Case details

Patient: Cold therapy device was inherently dangerous

SUMMARY

$12696220.38

Amount

Verdict-Plaintiff

Result type

Not present

Ruling
KEYWORDS
disfigurement, knee, scar
FACTS
On May 23, 2003, plaintiff Whitney Engler, 15, underwent a minimally invasive arthroscopic procedure to remove loose bodies in her left knee, performed by Dr. David Chao at his San Diego clinic, Oasis, MSO. Chao recommended to Engler and her parents that she use a mechanized cryotherapy (cold therapy) device called Breg’s Polar Care 500 following the surgery. Engler claimed that Chao said the Polar Care 500 was better than a bag of ice, because it could be used continuously, and should be used as much as possible following the surgery, including sleeping with the device, to maximize her chances of making a full recovery. Engler began to use the Polar Care 500 continuously, and claimed that within a week she started exhibiting symptoms of a non-freezing cold injury to her left leg. She returned to Chao on May 30 and claimed that he told her to continue using the device, which was being rented from Chao’s clinic, as much as possible. On the morning of June 12, Engler woke up to find a large black eschar underneath where the Polar Care 500 pad was placed. Her parents called Chao and brought her in for an emergency visit. Engler claimed that Chao said he had never seen the injury before. Chao referred her to a plastic surgeon for consideration of a full thickness skin graft. Engler had medical procedures performed over the years to minimize the scar over her knee. Engler sued Chao, Oasis, MSO Inc., and Breg Inc., the manufacturer of the Polar Care 500. She brought causes of action against Chao and Oasis for professional negligence, and brought causes of action against all defendants for fraud by misrepresentation and concealment. Engler additionally alleged breach of fiduciary duty against Chao and Oasis, and products liability against Oasis and Breg. Engler’s counsel contended that Chao and Oasis were involved in an unlawful scheme to profit from the prescription of Breg’s product and that the program, as developed by Oasis, was used by Breg to market the product to other physicians, in contravention of ethical principles applicable to physicians. He further argued that the defendants claimed the device could be used continuously without risk, when they knew that the longer you use the Polar Care 500, the greater the risk that a patient would develop non-freezing cold . These claims were disputed by Breg. Engler’s counsel claimed that Breg gambled on patient non-compliance: that patients would use device for the first couple of days, but lose interest in using the product as the pain and swelling following surgery dissipated. He claimed that most patients injured by the product, however, followed the manufacturer’s and doctor’s instructions precisely, using the device continuously in an effort to speed their recovery. Engler’s counsel maintained that the product was inherently dangerous, when used as directed, and that despite numerous changes made to the warnings and operating temperature of the device, the claims of non-freezing cold injury kept on mounting. He claimed that nevertheless, Breg never changed the instructions to warn users to use the device intermittently, because the company knew that no one would pay $350 for a device that should be used similarly to a bag of ice. Engler’s Counsel further claimed that Chao’s representations were false, as in 1999, Chao and Breg were sued by another one of Chao’s patients, Jeff Warner, who claimed that he sustained a serious injury to his right knee following Chao’s prescription of the Polar Care 500 for continuous use. Engler’s counsel contended that the prescription of the device to her took place only one year after Chao had settled the Warner litigation. Chao and Oasis contended that it was OK to prescribe, rent and sell the device because it wasn’t available through drug stores and was made available as a patient “convenience.” Breg argued that the medical articles that plaintiff’s experts used as the basis for their opinions discussed a phenomenon termed “non-freezing cold injury,” which was the result of soldiers walking in wet and cold trenches during military campaigns. Breg argued that the injury Engler allegedly sustained was vastly different from the phenomenon discussed in the articles. Additionally, Breg argued that Engler didn’t meet the diagnostic criteria for a non-freezing injury/trench foot, as discussed in the literature. Breg further claimed that the device had a long history of safe use when used properly, and that there were numerous peer-reviewed randomized trials that demonstrate the safety and efficiency of cold therapy for longer than 20 minutes at 45 degrees Fahrenheit or above. , Engler contended that she incurred $34,910 in past medical costs from approximately 15 surgical procedures to her left knee. She claimed that the procedures included approximately a dozen debridements of the wound followed by two scar revisions. Engler claimed she will require two additional scar revisions in the future, at an estimated cost of $10,000 to $24,000. She claimed that although her injury is primarily cosmetic at this point, she suffers from hyperthesia and dysthesia over portions of the wound. Engler further claimed that she cannot put weight on her knee without severe discomfort, and experiences discomfort in cold weather.
COURT
Superior Court of San Diego County, San Diego, CA

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