Gomez v. St. Jude Med. Daig Div. Inc.

Products Liability

Gomez v. St. Jude Med. Daig Div. Inc., No. 04-30202 (5th
Cir. Mar. 14, 2006)

The
Fifth Circuit of the United States Court of Appeals remanded a products liability
case for a new trial to determine whether the medical device was defective
as a result of the manufacturer’s failure to meet the specifications approved
by the Food and Drug Administration (FDA). After a patient underwent a surgical
catheterization to treat a blockage in an artery, the surgeon used the medical
device, which uses collagen on the outside of the artery wall, to cause a
clot to stop any bleeding. However, the patient alleged she suffered injury
when the collagen from the device got inside her artery, causing a large blockage
that had to be surgically removed. After the close of evidence at trial, the
district court granted the manufacturer’s motion for judgment as a matter of
law, and the patient appealed. The Fifth Circuit remanded the case to trial,
finding there was enough evidence to support the patient’s defective manufacturing
claim to allow a jury to resolve the matter.