In Beard v. Johnson & Johnson, the Pennsylvania Supreme Court found that a court conducting a risk-utility analysis on an allegedly  defective product should consider all of the uses of that product, not just the use that resulted in harm. The underlying state court case involved a woman who died of sepsis after bariatric surgery when the staples from the surgery did not close properly.  The plaintiff’s estate claimed that the area the surgeon stapled was too thick for the instrument used to insert her staples.  An Alleghany County jury agreed and award of $5 million.

The product at issue, an endocutter, was manufactured by a subsidiary of Johnson & Johnson. Although the plaintiff underwent open surgery, the endocutter is most commonly used for laparoscopic surgery.  The Superior Court overturned the jury’s award in part because the plaintiff’s estate failed, under a risk-utility assessment, to prove that the risks of the endocutter outweigh its benefit, especially during laparoscopic surgeries. At the Supreme Court, the plaintiff’s estate argued that since the endocutter was not used labroscopically during the plaintiff’s surgery that particular use should not factor into the risk-utility assessment. The assessment should be limited solely to the one implicated by the circumstances of plaintiff’s injury. However, the Supreme Court resoundingly rejected this contention and held that the appropriate focus of a design-defect risk utility analysis should not be limited to a particular intended use. Because the Pennsylvania trial courts are required to consider all aspects of a products use in their role as a “social philosopher”, they should not be required to put on blinders to avoid all practical uses of a given product.

Special thanks to Remy Cahn for her contributions to this post.  For more information, please contact Bob Cosgrove at .