Faegre Drinker on Products, Author at Faegre Drinker on Products

Faegre Drinker on Products

View the full bio for Faegre Drinker on Products at the Faegre Drinker website.

Articles by Faegre Drinker on Products:

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.

Continue reading “EPA’s Final EtO Rule Has Landed: What Now?”

Michigan Repeals Pharma Immunity Provision

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 (SB 410)—removes this immunity, leaving intact a rebuttable presumption of non-liability and caps on non-economic damages.

SB 410 goes into effect on February 13, 2024, and is likely non-retroactive, meaning alleged injuries would have to occur after that date for the new law to apply. Commentators predict increased Michigan litigation relating to opioid use, insulin price gouging, and Medicaid fraud.

Continue reading “Michigan Repeals Pharma Immunity Provision”

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).

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”

In Case You Missed It – Summer 2023

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.

Ethylene Oxide Alert: Where Is Your Warehouse?

For over a year now, the U.S. Environmental Protection Agency (EPA) has been focused on reducing or eliminating ethylene oxide (EtO) emissions from industrial sites, commercial sterilizing facilities, and even hospitals. After a brief extension, the comment period for new proposed Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and National Emission Standards for Hazardous Air Pollutants (NESHAP) regulations closed at the end of June with over 1,000 unique written comments. It is anticipated that EPA is going to take some time to sort through those comments before issuing final rules, which are expected in March 2024. At the same time, EPA has forecasted releasing a proposed rule specific to hospital sterilizers in early 2024.

Next up on EPA’s agenda appears to be warehouses that store products sterilized with EtO. The looming question appears to be “where is your warehouse?” Onsite warehouses are the first to be in EPA’s crosshairs, but in classic agency style they are leaving the option to expand that focus open for the time being. Meanwhile, environmental groups are asking EPA not to wait to expand that focus, and states like California and Georgia are taking matters into their own regulatory hands.

Continue reading “Ethylene Oxide Alert: Where Is Your Warehouse?”

Dismissal of a Broken Chair Claim Shows That Expert Testimony May Be Essential Even for a “Simple” Product

In Mehner v. Furniture Design Studios, Inc., 2023 WL 2351688 (D. Neb. Mar. 3, 2023), the court granted summary judgment on product defect claims by a plaintiff allegedly injured by the collapse of a restaurant chair eight years after the manufacturer delivered it. This well-reasoned decision reminds us that even for fairly simple products, expert proof may be required to establish a defect – and failure to develop the factual predicate in discovery may leave the plaintiff without an opinion (and without a case). It also highlights important limitations in the “malfunction theory” that sometimes allows a plaintiff to proceed without expert proof or identification of a specific defect.

Plaintiff was eating at a restaurant in Omaha when his chair allegedly collapsed. He sued Furniture Design Studios (FDS), which designed, manufactured and sold the chair, asserting strict liability and negligence design defect claims.

Continue reading “Dismissal of a Broken Chair Claim Shows That Expert Testimony May Be Essential Even for a “Simple” Product”