Category: Regulatory and Industry Standards

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.

FDA Publishes New Artificial Intelligence & Medical Products White Paper

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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?

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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).

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EU Reaches Legislative Deal on Proposed ‘Digital Age’ Updates to Product Liability Directive

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Last week, the European Union made a significant breakthrough towards its goal of overhauling the 40-year-old Product Liability Directive for the demands of the “digital” age and modern economy. To amend the directive, the elected European Parliament and the European Council (comprised of government representatives of the 28 member states) must agree on final language and separately pass the draft legislation through their respective bodies. After extensive legislative efforts and negotiations, the European Council (currently led by the Government of Spain) and the European Parliament issued press releases announcing that they have reached a political agreement regarding the proposed updates to the directive.

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In Case You Missed It – Summer 2023

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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.

Experts Who Cannot Articulate a Standard Cannot Opine That a Defendant Failed to Meet the Standard

By Eric M. Friedman

Burns v. Sherwin-Williams Co. is the latest in a line of cases that apply variations on a simple, common-sense theme — an expert who cannot articulate the applicable standard should not be allowed to opine that a defendant failed to meet the applicable standard. Such testimony is not a “shaky but admissible” opinion to be attacked on cross-examination; it is internally inconsistent, is inherently unreliable, and should be excluded under Rule 702.

Courts Are Citing the Rule 702 Amendments — And Litigants Should, Too

By Christin Jaye Eaton and Eric M. Friedman

Though the pending amendments to Federal Rule of Evidence 702 have not officially taken effect yet, courts already have begun to cite them, echoing the Advisory Committee’s sentiment that the amendments will not change the substance of the law as it was meant to be applied, but that many courts have not been applying it correctly. Litigants should follow suit, citing both the amendments and the Advisory Committee’s notes to alert courts that old precedent — particularly “weight, not admissibility” cases — may not be consistent with newly amended Rule 702.

Can a Treating Physician Opine on Causation? Eleventh Circuit Says It’s About Intent, Not Content

By Eric M. Friedman and Ross W. Johnson

Rule 26(a)(2)(B) requires witnesses who are “retained or specially employed to provide expert testimony in the case” — i.e., “retained” experts — to prepare and sign a report that discloses “a complete statement of all opinions the witness will express and the basis and reasons for them.” In contrast, Rule 26(a)(2)(C) imposes less arduous disclosure requirements on non-retained experts and calls on the party, not the expert, to make those disclosures. As the Eleventh Circuit recently noted in Cedant v. United States, “an expert’s status as a retained witness depends on the original purpose of his retention.” As was the case before Cedant, litigants would be wise to support critical elements of their claims and defenses with testimony from a retained expert and not assume a court will allow a non-retained expert to supply what is needed.