Category: Environmental and Toxic Tort Advisor

Will EPA’s Recent Ban on Methylene Chloride Uses Result in Exponential Litigation Similar to Asbestos?
This article was authored by Joshua Fine, Manager, Environmental Claims, Crum & Forster

Methylene Chloride – A Hazard to Public Health

Methylene chloride, also known as dirchloromethane [osha.gov], is a volatile, colorless liquid with a chloroform like odor. Historically, it has been used in various industrial processes, such as pharmaceutical manufacturing, metal cleaning and degreasing, paint stripping, and paint remover manufacturing. Human exposure to methylene chloride occurs through inhalation, ingestion and skin contact. While exposure to methylene chloride from consumer products either in a home or occupational setting leading to fatalities has been documented since 1947 [dcreport.org], United States agencies [ocf.berkeley.edu], such as the Consumer Product Safety Commission and the Environmental Protection Agency (“EPA”) refrained for years from thoroughly addressing the health hazard.

Humans may suffer from acute and chronic exposure [toxicfreefuture.org] to methylene chloride. Acute exposures to methylene chloride can cause death by heart attack or asphyxiation, as it transforms to carbon monoxide in the body and can cut off the oxygen supply to the heart, and at high doses, turns off the breathing center of the brain. In particular, fetuses exposed to high concentrations of methylene chloride may experience these nervous system effects, as carbon monoxide binds tightly to fetal hemoglobin. Chronic exposures have been associated with cognitive impairment, effects on attention, non-Hodgkin’s lymphoma, multiple myeloma, liver, kidney, and reproductive toxicity, and cancer of the brain, liver and lung.

Increasing Regulation of Consumer and Commercial Uses of Methylene Chloride

Methylene Chloride in Consumer Products

In 2017 [epa.gov], EPA estimated that 32,000 workers and about 1.3 million consumers use methylene chloride paint removers annually. In March 2019, EPA issued a final rule titled “Methylene Chloride; Regulation of Paint and Coating Removal for Consumer Use Under TSCA Section 6(a),” which proscribed the manufacturing, processing, and distribution of methylene chloride for consumer paint removal products but not the commercial sale or use of such products in the workplace. In April 2019, various environmental groups challenged this rule in the Second Circuit of the United States Court of Appeals, seeking to expand the prohibition to commercial uses. In 2021 [law.justia.com], the court denied the petitions for review of the rule, in part, holding that the retailer distribution ban was a fair means for EPA to accomplish its goal of ensuring protection from the risks of methylene chloride consumer uses.

In a 2021 JAMA article, titled Assessment of Methylene Chloride–Related Fatalities in the United States, 1980-2018 [ncbi.nlm.nih.gov], a case series of 85 methylene chloride–related fatalities from 1980 to 2018, found that 75% of the deaths occurred from exposures on the job. In November 2022 [epa.gov], the EPA found that most uses of methylene chloride constitute an “unreasonable risk of injury to health,” and in 2023, the EPA proposed a ban of most uses of methylene chloride, which it adopted on April 30, 2024. The EPA’s final rule titled “Methylene Chloride; Regulation under the Toxic Substances Control Act (“TSCA”), which was issued on May 8, 2024 [epa.gov], and became effective as of July 8, 2024 [federalregister.gov], will prohibit the manufacturing, processing and distribution of the chemical for all consumer uses by May 5, 2025, and most of its industrial and commercial uses by April 28, 2026.

Methylene chloride is only the second compound, after asbestos, to be banned under the 2016 Amended TSCA. Exemptions to the EPA ban [epa.gov] include using methylene chloride as a laboratory chemical and as a raw material in the production of electric-vehicle batteries and climate-friendly refrigerant chemicals. EPA’s final rule [epa.gov] also creates strict workplace protections to ensure that workers will not be harmed by methylene chloride in its exempted uses, and requires records maintenance, and notification of its restricted uses to companies to whom the chemical is being shipped by manufacturers, processors, and distributors.

Methylene Chloride in Food

Both the food additive and color additive Delaney clauses [ncbi.nlm.nih.gov] of the Federal Food, Drug and Cosmetic Act prohibit a cancer-causing substance for use in food. However, to date, methylene chloride is still listed as approved for use in food. In late December 2023, the Environmental Defense Fund, Breast Cancer Prevention Partners, Center for Environmental Health, Environmental Working Group (EWG), and Lisa Lefferts, an environmental health consultant, filed a food-additive petition [federalregister.gov] and a color-additive petition [govinfo.gov] with the Food and Drug Administration (“FDA”) requesting revocation of its approval of four solvents, including methylene chloride, from use in food. On 1/11/24, the FDA published a proposed rule to ban several food additives including methylene chloride, which is used to decaffeinate coffee [cspinet.org], for which electronic or written comments were accepted through 3/11/24. Proponents of these petitions, such as the Center for Science in the Public Interest, have asserted that although exposure to solvents, such as methlyene chloride, may only present a small cancer risk they should be banned from use in food. On the state level, California Assembly Bill 2066 [legiscan.com] calls for the Office of Environmental Health Hazard Assessment to conduct a study on the health impacts of the consumption of methylene chloride and to update its no significant risk level and its maximum allowable level of methylene chloride by January 1, 2026.

Chevron Deference’s Demise

There will likely be challenges to the EPA’s ban by various companies and industry associations. Already, on May 10, 2024, two Texas based-paint companies, East Fork Enterprises Inc. and Houston-based Epic Paint Co., filed a joint petition the U.S. Court of Appeals for the Fifth Circuit to review the EPA’s methylene chloride rule Federal Rule of Appellate Procedure 15, the TSCA § 19(a), 15 U.S.C. § 2618, the Administrative Procedure Act, 5 U.S.C. §§ 701-706, and the Small Business Regulatory Enforcement Fairness Act, 5 U.S.C. § 611. Subsequent to the filing of the joint petition, on June 28, 2024, the U.S. Supreme Court issued its decision in Loper Bright Enterprises v. Raimondo [supremecourt.gov] (“Loper Bright”), which ended the 40-year-old precedent of Chevron v. Natural Resources Defense Council [supreme.justia.com]. Under the Chevron doctrine, courts were to defer to agencies’ expertise to determine how ambiguous language relating to their work should be interpreted. In its stead, the Loper Bright decision requires courts to “exercise their independent judgment in deciding whether an agency has acted within its statutory authority,” and “not defer to an agency interpretation of law simply because a statute is ambiguous.” The U.S. Supreme Court’s overruling of Chevron may curtail the ability of agencies like the EPA and FDA to expand their regulatory authority, as their rules regarding methylene chloride endeavor to do, absent explicit authorization from Congress.

Future Litigation Involving Methylene Chloride

For now, should the EPA’s finalized methylene chloride rule be upheld, considering the number of workers and consumers that may experience acute or chronic exposure to methylene chloride, there is clearly potential for litigation due to methylene chloride exposures to grow exponentially.

The views expressed by the author are neither those of, or endorsed by, Crum & Foster.

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The recent decision by the Sixth Circuit in Hardwick and a review of the law from various jurisdictions supports the challenges that Plaintiffs face in proving standing for class certification in PFAS lawsuits. Late in 2023, the U.S. Court of Appeals for the Sixth Circuit struck down class certification for plaintiffs alleging injuries from exposure to per- and polyfluroaylkyl substances (PFAS), known as “forever chemicals.” In Re: E.I. Du Pont de Nemours and Co. C-8 Pers. Inj. Litig., (Hardwick v. 3M Co.), 87 F.4th 315 (6th Cir. 2023).

In Hardwick, the Sixth Circuit addressed an effort by a career firefighter to certify a statewide class action for exposure to PFAS in firefighting foam. At the district court level, suit was filed against 10 alleged PFAS manufacturers following blood tests that showed the named plaintiff had traces of five PFAS compounds in his blood. The district court was asked to certify a nationwide class consisting of every person residing in the United States for one year or more since 1977 with 0.05 ppt or more of PFOA and PFAS in their blood. However, the district court only certified a statewide class of 11.8 million persons subject to Ohio laws.

On appeal, the Sixth Circuit vacated the district court’s class certification and remanded the case with instructions to dismiss the case for lack of jurisdiction linked here. The court held that the plaintiff lacked standing due to the absence of particular allegations that each individual defendant manufactured or provided a traceable pathway for exposure to any of the specific PFAS compounds detected in his system. The court was not impressed by plaintiff’s pleading against the defendants as a collective, and asserting only conclusory allegations that failed to identify which companies manufactured the PFAS compounds to which he was allegedly exposed.

The court’s standing examination considered the elements: 1) had plaintiff suffered an actual injury; 2) traceable to a defendant; and 3) that a court may redress. The court’s review focused on traceability, an element that requires plaintiff’s allegations to demonstrate facts “plausibly supporting an inference that each defendant ‘likely caused’ at least one of those PFAS compounds to end up in his blood.” The court rejected the plaintiff’s collective allegations against all defendants, stating the plaintiff “must tie his injury to each defendant.” Essentially, the court stated that a plaintiff may not sue multiple defendants by making them a collective group in the general allegations when more particular facts may only allow the plaintiff’s claims against specific defendants, not all.

The court’s scrutiny of the plaintiff’s claims in Hardwick is potentially useful not only in the growing glut of PFAS litigation, which seems only likely to expand, but in many claims where a plaintiff alleges exposure to toxic substances, but fails to particularize the substance and its manufacturer, and instead simply asserts claims against an industry group of defendants as a collective. Utilizing standing and applying a similar test to claims as done in Hardwick to combat vague pleadings may be more useful in some jurisdictions than others.

For instance, in Illinois, courts have considered similar arguments when a plaintiff brings a claim against a collective or an industry and fails to particularize its exposure. In Smith v. Eli Lilly & Co., 137 Ill.2d 222, 232, 560 N.E.2d 324 (1990), the Illinois Supreme Court found that: “A fundamental principle of tort law is that the plaintiff has the burden of proving by a preponderance of the evidence that the defendant caused the complained-of harm or injury; mere conjecture or speculation is insufficient proof.” Id. The court stated that while each manufacturer owes a duty to those who will use its product or who might be injured by it, that duty is not so broad as to extend to anyone who uses or might be injured by a like-kind product supplied by another. Smith, 137 Ill.2d at 265, 560 N.E.2d 324, at 343.

Illinois courts have gone on to find that the causation-in-fact element of a cause of action requires a plaintiff to establish a causative link between the tortious acts of a specific defendant and the injuries for which recovery is sought. Thus, the failure to identify to which of the defendants’ products, amongst an industry group of defendants, Plaintiff was actually exposed is grounds for dismissal of a complaint for failure to properly allege causation in fact. Lewis v. Lead Indus. Ass’n, Inc. 342 Ill.App.3d 95 (2003).

Further, in Raja Tr. of Bharti Sona Tr. v. Patel, No. 16 CVS 4472, 2017 WL 1129981 (N.C. Super. Mar. 23, 2017), a North Carolina court granted defendants’ motion to dismiss because the plaintiffs failed to establish standing to sue other members of the LLC. The plaintiffs failed to make “any allegations or advanced any evidence concerning any economic loss or injury that [plaintiffs] may have suffered as a result … including any allegation or proof that Defendants caused [plaintiffs] to suffer injury … .” Instead, the plaintiffs’ allegations were conclusory and non-specific. At best, the plaintiffs alleged the possibility of a future injury, which North Carolina courts have made clear is insufficient to establish a cognizable injury in fact. See, e.g., Pierson v. Buyher, 330 N.C. 182, 186, 409 S.E.2d 903, 906 (1991).

In a Fifth Circuit property dispute case, 920 S. Beach Blvd., LLC v. City of Bay St. Louis, Miss., No. 1:21-CV-263-TBM-RPM, 2023 WL 2749170 (S.D. Miss. Mar. 31, 2023), the court held that the plaintiff had standing against the City because the plaintiff specifically pleads a causal connection between the violation of his rights and the conduct of the City. However, Plaintiff lacked standing against the remaining two defendants because general factual allegations of injury resulting from the defendant’s conduct may satisfy a plaintiff’s burden at the pleadings stage, “traceability nevertheless requires something more than conjecture.” Id., at *9. Similar to the Sixth Circuit ruling in Hardwick, the plaintiff’s allegations in 920 S. Beach Blvd., LLC were mere conjecture.

In a Louisiana data breach case, Bradix v. Advance Stores Co., 226 So. 3d 523, 528-529, 2017 La. App. LEXIS 1496, *6-8, 2017-0166 (La.App. 4 Cir. 08/16/17), the court found that the plaintiff had not established standing because his allegations regarding damages were hypothetical. “Louisiana’s standing requirement … provides that [e]xcept as otherwise provided by law, an action can only be brought by a person having a real and actual interest in what he asserts.‘” Id. at 6. Similar to the allegations in Hardwick, the plaintiff in Bradix brought claims alleging potential damages, which the court deemed insufficient.

However, in the Second Circuit, in Whitfield v. ATC Healthcare Servs., LLC, No. 22CV5005JMALGD, 2023 WL 5417330, at *4 (E.D.N.Y. Aug. 22, 2023), another data breach case, the court found the Plaintiff had established standing stating: “While a plaintiff’s injury must be ‘fairly traceable’ to a defendant’s actions, the causal connection element of standing creates ‘a standard lower than that of proximate causation.’ Quoting Carter v. HealthPort Tech., LLC, 822 F.3d 47, 55 (2d Cir. 2016). ‘A defendant’s conduct that injures a plaintiff but does so only indirectly, after intervening conduct by another person, may suffice for Article III standing.’” Id. at 55–56. Further, in a state court decision addressing a class action complaint for medical monitoring damages for alleged PFAS exposures, a New York appellate court upheld certification of a class of residential property owners with property near a manufacturing facility. Burdick v. Tonoga, Inc., 112 N.Y.S.3d 342 (N.Y. App. Div. 2019). Notably, neither standing nor traceability was addressed.

In the Third Circuit, in Salas v. Acuity-CHS, LLC, No. CV 22-317-RGA, 2023 WL 2710180, at *6 (D. Del. Mar. 30, 2023), another data breach case, the court found Plaintiff had satisfied the standing requirement at the motion to dismiss stage: “Although the traceability requirement ‘does not mean that plaintiffs must show to a scientific certainty that defendant’s [actions], and defendant’s [actions] alone, caused the precise harm suffered by plaintiffs,’ [citation omitted], plaintiffs must nevertheless show that their injuries ‘relate directly’ to the defendant’s conduct. See Id.” In Long v. Se. Pennsylvania Transportation Auth., 903 F.3d 312, 322 (3d Cir. 2018), a Fair Credit Reporting Act case, the Third Circuit noted that in addressing standing, “the injury-in-fact element is not Mount Everest. The contours of the … requirement, while not precisely defined, are very generous, requiring only that claimant allege some specific, identifiable trifle of injury.’’ [citation omitted].

The standing requirement for proving PFAS and other chemical exposure class certification lawsuits is certainly an issue that will continue to be litigated, and the Hardwick decision adds to defendants’ arguments particularly as to traceability of exposures.

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Delaware Attorney General Kathleen Jennings filed a lawsuit in late October against 14 defendant chemical companies for manufacturing and sale of fire-fighting foams that contained PFAS, known as “forever chemicals,” used extensively on military bases and airports that allegedly contaminated groundwater and other natural resources.

The lawsuit alleges the “forever chemicals” — polyfluoroalkyl substances (“PFAS”) from aqueous film-forming foam (AFFF) products – contaminated natural resources on or near the New Castle County Airport and the Dover Air Force Base in Kent County. They are called “forever chemicals” due to the extraordinarily strong carbon-fluorine bond that defines these compounds and makes them resistant to natural degradation processes. In nearly 30 pages of background allegations, the complaint outlines decades of sales and usage of the chemicals after the 3M Company had information, which it allegedly withheld from regulators, that the chemicals had “spread far beyond the immediate site of their application and were ‘more toxic than anticipated.'” In addition, the complaint alleges safer alternatives to the chemicals were available, and adequate warnings and instructions may have eliminated or limited the release of the chemicals into the environment.

In announcing the lawsuit, Attorney General Jennings stated, “3M and the other defendants knew the dangers that PFAS posed and they still chose profits over our neighborhoods and our children. Delawareans shouldn’t have to pay the costs of corporate greed, and we’re taking action to ensure that they won’t.”

The complaint claims it qualifies for assignment to the Delaware Superior Court Complex Commercial Litigation Division because the damages claimed exceed $1 million and sets out five claims for public nuisance, design defect, failure to warn and instruct, negligence, and trespass. The State seeks monetary and punitive damages for “historic, current and future” injuries and losses to Delaware’s natural resources and ecological services to restore those impacted natural resources, to test and monitor the contamination, and funding for state-run public health programs.

The complaint makes clear that this action pertains to only the design, manufacture, marketing, distribution, supply, and sale of AFFF products and ingredients in those products. The complaint expressly states that this current action does not pertain to nor include claims relating to injuries caused by non-AFFF products, including any products containing PFAS compounds other than AFFFs. Further, the action does not pertain to claims related to injuries caused by the disposal of PFAS compounds. Importantly, this leaves open the option for future suits directed at manufacturers, suppliers, distributors, or disposers of PFAS-containing products not related to AFFFs in the future.

In a reported statement, 3M stated it is committed to remediating PFAS, investing in water treatment, and collaborating with communities. It is reported that at least 26 states have filed or settled lawsuits related to PFAS contamination, with 3M Co. involved in most of the lawsuits. In 2021, Delaware settled a PFAS contamination lawsuit with DuPont, Corteva, and Chemours for $50 million. The defendants, in addition to 3M, named in the Delaware complaint include Tyco Fire Products, LP; Chemguard, Inc.; Buckeye Fire Equipment Co.; Arkema, Inc.; BASF Corp.; Clariant Corp.; Archroma U.S. Inc.; Dynax Corp.; AGC Chemicals Americas, Inc.; Daikin America, Inc.; Chemdesign Products, Inc.; Chemicals Inc.; and Deepwater Chemicals, Inc.

State of Delaware, ex rel. Kathleen Jennings, Attorney General of the State of Delaware v. 3M Company, et al., C.A. N23C-10-272 JRJ, Oct. 26, 2023.

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Reaffirming Delaware’s position on medical monitoring claims apart from its neighboring states, the Delaware Supreme Court answered a question certified to it by the Third Circuit ruling that there must be a manifestation of physical harm for a claim to be made for an increased risk of illness under Delaware law. In Baker v. Croda, Inc., No.393, 2002 (Aug. 24, 2023), the Delaware high court ruled: “[A] risk of harm only constitutes a cognizable injury once it manifests in a physical disease.”

The question was certified to the Delaware high court from the Third Circuit in an appeal of the dismissal of a class action seeking medical monitoring for residents near a Delaware chemical plant that leaked ethylene oxide, a known carcinogen, into the environment. Catherine Baker v. Croda Inc., No. 393, 2022 (Del. 2022) (Certification of Question of Law from the U.S. Court of Appeals for the Third Circuit, Appeal Nos. 21-3360 & 22-1333, 2022 WL 19010312 (3d Cir. Oct. 21, 2022)).

Writing for the Delaware Supreme Court sitting en banc Justice N. Christopher Griffiths pointed to two asbestos cases, one decided by the U.S. Supreme Court (Metro-North Commuter Railroad Co. v. Buckley, 521 U.S. 424 (1997)), and one Delaware case (Mergenthaler v. Asbestos Corp. of America, 480 A.2d 647 (Del. 1984). In Metro-North, the U.S. Supreme Court had rejected a claim for medical monitoring under a federal statute, highlighting the serious public policy concerns of a “flood” of litigation “that can accompany ‘unlimited and unpredictable’ liability.” In Mergenthaler, the Delaware high court had previously held that present physical disease was required to state a claim, rejecting mental anguish claims by present and former asbestos workers and their spouses who could not show physical injury from asbestos exposure.

Plaintiff Baker had attempted to use prior decisions to argue that claims based on fear of disease when accompanied by “actual exposure” were permitted. The court, however, cited an additional precedent, Brzoska v. Olson, 668 A.2d 1355 (Del. 1995), in which the court found support that “damages for claims of emotional distress or mental anguish … are recoverable only if [an] underlying injury is shown,” then stated that to rule otherwise would “constitute a significant shift in our tort jurisprudence.”

This decision reaffirms Delaware’s distinctive position from its neighboring states which have recognized liability claims for increased risk of pollution-related illnesses: Pennsylvania (Redland Soccer Club, Inc., v. Dep’t of the Army, 696 A.2d 137 (Pa. 1997)); New Jersey (Ayers v. Township of Jackson, 525 A.2d 287, 298 (N.J. 1987)); and Maryland (Exxon Mobil Corp. v. Albright, 433 Md. 303, 350, 71 A.3d 30, 59, on reconsideration in part, 433 Md. 502, 71 A.3d 150 (2013)). In Baker, the court mentions two other states that allow medical monitoring claims for those with increased risk of disease without a present illness: Massachusetts and California.

In the Baker opinion, the court lastly examined the public policy concerns: “[R]ecognizing an increased risk of illness, without more, as a cognizable injury could open the floodgates to ‘endless and limitless’ litigation. Dispensing with the physical injury requirement could also diminish the resources that are presently used for those who have suffered physical injury.” The Delaware General Assembly, the Court wrote, is better suited to address the complicated issues recognizing medical monitoring claims as a separate cause of action, such as when the limitations period would begin to run, whether a higher pleading standard might be required, the type of test to be utilized to determine who qualifies for medical monitoring, and whether medical monitoring costs would be provided by a court-supervised fund.

Baker v. Croda Inc., No. 393, 2022, 2023 WL 5517797 (Del. Aug. 24, 2023).

For over a decade, talc litigation has been a staple of mass toxic tort practices around the country and persists today. For those who are unfamiliar, talc is a naturally occurring mineral rock mined from the Earth that can occasionally cross paths and mix with asbestos during the mining and production process. When talc and asbestos mix in this setting, the risk of developing an illness arises. Talc came to be known for its fast absorption of moisture and its reduction of friction, properties which made it a common additive to cosmetic and hygiene-related products. For years, talc could be found in an abundance of products, most commonly in various cosmetic products, baby powder, and body powders.

The cases that involve talc are commonly standalone talc exposure cases, or they can include allegations of talc and asbestos exposure. Whichever style of claim is brought, these cases would not exist without the allegations of exposure-related injury, and in talc litigation, like asbestos, that injury is commonly alleged to be the onset of mesothelioma. When a case is filed under both a talc cause of action and an asbestos exposure cause of action, plaintiffs’ attorneys are likely to attempt to develop the theory that the mesothelioma, or other disease, is caused by exposure to both asbestos and talc. In 2022, 11% of asbestos filings also included allegations of talc exposure.

Talc litigation continues to evolve, and a review of the recent claims against industry defendants reveals that the stakes have never been higher. In the last 18 months, from October 2021 to May 2023, there have been a total of nine jury verdicts for cosmetic-only talc matters. The average award being a whopping $29,245,454.00. One reason that many consider why the average jury verdict is so outrageously high for talc-only exposure cases is the personal nature of these claims. Personal in the sense that talc exposure can occur in private, while you’re in a vulnerable state, in the safety of your home, and even with a newborn.

However, not all talc cases return results for the plaintiff. In Cook County, Illinois, a Decedent alleged talc exposure through after bath powder products. The Decedent suffered from mesothelioma and was 73 years old at the time of his death. The jury returned a defense verdict.

Today, due to the growing number of talc cases filed, a few talc suppliers, including Whitaker Clark & Daniels, have had to file for Chapter 11 bankruptcy. In April 2023, the New York Times reported that Johnson & Johnson has agreed to pay $8.9 billion over the next 25 years to those who claim talcum powder, produced by Johnson & Johnson, caused their cancer. In fact, talc litigation is so critical to Johnson & Johnson’s corporate survival that, according to annual filings, Johnson & Johnson has paid $7.4 billion in litigation expenses between 2020 and 2021, with talc litigation as the primary legal expense.

If this talc litigation trend continues, subsequent bankruptcies and payouts by companies could occur potentially affecting who is sued, the allegations of exposure, and target defendants. This litigation is only growing, and it will be interesting to see future jury verdicts, bankruptcies, and theories.

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The Delaware Supreme Court heard arguments on June 14, 2023, on a question certified to it from the Third Circuit of the U.S. Court of Appeals, as to whether medical monitoring claims can be made in Delaware without proof of any current physical harm.

The appeal to the Third Circuit was from the dismissal of a class action seeking medical monitoring for residents near a Delaware chemical plant that leaked ethylene oxide into the environment, a known carcinogen. In dismissing the class action at the federal trial court level, U.S. Circuit Judge Stephanos Bibas sitting by designation in the U.S. District Court for Delaware held: “[T]his class cannot recover damages for the risk of diseases that they do not yet have. … because each tort requires an injury, none of Baker’s torts survives this flaw.” Catherine Baker is the first named Plaintiff representing the class of alleged affected residents.

In its Petition for Certification of Question of Law, the Third Circuit panel of judges cited several Delaware decisions, stating that: [While those decisions] “may serve as a bellwether of the requisite elements of an injury-in-fact in Delaware, they are not sufficiently clear to allow us to decide the issue. A substantive difference exists between an injury based on a fear of disease and an injury based on an increased risk of disease. We decline on our own to conflate the two.” The specific certified question from the Third Circuit panel to the Delaware high court was: Whether an increased risk of illness, without present manifestation of physical harm, is a cognizable injury under Delaware law? Or, put another way, does an increased risk of harm only constitute a cognizable injury once it manifests in a physical disease?

At the hearing, some of the issues addressed by the Court to Plaintiffs/Appellants’ counsel included:

Chief Justice Collins J. Seitz, Jr. questioning as to how to limit the application of any medical monitoring – “How wide is the net cast for the plaintiffs? Is it everyone in the State of Delaware, is it New Castle County, is it residents surrounding the plant, and that leads to the public policy we are considering here, and that is where is the end of this?”
Justice Gary F. Traynor questioning as to the policy concern about the amount of medical monitoring – “What’s the framework envisioned for determining what medical monitoring is related to the exposure as opposed to normal medical monitoring?” and
Justice Abigail M. LeGrow questioning as to the effect of allowing such claims on the statute of limitations – “Currently the statute of limitations begins to run when an injured person feels the physical effects, if there are no physical effects but we are nevertheless saying there is a claim here, does that mean that later on, to the extent someone actually has one of these diseases, the statute has run?”

Other issues addressed included:

whether recognizing such claims is a legislative issue rather than a judicial issue, and if such claims are to be recognized, should it be the legislature that does so, not the courts;
what the Restatement of Torts says on the issue; and
is it semantics, or is there a distinction between proven increased risk of illness and potential future harm.

Based on prior Delaware jurisprudence and the concerns expressed at oral argument by the Court, it is likely the Court will decline to recognize the medical monitoring claims asserted by the appellants/plaintiffs. The Court has taken the matter under advisement, and a decision is expected later this year.

Catherine Baker v. Croda Inc., No. 393, 2022 (Del. 2022) (Certification of Question of Law from the U.S. Court of Appeals for the Third Circuit, Appeal Nos. 21-3360 & 22-1333, 2022 WL 19010312 (3d Cir. Oct. 21, 2022)).

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Earlier this year, the news was rampant with misleading stories that New York became the first state in the union to ban certain laundry detergents for containing 1,4-Dioxane after a third-party lab conducted testing on certain detergents. Fuel was added to the fire as reports of this “laundry detergent ban” spread quickly across social media such as TikTok. Despite the claims being made by social media influencers, New York did not ban any laundry detergent products. Rather, effective, January 1, 2022, New York amended its Environmental Conservation Law (ECL) Articles 35 and 37 to establish limits on the amount of 1,4-Dioxane that is permitted to be present in household cleaning, personal care, and cosmetic products sold or offered for sale in New York.

The amended maximum allowable limits were set at 2 PPM for household cleaning and personal care products and 10 PPM for cosmetics. The current 2 PPM limit for presence of 1, 4-Dioxane in detergents and cleaners is expected to be further lowered to 1 PPM by the end of 2023 though many interest groups are calling for the eradication of 1, 4-Dioxane in household products, entirely.

1,4-Dioxane, a colorless liquid with a faint sweet odor is a heterocyclic organic compound and it is classified as an ether. It is used as a solvent (for inks, adhesives, and cellulose esters), as a stabilizer for transporting chlorinated hydrocarbons in aluminum containers, and as a substitute for tetrahydrofuran in some processes because it has a lower toxicity and higher boiling point than tetrahydrofuran. From a defense standpoint, it must be noted that 1,4-Dioxane is only detectable by lab equipment and has been found in many household and other products (including paint strippers, dyes, greases, antifreeze, aircraft deicing fluids, food supplements, food containing residue from packaging with adhesives, food crops treated with pesticides that contain 1, 4- Dioxane), making it difficult to pinpoint any guaranteed exposure sources in plaintiffs. Further, 1, 4-Dioxane is short lived in an air environment and, per the CDC fact sheet for 1, 4-Dioxane, only has a half-life of one-three days and though it biodegrades more slowly in the water and soil, the EPA has classified it only as “likely to be carcinogenic to humans,” though in 1988 the California added 1, 4-dioxane to a list of chemicals “known” to cause cancer.

The inaccurate reporting regarding the so called “laundry detergent ban” claimed that certain detergents did not comply with New York’s laws regarding limitations on the presence of 1, 4-dioxane in final products sold to consumers and made misleading statements to the public that these noncompliant laundry detergents and household products were illegal or banned. These sensationalist reports were also misleading in that they largely glossed over the fact that 1, 4-dioxane is not an ingredient in laundry detergents and household cleaning products but is simply a by-product that can occur during the manufacturing process of these household items and is typically only present in very low trace levels, if at all, in the detergents and cleaning products improperly reported as having been “banned.”

Language is important, and despite claims made across social media, it was not brands that were banned, but certain formulations of brands that would no longer be acceptable under the amended 2 PPM limit. In reality, manufacturers were permitted time to reformulate their at-risk brands to comply with the new limits and, by the time of the drafting of this post, many popular brands have already done exactly that, well ahead of the statutory deadlines set by the New York State Department of Environmental Conservation. The law also permits products exceeding the 1, 4-Dioxane limit to be sold in New York if they have a waiver from the DEC, which some products have already received. The waiver allows manufacturers additional time to achieve compliance with the lowered 1, 4-Dioxane allowable limits.

Given the attention already seen with respect to this topic, we can expect more and more cases to pop up related to 1, 4-Dioxane exposure over the coming years, especially as potential claimants are fueled by social media fires. As these cases arise, it is important to remember to engage experts early to assist in developing defense strategies with counsel from the start of litigation. These include consideration of all possible avenues of exposure and alternate theories of causation and staying abreast of changing standards. With the recent trend of holding manufacturers to stricter and stricter environmental standards, especially with respect to new and emerging chemicals, it is certain that laundry detergent will not be the last product under the microscope.

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On May 25, 2023, the U.S. Supreme Court issued an opinion in the case of Sackett v. U.S. Environmental Protection Agency regarding the scope of regulatory powers applicable to wetlands and issued a more clear definition of “waters of the United States” covered by the Clean Water Act (“CWA”). In sum, the Court decided the definition established by the U.S. Environmental Protection Agency (EPA) and the U.S. Army Corps of Engineers (Corps) of regulated wetlands was too broad and should be restricted to property adjacent to a body of water with a “continuous surface connection” to that water. While the Sackett decision applies to wetlands matters, it may well have an impact on other environmental regulatory matters, as the decision certainly appears to restrain the Environmental Protection Agency’s authority to broadly interpret federal statutes.

The Court in Sackett clarifies that the CWA’s grant of regulatory powers over the “waters of the United States” does not confer power to the EPA and Corps to regulate wetlands that are “merely nearby” covered waters. Rather, the CWA extends only to those wetlands that are “as a practical matter indistinguishable from waters of the United States.”

The case began many years ago when Michael and Chantell Sackett purchased a half-acre lot within 300 feet of Priest Lake, an attractive recreation location for vacationers and residents. Priest Lake is one of the largest lakes in Idaho, spanning approximately 23,000 acres of beautiful water lying within the slopes of the Selkirk Mountains. The Sacketts’ lot was originally somewhat soggy but did not actually front the lake. The lot sits between roads to the north and the south. A large wetland drains into an unnamed tributary across the road to the north of the Sacketts’ lot. To the south of the Sacketts’ lot, there is another road, across which is a row of existing homes which front Priest Lake. The Sacketts obtained building permits from local authorities and began site preparation by filling parts of the lot with sand and gravel. The EPA and the Corps stepped in to stop the site work, finding that the Sacketts’ lot could not be filled without a wetlands permit under the CWA. These federal agencies found that the marshy quality of the Sacketts’ property rose to the level of “waters of the United States,” and had an impact on the environment of the nearby lake. Not only did they have to stop back-filling the lot, but the Sacketts were also ordered to remediate the already completed back-filled areas of their lot within five months or face penalties of $40,000 per day.

The EPA and the Corps had noted that parts of the lot which had yet to be filled with earth were either flooded or contained wetland vegetation, both factors these agencies have often used in determining whether a property is in a wetland. The site inspection report by the EPA stated that the Sacketts’ property, where no fill material had been placed, was inundated and ponded with groundwater. The EPA and the Corps had determined that the Sacketts’ lot contained wetlands, and the sand and gravel deposited there constituted pollution which had to be removed.

In their arguments to the Supreme Court, the EPA asserted that it had regulatory control over any “adjacent” wetlands that “possess a significant nexus to traditional navigable waters,” and that wetlands are “adjacent” when they are “neighboring” covered waters. Essentially, the arguments of the EPA would have granted the agency expansive powers over any wetlands nearby covered waters, even in cases such as the Sacketts’ where the connection (or nexus) identified by the EPA was not any direct surface connection of flowing water between the wetlands and lake, only that the environment of the lake might be affected. The Court rejected this position and declared that “‘adjacent’ cannot include wetlands that are merely nearby covered waters.” For government agencies to exercise control over wetlands through the CWA, the connection between the wetlands and covered waters cannot be attenuated, or even an underground connection; it must be a continuous, surface-level connection.

With this decision, the Court set forth a definition of “waters of the United States” which is far narrower than the definitions previously proposed by the regulatory agencies. As set forth in Sackett, “the waters of the United States” include “only those relatively permanent, standing or continuously flowing bodies of water ‘forming geographical features’ that are described in ordinary parlance as ‘streams, oceans, rivers, and lakes.” The Court next endorsed a two-part test, first set forth in the case of Rapanos v. United States, to establish whether any particular wetlands are “indistinguishable from waters of the United States,” namely:

The land must be “adjacent” to a body of water which constitutes “waters of the United States” under the newly endorsed definition above.

The wetland must have a continuous surface connection to that water.

Importantly, while the Rapanos decision had only received a 4-vote plurality, the Sackett decision’s doctrine is established by a 5-4 majority. While 4 justices did not join in the Majority Opinion setting forth the new definition of “waters of the United States,” all 9 justices agreed that EPA had overstepped its authority in claiming jurisdiction over the Sacketts’ property.

The Sackett decision provides long-needed clarity for developers and other large property owners regarding soggy or wet ground by establishing clearer definitions and rules that help determine whether a particular property may properly fall under the regulatory powers of US government agencies. Yet, beyond property-related wetlands considerations, environmental legal observers will likely be discussing the impact of Sackett on other environmental regulatory matters for many years to come.

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The Pennsylvania Superior Court recently issued two decisions that present challenges to defendants in prevailing at summary judgment in asbestos cases.

In Korol v. Warren Pump, the Superior Court held that the plaintiff presented sufficient evidence to overcome summary judgment.[i] This lawsuit alleged that the decedent, Thomas Korol, developed mesothelioma from exposure to asbestos while working onboard the U.S.S. Dahlgren as a fireman and fireman’s apprentice from 1961 to 1963.[ii] Mr. Korol was never deposed but relied on the testimony of three coworkers from the U.S. Navy.[iii] Two of the coworkers testified that they did not specifically remember Mr. Korol from their time aboard the U.S.S. Dahlgren.[iv] The third coworker testified he worked with Mr. Korol for a “short time” in the fireroom on the U.S.S. Dahlgren.[v] He never actually saw Mr. Korol removing gaskets from pumps but testified that if someone were a fireman, they would have removed gaskets.[vi]

A pump manufacturer (Warren) and a valve manufacturer (Crane) moved for summary judgment, arguing that none of the testimony from the decedent’s coworkers established that they saw the decedent work on their products or saw anyone else work on their products in the vicinity of the decedent.[vii]

The Superior Court held that, given the totality of the evidence, the plaintiff presented sufficient evidence of asbestos exposure to overcome summary judgment.[viii] The Court reasoned that the following record evidence was sufficient to create genuine issues of material fact: the decedent worked as a fireman and fireman’s apprentice in the firerooms and engine rooms on the U.S.S. Dahlgren for 28 months; one coworker testified he worked with the decedent for a “short time” in the fireroom of the U.S.S. Dahlgren; those rooms contained valves manufactured by Crane and pumps manufactured by Warren; in those rooms, sailors often removed and replaced asbestos gaskets and packing on pumps and valves by scraping the gaskets from the metal surfaces; this scraping created dust that was released into the air; the confines of the firerooms and engine rooms were extremely tight; and, because of the close quarters, anyone who worked in the firerooms and engine rooms would have been very close to someone scraping a gasket or would, himself, have been scraping a gasket.[ix]

In Mullen v. American Circuit Breaker Corporation, the Superior Court held that testimony by the decedent’s coworker that the rope gasket “looked like standard asbestos rope,” combined with his personal experience with asbestos, was sufficient to overcome summary judgment.[x] This lawsuit alleged that the decedent, James Myers, contracted mesothelioma during his time working at Sunbeam Equipment Corporation from 1967 to 2017.[xi] Mr. Myers was never deposed but relied on the testimony of numerous coworkers from Sunbeam.[xii]

George Carl, one of the decedent’s coworkers, testified there were Firecheck safety valves at Sunbeam that contained rope gasket.[xiii] This rope gasket sometimes had to be replaced, which created dust.[xiv] He testified this rope gasket material “looked like standard asbestos rope,” and based on his personal experience, the gaskets used in the Firecheck valves looked like asbestos.[xv] Mr. Carl never saw any documentation that the rope contained asbestos.[xvi] He testified that the decedent was in his vicinity while he worked with the gaskets and rope on the Firecheck safety valves.[xvii]

The Superior Court held that the plaintiff presented sufficient evidence to overcome summary judgment and that the facts sufficiently identified Firecheck valves as well as the frequency, regularity, and proximity of the decedent’s exposure to them.[xviii]

These two recent Superior Court decisions raise new challenges for defendants in winning summary judgment motions in asbestos cases in Pennsylvania. Korol suggests that summary judgment can be denied despite testimony that a coworker did not personally see the plaintiff performing work on a specific manufacturer’s product, if the totality of the evidence creates a material issue of fact as to the regularity of the plaintiff’s contact with a defendant’s product. Mullen suggests that testimony that a product looked like asbestos, combined with personal experience with asbestos, can create sufficient evidence to overcome summary judgment.

[i] Korol v. Aurora Pump Company, 2023 WL 1980858 (Pa Super. Feb. 14, 2023).

[ii] Id. at *1.

[iii] Id.

[iv] Id. at *2.

[v] Id. at *1.

[vi] Id.

[vii] Id. at *2.

[viii] Id. at *6.

[ix] Id.

[x] Mullen v. American Circuit Breaker Corporation, 2023 WL 2770765 (Pa. Super. April 4, 2023).

[xi] Id. at *1.

[xii] Id.

[xiii] Id. at *6.

[xiv] Id.

[xv] Id.

[xvi] Id. at 1.

[xvii] Id. at 6.

[xviii] Id. at 7.

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The Delaware Supreme Court heard arguments in late March in a lawsuit on appeal by the State of Delaware seeking to hold Monsanto as a manufacturer responsible for polychlorinated biphenyls (PCBs) that have contaminated waterways, negatively impacted wildlife, and entered the food chain.

In the trial court decision appealed to the Delaware high court, Superior Court Judge Mary M. Johnston dismissed each of the claims, which included public nuisance and trespass for failure to state a claim and unjust enrichment for lack of jurisdiction.

A key issue considered in the appeal is whether allowing the state to pursue its claims against Monsanto and its spinoff corporate entities, Solutia Inc. and Pharmacia LLC, would open the floodgates for unlimited liability against manufacturers for similar trespass, public nuisance, and unjust enrichment claims.

At the argument, Justice Gary F. Traynor questioned: “If your theories are accepted, for instance your trespass theory, that would be a cause of action involved to virtually the entire population, would it not? What we are understandably struggling with is, what is the limiting principle to your theory?”

Delaware Assistant Attorney General Ralph Durstein, III, for the State agreed, stating that guardrails could be applied by looking at the elements of common law which are demanding of a plaintiff, and in this case, there are unique circumstances including a sole distributor, knowledge of the problems created by the chemicals, and persistence in the conduct that caused the harm. He argued there would not be that many cases with similar facts, and that allowing the causes of action to proceed would not create a floodgates’ problem.

Alternatively, Kim Kocher, of Shook Hardy & Bacon, LLP, argued for Monsanto that allowing the claims to proceed would create an entirely new tort, and would open the floodgates with limitless, unpredictable liability for nearly every manufacturer who sells products in Delaware. “We all know that motor oil, plastic straws, bottle caps, antifreeze, cars themselves, inevitably end up in the environment. There’s no limiting principle to this theory of liability,” she argued. Further, she asserted the application would be particularly unfair in this case because Monsanto ceased the production of its product 45 years ago.

Monsanto made PCBs which were sold in bulk from 1935 to about 1977 and were used by third parties in the manufacturing of insulating fluids for electrical equipment, hydraulic fluids, and heat transfer fluids, according to the complaint.

Other issues the justices questioned, included the legal significance of the alleged knowledge of Monsanto that the PCBs contaminated waterways; and whether the Court should reverse the lower court’s dismissal if it applied the Restatement law. A decision from the Court is expected this spring.

State of Delaware et al. v. Monsanto Co. et al., Case No. 279, 2022, argued on March 29, 2023, before the Delaware Supreme Court; and in the Superior Court – State ex rel. Jennings v. Monsanto Co., No. CVN21C09179MMJCCLD, 2022 WL 2663220 (Del. Super. Ct. July 11, 2022).

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On January 26, 2023, the Delaware Superior Court applied the “bare metal defense” in ruling that the Plaintiffs had failed to prove exposure to asbestos for which a pump manufacturer is responsible under maritime law granting summary judgment for Aurora Pump Company in two rulings. The plaintiffs in the two cases alleged exposure to asbestos when working with pumps on naval vessels in the 1960s and 1970s. The court held there was no evidence in the record that the gaskets and insulation for the pumps were required in order for the pumps to function properly applying the decision by the U.S. Supreme Court in Air & Liquid Sys. Corp. v. DeVries, 139 S.Ct. 986 (2019). The Shears case also involved alleged exposure to asbestos from work with Aurora pumps in Texas, and the court also held in that case there was no duty to warn for components provided by third parties under Texas law. The Court granted summary judgment for Aurora as to all claims in both cases. Linda Hutto, Individually and as Administrator of the Estate of Robert Sterling Hutto v. Air & Liquid Systems Corp. (Aurora Pump Co.), C.A. No. N18C-10-329 ASB (Del. Super. Jan. 26, 2023); and Robert and Claire Shears v. ABB, Inc. (Aurora Pump Co.), C.A. No. N19C-11-264 ASB (Del. Super. Jan. 26, 2023).

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On January 30, 2023, the Third Circuit dismissed Johnson & Johnson (J&J)’s subsidiary LTL’s Chapter 11 bankruptcy petition because the facts did not support the financial distress required for the entity’s good faith filing for bankruptcy.

“While LTL inherited massive liabilities, its call on assets to fund them exceeded any reasonable projections available on the record before us. The ‘attenuated possibility’ that talc litigation may require it to file for bankruptcy in the future does not establish its good faith as of its petition date. At best, the filing was premature,” the appellate court wrote. Therefore, the petition did not serve a valid bankruptcy purpose, and LTL could not show it was filed in good faith.

In 1979, J&J transferred J&J’s baby powder assets to Old Consumer. Thereafter, in October 2021, J&J established LTL, a subsidiary, to be responsible for essentially all liabilities of Old Consumer talc-related claims. Prior to LTL’s bankruptcy petition, Old Consumer had paid about $3.5 billion for talc-related verdicts and paid nearly $1 billion in defense costs at a rate of $10 to $20 million per month. Nonetheless, Old Consumer was estimated to have a value of $61.5 billion. LTL, once established, received Old Consumer’s talc liability, rights under a Funding Agreement, a royalties business, and cash, and then, days later, on October 14, 2021, filed a Chapter 11 bankruptcy petition in the Bankruptcy Court for the Western District of North Carolina.

At which time of its filing, LTL also sought to extend the automatic stay afforded to it under the Bankruptcy Code to talc claims asserted against non-debtor entities, including affiliates, insurers, and third-party retailers arising from Johnson’s Baby Powder (referred to collectively as the “Protected Parties”). The North Carolina Court initially issued an order enjoining these types of claims against Protected Parties for a period of sixty (60) days and then transferred LTL’s bankruptcy to the District of New Jersey.

An Official Committee of Talc Claimants was subsequently formed in the case pending in the New Jersey Court and moved to dismiss the bankruptcy petition pursuant to §1112(b) of the Bankruptcy Code as not having been filed in good faith. In February 2022, the New Jersey Bankruptcy Court held a five-day trial on the Talc Committee’s motions to dismiss and LTL’s renewed attempt for a permanent injunction of claims asserted against the Protected Parties. The New Jersey Bankruptcy Court denied the motions to dismiss and granted LTL’s injunction motions enjoining the numerous third-party claims against the Protected Parties. The Talc Committee timely appealed the Bankruptcy Court’s order denying its motions to dismiss and the order enjoining third-party claims against the Protected Parties, which appeals were subsequently certified by the Bankruptcy Court for submission to the Circuit Court of Appeals pursuant to 28 U.S.C. §158(d)(2).

Writing for the federal appellate court three-judge panel, U.S. Circuit Judge Thomas L. Ambro reversed the denial of the motions to dismiss because the bankruptcy filing did not meet the good faith requirement, and the appellate court focused on LTL’s assets, liabilities, and critically, the funding backstop it has in place to pay those liabilities. The 3rd Circuit held that LTL was not in financial distress when it filed its Chapter 11 petition. The appellate court wrote that the Bankruptcy Court misdirected its review to how talc litigation affected Old Consumer rather than the Funding Agreement’s benefit to LTL. That misdirection was a legal error. Further, the Bankruptcy Court estimated that future claims imperiled the viability of all J&J companies, ignoring the possibility of settlements and successful defenses and dismissals. The appellate court was also concerned with “the casualness of the calculations supporting the Court’s projections,” which “engenders doubt as to whether they were factual findings at all, but instead back-of-the-envelope forecasts of hypothetical worst-case scenarios.” LTL did not have any likely need in the present or the near-term, or even in the long-term, to exhaust its funding rights to pay talc liabilities, the appellate court wrote.

The Bankruptcy Court also held as an independent basis for its decision “unusual circumstances.” The Bankruptcy Court ruled that “the interests of current tort creditors and the absence of viable protections for future tort claimants outside of bankruptcy . . . constitute such ‘unusual circumstances’ as to preclude . . . dismissal.” The appellate court held its ground for dismissing the bankruptcy filing because LTL lacked financial distress, and “[n]o ‘reasonable justification’ validates that missing requirement in this case.”

The appellate court also noted that J&J’s triple A-rated payment obligation for LTL’s liabilities weakened LTL’s case to be in bankruptcy. “[T]he bigger a backstop a parent company provides a subsidiary, the less fit that subsidiary is to file. But when the backstop provides ample financial support to a debtor who then seeks shelter in a system designed to protect those without it, we see this perceived incongruity dispelled.”

The Third Circuit ruling reversed the New Jersey Bankruptcy Court’s denial of the Talc Committee’s motions to dismiss, with instruction to dismiss LTL’s bankruptcy filing and further ruled that dismissal thereby annulled the litigation stay.

In re: LTL Management, LLC, No. Nos. 22-2004, 22-2003, 22-2005, 22-2006, 22-2007, 22-2008, 22-2009, 22-2010, 22-2011 (3d Cir. Jan. 30, 2023).

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