Products Liability Law Reporter

The Fifth Circuit Court of Appeals held that a heart surgery patient’s claims alleging defective design and breach of implied warranty could proceed against Medtronic, Inc.

Dennis Harrison underwent heart surgery, during which physicians implanted a Medtronic external pulse generator (EPG), which is a type of pacemaker. Harrison experienced cardiac arrest a day after the surgery, leaving him with permanent injuries, including chest pains and neurological issues. Harrison and his wife sued Medtronic, Inc., asserting claims for manufacturing, marketing, and design defects, plus breach of the implied warranty of merchantability. The plaintiffs claimed the EPG led to the cardiac arrest in that it fired a mistimed electrical pulse in between Harrison’s heartbeats. Suit alleged the malfunction resulted from a loose battery or corroded lead connector.

The defendant moved to dismiss for failure to state a claim. The district court granted the motion but allowed the plaintiffs to file a third amended complaint. The court later found that the plaintiffs’ third amended complaint was substantially similar to the second amended complaint with the exception of two new factual allegations regarding the EPG’s alleged design defect. The court dismissed the third amended complaint, determining that the new allegations—specifically that the EPG’s battery should have been secured by a clip or phalange to prevent power malfunctions and that its lead connector should have been made of noncorrosive metal—were conclusory and insufficiently specific.

Affirming in part and reversing in part, the court noted that to prevail on their strict liability claims, the plaintiffs must show that the defective product was unreasonably dangerous, did not substantially change from its original condition when it reached Harrison, and led to his alleged injuries. To prove manufacturing defect, the court added, the plaintiffs must plead that the product deviated in its construction or quality from its specifications and that this rendered it unreasonably dangerous. Citing case law, the court said that the basis of such a claim is that the allegedly defective product differed from other products in the same product line. Here, the court found, the plaintiff’s third amended complaint claimed only that the EPG may have contained a manufacturing defect but did not identify anything specific about the device that deviated from the specifications. Under relevant case law, pleading a mere possibility of misconduct is insufficient, the court said, adding that the res ipsa loquitur evidentiary rule also is not a valid substitute for specifying a manufacturing defect. Thus, the court found that the district court had correctly concluded that the plaintiffs had failed to allege a manufacturing defect.

Similarly, the court concluded that the plaintiffs’ marketing defect claim could not proceed. The adequacy of such a claim—which exists when a defendant knows or should know of a potential risk of harm presented by a product but fails to adequately warn buyers—is a question of fact. Here, the complaint mostly repeated the legal elements of a marketing defect claim without identifying which of the defendant’s warnings were allegedly defective. A general allegation, including that a manufacturer failed to inform users of the nature of a danger, does not meet the pleading standard, the court found.

Turning to the plaintiffs’ design defect claim, the court concluded that the third amended complaint satisfied the applicable standard. The complaint pleaded that the EPG was defectively designed in that its battery did not maintain constant connection with the battery drawer and the lead connector had a propensity to—and did—corrode. The plaintiffs also allege that the EPG was unreasonably dangerous because the defendant could have mitigated this risk by inserting a clip or by using a silver or copper connector less prone to corrosion. These allegations, at the motion to dismiss stage, are sufficient to allege a design defect claim under Texas law, the court concluded, noting that the plaintiffs were not required to be more specific about the proposed alternative designs. Such detailed allegations can wait until the plaintiffs have had an opportunity for discovery, the court said. Because the plaintiffs sufficiently pleaded their design defect claim, the court added, their implied warranty claim also cannot be dismissed. The court noted that the defendant also failed to explain why the less than two-year delay in filing the plaintiffs’ warranty claim made their notice so unreasonable that it should fail as a matter of law.

Consequently, the court remanded the case for further proceedings.

Citation: Harrison v. Medtronic, Inc., 2022 WL 17443711 (5th Cir. Dec. 6, 2022).

Plaintiff counsel: AAJ member Charles R. Houssiere III and Randal A. Kauffman, both of Houston.