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 As a result of these defects, the Physiomesh device was voluntarily withdrawn from the market in May of 2016.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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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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