Maker of cold therapy device concealed risks causing teen’s frostbite

Whitney was a 15-year-old track star when she underwent a minimally invasive arthroscopic procedure on her left knee.

After the procedure, her surgeon, Dr. Chao, prescribed the Breg Polar Care 500, a mechanized cryotherapy device, and recommended she use it as much as possible, even while sleeping, to maximize her chances of a full recovery.

After she used the device continuously for one week, she began exhibiting symptoms of a cold injury to her leg. When she returned to see her doctor, he advised her to continue using the device as much as possible. She complied and twelve days later awoke to find a large black eschar on her leg underneath the cold pad. An eschar, or large piece of dead tissue which sloughs away from the skin, is similar to “trench foot,” which is a condition common with soldiers who fought in the damp and unsanitary trenches during WWI, that often led to gangrene, a common cause of amputation.

When the victim presented to her surgeon on an emergency visit that day, the surgeon claimed never to have seen an injury of that type before and referred her to a plastic surgeon.

As a result of using the device, the victim suffered residual neuropathy, which has left her with diminished feeling and sensitivity in her knee. She has difficulty kneeling and engaging in sports she previously enjoyed.  She suffered significant scarring, for which she is self-conscious.  She has undergone numerous surgeries to minimize scarring and improve function in her knee, and will require at least two more procedures. Her past medical expenses totaled $34,900 and her future medical expenses are estimated somewhere between $10,000 and $24,000.

The victim is a veterinary student and will incur an estimated $14,000 in lost earnings based on time she will miss while undergoing future rehabilitation.

The victim sued Dr. Chao, Oasis MSO, Inc., (the clinic where he is a majority partner), and the manufacturer of the cold therapy device, Breg Inc.  The victim alleged professional negligence and breach of fiduciary duty against defendants Chao and Oasis MSO, Inc., as well as theories of product liability against Breg and Oasis MSO, Inc.  The victim further alleged fraud by misrepresentation and concealment against all defendants.  Specifically, she claimed that defendants were aware that the Polar Care 500 would cause injury if used continuously, but recommended continuous use regardless, assuming that most patients would deviate from their instructions and use the device less, as their underlying injuries healed.

The victim stated that the Polar Care 500 was dangerous when used as her doctor directed because it created a substantial risk of non-freezing cold injuries, with resulting nerve injury and scarring.  She said the manufacturer marketed the device as superior to ice packs because it could be used continuously without risk, when the company knew the continuous use of the device could cause non-freezing cold injuries. The victim also alleged that Breg was aware of the mounting injuries from the device but failed to warn patients to only use it intermittently, like an ice pack, because the company believed that no one would pay $350 for a device that had to be used like a simple ice pack.

At trial, Plaintiff was able to show a longstanding scheme between defendants Chao and Breg to profit from the treatment and rental of the product. This arrangement was so profitable, that Breg used its program with Chao as a marketing tool to establish similar agreements with other physicians.  The victim was also able to prove Dr. Chao’s claim that he had never seen an injury similar to the one the victim has sustained was patently untrue. Just prior to prescribing the Polar Care 500 to the victim, Chao was sued by a former physician who suffered a similar injury after using the device on his knee.

Evidence showed that prior to this lawsuit, another patient of Dr. Chao’s, who suffered the same injury, had sued Chao, his clinic and Breg under the same theories. Chao settled that lawsuit about one year before prescribing the device to the victim. She also reported that from the time the Polar Care products were introduced in 1992 through 2010, there were about 137 claims against Breg for non-freezing injuries caused by the device.

The defendant denied wrongdoing and claimed that it was ethical to prescribe, rent and sell the cold therapy device because it was not available in stores and was being offered to patients as a matter of convenience. Defendant further denied that the Polar Care 500 caused the victim’s injuries.

During pretrial proceedings, the plaintiff offered to settle with all of the defendants for $4 million. Breg countered with an offer of $275,000 and later offered $500,000, which the plaintiff rejected.

The jury returned a verdict for the victim in the amount of $12,696,220.  Chao, who was found 50 percent liable, continues to practice at Oasis MSO, Inc. in San Diego, California, in addition to serving as Head Team Physician for the San Diego Chargers and Chief Medical Officer for the ESPN Summer/Winter X Games.

A jury in San Diego has awarded $500,000 in punitive damages against Dr. Chao. The jury also awarded $7 million in punitive damages against Breg Inc., the maker of the Polar Care 500 cryotherapy device that allegedly gave the victim frostbite. The compensatory damage award is $5.2 million.

The jury found that Breg failed to adequately warn of the device’s risks, and that Chao and Breg intentionally concealed information about the device with an intent to deceive the victim.

This lawsuit is one of a growing number of complaints filed over cryotherapy. In addition to the Polar Care lawsuit against Breg, a number of similar products have faced claims, including DeRoyal Cold Therapy Units, DonJoy Iceman, EBIce, Aircase Cryo Cuff, Game Ready and others. This lawsuit is believed to be one of the first verdicts in the U.S. for damages from cold therapy or ice therapy machines.

This case received more press than usual civil lawsuits because the doctor involved happens to be the team doctor for the San Diego Chargers.  The California Medical Board is seeking to revoke his license based on three alleged incidents of negligent care, in unrelated cases.

Do you think this was a fair settlement? Feel free to comment on this blog post. Contact one of our Gacovino Lake attorneys at 1-800-246-HURT (4878).

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