Design Defect Under Ohio Product Liability Act

Claimants may establish defective design or formulation under the Act by showing that the foreseeable risks associated with a product's design or formulation exceeded the benefits.

Claimants may establish defective design or formulation under the Act by showing that the foreseeable risks associated with a product's design or formulation exceeded the benefits.

Factors for Design Defect

The Legislature considers the following non-exhaustive list of factors when determining the risks and benefits associated with a product:

1. the nature and magnitude of the risks of harm associated with that design or formulation in light of the intended and reasonably foreseeable uses, modifications, or alterations of the product;
2. the likely awareness of product users, whether based on warnings, general knowledge, or otherwise, of those risks of harm;
3. the likelihood that that design or formulation would cause harm in light of the intended and reasonably foreseeable uses, modifications, or alterations of the product;
4. the extent to which that design or formulation conformed to any applicable public or private product standard that was in effect when the product left the control of its manufacturer;
5. the extent to which the design or formulation is more dangerous than a reasonably prudent consumer would expect when used in an intended or reasonably foreseeable manner;
6. the intended or actual utility of the product, including any performance or safety advantages associated with that design or formulation;
7. the technical and economic feasibility, when the product left the control of its manufacturer, of using an alternative design or formulation; and
8. the nature and magnitude of any foreseeable risks associated with an alternative design or formulation.

Medical Device and Pharmaceutical Defect

An ethical drug or medical device is not considered defective in design or formulation simply because an aspect of the drug or device is unavoidably unsafe, if the manufacturer provides adequate warning and instruction.(3) A warning is adequate if it reasonably discloses all of the risks that are inherent in the use of a drug and that the manufacturer knew or should have known to exist.(4) The FDA's review, analysis, and approval of a drug package does not necessarily insulate a drug manufacturer from a claim that the warning is inadequate.

Inherent Characteristic Defense

A product is not defective in design or formulation if the claimant's injury was caused by “an inherent characteristic of the product which is a generic aspect of the product that cannot be eliminated without substantially compromising the product's usefulness or desirability and which is recognized by the ordinary person with the ordinary knowledge common to the community.”(6)

Likewise, a product is not defective in design or formulation if, when the product left the manufacturer's control, “a practical and technically feasible alternative design or formulation was not available that would have prevented the harm for which the claimant seeks to recover compensatory damages without substantially impairing the usefulness or intended purpose of the product.”(7)

1. §2307.75(A)
2. §2307.75(B)
3. § 2307.75(D)
4. §2307.76; Wagner v. Roche Labs., 77 Ohio St. 3d 116, 120, 671 N.E.2d 252, 256 (1996)
5. Wagner, 77 Ohio St. 3d at 123, 671 N.E.2d at 258
6. Ohio Rev. Code Ann. §2307.75(E); Glassner v. R.J. Reynolds Tobacco Co., 223 F.3d 343 (6th Cir. 2000) (affirming dismissal of OPLA claims when “there existed a widespread public awareness of the health risks associated with smoking such that [the Court] must impute this ‘common knowledge' to [decedent] and presume she was aware of and assumed those risks”)
7. Ohio Rev. Code Ann. §2307.75(F); Jacobs v. E.I. DuPont de Nemours & Co., 67 F.3d 1219, 1242 (6th Cir. 1995) (exempting a manufacturer from liability where the claimant failed to identify a safe and efficacious alternative design).