Cold Therapy Cryotherapy Lawsuit | 2026 Latest Updates

Water-circulating cold therapy devices, such as the Breg Polar Care 500, have been associated with injuries ranging from numbness to frostbite. Serious cases could require skin grafts or amputation. No class action or MDL exists for these devices. The known legal activity is individual product-liability claims, including a July 31, 2012 San Diego jury verdict against Breg International and Dr. David Chao. The FDA also issued a consumer update on September 9, 2020. If you have a serious reaction, stop using the device and call your health care provider.

Latest Cold Therapy Cryotherapy Lawsuit Updates

September 9, 2020: FDA Issues Consumer Update on Cold Therapy Devices

On September 9, 2020, the FDA published a consumer update titled “Cold Facts to Help Avoid Injury from Water-Circulating Hot/Cold Therapy Devices” [1]. The update warns that these devices can cause injury if not used properly. It advises people to talk with a health care provider about their use. It also lists steps for checking the skin and reporting problems.

July 31, 2012: San Diego Jury Awards Punitive Damages Against Breg

On July 31, 2012, a San Diego jury awarded Whitney Engler $7.5 million in punitive damages, NBC 7 San Diego reported [2]. The jury ordered $7 million from Breg International and $500,000 from Dr. David Chao. The award followed $5.2 million in compensatory damages the week before. The jury found Breg negligent in the design of the Polar Care 500. The award reflects one jury finding in one case.

What Is Cold Therapy (Cryotherapy)?

According to the FDA, water-circulating hot/cold therapy devices move heated or chilled water through a tube. The water flows into a wrap placed on the body part being treated. Cold therapy is also called cryotherapy. The FDA describes cryotherapy as the therapeutic use of cold, from ice packs to whole body cryotherapy. Cleveland Clinic uses the word for a different treatment that freezes abnormal tissue [3].

Who May Be Affected?

People who use a water-circulating hot/cold therapy device while recovering from surgery or an injury may be affected. The FDA says conditions that affect circulation or decrease skin sensation may raise the risk of injury. Serious reactions include numbness, increased or unexpected pain, burning, blisters or welts, and skin discoloration. Only an individual legal review can say whether you may qualify, based on the device you used and how you were hurt.

Reported Injuries or Damages

In its September 2020 update, the FDA says it has received reports of pain or injuries associated with cold, hot and compression therapy. The most serious injuries to skin and tissue have been associated with cold therapy. Those injuries range from numbness to frostbite. Reports like these do not prove that a device caused each injury. Whitney Engler said her skin began to die after she used the Polar Care 500. Her doctor prescribed it after knee surgery in 2003. She had an open wound for a summer and numerous reconstructive surgeries, and says she will need two more.

Recall and Regulatory Background

No recall has been announced for water-circulating cold therapy devices. The FDA’s September 9, 2020 update is a warning about use, and a warning does not establish liability. The FDA advises keeping the wrap off bare skin with a cloth or bandage as a barrier. It also advises against adjusting the wrap too tightly and says to check the skin often. The FDA says to call a health care provider if numbness, increased pain, burning, blisters, swelling or discoloration appear. Injuries can be reported through the FDA’s MedWatch program.

Evidence to Preserve

Keep the following items, because they may matter to any review of a cold therapy injury:

• The device, including its brand and model (for example, Polar Care), its manual, wrap and packaging
• Prescription, rental or purchase records
• Photographs of the skin over time
• Medical records of the injury and treatment
• Notes on how long and how often the device was used
• Messages with the prescriber, supplier or manufacturer
• A copy of any report filed with the FDA

Keep these items together in one place. Write down the dates of use, the first sign of a problem and each visit to a provider while you remember them.

Filing Deadlines

Deadlines for an injury claim are set by state law, so they depend on where you live. They also depend on the date the injury happened and the date it was diagnosed. A missed deadline can end an injury claim, whatever the facts show. Talk to a lawyer promptly about your own situation.

Frequently Asked Questions

Who Did the Jury Blame in the 2012 San Diego Trial?

In the 2012 San Diego trial over the Polar Care 500, the jury found Dr. Chao negligent. It split fault 50 percent to Dr. Chao, 40 percent to Breg International and 10 percent to Chao’s company, Oasis.

What Did Breg and Dr. Chao Say About the 2012 Verdict?

Breg said it could not comment on the specifics of the 2012 verdict. It said cold therapy devices have a “strong and consistent track record.” Dr. Chao’s attorney called it “primarily a products liability case.”

What Does the Research Say About Cold Therapy Devices and Ice Packs?

The FDA says water-circulating cold therapy devices can stay colder for longer periods than ice packs. That is why the agency says it is especially important to use them properly.

Can a Cold Therapy Device Numb the Skin Without Warning?

A cold therapy device can numb the skin without warning, according to trial testimony. The testimony said the numbness can reach the point that a patient cannot feel frostbite setting in. It came from one trial and is not a general finding.

Are Cold Therapy Cryotherapy Lawsuits Filed One at a Time?

Cold therapy cryotherapy lawsuits in San Diego were filed as separate suits. NBC 7 reported more than 200 lawsuits filed in San Diego County against Breg International by August 1, 2012. Each suit is its own case.

References

1. https://www.fda.gov/consumers/consumer-updates/cold-facts-help-avoid-injury-water-circulating-hotcold-therapy-devices
2. https://www.nbcsandiego.com/news/local/polar-care-500-david-chao-breg-international-jury-award/1929962/
3. https://my.clevelandclinic.org/health/treatments/21099-cryotherapy