Willett v. Baxter International, Inc.

Patients Gene Earl Willett (plaintiff) and Mrs. Albert Spriggins brought a products-liability design-defect action against Baxter Healthcare Corporation and Carbomedics, Inc. (defendants), the manufacturers of an artificial heart valve made with pyrolytic carbon that had been implanted in each patient. The patients’ suit was prompted when the patients became fearful that their valves would fail after they read reports that 17 of nearly 20,000 similarly implanted heart valves had failed. All the failed valves were manufactured before the manufacture date of the patients’ valves. The manufacturers moved for summary judgment, citing three clinical reports suggesting that the valve failures were caused by improper surgical technique and not a manufacturing defect. The patients argued that the manufacturing process produced soot pockets in the pyrolytic carbon that inevitably lead to weak spots in the valves, which could cause them to fail. However, the patients’ expert did not testify that another material would be more suitable or that a different process could have reduced the theoretical soot-pocket problem. Nor did the patients produce any evidence that either of their valves had a soot-pocket issue or were not performing as they were designed. The district court granted summary judgment for the manufacturers, and the patients appealed.