain.”

Baptist further indicates that an unacceptable number of reports link the toxic mesh to numerous other complications. These include erosion, tissue reactions, organ perforation, bleeding, severe pain, shrinkage, infection, and hernia recurrence, as well as mesh migration and degradation. Furthermore, his lawsuit indicates that it is often difficult or impossible to completely remove the mesh.

Toxic Mesh Litigation

Baptist joins a growing number of individuals filing similar hernia mesh lawsuits alleging dangerous mesh toxicity and debilitating design defects with the popular surgical hernia repair products. Most of the currently pending cases involve Atrium C-Qur or Ethicon Physiomesh. However, increasingly people are taking Bard to task for similarly defective devices.

The FDA approved Atrium C-Qur in March 2006. The device features a polypropylene mesh with an Omega-3 gel outer coating. But, significant injury reports connect this “protective” coating to infections, allergic reactions, and other substantial problems necessitating further surgeries.

Johnson & Johnson’s Ethicon unit introduced its Physiomesh in March 2010. The massively defective product featured a unique, multilayer design that produced substantially higher profit margins. However, it failed spectacularly on returns on investment when it came to patient health. Amidst outrageously high failures, the manufacturers quietly withdrew the product from the global market in March 2016.

As the toxicity of these mesh products becomes more and more clear, the FDA continues to protect Big Pharma over injured U.S. patients with its inaction against these dangerous devices.

 

Century Fox Reaches Landmark $90M Investor Settlement

By Emily Cox
Century Fox
Flickr/Logoprof

According to an agreement filed Monday in Delaware state court, Twenty-First Century Fox Inc. reached a $90 million deal to settle derivative claims from investors over a series of sexual harassment incidents at Fox News. The settlement also requires the media outlet to create an advisory council to improve workplace culture.

The agreement requires third-party insurers of Fox News Chairman Robert Murdoch, the estate of former CEO Roger Ailes, and Twenty-First Century Fox board members to pay $90 million back to the company. Furthermore, shareholders claim board members failed to acknowledge a culture of rampant sexual harassment at Fox News.

Fox reached the deal as reports of sexual misconduct in the entertainment industry continue to skyrocket. The lead plaintiff is Michigan-based City of Monroe Employees’ Retirement System. The entity engaged in more than a year of discovery before Fox struck the settlement. The plaintiff’s lawyer is hailing the settlement as a historic step in addressing sexual harassment, discrimination, and retaliation in the workplace.

“For far too long, corporate leaders failed to act against harassing conduct in their midst by treating it as isolated incidents,” the attorney said in a statement. “The events giving rise to this case and the stream of reported misconduct by powerful individuals in the media industry and beyond show that corporate boards have an obligation to implement policies and structures that will protect current and future employees from the widespread improper abuse of the past.”

In addition to monetary provisions, the agreement will require the implementation of the Fox News Workplace Professionalism and Inclusion Council. The council will provide the company with top-tier guidance on inclusion, diversity, and how to better its workplace environment.

Century Fox Sexual Harassment Allegations

Fox News sexual harassment stories began to leak last July when TV host Gretchen Carlson sued Ailes in New Jersey state court. According to her complaint, Carlson was fired for speaking up and defending herself against Ailes’ inappropriate, sexually harassing comments. In response, Twenty-First Century Fox fired Ailes and agreed to settle Carlson’s lawsuit for $20 million. Ailes died in May.

According to court documents, Ailes had also targeted other women at Fox. These included Megyn Kelly and Rudi Bakhtiar. Furthermore, former host Andrea Tantaros filed a claim against Fox News and several network leaders while Carlson’s suit was ongoing.

Six months after Fox News ousted Ailes, Bill O’Reilly struck a massive sexual harassment settlement. The popular host agreed to pay $32 million to Lis Wiehl, a longtime network analyst to settle sexual harassment allegations. These included allegations of continual harassment, a nonconsensual sexual relationship, and sending gay pornography and other sexually explicit material to Wiehl. Furthermore, this was at least the sixth, and largest, agreement O’Reilly or Fox have made to settle harassment allegations against him. In the midst of these continual lawsuits, Fox granted O’Reilly a four-year contract extension for $25 million a year. The network only finally ousted the host when some of the settlements and allegations became public. After leading advertisers began to boycott his show, Fox forced the controversial host out to protect the company.

Century Fox Derivative Action Claim

In conjunction with the settlement, a derivative action was filed Monday against Ailes, Murdoch, his son and CEO James Murdoch, his son and Executive Chairman Lachlan Murdoch, and other members of the Century Fox board. Claims include breaches of fiduciary duty against Murdoch and directors. There is also an unjust enrichment claim against Ailes’ estate.

Shareholder court documents indicate that the City of Monroe system served a demand for books and records to Century Fox mere weeks after Carlson filed her complaint.

“The public revelations of the toxic culture since July 2016 have led not only to numerous sexual harassment settlements and racial discrimination lawsuits, but to departures of talent and damage to good will,” the complaint says. “This, in turn, has caused damage to the Company’s reputation and good will, as well as significant financial harm.”

The shareholders claim that breaches in fiduciary duty caused at least $200 million in harm. This includes $47 million for Ailes’ severance pay, $25 million for O’Reilly’s, and more than $55 million to settle sexual harassment and racial discrimination claims against Fox News. Court documents indicate that the company has also paid an estimated $20 million in litigation costs.

“Fox News has a sustained and systematic history of sexual harassment by its executives and talent,” the complaint says. “Had the Board exercised even minimal oversight, they would have been aware of this history, given the negative publicity around many of these lawsuits, and given the sheer number and in some cases substantial sizes of the settlements relative to the salaries of the plaintiffs.”

Century Fox Workplace Professionalism Council

The investor settlement emphasized the implementation of the new Workplace Professionalism and Inclusion Council. The council will report to the Century Fox board. It will have the power to oversee and recommend policies and procedures. This includes the hiring of outside consultants and conducting independent investigations.

Top human resources executives at Fox will staff the council along with four independent members. Former U.S. District Judge Barbara S. Jones used to serve in the Southern District of New York and is now a law firm partner. Sylvia Ann Hewlett is the founder and CEO of the Center for Talent Innovation and founder of Hewlett Consulting Partners. Virgil L. Smith is chairman of the consulting group Smith Edwards Group. He also spent a combined 44 years at Gannett Co. and McClatchy Newspapers. Finally, Brande Stellings is a leading expert on women’s leadership and diversity. She also used to serve as the vice president of litigation at NBC Universal.

“The Workplace Council gives our management team access to a brain trust of experts with deep and diverse experiences in workplace issues,” Jack Abernethy said. Abernathy is the co-president of Fox News Channel. “We look forward to benefiting from their collective guidance.”

 

 

Consumer Advocacy Group Calls for Benicar Ban

By Emily Cox

Benicar ban

On the heels of a $300 million Benicar (olmesartan) settlement, a consumer advocacy group has petitioned the FDA to institute a formal Benicar ban.

The organization Public Citizen that Ralph Nader originally founded formally petitioned the FDA on November 15. The group is calling for the Benicar ban due to the controversial blood pressure medication’s “life-threatening” side effects.

“Keeping the medication on the market would continue to put hypertension patients’ lives at risk for the sake of corporate profits,” the organization warned in a press release after it sent the 20-page petition to the FDA. The FDA has acknowledged receiving the Benicar ban petition. However, it is still not known what the agency will do with the petition. Historically, the FDA has taken years to consider similar requests. Meanwhile, Benicar patients will continue to suffer serious side effects and weight loss. These stem from a severe gastrointestinal condition that often requires hospitalization.

Benicar causes sprue-like enteropathy. The condition “leads to severe and chronic diarrhea, vomiting, abdominal pain and weight loss,” Public Citizen states.

“The condition is called sprue-like enteropathy because of its similarity to sprue or celiac disease – a gastrointestinal illness triggered by gluten ingestion. However, unlike with celiac disease, sprue-like enteropathy does not improve with a gluten-free diet.”

The debilitating condition can be misdiagnosed as celiac disorder, leading to ineffective treatment protocols.

Benicar Ban Background

Benicar is a hypertension drug that the FDA indicates for the treatment and management of high blood pressure. Olmesartan is effective in this role. However, patients and Public Citizen indicate that Benicar side effects and risks far outweigh the benefits. Furthermore, other hypertension medications are equally effective at lowering blood pressure. And, they do it without dire side effects like sprue-like enteropathy, illness, and weight loss. Benicar, Azor, Benicar HCT, and Tribenzor are unique in their link to sprue-like enteropathy. Consequently, manufacturers are facing product liability lawsuits and Public Citizen wants the drugs off the market.

“There is overwhelming evidence that olmesartan causes severe sprue-like enteropathy and that the risk of this life-threatening complication is far greater with olmesartan than with the other seven FDA-approved ARBs,” said Dr. Michael Carome, director of Public Citizen’s Health Research Group. “There is no justification, other than corporate profits, to subject any patient to this danger when there are so many effective but much safer alternatives for treating hypertension.”

Benicar Ban Petition

In its Benicar ban petition, the advocate cited a 2012 Mayo Clinic study. The study documented the connection between olmesartan and sprue-like enteropathy. In 2013, the FDA concluded that olmesartan “can cause” the condition as well. However, the agency only issued a safety warning about the drugs.

“However, rather than pulling olmesartan from the market, the agency required only the addition of a weak warning about this risk to the product’s labeling,” Public Citizen said in a press release.

“Since 2012, numerous studies together have documented more than 150 cases of this disorder in patients worldwide who took this medication,” Public Citizen continued. “The studies found that most of the patients experienced serious complications – including profound malnutrition and kidney injury – and required hospitalization.”

The group pled the FDA to  “immediately require the removal from the market of all medications containing olmesartan medoxomil, including medications branded as Azor, Benicar, Benicar HCT, and Tribenzor, as well as all generic versions of these drugs.”

In the past, Public Citizen has sued the FDA when the group felt the agency was dragging its heels on an issue, while patients were suffering. But, it is still too early to tell if the advocacy group will push the FDA into court once more.

 

Forced Arbitration Bill Prioritizes Banks Over Consumers

By Emily Cox
Forced arbitration
Flickr/Mike Mozart

Recently, American consumers lost the right to hold massive financial institutions like Wells Fargo and Equifax accountable. Vice President Mike Pence and 50 U.S. senators signed the disgraceful forced arbitration bill in the dead of night this past month, killing essential Consumer Financial Protection Bureau (CFPB) regulations. President Trump quickly signed the bill into law, wiping out the CFPB rule that protected Americans’ constitutional rights to take financial giants to task in court when they break the law.

The bill restores forced arbitration. This allows big banks to use the fine print in customer agreements to force consumers into a rigged arbitration process. Banks designed and controlled this system to avoid taking responsibility for illegal acts. Forced arbitration also allows banks to hide scandals and avoid public accountability. Senators are well aware that giving these massive financial entities the power to strip consumers of their rights is inherently wrong. So, they waited until well after 10pm when the public wasn’t looking to make their move. Furthermore, the Senate does not seem to fully grasp the reality of forced arbitration, and U.S. consumers, seniors, and service members will pay the price.

The Realities of Forced Arbitration

The bill allows large institutions to defraud overseas service members, abuse seniors in nursing homes, and sexually harass women at work with little to no provisions for these individuals to seek recourse for these violations. The bill forces these individuals to go it alone behind closed doors in secretive arbitration processes.

After deducting attorney fees and court costs, 6.8 million consumers recover $440 million from class actions against these entities each year. On average, only 16 consumers receive cash relief from arbitration each year. Big banks know that if consumers can’t band together, very few will be able to hold them accountable in court alone due to time and money constraints.

Proponents of the bill claim they are protecting small banks and credit unions. However, 97 percent of credit unions don’t use arbitration clauses. And, a mere eight percent of smaller banks use these provisions. Credit unions even told lawmakers that there was “very minimal usage, if any.”  However, these admissions did not stop senators from using these claims as a prop for the bill.

Opposition to Forced Arbitration

Some of the Senate is claiming that the CFPB rule they annihilated would force consumers into court. However, the rule only restored Americans’ ability to join other consumers to hold Wall Street accountable or go to arbitration. Suggesting that the rule forces individual to bring civil claims in court against their will is absurd.

More than 370 respected organizations want the rule upheld. These include the American Legion, the Military Coalition, AFL-CIO, NAACP, and AARP. These organizations insist the Senate does not have facts or logic to support its decision. They are questioning why Wall Street deserves more protection than seniors, service members, and consumers.  Why are special favors for Wall Street more important than our constitutional rights? Also, the bill only strips consumer protections. Banks still retain the right to sue their customers. Consequently, many Americans are questioning the types of behavior Mike Pence and half the Senate are protecting.

Equifax tried to force 145.5 data breach victims into the rigged arbitration system. Wells Fargo also did it after being caught opening millions of fraudulent accounts in its customers’ names. The financial institution also operated an extensive scam to slap customers with illegitimate overdraft fees. Consequently, voters across all parties line strongly support upholding the CFPB rule. Unfortunately, the federal government isn’t listening. Now, thousands of constituents may not be able to fight back against stolen identities, unauthorized credit cards, and mysterious bank charges. The Senate and President Trump are going to have to answer for it. And, simply demonizing lawyers is not going to cut it.

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