Products Liability Law Daily Wrap Up, DESIGN AND MANUFACTURING DEFECTS—MEDICAL DEVICES—W.D.La: Knee replacement suit dismissed for lack of defect or causation evidence, (May 20, 2021)

By Gregory Kane, J.D., M.B.A.

A manufacturer of medical devices succeeded in its motion for summary judgment in a redhibition case because the patient failed to identify evidence of a specific defect or legal causation.

A federal district court in Louisiana has granted a medical device manufacturer’s cross-motion for summary judgement dismissing a knee implant patient’s claims for redhibition relating to an artificial knee that subsequently loosened and required the implantation of a new device. The patient failed to show specific evidence of a product defect as required by statute and did not provide any expert testimony or other evidence to show that a defect in the device was the cause of her injuries (Phillips v. Medical Device Business Services, Inc., May 10, 2021, Doughty, T.).

Background. In March 2016, a seventy-year-old woman had an artificial knee device implanted in her right leg but experienced problems with the new knee after its implantation. In 2019, she underwent revision surgery to replace the original implanted device with a new one. During the procedure, the surgeon reported a failure of the bone cement used to bond the device. The patient has never fully recovered the use of her right leg and brought suit seeking damages allegedly arising from the failure of the initial implant under Louisiana’s redhibition statute. Following discovery, the patient moved for partial summary judgment stating that her action under Louisiana law was not preempted by federal law and that she was entitled to recover nonpecuniary damages. The medical device maker filed a cross motion for summary judgement seeking dismissal of all claims on the grounds that the patient had failed to prove the presence of a defect or that such a defect caused her injuries.

Specific defect. To support a claim for redhibition, the patient was required to prove that there was a hidden defect that rendered the product worthless as well as proving that the defect was the legal cause of her injuries. The patient never identified a specific defect, claiming generally that the bone cement failed. She asserted that a defect could be inferred by the failure of the device during its normal use. Regardless of whether a defect can be inferred, the patient failed to provide sufficient evidence that the bone cement failed to achieve its intended purpose, the court determined.

The patient never identified specific evidence in the record that the there was a defect in the cement, nor that such a defect was hidden. According to the treating physician, the bone cement in question had an "excellent clinical track record" and revision surgery, including loosening of the implant, can happen without fault and in the absence of any defect in the medical device. Further, to the extent that the patient rested her claim on the doctrine of res ipsa loquitor, that doctrine did not apply to a redhibition claim. Therefore, with no proof of a redhibitory defect, the patient’s redhibition claim failed.

Causation. The court next found that even if a defect had been shown to exist, the patient failed to provide evidence that the supposed failure of the bone cement was the legal cause of her injuries. Neither of the patient’s treating doctors testified that there was a defect in the bone cement or that such a defect caused the patient’s injuries. Without any such expert testimony, the patient could not prove causation. The evidence on record showed that the patient experienced a known and understood risk of knee implant surgery (loosening) and that this risk was present even if there were no defects present. The evidence showed, at most, that the patient experienced a known and expected risk associated with total knee replacement. It did not support her claim of having sustained a personal injury caused by a defective product. As there was no evidence of a defect or causation, the manufacturer’s cross motion for summary judgement was granted, the suit was dismissed with prejudice, and the patient’s motion for summary judgment was denied as moot.

The case is No. 3:19-CV-01447.

Attorneys: Donald R. Wilson (Wilson & Wilson, P.C.) for Clifford Phillips and Linda Bailey Phillips. David Schmahmann (Law Office of David Schmahman) for Medical Device Business Services Inc. and DePuy Synthes Sales Inc.

Companies: Medical Device Business Services Inc.; DePuy Synthes Sales Inc.

Cases: CourtDecisions DesignManufacturingNews CausationNews MedicalDevicesNews LouisianaNews