A jury in California has awarded nearly $80 million to a woman whose anal canal was accidentally sealed by a defective Ethicon surgical stapler. The jury awarded $8.5 million in compensatory damages and $70 million in punitive damages, which was to punish the Johnson & Johnson subsidiary for gross negligence. The lawsuit was filed by Florence Kuhlmann, who claimed that an Ethicon Proximate stapler misfired and stapled her anal canal shut during surgery in January 2012. As a result, Ms. Kuhlman was hospitalized, suffered an infection and had to undergo a colostomy and full laparotomy. She continues to suffer severe complications from the botched surgery, must use a colostomy bag and has a deformed bowel.
The Alameda County Superior Court jury found that the device was defective and fired with force beyond its specifications. The compensatory damages were awarded to Ms. Kuhlmann for pain and suffering, medical costs, disfigurement and humiliation. The jury also awarded $1.3 million in her husband’s claim for loss of consortium.
At the conclusion of the first phase of the trial, the jury found that the device was defective and fired with force beyond its specifications. In the second phase, the jury awarded the additional $70 million in punitive damages. This type damages are only awarded in cases where it is established that the Defendant acted with gross negligence or reckless disregard for the safety of others. Punitive damages are designed to act as a punishment for the manufacturer, and are not directly connected to the degree of injury suffered by the Plaintiff.
In August 2013, an Ethicon Proximate stapler recall was announced after complaints from doctors indicated that the surgical staplers were too difficult to fire. One of the surgical stapler problems filed with the FDA’s adverse event reporting system was from a surgeon who said the device misfired during a hemorrhoidectomy, leaving the suture still attached to the stapler. The surgeon cut the suture free, abandoned attempts to use it, and performed the closure manually.
Originally, the Ethicon Endo-Surgery said it checked the device and determined that it appeared to be in proper working order. However, by the time of the recall, the company admitted that the staplers appeared to be difficult to fire “which may result in incomplete firing stroke that may result in an incomplete staple formation.”
Ethicon announced a second Proximate stapler recall in October of 2012, affecting even more units. The manufacturer noted that failure to complete the firing stroke of the stapler could result in severe pain, sphincter dysfunction, rectal wall damage, sepsis, bleeding, and occlusion of the rectal canal. Failure to complete the firing stroke could also result in poor staple formation, dehiscence of the rectal wall staple line and bleeding, the company warned.
The jury did the right thing in this case in awarding both compensatory and punitive damages. Nina Shapirshteyn, located in California, represented the Plaintiff in this case and did an outstanding job.