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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Roundup Litigation News

Bayer-Monsanto’s proposed $2 billion settlement for future victims continues to face harsh criticism from current plaintiffs, cancer victim advocates, and many others. The plan would allow the company to continue to market and sell glyphosate products while limiting their liability toward those whose lives they devastate.

The settlement, which is only for people who have not yet been diagnosed with cancer or who have not yet retained an attorney has not been approved by the court. We are among the many parties that submitted objections. As it stands, we are hopeful that the settlement proposal will not be accepted by the court.

Some of the plans highlights (or lowlights, as it were) include:

  • The four-year plan includes $1.35 billion for class member compensation; $210 million for diagnostic services; $55 million for research; and $170 million for a legal fund.
  • Under this plan, Bayer establishes trust through community healthcare centers, signs people to the class so they can get free healthcare services, then forwards them through the settlement process when they are diagnosed with NHL. NHL victims, who are targeted because they are itinerant, who lack exposure to traditional media, and who do not speak English as a first language, are told they can get $5,000 immediately if they accept. This is the equivalent of dangling a glass of water in front of a person dying of thirst without telling them they could have access to a well.
  • Class members can qualify for $5k-$200k. However, the tier system is structured so that the vast majority of class members would receive $5,000.
  • The settlement severely limits additional recourse for class members, even if they are released from the class. It also imposes a four-year stay on filings.
  • It establishes a Science Advisory Panel, chosen in large part by Bayer-Monsanto, and a research fund to conduct “research” that we feel will likely be skewed toward the corporation’s interests. Those findings can then be used against plaintiffs in the MDL or in future litigation.
  • It establishes an “education program” funded by Bayer that will, no doubt, include pro-Bayer propaganda.
  • It gives Bayer-Monsanto the ability to include on Roundup labels “a reference to information regarding whether exposure to Roundup causes NHL.” There is no question that the “information” they choose will be skewed in their favor.

There are many other horrible provisions of the proposed settlement, and we believe strongly that the majority of the plan is unfair to victims. It is a blatant attempt to stop victims from joining MDLs or other litigations that would compensate them more fairly.

We know — and Bayer knows — that tens of thousands of hard-working people, if not more, will be diagnosed with glyphosate-related non-Hodgkin’s lymphoma in the coming years. The proposal fails on many fronts to pay adequate restitution to the vast majority of victims and does a huge disservice to thousands of American families who put their trust in Monsanto, only to suffer due to the corporation’s lies and deceit.

We will continue to follow this proposal, and to fight it at every opportunity.

As courts begin to open again and new trial dates are established, plaintiffs’ attorneys will continue to push Bayer-Monsanto toward a fair settlement.

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Johnson & Johnson Litigation Update

*Jim Onder is speaking at our (in-person/live) Mass Tort Nexus course June 11-14 in Fort Lauderdale. He will be updating us on the state of settlement for both Talc and RoundUp. Jim holds the largest number of cases in both of these litigations. He will also be contributing information at our course, regarding the emerging litigation, Paraquat. Seating is very limited.

Johnson & Johnson continues to avoid responsibility for cruelly and intentionally destroying women’s lives by profiting from cancer-causing talc. Imerys Talc America’s bankruptcy plan has now become a pawn for J&J’s attempts to sidestep indemnification.

Just how the dust (or powder, in this case) will settle is not yet clear, but the initial disbursement plan for $233 million in Imerys assets has gained the 75% vote needed to pass.

Johnson & Johnson is eager to join the Imerys bankruptcy and obtain a channeling injunction, so as to cut off future liabilities. A channeling injunction would enable J&J to fund a trust for the benefit of past and future claimants. Thereafter, the sole claim would be against the trust.By cutting off future liability, J&J would have a finite dollar amount established with which to pay cancer claims, as opposed to being asked to write a blank check. They and their shareholders would like to see these claims to essentially go away. However, the current amount they have suggested they would pay is inadequate to compensate past and future victims.

As a threat to force acceptance of a parsimonious offer, J&J is threatening bankruptcy.

Texas Two-Step Threat

In a move that’s in line with the unscrupulous tactics they have exercised for decades, J&J are making what is likely an idle threat to declare bankruptcy in a dicey back-handed method called the “Texas two-step.” If successful, they hope to discharge their liability from talc lawsuits throughout the country.

What is the Texas Two-Step?

The State of Texas has a divisive merger statute. Essentially it allows a company to divide into two separate entities.

Step 1:
J&J can, in theory, split off some of their assets along with their talc liabilities into a separate inadequately funded entity in Texas.

Step 2:
J&J could attempt to change the domicile of that entity to North Carolina, then file bankruptcy to discharge liabilities.

While we would like to believe this is another smokescreen, the threat may be real. Three asbestos manufacturers have used this tactic, and their cases have yet to be heard in appellate court. Johnson & Johnson has a long history of unethical, self-serving behavior in their attempts to minimize compensation for victims. We’re keeping an eye on the situation and carefully weighing the validity of this and any other scare tactic they present.

What’s Next?

We are up against a corporation that simply refuses to take responsibility. As such, we have yet to come up with a final outcome with which everybody is satisfied. We are working daily toward that end.

After nearly a year and a half of delays due to Covid, courts are slowly reopening and trial dates are being established. Several trials are now on the docket for later this summer and beyond.

Every time Johnson & Johnson has to step foot in a courtroom, it puts them under increasing pressure to settle. Their losses have already cost them hundreds of millions of dollars, and their shareholders are eager to put the bad publicity and risk behind them. We are doing all we can to ensure their tactics to avoid responsibility will fail and these trials will push them closer to a settlement.

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PARAQUAT LITIGATION THE TIP OF A VERY LARGE ICEBERG

MTN will conduct our first in a series of “Whiteboard Wednesdays” related to the current Paraquat litigation on Wednesday, April 21st from 2:00pm -4:00pm EST.

Although our initial Whiteboard Wednesday session will focus on Paraquat, future sessions will focus more broadly on litigation involving other products regulated by the EPA as well as State agencies that generally fall under the auspices of FIFRA as well as each State’s relevant laws.

WHY LOOK BEYOND PARAQUAT

MTN research has concluded that the recent EPA action related to Paraquat is likely to be the first in a series of actions related to Restricted Use Products (RUP), that are likely to give rise product liability/personal injury litigations resulting from direct exposure (farmers and agricultural workers), as well as chemical trespass (individuals who reside near farms exposed via overspray and drift).

WHY DO WE BELIEVE PARAQUAT IS THE TIP OF THE ICEBERG?

The EPA is required to review every RUP products safety and labeling at least once every 15 years. As it turns out, every single RUP product on the market is up for the 15-year review by or before October 1, 2022. The new restrictions, warnings, and instructions relevant to Paraquat were a result of the “15 year” review of this single product. Given the heightened awareness of the issues of overspray and drift, we have every reason to believe that the 15-year reviews of other RUP Herbicides and Pesticides, will result in additional EPA actions like those relevant to Paraquat.

More simply stated, changes in the way these dangerous products are handled and used are overdue, and despite industry efforts to forestall their fate, time has run out.

Prudent Plaintiffs firms should begin developing broad expertise in this species of litigation now, as we believe these litigations may become as common as drug and medical device litigation.

RESTRICTED USE PRODUCTS DEFINED

Restricted Use Products or RUPs (as opposed to General Use Products) are not available for purchase or use by the general public. RUPs have the potential to cause unreasonable adverse effects to the environment and injury to applicators or bystanders without added restrictions. The “Restricted Use” classification restricts a product, or its uses, to use by a certified applicator or someone under the certified applicator’s direct supervision. See detailed information on the restricted use classification: 40 CFR 152.160 – 152.175.

SIMILARITIES TO ASBESTOS

On first blush, it would be reasonable to conclude that the Paraquat and other potential RUP litigations would be like the current Roundup litigation, or possibly the Agent Orange litigation; however, MTN is of a different opinion. Our research concludes that this litigation as well as likely future litigations involving RUPs bear more similarity to the Asbestos litigation and general pharmaceutical product litigations. We will explain our conclusions in the upcoming Whiteboard Wednesday as well as why it is important to approach these litigations with the proper “historical” and “commonality” perspective. Register Now!

IF YOU COULD ROLL BACK TIME

As a plaintiff’s lawyer, if you could roll back time and be involved in the asbestos/mesothelioma litigation at the emerging phase, would you? Of course, you would!

Having rolled back time, would you also take the time and put forth the effort to learn everything you possibly could to retain and best represent your asbestos/mesothelioma clients? Of course, you would!

Will you be kicking yourself in the future if you fail to realize that the current Paraquat litigation has far more in common with the asbestos/mesothelioma litigation than you might think, and thus fail to act now to gain the knowledge and information required to be on the forefront of this litigation? Of course, you will! Avoid kicking yourself in the future, it hurts and kicking oneself should never be on any to do list. Join MTN for our first in a series of Whiteboard Wednesdays. Register Now!

PRIMER FOR FIRST PARAQUAT LITIGATION WBW SESSION: WHAT WAS KNOWN ABOUT PARAQUAT?

The fact that Paraquat causes certain adverse health consequences has been well documented in the scientific literature for over a decade. Additionally, the fact that the very low level of exposure required to cause these adverse health consequences, is also well documented.

Adverse health events show to be caused by paraquat include but are not limited to:

  1. Parkinson’s disease (long latency period).
  2. Brain damage absent Parkinson’s pathology. (generally long latency period).
  3. Liver Injury, including liver failure. (latency dependent on dose exposure and accumulation).
  4. Kidney injury, including bilateral kidney failure. (latency dependent on dose exposure and accumulation).
  5. Lung damage described in the literature as “Paraquat Lung” including complete respiratory arrest and failure (latency dependent on dose exposure and accumulation).
  6. Heart Failure, as a primary injury as well as secondary to lung damage (cardiopulmonary injury).
  7. (latency dependent on dose exposure and accumulation).
  8. Still Births and Birth Defects. The weight of the literature relevant to Still Births and Birth Defects caused by Paraquat is limited.

The current Paraquat litigation did not arise from the sudden recent discovery that this highly toxic substance, given sufficient exposure, causes adverse health consequences, including those listed above.

The forgoing begs the question; If the adverse health consequences of paraquat were known for over a decade, why are Plaintiffs filing claims now?

SUMMARY OF THE CURRENT CAUSE OF ACTION

The makers of Paraquat (defendants) containing products were, under a duty to instruct (warn) applicators (generally farmers) of steps and precautions required to prevent human exposure to the toxic substance, in sufficient doses to cause adverse health consequences.

The manufacturers (defendants) failed to properly instruct applicators, regarding the steps and precautions required to prevent exposure to the toxic substance in sufficient dosages to cause the adverse health consequences the substance is known to cause.

Additionally, the manufacturers failed to instruct applicators steps and precautions required to prevent chemical trespass from overspray and chemical drift.

The defendants failed to fulfill their duties.

THE EVIDENCE and THE WHY NOW

After many years of industry resistance, the EPA recently acted to (among other things) cause the makers of paraquat containing products to revise their labels to contain instructions for use and other information’s which plaintiffs contend should have been in place prior to their suffering injuries due to the absence of such instructions and warnings.

Additionally, the EPA has placed a complete restriction on the spraying of paraquat containing products from crop dusters as well as large scale mechanically pressurized ground based spraying equipment.

EPA has completed review of the public comments, and in October 2020 released the Proposed Interim Decision. In this document, EPA is proposing the following protections to reduce exposure to paraquat.

Prohibiting aerial application for all uses and use sites except cotton desiccation; Prohibiting pressurized handgun and backpack sprayer application methods on the label;

Requiring a residential area drift buffer and 7-day restricted entry interval (REI) for cotton desiccation.

Limiting the maximum application rate for alfalfa to one pound of active ingredient per acre;

Requiring enclosed cabs or PF10 respirators if area treated in 24-hour period is 80 acres or less;

Requiring a 48-hour REI for all crops and uses except cotton desiccation; and

Adding mandatory spray drift management label language.

USEFUL LINKS

https://www.epa.gov/ingredients-used-pesticide-products/paraquat-dichloride#action

https://www.epa.gov/pesticide-reevaluation/registration-review-schedules

https://www.epa.gov/ingredients-used-pesticide-products/paraquat-dichloride

https://www.epa.gov/pesticide-worker-safety/paraquat-dichloride-one-sip-can-kill

https://www.regulations.gov/docket/EPA-HQ-OPP-2011-0855/document

https://www.epa.gov/pesticide-worker-safety/restricted-use-products-rup-report

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TAXOTERE MDL TIPPING THE SCALES OF JUSTICE

The Taxotere MDL Court continues to grant Defense motions to dismiss (on a case-by-case basis), allowing Defendants to raise matters outside of the pleadings (not previously pled in the Master Answer), without seeking leave to amend prior to filing the motions, to address the matters not previously pled, while generally limiting Plaintiffs leave to amend in anticipation of such motions (which is not required in the first instance), or to counter such motions once filed.

THE NEXUS OF THE ISSUE

The Master Complaint refers to permanent chemotherapy-induced alopecia, as an absence of incomplete hair regrowth six months after completion of chemotherapy.

The Taxotere MDL Court has construed the above as admission of fact by individual Plaintiffs adopting the Master Complaint, as an admittance on the record that that specific Plaintiff possessed this knowledge six months after completion of chemotherapy.

One might pose the question to Her Honor, prior to appointment to the Taxotere MDL, “Did you know that the failure of hair to regrow within six months after completion of chemotherapy was conclusive of the condition being permanent?”

How can it be said that the aforementioned “admission of fact” by any given Plaintiff is any more than admission that the Plaintiff was aware (knew/discovered) of this fact at any time prior to the filing of the complaint, specific to that Plaintiff. The Taxotere MDL Court has somehow reached such a conclusion.

More simply stated, admitting that a Plaintiff knew a fact on the day she filed her complaint, is not an admittance that she possessed, discovered nor reasonable would have been expected to discover, that same fact, at an earlier point in time, and thus should have filed her complaint at some earlier point in time, based on the knowledge (discovery) to avoid the complaint being SOL barred.

It is also important to note that Plaintiffs are not required to plead matters in their complaint in anticipation of any affirmative defense.
Additionally, it is important to note that Fed. R. Civ. Pro. 12 applies not only to Plaintiff pleadings, Rule 12 also applies to affirmative defenses raised by Defendants.

DEFENDANTS’ MOTIONS TO DISMISS BASED ON SOL

Defense motions to dismiss individual Plaintiffs’ cases in MDLs, based on SOL are generally brought under Rule 12(b)(6) (Failure to State a Claim Upon Which Relief Can be Granted) or Rule 12(c) Motion for Judgment on the Pleadings (see citations at the end of this article).

If a Defendant wishes to raise SOL matters under 12(b)(6), they must do so by the filing of a motion.

In the MDL context, this means that the “Master Answer” would need to adequately plead the SOL Statutes and Jurisprudence of all 50 States, as well as every possible set of Plaintiff facts that might later arise (on a case-by-case basis) relevant to those SOL Statutes and Jurisprudence of all 50 States. If the Master Answer was not plead as above, the Defendant would need to file for leave to amend, and file said amendment to the answer of the given specific Plaintiff’s case.

In that it would be impossible for a Defendant to accomplish the above in the “Master Answer”, a Defendant should be required to file a motion for leave to amend (to plead facts, law, and other matters not pled in the Master Answer) specific to the given Plaintiff against whom they move).

In this scenario, a Plaintiff Motion to Strike pursuant to Rule 12(f) should be considered, based on Defendant’s failure to adequately plead the defense in the answer. Additionally, the Defendant having raised matters (like specific state law) in the motion to dismiss, not raised in the answer (matters outside the pleadings).

If the Defendant Motion for Judgment on the Pleadings Fed R. Civ. Pro. 12(c), and raises any matter (case law citation, statute, or fact) not cited and raised in the Master Answer, the Court must treat this motion as a Motion for Summary Judgement and apply Fed. R. Civ. Pro. 56, pursuant to Fed. R. Civ. Pro. 12 (d).

Under either scenario, it would be arguably prejudicial and an abuse of discretion for a Court to allow a Defendant leave to amend their answer, for the purpose of filing a motion under 12(b)(6), and then deny the Plaintiff the same leave (to amend the complaint), once the Defendant’s motion was filed.
According to Fed R. Civ. Pro. 12(c) (which invokes Fed. R. Civ. Pro. 56), it would arguably be an abuse of discretion for the Court to deny a Plaintiff’s motion to amend, in the face of a motion under these rules. In fact, the widely held (the term “black letter case law” is apt) that leave to amend is to be freely granted, is not merely a concept, as the premise behind the concept is rooted in the right to due process granted under the U.S. Constitution.
The Taxotere Court seems to be willing to allow Defendants to file dismissal motions, raising matter (case law, statute etc.) not previously raised (matters outside the [prior] pleadings) at the late stages of the litigation, while denying Plaintiffs leave to amend, holding that it would be prejudicial (to Defendants) for the Court to allow Plaintiffs to amend their complaints at “this late stage”.

“You can’t amend your answer at this late stage, to counter a motion brought by Defendants at this late stage.” One wonders how a court of equity justifies such an inequitable holding.

AUTHORITIES

Rule 15 (a) declares that leave to amend, “shall be freely given when justice so requires”; this mandate is to be heeded. Foman v. Davis, 371 US 178 – Supreme Court 1962 id at 182.

We review the decision to deny a party leave to amend its complaint for abuse of discretion. United States ex rel. Willard v. Humana Health Plan of Tex., Inc., 336 F.3d 375, 387 (5th Cir.2003). Leave to amend should be freely given, FED. R. CIV. P. 15(a), and outright refusal to grant leave to amend without a justification such as, “undue delay, bad faith or dilatory motive on the part of the movant, repeated failure to cure deficiencies by amendments previously allowed undue prejudice to the opposing party by virtue of allowance of the amendment, futility of amendment, etc.” is considered an abuse of discretion. Foman v. Davis, 371 U.S. 178, 182, 83 S.Ct. 227, 9 L.Ed.2d 222 (1962); see also Humana Health Plan, 336 F.3d at 386 (citing Foman for examples of permitted reasons to deny leave to amend). US ex rel. Adrian v. Regents of Univ. of Calif., 363 F. 3d 398 – Court of Appeals, 5th Circuit 2004.

It is too late in the day and entirely contrary to the spirit of the Federal Rules of Civil Procedure for decisions on the merits to be avoided on the basis of such mere technicalities. “The Federal Rules reject the approach that pleading is a game of skill in which one misstep by counsel may be decisive to the outcome and accept the principle that the purpose of pleading is to facilitate a proper decision on the merits.” Conley v. Gibson, 355 U. S. 41, 48. Foman v. Davis, 371 US 178 – Supreme Court 1962 id at 182.

Every defense to a claim for relief in any pleading must be asserted in the responsive pleading if one is required. But a party may assert the following defenses by motion: (6) failure to state a claim upon which relief can be granted; (Fed. R. Civ. Pro. 12(b)(6)
Motion for Judgment on the Pleadings. After the pleadings are closed—but early enough not to delay trial—a party may move for judgment on the pleadings. Fed R. Civ. Pro. 12(c)

Result of Presenting Matters Outside the Pleadings. If, on a motion under Rule 12(b)(6) or 12(c), matters outside the pleadings are presented to, and not excluded by, the Court, the motion must be treated as one for summary judgment under Rule 56. All parties must be given a reasonable opportunity to present all the material that is pertinent to the motion. Fed. R. Civ. Pro. 12 (d)

Disclaimer:

This article was written by John Ray. John Ray is not an attorney. No word, statement, utterance nor implication herein, should be construed as legal advice. The expressions in this article are the thoughts and opinions of the author and should not be attributed to any third party. The Statutes, Rules and Case Law cited herein, speak for themselves.

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Zantac / Ranitidine Litigation Common Misconceptions By John Ray

The topic below will be discussed in depth in the Mass Tort Nexus (MTN) Whiteboard Wednesday (January 20, 2021), if you have not registered for the session, you can do so here: https://www.masstortnexus.com/Whiteboard

Common Misconception: Sales of prescription versions of Zantac/Ranitidine were insignificant after the OTC versions were approved.

Fact: Sales of prescription versions of Zantac/Ranitidine remained strong even after the OTC versions were approved. Between 18 million and 20 million prescriptions were written for Zantac/Ranitidine, each year, over the last decade. Zantac/Ranitidine made the list of “Top 50 Most Prescribed Drugs” every single year over the last decade.

Why is this important?

  1. There will be a potentially far greater number of potential Zantac/Ranitidine “prescription use” plaintiffs.
  2. Due to the significant number of arguably counterfeit Zantac/Ranitidine finished drugs, placed into the stream of commerce by “repacking entities,” combined with the fact that the FDA has discovered these products and deactivated the NDC codes for many of these products, it is highly unlikely that your firm has a complete list of Zantac/Ranitidine NDC codes.

Why does this matter?

1. When the FDA deactivates an NDC code, it is removed from the public database of active NDC codes. MTN has uncovered and compiled these deactivated NDC codes.
2. Firms accepting Zantac/Ranitidine clients may believe they have a full list of all Zantac/Ranitidine NDC codes; however, it is improbable that any firm is working from a complete list of codes (it took MTN over 9 months to locate all Zantac/Ranitidine NDC codes, including those that have been deactivated by the FDA, or removed from the public view for other reasons).

Why is having a complete list of NDC codes critical?

  1. Your firm has a prospective client that claims to have taken prescription Zantac/Ranitidine, you sign the client and order their pharmacy records.
  2. Your record review department or company reviews the pharmacy and/or insurance records, looking for Zantac/Ranitidine NDC codes; the proof that your client did, in fact, consume a prescription Zantac/Ranitidine product.
  3. If you are not working from a complete list of Zantac/Ranitidine NDC codes (which is likely), then your record review may conclude that your client who claims to have taken prescription Zantac/Ranitidine, did not, because the NDC code for the product they consumed is not on the “incomplete” list of NDC codes in your possession.

Additionally, once you have access to a comprehensive list of NDC codes, you are likely to discover that many of your clients consumed one of the repackaged (arguably counterfeit) versions of prescription Zantac/Ranitidine.

In addition to the reasons previously stated, identifying all of your clients who took repackaged (arguably counterfeit) versions of Zantac/Ranitidine, is also crucial for the following reasons:

  1. Overcoming PLIVA v Mensing (in addition to the other facts that make Mensing inapt).
  2. A majority of the repacking entities are located in California, were the JCCP has already established an MDL-like consolidation for these cases.
  3. Given the ever-growing appearance, that the Zantac/Ranitidine MDL has landed in the hands of a defense-friendly Judge, the ability to establish jurisdiction and file cases in various State Court Consolidation, is now of paramount importance.

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ROUND UP SETTLEMENT REDUX – ARE THEY FOR REAL THIS TIME?

BACKGROUND

On June 24, 2020, Bayer announced agreements to resolve major legacy Monsanto litigation. The press release, issued primarily for the benefit of nervous Bayer investors, implied that Bayer had reached settlement to resolve the majority of Plaintiff cases. Bayer claimed that the settlement would range between $10.1 billion to S10.9 billion U.S.

Although Mass Tort Nexus (MTN) had serious doubts that Bayer would accomplish substantial resolution of the litigation at a cost of $10.1 billion to S10.9 billion U.S., we waited several months before publishing our article titled, Dear Bayer, the number is $22 Billion.

It appears that Bayer has given up any hope of a global settlement of Plaintiff cases, at significantly subpar settlement values.
The latest information received from MTN sources leads us to believe that Bayer is now attempting to settle for more reasonable values, with firms considered to be a “litigation threat”, while offering firms they do not consider to be a trial threat, far lower average case values.

WILL THIS NEW STRATEGY WORK?

It is probable that Bayer will reach settlement with firms that have already scored big trial wins, by offering reasonable average case values. As is generally the case, settlement agreements with these firms are likely to include “gentlemen’s agreements”, precluding these firms bringing new cases post settlement of their existing dockets.

It is also probable that Bayer will succeed in reaching settlement, at significantly subpar values, with a number of those firms Bayer does not consider a litigation or trial threat.

The wild card for Bayer in this strategy arises from any assumption that they have correctly identified all firms that might pose serious litigation/trial threat. Even if a given firm or attorney has never brought down a jury award in excess of $100 million or $1 billion, does not mean they are incapable of such an achievement. It is important to note, among those firms that are members of this very small club, prior to their having acquired their first earth shattering (and stock price impacting) jury award, they might have been included in the group Bayer does not consider to be a threat. There is a first time for everything.

Additionally, it is never wise to insult (directly or indirectly) any Plaintiff’s attorney if you are trying to reach settlement. Many Plaintiffs’ attorneys would consider being thought of as “no threat” at trial, an insult to be addressed by disproving the assumption.

Bayer stockholders have long ago lost patience with the company’s handling of the Round Up litigation. Bayer stock would not likely fair well if another $100 million or $1 billion dollar verdict was handed down.

Twenty-nine years ago, Mark Lanier was just another attorney, (as far as anyone knew) fast forward to 2021, and over $20 billion(ish) in jury verdicts later, Mark Lanier, is now “that Mark Lanier” . Twenty-nine years ago Bayer would not likely have considered Mark a serious threat and would have likely paid the price for their underestimation.

Jim Onder was just a down to earth unassuming fellow raised in the mid-west, and although Jim is still a down to earth unassuming fellow however, Jim Onder is now “that Jim Onder.”

Atticus Finch was not, ‘that Atticus Finch”, until he was.

THE BOTTOM LINE

Bayer plays a risky game, at very high stakes, if they fail to recognize any attorney they do not consider a serious threat, might not be the next Atticus Finch, just waiting to become “that Atticus Finch.”

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Paragard IUD: Low Numerosity and Late Consolidation Present Obstacles

In December of 2020, the Paragard IUD device was consolidated in the Northern District of Georgia under Judge Leigh Martin May. Defendants include: Teva Pharmaceuticals USA, Inc., Teva Women’s Health, Inc., Teva Women’s Health, LLC, Teva Branded Pharmaceutical Products R&D, Inc., The Cooper Companies, Inc., and CooperSurgical, Inc.

The intake is very conservative for this case and consists of the following:

1.) Breakage in the T-arm (only)
2.) AND surgical removal, or otherwise egregious type of injury, such as a hysterectomy

It is the opinion of this office that the PPN is very low. Possibly less than 5,000. The SOL on this case will be the biggest hurdle due to Statute of Limitations issues.

That said, this action may lend itself to fighting the Learned Intermediary Doctrine against the Doctrine of Informed Consent, when deposing treating physicians. Most states require written (express) informed consent, when exposing a patient to potentially life-threatening risk. Failure to acquire Informed Consent is, at worst, battery under most state laws.

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YOUR FIRM SHOULD BE MARKETING FOR ELIMIRON CASES NOW

Mass Tort Nexus (MTN) is adding the emerging Elmiron litigation to our January 20, 2021, Whiteboard Wednesday session. If your firm does not have an immediate plan to market for and acquire clients in this litigation, you will likely be kicking yourself later. If you sat on the sidelines for, “Invokana Amputation Cases,” you probably still have bruises from kicking yourself. Avoid future self-recrimination by gaining the “why” and “how” knowledge required to start retaining Elmiron clients now.

MTN will continue our discussions related to State Court Consolidation filing strategies in the Zantac/Ranitidine litigation following the MDL Court’s recent preemption rulings (and why your firm should continue marketing for these cases). The MDL is not “dead” by any means, and concurrent State Court Consolidations simply make sense, especially while the MDL PSC works out the “bumps in the road,” for which they are not to blame, but must deal with, nonetheless.

While many of you may have been taking time off for Christmas and New Year’s, The Judicial Panel on Multidistrict Litigation granted a petition to Transfer and Consolidate cases involving the drug Elmiron to the District of New Jersey, forming MDL 2973.

The following statements may be confusing if you have not attended the Mass Tort Nexus “Four Days to Mass Tort Success Course”. If you have not taken the course, register for the upcoming March course today. You need the fundamental “tool kit” of knowledge and skills provided in the course, if you plan to talk the talk, much less walk the walk (be) a successful Mass Tort firm.
If your firm has been following the emerging Elmiron litigation and have concluded that the litigation does not meet the Potential Average Case Value/Potential Plaintiff Numerosity required ratio to justify your firm marketing for these cases, you erred. YOUR FIRM SHOULD BE MARKETING FOR ELMIRON CASES! The PPN is higher than you might think, and the PACV justifies a significant average cost per case acquired figure. We apologize to those who have not taken “the course,” as we teach the language of Mass Tort.

Attendees of the MTN January 20, 2021, Whiteboard Wednesday session, will receive an “Elmiron Litigation Package” after the session. The package will include sample complaints, as well as MTN suggested client qualifying questions. In this litigation, firms that do not have a thorough understanding of all of the relevant facts are more likely to disqualify potential clients that they should retain, than the inverse.

HIGH POINTS ON ELMIRON

Elmiron is the only drug approved by the FDA to treat Interstitial Cystitis. The primary symptoms of Interstitial Cystitis are chronic pain in the bladder and pelvic area.
The primary adverse event in the Elmiron litigation is Pigmentary Maculopathy. Pigmentary Maculopathy induced by Elmiron is latent (important to SOL), progressive, and irreversible. If diagnosed early, treatment may slow the progression of the disease; however, there is no cure. Pigmentary Maculopathy often leads to complete blindness, or near blindness, over time.

WHAT YOUR FIRM SHOULD DO TODAY

If your firm, (or lead generation company) was involved in the Transvaginal Mesh Litigation, have your staff begin compiling a list of every woman that contacted your organization (without regard to whether they qualified for retention as a TVM client). After attending the January 20, 2021 Whiteboard Wednesday session (and receiving our Elmiron Litigation Package with the suggested qualifying criteria), you will want to reach out to all TVM plaintiffs (including those you rejected) and ask if they were prescribed Elmiron. If they answer is yes, you should then proceed to asking the qualifying questions relevant to Elmiron (see recent label changes at the end of this article).

If you have attended the MTN Four Days to Mass Tort Success Course, you already know that “past clients” (including those that contacted your firm, but were not retained) are your best, first source of new clients in any mass tort litigation.

You are very likely to find that many of the women who contacted your firm about a potential Transvaginal Mesh Litigation, were also prescribed Elmiron, before, during, or after their TVM surgeries.

Given the extremely high rate of progressive maculopathy apparently associated with long term consumption of Elmiron, you are likely to find a significant number of Elmiron potential plaintiffs, in your firms TVM files. Do you really want another firm to sign a client that your firm has already contacted or represented, simply because you did not take the time to reach out to the one group of people your firm can initiate direct contact with?

As a primer, the relevant changes to the Elimiron label are below. Keep in mind, this adverse event is latent, progressive, and irreversible. Do not assume that the 06/16/2020 label change date will have begun the SOL running on the majority of potential plaintiff cases.

ELMIRON (NDA-020193)

(PENTOSAN POLYSULFATE SODIUM)

06/16/2020 (SUPPL-14)

Approved Drug Label (PDF)

5 Warnings and Precautions

Retinal Pigmentary Changes

(Newly added subsection)

Pigmentary changes in the retina, reported in the literature as pigmentary maculopathy, have been identified with long-term use of ELMIRON® (see ADVERSE REACTIONS). Although most of these cases occurred after 3 years of use or longer, cases have been seen with a shorter duration of use. While the etiology is unclear, cumulative dose appears to be a risk factor.

Visual symptoms in the reported cases included difficulty reading, slow adjustment to low or reduced light environments, and blurred vision. The visual consequences of these pigmentary changes are not fully characterized. Caution should be used in patients with retinal pigment changes from other causes in which examination findings may confound the appropriate diagnosis, follow-up, and treatment. Detailed ophthalmologic history should be obtained in all patients prior to starting treatment with ELMIRON®. If there is a family history of hereditary pattern dystrophy, genetic testing should be considered. For patients with pre-existing ophthalmologic conditions, a comprehensive baseline retinal examination (including color fundoscopic photography, ocular coherence tomography (OCT), and auto-fluorescence imaging) is recommended prior to starting therapy. A baseline retinal examination (including OCT and auto-fluorescence imaging) is suggested for all patients within six months of initiating treatment and periodically while continuing treatment. If pigmentary changes in the retina develop, then risks and benefits of continuing treatment should be re-evaluated, since these changes may be irreversible. Follow-up retinal examinations should be continued given that retinal and vision changes may progress even after cessation of treatment.

6 Adverse Reactions
Post-Marketing Experience

(Newly added information)

The following adverse reactions have been identified during post approval use of pentosan polysulfate sodium; because these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:

  • pigmentary changes in the retina (see WARNINGS).

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

Patient Information

(Newly added information)
Patients should be informed that changes in vision should be reported and evaluated. Retinal examinations including optical coherence tomography (OCT) and auto-fluorescence imaging are suggested for all patients within six months of starting ELMIRON® and periodically during long-term treatment (see WARNINGS).

Other

Patient Leaflet

(Extensive changes; please refer to label)

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Cook Medical Recalls Two Devices

Cook Medical Recalls Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers Due to Separation in Device

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Recalled Products

Flexor Check-Flo Introducers

• Catalog and Lot numbers: See Full List
• Manufacturing Dates: February 17, 2020 to September 29, 2020
• Distribution Dates: May 23, 2020 to November 17, 2020
• Devices Recalled in the U.S.: 37,326
• Date Initiated by Firm: November 24, 2020

Device Use

The Cook Medical Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select) are catheters that have a coated shaft, a valve, a dilator, and markers that show up on an x-ray. The catheters help insert other medical devices used for therapy or diagnosis into the vessels, except those of the heart and brain, during surgery or other procedures.

Fig. 1: Pictures of the Flexor Check-Flo Introducer and the Flexor Tuohy-Borst Side-Arm Introducer (Shuttle Select) with a red arrow showing where separation usually happens (proximal bond site).

Reason for Recall

Cook Medical is recalling the Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers (Shuttle Select) because of an increased chance of separation at a specific point (proximal bond site) shown in Figure 1. If the device separates during use, this may lead to life-threatening adverse events.

Use of the affected product may cause serious adverse events, including longer procedure time, another procedure to take out a separated piece, blocking blood flow to vital organs, vessel injury, and bleeding.

Not All Recalls Lead to Litigation

MTNs review of the FDA Maude Adverse Event reporting database and found less than 57 total adverse events reported, related to these recalled devices. In the reported adverse events, the Surgeon was generally able to mitigate the impact of the device defect. There were no reports of death however, there were 14 reports of serious injuries.

These devices are primarily used by Interventional Radiologist. The devices are used in procedures under imaging. Any device failure that might otherwise have caused injury absent real time imaging during the procedure, would generally allow the Surgeon to take immediate corrective action.
MTN does not expect the number of individuals injured by this device will be sufficient to justify a consolidated mass litigation. If your firm receives an inquiry from any individual injured by the defect in these devices, contact our office for more information if you are considering filing an individual plaintiff action.

MTN will keep our readers abreast of any changes in our initial impressions related to this matter.

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