11th Circuit Upholds Ruling that Recall Notice was Insufficient to Establish Defect or Causation in Medical Device Case

May 31, 2011

As we previously reported, the Northern District of Alabama rejected a plaintiff’s attempt to use a recall notice and warning letter as evidence of causation in a medical device manufacturing defect case. Hughes v. Stryker Sales Corp., 2010 U.S. Dist. LEXIS 47062 (ND AL May 13, 2010). The 11th Circuit recently affirmed that decision.

In Hughes, the plaintiff alleged that a manufacturing defect in her prosthetic hip replacement led to its failure and caused her to undergo additional hip surgery. Four months after the plaintiff received her prosthetic hip, the manufacturer sent a product recall notice about manufacturing variances and the potential risk that the device may fail to achieve biological fixation. The plaintiff did not designate any expert witnesses to prove product defect or causation. Stryker moved for summary judgment, arguing that the plaintiff could not meet her burden of proof on defect or causation without expert testimony. The plaintiff argued that the manufacturer’s admissions in the “urgent product recall” notice, coupled with medical records, were sufficient to create triable issues of defect and causation without expert testimony. Id. at *13.

Although the recall letter identified various manufacturing issues with the device, the Hughes court found that it was “hardly a mea culpa that all (or any) devices … were defective … and cannot reasonably support such an inference.” Id. Moreover, because prosthetic hip devices can fail for a plethora of reasons “wholly divorced from, and independent of, any defect,” the recall notice was also insufficient to demonstrate causation. Id. at *24. Although the court acknowledged Rule 407 concerns regarding the admissibility of the recall notice as a subsequent remedial measure, its primary rationale was clearly that the notice was insufficient proof to establish defect or causation.

On April 14, 2011, the 11th Circuit Court of Appeals upheld the Hughes trial court’s ruling. See Hughes v. Stryker Corp., 2011 U.S. App. LEXIS 7811 (11th Cir. Apr. 14, 2011). In so ruling, the 11th Circuit reiterated that under Alabama law:

The fact of an injury does not establish the presence of a defect. Instead, a plaintiff must show that the product’s failure of performance is causally related in fact to the product’s defective condition at the time of its sale. Ordinarily, expert testimony is required to prove that the product was defective and that the defect caused the injury because of the complex and technical nature of the commodity. But expert testimony is not required if the inference that the defective condition of the product is the cause of the product’s failure and the plaintiff’s resultant injury may be reasonably made from the product’s failure of performance under all the attendant circumstances.

Id. at *3-4 (internal quotations and citations omitted).

Applying this standard, the 11th Circuit found that the district court correctly rejected Hughes’ arguments premised on the recall notice because that notice, which stated only that “in some cases” the level of manufacturing residuals exceeded the company’s “self imposed conservative acceptance criteria,” did not amount to an admission by the defendants that the product was defective, and in any event the recall notice was inadmissible as evidence of subsequent remedial measures used to show product defect. Id. at 6 (citing Fed. R. Evid. 407).

Turning to the remaining evidence, the appellate court found that the recall notice was insufficient to prove the existence of a defect because, while it describes the company’s failure to establish and maintain certain general quality control procedures, it says nothing about the presence of residuals in any particular Trident acetabular cup. Id. Nor were the medical records indicating a “hardware failure” enough to permit a jury to conclude that the product was defective because, under Alabama law, the “mere failure of a product does not presuppose the existence of a defect.” Id. (citing Sears, Roebuck & Co. v. Haven Hills Farm, Inc., 395 So. 2d 991, 995 (Ala. 1981)). While a defect, and its causal relation to a plaintiff’s injury, may sometimes be inferred “from the product’s failure of performance under all the attendant circumstances,” the circumstances of this case did not permit such an inference. Id. at *7.

Although the 11th Circuit did not rule that “expert testimony is always necessary to prove product defect and breach of duty in products liability cases involving complicated medical devices” (Id. at *8 n. 4.), plaintiffs attempting to bring a medical device case without such evidence are clearly operating at significant peril. Alternately, from the defense perspective, the Hughes affirmation is valuable precedent in any case where a plaintiff attempts to use a recall notice or warning letter to make or support a causation theory.