Medical Error Is Not Included On Death Certificates Or CDC Rankings Of Cause Of Death

 

 

 

 

 

 

 

 

 

By Mark A. York (August 30, 2019)

Medical Errors Are Third Leading Cause of Death in the U.S.

Are 10 percent of U.S. deaths due to preventable medical mistakes?

Medical errors are an “epidemic” that claim hundreds of thousands of lives annually, according to medical reports.

MEDICAL ERRORS ARE THE third leading cause of death in the U.S., after heart disease and cancer, causing at least 250,000 deaths every year, according to recently released data indicating that patient safety efforts fall far short.

Medical error—the third leading cause of death in the US – British Medical Journal

Types of PAEs

The cause of PAEs in hospitals may be separated into these categories:

  • Errors of commission,
  • Errors of omission,
  • Errors of communication,
  • Errors of context, and
  • Diagnostic errors

https://www.pbs.org/newshour/show/is-fatal-medical-error-a-leading-cause-of-death

“People don’t just die from heart attacks and bacteria, they die from system-wide failings and poorly coordinated care,” says the study’s lead author, Dr. Martin Makary, a professor of surgery and health policy at Johns Hopkins University School of Medicine. “It’s medical care gone awry.”

Medical errors rank behind heart disease and cancer as the third leading cause of death in the U.S., Johns Hopkins researchers say. … Based on an analysis of prior research, the Johns Hopkins study estimates that more than 250,000 Americans die each year from medical errors.

Historical analysis of papers that focused on mortality due to medical errors in 1999-2000, took  a number of different approaches and perspectives, summarized in, “To Err is Human” which estimated that 44,000 to 98,000 deaths per year were due to medical error. There was an uproar, and many pundits dismissed it out of hand. Using a weighted average of four previous studies, a meta-analysis in 2013 “A New, Evidence-based Estimate of Patient Harms Associated with Hospital Care” estimated more than 400,000 deaths due to medical error per year. In 2016, “Medical error—the third leading cause of death in the US” estimated 251,454 deaths, based on 35,416,020 hospitalization.

Objectives Based on 1984 data developed from reviews of medical records of patients treated in New York hospitals, the Institute of Medicine estimated that up to 98,000 Americans die each year from medical errors. The basis of this estimate is nearly 3 decades old; herein, an updated estimate is developed from modern studies published from 2008 to 2011.

Methods A literature review identified 4 limited studies that used primarily the Global Trigger Tool to flag specific evidence in medical records, such as medication stop orders or abnormal laboratory results, which point to an adverse event that may have harmed a patient. Ultimately, a physician must concur on the findings of an adverse event and then classify the severity of patient harm.

Results Using a weighted average of the 4 studies, a lower limit of 210,000 deaths per year was associated with preventable harm in hospitals. Given limitations in the search capability of the Global Trigger Tool and the incompleteness of medical records on which the Tool depends, the true number of premature deaths associated with preventable harm to patients was estimated at more than 400,000 per year. Serious harm seems to be 10- to 20-fold more common than lethal harm.

Conclusions The epidemic of patient harm in hospitals must be taken more seriously if it is to be curtailed. Fully engaging patients and their advocates during hospital care, systematically seeking the patients’ voice in identifying harms, transparent accountability for harm, and intentional correction of root causes of harm will be necessary to accomplish this goal.

In a Mayo Clinic study with the American College of Surgeons, 8.9% of participating U.S. surgeons reported the belief that they’ve made a major medical error within the last 3 months — and 1.5% believe their error resulted in a patient’s death, according to Tait Shanafelt. “When you think about that for a minute, it’s a staggering number,” Shanafelt says. Suicide ideation doubles in that 3-month window as well, he notes, independent of depression — the risk of which triples. “So when we make mistakes — and all physicians will make mistakes during the course of their career — it has a substantial toll on us. And there’s a strong link there with burnout.”

Preventing Hospital Medical Errors/sciencedaily

The magnitude of the death toll – roughly 10 percent of U.S. deaths annually – is striking coming, as it does, in an era dominated by efforts to reform the health system to ensure safe, high quality, high-value medical care. Patient

no systematic effort to study medical errors or to put effective safeguards in place.

“Throughout the world, medical error leading to patient death is an under-recognized epidemic,” Makary and his co-author, Dr. Michael Daniel, also of Johns Hopkins, write in Tuesday’s British Medical Journal. They define medical errors as lapses in judgment, skill or coordination of care; mistaken diagnoses; system failures that lead to patient deaths or the failure to rescue dying patients; and preventable complications of care.

Their report comes nearly two decades after “To Err is Human,” a report by the Institute of Medicine, asserted that medical mistakes are rampant in health care. The IOM, a quasi-public think tank made up of leading scientists, drew on existing data to estimate that 44,000 to 98,000 people die in U.S. hospitals each year. Even then, some researchers claimed the estimates were low and based on outdated information.

The new estimate is drawn from more-recent studies indicating the number may be much higher. For instance, a report published in the journal Health Affairs in 2011 calculated that just over 1 percent of hospital patients die each year because of medical errors. When applied to the more than 35 million people hospitalized each year, Makary and Daniel say, this would “translate into 400,201 deaths per year, more than four times the original IOM report estimate.”

The Hopkins team used evidence from four studies that analyzed medical death rate data from 2000 to 2008, including one by the U.S. Department of Health and Human Services’ Office of the Inspector General and the Agency for Healthcare Research and Quality. Using these data, they were able to calculate a mean death rate for medical errors in U.S. hospitals. Applying this rate to the 35 million admissions in 2013, they calculated that 251,454 deaths resulted from medical mistakes.

The researchers acknowledge that this figure most likely represents an undercount, because they were unable to capture data from deaths that occur in outpatient clinics, nursing homes and other non-hospital settings where health care workers care for fragile patients who need complex care.

“It’s fair to say that this number is controversial,” says Dr. Robert Wachter, a professor of medicine at UCSF School of Medicine. “I wouldn’t take this number to the bank.”

Dr. Ashish Jha, a patient-safety expert and director of the Harvard Global Health Institute, agreed that many researchers will be temped to debate which of the estimates are the most accurate.

“It doesn’t matter,” he says, “because all these numbers are so big. They’re a reminder of how big the problem is and how little is being done to address it.”

Much of the effort put into patient safety and performance improvement over the last two decades has been misdirected or ineffective, Jha says. “If you called the CEO of a big hospital and asked, ‘How many medical errors did you have last month? How many falls? How many falls that resulted in serious injury?’ They won’t know.”

Another issue, Wachter says, is that patient safety is being crowded out by newer initiatives. “My concern,” he says, “is that patient safety efforts, which gained so much momentum following the publication of the IOM report, have lost ground in recent years, defused by all the other performance improvement mandates that have come down the highway.”

Makary and Daniel are calling for reforms that would improve the reporting of medical errors, which in turn could inform prevention efforts. In a letter dated May 1, they asked the Centers for Disease Control and Prevention, which gathers births, deaths and other vital statistics, to rank medical errors on the list of leading causes of death. They also asked CDC to alter death certificates so that doctors, medical examiners and coroners can routinely report medical errors that contribute to a patient’s death.

The letter takes pains to point out that the U.S. government and private sector spend “a lot of money” on heart disease and cancer research and prevention. “It is time for the country to invest [a proportional amount] in medical quality and patient safety,” it says.

So far, the researchers have not received an official response, but CDC officials acknowledged that errors are under-reported and that there are ways to capture the data, Makary says. CDC experts were not available for comment.

Wachter is skeptical that the practice of using death certificates to report medical errors will take hold among doctors. “The idea they’ll begin recording this faithfully, or without concern for a malpractice suit, doesn’t strike me as very plausible,” he says.

Makary adds that it was his perception that medical-error research is “underfunded and under-appreciated” that prompted him to embark on an analysis that would elevate fatal mishaps to their proper place near the top of the list of all causes of death.

The findings, Jha says, illustrate that the policies and practices we’re putting in place “are completely inadequate to the size of the problem we have.”

“We can do this,” Jha says. “This is not beyond the creativity and ingenuity of the health care community. We’ve just got to make it a real priority.”

At what point do US consumers start to realize that the healthcare system in the United states is not geared toward “health care” but toward making profits for the medical industry as a whole. Which includes- Big Pharma, For-profit hospitals (owned by non-profits), insurance companies, third party benefit providers, pharmacies that pay and receive rebates (pay to play kickbacks) from drug makers and distributors, doctors paid by Big Pharma to author slanted medical papers and the list goes on and on.

 

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JOHNSON & JOHNSON OKLAHOMA OPIOID TRIAL VERDICT ANNOUNCED – $550 MILLION VERDICT

“MORE BAD CONDUCT SHOWN IN OKLAHOMA OPIOID TRIAL”

By Mark A. York (August 26, 2019)

(MASS TORT NEXUS MEDIA) The first court verdict to come out of the massive litigation over the opioid crisis has resulted in a verdict against Johnson & Johnson for $550 MILLION at 4:05p.m. today, August 26, 2019 in one of the most important drug related lawsuits in U.S. history.

This is the first of several upcoming opioid lawsuits against a drugmaker to go to trial, and it could set a precedent for cases across the country. Depending on how the judge rules, it could give lawyers a new strategy for holding large corporations accountable.

For weeks, the state of Oklahoma has argued that Johnson & Johnson and its pharmaceutical subsidiary Janssen helped create a “public nuisance” by intensely marketing opioid painkillers while downplaying the risk of addiction.

“This is very personal to all of us,” said state attorney Reggie Whitten. “My partner lost a niece to this opioid epidemic. I lost my firstborn son to the opioid epidemic.”

The 2017 filing named multiple defendants. Purdue Pharma and Teva Pharmaceuticals USA settled out of court for a combined total of $355 million, without admitting wrongdoing.

But Johnson & Johnson and Janssen decided to go to trial.

“When you’re right, you fight,” said their attorney, Sabrina Strong, a partner at O’Melveny and Myers. “And that’s what you’re seeing here. We have sympathy for those who suffer from substance abuse. But Janssen did not cause the opioid crisis in this country.”

THIS TYPE OF COMMENTARY SEEMS TO BE A REPEAT OF J&J’s NOW OFT REPEATED CLAIM  “WE’VE DONE NOTHING WRONG” WHICH IS NOW PROVEN TO BE AN OUTRIGHT FALSE STATEMENT, WHETHER BY DEFENSE COUNSEL OR THE COMPANY PR MACHINE. JOHNSON & JOHNSON HAS BEEN SHOWN TO HAVE OUTRIGHT LIED, MISLED THE PUBLIC ANFD MANIPULATED SCIENCE AND MEDICAL INDUSTRY OPINIONS RELATED TO MANY COMPANY PHARMACEUTIAL PRODUCTS AND THE RELATED MARKETING CAMPAIGNS. 

J&J HISTORY OF BAD CONDUCT

Payments To Industry Insiders

Introduction of evidence in J&J Talc cancer trial in the last year, show that two individuals involved in the Cosmetic Industry Review (CIR), which has deemed talcum powder to be safe, which is data J&J has relied on in prior trials, had received payments from Johnson & Johnson for speeches and other engagements. This damaging information was discovered while cross-examining the group’s former director, Alan Andersen, who was a defense witness, and he was forced to disclose the prior unknown financial relationship of the CIR and Johnson & Johnson.

Bad Science

A major blow to J&J’s defense came when a defense witness, Senior Johnson & Johnson epidemiologist, Dr. Douglas Weed, was revealed to have been sanctioned for perjury in another trial in North Carolina, for lying under oath about whether he retained notes to his expert report, which plaintiffs attorneys were able to show.

“J&J presented these unbelievable and non-credible witnesses on an issue that is very important to our case,” Smith said. “Attempts to influence witnesses and alter facts, along with the fact other companies are warning of the cancer link and have been warning for eight to 12 months now. This was new evidence that proved very compelling to the jury as well as a reflection of J&J’s willingness to manipulate the trial process in their favor”, leading many to wonder what else J&J may have done.

In a post trial statement J&J declined to address the specifics of the case, stating: “We will appeal today’s verdict because we are guided by the science, which supports the safety of Johnson’s baby powder. In April, the National Cancer Institute’s Physician Data Query Editorial Board wrote, ‘The weight of evidence does not support an association between perineal talc exposure and an increased risk of ovarian cancer.’ We are preparing for additional trials in the U.S. and we will continue to defend the safety of Johnson’s baby powder.”

In response, the Plaintiff team stated “The new evidence that came into the California case could play a role in the next talcum powder trial, which is set for Oct. 16 in Missouri, we certainly think it is evidence that should be presented, and we’ll make every attempt to do so,” Ted Meadows said.

Meanwhile, separate from the Oklahoma opioid trial,  reports are now official that the Department of Justice is pursuing a criminal probe into whether J&J lied about possible cancer risks in its talcum baby powder. The investigation follows a slew of talc-related lawsuits filed against the company, two of which recently resulted in multimillion-dollar plaintiff awards.

Now that ‘OPIOID BIG PHARMA” and their executive suites are being held accountable by the public and in both state and federal courts, there needs to be a formal accounting of how and why these “pharmaceutical titans” were able to develop dangerous drugs and then create horrendous off-label and life threatening marketing campaigns, all the while earning literally billions of dollars annually. At what point do the US consumers and general public say “enough is enough” and demand the corporate decision makers be held criminally liable as a regular part of the executive suite checks and balances oversight?

As long as the drug makers “cost of litigation” remains part of the risk management analysis in the year-end SEC filings, it’s likely that dangerous drugs and the bad conduct that often travels along, will remain a “cost of doing business” and the trail of destruction will continued to be ignored by the Alex Gorskys and Richard Sacklers of the drug industry.

Risperdal Off-Label Drug Marketing

Johnson & Johnson conducted a misleading marketing campaign for their anti-psychotic drug, Risperdal. Approved by the U.S. Food and Drug Administration (FDA) to treat adults with schizophrenia, Johnson & Johnson marketed the drug for use in children.

According to the U.S. Department of Justice, Johnson & Johnson, and their subsidiary, Janssen, were aware of the dangers the drug Risperdal posed when used by children. Even so, company representatives marketed the drug to mental health professionals who worked with children.

As a result of their misleading Risperdal marketing campaign, Johnson & Johnson was ordered in 2013 by the U.S. Department of Justice to pay a $2.2 billion fine.

Risperdal was approved by the U.S. Food and Drug Administration (FDA) in 1993 for the treatment of schizophrenia in adults. It was not approved for use in children or adolescents until 13 years later, in 2006.

Evidence from lawsuits showed that pharmaceutical representatives from Johnson & Johnson had been pushing doctors (including the plaintiffs doctor) to prescribe Risperdal to children and teenagers even though it had not yet been tested on young people

Juries have found that Johnson & Johnson failed to adequately warn patients and doctors of harmful potential side effects, and verdicts against J&J and Risperdal marketing have been ongoing in courts for more than five years over this medication.

Johnson & Johnson paid the multi-billion dollar fine to the Department of Justice in criminal and civil fines as a result of the now proven illegally marketing of Risperdal for unapproved purposes, but are now denying in civil lawsuits that they were involved in anything improper in off-label marketing of Risperdal. Individual patients who were harmed by Risperdal, do not yet have a remedy other than filing a lawsuit against Johnson & Johnson.

Risperdal Male Breast Growth

 When used by children and adolescents, Risperdal has been known to cause male breast growth, also known as gynecomastia, due to the drug triggering the production of the hormone prolactin. For some patients who have suffered from gynecomastia as a Risperdal side effect, they have also dealt with decreased psychological and emotional well being as a result of physical changes.

Shareholders Sued J&J Over Off-Label Marketing and Bad Conduct–Complaint Attached

Johnson & Johnson says its opioid products account for less than one percent of the Oklahoma market. But the state disputes that.

Oklahoma Attorney General Mike Hunter told CBS News correspondent Omar Villafranca, “They made money whether they sold their drugs or when somebody else sold opioids, because they were supplying everybody else. And this ‘one percent’ thing, that’s a complete canard.”

If the judge rules against Johnson & Johnson, the “public nuisance” argument that was previously used successfully to fight Big Tobacco could possibly be used in opioid lawsuits set to go to trial in Ohio this fall.

https://www.law.du.edu/documents/corporate-governance/independent-director/johnsonjohnson/Opinion-In-re-Johnson-and-Johnson-10-cv-2033-D-NJ-Sept-29-2011.PDF

“Thousands of people being addicted to prescription opioids, thousands of people  dying, you’ve a public nuisance, you’ve got harm that’s occurring,” said Hunter.

Both sides in Oklahoma say they’ll appeal if the judge rules against them.

In addition to the cases in Ohio, suits were filed last week in West Virginia accusing Johnson & Johnson, as well as Teva, of misrepresenting the risks of their opioid products.

The J&J CEO Alex Gorsky approved bad conduct and medical industry manipulation dovetails perfectly along with the Purdue Pharma and Sackler Family marketing abuses, that were uncovered in a federal criminal indictment. The indictment of Purdue and company executives, was hushed up by a $650 million fine to the US Department of Justice in 2007, by none other than bad-conduct fixer Rudy Giuliani.

Many states including Masschusetts, (see complaint below) have decided to sue the Sackler family directly, to reclaim some of the billions the Sacklers earned over the many years the opioid crisis has killed thousands of people.

Related-Official Court Records: Purdue and Sackler Family Bad Conduct

Richard Sackler of Purdue Pharma Deposition Transcript Re: Oxycontin Train

https://www.documentcloud.org/documents/5745864-Purdue-Statement-in-Response-to-Leak-of-2015.html

State of Massachusetts vs. Purdue and The Sackler Family Amended-Complaint-2019-01-31.html

In 2007, Purdue Frederick Co. (not Purdue Pharma) and three company executives pled guilty to misbranding OxyContin and agreed to pay $634.5 million to resolve a U.S. Department of Justice investigation, in the US District Court of Virginia, see Purdue Criminal Plea Agreement US Department of Justice May 10, 2007. This plea deal “a get-out-of-jail free card” was engineered by none other than former New York City Mayor and political/corporate fixer, Rudy Guiliani, by directly leveraging high level US DOJ contacts and other DC insiders to derail the prosecution of Purdue Pharma, and instead offer up Purdue Fredrick Co. as the guilty party and thereby permitting the multi-billion dollar per year Oxycontin assembly line to continue operations.

The Sackler family has always been protected by the company shield, even though their most profitable selling opioid drug Oxycontin, and its boardroom coordinated marketing campaign was the brainchild and a direct result of the Purdue Pharma company founders, the Sackler brothers and their tried and true business model.

he Sacklers named in the lawsuits include Theresa and Beverly, widows of Purdue founders, brothers Mortimer and Raymond Sackler and Ilene, Kathe and Mortimer David Alfons Sackler, three of Mortimer’s children; Jonathan and Richard Sackler, Raymond’s two sons; and David Sackler, Raymond’s grandson. The Sackler family is worth conservatively, an estimated$13 billion according to Forbes, which has been generated from sales of OxyContin.  As is normal procedure by the Sackler family and the company itself, the Sackler family feuding members always decline requests for comment on the catastrophic opioid crisis and avoid discussing any Purdue Pharma links to how the crisis came about.

As Purdue Pharma comes to grips with the fact that they are being designated as the primary litigation targets of states, counties and cities across the country for being the Opiate Big Pharma leader in creating the current opioid crisis in the United States, they may need to determine how they will pay the billions of dollars in jury verdicts and affiliated legal settlements resulting from the lawsuits that now number over 1,200 cases in state and federal courts.

The entire Sackler brothers’ Oxycontin marketing plan followed their previously proven drug marketing test drive of “Valium” – when Hoffman-LaRoche hired the Sacklers to market their new drug “diazepam” commonly known as Valium and its sister drug Librium.

While running the drug advertising company, Arthur Sackler became a publisher, starting a biweekly newspaper, the Medical Tribune, which eventually reached 600,000 physicians. He scoffed at suggestions that there was a conflict of interest between his roles as the head of a pharmaceutical-advertising company and the publisher of a periodical for doctors. Later it emerged that a company he owned, MD Publications, had paid the chief of the antibiotics division of the FDA, Henry Welch, nearly $300,000 in exchange for Welch’s help in promoting certain drugs. Sometimes, when Welch was giving a speech, he inserted a drug’s advertising slogan into his remarks. After the payments were discovered, Welch was forced to resign from the FDA.

When Purdue Pharma started selling its prescription opioid painkiller OxyContin in 1996, Dr. Richard Sackler asked people gathered for the launch party to envision natural disasters like an earthquake, a hurricane, or a blizzard. The debut of OxyContin, said Sackler — a member of the family that started and controls the company and then a company executive — “will be followed by a blizzard of prescriptions that will bury the competition.”

Five years later, as questions were raised about the risk of addiction and overdoses that came with taking OxyContin and opioid medications, Sackler outlined a strategy that critics have long accused the company of unleashing: divert the blame onto others, particularly the people who became addicted to opioids themselves.

“We have to hammer on the abusers in every way possible,” Sackler wrote in an email in February 2001. “They are the culprits and the problem. They are reckless criminals.”

Sackler’s comments at the party and his email are contained in newly public portions of a lawsuit filed by the state of Massachusetts against Purdue that alleges that the company, the Sackler family, and company executives misled prescribers and patients as they aimed to blanket the country with prescriptions for their addictive medications.

 

Addiction Recovery Issues

White drug users addicted to heroin, fentanyl and other opioids have had near-exclusive access to buprenorphine, a drug that curbs the craving for opioids and reduces the chance of a fatal overdose. That’s according to a study out Wednesday from the University of Michigan. It appears in JAMA Psychiatry.

 Researchers reviewed two national surveys of physician-reported prescriptions. From 2012 to 2015, as overdose deaths surged in many states so did the number of visits during which a doctor or nurse practitioner prescribed buprenorphine, often referred to by the brand name Suboxone. The researchers assessed 13.4 million medical encounters involving the drug but found no increase in prescriptions written for African Americans.

“White populations are almost 35 times as likely to have a buprenorphine-related visit than black Americans,” said Dr. Pooja Lagisetty, an assistant professor of medicine at the University of Michigan Medical School and the study’s lead author.

 The dominant use of buprenorphine to treat whites occurred while opioid overdose deaths were rising faster for blacks than for whites.

“This epidemic over the last few years has been framed by many as largely a white epidemic, but we know now that’s not true,” Lagisetty said.

What is true, Lagisetty added, is that most of the white patients either paid cash (40%) or relied on private insurance (35%) to fund their buprenorphine treatment. The fact that just 25% of the visits were paid for through Medicaid and Medicare “does highlight that many of these visits could be very costly for persons of low income,” Lagisetty said.

Doctors and nurse practitioners can demand cash payments because there’s a shortage of clinicians who can prescribe buprenorphine, according to Dr. Andrew Kolodny, co-director of Opioid Policy Research at Brandeis University’s Heller School for Social Policy and Management. Only about 5% of physicians have taken the special training required to prescribe buprenorphine.

“The few that are doing it are really able to name their price, and that’s what we’re seeing here and that’s the reason why individuals with more resources — who are more likely to be white — are more likely to access treatment with buprenorphine,” said Kolodny, who was not involved in the study.

Kolodny wants the federal government to eliminate the required special training for buprenorphine and a related cap on the number of patients a doctor can manage on the drug.

Some physicians who’ve studied racial disparities in addiction treatment say the root causes date to 2000, when buprenorphine was approved. At that time, proponents argued that buprenorphine was needed to help treat suburban youth, according to Dr. Helena Hansenat New York University. Those young patients didn’t see themselves as addicted to heroin in the same way as hard-core urban heroin users who went to methadone clinics for treatment.

“Buprenorphine was introduced as private-office treatment, for a private market with the means to pay,” said Hansen, an associate professor of psychiatry and anthropology. “So the unequal dissemination of buprenorphine for opioid dependence is not accidental.”

Hansen added that the fix must include universal access to treatment in a primary care setting, an end to the criminalization of opioid dependence (which puts more blacks in prison for drug use than whites) and more federal funding to expand access to buprenorphine for all patients.

Several leaders in the fight to reduce opioid overdose deaths say the study results are disturbing.

“It really demands for us to be looking at equitable treatment for addiction for African Americans as we do for white Americans,” said Michael Botticelli, director of the Grayken Center for Addiction at Boston Medical Center and the former director of the Office of National Drug Control Policy.

Botticelli identified key issues that may contribute to the racial treatment gap and deserve further investigation. For example, he wants to know if Medicaid reimbursement rates are simply too low to entice more doctors to work with low-income patients, or if there are too few inner-city doctors prescribing buprenorphine or if African Americans themselves are somehow reluctant to seek this form of treatment.

Dr. Nora Volkow, director of the National Institute on Drug Abuse at the National Institutes of Health, called the findings surprising and disturbing. Surprising because the disparity is so large, and disturbing because her agency has prioritized educating doctors about the value of prescribing buprenorphine.

Volkow also expressed disappointment that federal parity laws, which are supposed to guarantee equal access to all types of medications, don’t seem to be working for buprenorphine.

“We need to ensure that we have capacity to provide these treatments,” Volkow said, “because if you say you have to pay for them, but there are no services that can provide the treatments, then the issue of paying for them is secondary.”

Volkow has noted that fewer than half of Americans with an opioid use disorder have access to buprenorphine or two other medications used to treat opioid addiction: methadone and naltrexone. Volkow said she’s glad that the use of buprenorphine is on the rise, but the U.S. needs to understand why this lifesaving treatment isn’t benefiting all patients who need it.

Related materials >Targeting Big Pharma and Their Opiate Marketing Campaigns: Across The USA

OPIOD LITIGATION UPDATE: FOR FEDERAL AND STATE COURT DOCKETS

To access the most relevant and real time information on the Opioid Litigation, Kevin Thompson (NAS Addicted Infant Litigation) and Steve New (Opioid Adult Injury Litigation) will be speaking at the Mass Tort Nexus Class September 13 – 16, 2019 in Fort Lauderdale, to attend follow the links below. 

Mass Tort Nexus “CLE Immersion Course”

September 13-16, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Anne-Marie Kopek at 954.837.3423 or AnneMarie@masstortnexus.com

  1. For the most up-to-date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.
  2. To obtain our free newsletters that contains real time mass tort updates, visit com/news and sign up for 

For more Mass Tort Nexus Information See: Mass Tort Nexus Newsletters and MDL Updates

Note: (Excerpts within this article include print materials and other online media sources)

 

 

 

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Mass Tort Billionaires

 

Mass Tort Billionaires

What do they know that you don’t?

 

Fact: Mass Torts have made more plaintiff lawyers billionaires (or billionaire adjacent) than any other practice area.

Myth: Most Mass Tort billionaires made their money from the massive trial verdicts we hear about in the news (RoundUp, Talcum Powder etc.).

Fact: The majority of Mass Tort billionaires (or billionaire adjacent) did not reach this lofty status from major trial verdicts, they built their practice over time, accumulating the knowledge and skills required to independently evaluate a mass tort litigation before taking a financial risk.

Most Successful Mass Tort Firms Learned by Trial and Error

There is an easier way!

The Mass Tort Nexus Four Days to Mass Tort Success Course gives you the knowledge, information and skills that current “mass tort insiders” learned the hard way (trial and error).  It is better to learn from the mistakes of others, than to make those same mistakes yourself.

You may not be willing to take the risk required to become a “mass tort billionaire”, however, if you are interested in working smarter vs harder and reaching the financial goals you have set for yourself and your firm, the Four Days to Mass Tort Success Course is the place to start. Click on the image below to get more information about the September Course.

You may also simply call or email Barbara Capasso or Anne Marie Kopek at 954-530-9892, email- barbara@masstortnexus.com or annemarie@masstortnexus.com

How Most Lawyers Get Started in Mass Torts

One Lawyer, we will call him Mr. Mass Tort Big Bucks, gives another lawyer, we will call Mr. Mass Tort Outsider, an inside tip on a great new mass tort in which Mr. Big Bucks is involved. Mr. Outsider takes the tip and runs with it.

One of two things happen:

Scenario A: The litigation does South and Mr. Outsider thinks “Mass Torts is just a big gamble”, I am never doing that again.

Scenario B: The litigation pays off big and Mr. Outsider becomes overly optimistic, thinking, “Wow this Mass Tort thing is great”, I am going to bet on every new case that come along.

Neither Scenario Is Good for Mr. Outsider

In Scenario A, now “mass tort pessimistic” Mr. Outsider is likely to take himself out of the game (mass tort plaintiff law) that has created more plaintiff lawyer billionaires than any other practice area.

In Scenario B, now “mass tort overly optimistic” Mr. Outsider is likely to throw money at every mass tort litigation that comes along and is at risk of eventually losing his shirt.

  1. Big Bucks, who is already sold on a litigation, is not an objective source of information.
  2. Big Bucks can probably afford to lose money that Mr. Outsider may not be able to afford to lose.

Become a Mass Tort Insider!

Instead of relying on tips from other lawyers or the mass tort rumor mill, gain the “insider knowledge“ that will allow you to evaluate mass tort litigation’s objectively. The next time you get a tip from another lawyer, have the information and knowledge that will allow you to do your homework before taking a leap into a mass tort litigation.

The course starts at the most basic level, discussing the difference between Class Actions and Multi-district Litigation and then progresses to providing the tools needed to evaluate the “metrics” relevant to all mass tort litigation’s which need to be considered before taking a financial risk. The basic metrics (below) are explained in detail before the course progresses to how firms can apply these metrics to make decisions and develop strategies that lead to success.

 

On the third day of the course, lead litigators step in and give presentations on various mass torts in which they are currently involved. Course attendees will be armed with the knowledge developed in the first two days of the course, to ask the lead litigators informed questions and use the metrics and other information they have gained thus far in the course to make decisions about which litigation they may be interested in.

The relatively small class size allows course attendees to interact with the lead litigators in the classroom as well as during the outside activities “up close and personal”.

What do past course attendees have to say?

 

 

Visit our YouTube Channel to hear what other past attendees have to say about the course.

https://www.youtube.com/channel/UC8I9zGYo3YC5BhulgxthCOw/videos

 

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Xarelto Settlement Not So Fast Gentlemen

Those Aggrieved by the Proposed Xarelto Settlement

May Still Get a Chance to be Heard

Thus far firms representing absent plaintiffs (those not represented by leadership) have yet to be given an opportunity to be heard by the court regarding any aspect of the proposed Xarelto settlement.  I previously addressed this issue in another article.

https://www.masstortnexus.com/mass-torts-news/xarelto-settlement-judicial-activism-vs-judicial-tyranny/

Due Process Refresher 

The Fifth and Fourteenth Amendments to the United States Constitution each contain a due process clause. Due process deals with the administration of justice and thus the due process clause acts as a safeguard from arbitrary denial of life, liberty, or property by the government outside the sanction of law. The Supreme Court of the United States interprets the clauses broadly, concluding that these clauses provide four protections: procedural due process (in civil and criminal proceedings), substantive due process.

The core of these requirements is notice and a hearing before an impartial tribunal.

Fuentes v. Shevin, 407 U.S. 67, 81 (1972). At times, the Court has also stressed the dignitary importance of procedural rights, the worth of being able to defend one’s interests even if one cannot change the result.

Mathews v. Eldridge, 424 U.S. 319, 333 (1976). “Parties whose rights are to be affected are entitled to be heard.” Baldwin v. Hale, 68 U.S. (1 Wall.) 223, 233 (1863).

Picking Up Where We Left Off

Without Regard to the points made in the prior article, even if the proposed Xarelto settlement agreement reaches the required participation numbers, it should not be a done deal. For Judge Fallon to grant specific common benefit fee requests, it will arguably be necessary to form a “Settlement Class Action” under FRCP 23. Once this occurs, his honor will not have the option of ignoring FRCP 23(e), the requirement to conduct fairness hearings before final approval of the settlement. This will be the time at which firms representing absent plaintiffs may get their chance to be heard and I believe these firms will have much to say.

If Judge Fallon allows the proposed Xarelto settlement to impact plaintiffs, without ever having engaged in any act to protect the rights of absent parties, this egregious failure may well define his legacy, overshadowing and otherwise admirable judicial career.

Note: Nothing would prevent a firm representing a non-settling client from moving to form a Class Action for non-settling plaintiffs, aggrieved by the settlement.

Due to the fact that the proposed Xarelto Settlement did not follow the “opt in” reasoning (see article by Judge Fallon below), the only way the necessity of creating a settlement class could be avoided would be if 100% of all Xarelto plaintiffs accepted the settlement. Even under this circumstance, jurisdictional issues would still exist. I will address this subject more thoroughly later in this article.  First, I will cover recent developments.

Latest Spin on the Xarelto Settlement

I have learned that leadership claims that 26,000 enrollment packages have been received by Brown Greer and they are very confident that they will reach 98% participation. MTN can not verify leaderships statements with Brown Greer as they seem to have been gagged by leadership. Regardless, the proposed settlement only covered 25,000 plaintiffs. The total number of complaints on file in the MDL and Philadelphia Court of Common Pleas has ballooned to over 31,339 plaintiffs since the proposed settlement was first announced. The foregoing begs the question “98% of what”.  26,000 is 82.96% of 31,339. If we take leadership at their word and believe 26,000 plaintiffs have accepted the settlement, then we must assume that the settlement is going to include more than 25,000 plaintiffs and base on “participation calculus” on the total number of cases on file, which is at least 31,339.

Settling 26,000 cases would leave 5339 remaining. I do not believe that the defendants can sell a settlement to their stockholders that leaves 5339 cases (unknown risks) unresolved.

A reliable source has informed me that the “98% participation claim” was based on 98% of the 70% of plaintiffs that have returned the enrollment package, not 98% of all plaintiffs. Maybe leadership is counting on using the “dismissal machine” they have arguably created in co-operation with defense, to get rid of the non-enrollers and therefore do not think these plaintiffs need be counted.

Though I can not verify the foregoing (Brown Greer gagged), I believe the 26,000-enrollment number may be significantly exaggerated or at minimum skewed. Leading non leadership firms to believe the proposed settlement will consummate would be a good way to get firms reluctant to encourage plaintiffs to except the settlement to change course. A self-fulfilling prophecy (stated as fact) if you will.

The Chance and Right to be Heard

I stated, in the previous article (link above) that Judge Fallon arguably lacks subject matter jurisdiction to issue orders related to an MDL settlement. I also stated that since Judge Fallon is an MDL judge that subscribes to the MDLs as Quasi  Class Actions theory and therefore should have held FRCP 23(e) fairness hearings before or currently with issuing in order related to settlement as His Honor did in Vioxx and other MDLs in the past.

Putting aside the above, absent Xarelto plaintiffs (those not represented by leadership firms) may still have a chance to be heard.

How an MDL Judge can properly involve  themselves in settlement:

  1. Plaintiff Leadership and Defense reach a settlement agreement without seeking orders from the court.
  2. Plaintiff Leadership presents the settlement to firms representing absent plaintiffs and if enough those plaintiffs opt into the settlement to meet the required participation threshold, then the settlement can be consummated (only for those that opted in).
  3. Only after the foregoing, would it be proper for the court to become involved. Plaintiff Leadership and Defense can present the consummated agreement (with all opt ins) to the Judge and seek to form a Settlement Class Action (under FRCP 23).

Obviously the ship has sailed with regard to Judge Fallon conducting FRCP 23(3) fairness hearings before or concurrently with issuing orders related to settlement however, it would be inconceivable for His Honor to issue orders granting specific Leadership and PSC Firms common benefit fees without a “Settlement Class Action” being formed.

Why? Without a Settlement Class Action in place, Judge Fallon will have no control over or authority to grant any order related to the global proceeds of the mass settlement.

The Opportunity to Be Heard- Finally?

If the proposed Xarelto Settlement reaches the required participation numbers and is consummated, Judge Fallon will only be able to take control of the global proceeds (in order to grant common benefit fees) via a Settlement Class Action. This will be the point at which firms representing absent plaintiff firms will (as required FRCP 23(e) to be heard). If Judge Fallon neglects to conduct fairness hearings before granting fees, an appellate court is likely to overturn any order granting common benefit fees.

The link below is from a 9th Circuit in the Hyundai Kia MDL. A settlement was reached in this MDL and a Settlement Class Action was granted by the MDL Judge. Suit was filed by firms representing absent plaintiffs related to the common benefit fees awarded arising from the settlement. The

https://www.consumerfinancialserviceslawmonitor.com/wp-content/uploads/sites/501/2019/06/In-re-Hyundai.pdf

Excerpts from Ruling:

On December 23, 2013, the settling parties sought preliminary approval of the nationwide class settlement and moved to certify a settlement class. The district court ordered multiple rounds of briefing concerning the fairness of the settlement, sufficiency of the class notice, the claims process, class certification, choice of law, and other issues. At four hearings held between December 2013 and August 2014, the parties addressed concerns raised by the court sua sponte as well as by objectors and other non-settling plaintiffs. In response to these concerns, the settling parties twice revised the settlement agreement and notice provisions.

After issuing several detailed written rulings, the district court granted preliminary approval of the settlement and certified the class for settlement purposes on August 29, 2014. The court appointed Hagens Berman and McCuneWright as settlement class counsel. In September and October 2014, the district court held four additional hearings, at which it requested that the parties make additional changes to the settlement notices and website, such as adding information about the Reimbursement Program, and rewording the notices to make them easier to understand.

A binding settlement must provide notice to the class in a “reasonable manner” and otherwise be “fair, reasonable, and adequate.” Fed. R. Civ. P. 23(e)(1), (2)

Before the district court approves a class settlement under Rule 23(e), it is “critical” that class members receive adequate notice. Hanlon, 150 F.3d at 1025. To satisfy Rule 23(e)(1), settlement notices must “present information about a proposed settlement neutrally, simply, and understandably.” Rodriguez v. W. Publ’g Corp., 563 F.3d 948, 962 (9th Cir. 2009). “Notice is satisfactory if generally describes the terms of the settlement in sufficient detail to alert those with adverse viewpoints to investigate and to come forward and be heard.’” Id. (quoting Churchill Vill., LLC v. Gen. Elec., 361 F.3d 566, 575 (9th Cir. 2004)).

Rule 23(e) ensures that unnamed class members are protected “from unjust or unfair settlements affecting their rights.” Amchem, 521 U.S. at 623 (1997).

Over the course of several years, the district court performed an admirable job of managing this complex litigation. After the settlement was announced, the district court held multiple status conferences and requested several rounds of briefing to ensure that all of the litigants’ concerns were heard and addressed.

Note: The 9th circuit ruling leave little doubt that had the settlement court failed to comply with FRCP 23(e), that courts grant of attorney’s fees  to “Class Counsel”  would not have withstood appeal.

End Excerpts

 

 

Moving Forward -Two Possible Outcomes

  1. Judge Fallon moves forward with a settlement class (if the settlement consummates) without the required FRCP 23 (e) fairness hearings, in which case any grant of common benefit fees arising from the court would likely be overturned on appeal.

 

  1. Judge Fallon moves forward with a settlement class and does (as required) conduct fairness hearings per FRCP 23(e). Although belated, this would give firms representing absent class members to object to the terms of the settlement as well as any common benefit fees being awarded from the settlement proceeds. Even those plaintiffs that rejected the settlement or were subject to dismissal arising from a settlement related order would arguably have standing (the right to be heard).

 

  1. Leadership Self-Dealing (subject of a future article).
  2. Leadership Conclusion with defense to create a “dismissal machine.
  3. Unwarranted Discounts.
  4. Overly Complex processes created by settlement orders, leading to denial of due process.
  5. Settlement related orders issued absent jurisdiction over the subject matter.

The article below, written by Judge Fallon

COMMON BENEFIT FEES IN MULTI-DISTRICT LITIGATION

https://judicialstudies.duke.edu/sites/default/files/centers/judicialstudies/mdl2014/Common_Benefit_Fees.pdf

By: The Honorable Eldon E. Fallon

Note:. In the article, Judge Fallon, as he has on numerous occasions, referred to “private mass tort settlements” as opt in (vs class actions which are opt outs). His Honors reference to these settlements as Opt In vs Opt Out seems to imply that his jurisdiction over settlement arises from the agreement of the parties that Opt In. By Implication this would mean that any party that does not opt in should not be negatively impacted by the given settlement. This has obviously not held true in the proposed Xarelto Settlement.

The following excerpt from the article by His Honor express the same view he expressed in Vioxx, which involved a settlement very similar to the proposed Xarelto Settlement (with 4 billion additional dollars for roughly the same number of plaintiffs) . In Vioxx, Judge Fallon conducted the Rule 23(e) hearing he references below to allow absent plaintiffs a voice in the settlement. I have yet to discern why His Honor believes Xarelto plaintiffs are less deserving of due process than Vioxx Clients.

Excerpt

The argument used by the courts supporting their equitable authority to review attorneys fees is that Rule 23 of the Federal Rules of Civil Procedure expressly provides that a district court presiding over a class action has a duty to scrutinize the attorneys fees of class counsel to assure that they are reasonable. The transferee judge in MDLs should have the same responsibility because MDLs are quasi class actions since their purpose and function is the same as the traditional class action namely efficiency and coordination before a single court. Furthermore, many MDLs contain multiple class actions along with the individual claims and it is not unusual to utilize the settlement class vehicle provided by Rule 23(e) to resolve the entire Thus Rule 23 is often an integral part of the MDL process.

End Excerpt

 

Has Judge Fallon Became to Chummy with Xarelto Leadership?

Just out of curiosity I have submitted a Form A0 10A to the Judicial Committee on Financial Disclosures, requesting Judge Fallon’s financial disclosures for 2013-2018. I already have copies of his disclosures through 2012 and His Honor discloses that his travel and other expenses are paid by third parties when he attended conferences 2012 and prior. I am curious to find out if MTMP paid Judge Fallon’s expenses when he attended MTMP conferences over the past few years. Paying for trips to lavish resorts in sin city for a Federal Judge before whom a firm currently has matters subject to litigation, is something I find worth exploring.

 

Required Reading for those wanting to improve their knowledge of all things MDL settlement.

Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation

But this book, it may shock even the most cynical!

https://www.amazon.com/Mass-Tort-Deals-Bargaining-Multidistrict-ebook/dp/B07S7DMN7Z

By: Elizabeth Chamblee Burch

Elizabeth Chamblee Burch is the Fuller E. Callaway Chair of Law at the University of Georgia. Her teaching and research interests include mass torts, class actions, and civil procedure. She has been a Visiting Professor at Harvard Law School.

Other worthwhile reading authored by Professor Burch:

Monopolies in Multidistrict Litigation

https://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?referer=https://www.google.com/&httpsredir=1&article=2113&context=fac_artchop

Repeat Players in Multidistrict Litigation

https://scholarship.law.cornell.edu/cgi/viewcontent.cgi?article=4737&context=clr

DISAGGREGATING

https://openscholarship.wustl.edu/cgi/viewcontent.cgi?article=6002&context=law_lawreview

Judging Multidistrict Litigation 

https://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1993&context=fac_artchop

Morphing Case Boundaries in Multidistrict Litigation Settlements

By: Margaret S. Thomas

http://law.emory.edu/elj/_documents/volumes/63/6/responses/thomas.pdf

About Professor Thomas: https://www.law.lsu.edu/directory/profiles/margaret-s-thomas/

 

Once Size Doesn’t Fit All: Multidistrict Litigation, Due Process and the Dangers of Procedural Collectivism

http://www.bu.edu/bulawreview/files/2015/02/REDISH.pdf

By: MARTIN H. REDISH & JULIE M. KARABA

Martin H. Redish is the Louis and Harriet Ancel Professor of Law and Public Policy at the Northwestern University Pritzker School of Law. Redish has written 19 books and over a hundred law review articles in the areas of civil procedure and constitutional law.

About Professor Redish: http://www.law.northwestern.edu/faculty/profiles/MartinRedish/

Julie Karaba (Siegal is) currently a Clerk for Chief Justice John Roberts, United States Supreme Court.

https://www.sesp.northwestern.edu/news-center/news/2018/03/sesp-alumna-to-clerk-for-chief-justice-of-the-united-states-john-g.-roberts,-jr..html

 

Judicial Review of Private Mass Tort Settlements

By: Jeremy T. Grabill

https://scholarship.shu.edu/cgi/viewcontent.cgi?referer=&httpsredir=1&article=1418&context=shlr

About Jeremy Grabill: https://www.phelps.com/jeremy-grabill

TAKING A SECOND LOOK AT MDL PRODUCT LIABILITY SETTLEMENTS: SOMEBODY NEEDS TO DO IT

https://kuscholarworks.ku.edu/bitstream/handle/1808/25557/Mueller_FINAL.pdf;jsessionid=DFE28872C148C01DAF73FED1CD91E292?sequence=1

By: Christopher B. Mueller

About Professor Mueller: https://lawweb.colorado.edu/profiles/profile.jsp?id=38

 

DUBIOUS DOCTRINES: THE QUASI-CLASS Action

https://scholarship.law.uc.edu/cgi/viewcontent.cgi?article=1095&context=uclr

By: Linda S. Mullenix

 

AGGREGATE LITIGATION AND THE DEATH OF DEMOCRATIC DISPUTE RESOLUTION

https://scholarlycommons.law.northwestern.edu/cgi/viewcontent.cgi?article=1063&context=nulr

Also by: Linda S. Mullenix

About Professor Mullenix: https://law.utexas.edu/faculty/linda-s-mullenix

Books by Professor Mullenix: https://www.amazon.com/Linda-S.-Mullenix/e/B001HML766

Managing Related Proposed Class Actions in Multidistrict Litigation

https://www.fjc.gov/sites/default/files/materials/21/Managing_Related_Proposed_Class_Actions_in_Multidistrict_Litigation.pdf

By: Catherine R. Borden

Government of the United States of America – Federal Judicial Center

GLOBAL SETTLEMENTS IN NON-CLASS MDL MASS TORTS

https://www.fjc.gov/sites/default/files/materials/21/Managing_Related_Proposed_Class_Actions_in_Multidistrict_Litigation.pdf

 

https://law.lclark.edu/live/files/25156-saackreadyforwebsitepdf

By: Amy L. Saack

About Amy Sacck: http://www.davisrothwell.com/attorney/amy-saack/

 

 

STANDARDS AND BEST PRACTICES FOR LARGE AND MASS-TORT MDLS

BOLCH JUDICIAL INSTITUTE, DUKE LAW SCHOOL

https://judicialstudies.duke.edu/wp-content/uploads/2018/10/standards_and_best_practices_for_large_and_mass-tort_mdls-Bolch-Judicial.pdf+

 

Disclaimer: The author of this article, John Ray, is not an attorney. Nothing in this article should be considered legal advice. The opinions expressed in this article are those of John Ray. Publication of this article by any third party should not be considered endorsement of nor agreement with the opinions expressed by the author.

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Xarelto Settlement Judicial Activism vs Judicial Tyranny

Xarelto Proposed Settlement 

The death MDL settlements as we know and love them?

 

Foreword: Non leadership firms representing Xarelto plaintiffs facing potential dismissal from orders issued related to the proposed Xarelto settlement might find this article very beneficial.

Although it is still doubtful that the proposed Xarelto settlement will consummate, it appears that Judge Fallon is set to dismiss individual cases for failure to comply with orders arising from the proposed settlement. Such dismissals would arguably be ripe for appeal.

Spoiler Alert: MDL Judges arguably Lack Subject Matter Jurisdiction to issue orders arising from MDL settlements. Any case dismissed for failure to comply with an order issued absent jurisdiction over the subject matter giving rise to the order, would also be a juridical act undertaken without proper jurisdiction. Parties can not wave Subject Matter Jurisdiction, by act nor agreement. There is no time limit to file an appeal related to an order issued in the absence of jurisdiction over the Subject Matter. Orders issued lacking subject matter jurisdiction  are null from the onset and void on their face. Res Judicata does not apply to orders issued in want of jurisdiction over the subject matter.  See Citations of Relevant Law at the end of this article).

The Road to Hell and Good Intentions 

Certain well intended MDL Judges, including Judge Eldon Fallon have subscribed to the theory that “MDLs are Quasi Class Actions” and despite the fact the USC 1407 provides MDL judges with no jurisdiction to participate in MDL settlements, MDL judges could none the less exercised the powers of their court and involved themselves in MDL settlements, reasoning that MDLs are merely Quasi Class Actions. MDL judges ascribing to the “MDLs as Quasi Class Actions” theory have reasoned intra alia that  Federal Judges have jurisdiction over Class Action Settlements and therefore Federal Judges presiding over MDLs (Quasi Class Actions by their  reasoning) have the same jurisdiction as a Federal Judge Presiding over a Class Action, so long as they comply with the requirements of FRCP 23, in particular the requirements of FRCP 23(e) .

MDL Judges willing to arguably overstep their jurisdiction and exercise the power of their courts in MDL settlements, have justified doing so by  simultaneously complying with duties imposed under FRCP 23(e).

FRCP 23(e) requires Federal Judges presiding over Class Actions to conduct fairness hearings and approve any Class Settlement. These fairness hearings are intended in part to provide class action “absent plaintiff parties” protection from would be unscrupulous self-dealing lead class counsel.

Xarelto Settlement Where Activism turned to Tyranny 

Prior to the Xarelto Settlement, all MDL judges who have inserted themselves into MDL settlements have complied with FRCP 23(e) by conducting fairness hearings to allow parties not represented by plaintiffs leadership a voice before imposing any order related to the settlement that might negatively impact any absent plaintiffs case. Judge Fallon conducted extensive fairness hearings in the settlement of the Vioxx litigation. For reasons unknown to the author, Judge Fallon apparently does not view Xarelto plaintiffs as being deserving of the same protections provided Vioxx plaintiffs.

Although Quasi Class Actions do not actually exist, (MDLs are not Quasi Class Actions) and MDL judges arguably have no jurisdiction to involve themselves in MDL settlements, the Judicial Activism undertaken by Quasi Class Actions MDL judges has arguably been beneficial to defendants as well as plaintiffs desiring efficient mass settlement. Neither defendants nor plaintiffs have complained in the past however, Judge Fallon’s failure to conduct fairness hearings related to the proposed Xarelto Settlement may result in an end to the long running gravy train of MDL settlements achieved by activist MDL Judges willing to overstep their jurisdiction to assist parties in effectuating settlement.

In addition to failing to conduct fairness hearings related to the proposed Xarelto settlement, Judge Fallon also appears to be set to dismiss individual plaintiffs’ cases for failure to comply with orders arising from the settlement. These  orders were arguably issued absent jurisdiction over the subject matter. Any future order arising from the settlement orders, including an order dismissing a case for failing to comply with the settlement related orders, would also be issued without jurisdiction over the subject matter.

Appeals arising from the forgoing, may result in the creation of case law that puts an end to MDL judges inserting themselves into MDL settlements, making reaching mass settlement in MDLs a far more difficult task.

It should be noted I (John Ray) hold Judge Fallon in high esteem. I believe Judge Fallon is wise and fair minded. Despite the foregoing, even wise and fair-minded Judges can err.  I do not view Judge Fallon as a tyrant in general however, acts of tyranny are acts of tyranny, without regard to the general character of those that commit the acts.

 

Back Ground

MDL Judges presiding over Class Actions (FRCP 23) not only have jurisdiction over settlement, Judges presiding over Class Actions have a duty to insure than any proposed settlement is fair to all parties including “absent” parties. FRCP 23(e) Requires Judges presiding over Class Actions to conduct fairness hearings, and rule on the fairness of a class action settlement.

Rule 23(e) is the only safeguard provided to absent class members under Rule 23, protecting these vulnerable parties from self-dealing class action lead counsel that might be inclined to act to the common detriment of absent class members vs the common benefit of those absent parties.

Conversely USC 1407, passed by Congress in 1968, formerly codifying Multidistrict Litigation as a means by which very Federal Jurisdiction can be imposed, provided no jurisdiction for MDL judges to oversee, assist in, issue orders related to or arising from, mass settlement. Additionally, USC 1407, having extended no “settlement jurisdiction” to MDL judges also provided no protection from would be self-dealing lead counsel in MDLs that might act to the common detriment of absent plaintiffs (those not represented by leadership firms).

How Can This Be?

Common Misconception: MDL Judges Have Jurisdiction of the Subject Matter as Well as Personal Jurisdiction to oversee or enter orders to assist mass settlement.

Jurisdiction over the Subject Matter: Arguably does not exist!

Personal Jurisdiction: Arguably does not exist, except for cases that arose in the MDL Courts home State and then only if that court would otherwise have jurisdiction.

Wait a Second!

Wait a Second – MDL Judges frequently involve themselves in MDL mass settlements, how do they justify acting in excess of their Jurisdiction? How could the question of these judges jurisdiction over MDL settlement remained unresolved?

No party to an MDL to date,  has been so aggrieved by an MDL Judges overreach on settlement to force higher courts to deal with the issues. The Xarelto settlement is likely to change the foregoing.

 

The Birth of MDLs as Quasi Class Actions

Judge Jack B. Weinstein, presiding over the Zyprexa Litigation (MDL 1596), was the first MDL Judge (that we are aware of) to presume jurisdiction over settlement matters in Multidistrict Litigation under the “MDLs as Quasi Class Actions“ theory.

Weinstein reasoned that MDLs are “Quasi Class Actions” and cited (inter alia), his inherent authority under the “All Writs Act 28 U.S.C 1651” as providing him “inherent authority” over MDL settlements.

Judge Eldon Fallon, while presiding over the Vioxx Litigation, llowing Judge Weinstein’s Quasi Class Actions theory exerted his self-claimed inherent authority to wade into settlement of that litigation. Other MDL Judges (but not all) have also subscribed to Judge Weinstein’s “MDLs as Quasi Class Actions” theory.

Judge Eldon Fallon in Vioxx, as well as other “MDLs as Quasi Class Action  Judges” have reasoned that their involvement in MDL settlements is equitable, so long as the provisions of FRCP 23(e), are observed.  FRCP 23(e) is intended to provide protection from would be self-dealing lead Class Counsel. FRCP 23(e) obligates Federal Judges overseeing Class Actions to conduct fairness hearings (giving absent class members a chance to be heard) as well as rule on the fairness of any propose class settlement prior to approving the settlement and issuing any order related to the settlement that might negatively impact any individual plaintiff.

Judge Fallon in Vioxx as well as other “Quasi Class Action MDL judges” prior to the current Xarelto settlement have in fact held fairness hearings per FRCP 23(e) in all MDL mass settlements in which the court has involved itself via settlement related orders or other oversight.

Judge Fallon did not conduct fairness hearings before issuing orders related to the Xarelto settlement.

These “fairness hearings” are intended (according to “Quasi Class Action MDL judges”) to provide extend the protections provided absent parties in Class Action to absent parties in MDLs. In the MDL context “absent parties” would be all plaintiffs not represented by plaintiff’s leadership (retained by the leadership firms)

Why Do Xarelto Plaintiffs deserve Less Judicial protection than Vioxx Plaintiffs?

Only Judge Fallon could explain why he neglected to follow his own past reasoning (the requirement to conduct fairness hearings) and denied absent Xarelto Plaintiffs the same rights and protections as Vioxx plaintiffs.

Although the proposed Xarelto settlement is repeatedly referred to as a “Private Settlement” (extra udicial) reach by the parties, the label is inaccurate. The settlement was reached after negotiations between defense counsel and plaintiffs’ leadership. Plaintiffs leadership is not a party, nor do they represent any party (plaintiff) other than those retained by their respective firms.

Furthermore, the proposed Xarelto “Private Settlement” ceased to be Private (extrajudicial) the minute the “parties” crossed the threshold of the court seeking an order related to the settlement.

If the courts excuse for not conducting fairness hearings is “because this is a private settlement”, that dog simply won’t hunt.

Any contention that the court is acting under authority agreed to by the parties also fails. Plaintiff Leadership nor Defense Counsel all the “parties”. Plaintiff lead counsel can enter agreements binding on the clients retained by their firms (those parties) however, leadership does not represent all “parties” and therefore cannot stipulate to jurisdiction on behalf clients they do not represent. Additionally, issues related to subjected matter jurisdiction  cannot be waived by stipulation or agreement by the parties.

Jurisdiction Under the “All Writs Act”?

[A]ll courts established by Act of Congress may issue all writs necessary or appropriate in aid of their respective jurisdictions and agreeable to the usages and principles of law.”  28 U.S.C. § 1651(a).

In should be noted that Judge Weinstein, Judge Fallon  and “Quasi Class Action MDL Judges” never appear to claim to have  actual jurisdiction over MDL settlements, they instead cite their inherent authority, which would arise under the “All Writs Act”:

“All courts established by Act of Congress may issue all writs necessary or appropriate in aid of their respective jurisdictions and agreeable to the usages and principles of law.”  28 U.S.C. § 1651(a).”

The All Writs Act however, only provides “inherent authority” over subject matter for which the given Federal Court otherwise has jurisdiction. Absent Jurisdiction over the Subject Matter of MDL settlement, MDL Judges have no inherent authority  arising under 28 U.S.C. § 1651 related to the same subject matter (MDL settlements).

 

Judicial Activism Morphing into Tyranny

Judge Fallon, as well as other MDL judges who subscribe to the quasi-class action theory within the restraints of FRCP 23(e), have in the past been potentially guilty of well-intended judicial activism even when judicial acts arising from that activism may have strayed beyond their  jurisdiction.

The inherent problem always accompanying judicial activism is the risk of activism turning into tyranny.

Xarelto Plaintiffs aggrieved by the proposed settlement, with no forum in which to voice their grievances, while plaintiff leadership arguably acting to their common detriment and a court turning a deaf ear to their plight, might justifiably feel they are victims of judicial tyranny.

Many Judicial Scholars have expressed concern over the possible negative consequences of judicial activism. Many of the concerns expressed by these judicial scholars have now been realized in the proposed Xarelto Settlement.

The Author would argue that Judge Fallon’s failure to conduct fairness hearings, while issuing orders related to the Xarelto settlement, that may negatively impact individual plaintiffs, crossed the line from judicial activism to  judicial tyranny.

 

Don’t Take My Word for It

Due to the fact several members of Xarelto leadership directly threatening me and attempting to lead attorneys representing absent Xarelto plaintiffs (non-leadership) firms, to believe they are somehow at risk of ethical violations if they take the opinions of a non-lawyer (me) into consideration, I will provide the several links below to scholarly papers and articles written by judicial scholars who are actually attorneys. Draw your own conclusions.

Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation

Elizabeth Chamblee Burch

https://www.amazon.com/Elizabeth-Chamblee-Burch/e/B00G61EI2I/ref=dp_byline_cont_ebooks_1

About Professor Burch: http://www.law.uga.edu/profile/elizabeth-chamblee-burch

Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation is available for purchase on Amazon. Professor Burch has been conducing research related to MDL settlements for many years. Her most recent work “Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation” is an eye opening read even for those that believe they are already familiar with all of the “dirty little lies and secrets” of mass torts.

Other work by Professor Burch includes “Monopolies in Mass Torts”

https://digitalcommons.law.uga.edu/cgi/viewcontent.cgi?referer=https://www.google.com/&httpsredir=1&article=2113&context=fac_artchop

 

You can obtain a copy of Monopolies in Mass Torts free at the link above. This paper is somewhat of a prequel to Mass Tort Deals: Backroom Bargaining in Multidistrict Litigation. If you read the prequel you will want to buy the book.

 

DUBIOUS DOCTRINES: THE QUASI-CLASS ACTION  by Linda Mullenix

https://scholarship.law.uc.edu/cgi/viewcontent.cgi?article=1095&context=uclr

Note: This article written by Linda Mullenix in 2012 is as apt today as the day it was written.

About Professor Mullenix:  https://law.utexas.edu/faculty/linda-s-mullenix

Excepts:

In the past few years, the term ―quasi-class action has been appearing with increasing, uncritical frequency in a spate of federal court decisions. While it may be premature to characterize these sporadic references as a trend, it is perhaps soon enough to call attention to the misuse of loose labels that carry with them significant consequences. Before the quasi-class action gains any further traction, there are several valid reasons for definitively quashing this quasi

Before the inspired fabrication of the quasi-class action, global agreements accomplished under MDL auspices had to be settled pursuant to formal class requirements and due process protections. By engrafting the label quasi-class action onto MDL procedure, self-interested actors have created a perfect staging ground for negotiating back-room deals that carry a false aura of judicial legitimacy, liberated from the constraints of the formal class action rule.

MDL judges, in turn, by endorsing the concept of the quasi-class action have greatly expanded the scope of their authority and have become complicit in allowing private parties to accomplish the very backdoor settlements that the Supreme Court and federal courts have disallowed for decades. The quasi-class action, then, represents an ultimate, cynical expression of an aggregate claims-resolution model that enables self-interested actors to resolve claims in the actors‘ best interests rather than the interests of injured claimants.

At first blush, the sheer frequency of federal use of the term quasi-class action would seem to suggest that the quasi-class action is a well-recognized and well-established doctrine in federal jurisprudence. Since 1946, sixty-eight federal cases have cited the label. However, careful reading of this case law suggests an entirely different conclusion: the quasi-class action is a phantasm. None of these cases actually discussed the concept of the quasi-class action, and rarely-cited authority is inapposite or inaccurate.

Important Case Law

Although SCOTUS has yet to address the question : Does and MDL Judge (like a Class Action Judge) have jurisdiction over settlement, as the question has yet to be presented to SCOTUS, the high court has ruled on other questions in a manner which may be of value to any firm representing a plaintiff in the Xarelto litigation if said plaintiff case is dismissed or otherwise prejudiced by any of the orders related to or arising from the prosed Xarelto Settlement.

Lexecon v Milberg (Scotus)

https://www.oyez.org/cases/1997/96-1482

Note: Lexecon did not directly address the question of an MDL Judges jurisdiction over MDL settlement however, SCOTUS made it clear that USC 1407 does not extend an MDL judges jurisdiction beyond the exact language codified by Congress in 1407.

Federal Judges have broad discretion over many matters however, Federal Judges have no discretion in any matter (subject matter nor personal) beyond the specific grant of jurisdiction by Congress under which the court acts.

Question

May a federal district court conducting “pretrial proceedings” under 28 USC section 1407(a) invoke section 1404(a) to assign a transferred case to itself for trial?

No. In an opinion delivered by Justice David H. Souter, the Court held that a district court conducting pretrial proceedings pursuant to section 1407(a) has no authority to invoke section 1404(a) to assign a transferred case to itself for trial. The Court noted that the Panel’s section 1407(a) instructions are crouched in the word “shall,” which “creates an obligation impervious to judicial discretion.” Justice Souter wrote for the Court that, “the straightforward language imposing the Panel’s responsibility to remand… bars recognizing any self-assignment power in a transferee court.” The opinion was unanimous except insofar as Justice Antonin Scalia did not join Part II-C.

Lexecon Inc. was a defendant in a class action lawsuit. Under 28 USC section 1407(a), the lawsuit was transferred for pretrial proceedings to the District of Arizona. Section 1407(a) authorizes the Judicial Panel on Multidistrict Litigation to transfer civil actions with common issues of fact “to any district for coordinated or consolidated pretrial proceedings,” but provides that the Panel “shall” remand any such action to the original district “at or before the conclusion of such pretrial proceedings.” After claims against it were dismissed, Lexecon brought suit against Milberg Weiss Bershad Hynes & Lerach and others (Milberg) in the class action lawsuit in the Northern District of Illinois. Ultimately, the Panel, under section 1407(a), ordered the case transferred to the District of Arizona. Afterwards, Lexecon moved for the Arizona District Court to remand the case to Illinois. Milberg filed a countermotion requesting the Arizona District Court to invoke section 1404(a) to “transfer” the case to itself for trial. Ultimately, the court assigned the case to itself and the Court of Appeals affirmed its judgment.

 

AMCHEM PRODUCTS, INC., et al., PETITIONERS v. GEORGE WINDSOR et al.

Note: AMCHEM arose from the asbestos litigation, the ruling addressed attempts to settle cases filed in MDLs as well as cases filed in Class Actions. SCOTUS did not address the question of MDL Courts jurisdiction (nor lack thereof) over MDL settlement as this issue was not raised. SCOTUS ruling in AMCHEM did however make it clear that any mass tort judge, whether presiding over an MDL or a Class Action, has a duty to protect the interest of “absent plaintiffs”.

Excepts from AMCHEM

This case concerns the legitimacy under Rule 23 of the Federal Rules of Civil Procedure of a class action certification sought to achieve global settlement of current and future asbestos related claims. The class proposed for certification potentially encompasses hundreds of thousands, perhaps millions, of individuals tie d together by this commonality: each was, or some day may be, adversely affected by past exposure to asbestos products manufactured by one or more of 20 companies. Those companies, defendants in the lower courts, are petitioners here.

Rule 23(e), on settlement of class actions, reads in its entirety: “A class action shall not be dismissed or compromised without the approval of the court, and notice of the proposed dismissal or compromise shall be given to all members of the class in such manner as the court directs.” This prescription was designed to function as an additional requirement, not a superseding direction, for the “class action” to which Rule 23(e) refers is one qualified for certification under Rule 23(a) and (b). Cf. Eisen, 417 U. S., at 176-177 (adequate representation does not eliminate additional requirement to provide notice). Subdivisions (a) and (b) focus court attention on whether a proposed class has sufficient unity so that absent members can fairly be bound by decisions of class representatives. That dominant concern persists when settlement, rather than trial, is proposed.

The settling parties, in sum, achieved a global compromise with no structural assurance of fair and adequate representation for the diverse groups and individuals affected. Although the named parties alleged a range of complaints, each served generally as representative for the whole, not for a separate constituency. In another asbestos class action, the Second Circuit spoke precisely to this point:

[W]here differences among members of a class are such that subclasses must be established, we know of no authority that permits a court to approve a settlement without creating subclasses on the basis of consents by members of a unitary class, some of whom happen to be members of the distinct subgroups. The class representatives may well have thought that the Settlement serves the aggregate interests of the entire class. But the adversity among subgroups requires that the members of each subgroup cannot be bound to a settlement except by consents given by those who understand that their role is to represent solely the members of their respective subgroups.” In re Joint Eastern and Southern Dist. Asbestos Litigation, 982 F. 2d 721, 742-743 (CA2 1992), modified on reh’g sub nom. Inre Findley, 993 F. 2d 7 (CA2 1993).

The Third Circuit found no assurance here–either in the terms of the settlement or in the structure of the negotiations–that the named plaintiffs operated under a proper understanding of their representational responsibilities. See 83 F. 3d, at 630-631. That assessment, we conclude, is on the mark.

The argument is sensibly made that a nationwide administrative claims processing regime would provide the most secure, fair, and efficient means of compensating victims of asbestos exposure. Congress, however, has not adopted such a solution. And Rule 23, which must be interpreted with fidelity to the Rules Enabling Act and applied with the interests of absent class members in close view, cannot carry the large load CCR, class counsel, and the District Court heaped upon it. 

Subject Matter Jurisdiction Case Law 

Note: There are literally thousands of appellate rulings related to Lower Courts (Federal) issuing judgments and orders in excess of their jurisdiction. The citations below are merely examples of the vast number of rulings on the subject.

Void judgment is one entered by court that lacks the inherent power to make or enter the particular order involved, and it may be attacked at any time, either directly or collaterally; such a judgment would be a nullity, People v. Rolland 581 N.E.2d 907, Ill.App. 4 Dist. 1991)..

Invalidity need to appear on face of judgment alone that judgment or order may be said to be intrinsically void or void on its face, if lack of jurisdiction appears from the record, Crockett Oil Co. v. Effie, 374 S.W.2d 154 (Mo.App. 1964).

Note: MDL Court Judges imposing themselves into MDL settlements never seem to actually claim to have jurisdiction in the record, instead they  claim to have “inherent authority”. No authority exists absent jurisdiction.

Decision is void on the face of the judgment roll when from four comers of that roll, it may be determined that at least one of three elements of jurisdiction was absent: (1) jurisdiction over parties, (2) jurisdiction over subject matter, or (3) jurisdictional power to pronounce particular judgment that was rendered, B & C Investments, Inc. v. F & M Nat. Bank & Trust, 903 P.2d 339 (Okla. App. Div. 3, 1995).

A void judgment which includes judgment entered by a court which lacks jurisdiction over the parties or the subject matter, or lacks inherent Power to enter the particular judgment. or an order procured by fraud,can be attacked at any time, in any court, either directly or collaterally, provided that the party is properly before the court. Long v. Shorebank Development Corp., 182 F.3d 548 ( C.A. 7 Ill. 1999).

A void judgment is one which from its inception was a complete nullity and without legal effect, Lubben v. Selective Service System Local Bd. No. 2 7, 453 F.2d 645, 14 A.L.R. Fed. 298 (C.A. 1 Mass. 1972).

A void judgement is one which from its inception and forever continues to be absolutely null. without legal efficacy, ineffectual to bind the parties or to support a right, of no legal force and effect whatever, and incapable of enforcement in any manner or to any degree – Loyd v. Director, Dept. of Public Safety, 480 So. 2d 577 (Ala. Civ. App. 1985).

A judgment shown by evidence to be invalid for want of jurisdiction is a void judgment or at all events has all attributes of a void judgment, City of Los Angeles v. Morgan, 234 P.2d 319 (CaLApp. 2 Dist. 1491).

Res judicata consequences will not be applied to a void judgment which is one which from its inception is a complete nullity and without legal effect, Allcock v. Allcock 437 N.E. 2d 392 (Ill. App. 3 Dist. 1982).

Void judgment is one which has no legal force or effect whatever, it is an absolute nullity, its invalidity may be asserted by any person whose rights are affected at any time and at any place and it need not be attacked directly but may be attacked collaterally whenever and wherever it is interposed, City of Lufkin v. McVicker, 510 S.W. 2d 141 (Tex. Civ. App. – Beaumont 1973 1991)..

Disclaimer: The author of this article, John Ray, is not a lawyer. Nothing in this article should be taken as legal advice. The opinions expressed in this article are the opinions of the author. Publication of this article by any third party should not be considered an endorsement of nor agreement with the opinions expressed by the author.

 

 

 

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Bayer’s Roundup Litigation Headaches Continue to Grow – When Will They Settle?

How many billions is Bayer AG setting aside?

By Mark A. York (August 9, 2019)

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The Bayer AG executive suite seems to be leaning toward settling the Monsanto (Bayer) Roundup MDL 2741 litigation, along with the thousands of cases in state courts around the country. A previous statement on settlement was, this is “financially reasonable” to review settlement of all litigation over the weedkiller Roundup, and is under review.

Bayer engaged additional senior defense counsel from Skadden, Arps and there is word of casual settlement discussions among people directly involved in the litigation. MDL Judge Chhabria has set a hard remand docket, and also appointed mediator Ken Feinberg to help move settlement along. How this all comes together in settlement discussions remains to be seen.

Is this where all plaintiff counsel remain together in forcing Bayer into high-value settlement, or where individual firms will attempt to carve out settlements based on their firm inventory?

The number of lawsuits from people in the U.S. who say the herbicide caused them to develop cancer rose by about 5,000 to 18,400. That is an enormous increase in lawsuits and there’s now an effort to make sure Bayer pays a premium settlement as the docket continues to grow.

BAYER IS SELLING ASSETS

Bayer is selling units to sharpen its focus after the $63 billion purchase of Monsanto, which saddled it with thousands of lawsuits claiming that the Roundup weedkiller it acquired in that deal causes cancer. The German giant agreed to unload its majority stake in a chemicals venture Wednesday in a deal valued at $3.9 billion, and two Roundup trials have been delayed as pressure builds to settle. Cash received from Bayer asset sales, may be going directly into the Roundup settlement fund.

Quarterly sales and earnings missed estimates and the German company questioned its ability to meet its full-year forecast. The shares fell 3.4 percent in Frankfurt.

Baumann has staked his credibility on last year’s $63 billion takeover of Monsanto Co., claiming the company is better off balancing its portfolio between agriculture and health care. But the surge in U.S. lawsuits alleging that Roundup — which Bayer inherited from Monsanto — causes cancer suggest settling the claims will become more much more expensive than previously thought.

“The jump in lawsuits is worrying,” said Mustaq Rahaman, a credit analyst at Bloomberg Intelligence. “This set of results will do little to stem calls for more dramatic action including a split.”

The chemicals and pharmaceutical giant said it would create a special committee of eight supervisory board members to monitor Roundup lawsuits and consult with management on legal strategies.

Bayer named U.S. lawyer John H. Beisner, an expert on mass tort and product litigation at Skadden, Arps, Slate, Meagher & Flom LLP, to advise the board on all Roundup legal matters, including trial tactics and mediation.

Bayer cited Mr. Beisner’s experience in negotiating high-profile settlements and said it looked forward to “constructively engaging in the mediation process.” A U.S. judge has provisionally appointed Kenneth Feinberg to serve as mediator in the consolidation of hundreds of Roundup cases filed in federal court. Mr. Feinberg has served as mediator in high-profile cases, including the Deepwater Horizon oil spill in the Gulf of Mexico in 2010.

U.S. hedge fund Elliott Management Corp., which owns some €1.1 billion ($1.25 billion) worth of Bayer shares, or about 2% of the company, backed Bayer’s latest steps. It said the new committee would provide “a new level of oversight and a fresh perspective to a litigation strategy in need of radical overhaul and help guide the company towards a rational, fair and swift settlement.”

U.S. Judge Vince Chhabria is handling the Roundup MDL 2471 lawsuits and has been moving the docket at a very fast pace, and denied Bayer’s Motion to Overturn the recent jury verdict, for case information see,  ROUNDUP-MONSANTO-(GLYPHOSATE)-MDL-2741-(USDC-ND-California).

Baumann said on a conference call that he is open to a settlement as long as it resolves all Roundup litigation. He repeated that the herbicide is safe, that the cases have no merit and that the company is “constructively engaging” with court-appointed mediator Ken Feinberg.

After the call, Bayer declined to say how much a “financially reasonable” sum would be or whether Baumann was referring only to the current load of cancer cases or the possibility of future Roundup suits tied to other ailments.

Bayer’s definition of what a reasonable settlement amount would be for all the Roundup cases isn’t likely to match up with estimates from lawyers for users of the weed-killer, said Carl Tobias, a professor at the University of Richmond’s law school who teaches about mass-tort litigation. “They aren’t going to like the numbers the plaintiffs are going to demand,” Tobias said. “Maybe Ken Feinberg can work something out.”

Bayer’s legal woes at the agricultural unit are being compounded by bad weather. In North America, heavy flooding has delayed planting season for farmers, while trade tensions with China hurt U.S. farmers’ ability to export soybeans, curbing demand for Bayer’s products. Just as Bayer reported earnings, U.S. President Donald Trump lashed out at China for what he said is an unwillingness to buy American agricultural products.

Bayer’s pesticide sales struggled in Europe too, due to unusually dry weather. Revenue at the crop science unit fell 3.1% after adjusting for currency and portfolio effects associated with the Monsanto takeover, Bayer said.

New Medicines

The Leverkusen, Germany-based company reiterated its annual financial forecast and its plan to defend itself in the Roundup litigation, while saying it will “constructively engage” in the mediation process ordered by a California judge. The company has aimed for about 46 billion euros ($51 billion) in revenue and profit of about 6.80 euros a share for this year.

Bayer’s other challenges include selling off its animal health division, rekindling growth at its ailing consumer-health division and coming up with promising new medicines for its pharma unit, where top-selling treatments Xarelto and Eylea both face losing patent protection next decade.

Bayer’s shares have plunged about 40% in the past 12 months amid concern over legal claims that Roundup and its main ingredient glyphosate can cause cancer. Activist shareholder Elliott Management Corp., which unveiled a $1.3 billion stake in last month, has said the company could unlock 30 billion euros in shareholder value with a settlement.

Still, some analysts say the company is right to spread its focus between different businesses to help manage the ebbs and flows of each unit.

“If Bayer just had the pharma business, the stock would be super risky, because the pharma business has some medium to long-term concerns,” said Dennis Berzhanin of Pareto Securities. “Yes, they’re having short-term problems right now with crop science, but it reduces the risk of the company in general and supports their growth going forward.”

YEARS OF BAD CONDUCT BY MONSANTO

There are numerous documents and media articles that underscore the lengths to which the agrochemical company has taken to protect its image, and the dangers of Roundup.  Documents show that Henry I. Miller, an academic and a vocal proponent of genetically modified crops, asked Monsanto to draft an article for him that largely mirrored one that appeared under his name on Forbes’s website in 2015. Mr. Miller could not be reached for comment.

A similar issue appeared in academic research. An academic involved in writing research funded by Monsanto, John Acquavella, a former Monsanto employee, appeared to express concern with the process see Monsanto internal e-mail expressing concern over Roundup , in the 2015 email to a Monsanto executive, “I can’t be part of deceptive authorship on a presentation or publication.” He also said of the way the company was trying to present the authorship: “We call that ghost writing and it is unethical.”

A Monsanto official said the comments were the result of “a complete misunderstanding” that had been “worked out,” while Mr. Acquavella stated via mail that “there was no ghostwriting” and that his comments had been related to an early draft and a question over authorship that was resolved. Even though there are other documents that refute this version of Monsanto’s “official” statement.

Monsanto has been shown to have actively ghostwritten, drafted and offered direction on formal EPA studies, press releases and other “official” documents, introduced in the pending Roundup federal litigation.

The documents also show internal discussions about Roundup’s safety. “If somebody came to me and said they wanted to test Roundup I know how I would react — with serious concern,” one Monsanto scientist wrote in an internal email in 2001.

The documents also show that A. Wallace Hayes, the former editor of a journal, Food and Chemical Toxicology, has had a contractual relationship with Monsanto. In a further example of Monsanto collusion and influence in 2013, while he was still editor, Mr. Hayes retracted a key study damaging to Monsanto that found that Roundup, and genetically modified corn, could cause cancer and early death in rats.

Selling Assets For Settlement?

Elanco Animal Health Inc., the business Eli Lilly & Co. listed last year, is aiming to reach an agreement soon, where they would combine with Bayer AG’s animal-health unit. The companies hope to announce a deal around the time of Elanco’s Aug. 13 earnings release, the people said, asking not to be identified as the discussions are private. Elanco, which has a market value of about $12.3 billion, plans to pay at least part of the acquisition cost using stock, the people said.

Elanco lost 4.2% Wednesday to close at $31.47. Bayer rose as much as 2.6% early Thursday in Frankfurt.

Bayer would get a significant minority stake in Elanco under the deal being discussed, according to another person. The companies are currently hammering out potential antitrust issues by identifying which businesses they will likely need to sell to gain regulatory approval, the person said.

While Bayer prefers a deal with Elanco, no final agreements have been reached and the talks could drag on or fall apart, the people said. Bayer may proceed with its previous plans for a broader auction process if it can’t agree on terms with Elanco by early September, one person said.

A deal between Elanco and Bayer would preempt a sale process that was expected to be one of Europe’s most hotly contested deal situations this year. It had attracted a flurry of initial interest from buyout firms ranging from KKR & Co. to Blackstone Group Inc. and CVC Capital Partners, which have increasingly been bidding against each other as they try to spend the record amounts of capital the industry has amassed.

Bayer said in a statement that it’s on track with plans to exit the animal-health business and its primary focus is on a sale. The German company also continues to consider all value-maximizing options, it said in the statement, declining to comment further.

Elanco has grown rapidly through at least 10 acquisitions since 2007, including the $5.4 billion takeover of Novartis AG’s animal-health unit. A representative for Elanco, which is based outside Indianapolis, declined to comment.

The sale of Bayer’s animal-health unit was expected to fetch as much as 8 billion euros ($9 billion). The process was initially slated to kick off in the second quarter, people with knowledge of the matter said in March, though Bayer has repeatedly pushed back the start of the auction.

The Bayer business offers medicine and antibiotics to farm animals and pets. The division’s best-selling product line is the Advantage flea, tick and worm treatments for small animals.

Monsanto (Bayer)  has been proven time and time again to be directly responsible for corporate sponsored  collusion, influence peddling in both the public and private sectors and manipulation of data released to the public regarding the now known carcinogenic links of exposure to Monsanto’s primary product, Roundup and the main ingredient glyphosate.

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Opioid MDL 2804 Class Settlement: Judge Polster tells state AGs to come up with a better model

 

Their response: “The nation’s top three drug distributors—McKesson, AmerisourceBergen and Cardinal Health—have verbally offered a $10 billion settlement with state attorneys general, according to the news service. AGs hit back with a much higher demand of $45 billion”

By Mark A. York (August 8, 2019)

(MASS TORT NEXUS MEDIA) Opiate drugmaker stocks fell sharply after Bloomberg reported that a coalition of state attorneys general had demanded $45 billion from the three leading drug distributors in the U.S. to settle litigation over opioids.

According to Bloomberg, the counteroffer came after the distributors proposed a $10 billion settlement. The reported offers were made in negotiations between the National Association of Attorneys General andMcKesson (ticker: MCK), Cardinal Health (CAH), and AmerisourceBergen(ABC).

The report appears to be spooking investors. Shares of Cardinal were down 6.4% in afternoon trading, McKesson fell 5.9%, and AmerisourceBergen declined 6.1%.

Generic drugmakers also suffered large drops – . Teva Pharmaceutical Industries(TEVA) was down 8.7%, Mylan (MYL) was down 6.6%, and Endo International(ENDP) and Mallinckrodt (MNK)—which both released earnings Tuesday—were down 19% and 11.7%, respectively.

Those amounts appear to be far higher than investors expected. In a note Tuesday, Evercore ISI analyst Ross Muken wrote that investors he had spoken with had expected the distributors to pay $5 billion.

“Ohio Attorney General letter to Opiate MDL Judge Pollster citing caselaw”

The motion excludes state attorneys general, some of whom have brought lawsuits in state courts across the country, and sets up a procedure in which 24,500 cities, counties and other smaller governments could resolve their claims. It comes two days after Alabama Attorney General Steve Marshall voluntarily dismissed the state’s case in federal court and as Oklahoma Attorney General Mike Hunter is in the midst of the first opioid trial in the nation against manufacturer Johnson & Johnson.

Ohio AG Response

The Ohio AG wrote a letter to Federal Judge Dan Polster, where he challenged the legitimacy of the strategy pursued by private plaintiff attorneys, some of them veterans of the 1997 settlement between the states and the tobacco industry, who have signed up thousands of individual cities and counties as clients to try to pressure opioid manufacturers and distributors into a multibillion-dollar settlement. Private lawyers reaped some $14 billion in fees from the $260 billion tobacco settlement.

Yost criticized “the self-admitted power grab being made by unelected private attorneys to control the distribution of public moneys within the States.”

“The proposed negotiating class, and perhaps this very litigation, threatens the sovereignty of the States like nothing else in recent history,” he wrote. “It seeks to represent not a single political subdivision asserting parens patriae standing, but all of them. In other words, this motion seeks to permit the class to stand in the shoes of the States — nothing short of usurpation.”

Yost also criticized the allocation mechanism the lawyers have proposed. According to an “Allocation Map” the lawyers have placed online, Coshocton County, Ohio, would get $1.99 per capita or a total of $73,265 out of a $1 billion settlement, after lawyers claimed $100 million in fees.

“Distributing a few thousand dollars to local communities is meaningless.”  Ohio was among 27 states, including Texas and California, that filed a letter in June asking Judge Polster to delay any decision on a class.

See OPIOID-CRISIS-BRIEFCASE-INCLUDING-MDL-2804-OPIATE-PRESCRIPTION-LITIGATION

The motion also comes as U.S. District Judge Dan Polster of the Northern District of Ohio has pushed for global settlement talks while setting the first trial in the MDL for Oct. 21. In a brief supporting their motion a settlement class, which included 40 class representatives, including counties in California, Florida, Georgia, New Jersey and New York, and major cities such as Atlanta, Chicago, Denver, Los Angeles and San Francisco.

“This precise vehicle has never been used before, but we are very confident that this is a valid use of the procedure and that the court will, we are hopeful, welcome this as an opportunity to move the resolution of these cases forward,” said co-lead plaintiffs attorney Paul Hanly of Simmons Hanly Conroy in New York.

The federal litigation link is, Opiate Prescription MDL 2804, US District Court of Ohio link.

The move is also designed to provide some assurances to defendants—manufacturers and distributors of the prescription painkillers, as well as pharmacies—about the total scope of lawsuits that are out there.

The federal judge overseeing multidistrict litigation against opioid manufacturers and distributors left little doubt he supports a plan developed by private lawyers to assemble an unprecedented “negotiating class” consisting of every city and county in the U.S.

Rejecting complaints that the proposal would violate federal law and trample on states’ rights, U.S. District Judge Dan Aaron Polster repeatedly said “there has to be a vehicle” for resolving the nearly 2,000 cases by cities and counties that have been concentrated in his court. Along with hundreds of lawsuits still in state court and litigation by individual states, Indian tribes and other entities such as healthcare agencies and pension funds, Judge Polster said, the mass of litigation must be settled somehow.

“Everyone knows that trying 2,500 cases would sink the state and federal judiciaries, but also the amount of private resources would also be staggering and no one would want that,” the judge told lawyers for both sides during 1.5-hour hearing in Cleveland Tuesday morning.

A majority of state attorneys general as well as defendants including drug distributors are opposed to the proposal, under which Judge Polster would certify a procedure that specifying how funds from an opioid settlement are distributed to individual counties before any money is on the table. In filings with the court in late July, Ohio AG Dave Yost called the plan a “power grab” by private lawyers who represent most of the cities and counties in the litigation.

August 6, 2019 Development

“The nation’s top three drug distributors—McKesson, AmerisourceBergen and Cardinal Health—have verbally offered a $10 billion settlement with state attorneys general, according to the news service. AGs hit back with a much higher demand of $45 billion”

Among other objections, critics of the plan say it would violate Rule 23 of the Federal Rules of Civil Procedure, which governs class actions, and U.S. Supreme Court decisions requiring class action lawyers to fairly represent both their own clients and so-called “absent” class members who aren’t participating in settlement negotiations or may not even be aware of the litigation.

In a back-and-forth exchange with Sonja Winner, a Covington Burling attorney representing McKesson, the judge dismissed the idea the proposal might violate the most important Supreme Court precedent, Amchem v. Windsor. In that 1997 decision, the court said any class action must satisfy Rule 23 requirements, including that the claims are typical across the entire class and the interests of absent class members are represented.

Winner said the proposed mechanism for allocating money under a settlement only reaches as far as the counties, leaving cities to negotiate their share of the money with the counties that theoretically represent them in the class. The conflict between the two groups would be fatal under Amchem, she said.

“I’m not worried about the Supreme Court — the issue is what I will do,” Judge Polster responded.

“I’ve got 2,000 cases. There has to be a vehicle for solving them as a group.”

According to a calculator the plaintiff lawyers have put online, Fremont County in Wyoming would get $98,000 of a hypothetical $1 billion settlement, while the town of DuBois would get nothing because its $98 payout would fall below a $500 minimum. Winner said that was typical of the uneven results that individual cities and counties might not be aware of before they are asked to decide whether to sign off on the settlement procedure or opt out.

The judge also brushed aside objections from other AG’s, who stated that the complex allocation formula would intrude on the power of the states to allocate money among their political subdivisions as they see fit. Judge Polster said he wouldn’t approve any language undermining state sovereignty, but went on to say he also won’t approve any settlement that directs all of the money into state treasuries, as some politicians demand.

He cited the 1997 tobacco settlement, in which little of the money paid over by cigarette companies actually went toward treating smoking-related disease. He said it was a “problem” that “in a number of states any money that the state AG obtains …goes into the general fund.”

Because the litigation in his court “encompasses the cities and counties,” any settlement “has to account for the matter of putting money into state general funds,” the judge said. “Because that idea isn’t going to fly.”

Clearly Judge Polster’s views on the opioid litigation have evolved since the early days, when he envisioned a swift settlement that included significant changes in how the industry does business. He repeatedly agreed with defendant companies that they have no incentive to settle unless plaintiff lawyers can offer them global peace, and that is impossible without the participation of the states and possibly even the federal government.

“Everybody understands no defendant is going to settle with the states alone and not the cities and counties,” or vice versa, he said. “That would be lunacy.”

The judge also told critics, including defendant companies, to come up with a better solution if they don’t like the one the plaintiff lawyers have proposed.

“Nobody has a monopoly on good ideas,” he said. “The more ideas floated, the better.”

He did recognize one glaring conflict of interest in the current proposal: Some of the same lawyers, most prominently Motley Rice, represent states and hundreds of members of the proposed class of cities and counties. He barred those lawyers from participating in the hearing or arguing in favor of the proposal.

“Those lawyers have a conflict at the moment because all or most of the state attorneys general are opposing this motion,” he said.

The judge also said that if he approves the mechanism, which seemed likely from his comments, he will appoint an independent representative on behalf of the tens of thousands of cities and counties that haven’t sued but could belong in the class. He also said he would limit settlement releases to claims under federal law and would have 13 nationwide “families” of defendants.

The pharmaceutical industry spent a vast $6.4 billion in “direct-to-consumer” advertisements to hype new drugs in 2016, according tracking firm Kantar Media. That figure has gone up by 62% since 2012, Kantar Media says. This number may seem large at first but compared to the multi-billions in yearly profits just by opioid manufacturers over the last 15 years, the numbers is small.  Corporate earnings have risen every year since the push to increase opioid prescriptions in every way possible, to became an accepted business model in Big Pharma boardrooms across the country.

Opioids were involved in more than 42,000 overdose deaths in 2016, the last year for which data was available, according to the U.S. Centers for Disease Control and Prevention. Kentucky, one of the nation’s hardest-hit states, lost more than 1,400 people to drug overdoses that year.

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