The Fifth Circuit gave the plaintiff in Bruno v. Biomet, Inc., 2023 U.S. Dist. LEXIS 213826 (E.D. La. Dec. 1, 2023) a second chance, but it was short lived. This case had been dismissed on statute of limitations grounds. On appeal, the Fifth Circuit reversed that holding and remanded the case for the district court to rule on the remaining arguments raised by defendants in their motion for summary judgment. That’s just what the court did—granting summary judgment for defendants on all 5 of plaintiff’s claims.
Plaintiff had shoulder surgery with implantation of defendants’ device. Thereafter plaintiff suffered a recurring infection from “Enterobacter” bacteria. The infection was resistant to antibiotics and eventually necessitated surgical removal of the device. Id. at *2-3. Shortly before the explant surgery, defendants received an FDA Warning Letter advising that an inspection performed 2 years after plaintiff’s device was manufactured revealed some regulation violations regarding cleaning and sterilization. Almost one year after the explant surgery, defendants voluntarily recalled several products due to issues with a supplier’s quality standards. The recall letter noted some possibility of increased bacterial endotoxin, but “there is not an elevated risk of infection as the sterility of the devices is not impacted.” Id. at *4. Against this background, plaintiff filed his lawsuit alleging manufacturing defect, design defect, warning defect, and express warranty under the Louisiana Products Liability Act, and a common law claim for redhibition.
On the manufacturing defect claim, plaintiff had to show what the defendants’ specifications or performance standards are and how the product at issue deviated from those standards to make the product unreasonably dangerous. Id. at *9. To meet his burden, plaintiff relied on his expert and the FDA Warning Letter. First, plaintiff’s expert did not test the device nor had ever seen defendants’ specifications or performance standards. His opinions were based exclusively on the FDA Warning Letter and voluntary recall. Second, the court tossed the voluntary recall as inadmissible evidence of a remedial measure under. While in some circumstances an expert may be permitted to rely on inadmissible evidence, “allowing [plaintiff’s expert] to opine to a jury as an expert that the Device had a manufacturing defect based on Defendants’ recall would undermine the very purpose of Rule 407.” Id. at *10. Third, at most the FDA Warning Letter found defendants failed to meet certain regulatory standards. What it does not do is provide any evidence to support any argument about the specific device implanted in plaintiff. Notably, none of the FDA’s observations pertained even to the type of device at issue nor referenced Enterobacter being located on any of defendants’ devices. Id. at *12. At best plaintiff has general evidence from which he hopes “a jury will extrapolate” to find the device implanted in plaintiff had been contaminated with the bacteria that caused his infection. But that “leap of logic” is insufficient to carry plaintiff’s burden of proof. Id. at *15.
On design defect plaintiff’s argument was even thinner. The alleged design defect was failure to follow protocols for cleaning and sterilizing, which is a manufacturing claim not a design defect claim. Nor did plaintiff offer any evidence of a safer alternative design. So, plaintiff failed to meet his burden on this claim as well. Id. at *16.
Plaintiff’s warning claim was, of course, subject to the learned intermediary rule. Plaintiff alleged that defendants failed to warn his surgeon “about the issues with cleaning, processing, and sterilizing” the devices. Id. at *18. But defendants are not required to warn physicians about “cleaning issues.” Rather, they were required to warn about potential harms to plaintiff. The potential harm in this case is the risk of infection; a risk plaintiff does not dispute his surgeon was warned about. Again, summary judgment granted.
The court quickly did away with plaintiff’s express warranty claim for the simple reason that he could not identify any express warranty made to plaintiff. Plaintiff could only argue that it was “common sense” for a patient to expect a device to be free from contamination. But common sense is not a basis for an express warranty. Id. at *19-20.
That left only the redhibition claim. In Louisiana, a seller warrants against redhibitory defects. To make a claim for redhibition plaintiff must show that the product was defective. And since plaintiff did not offer anything different in support of this defect claim, it met the same fate as his defective design claim.
I guess we can thank the Fifth Circuit for remanding the case and creating the opportunity for this excellent substantive win for the defense.
This article was written by Michelle Yeary of Dechert LLP