Chemical Products Archives - Faegre Drinker on Products

Subject: Chemical Products

Significant Drug & Device Developments of 2025

As we welcome the new year, it is time to reflect on some of the most significant legal developments in the drug and device space in 2025.

1. Navigating a New Skepticism in Science

Not long ago, the average American likely could not name the U.S. secretary of health and human services. Yet, following this year’s change in administration and major shakeup in the regulatory landscape, skepticism in science has become the elephant in the room for anyone working in the drug and device sphere. Practitioners should start thinking about how to present scientific evidence to juries in 2026 as the old norms may no longer apply.

Read the full article on the Faegre Drinker website.

Same Song, Different Verse — Causation Experts for Second Group of Bellwether Plaintiffs Excluded for Same Reason as First Group’s Expert in In re Deepwater Horizon BELO Cases

Multidistrict litigation is meant to “promote the just and efficient conduct” of actions “involving one or more common questions of fact” by transferring those actions to a single district court “for coordinated or consolidated pretrial proceedings.” 28 U.S.C. § 1407(a). In MDLs involving alleged physical injury or illness caused by a product, one “common question of fact” is general causation. Each plaintiff in the MDL must prove that the product is capable of causing the injury or illness. We think it is usually — if not always — most “just and efficient” to address general causation on an MDL-wide basis as early as practicable. Some courts disagree, testing general causation initially on just a subset of plaintiffs in the MDL; when those efforts fail, other plaintiffs may be permitted to try again, perhaps with new general causation experts. But the plaintiffs’ second attempt to establish general causation often fails to remedy the problems that doomed the first attempt (as we have discussed before), merely amplifying costs for both parties before reaching the same result. The In re Deepwater Horizon BELO (Back-End Litigation Option) Cases litigation, while not formally centralized as an MDL itself, provides another example. In re Deepwater Horizon BELO Cases, 119 F.4th 937 (11th Cir. 2024).

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Expert’s Results-Driven Methodology Leads to Exclusion and Summary Judgment in Paraquat MDL

An expert witness is not supposed to pick a desired result and then reverse engineer inputs and methods that reach that result. As the Ninth Circuit observed 30 years ago, “[c]oming to a firm conclusion first and then doing research to support it is the antithesis of [the scientific] method.” Claar v. Burlington Northern R.R. Co., 29 F.3d 499, 502-03 (9th Cir. 1994). A recent opinion from the Southern District of Illinois offers a fine example of an expert with a results-driven approach and a court that called him out on it.

In re Paraquat Products Liability Litigation, 2024 WL 1659687 (S.D. Ill. Apr. 17, 2024), arises from a multidistrict litigation (“MDL”) in which the plaintiffs claim to have developed Parkinson’s disease as a result of exposure to an herbicide, paraquat. Four plaintiffs whose cases had been chosen for the MDL’s first trials offered a statistician (the parties disputed whether he also qualified as an epidemiologist) as their sole expert to establish general causation. He had a difficult task, as no peer-reviewed literature established a link between paraquat exposure and Parkinson’s disease. Indeed, when the court asked the plaintiffs to identify such literature, the plaintiffs could cite only a single opinion article. That article had been shared with another of the plaintiffs’ experts before it was published, leading the court to conclude in deciding a prior discovery dispute that there was reason to investigate “whether counsel for the MDL plaintiffs, their experts, or other third parties may have influenced the contents of the article for the benefit of one side in the MDL.” 2023 WL 8372819 (S.D. Ill. Dec. 4, 2023).

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Sue Generous and the Laws of Legal Physics: Preventing Asbestos Mission Creep in California Courts

It is virtually a law of legal physics in California that liability tends to expand until a critical mass of appellate courts rule that it has reached its limit, or the Supreme Court puts up a stop sign (a vanishingly rare occurrence).

This judicial tendency reaches its zenith in asbestos litigation. Asbestos cases feature a combination of factors that pressure-test the boundaries of traditional tort law. Asbestos fibers, in most cases, are relatively fungible, and the exposures are anecdotal and undifferentiated. The injuries have extremely long latency periods, leaving exposure details fuzzy, ancient lore. The biological mechanisms are largely mysterious. In many cases, the plaintiff can prove an asbestos injury but cannot reliably prove causation under traditional tort standards.

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Updated EPA Analysis on Long-Term Health Effects of Formaldehyde Exposure Could Have Lasting Implications for Manufacturers

On April 14, 2022, the Environmental Protection Agency (EPA) released draft conclusions in a report updating its analysis regarding formaldehyde exposure, suggesting that long-term exposures to small amounts of formaldehyde in the environment can increase the risk of rare head and neck tumors, leukemia, and other threats to health. The conclusions are not final agency action. Still, manufacturers should be aware of the potential for EPA’s analysis to influence both regulation and litigation at both the state and federal levels.

For over a decade, there has been much debate and study on the long-term effects of exposure to formaldehyde. The EPA’s new analysis is an update of a 2010 draft EPA report that was heavily panned by scientists, legislators, and chemical manufacturers and that drove the EPA back to the drawing board. For example, the National Academies of Sciences, Engineering, and Medicine criticized the 2010 draft EPA report for failing to describe the rationale behind its methodology and failing to sufficiently support its conclusions.

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New Phthalates Study Garnering Media Attention Purports to Show Only an Association – Not Causation – with Certain Mortalities

A new study regarding phthalates has garnered media attention this month, but readers should recognize the study’s limitations. Some media coverage of this study blurs the important distinction between “association” and “causation.”

What Are Phthalates?

Phthalates, sometimes called plasticizers, are a group of chemicals generally used to make plastics more durable, or to dissolve other materials. Phthalates may be found in products such as vinyl flooring, food wraps, intravenous tubing, lubricating oils, and some personal care products such as shampoos, soaps, and hairsprays.

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