Products Liability Law Daily Patient’s claim against maker of epidural catheter dismissed for lack of direct evidence of alleged defect
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Wednesday, October 28, 2020

Patient’s claim against maker of epidural catheter dismissed for lack of direct evidence of alleged defect

By Nicholas Kaster, J.D.

Patient was required to do more than make a broad claim that because the catheter broke, it was defective.

A patient’s defective product claim against the manufacturer of an epidural catheter was properly dismissed because she failed to provide direct evidence of the alleged defect in the catheter, the Arizona state court of appeals ruled. In affirming the lower court’s grant of summary judgment to the manufacturer, the appellate court found that the patient provided no evidence to support her claim that a catheter does not normally break unless defective. Nor did she provide any expert evidence or other analysis of the catheter’s condition (Emmons v. Teleflex Inc., October 27, 2020, Cruz, M.).

While in the hospital, a patient received an epidural to assist with the pain during her child’s birth. After delivery, a nurse attempting to remove the catheter experienced some resistance and a portion of the catheter broke off and remained in the patient’s back. The catheter had included instructions for use and provided an alternative removal technique if resistance was encountered. The instructions also included multiple warnings and cautions against tugging or quickly pulling on the catheter during removal and cautioned against applying additional tension on the catheter if it began to stretch excessively.

On the basis of a doctor’s strong recommendation to leave the fragment, the patient decided not to undergo surgery at that time. However, following discharge, she experienced continuing back and leg pain, and later decided to have the catheter removed surgically.

The patient sued the hospital, alleging negligence by its employees during the removal of the epidural catheter. The hospital filed a notice of nonparty at fault, alleging that the catheter was defective and that the manufacturer of the catheter, Teleflex, Inc., was wholly or partially at fault. The patient amended her complaint to include Teleflex as a defendant, bringing products liability claims for manufacturing defect and failure to warn. She later settled her claims against the hospital and it was dismissed from the lawsuit, leaving only the claims against Teleflex.

Teleflex filed a motion for summary judgment, arguing that the patient failed to present any evidence of a defect or failure to warn. In her response, the patient argued that a product’s failure under normal use could be used as proof of a defect, and that circumstantial evidence could be used to establish the existence of a defect. She later conceded that she was arguing only a manufacturing defect, not failure to warn. The Arizona superior court granted Teleflex’s motion for summary judgment. The current appeal ensued.

Manufacturing defect. As the superior court noted, the patient failed to provide any direct evidence of the catheter’s alleged defect. Nor did she provide any expert evidence or other analysis of the catheter’s condition. Instead, she relied on a res ipsa loquitur argument. Res ipsa loquitur, applicable in some negligence cases, is "a rule of circumstantial inference of responsibility for an injury."

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However, the patient brought a products liability claim for a manufacturing defect. Such a claim alleges a defective product "flawed as a result of something that went wrong during the manufacturing process." To establish a prima facie case of strict products liability, a plaintiff must show that the product is in a defective condition and unreasonably dangerous, that the defective condition existed at the time the product left the defendant’s control, and that the defective condition is the proximate cause of the plaintiff’s injury.

The patient here argued that: (1) a catheter does not normally break in a patient’s spine unless it is defective; (2) the nurse complied with the instructions on how to remove the catheter; and (3) the nurse’s actions in removing the catheter were not the sole cause of the catheter breaking in the patient’s spine. However, the court found that the patient failed to provide any evidence to support these contentions, and "an opposing party may not rely merely on allegations or denials of its own pleading."

The patient provided no evidence to support her claim that a catheter does not normally break unless defective, and the catheter’s instructions themselves indicated that "epidural catheters can be inadvertently separated if excessive force is applied during removal." In some products liability cases, common knowledge may enable a layperson to conclude reasonably that the type of injury suffered by the plaintiff would ordinarily occur due to a defective product. However, the court stated, this case involved removing a medical device, and an accident of this nature cannot solely be analyzed by common sense.

The patient also pointed to no admissible evidence that the nurse had complied with the instructions and properly removed the catheter. Absent such evidence, res ipsa loquitur did not support an inference that the cause of her injuries must have been due to a defective catheter. Teleflex, on the other hand, provided evidence from the patient’s medical records that indicated the nurse had encountered resistance when removing the catheter.

The patient argued that she was not required to present her entire case file and that the burden was on Teleflex, as the movant, to prove it was entitled to summary judgment. However, the court noted that the initial burden of production is on the moving party to show that the non-moving party does not have enough evidence to carry its ultimate burden of proof at trial. Once the moving party meets this burden, the burden then shifts to the non-moving party to present sufficient evidence demonstrating the existence of a genuine factual dispute as to a material fact. The court emphasized that the patient could not just "rest on [her] pleadings"; rather, she had to produce some significant probative evidence that created a material question of fact.

Although the patient’s claim was based upon a circumstantial inference of Teleflex’s responsibility for her injury, she had to do more than make a broad claim that because the catheter broke, it was defective, the court stated. She was required to point to some evidence that tended to prove her claims, and the court found that she failed to do so.

Finally, the patient argued that the lower court used her allegations against the hospital as an admission to "bar application of an inference of a defect." The superior court made it clear that it had granted Teleflex’s motion for summary judgment because the patient "did not point to admissible evidence on summary judgment that would satisfy her burden of proof." Nevertheless, the appellate court stated, it is also true that parties are bound by their pleadings and evidence may not be introduced to contradict or disprove what has been admitted or asserted as fact in their pleadings, and a party may not introduce evidence in contradiction of express allegations of the complaint.

Thus, the appellate court found that the superior court did not err in granting Teleflex’s motion for summary judgment and, accordingly, affirmed the lower court’s holding.

This case is No. 1 CA-CV 19-0678.

Attorneys: Mick Levin (Mick Levin, P.L.C.) for Christine Emmons. Ashley Wiberg (Snell & Wilmer, L.L.P) for Teleflex Inc. d/b/a Arrow International, Inc.

Companies: Teleflex Inc. d/b/a Arrow International, Inc.

MainStory: TopStory MedicalDevicesNews DesignManufacturingNews ArizonaNews

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