United States: The Difference Between Manufacturing And Design Defects

Last Updated: June 30 2016
Article by James Beck

Some plaintiffs seem to think that if they allege any problems about anything in the manufacturing process of a prescription medical product, then it falls under the rubric of "manufacturing defect." They're wrong, of course. "Manufacturing defect" − as we've discussed before − has a precise and universally adopted meaning. It is some kind of error in the manufacturing process for a product that results in a unit that fails to meet the manufacturer's own design specifications. As the Third Restatement puts it:

[A] manufacturing defect [exists] when the product departs from its intended design, even though all possible care was exercised in the preparation and marketing of the product.

Restatement (Third) of Torts, Products Liability §2(a) (1998). Or, as the California Supreme Court held, before the Third Restatement existed:

A manufacturing defect is one which results from an error in the production process. The product comes off the assembly line in a substandard condition: in some way it differs from the manufacturer's intended result or from other ostensibly identical units of the same product line.

Finn v. G. D. Searle & Co., 677 P.2d 1147, 1163 (Cal. 1984) (citation and quotation marks omitted).

An allegation of some more global problem with a product's manufacturing process, which results in some purported "defect" in all of the defendant's products, isn't a manufacturing defect claim at all, and courts have recognized this. In a batch of essentially identical opinions, out of Connecticut, one court addressed allegations that attacked the manufacturing method by which the defendant fashioned the exterior surface of an implant. E.g., Johannsen v. Zimmer, Inc., 2005 WL 756509, at *5 (D. Conn. March 31, 2005). This claimed problem, because it allegedly involved how the defendant manufactured all of its implants, didn't involve a manufacturing defect:

Summary judgment is granted on the alleged defect in the manufacturing process. There is nothing in the record to support the contention that [defendant's] manufacturing efforts were substandard in any respect. . . . Plaintiff relies heavily on claims that the choice of manufacturing process − the decision to engage in grit-blasting and precoating − created a defect, but this is not evidence of a manufacturing defect; rather, it is possible evidence of a design defect. A product can be manufactured correctly, according to all designs and regulations, and yet be defective-but the defect would not be the result of a manufacturing failure.

Id. at *8 (emphasis added). Accord Fuentes-Weed v. Zimmer, Inc., 2005 WL 756533, at *8 (D. Conn. March 31, 2005); Lopes v. Zimmer, Inc., 2005 WL 756535, at *8 (D. Conn. March 31, 2005); Dunn v. Zimmer, Inc., 2005 WL 756538, at *8 (D. Conn. March. 31, 2005); Vino v. Zimmer, Inc., 2005 WL 756540, at *9 (D. Conn. March 31, 2005).

How a defendant generally chose to go about manufacturing a drug or device is not a manufacturing defect claim, because a general practice does not create a deviation from intended standards, but rather sets such standards. A claim targeting some aspect of the manufacturing process is more in the nature of a design defect claim. "Although this process is part of the manufacturing process of the . . . products, it would fall within the category of a design defect and not a manufacturing defect." In re C.R. Bard, Inc., 2013 WL 5591948, at *4 (S.D.W. Va. June 4, 2013) (applying Mississippi law) (emphasis original). Thus, a "claim of selection of improper materials is a design defect claim, not a manufacturing defect claim." Frankum v. Boston Scientific Corp., 2015 WL 1956298, at *6 (S.D.W. Va. April 29, 2015) (applying North Carolina law) (identical opinions at: 2015 WL 2137180, at *6; 2015 WL 2137145, at *5; 2015 WL 1956355, at *6; 2015 WL 1956354, at *6; 2015 WL 1956348, at *5; 2015 WL 1956346, at *5). Likewise, any claim that "calls into question the entire product line . . . is properly construed as a design defect claim, not a manufacturing defect claim." Booker v. Johnson & Johnson, 54 F. Supp.3d 868, 876 (N.D. Ohio 2014) (applying Georgia law) (allegation about a product's side effects is not a proper manufacturing defect).

This distinction matters because plaintiffs have a variety of reasons for trying to disguise design defect claims as manufacturing defect claims. Some states, like California and Pennsylvania, preclude strict liability design defect claims altogether in cases involving prescription medical products. The Third Restatement applies a negligence standard to design defect claims, while retaining strict liability for manufacturing defects. In cases involving pre-market approved medical devices, preclusion of design defect claims by federal preemption is well-established, whereas the law is less settled concerning manufacturing defect claims. Thus, defendants are well-advised to scrutinize what might appear to be boilerplate manufacturing defect claims carefully, and to make appropriate motions against any attempts to infiltrate design defect claims through the back door.

This article is presented for informational purposes only and is not intended to constitute legal advice.

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