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Polar Care ________ cold therapy's defective design allegedly causes frostbite on the toes - Amputation of great toe and metatarsal.

U.S. District Court, Western District of Wisconsin.

In this product liability matter, the plaintiff alleged that the design of a cold therapy device was dangerous and/or defective in that it caused her to suffer frostbite on two toes. The plaintiff had to undergo an amputation of the affected area. The defendant argued that there was no design defect when the product was used correctly.

On May 31, ________, the female plaintiff underwent surgery on her right great toe. Following the surgery, the plaintiff’s podiatrist prescribed the use of the defendant’s medical device, the Polar Care ________ for continuous cold therapy to assist in reducing pain and inflammation of the surgical site. The plaintiff’s physician prescribed that the plaintiff use the defendant’s device for 20 continuous days without any instruction to periodically check the skin on her foot and toes. The plaintiff used the device for ten continuous days and did not periodically check the condition of her foot or toes. The plaintiff, after ten days of use, noticed some discoloration of two of her toes. She contacted her physician. Approximately two months later, the plaintiff underwent an amputation of her great toe and metatarsal.

The plaintiff brought suit against the defendant alleging that the device was dangerous and there was no warning or instruction regarding continuous use of the device and the necessity for periodic checking of the area. The plaintiff alleged that the defendant’s device permitted the skin to become too cold and caused frostbite on her big toe.

The defendants maintained that the device was not dangerous or defective when it was used properly. The defendant maintained that the device had been approved by the FDA as a Class II medical device. The defendant demonstrated at trial that the device does not generate temperatures cold enough to cause frostbite injuries. The defendant maintained that the device contained sufficient warnings and instructions. The defendant argued that since this was a Class II medical device, it could only be obtained through a prescription and it was incumbent upon the plaintiff’s doctor to instruct the plaintiff, based upon the plaintiff’s individual condition and concerns. During the course of the trial, the defendants were able to demonstrate that neither the plaintiff nor the prescribing doctor ever read the instructions or warnings listed on the device.

Further, the defendant argued that the loss of the plaintiff’s toe was unrelated to any alleged defect in the product. This was the fifth surgery that the plaintiff had undergone for her toe and prior surgeries resulted in significant bone loss and tissue damage. The defendant was able to demonstrate through cross examination that this surgery was a "last ditch" effort and that the plaintiff failed to obtain any treatment for her allegations of frostbite to the toe.

At the conclusion of the trial, after a little more than one hour of deliberations, the jury returned a unanimous verdict in favor of the defendant and against the plaintiff.

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