The U.S. Court of Appeals for the Ninth Circuit handed a victory to DePuy Spine Inc. in a product liability lawsuit over one of its spinal disc implants.
Camille Carson sued the Raynham, Mass.-based Johnson & Johnson (NYSE:JNJ) subsidiary in 2006, after a February 2005 discectomy procedure to replace two of her vertebral discs with DePuy Charite implants. Experiencing extreme pain a few months after the surgery, Carson had a second procedure in November 2005 which revealed that one of the Charite discs was broken and had to be removed in pieces, according to court documents. Carson accused the company of being liable for manufacturing a defective product and for promoting the off-label use of the device.
Judge Valerie Fairbank of the U.S. District Court for Central California found that DePuy was not liable for the allegedly defective implant, a decision upheld by the Ninth Circuit.
The appeals court found that Carson failed to prove DePuy was negligent in manufacturing the device because she failed to demonstrate that it varied from DePuy’s own specifications and from the specs detailed in the Food & Drug Administration’s PMA clearance of the product. Carson also failed to prove that the alleged defect caused her injury, the court found.
“The district court properly concluded that Carson did not present sufficient evidence creating a genuine issue of fact as to any of the elements of a manufacturing defect claim,” according to court documents. “The uncontroverted testimony of [Carson’s physician] Dr. Kropf reveals that the disk did not have any visible problems upon implementation, that Carson developed a spinal condition where her vertebrae began moving in a fashion that put extreme stress on the disk, and likely caused the polyethylene to deform in response to the stressors, and that he himself broke the disk while removing it during the revision surgery in order to complete a spinal fusion that addressed Carson’s spinal condition.”
As for the off-label promotion charges, the appeals court found “no evidence in the record to support Carson’s claim that DePuy illegally promoted an off-label use of the Charite Disc, that Dr. Kropf was influenced by such promotion, or that the off-label use of the disk caused Carson’s injury. In fact, the only evidence in the record is to the contrary,” according to court documents.