Faegre Drinker on Products

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In Case You Missed It: Faegre Drinker on Products — Fall 2025

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Catch up on the latest developments of interest for product manufacturers. Here’s a quarterly compilation of the most popular blog posts on Faegre Drinker on Products.

Register to Do Business, Register to Be Sued? Illinois’ New Jurisdictional Trap for Toxic Tort Litigants

By Elizabeth C. Christen, Jenna Seiler, Natalie Abdou & Bryan D. Pasciak

For companies operating nationwide, rules governing where they can be sued are consequential — especially in high-exposure toxic tort litigation. Illinois’ enactment of SB 328 raises the stakes in these cases even more, conferring general jurisdiction over companies who register or merely transact business in Illinois.

Close, But Not Quite: Eastern District of North Carolina Excludes Experts Whose General Expertise Does Not Enable Specific Opinions Offered

By Eric M. Friedman

Even “[a] supremely qualified expert cannot waltz into the courtroom and render opinions” without passing muster under Federal Rule of Evidence 702. Clark v. Takata Corp. (7th Cir. 1999). A recent case from the Eastern District of North Carolina shows this principle is at play not only when critiquing an expert’s methodology, but also the expert’s expertise.

No Defect, No Negligence: Lessons from Rudzinskas v. Retractable Technologies, Inc.

By Alena Markley

A summary judgment from the Southern District of Georgia shows the critical role of defect evidence (or lack thereof) in negligence claims involving medical devices. In Rudzinskas, allegations that a medical device malfunctioned were not sufficient evidence to survive summary judgment on negligent manufacturing and failure-to-warn claims.

In Case You Missed It: Faegre Drinker on Products — Summer 2025

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Catch up on the latest developments of interest for product manufacturers. Here’s a quarterly compilation of the most popular blog posts on Faegre Drinker on Products.

Tort Reform Is Top of Mind in 2025: Legislative Updates in Georgia, South Carolina, Louisiana and Arkansas

By Elizabeth A. Wurm, Jenna Seiler & Elizabeth C. Christen

Some states that are home to “Judicial Hellhole” venues, often known for producing nuclear verdicts, have rallied for successful tort reform. In the most recent state legislative sessions, Georgia, South Carolina, Louisiana and Arkansas implemented tort reform bills which may serve to neutralize the nuclear verdicts coming out of their courts.

 

Message Received — Delaware Follows Federal Rule of Evidence 702

By Eric M. Friedman & Emma DeLaney Strenski

The Delaware Superior Court took the mass tort world by surprise with its refusal to exclude the plaintiffs’ experts’ causation opinions in the Zantac litigation. But the Delaware Supreme Court granted the defendants’ request for interlocutory appeal and has reversed the Superior Court’s decision and remanded for further proceedings.

 

ChatGPT As Your New Testifying Expert Under Proposed Federal Rule of Evidence 707? Maybe Not.

By Nikolas G. Spilson & Eric M. Friedman

Tools that can reduce the time and cost of litigation have long been in high demand by both clients and counsel. But the tool must be fit for its purpose, and tools that generate evidence or other outputs that will be submitted to the court must pass judicial scrutiny. One of the newer fights concerns the admissibility of machine-generated “expert” opinions.

In Case You Missed It – Winter 2024

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Catch up on the latest developments of interest for product manufacturers. Here’s a quarterly compilation of the most popular blog posts on Faegre Drinker on Products.

Michigan Repeals Pharma Immunity Provision

By Jacqueline E. McDonnell

Michigan recently signed into law a repeal of the immunity provision under its Product Liability Act, presenting a new litigation risk in Michigan for pharmaceutical companies. The provision had granted near-complete immunity to pharma for the past 30 years, as the only of its kind nationwide. Michigan’s new law — Senate Bill 410 — removes this immunity, leaving intact a rebuttable presumption of nonliability and caps on noneconomic damages.

Pennsylvania Stays in a Minority of Two States in Prohibiting Evidence of Compliance With Government and Industry Standards in Product Liability Design Defect Cases

By David F. Abernethy

Just before Christmas, the Pennsylvania Supreme Court delivered a lump of coal to product liability defendants: Sullivan v. Werner Co., 2023 WL 8859656 (Pa. Dec. 22, 2023), affirming a lower court ruling that barred evidence of a product manufacturer’s compliance with government and industry standards in a strict liability design-defect case. The lower courts held that such evidence goes to due care and is relevant only to negligence, not strict liability. The affirmance appears to support the exclusion of such evidence in design-defect cases based on a risk-utility theory, but leaves uncertainty for the future because only three justices joined the principal opinion; a fourth justice concurred with the result but concluded the record was inadequate to resolve the legal issue, while two others dissented.

EPA’s Final EtO Rule Has Landed: What Now?

By Adrienne Franco Busby

The U.S. Environmental Protection Agency recently released their long-awaited final rule regulating ethylene oxide (EtO) emissions from commercial sterilizers. The final rule comes after five years of development, over 1,000 comments, and with estimated compliance costs for industry of up to $900 million.

EPA’s Final EtO Rule Has Landed: What Now?

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The U.S. Environmental Protection Agency (EPA) recently released their long-awaited final rule regulating ethylene oxide (EtO) emissions from commercial sterilizers. The final rule comes after five years of development, over 1,000 comments, and with estimated compliance costs for industry of up to $900 million.

The final rule differs significantly from EPA’s initial proposed rule. See initial proposal back in April 2023. The changes result in a still restrictive and costly rule, but with more time and options for compliance. These changes come after significant interagency discussions, including discussions with the U.S. Food and Drug Administration (FDA) about the impact of these rules on the medical devices, about half of which are currently sterilized by EtO. According to EPA, there will be no need for companies to revalidate their medical devices due to this final rule. It seems likely, however, that a facility’s ability to comply with the new regulation ultimately may affect sterility validation, so revalidation concerns should not be completely discounted just yet.

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Pennsylvania Stays in a Minority of Two States in Prohibiting Evidence of Compliance With Government and Industry Standards in Products Liability Design Defect Cases

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Just before Christmas, the Pennsylvania Supreme Court delivered a lump of coal to products liability defendants: Sullivan v. Werner Co., 2023 WL 8859656 (Pa. Dec. 22, 2023), affirming a lower court ruling that barred evidence of a product manufacturer’s compliance with government and industry standards in a strict liability design defect case. The lower courts held that such evidence goes to due care and is relevant only to negligence, not strict liability. The affirmance appears to support the exclusion of such evidence in design defect cases based on a risk-utility theory, but leaves uncertainty for the future because only three justices joined the principal opinion; a fourth justice concurred with the result but concluded the record was inadequate to resolve the legal issue, while two others dissented.

Plaintiff sued the maker of a mobile scaffold which collapsed. Defendant served an expert report that relied in part on government (OSHA) and industry (ANSI) standards. Plaintiff filed a motion in limine to exclude evidence of compliance with those standards, relying mainly on Lewis v. Coffing Hoist Div., 528 A.2d 590 (Pa. 1987), which excluded such evidence in strict liability cases. But Defendant argued the Supreme Court’s later ruling in Tincher v. Omega Flex, 104 A.3d 328 (Pa. 2014), undermined Lewis by overruling Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978), a decision that had taken an extremely narrow view of the relevant facts in strict liability claims under section 402A of the Second Restatement of Torts. Tincher held that section 402A remained Pennsylvania law but “overruled Azzarello’s narrow construction . . . that prevented the jury from considering negligence-related rhetoric and concepts . . . .” Nevertheless, the trial court in Sullivan granted the motion in limine and an appellate court affirmed. Sullivan v. Werner Co., 253 A.3d 730 (Pa. Super. 2021).

Continue reading “Pennsylvania Stays in a Minority of Two States in Prohibiting Evidence of Compliance With Government and Industry Standards in Products Liability Design Defect Cases”