Medical Device: Summary Judgment in Favor of Manufacturer for Lack of Expert Testimony

A Connecticut district court finds that the mere fact a medical device broke is insufficient to withstand summary judgment in a products liability action. On December 17, 2009, the United States District Court for the District of Connecticut in Koger v. Synthes North America, Inc., No. 3:07-CV-01158, 2009 WL 5110780 (D. Conn. Dec. 17, 2009), affirmed the rule that when the alleged defective product is outside of the ordinary consumer’s common knowledge, expert testimony establishing defective condition and causation is required.

Koger suffered a posterior pelvic fracture in a motorcycle accident. The fracture was repaired using “two Synthes fully-threaded cannulated screws.” Approximately two years later, an x-ray of Koger’s pelvic region showed that the two screws had broken. As a result, Koger filed suit against Synthes North America, Inc., the manufacturer of the screws, pursuant to the Connecticut Products Liability Act.

Synthes moved for summary judgment arguing that Koger lacked the necessary expert testimony to prove her claim. The district court agreed with Synthes. Connecticut courts apply the Restatement (Second) of Torts consumer expectation test for strict liability, but use a “modified consumer expectation test” for products not within the ordinary consumer’s common knowledge. The Koger Court found that the Synthes screws were outside the ordinary consumer’s common knowledge and subject to the “modified consumer expectation test.” Therefore, proof of the product’s defective condition and the causal link required expert testimony.

Koger submitted the opinion of a medical doctor that corrosion of the screws “could be the cause of the breakage.” However, Synthes submitted an expert opinion that provided that the screws broke due to nonunion of her pelvic area and not because they were defective. The Court found Koger’s evidence insufficient as it did not establish that it was “more probable than not that a defect caused the injury.”

In a final attempt to survive Synthes’ motion for summary judgment, Koger argued the “malfunction doctrine,” which provides that a defect can be inferred by circumstantial evidence. The Court rejected her argument stating that this case required complex medical and technical expert testimony to determine whether the product was defective and that Koger failed to provide such expert testimony.

This case highlights the rule that a broken product alone, absent any expert testimony as to defect and causation, is not enough to win a products liability action when the product is outside the knowledge of the common consumer. The Drug and Medical Device Blog recently provided an extensive review of precedent around the country reaching similar conclusions as the Koger Court that a broken device is not enough.

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