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Chlopek v. Breg, Inc.

Apr 25, 2006

Heart monitor and pill icon - drug and medical device

Eau Claire jury unanimously finds Breg Inc.'s medical device is not defective

EAU CLAIRE, WI - On Tuesday, April 25, 2006 a unanimous federal court jury found that Breg, Inc.'s Polar Care 300, a Class II medical device, was not defective in the case of Chlopek v. Breg, Inc .  The jury of four women and three men took only 80 minutes to deliberate and came back with a unanimous finding of no product defect. 

The case arose following Mrs. Chlopek's fifth surgery on her right great toe which took place on May 31, 2005.  Following the surgery, Mrs. Chlopek's podiatrist prescribed the use of Breg, Inc.'s Polar Care 300 for continuous cold therapy to assist in reducing pain and inflammation of the surgical site.  The physician prescribed Chlopek to use the Polar Care 300 for 20 continuous days, without instructions to periodically check the skin on her foot and toes.  After using the cold therapy tool for 10 straight days (and without checking the condition of her skin under the polar pad on her toe or foot), Mrs. Chlopek, a registered nurse, began to notice some discoloration in two of her toes and contacted her physician.  Approximately two months later, her right great toe and metatarsal had to be surgically amputated.  Mrs. Chlopek and her husband sued Breg, Inc., claiming that the Polar Care 300 was a defective product alleging that it allowed the skin to get too cold and caused frostbite to her right great toe.  The Chlopeks also claimed Breg, Inc. did not provide adequate warnings and instructions regarding the proper use of the Polar Care 300, in particular, telling patients how long to use the device.

During trial, Breg, Inc. argued that the Polar Care 300 is a safe and effective medical device when used properly - it is not defective nor unreasonably dangerous.  The Polar Care 300 has been approved by the FDA as a Class II medical device. Breg, Inc. demonstrated, through product testing conducted by its expert engineer, as well as testing done by the plaintiff's' own expert, that the Polar Care 300 does not generate temperatures cold enough to cause frostbite injuries. Additionally, the on-product warnings and instructions were appropriate and easily understood.  Because this Class II medical device could only be obtained by prescription for Mrs. Chlopek, it was up to her doctors to provide any additional instructions for use as the prescribing doctor is the one who knows each patient's particular conditions and medical concerns.  Breg, Inc. also demonstrated that neither the Chlopeks nor the prescribing doctor ever read and/or followed the warnings and instructions Breg, Inc. did provide on the Polar Care 300.

Breg, Inc. argued Mrs. Chlopek was destined to lose her right great toe long before she ever used the Polar Care 300.  Numerous prior surgeries on this same toe resulted in significant bone loss and tissue damage.  Breg, Inc. argued, largely through the cross examination of Mrs. Chlopek's surgeon, that the May 31 surgery was a last-ditch salvage effort that was doomed to fail.  Breg, Inc. also demonstrated that if, in fact, Mrs. Chlopek and her doctor believed she had actually received frostbite injuries from the use of the Polar Care 300, she never actually received any medical treatment for frostbite.  Breg, Inc. is a California based company specializing in the design and manufacture of orthopaedic products, and this was their first trial involving the Polar Care 300. 

Chlopek v. Breg, Inc. 
Case No. 05-C-545-S
Judge John C. Shabaz
United State District Court - Western District of Wisconsin

Attorneys for Defense:   
Kim M. Schmid of Bowman and Brooke's Minneapolis office and Nathan H. Bjerke, formerly of Bowman and Brooke

Attorneys for Plaintiff:
J. Dreq Ryberg of Ryberg & Happe, S.C., Eau Claire, WI

Experts appearing at trial for Defense:  
Bradley Urban, Thermal Science, Exponent, Menlo Park, CA; Dr. Lance Silverman, Orthopaedic Surgeon, Silverman Orthopaedics, Edina, MN

Experts appearing at trial for Plaintiff:   
Lee Sapetta, Engineer, Sapetta Engineering, Ham Lake, MN; Dr. Andrew Pankratz, Podiatrist, Marshfield Clinic, Eau Claire, WI

Trial Team