The three-judge panel of the U.S. Court of Appeals for the Southern District of Indiana (Seventh Circuit) found that the estate of Georgia Bowersock failed to prove that the Bard patch caused the abdominal abscess that led to Bowersock’s death in 2006.
The patch consists of two pieces of mesh that surround a flexible plastic ring. Bard recalled several versions of the patch in late 2005 and early 2006 following reports that the plastic ring sometimes broke, exposing a sharp edge that could perforate the patient’s intestines, according to the appellate court decision. Other times the ring caused the patch to bend and warp, exposing the patch’s adhesive to a patient’s viscera, the decision said.
Bard recalled the patch in 2005 and expanded the recall in 2006. Unlike allegedly defective patches in other injured patients, Bowersock’s patch did not adhere to her bowel or perforate her organs with a broken, sharp edge, appeals court Judge Diane Sykes wrote in the decision. Sykes and appeals court Judge Amy Barrett were joined by Chief Judge William Griesbach of U.S. District Court for the Eastern District of Wisconsin in making the ruling.
Bowersock’s estate was appealing the summary judgment decision that U.S. District Court Judge Larry McKinney had granted Bard after excluding Bowersock’s expert testimony. One of the experts claimed that the ring had buckled, forming a stiff edge that rubbed against and imperceptibly perforated her internal organs. Another expert, a medical engineering professor, testified that the ring buckling likely caused the bowel injury, but admitted that he never examined or viewed images of Bowersock’s patch.
Bard moved to exclude the expert testimony. McKinney found that the “buckling” theory was not sufficiently reliable.
“The novel theory of causation was not peer-reviewed, professionally presented, consistent with Mrs. Bowersock’s medical records or autopsy, or substantiated by other cases,” Sykes wrote for the appeals court. “The judge therefore did not abuse his discretion in excluding the expert testimony.”