Fed. Court Rules Medical Device Defect Claims Cannot Center on Alternative Products with Same Function

On Friday, in the Eastern District of Louisiana, Judge Carl J. Barbier allowed a design defect case to survive a motion to dismiss, centered around the appropriate viscosity level for bone cement. The underlying litigation involved a suit by an injured consumer of high-viscosity bone cement against the creator of said cement, Cardinal Health. The plaintiff sought damages from the defendant, pointing to research that showed that bone cement that was medium or low-viscosity would have prevented the plaintiff’s injury. 

The plaintiff received a total knee arthroplasty using Cardinal’s high viscosity bone cement, which ultimately had to be redone. Following the revision surgery, the plaintiff filed suit for design defect against the defendant on grounds that “high viscosity bone cements…have been proven worse than lower viscosity bone cements because they fail more often and have an increased risk of mechanical loosening.” The defendant sought to dismiss the plaintiff’s case, arguing that medium or low viscosity bone cements constitute new products, not simply alternative designs to the high viscosity bone cement. 

The judge disagreed and ruled against the defendant’s motion to dismiss. All the law requires, ruled Judge Barbier, is for the plaintiff, as done here, to plead that “there existed an alternative design that was capable of preventing the claimant’s damage and…the risk avoided by the alternative design outweighed the burden of its adoption by the manufacturer and any adverse effect the alternative design would have on the product’s utility.” Furthermore, the court concluded, the alleged medium or low viscosity bone cement available is an “alternative design,” not an alternative product, as 5th Circuit precedence holds that “alternative designs are variations in the characteristics of a single type of product” resulting in altered functionality of the same product, not “different types of products that perform the same function.” 

The plaintiff is represented by Wagstaff & Cartmell and Gainsburgh, Benjamin, David, Meunier, & Washauer.