Regulatory Archives - Faegre Drinker on Products

Category: Regulatory

Loper Bright & Corner Post Review: Supreme Court’s Overturning of Chevron Doctrine Spells Uncertainty for Food Industry Regulations

On June 28, 2024, the U.S. Supreme Court overturned the Chevron doctrine of agency deference in its Loper Bright Enterprises v. Raimondo decision. The doctrine takes its name from a 1984 Supreme Court case, Chevron U.S.A., Inc. v. Natural Resources Defense Council, Inc, 467 U.S. 837 (1984), which announced a bright-line rule governing whether a regulation promulgated by an executive branch agency, like FDA or USDA, was enforceable based on the scope of statutory authority Congress delegated to the agency. Chevron held that if a court concluded that a statute was silent or ambiguous as to an issue (Step One), then the court must defer to an agency’s permissible construction of the statute in the regulations it promulgated (Step Two). In overturning Chevron deference, Loper Bright announced that courts “must exercise their independent judgment in deciding whether an agency has acted within its statutory authority.”

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Extended Producer Responsibility (EPR) is Here and It’s Time to Register With a Producer Responsibility Organization (PRO)

As Extended Producer Responsibility (EPR) kicks off across the U.S., manufacturers should be mindful of sustainability claims, especially related to packaging materials and recycling. EPR reporting will generate significant, publicly available data, which could potentially be used in greenwashing claims against covered producers.

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In Case You Missed It – Winter 2024

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.

FDA Publishes New Artificial Intelligence & Medical Products White Paper

On March 15, the United States Food & Drug Administration published a white paper entitled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” FDA announced the paper by sharing a short letter from Commissioner Califf, where he reaffirmed the Agency’s commitment to “promoting the responsible and ethical development, deployment, use, and maintenance of safe and effective medical products that incorporate or are developed with AI.” The white paper does not contain any new pronouncements of FDA position, but refers to existing guidance and serves as a reinforcement for existing FDA policy regarding AI.

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

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

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).

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