As a general matter, products liability litigation can be divided into two categories, including claims that a product causes an injury, and claims that the label or advertising of a product is inaccurate or misleading.
The first category usually is best suited to mass tort actions, and the second category often leads to class actions.
Both class actions and mass torts - often brought in what is known as a multi-district litigation (MDL) - are procedural tools used to manage and resolve mass tort or complex litigation cases involving multiple plaintiffs. While both mechanisms are designed to streamline the legal process, they differ in key aspects.
In a class action, a single representative plaintiff (or a few named plaintiffs) sues on behalf of a class of individuals who have similar claims against a defendant. The members of the class are typically numerous, but their claims are often similar, such as product liability or consumer fraud cases. The MDL proceeding is not a lawsuit itself but a procedural tool to centralize and manage pretrial proceedings when multiple similar cases are filed in different federal courts across the country. It involves the consolidation of cases with shared factual or legal issues.
Another key difference is that for MDL proceedings, each individual case maintains its identity and representative plaintiffs do not litigate on behalf of a single consolidated class. Instead, it serves as a coordination of pretrial matters, such as discovery and motions, while cases are still separate. For these reasons, MDL proceedings are not required to go through the class certification process because each individual case maintains is own autonomy as the goal is to streamline pretrial issues related to discovery, and not to create a unified class.
Regarding settlement, in a class action the settlement is usually made on behalf of the entire class, whereas with MDL proceedings, each case may be required to undergo individual settlements, although, most times an MDL settlement arises from a common benefit fund.
Mass tort actions often cannot satisfy the requirements of Rule 23, or similar state procedural laws, because the claim of injury involves individualized issues and plaintiff-specific circumstances, requiring individual proof of injury. For example, a mass tort claim may allege that ingestion of medication caused the plaintiffs to develop various types of cancer. The individual claims of different types of cancer, based upon plaintiffs' unique social and medical histories, can be used to argue against class certification.
However, while product injury cases are highly susceptible to opposition to class certification because of the individualized nature of the injury, such lawsuits can lend themselves to multi-district litigation and other coordinated proceedings that involve the same product, a similar set of operative facts, and the same defendants.
Claims regarding labeling, however, often involve the exact same label across a broad range of individuals, and the injury claimed is often identical. Labeling-related cases may involve claims of consumer fraud, but injuries resulting from failing to disclose certain ingredients in the product for which that specific ingredient led to an injury may result in a successful class certification motion. However, these types of class actions are of course highly dependent on the nature of the injury insofar as everyone at issue still possesses a unique medical history which involves differing level of susceptibility to certain injuries and different levels of use to name a few differences across the class.
In 2024, plaintiffs were successful in obtaining class certification in products liability and mass tort actions. The certification rate was 50% with 3 motions for class certification granted and 50% or 3 motions denied.
I. Opioid Litigation
One example of extensive, high-stakes lawsuits in this space is the nationwide opioid litigation, which was consolidated into MDL No. 2804 in 2017 in the U.S. District Court for the Northern District of Ohio. Other similar MDL proceedings involve prescription medication, PFAS chemicals, and allegedly defective products. These lawsuits stemmed from the national public health crises created by the vast use and addiction to opiates. The manufacturers are accused of hiding or otherwise not being as forthright about the addictive properties of opiates, and are battling claims alleging public nuisance, products liability, negligence, and violations of the various states' consumer protection laws.
The Centers for Disease Control (CDC) reported around 95,000 opioid-related drug overdoses from May 2023 to May 2024. The opioid litigation has seen over 3,000 lawsuits brought by governmental entities and private individuals. The first opiate related lawsuits began in 2014 and were brought by Santa Clara and Orange Counties in California. Other states and private individuals soon followed, bringing claims of public nuisance, products liability, negligence, and violations of the various states' consumer protection laws. Since the initial onset of litigation, settlements have reached in the billions of dollars, and some of those proceeds were paid directly by the individuals who owned the pharmaceutical companies that manufactured opiates.
The class actions in this regard have targeted myriad of defendants. Purdue Pharma and Johnson & Johnson, as manufacturers, have been accused of hiding the addiction risk. Distributors like McKesson, Cardinal Health, and AmerisourceBergen have faced allegations of failing to act with respect to suspicious opiate orders. Drug stores such as CVS, Walgreens, and Walmart were also named as defendants.
As of 2024, the settlement payouts from these companies have exceeded $50 billion. However, some settlements are still being contested. In the proceeding captioned In Re National Prescription Opiate Litigation, No. 22-3750 (6th Cir.), the Sixth Circuit is considering whether to enforce a $650 million dollar judgement against the pharmacies for fueling the opioid epidemic in two Ohio counties – Trumbull and Lake counties. The Sixth Circuit has asked Ohio's Supreme Court to weigh in and determine whether state law permits the public nuisance claim, a type of claim that is asserted to address public problems such as chemical spills. The Ohio Supreme Court heard oral argument on March 26, 2024 in In Re National Prescription Opiate Litigation, Case No. 2023-1155 (Ohio Mar. 26, 2024). The Ohio Supreme Court has yet to issue an answer to the certified question.
Opioid litigation has led state and local governments to use public nuisance claims to address social issues. Specifically, In Re National Prescription Opiate Litigation alleges that the companies' marketing and distribution of opioids constituted a public nuisance. Trumbull County asserts that between 2000 and 2014, the pharmacies distributed 68 million doses of opioids, or the equivalent of 320 pills for every resident.
Finally, the U.S. Supreme Court held oral arguments and ruled as to the bankruptcy proceedings concerning Purdue and its affiliates. The case, Harrington, United States Trustee, Region 2 v. Purdue Pharma L.P., 144 S. Ct. 2071 (2024), involved a challenge to Purdue's Chapter 11 bankruptcy plan and the broad releases of liability it sought for various parties, including the Sackler family, which owned the company. In 2019, Purdue Pharma filed for Chapter 11 bankruptcy protection as part of an effort to address the thousands of lawsuits filed against it by state and local governments, municipalities, and individuals, all related to the opioid epidemic. The lawsuits claimed that Purdue's aggressive marketing and distribution of OxyContin contributed to widespread opioid addiction and overdose deaths. As part of its bankruptcy proceedings, Purdue proposed a reorganization plan that would involve restructuring the company and creating a public-benefit trust to handle its assets and liabilities. Under the plan, Purdue would pay out billions of dollars to settle opioid-related claims. Additionally, a significant portion of the settlement was earmarked for treatment programs, harm reduction initiatives, and other community-based efforts to address the opioid crisis. One of the most controversial aspects of Purdue's bankruptcy plan was the proposal to grant a release of liability to the Sackler family, the owners of Purdue. The Sacklers were accused of personally profiting from Purdue's aggressive marketing strategies that helped fuel the opioid epidemic. However, as part of the bankruptcy settlement, the Sacklers were seeking protection from further litigation, which would shield them from being held personally liable for the company's role in the opioid crisis. Under the proposed plan, the Sacklers would pay billions of dollars into the settlement trust but would not be held personally accountable for the opioid epidemic, nor could they face any future lawsuits related to their actions at Purdue. Several state attorneys general argued that this provision allowed the Sacklers to avoid full accountability for their role in the crisis. Andrew V. Harrington, the U.S. Trustee for Region 2 (a division of the U.S. Department of Justice responsible for overseeing bankruptcy cases), filed an objection to Purdue's bankruptcy plan. Harrington argued that the proposed bankruptcy plan was unfair and illegal, particularly the provision that would grant the Sacklers broad legal immunity from further opioid-related lawsuits. Harrington contended that the bankruptcy court lacked the authority to grant the Sacklers a release from personal liability, particularly when they had not filed for bankruptcy themselves and were not technically part of the bankruptcy proceedings. The U.S. Trustee argued that the releases violated established bankruptcy law, which generally does not allow for the release of third parties (such as the Sacklers) from liability unless they are directly involved in the bankruptcy. The objection also focused on the fairness of the bankruptcy plan. The U.S. Trustee argued that the plan unfairly favored the Sacklers over the victims of the opioid epidemic, who would not receive full compensation for their harm under the proposed terms. The objection also argued that the proposed release of the Sacklers and the settlement terms did not adequately reflect the public policy interest in holding corporations and their owners accountable for actions that harm public health and safety. The bankruptcy court initially approved Purdue's bankruptcy plan, including the releases of liability for the Sacklers. In 2021, the Second Circuit issued a decision to allow Purdue's bankruptcy plan to proceed with certain modifications. In particular, the Second Circuit upheld the bankruptcy court's ruling granting releases to the Sackler family, but it did so with some revisions and further scrutiny over how the trust would operate and the amount of money the Sacklers would contribute.
The U.S. Supreme Court agreed to hear the case in 2023. After hearing oral argument in early 2024, the Supreme Court ruled in June of this past year that the bankruptcy code does not authorize a release or injunction as part of a Chapter 11 reorganization plan that seeks to discharge claims against a non-debtor, such as the Sacklers, without the consent of the affected claimants. When a debtor files for bankruptcy, it creates an estate that includes nearly all the debtor's assets. Under Chapter 11, the debtor must propose a reorganization plan to govern the distribution of those assets. This plan is subject to bankruptcy court approval. A confirmed bankruptcy plan can discharge the debtor from certain pre-petition debts, but in this case, the Sacklers did not file for bankruptcy themselves. Despite this, they sought a release that essentially would have discharged them from future claims. The Supreme Court found that there is no provision in the bankruptcy code that allows such a discharge for non-debtors. The Supreme Court stated that § 1123(b) of the Bankruptcy Code outlines the types of provisions that may be included in a Chapter 11 plan. While some provisions apply to the debtor's responsibilities, a catch-all provision allows for other provisions deemed "appropriate." Id. at 726. However, the Supreme Court ruled that this catch-all does not authorize a bankruptcy court to discharge the debts of non-debtor parties, such as the Sacklers, without the consent of those affected by the claims. The Supreme Court explained that the broader powers in § 1123(b)(6) must be interpreted in the context of the surrounding provisions, which focus on the debtor's relationship with creditors. The Supreme Court held that this provision cannot be used to grant a discharge of claims against non-debtors. The Bankruptcy Code generally reserves discharge for debtors who place substantially all of their assets into the bankruptcy estate. Furthermore, the Code does not typically allow the discharge of claims based on fraud or willful injury. The Sacklers, however, had not filed for bankruptcy or placed their assets on the table for creditors, yet they sought a discharge of broad claims, including those for fraud and willful injury. The Supreme Court found that allowing such a discharge would violate the basic principles of bankruptcy law. The Supreme Court also looked to historical practice, noting that bankruptcy laws dating back to the 1800's typically reserved discharge benefits to debtors who surrendered their property fairly and completely. There was no indication in the 1978 bankruptcy code that it was meant to radically change this tradition, particularly in regard to non-debtor releases. The Supreme Court opined that if Congress had intended to grant courts such broad powers over third-party claims, it would have explicitly stated so. Accordingly, the Supreme Court reversed the Second Circuit's decision and remanded the case for further proceedings. The Supreme Court's ruling made clear that bankruptcy courts cannot release claims against third parties like the Sacklers without the affected parties' consent.
II. PFAS Litigation
Another recent hotbed of litigation involves PFAS (per- and polyfluoroalkyl substances). These chemicals are commonly known as "forever chemicals" due to the time it takes for them to break down. PFAS are widely used and found in many products. They exist in water supplies, fish, and soil locations across the globe, and based on some scientific studies, PFAS may be linked to harmful health effects in humans.
Numbering in the thousands, PFAS are found in consumer, commercial, and industrial products, and due to their presence in so many products, it is challenging to assess the health impact of PFAS. In recent years, the EPA has issued a number of guidelines around PFAS in drinking water and shown commitment to better understanding ways to detect PFAS and the amount of human exposure. Moreover, the U.S. Environmental Protection Agency has undertaken efforts to understand how to remediate, manage, and dispose of PFAS present in drinking water supplies more efficiently.
Another six states enacted PFAS regulations that went into effect in 2024 and will continue in 2025, including Colorado, Maryland, Connecticut, Minnesota, Hawaii, and New York. The graphic outlines these regulations.
The discovery of PFAS in drinking water has spurred states attorneys' general to bring lawsuits on behalf of the constituents. These lawsuits seek to impose liability on the PFAS manufacturers related to drinking water contamination and assert claims under various products liability laws and negligence.
In April 2024, the EPA finalized a rule setting the first-ever limits for PFAS in drinking water and is already subject to multiple legal challenges. In October of 2024, the White House's Office of Science and Technology Policy said in a report that it will continue to look for new technologies to remove so-called forever chemicals from the environment and find safe alternatives for the substances.
Since 2018, more than 300 lawsuits have been filed over PFAS contamination, with many suits being consolidated in the South Carolina-based MDL focused on pollution involving the chemicals in aqueous filmforming foam used in firefighting applications. On March 29, 2024, the court granted final settlement approval of $10.3 billion in In Re Aqueous Film-Forming Foams Product Liability Litigation, MDL 2873 (D.S.C. Mar. 29, 2024), to resolve claims with 3M by utilities that maintain it is liable for the damage they have and will incur due to its signature PFAS that were used for decades in specialized fire suppressants, called aqueous film-forming foams (AFFF), that were sprayed directly into the environment and reached drinking water.
While the plaintiffs' bar has been filing lawsuits for nearly a decade over alleged health and environmental consequences associated with PFAS, as of late the types of plaintiffs and defendants have evolved in this rapidly expanding landscape.
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