Chlopek v. Federal Insurance

499 F.3d 692, 2007 U.S. App. LEXIS 20548, 2007 WL 2416520
CourtCourt of Appeals for the Seventh Circuit
DecidedAugust 28, 2007
Docket06-2927
StatusPublished
Cited by73 cases

This text of 499 F.3d 692 (Chlopek v. Federal Insurance) is published on Counsel Stack Legal Research, covering Court of Appeals for the Seventh Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Chlopek v. Federal Insurance, 499 F.3d 692, 2007 U.S. App. LEXIS 20548, 2007 WL 2416520 (7th Cir. 2007).

Opinion

ROVNER, Circuit Judge.

Denise and Jaron Chlopek sued Breg, Incorporated, the manufacturer of the Polar Care 300, a device that delivers cooling therapy to postoperative patients. After nearly ten days of continuous use of the device on her right foot, Denise experienced decreased blood flow and tissue damage in her right big toe. The Chlo-peks alleged that the Polar Care 300 was defective because it contained no warning about the dangers of continuous use. However, a jury found that the device was not defective. The Chlopeks appeal, arguing that the district court erroneously denied their motion for a new trial. They assert that errors relating to evidentiary matters, the jury instructions, and the district judge’s conduct rendered their trial unfair. Having determined that none of the alleged errors resulted in an unfair trial, we affirm the judgment of the district court.

I.

After undergoing several surgeries on her right big toe in the late 1980s, Denise Chlopek functioned well for more than a decade. She was mobile, experienced minimal pain, and was able to work as a nurse. But in early 2002, she suddenly began to experience severe pain in her right foot, and she sought treatment from Dr. Andrew Pankratz, a podiatrist at the Marsh-field Clinic in Eau Claire, Wisconsin. Dr. Pankratz determined that the artificial joint that had been implanted in Chlopek’s toe in 1989 had fractured and failed. Chlo-pek’s toe was significantly deformed. After discussing two treatment options with Dr. Pankratz, Chlopek elected to have “fusion surgery,” wherein a bone fragment from her hip would be implanted in her big toe to improve stability and weight-bearing capability.

Chlopek underwent surgery at the Eau Claire Surgical Center on May 31, 2002. Dr. Pankratz, along with an orthopedic surgeon, performed the surgery, which was uneventful. After the procedure, Dr. Pankratz prescribed cold therapy for Chlo-pek to prevent swelling and treat pain. Toward that end, he prescribed a Polar Care 300, which he applied to Chlopek’s *696 foot himself after wrapping the foot in several layers of bandages.

The Polar Care 300, manufactured by Breg, is a device consisting of a cooler attached by a tube to a pad that is wrapped around the patient’s affected area. A pump, powered by electricity, circulates ice water from the cooler through the tube and into the pad, allowing for more cold water to cycle into the pad as heat from the body warms it. Breg markets the Polar Care as “continuous cooling therapy.” The device is a Class II medical device, which, for purposes of this case, means that the Food and Drug Administration must initially approve the device for its intended use and thereafter the manufacturer must report complaints about the device to the agency. The Polar Care 300 is not marketed to the public; rather, Breg sells the devices to medical professionals who in turn prescribe it to their patients. In 2002, the Polar Care 300 had a warning label affixed to its side with the following admonitions:

Caution: Federal law restricts this device for sale by or on the order of a licensed health care practitioner. Warning: Carefully read use instructions and warnings before operation. Warning: Always apply a dressing or other moisture barrier between the pad and the patient’s skin.
Warning: A licensed health care practitioner must consider each patient’s sensitivity to cold. A periodic inspection of the patient’s skin under the pad is recommended. If a noticeable change in skin appearance in the area of the cold application is observed such as burning, itching, blistering, discoloration, or increased swelling more than an hour after use, discontinue use of this product and consult physician immediately. Always apply a barrier or dressing between the pad and the patient’s skin. Caution should be taken during prolonged use, for children, diabetics, incapacitated patients, and those with decreased skin sensitivity or poor circulation.
Warning: Carefully read use instructions and warnings provided with the water circulating pad that is to be used with this pump.

Chlopek was discharged on May 31, the day of her surgery. Dr. Pankratz did not give her any directions with respect to the proper use of the Polar Care 300 and admittedly did not read the warnings on the unit. However, before Chlopek left the clinic, a discharge nurse gave her written instructions to keep her foot elevated, leave the bandage in place at all times, and continue using the cold therapy for two weeks. 1 Chlopek was due back at the clinic for a follow-up appointment on July 19.

Chlopek followed the instructions that the discharge nurse gave her, but she did not read the warning label on the Polar Care 300. Her husband did read the label, and, concluding the warnings were not inconsistent with the discharge instructions, continued to follow the nurse’s instructions. Accordingly, Chlopek used the Polar Care device continuously, removing the cooling pad only when she went to the bathroom. After nine days, she noticed that her baby toe — which, according to Chlopek, was then visible only because the dressing applied by Dr. Pankratz had shifted — was purple. (Dr. Pankratz maintains that the tips of Chlopek’s toes were *697 always visible.) She returned to the clinic the next day.

According to Chlopek, when Dr. Pan-kratz removed the bandage on her foot, he exclaimed, “This looks like frostbite!”. Dr. Pankratz instructed Chlopek to discontinue use of the Polar Care 300, but he advised her to apply ice behind her knee three times per day. His treatment notes for the day of his visit do not say anything about frostbite or thermal injury, but he noted blistering and “grayish discoloration” characteristic of ischemia (decreased blood flow) on Chlopek’s toes. Over the next month, Chlopek returned to the clinic for a series of follow-up appointments. The damaged tissue in Chlopek’s toe was beyond repair, and so Dr. Pankratz waited until a clear demarcation became evident between the damaged and healthy tissue. At that point, on July 18, he amputated the damaged tissue, which amounted to Chlo-pek’s entire right big toe.

After the amputation, the Chlopeks sued Breg and its insurer in the Circuit Court of Eau Claire County, Wisconsin. They alleged that the Polar Care 300 was defective because its warning label did not caution consumers that continuous use could lead to thermal injuries. After service the defendants removed the case to federal district court. The Chlopeks survived Breg’s motion for summary judgment, and a jury trial was scheduled. Over the plaintiffs’ objection, the district court decided to bifurcate the trial; only if the jury found during the first phase that Breg’s product was defective would a trial on the Chlo-peks’ damages be held.

Before trial, the district court resolved a number of evidentiary motions. As relevant here, the court granted in large part the defendants’ motion to exclude evidence — in the form of Breg’s records of customer complaints — of other thermal injuries potentially caused by the Polar Care 300 and its sister unit, the Polar Care 500. 2

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Bluebook (online)
499 F.3d 692, 2007 U.S. App. LEXIS 20548, 2007 WL 2416520, Counsel Stack Legal Research, https://law.counselstack.com/opinion/chlopek-v-federal-insurance-ca7-2007.