Alabama Court Rules Recall Notice Insufficient to Establish Defect or Causation in Medical Device Case

July 6, 2010

A major drug or medical device recall often is followed by a spate of product liability lawsuits by claimants hoping for recovery made easier by the manufacturer’s perceived admissions in the recall notice. When the personal injury cases come to trial, however, a fierce evidentiary fight inevitably rages over the admissibility of the recall notice.

Though there are exceptions, courts have typically analyzed the issue under Rule 407, and ruled that recall notices are “subsequent remedial measures” and inadmissible to prove negligence, culpable conduct or defect. Recently, however, a federal court faced with a plaintiff’s unconventional reliance on a recall notice to make a prima facie case without expert testimony engaged in an equally unconventional analysis.

In Hughes v Stryker Sales Corp., 2010 U.S. Dist. LEXIS 47062 (ND AL May 13, 2010), plaintiff alleged that a manufacturing defect in her prosthetic hip replacement led to its failure and caused plaintiff to undergo additional hip surgery. Four months after 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. Plaintiff did not designate any expert witnesses to prove product defect or causation.

Stryker moved for summary judgment, arguing that plaintiff could not meet her burden of proof on defect or causation without expert testimony. 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. Rather than relying solely on a standard Rule 407 analysis, the court analyzed the language of the recall notice and determined that it was “simply untrue” that the manufacturer admitted that plaintiff’s device had a manufacturing defect, or that it was the cause of her second surgery. Id. at *18.

Although the recall letter identified various manufacturing issues with the device, 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 with the admissibility of the recall notice, its primary rationale was clearly that the notice was insufficient proof to establish defect or causation.

While the Hughes decision certainly isn’t surprising, it offers a unique rationale for excluding evidence of product recalls, and may prove persuasive to any court that might otherwise be inclined to admit recall evidence as an exception to Rule 407. At the least, Hughes is another arrow in the quiver of manufacturers’ litigating in a post-recall environment.