Register today for the Mass Tort Nexus 4-Day Immersion Course, September 24th-27th in Ft. Lauderdale, FL. Few seats remain, lock yours in TODAY!

Paraquat: Poisoning America’s Heartlands

Paraquat (paraquat dichloride), a toxic weed-killing herbicide, has been used commercially since the 1960s, and is currently banned in 32 countries. It is used by farmers and agricultural laborers to kill and prevent growth of grasses and weeds. Paraquat is also linked to harmful and sometimes deadly side-effects, including Parkinson’s Disease; however, Paraquat is NOT like RoundUp – this toxic herbicide is completely different. Paraquat poisoning occurs when someone:

• Comes into contact with grasses or weeds sprayed by Paraquat
• Gets paraquat on their skin
• Inhales or ingests Paraquat
• Mixes, loads, or administers the application of Paraquat on grasses or weeds

As Paraquat is only available for commercial (versus recreational / residential) use, it is also used as an alternative to glyphosate (main ingredient in Monsanto’s RoundUp), on areas that have become glyphosate-resistant.

 

Philips’ CPAP and BiPAP Litigation: The Problem and the Optics

The problem: Degradation of the polyester-based polyurethane (PE-PUR) sound dampening foam used by Philips Respironics in the design and manufacture, of a series of recalled Ventilator, CPAP and BiPAP devices.

Based on statements made by Philips, the degradation of the PE-PUR foam can lead to the release of several gaseous Volatile Organic Compounds (VOCs), including diethylene glycol, Toluene Diisocyanate, Toluene Diamine, Phenol Dimethyl Diazine as well as potential inhalation of degraded particles of the sound dampening foam.

The Optics: Exposure to diethylene glycol, resulting in 115 deaths in a two-month period in 1937, was the catalyst for the enactment of the Food, Drug and Cosmetic Act of 1938 and the creation of the modern-day FDA. Eighty-three years later, diethylene glycol is included in the list of toxic chemicals users of Philips Respironics Ventilator, CPAP and BiPAP recalled devices may have inhaled in significant doses (See more below on the history of Diethylene glycol and the creation of the FDA after “The Massengill Incident of 1937”).
These VOCs, when released, are likely to be delivered in high doses to the users of the recalled Ventilator, CPAP and BiPAP devices via direct inhalation.

 

Don’t miss the LAST Mass Tort Nexus 4-Day Immersion Course in 2021, September 24th-27th in Ft. Lauderdale, FL:

Aimee Wagstaff – Wagstaff Law Firm, Denver, CO

Mark O’Mara – O’Mara Law Group, Orlando, FL

Melanie Muhlstock – Parker Waichman, New York

Jim Onder – OnderLaw, St. Louis, MO

Patrick Luff – Fears Nachawati, Dallas, TX

Kelsey Stokes – Fleming Nolen Jez, Houston, TX

Marcus Susen – Susen Law Group, Ft. Lauderdale, FL

Josh Kincannon – Wilentz, Goldman & Spitzer, Woodbridge, NJ

Annesley DeGaris – DeGaris Wright McCall, Birmingham, AL


Litigations covered include:

Paraquat
Philips CPAP
Elmiron
Zantac
RoundUp
Hip Litigation
Paragard
Hernia Mesh
Allergan Breast Implants
Talc Settlement Updates
IVC Filter Settlement Updates

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Mass Tort Nexus Welcomes Litigator Aimee Wagstaff to the September 4-Day Immersion Course

In 2010, Aimee became a founding partner of Andrus Wagstaff. In 2021, Aimee founded the Wagstaff Law Firm, with principal offices in Denver, CO. Aimee Wagstaff has dedicated the entirety of her professional life fighting against pharmaceutical and medical device companies who harm her clients by continually putting profits before safety. The vast majority of Aimee’s litigation is done through national mass tort consolidations, usually multidistrict litigations (MDLs) or Judicial Council Coordinated Proceedings (JCCPs). In that regard, Aimee has been appointed by federal and state court Judges across the country to co-lead four national litigations by the age of 40, such litigations representing tens of thousands of injured claimants.

Although Aimee is licensed to practice in California, Colorado, and Missouri, she mainly resides in Denver, Colorado. Recently, the Colorado Trial Lawyers Association (“CTLA”) presented Aimee with the “Access to Justice” award, which honors the “perseverance, courage and character shown over and over again in cases of extraordinary circumstances.”

In 2019, the Honorable Vince Chhabria appointed Aimee to serve as national Co-Lead counsel of MDL 2741- In Re: Roundup Products Liability Litigation, situated in the United States District Court for the Northern District of California. In that MDL, Plaintiffs allege that exposure to Monsanto’s billion dollar weed killer, Roundup, causes cancer. Because Roundup is sprayed on (an estimated) 80 percent of the food we eat, the case has generated considerable media attention. Here are a few of the articles: “EPA Official Accused of Helping Monsanto ‘Kill’ Cancer Study”, “Monsanto Weed Killer Roundup Faces New Doubts on Safety in Unsealed Documents”, “Monsanto Ghostwrote Cancer Studies of Its Own Weed Killer, Plaintiffs in Lawsuit Say.

Aimee served as lead trial counsel in the first, and only, federal Roundup trial – Hardeman v. Monsanto. After a hard-fought month-long trial, the jury unanimously returned a verdict for Mr. Hardeman in the amount of $80,267,634.10. Shortly after that historic verdict, and while the Hardeman verdict is on appeal, Monsanto announced it has resolved 75% of the national lawsuits for almost $11,000,000,000.00 (eleven billion dollars). That settlement included over a billion dollars for Andrus Wagstaff clients. The Colorado Trial Lawyers Association (“CTLA”) recognized the impact of the Hardeman verdict by voting it the “Case of the Year.”

In 2015, Aimee made MDL history when the Honorable Judge Kathryn H. Vratil appointed her to serve as Co-Lead counsel of the first ever majority women MDL plaintiffs’ steering committee (PSC) – MDL 2652: In Re: Ethicon, Inc., Power Morcellator Products Liability Litigation, situated in the United States District Court for the District of Kansas. The morcellator litigation involves women and their families all over the United States who have been diagnosed with devastating and permanent injuries, including leiomyosacroma (“LMS,” a deadly form of cancer), following the use of Ethicon’s power morcellator during a fibroid removal or hysterectomy surgery. That MDL was also historic for its pace of resolution, within a year.

Additionally, the Honorable Joseph R. Goodwin, Chief Judge, United States District Court for the Southern District of West Virginia, appointed Aimee to serve on the TVM Plaintiffs’ Steering Committee overseeing all 7 TVM MDLs and also appointed Aimee to serve on the eight-member national executive committee overseeing the TVM MDLs and to serve as national co-lead of MDL 2326 against Boston Scientific Corporation. To date, Juries across the County, in several different jurisdictions have awarded TVM Plaintiffs over $500,000,000.00. Aimee was part of the trial team against Boston Scientific wherein a jury from the Southern District of West Virginia awarded 4 TVM Plaintiffs $18,500,000.00 after determining that Boston Scientific’s Obtryx product was defectively designed. The TVM MDLs will be remembered as one of the biggest (both in volume and value) product liability cases in American jurisprudence. To date, the TVM litigations have generated an estimated 10 billion in settlement monies.

In March 2013, Aimee founded and hosted the first annual “Women En Mass” (WEM) retreat that was held in Aspen, Colorado. WEM is an annual working retreat for amazing women in mass torts — a time to relax and enjoy each other’s company while creating new, and fostering old, relationships. If you are interested in attending, check out WEM’s website or contact Aimee directly, she would love to include you on the next invite/distribution list. If you are a social media type, “Like” Women En Mass on Facebook.

Prior to founding AW, Aimee gained invaluable experience with the defense bar as she billed countless hours working as a green associate for a large defense firm.

Aimee earned her undergraduate degree in Marine Science and Communications from the University of San Diego, where she played on the women’s soccer team.

Recent Success Stories

$80,267,634.10 Roundup Verdict: AW partner Aimee Wagstaff was lead trial counsel in the first, and only, federal Roundup trial. The trial was particularly impressive as the case was bifurcated into two phases: Scientific Causation and “Everything Else.” Shortly after that historic verdict, Monsanto announced it had resolved 75% of the national lawsuits for almost $11,000,000,000.00 (eleven billion dollars).

$18,500,000.00 BSC TVM Verdict: Boston Scientific gets slammed with huge verdict. AW Partner Aimee Wagstaff was an integral part of the trial team that represented 4 Plaintiffs who were injured after being implanted with Boston Scientific’s Obtryx product. After a month trial in the Southern District of West Virginia, the trial team secured a verdict of 18.5 Million dollars, including punitive damages after the jury found the Obtryx product was defective and Boston Scientific failed to warn the doctors. The trial was held before the Honorable Irene Berger.

HUGE Boston Scientific TVM Verdicts: AW Partner Aimee Wagstaff serves as National co-lead counsel of the TVM MDL against Boston Scientific. Currently, juries across the Country have awarded Boston Scientific Plaintiffs in excess of $118,000,000.00.

10 Billion in Settlements and over 500 Million in TVM Verdicts: AW Partner Aimee Wagstaff serves on the 8 person Executive Committee overseeing all federal TVM litigation. To date, Defendants have pledged over 1.6 Billion dollars in resolution monies and juries across the land have awarded over $240,000,000.00 in verdicts to TVM Plaintiffs.

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Philips CPAP, BiPAP Recall, Emerging Major Litigation

This article is continuing our coverage of the Philips Respironics Ventilator, CPAP and BiPAP recall. If you did not read our first article, you may want to get up to speed before reading our first article at this link.

Our first article address why the Philips Respironics recalls may not have caught the attention of many law firms and why failing to understand the significance of these recalls would be a mistake for any plaintiffs’ law firm.

The “optics” for any defendant in a mass litigation are as important as any matter of law. This article will explain why the “optics” for Philips in the instant matter are, arguably, horrid.

The Problem and the Optics

The problem: Degradation of the polyester-based polyurethane (PE-PUR) sound dampening foam used by Philips Respironics in the design and manufacture, of a series of recalled Ventilator, CPAP and BiPAP devices.

Based on statements made by Philips, the degradation of the PE-PUR foam can lead to the release of several gaseous Volatile Organic Compounds (VOCs), including diethylene glycol, Toluene Diisocyanate, Toluene Diamine, Phenol Dimethyl Diazine as well as potential inhalation of degraded particles of the sound dampening foam.

The Optics: Exposure to diethylene glycol, resulting in 115 deaths in a two-month period in 1937, was the catalyst for the enactment of the Food, Drug and Cosmetic Act of 1938 and the creation of the modern-day FDA. Eighty-three years later, diethylene glycol is included in the list of toxic chemicals users of Philips Respironics Ventilator, CPAP and BiPAP recalled devices may have inhaled in significant doses (See more below on the history of Diethylene glycol and the creation of the FDA after “The Massengill Incident of 1937”).

These VOCs, when released, are likely to be delivered in high doses to the users of the recalled Ventilator, CPAP and BiPAP devices via direct inhalation.
This article will focus on the VOC, diethylene glycol as it was this toxic substance that led to the broad federalization of Food and Drug Law in the United States.

Given the history of diethylene glycol exposure in the United States, the recent exposure of humans to diethylene glycol presents horrible optics for Philips.

It is worth noting that this is not the first time Mass Tort Nexus has covered issues related to Diethylene glycol exposure to humans from FDA-regulated products. See this link.

MTN is currently compiling intake criteria and supporting clinical research, for the injuries known to be caused by the list of Volatile Organic Compounds (VOCs) associated with these devices. MTN members can obtain more detailed information by contacting Barbara Capasso at (954) 383-3932 or barbara@masstortnexus.com.

MTN is also working with MTN member case generation companies, record review companies and other service providers to assist those who assist your firm, in your marketing and case work-up for this major emerging litigation.

It is worth noting that qualifying clients, obtaining the required records and record review for this emerging litigation, will be complex and involve contact with medical providers your firm has likely never had reason to interact with.

The Massengill Incident of 1937

In 1937, a pharmaceutical manufacturer, S. E. Massengill Company, developed liquid oral preparation of sulfanilamide using diethylene glycol (DEG) as the solvent and excipient. The company branded the new drug as “Elixir Sulfanilamide”, Elixir Sulfanilamide, which was a liquid version (for oral ingestion) of the common antibiotic Sulfanilamide, commonly referred to as Sulfa. The diethylene glycol in Elixir Sulfanilamide was blamed for the deaths of approximately 100 individuals over the course of several months after its introduction.

Dr. Samuel Evans Massengill, when pressed to admit some measure of culpability, infamously answered, “We have been supplying a legitimate professional demand and not once could have foreseen the unlooked-for results. I do not feel that there was any responsibility on our part.”

Harold Watkins, the company’s chief pharmacist and chemist primarily responsible for the development of Elixir Sulfanilamide, committed suicide while awaiting trial on charges arising from the 105 deaths in 15 states during the months of September and October of 1937.

There have been numerous other international incidents of mass casualties attributed to the ingestion and inhalation of diethylene glycol since the Massengill Incident.

The Food Drug and Cosmetic Act of 1938

The Massengill Incident of 1937 caused a public outcry and pressure on the federal government to revisit the Pure Food and Drug Act of 1906, which did not require drug makers to test products for safety prior to exposing humans to their products.

Congress responded quickly to public pressure, and enacted the Food Drug and Cosmetic Act of 1938, which was signed into law by President Franklin Roosevelt on June 25th 1938.

Eighty-Three Years Later

Jun 14, 2021: Philips issues recall notification to mitigate potential health risks related to the sound abatement foam component in certain sleep and respiratory care devices.

Diethylene glycol is listed by Philips as one of the toxic substances emitted by the breakdown of the sound dampening foam used in their recalled BiPAP, CPAP and Ventilator devices.

Eighty-three years (to the month) after the Massengill/ Elixir Sulfanilamide incident led to the passage of the Food Drug and Cosmetic Act of 1938, and the ultimate creation of the modern FDA, we again appear to face an incident of a (now) FDA-regulated group of medical devices exposing humans to diethylene glycol, once again.

From an “optics” perspective, exposing individuals to diethylene glycol presents “optics” for Philips that they should never want to be put before a jury.

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MAJOR EMERGING HOME VENTILATOR LITIGATION

As a foreword, this litigation is one your firm should probably be signing clients for, now.

Caveat: The qualifying criteria (injury types) is still developing and will continue to do so.

This article expresses our opinions on possible criteria your firm may wish to consider at this stage of the litigation.

PREEMEPTION

Although we have not completed our review of all FDA approvals of the recalled devices, the fact that these devices are Class II makes it unlikely that any individual approval was sought or granted via the PMA process. Stay tuned.

These devices should not be confused with implantable Upper Airway Stimulation devices, which generally are subject to PMA approval.

THE RECALL

Philips Respironics has thus far issued recalls on a large number of their CPAP and BiPAP devices. See current recalled products at this link. Mass Tort Nexus expects more devices to be recalled.

While these devices are referred to as ventilators, they are not the type of device that you may normally think of when the you hear the word “ventilators.”
The term ventilator is often associated with the types of life-sustaining devices used in hospitals or surgery (when a person can not breath on their own). The use of these devices involves intubation with a tube past the bronchial bifurcation (Carina) to ensure that the air passed from the device to the patient enters the lungs vs the stomach.

WHAT IS CPAP AND BiPAP?

Conversely, CPAP and BiPAP devices, while technically, “ventilators,” are used by patients (generally at home), to mitigate the symptoms and effects of specific diseases, which we will discuss more in-depth herein.

The use of a CPAP and BiPAP does not involve intubation, the user simply places a mask over their nose and/or nose and mouth.

WHO USES THESE DEVICES?

Long term (chronic) users of BiPAP and CPAP devices generally suffer from one of two primary chronic diseases: Obstructive sleep apnea (OSA) and/or Chronic Obstructive Pulmonary Disease (COPD). COPD is more commonly referred to as Emphysema. These devices may also be used for shorter periods of time by individuals suffering from various acute disease states.

How Many Chronic Users Exist?

Based on statistical reports from reliable authorities, MTN estimates that between 8-10 million Americans user either a CPAP or BiPAP on a long term (chronic) basis.

Philips Respironics currently has 62.8% of the market. ResMed is the next biggest player, with a 32.2% share of the market.

For those readers that have taken the MTN Four Days to Mass Tort Success Course, as a matter of first impression, the Potential Plaintiff Numerosity for this emerging litigation appears to be in the hundreds of thousands, and possibly in excess of one million potential plaintiffs.

WHY WERE THESE PRODUCTS RECALLED?

According to reports, these devices used Polyester-based polyurethane (PE-PUR) as sound abatement foam. According to Philips, the recall was due to potential harmful effects (including cancer) caused by the degradation of the foam, allowing particles to enter the body of the user through inhalation. Additionally, Philips reported the outgassing of two toxic gases. Due to the fact that the product users are inhaling these gases directly, it is probable (at minimum) that these device users received far higher doses of these gases than is known to be safe.

ABOUT THE FOAM

Polyester-based polyurethane (PE-PUR) sound abatement foam is used in a wide variety of products as well as for numerous other purposes, such as “sound proofing” rooms. Polyester-based polyurethane is also used in the auto manufacturing industry to decrease the impact of “road noise” on drivers and passengers.

While Polyester-based polyurethane (PE-PUR) products are known to outgas (give off fumes) certain toxic chemicals, when used for the purposes described in the first paragraph, the level of exposure to humans should not exceed safe limits.

Philips Respironics used PE-PUR as a sound dampening material in BiPAP and CPAP devices. BiPAP and CPAP devices are primarily used by sufferers of Obstructive sleep apnea (OSA) and to a lesser extent, those who suffer from Chronic Obstructive Pulmonary Disease (COPD). COPD is more commonly referred to as Emphysema.

Users of BiPAP and CPAP devices affix a device over their nose while they sleep. The BiPAP and CPAP device provides positive pressure to the airways, preventing the airways from closing off during sleep, resulting in hypopnea. A hypopnea is a temporary cessation in breathing, that often causes a sufferer of OSA or COPD to partially awake numerous times during a sleep cycle. These disruptions of REM sleep result in sufferers essentially getting very little “beneficial” sleep. OSA or COPD sufferers often fall asleep while driving, resulting in an increased number of car accidents among those who suffer from these diseases.

Because the air of a BiPAP and CPAP machine is circulated through the device before entering the patients’ airways, any contamination of the air caused by the given BiPAP or CPAP device is breathed directly into the users’ airways (nose, throat, lungs).

The problems reported with the Philips Respironics BiPAP and CPAP devices are twofold:

1. The foam degrades over time. Particles of the foam break away and can directly enter the patients’ airways, ultimately lodging in the lungs.

2. The foam out gases two caustic, toxic chemicals (gasses), which are inhaled by users.

FOAM DEGRADATION

While the negative impact of absorption though inhalation of the gases emitted from Polyester-based polyurethane foam is well documented in the literature, we find no significant prior reports of wide scale inhalation of actual particles of the foam. This is likely due to the fact that Polyester-based polyurethane foam has never been widely used (with the immediate exception) in products that would likely increase human exposure though inhalation beyond safe limits.

HOW DO THE HUMAN LUNGS REACT TO THESE PARTICLES?

Again, for the same reasons stated above, the medical literature is bereft of information on this topic. It is reasonable to assume that when these Polyester-based polyurethane particles lodge in the lungs, the human body will react in one of two ways:

1. The body will attempt to encapsulate the particle (think asbestos/mesothelioma), which would increase the probability of cancer at the site of the particle (lungs).

2. The body is unable to encapsulate the particle, and therefore the particle continues to degrade and is absorbed in the blood stream, and the toxins within are then passed to every organ and anatomical structure of the human body.
We will continue to research the literature on the above topic, as we believe the subject will have been addressed by researchers to some degree, most likely evolving from mass industrial exposures (workers).

OUT GASING

The reported toxic “gases” which users of the recalled devices were exposed via inhalation included:

1. Dimethyl Diazine: Other names include: Azomethane; (CH3N)2; 1,2-Dimethyldiazene; Dimethyldiazene

2. Phenol, 2,6-bis (1,1-dimethylethyl)-4-(1-methylpropyl) (also called carbolic acid)

Exposure to low doses of Dimethyl Diazine is known to cause a variety of health maladies. As indicated by the weight of the literature, the potential injuries or health maladies most associated with Dimethyl Diazine exposure frequently occur in the kidneys or liver (including organ failure and cancers in these organs); In that the kidneys and liver are the primary elimination pathways of Dimethyl Diazine.

MTN will continue to search the literature for support for other injury types; however, firms that are currently considering signing Plaintiffs for this emerging litigation would be well advised to sign kidney and liver injury (including total organ failure), as well as kidney and liver cancer patients.
Interestingly, Phenol may have therapeutic benefits in treating certain types of cancer, while causing different cancers. MTN has not completed our evaluation of Phenol re: cancer. Stay tuned.

One definite known regarding Phenol is that the substance is highly caustic. Phenol will cause chemical burns on human skin (epithelia cells) if not quickly treated. Epithelia cells are also significantly present the human respiratory system.

Epithelial cells of the lung are located at the interface between the environment and the organism and serve many important functions including barrier protection, fluid balance, clearance of particulate, initiation of immune responses, mucus and surfactant production, and repair following injury.
For these reasons, it may be advisable for firms to investigate cases in which any of the following occurred:

1. Significant respiratory distress leading to secondary injury, primarily heart attack. Screening (by medical professionals) should include ruling out other possible causes of the significant respiratory distress (including prior occurrences pre device use), more likely to be the cause of the current event vs the recalled device(s).

2. Sudden onset total respiratory failure, applying the same medical screening cited above.

LUNG CANCER

Starting with the caveat that MTN has yet to find significant support for low exposure to the subject chemicals (in gas form) causing lung cancer, Pathophysiological and epidemiological testimony offered by experts may suffice to meet the burden of proof (causation) related to these particles and gases, when inhaled or introduced into the body in the dosages and manners present with the subject devices.

The bottom line: If your criteria is too narrow, you are likely to reject cases that might result in a positive outcome for your client. If your criteria turn out to be overly broad, you may sign clients for whom you are unable to achieve a positive outcome. This is nothing new.

CLIENT DEMOGRAPHICS

Diabetics are 83% more likely to suffer from a chronic condition that would lead to the need for the use of these devices, as compared to the general population. If your firm has ever been involved in a litigation involving a diabetes drug, you may want to reach out to these past clients.

While defendants (in kidney failure cases) may argue that that your Plaintiff was predisposed to this injury, that same defendant did not warn that diabetics were at a higher risk of any injury type, than non-diabetics.

Your client population will skew towards males and older individuals. 10% of men and 3% of women aged 30–49 suffer from sleep apnea, while 17% of men and 9% of women aged 50–70 have this disorder.

Individuals who are significantly overweight suffer from sleep apnea at far higher rates than those who are within the normal weight range for their height and body type.

African Americans suffer from sleep apnea at higher rates than Caucasians.

Note: Users of these devices generally purchase the device from Durable Medical Equipment Companies (DME). Additionally, the disposable supplies required to use these devices are marketed by the same DME companies, as well as by online providers.

After consideration of your state’s specific bar rules and HIPAA, you may be able to use the forgoing information to tailor a very targeted client awareness campaign. You will not be filing suit against the DME companies or disposable suppliers.

EXPECTED DEFENSES

Phillips has floated the possibility that certain common solutions (made for the specific purpose) used to clean the parts of BiPAP and CPAP devices may have contributed to the problems with the foam.

The problem such a defense would face raises obvious questions:

Did Phillips warn/instruct users to only use certain cleaning solutions?

Does the problem occur in the absence of the use of these cleaning solutions?

Lastly, having sold these devices for nearly two decades (ending in 1999), I, John Ray, can attest to the fact that cleaning solutions used by end users generally are only used on the disposable components and exterior parts of the device that can be accessed without disassembly, not on the interior of the device where the foam was installed.

Defendants are most likely hoping to gain ground from a 2020 FDA advisory related to approved products for cleaning these devices; however, the advisory lends no support to any argument that the manner in which these devices were cleaned by end users impacted foam on the inside of the device.

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Dalkon Shield, Essure, Paragard?

By Marcus Susen, Esq.

One question that is not raised enough, if at all, is why women disproportionally bear the burden of birth control. Almost all forms of birth control are aimed at women. Consequently, and unfortunately, women bear all the risks associated with these devices/drugs. Why is that?

From the 1970’s through today, women have been targeted by Big Pharma with different forms of birth control devices/drugs from the Dalkon Shield in the 1970s to Mirena, Essure, and Paragard in more recent years. Shockingly, all four of these devices/drugs have been the subject of mass litigation and two have been withdrawn from the market. (Dalkon Shield and Essure) On the other hand, there are no birth control devices for men. Many people are shocked to realize that male birth control pills are possible but Big Pharma is not pursuing this market with the same energy as it does with the devices/drugs aimed at women. Is this because Big Pharma has found, what it thinks, to be their easier “target”? If so, Big Pharma better rethink this strategy.

After the mass litigations regarding the Dalkon Shield, Mirena, and Essure, more recent news has been focused on Paragard birth control. Paragard is a temporary, non-hormonal, non-surgical IUD. It is essentially a T-shaped piece of plastic that is wrapped in copper wire which is intended to interfere with fertilization. However, more and more women have been reporting that the device has been breaking, especially upon removal, often causing significant and life altering injuries, such as infection, perforations, and infertility. Several reports have been made of surgical intervention to remove the broken device including hysterectomy- contradicting selling points made by the manufacturer (i.e. non-surgical, reversible). As a result of several of these incidents, a consolidated litigation has arisen involving Paragard in federal court in Northern GA against Teva Pharmaceuticals USA, Inc. and CooperSurgical, Inc. Once again, women across the country are speaking up.

Since Paragard was approved by the FDA, over 40,000 reports have been made by women and medical providers to the FDA according to the agency’s website. Over 16,000 of these have been labeled as “Serious Cases (including deaths).” However, drug safety experts estimate that only 10% of adverse events are actually reported to the FDA on a yearly basis.
The FDA relies on patients to report issues they have with medical devices or drugs on their MAUDE database. The FDA use this information to regulate devices and drugs. However, if the events are not being reported, the FDA does not have a complete picture of the risk/safety profile of a particular drug

or device. As a result, the FDA is less likely to require more safety studies, updated warnings, or even recall a device or drug.

The Paragard consolidated litigation may be yet another turning point for women. This is because when a woman files a lawsuit the manufacturer is required to report the event to the FDA. The amount of cases filed may help the FDA obtain a more accurate picture of the true risk/safety profile for Paragard. We saw this play out in the Essure litigation where after thousands of lawsuits were filed, the FDA required the manufacturer to conduct post-market studies, implement a black box warning, and patient-doctor decision checklist. Ultimately, the manufacturer pulled Essure from the market.

If manufacturers complain about lawsuits surrounding their drugs/devices, they might want to consider proactively following up with clients to see how their drug/device is doing and report the negative experiences to the FDA instead of waiting for the problems to come up in lawsuits. Maybe this is wishful thinking, but it would sure be cheaper than defending thousands of lawsuits. Then again, they can always begin to promote male birth control.

Marcus Susen

Marcus Susen is lead counsel of the Essure birth control litigation in the EDPA. After Essure was pulled from the market, for the global litigation settled for over $1.6B. He is currently on the Plaintiffs’ Steering Committee for the Paragard birth control litigation and focuses his practice on women’s health advocacy.

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Ethicon Hernia Mesh Litigation News

Case Totals Continue to Increase for Multiple Ethicon Hernia Mesh Products
By: Joshua S. Kincannon

The number of product liability cases filed against Johnson and Johnson and Ethicon for their defective hernia mesh products is on the rise. At the present rate, we can expect New Jersey state court cases to reach or surpass 3,000 by the Fall of 2021.

Cases have been consolidated into three litigations based on product, and all are set to be argued in Atlantic County, New Jersey, before the Honorable John C. Porto. All cases allege that these Johnson and Johnson and Ethicon polypropylene hernia mesh products are defective in their design, manufacture, and warnings. The following Ethicon products are included in the New Jersey Multi-County Litigations:

  • PHYSIOMESH: In Re Physiomesh Litigation Flexible Composite Mesh, Case No. 627, Superior Court of New Jersey, Law Division, Atlantic County.
  • PROCEED FLAT MESH and the PROCEED VENTRAL PATCH: In re Proceed Mesh Litigation, Case No. 630, Superior Court of New Jersey Law Division, Atlantic County.
  • PROLENE HERNIA SYSTEM (“PHS”): In re Prolene Hernia System Litigation, Case No: 633, Superior Court of New Jersey Law Division, Atlantic County.

Physiomesh Litigation

Plaintiffs allege that the Physiomesh implant is defective due to the dual-sided Monocryl coating, which causes the mesh to fail to adhere and leads to migration, recurrence, and device failure. As a result of these defects, the Physiomesh device was voluntarily withdrawn from the market in May of 2016.

Proceed Flat Mesh/Proceed Ventral Patch Litigation

The Proceed line of products differs from Physiomesh in that the polypropylene mesh core is coated with oxidized regenerated cellulose (“ORC”) as opposed to Monocryl. ORC is a poor coating that doesn’t work. It results in a chronic inflammatory response and severe adhesion formation when it fails and the patient’s bowels come into contact with the bare polypropylene mesh core. Further, the Proceed meshes are sterilized using a process known as gamma irradiation in air. This causes a breakdown of the molecular chains of the polypropylene core, weakening the mesh and rendering it ineffective for its designed, intended use. No other mesh product is coated in ORC or sterilized using gamma irradiation in air. Unlike the Physiomesh device, the Proceed line of products continues to be manufactured and sold.

Prolene Litigation

The Prolene Hernia System mesh is manufactured from a heavyweight, small-pore polypropylene mesh. It is a three-dimensional mesh product used primarily for inguinal hernia repair. Bare polypropylene triggers an intense, chronic inflammatory reaction when implanted in the human body. The PHS design only exacerbates this inherent material defect, as the sheer amount of polypropylene coupled with its dense hydrophobic design increases this deleterious inflammatory process exponentially. Defendants continue to sell this product.

Current Status of Litigations

Discovery is ongoing in these cases, with depositions of corporate witnesses continuing throughout the summer. The initial Bellwether pools have been chosen and those cases are being worked up for possible inclusion into the final trial pools. Selection of trial pool cases begins on June 1st with the Physiomesh litigation, where each side and the court will select a total of six cases for the final trial pool. The Proceed trial pool will be chosen in August, with each side and the court choosing nine cases. The PHS pool will be chosen in November, with four court picks and two picks each for plaintiffs and defendants. Trials are scheduled ninety days apart, beginning in May of 2022.

About the Author
Joshua S. Kincannon, Counsel in Wilentz, Goldman & Spitzer, P.A.’s Defective Drug & Device litigation practice, is lead liaison counsel on the New Jersey Ethicon Hernia Mesh cases. He can be reached at: jkincannon@wilentz.com.

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JOHN CARSON SR., M.D. ROUNDUP SETTLEMENT NEWS

In our previous coverage of the Carson matter we discussed what appears to be a pay-for-appeal scandal, arising from the case of Dr. John Carson Sr., M.D. In our initial article we mentioned the fact that several plaintiffs’ firms had filed a motion to intervene in the Carson case. See the documents from the motion to intervene here.

Jim Onder, as well as other major players in the RoundUp litigation will be speaking at the MTN Four Day Mass Tort Immersion Course June 11th – June 14th (register here). Attendees will be provided with up-to-date substantive information on the Roundup settlement negotiations. While newsworthy under the category of “bizarre,” the matter covered herein should not be considered substantive. We are covering a side show. Jim and others will give you a peek inside the “big tent” at our upcoming course.

Since our first article related to the deal Bayer made with plaintiff John Carson Sr., M.D., Bayer has publicly, and in court filings, fired back at the attorneys that filed the motion to intervene, although for the most part, Bayer/Monsanto’s utterances have been without significant, relevant substance, one of Bayer’s contentions seems to conflict with other prior contentions:

1. Bayer/Monsanto has made no secret of the fact that their appeal scheme involving Dr. John Carson Sr. is at least, in part, motivated by the desire to obtain an appellate ruling in the 11th Circuit or on further appeal to SCOTUS, that would benefit them in their defense of the remaining, approximately 125,000 Plaintiff cases.

2. However, when certain attorneys representing the interest of some of the 125,000 plaintiff cases filed a motion to intervene in the Carson appeal, Bayer/Monsanto filed a response asking the court to disregard these third parties’ filings, claiming that they have no interest in the very appeal that was filed with the intent (at least in part) of affecting those interests.

A more reasonable argument would be, the appeal court refusing to consider and hear the pleadings and interests of these third parties, would constitute a denial of the due process rights of these individuals.

Bayer/Monsanto seems to want to have their cake and eat it too:

Having their cake: We want to get appellate rulings that will help us defend against cases brought by Plaintiffs not initially named in the appeal. We want to dispose of the interest those third parties have in their claims against our organization, and this appeal will hopefully help.

Eating it too: Those third party plaintiffs that we hope to deprive of their interest in part via the Carson appeal, lack the necessary interest to intervene and be heard in the very appeal we hope will ultimately extinguish their interests.

THE CASE STANDS CLOSED

Normally, when an appellate court renders an opinion, the matter (case) is remanded back to the lower court, for further adjudication in accordance with the appellate ruling.

In the Carson case, the parties reached a private settlement agreement. Carson amended his complaint to drop the remaining claims that were not found to be preempted. The lower court then entered final judgement in favor of Bayer Monsanto and closed the case on March 30, 2021. (see below)

The settlement agreement, between Bayer and Carson was never filed or entered the docket of the lower Court in any manner. Now Bayer seeks to file a copy of the settlement agreement under seal in the appeals court in support of their argument pushing back against intervenors as well as in support of their arguments that the agreement is relevant to the appeals courts jurisdiction. The first question that must be ask is; How can appellate jurisdiction, in any way, rely or turn on evidence never summitted to nor considered by the lower Court?

Reports of Bayer’s public statements regarding intervenor action:

“Under the settlement, the company agreed to pay Carson $100,000 to drop the surviving design defect claims and to pursue the preemption ruling against him,” Bayer said in the statement. “If he succeeds in the appeal, he gets an additional substantial payment. If Carson drops the appeal, he would simply have to return the $100,000 settlement payment because he would be in breach of its terms. Thus, plaintiffs’ characterization of the $100,000 as a ‘penalty’ in a court filing is completely false, and nothing more than an effort to block this appeal on federal preemption grounds which threatens their interests in this litigation.”

Bayer’s statements are conclusive of the fact that regardless of the outcome of the appeal, there would be nothing for the lower court to adjudicate (reconsider) based on the appeal ruling, as the terms of the settlement agreement governs what occurs after the appeals court rules.

Federal Appellate Court Jurisdiction is limited to the authority to rule on errors in law and abuses of discretion by lower courts. Appellate Courts do not exist for the purpose of playing arbiter of agreements between private parties that are inherently extra judicial, unless and until a breach of said agreement is alleged and an action is filed arising from said breach, over which Federal Jurisdiction would then have to be proven to exist. More simply stated, it is not within the jurisdictional powers of a Federal Appellate Court to hear and rule on matters over which the resulting outcome does nothing more than determine the amount of money that one party pays, or another receives, arising from a private extra judicial agreement.

Stated differently, if no change or reconsideration of a lower court ruling would occur, regardless of the outcome of an appeal, that said appeal is not within the scope and purpose and jurisdiction of Federal Appellate Courts.

LACK OF APPELLANT JURISDICTION

Without regard to the intervenors’ motion, the 11th Circuit has an absolute obligation to affirmatively determine whether Federal Subject Matter Jurisdiction exists over the Carson appeal. Federal Courts are under a continuing obligation to affirmatively assure themselves of their jurisdiction over matters, even if no party (or third party) raises a jurisdictional challenge. See in general Steel Co. v. Citizens for Better Environment, 523 US 83 – Supreme Court 1998, Arbaugh v. y & H Corp., 546 US 500 – Supreme Court 2006, Ruhrgas Ag v. Marathon Oil Co., 526 US 574 – Supreme Court 1999, Insurance Corp. of Ireland v. Compagnie des Bauxites de Guinee, 456 US 694 – Supreme Court 1982.

Voluntary dismissal, moreover, may precede any analysis of subject matter jurisdiction because it is self-executing and moots all pending motions, obviating the need for the district court to exercise its jurisdiction. See Nix v. Fulton Lodge No. 2 of the Int’l Ass’n of Machinists, 452 F.2d 794, 797-98 (5th Cir.1971) University of South Alabama v. American Tobacco, 168 F. 3d 405 – Court of Appeals, 11th Circuit 1999 Id at 409.

It is, by now, axiomatic that the inferior federal courts are courts of limited jurisdiction. They are “empowered to hear only those cases within the judicial power of the United States as defined by Article III of the Constitution,” and which have been entrusted to them by a jurisdictional grant authorized by Congress. Taylor v. Appleton, 30 F.3d 1365, 1367 (11th Cir.1994).

FEDERAL JURISICTION OVER PRIVATE SETTLEMENT AGREEMENTS

Federal Jurisdiction over private settlement agreements is an often misunderstood topic. Parties to a case may agree and seek a consent order in which the Federal Court retains jurisdiction to enforce the terms of the settlement agreement. Otherwise, a settlement agreement is a contract governed by state law, under a given State courts jurisdiction, like any other contract.

For Federal Court to retain jurisdiction to enforce the terms of the settlement agreement, the settlement agreement must be incorporated into a consent order issued by the lower court. No copy of the Carson/Bayer settlement was filed in the lower court, much less incorporated into a consent order.

“Mere involvement in the settlement, however, is not enough. There must be some official judicial approval of the settlement and some level of continuing judicial oversight. Buckhannon, 532 U.S. at 604 n. 7, 121 S.Ct. 1835”.

The point that is often missed or misunderstood regarding a Federal Courts retention of jurisdiction to enforce the terms of the settlement agreement, is contingent on one party alleging breach of the agreement and instituting a new and fresh case and controversy arising from said breach, over which the Federal Court could then (and only then) exercise its retained jurisdiction to enforce the terms of the settlement agreement.

A SETTLEMENT AGREEMENT CANNOT CONFER APPELLATE JURISDICTION

“Subject matter jurisdiction is conferred and defined by statute. It cannot be created by the consent of the parties, see Fitzgerald v. Seaboard Sys. R.R., Inc., 760 F.2d 1249, 1251 (11th Cir.1985) (per curiam), nor supplanted by considerations of convenience and efficiency, see, e.g., E.R. Squibb & Sons, Inc. v. Accident & Cas. Ins. Co., 160 F.3d 925, 929 (2d Cir.1998), Morrison v. Allstate Indem. Co., 228 F. 3d 1255 – Court of Appeals, 11th Circuit 2000 Id at 1261.

“More specifically, the Court did not determine whether a plaintiff could achieve a sufficient “alteration in the legal relationship of the parties” through a settlement entered without a separate consent decree. In fact, private settlements were mentioned only in a footnote, which observed that private settlements do not entail the judicial approval and oversight involved in consent decrees. And federal jurisdiction to enforce a private contractual settlement will often be lacking unless the terms of the agreement are incorporated into the order of dismissal. Id. at 604 n. 7, 121 S.Ct. at 1840 n. 7 (citing Kokkonen v. Guardian Life Ins. Co. of Am., 511 U.S. 375, 114 S.Ct. 1673, 128 L.Ed.2d 391 (1994)). American Disability Ass’n, Inc. v. Chmielarz, 289 F. 3d 1315 – Court of Appeals, 11th Circuit 2002 Id at 1319 also see Anago Franchising, Inc. v. SHAZ, LLC, 677 F. 3d 1272 – Court of Appeals, 11th Circuit 2012.

THE DISAPPEARING SON – ATTORNEY JOHN CARSON Jr.

In our previous article, we mentioned the fact that a young attorney named John Caron Jr., who appears to the be the son of the plaintiff John Carson Sr. was added to the Certificate of Interest Parties filed by Carson on 04/02/21.

On 04/21/28 as part of the reaction to the intervenors motion, Bayer/Monsanto files a second Certificate of Interested Parties, with no mention of Attorney John Carson Jr.

At minimum, this appearance and sudden disappearance of John Carson Jr. from the appeal record deserves a “Hmmm” or rather a “Hmmmmmmmmmmm!”

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ROUNDUP LITIGATION SETTLEMENT SIDE SHOW

RECENT HEADLINES

“Bayer Deal Pays Roundup Plaintiff to Keep Fighting in Court.”
“Bayer Accused of ‘Pay to Appeal Scheme’ by Roundup Lawyers.”
“Bayer entered into an agreement that essentially pays a Georgia man to keep fighting the company in court.”

See links to referenced news reports at the bottom of this article.

PRELIMINARY

While MTN does not consider the matters covered in this article to be anymore than evidence of Bayer/Monsanto’s desperation to garner any leverage possible in settlement negotiations, we nonetheless thought this story was bizarre enough to merit coverage.

Jim Onder, as well as other major players in the Roundup litigation will be speaking at the MTN Four Day Mass Tort Immersion Course June 11th – June 14th (register here). Attendees will be provided with up to date substantive information on the Roundup settlement negotiations. While news worthy under the category of “bizarre,” the matter covered herein should not be considered substantive. We are covering a side show. Jim and others will give you a peek inside the big tent at our upcoming course.

BACKGROUND

Bayer/Monsanto has lost numerous trials in the Roundup litigation. The defendants have filed appeals; however, according to reports, Bayer does not believe they are likely to prevail in the appeal in the Circuits where they have pending appeals.

HERE’S WHERE THINGS GET BIZARRE

Now comes the case of Dr. John Carson. Dr. Carson was represented by a relatively young attorney, Ashleigh Madison, in his case filed in Georgia. (4:17-cv-00237-RSB-CLR Southern District of Georgia (Savannah).

From a review of Pacer, it appears that Madison would be accurately described as a general practitioner. We found no appellate cases in our review of cases in which Madison was listed as Plaintiffs counsel. While Madison appears to be a very competent attorney, her apparent lack of appellate experience is concerning considering what is at stake. The Bayer/Monsanto legal team on the other hand is comprised of high flying legal eagles with ample appellate experience.

The lower court Judge in the Carson case found preemption on certain claims brought by Carson; however, other claims survived. One might think, with some claims having survived the lower court’s ruling, the case would have continued to proceed towards trial; then something strange happened.

Although we can find no reference to a settlement in the Notice of Appeal filed in the lower court case, recent news reports inform us that a settlement was reached in which Bayer pays Carson certain undisclosed amounts now and potentially more at a later date.
Despite no particulars regarding the exact amount Carson would receive, it appears that Carson receiving any amount is contingent on his filing of the appeal Bayer wants filed.

It seems that it would be difficult for any Federal Court to find that a genuine adversary case and controversy exist, when the first party has paid the second party to bring an action against the first party. Absent a genuine adversary case and controversy, no Federal Jurisdiction can exist, appellate or otherwise per Article III Section II.

KEEPING IT IN THE FAMILY

What we also find puzzling is the fact that on appeal, Carson v. Monsanto Co., 21-10994, U.S. Court of Appeals for the 11th Circuit (Atlanta) another young Plaintiffs attorney who appears to be less seasoned than Madison, was added to the appellate team. It just so happens that the new attorney added to the team to ostensibly fight Carson’s appeal, appears to be John Carson Jr., the son of the Plaintiff, Dr. John Carson Sr. Like Madison, John Carson Jr. appears to be a perfectly competent attorney; however, we do not see how he brings any additional muscle to a high stake appellate case.

THE LOWER COURT KEPT IN THE DARK

No copy of the settlement was filed with the appeals court, yet a reference was made to the settlement without specificity in Carson’s arguments claiming appellate jurisdiction existed despite a settlement having been reached in the original case. Interestingly, the two cases cited by Carson from the 11th Circuit in support of appellate jurisdiction post-settlement were, Yunker v. ALLIANCEONE RECEIVABLES MANAGEMENT, INC., Court of Appeals, 11th Circuit 2012 and Druhan v. American Mut. Life, 166 F. 3d 1324 – Court of Appeals, 11th Circuit 1999. In both cases the 11th found no appellate jurisdiction existed.

INTERVENTION WAS INEVITABLE

If the Bayer/Monsanto legal team thought their scheme would go unnoticed by their equals (or betters) from the Plaintiffs’ side, they were quickly disappointed.

David J. Wool, Esq. of ANDRUS WAGSTAFF, P.C., R. Brent Wisner, Esq. of BAUM HEDLUND ARISTEI & GOLDMAN, P.C and Jennifer A. Moore, Esq. of MOORE LAW GROUP, PLLC sent a letter to the appeals court (see copy here) shortly after the appeal docket was opened. The letter was followed by a formal motion to intervene.

If Bayer/Monsanto really wants to see their scheme through to the end, it is already clear that they will not do so by out gunning their opposition on appeal. They will have to face the best and brightest of the Plaintiffs’ bar in a battle that is likely to get ugly.

MTN has downloaded the most relevant documents pertaining to this matter from PACER and will be happy to provide any Plaintiff firm interested in this matter with copies.

Lower Court Case: 4:17-cv-00237-RSB-CLR Southern District of Georgia (Savannah)
Appeal: 0:2021-10994 U.S. Court of Appeals, Eleventh Circuit

Links to referenced articles:

https://www.bloombergquint.com/onweb/bayer-accused-of-pay-to-appeal-scheme-by-roundup-lawyers
https://finance.yahoo.com/news/bayer-deal-pays-roundup-plaintiff-040100152.html
https://www.bloomberg.com/news/articles/2021-04-21/bayer-deal-pays-roundup-plaintiff-to-keep-fighting-it-in-court

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MAJOR DEVELOPMENT EFFECTING ROUNDUP By John Ray

Montana Federal District Court (4:21-cv-00003-BMM) took less than thirty days to strike down Trump-era EPA rule, “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information,” 86 Fed. Reg. 469 (Jan. 6, 2021) after Biden EPA offers no contest to relief sought by Plaintiffs (other similar cases stayed due to Biden EPA’s position). The rule would have been more aptly named, “The EPA can ignore and/or cherry pick science.”

The Montana Federal Court ruling should put an end to the EPA’s long-standing practice of engaging in willful scientific illiteracy, in which the EPA cherry picks the scientific literature it considers when clearing labeling for herbicides and pesticides, absent warnings of specific diseases and injuries shown by the weight of the scientific literature to be caused by a specific product.

If history is to record a single positive outcome from the Trump Presidency, that outcome may very well be the administration’s having taken a common and long-standing EPA practice, one step too far, giving the Judicial branch the opening it needed to put an end to the practice altogether.

The Montana ruling, as well as the Biden EPA’s position (essentially agreeing with Plaintiffs) is a significant positive development for Plaintiffs in the RoundUp, the emerging Paraquat Litigation, and is likely to contribute to MTN’s prior predictions becoming reality. More on the Montana case and the impact on RoundUp and other litigations later in this article..

MTN AND OTHERS PREDICTED THIS

MTN, as well as others, predicted (and hoped) that the Biden administration would roll back the EPA’s 2020 “ruling” on Glyphosate, which has been a major weapon for Defendants in settlement negotiations, as well as preemption arguments in the RoundUp litigation.

It appears that our predictions are in the process of coming true and in a fashion with much further reaching implications than expected.

(In a forward-looking prediction) MTN recently stated that we believed that litigation involving FIFRA-regulated products (pesticides, herbicides, etc.) would become as common as drug and medical device litigation. MTN has conducted two Whiteboard Wednesday sessions on this topic in the last month, with a specific focus on Paraquat.

First time attendees and returning Alumni of MTN’s upcoming Four Day Immersion Couse (June 11th-June 14th) will enjoy the benefits of a “deep dive” into all things FIFRA litigation as we intend to use this topic as a teaching tool in the June course.

EPA CHERRY PICKING DID NOT BEGIN WITH TRUMP

There is no better example of the dichotomy found in EPA determinations versus other authorities’ findings regarding the injuries and diseases potentially caused by a FIFRA-regulated product than is shown in a comparison of the CDCs statements, which list a host of injuries and diseases caused by Paraquat. Conversely, EPA-cleared Paraquat labels do not warn of any of the more serious injuries and diseases listed by the CDC.

MTN predictions arose from five primary beliefs/theories:

  1. The EPA has engaged in “cherry picking” scientific evidence for decades, clearing labels for FIFRA-regulated products that fail to warn of injuries and diseases for which an honest and rational review of the scientific literature would require. The EPA had “gotten away” with this practice for years, largely due to a lack of significant media and public attention.
  2. The Trump EPA arguably expanded the EPA’s practice of engaging in intentional scientific illiteracy. There is no better example of the foregoing than the EPA’s actions related to glyphosate (RoundUp), which provided one of the most potent playing cards available to defendants in the RoundUp litigation (including in settlement negotiations).
  3. In order to go further down the rabbit hole of intentional scientific illiteracy than at any time before, it was necessary for the Trump EPA to change its rules (vs hoping that its rulings did not draw much attention) to formally make the long-employed practice of “scientific cherry picking” lawful, or at least have the appearance of being lawful.
  4. MTN believed, that if Trump did not get reelected, the referenced Trump-era EPA rule change would be rolled back by Biden (or any Democrat that was elected), or declared unlawful by a Federal Court.
  5. That if #4 occurred via litigation (Judicial Ruling), the EPA would not only no longer be able to enforce the Trump-era rule, but the agency would also have to cease the practice of cherry picking the science altogether.

More simply stated, the EPA got away with cherry picking the science for years, the Trump EPA took it too far, the Courts stepped in, now the EPA will no longer be able to go back to the lighter version of intentional scientific illiteracy employed pre-Trump.

The foregoing coupled with the fact that:

  1. Through a twist of temporal fate, every single Restricted Use Pesticide (all RUP FIFRA regulated products) is up for the mandatory 15-year labeling and science review the EPA is required to conduct by law. The EPA, now absent the ability to cherry pick the science and rubber stamp the labels submitted by the makers of FIFRA regulated products, the EPA will have little choice but to order new and additional warnings regarding specific diseases shown to be caused by specific products, by an honest and complete review of the scientific literature.
  2. The Montana ruling should arguably cause the EPA to voluntary withdraw all statements/rulings and labels approved post the implementation of the Trump era unlawful rule (including Round Up) and issue new rulings statements, approvals (and disapprovals) based on an honest and complete review of the scientific literature.

DOES THE MONTANA ACTION MOOT THE TRUMP EPA’s ROUNDUP RULING?

In as much as the Trump EPAs Round Up Ruling (Interim Ruling/ Statement in January 2020) required the authority found in “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information,” now declared unlawful, the Montana ruling arguable moots the Trump EPAs action, rulings, statements etc. related to Round Up. Any act arising form or depending on a predicate unlawful act, can itself be considered lawful. Stated another way, in that the EPA cannot rely on, “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information,” 86 Fed. Reg. 469 (Jan. 6, 2021) to support the method and process by which the agency arrived at its conclusions leading to the Glyphosate ruling/statement, the agency has no basis to claim the Glyphosate ruling was made within the lawful authority of the EPA. Additionally, having conceded the fact that the Trump EPA exceeded in lawful authority in implementing, “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information,” 86 Fed. Reg. 469 (Jan. 6, 2021), the Biden EPA would not be likely be so hypocritical as to challenge any contest to the Glyphosate ruling or others dependent on the former.

Now it appears that the Trump EPA’s attempt to play “Fairy God Mother” to Bayer/Monsanto may have long term negative impact for the Big Pharma/Big Aggie player. Absent the past scientific practices previously engaged in by the EPA (for decades), the agency is likely to have no choice but to require Bayer/Monsanto and other such entities, to add long overdue specific warnings to their FIFRA-regulated product labels.” New warnings lead new failure to warn litigation.”

WHY DID BAYER/MONSANTO NEED THE EPA RULING ON GLYHOSPHATE

See 40 CFR § 152.46 – Notification and non-notification changes to registrations. and 40 CFR § 152.81 – Applicability

“A modification to registration of a currently registered product that may be accomplished under the notification or non-notification provisions of § 152.46 and any procedures issued thereunder. Notwithstanding the preceding sentence, compliance with this subpart is required if the Administrator has, by written notice under § 152.46, determined that the modification may not be accomplished by notification or non-notification. 40 CFR § 152.81 (b)(5)”

Prior to 2014, the language of 40 CFR § 152.81 left wiggle room for defendants to argue that FIFRA precluded makers of FIFRA regulated products from making unilateral changes to their product labels (like the CBE process and NDA drugs). Defendants took advantage of the lack of clarity in § 152.81 and convinced many courts that changes to their labels could only be made with the prior approval of the EPA. In 2014, the EPA changed § 152.81 to make it clear that changes under § 152.46 be unilaterally made by registrants so long as the EPA had not specifically and expressly ruled that the given change could not be made. The only other general restriction is that the change can not serve to “negatively impact the environment” per § 152.46.

Bayer/Monsanto in all probability was keenly aware of the changes in § 152.81 and thus needed the EPA to make an express statement holding that they could not add a warning related to Non-Hodgkin’s Lymphoma to their Round Up labeling.

Despite the contrary findings of some Courts, FIFRA never prevented Bayer/Monsanto from unliterally making changes to their label to include a warning of a link between the product and Non-Hodgkin’s Lymphoma.

Bottom line: The SCOTUS reasoning in Wyeth v. Levine, 555 US 555 – Supreme Court 2009 directly applies to 40 CFR § 152.46 and 40 CFR § 152.81. Additionally considering the SCOTUS jurisprudence found in in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 – Supreme Court 2019, no merit could be found in a defense argument that the EPA would not have allowed a label change, if the defendant never attempted to make the change via the unilateral authority that defendant enjoys under 40 CFR § 152.46 and 40 CFR § 152.81.

THE MONTANA RULING

“The Court declares that EPA unlawfully made the Final Rule effective immediately on publication in the Federal Register, Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information 86 Fed. Reg. 469 (Jan. 6, 2021); and The Court declares, therefore, that the Final Rule is ineffective until 30 days from its January 6, 2021, date of publication in the Federal Register.”

On April 30, 2018, The Trump EPA invoked 5 U.S.C. § 301 “general housekeeping rule” to propose and implement the challenged rule:

5 U.S.C. § 301 holds that: The head of an Executive department or military department may prescribe regulations for the government of his department, the conduct of its employees, the distribution and performance of its business, and the custody, use, and preservation of its records, papers, and property. This section does not authorize withholding information from the public or limiting the availability of records to the public.

5 U.S.C. § 301 is not a mechanism for an agency to circumvent 5 U.S. Code § 553 – Rule making when the changes being implemented are clearly not within the scope of § 30.

These are some of the Plaintiffs who also brought cases seeking the same relief sought and granted by the Montana Court. STATE OF NEW YORK, STATE OF CALIFORNIA, STATE OF CONNECTICUT, STATE OF DELAWARE, STATE OF ILLINOIS, STATE OF MAINE, STATE OF MARYLAND, COMMONWEALTH OF MASSACHUSETTS, PEOPLE OF THE STATE OF MICHIGAN, STATE OF MINNESOTA, STATE OF NEW JERSEY, STATE OF NEW MEXICO, STATE OF NORTH CAROLINA, STATE OF OREGON, COMMONWEALTH OF PENNSYLVANIA, STATE OF VERMONT, STATE OF WASHINGTON, STATE OF WISCONSIN, KING COUNTY WASHINGTON, CITY OF CHICAGO, CITY OF LOS ANGELES, and CITY OF NEW YORK

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THE NEXT BIG MASS ACTION PARAQUAT

The recent EPA actions related to Paraquat and Parkinson’s disease have caught the attention of the plaintiff bar, resulting in firms actively pursuing these cases.

It may come as a surprise to some that a significant number of “one off” cases have been brought, alleging injury caused by a FIFRA-regulated product, resulting in verdicts for plaintiffs- without reliance on any predicate action taken by the EPA.

The recent attention attracted by the EPA actions related to Paraquat should be a wake-up call to the plaintiffs’ bar. Paraquat is the tip of a very large iceberg. Plaintiffs’ firms should be reviewing cases for almost every product on the EPA’s Restricted Use List (RUP) for a host of injury categories specific to each product and product category.

Mass Tort Nexus will be hosting a series of Whiteboard Wednesday sessions beginning on Wednesday, April 21st (register here) intended to provide plaintiff firms with the background and education necessary to acquire and represent plaintiffs in the Paraquat litigation, as well as litigations against makers of other FIFRA-regulated products that are ripe and awaiting action.

In the first session we will cover:

  1. How and why the makers of FIFRA-regulated products (including Paraquat) have systematically failed to warn with specificity regarding adverse events (injuries) known to be caused by their products. The why is simple, the plaintiffs’ bar has yet to step up to protect the millions of people injured by these products. It is time to dispense with the one-off cases and show the industry the force for change that can be brought about by mass litigation, Paraquat and beyond!
  2. Why no EPA action is needed for plaintiffs suffering from one of these adverse events, in order for said plaintiff to prevail in product liability action against the maker of a FIFRA-regulated product that has failed to warn with specificity (see case example below Ferebee v. Chevron Chemical Co).
  3. Why changes in 40 C.F.R. § 152.81, in combination with the plain language of 40 CFR § 152.46 no longer support the reasoning of those Courts that have found preemption of state law Failure to Warn claims under FIFRA.
  4. Why it was necessary for the EPA to change the language of 40 C.F.R. § 152.81 after many courts ignored the brief filed by the United States Attorney General in Etcheverry v. Tri-Ag, 993 P. 2d 366 – Cal: Supreme Court 2000. Despite the Amicus brief filed by the AG, plainly stating in part:
    “FIFRA does not preempt state-law actions for damages. Section 136v(b) prohibits states from imposing labeling “requirements” in addition to, or different from, those imposed under FIFRA. While the term “requirements” may encompass common law duties in some contexts, the text, legislative history, and purposes of FIFRA demonstrate that Congress had no intent that the use of the term “requirements” in section 136v(b) would extinguish state law damages actions. When section 136v(b) was enacted in 1972, state law actions against pesticide manufacturers for failure to warn were a commonplace and uncontroversial feature of the legal landscape. No evidence from the text or legislative history of FIFRA suggests that Congress had any intent to extinguish those actions or that Congress even considered doing so. Indeed, Congress amended FIFRA in 1972 out of increasing concern for the human health and the environmental effects of pesticides such as DDT. Given that FIFRA establishes no private damages remedy for those injured by pesticides, it would be astonishing that, without any discussion, Congress could have intended to deprive injured persons of all means of relief.”

     

  5. The effect of the changes in 40 C.F.R. § 152.81 in light of the SCOTUS ruling in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 – Supreme Court 2019.
  6. 6. Why the approval of a label by the EPA is no more conclusive of the adequacy of the warnings provided therein, than is the approval of a label submitted to the FDA by a drug maker. The duty to provide adequate warnings (with specificity) always falls upon the manufacturer of the product, without regard to whether the product is regulated by the FDCA or FIFRA (EPA).

“When a pesticide is registered, the manufacturer must submit the proposed label to the EPA for approval. The label must be “adequate to protect health and the environment,” see 7 U.S.C. § 136(q)(1)(G), and “likely to be read and understood” See 7 U.S.C. § 136(q)(1)(E).”

“When an environmental hazard exists from the pesticide, precautionary language stating the nature of the hazard and the appropriate precautions to avoid potential accident, injury, or damage is required. § 156.10(h)(2)(ii).”

*Note: The word ‘pesticide’ is used generally in regulation and statute to describe all FIFRA regulated products.

BACKGROUND FOR FIRST SESSION

The remainder of this article, we will review Ferebee v. Chevron Chemical Co. and why those Courts that have followed the reasoning of Ferebee “got it right” and why those Courts that found contrary to Ferebee may have to revisit their rulings in light of the changes to 40 CFR § 152.81 combined with the EPA’s state reasons for implementing said changes.

Ferebee v. Chevron Chemical Co.

The Ferebee case was initially filed by Mr. Ferebee and then continued as a survival action after Mr. Ferebee’s pulmonary fibrosis caused his death prior to the case reaching trial.

Richard Ferebee was an agricultural worker at the Beltsville Agricultural Research Center (BARC), an installation of the United States Department of Agriculture located in Beltsville, Maryland.

The complaint alleged that Mr. Ferebee contracted pulmonary fibrosis resulting from long-term skin exposure to dilute solutions of paraquat.

The lower court denied defendants’ FIFRA-based preemption motions as well as other motions filed by Defendants to avoid the case reaching a jury.

At trial, the attorneys representing the Ferebee family put forth two experts in support of their contention that Paraquat was the cause of Mr. Ferebee’s pulmonary fibrosis. The first witness was a Pulmonologist that treated Mr. Ferebee prior to his death. The second was a physician employed by the National Institute of Health.

The Ferebee attorneys further argued that while the Paraquat label did contain some general health warnings, the fact that Paraquat was known to potentially cause pulmonary fibrosis posed a duty on the Defendant to specifically warn, relevant to pulmonary fibrosis.

Chevron’s expert witnesses testified intra alia; that although Paraquat could cause pulmonary fibrosis, it was not possible for Mr. Ferebee to have been exposed via skin absorption in amounts sufficient to cause pulmonary fibrosis.

The jury found Chevron’s arguments unavailing and rendered judgement and award in favor of the Ferebee family.

Chevron unsuccessfully appealed:
Ferebee v. Chevron Chemical Co., 552 F. Supp. 1293 – Dist. Court, Dist. of Columbia 1982
Ferebee v. Chevron Chemical Co., 736 F. 2d 1529 – Court of Appeals, Dist. of Columbia Circuit 1984
SCOTUS cert. denied, 469 U.S. 1062, 105 S.Ct. 545, 83 L.Ed.2d 432 (1985).

DID CHEVRON CHANGE THEIR LABEL POST-FEREBEE?

One might think that post-Ferebee, all makers of Paraquat products would have filed original or supplemental registrations with the FDA, adding a specific warning related to pulmonary fibrosis, to their labels.

Despite the verdict in Ferebee, as well as other cases, including cases arising from pulmonary fibrosis to this day, not a single maker of a Paraquat product provides a warning specific to pulmonary fibrosis, to date.

Additionally, despite the CDC listing all the following adverse events potentially caused by Paraquat exposure, not a single maker of the products specifically warns of any of these adverse events in their labeling:

  • Heart failure
  • Kidney failure
  • Liver failure
  • Lung scarring
  • Acute Kidney failure
  • Confusion
  • Coma
  • Fast heart rate
  • Injury to the heart
  • Liver failure
  • Lung scarring (evolves more quickly than when small to medium amounts have been ingested)
  • Muscle weakness
  • Pulmonary edema (fluid in the lungs)
  • Respiratory (breathing) failure, possibly leading to death
  • Seizures
  • If a person survives the toxic effects of Paraquat poisoning, long-term lung damage (scarring) is highly likely. Other long-term effects may also occur, including kidney failure, heart failure, and esophageal strictures (scarring of the swallowing tube that makes it hard for a person to swallow).

The CDC also lists the exposure routes that can lead to these injuries which include: inhalation, skin absorption, ingestion, skin and/or eye contact.

Bear in mind, this is just the CDC list of injuries known to be caused by Paraquat, no warning on the label of any product. There are 221 other RUP categories of products known to cause injuries of various types.

RETHINKING FIFRA PREEMPTION

The SCOTUS ruling in Merck Sharp & Dohme Corp. v. Albrecht, 139 S. Ct. 1668 – Supreme Court 2019 combined with the changes in 40 CFR § 152.81, provide significant arguments that the various Court rulings that have found contrary to Ferebee on preemption, many no longer be apt case law.

40 CFR § 152.46 provides a process similar to the Changes Being Affected (CBE) process (pharmaceuticals), which allows the registrant to unilaterally make a change to their labeling prior to the EPA approving the change. A registrant may make a change to their label and begin marketing the subject product under the new labeling as soon as the EPA receives notification of the change (before the EPA approves or disapproves the change). As is true of the CBE process, the EPA has the power to instruct the registrant to remove or alter the unilaterally implemented change after the fact, if the agency finds reason to do so.

Prior to 2014, 40 CFR § 152.81 included a list of the types of changes a registrant could make without prior approval pursuant to § 152.46. Citing the fact that the EPA never intended for the list contained in § 152.81 to be all inclusive, the EPA began the process of removing the list from the language of § 152.81 in November of 2010. The list was removed from §152.81 in 2014.

Currently, read in combination, 40 CFR § 152.46 and §152.81 allows registrants to make changes pursuant to 40 CFR § 152.46 so long as the changes, “…have no potential to cause unreasonable adverse effects on the environment.”

“Unreasonable adverse effects on the environment” are defined as, “any unreasonable risk to man (emphasis added) or the environment, taking into account the economic, social, and environmental costs and benefits of the use of any pesticide.” Id. § 136(bb) and 7 U.S.C. § 136a(c)(5).

Considering the foregoing, in combination with the SCOTUS decision in Albrecht, makers of FIFRA-regulated products are likely to have little success in arguing that any obstacle (impossibility) exists with regard to adding a “more specific warning” related to specific diseases and injuries known to be caused by their products.

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