$12 million for med mal and medical device product liability, including punitives. San Diego County.

Facts and Background

• Facts and Background:

  On May 23, 2003, plaintiff, a 15 year old, underwent minimally invasive arthroscopic procedures including a medial meniscectomy, plica resection, chondroplasty and removal of loose body material from her knee.  A Polar Care 500 device (mechanized cold therapy device) was prescribed by defendant Dr. Chao as part of plaintiff's post-surgery treatment.  The device consists of an ice chest, a pump, tubing to carry the cold water from the ice chest to the surgical site and a device to wrap around the surgical site through which the cold water is circulated.

  The Polar Care 500 is a Class II prescriptive device, requiring a physician's prescription. Dr. Chao's clinic, defendant Oasis,  sold and rented Breg's Polar Care 500 to surgical patients, and provided the device to plaintiff.

  On June 9, plaintiff and her parents noted blistering on the medial aspect of the knee.  On June 11, plaintiff's mother noted on her calendar "red angry wet wound" in the area of the blisters.

  On the morning of June 12, 2003, plaintiff woke up to find a large black eschar (dead skin) underneath where the Polar Care 500 pad was placed (in the same area as the blisters).  Her parents called Dr. Chao and brought her in to see him on an emergency basis.  Dr. Chao made an immediate referral to Dr. Eddelson, a plastic surgeon (not a defendant), who in turn referred her to another plastic surgeon, Dr. Gocken (not a defendant).  Dr. Gocken performed surgical debridement and said additional surgery would be required.  Plaintiff underwent two additional scar revision surgeries.

• Plaintiff's Contentions:

  That defendant Dr. Chao recommended to the plaintiff and her parents that they use the Polar Care 500 as it was was better than a bag of ice or frozen peas because it could be used continuously; that it should be used as much as possible following the surgery to minimize swelling, including sleeping with the device in place around the knee, in order to maximize her chances of making a full recovery.

  That plaintiff used the device continuously, and within a week started exhibiting the hallmark symptoms of a non-freezing cold injury. Plaintiff returned to see Dr. Chao on May 30, 2003, exhibiting the classic symptoms of non-freezing cold injury.  Plaintiff contended that Dr. Chao misdiagnosed the injury and told plaintiff and her mother to keep using the Polar Care 500, which they were renting from Dr. Chao's clinic.  This continued until the emergency visit on June 12.

  That in response to plaintiff's question as to the cause of her eschar injury,  defendant told her he had never seen anything like it before, and referred her to a plastic surgeon for consideration of a full thickness skin graft.

  That the Breg Inc. Polar Care 500 device was dangerous when used as directed; that Breg knew that the longer a patient used the device, the greater was the risk of developing non-freezing cold injuries; that even after learning of injuries from the device, Breg never changed the instructions/warnings on the device. 

  That defendants Dr. Chao and his clinic, Oasis were involved in an unlawful prescription scheme to profit from selling and renting Polar Care 500 devices; further, that the manner in which the device was rented/sold violated state law and medical ethics.

  That defendant Dr. Chao knew the Polar Care 500 device could cause injury because he had been sued by an earlier patient (Jeff Warner) who had been prescribed the same device and suffered a non-freezing cold injury (also known as trench foot) and almost lost his leg;  that the earlier case had been settled with Dr. Chao in  2002, only about a year before he prescribed the device to plaintiff with the same usage instructions.

• Defendant's Contentions:

  That plaintiff had misused the cold-therapy device; that use of the Polar Care 500 could not cause a non-freezing cold injury if used per instructions.  Further, defendant Chao maintained that plaintiff told him she had used the device at too cold a temperature; alternately, that she had used the device with the wrong surgical dressings.