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Wisconsin High Court - Inherent Chemical Characteristics Can't Be Design Defects

By James M. Beck and Mark Herrmann

In a decision with implications for similar claims in pharmaceutical cases, the Wisconsin Supreme Court held yesterday in a lead pigment case that an inherent chemical characteristic can't be a "design defect." The case is Godoy v. E.I. Dupont de Nemours & Co., slip op. (Wis. July 14, 2009).

The key paragraphs are numbers 31 and 37:

Lead is a characteristic ingredient of white lead carbonate pigment. By definition, white lead carbonate pigment contains lead. Removing lead from white lead carbonate pigment would transform it into a different product. Under these circumstances, we conclude that the design of white lead carbonate pigment is not defective.

The circuit court correctly concluded that the complaint failed to state claims of defective design. A claim for defective design cannot be maintained where the presence of lead is the alleged defect in design, and its very presence is a characteristic of the product itself. Without lead, there can be no white lead carbonate pigment. We therefore conclude that the complaint fails to allege a design feature that makes the design of white lead carbonate pigment defective.

Slip op. at pp. 16, 19.

Importantly, the ruling comes on a motion to dismiss - no need for expensive and time-consuming discovery.

Most drug cases - those involving the characteristics of a single molecule/chemical constituting an FDA-approved drug - are such that the Godoy rationale would apply to design defect claims. The "design" of this kind of drug cannot be changed without creating a different molecule, and thus a different product (and one requiring separate FDA approval). In that situation, under Godoy, and indeed under simple common sense, there can't be design defect claims, but only warning claims concerning the drug's inherent characteristics. That's basically what Restatement §402A, comment k is all about. Godoy is significant in that it states the proposition both clearly and generally.

Full post as published by Drug and Device Law on July 15, 2009 (boomark / email).