December 22, 2015 — A woman from California was awarded nearly $10 million in compensation for injuries caused by a defective surgical stapler made by Ethicon, Law360 reports.
Just days later, the California state jury awarded the plaintiff another $70 million in punitive damages after finding that Ethicon knew about the defects for 10 years and did nothing to change the design or manufacturing process.
The devices are used in colorectal procedures, including surgeries to cut off the blood-flow to hemorrhoids. The victim, Florench Kuhlmann, alleges that her surgeon misfired the stapler due to a defect found in one-third of the devices
Kuhlmann is a retired police officer from San Jose who underwent hemorrhoid surgery in January 2012. During the procedure, a defective Ethicon PPH 03 stapler misfired and sealed her anus shut. The problem caused her to suffer three weeks of emergency hospitalization, infections, and multiple surgeries. She must wear a colostomy bag and has suffered internal and external scarring.
In October 2012, Ethicon recalled more than 157,000 hemorrhoid staplers that were sold since April 2011. According to the FDA, misfires can result in incomplete staple formation:
“Failure to complete the firing stroke of the stapler can result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal.”
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