Muir v. CR Bard, Inc.

• Citation: 519 S.E.2d 583,336 S.C. 266
• Decision Date: 21 June 1999
• Docket Number: No. 3012.,3012.
• Parties: Dale MUIR, Employee/Claimant, Respondent, v. C.R. BARD, INC., Self-Insured Employer, Appellant.
• Court: Court of Appeals of South Carolina

336 S.C. 266

519 S.E.2d 583

Dale MUIR, Employee/Claimant, Respondent, v. C.R. BARD, INC., Self-Insured Employer, Appellant.

No. 3012.

Court of Appeals of South Carolina.

Heard May 11, 1999.

Decided June 21, 1999.

Rehearing Denied August 28, 1999.

Grady L. Beard and William R. Harbison, of Sowell, Todd, Lafitte, Beard & Watson, of Columbia, for appellant.

David. T. Pearlman and J. Kevin Holmes, of The Steinberg Law Firm, of Charleston, for respondent.

ANDERSON, Judge:

Dale Muir brought this Workers' Compensation action alleging he contracted hepatitis C, aplastic anemia and myelodysplasia as a result of examining used foley catheters in his employment with C.R. Bard, Inc. (Bard). The Single Commissioner found Muir's illnesses compensable as occupational diseases. In addition, the Single Commissioner refused to allow Bard a credit for payments of short term and long term disability. The Full Commission and the Circuit Court affirmed. Bard appeals. We affirm.

FACTS/PROCEDURAL BACKGROUND

The Single Commissioner, Full Commission, and Circuit Court treated Muir's claim as one for occupational disease. Accordingly, we address his claim as one for occupational disease, rather than accidental injury.

In 1977, Muir began working with Davol as a Senior Quality Assurance Engineer in its Moncks Corner facility. Bard purchased Davol in the fall of 1980. Muir continued working for Bard in the same capacity as he had with Davol. As part of his job, Muir inspected failed foley catheters to determine the cause of the problem. He made visual inspections and tried to duplicate the problems. For some catheters, he had to inflate and deflate the balloon. If the balloon did not deflate, Muir would use a syringe with a needle to remove the water. For approximately thirty percent of the catheters, Muir had to dissect them using scissors or exacto knives. He would then microscopically examine the catheter to find the defect. Muir estimated he examined 12,000 to 15,000 failed catheters during his years with Bard.

Initially, the failed catheters were sent to a Bard facility in either Covington, Georgia, or Murray Hill, New Jersey. The failed catheters arrived at the customer complaint department of the Covington facility. The department packaged each catheter, gave it a number, placed it in a corrugated box, and sent it to the sterilization department to be processed. It took approximately two days for a catheter to get from the customer complaint department to the sterilization department.

The sterilization process took a minimum of three days. First, the catheter went to a preconditioning area to prehumidify it for sterilization. Then, it went through a sterilizer of ethylene oxide gas (EtO). During the first twelve years Muir worked for Bard, the catheters were processed with a blend of EtO and freon. In late 1992, Bard began using 100 percent EtO. After sterilization, the department postconditioned the catheter to allow for off-gassing of the EtO. The catheter remained in postcondition for a minimum of 24 hours. According to Elizabeth Bruette, who is the Operations Manager in charge of EtO sterilization at the Covington facility, the minimum amount of time the catheters are kept in her department is four days.

Bruette testified EtO is labeled a toxic chemical and is possibly carcinogenic. EtO is not approved by the Federal Food and Drug Administration to sterilize used and contaminated medical products. Vivian Stephens, the Field Assurance Manager at Covington, stated there were no guarantees of sterility and no way to validate sterilization. The catheter is bagged without any capability of maintaining sterility. She said they did no decontamination of the samples for fear of alleviating the defective condition. Stephens insisted no other Bard employee has contracted hepatitis C or aplastic anemia.

Approximately one to two days after the sterilization process was completed, the customer complaint department sent the repackaged catheters to the manufacturer. The Covington facility usually sent the catheters to the Moncks Corner facility where Muir worked through regular mail, taking three to four days. Occasionally, the supervisor of the Field Assurance Department in Covington needed expeditious evaluation. Under these circumstances, as soon as the catheter was out of sterilization, it was dispensed through overnight delivery.

When the catheters arrived at the Moncks Corner facility, Muir's assistant would log them in. Muir, at that point, took the catheters to his office for evaluation. The failed catheters were packaged in a plastic bag which was folded over and stapled shut. A complaint number was written on the plastic bag. A complaint form identifying the complaining hospital, the number of the complaint, and the date of issuance was attached to the bag. A sticker was affixed to the bag indicating the catheter had been processed with EtO sterilization.

Muir described the appearance of the catheters when he received them: "[F]or the most part, considering how they've been used in the hospital, they were relatively clean, they may have some of the lubricant on them." However, approximately twenty-five percent of the catheters had blood on them. Some of the blood was dried on the outside. In catheters where the balloon was ruptured, there was blood underneath the soft, pliable parts of the balloon. In addition, the blood was sometimes covered with the lubricant. In some catheters, the drained lumen was full of crystals which had a "very strong urinary odor." Other catheters had types of odors Muir could not identify. Gloria Jean Kemmerer, the Quality Assurance Secretary assisting Muir, stated the used catheters were damp and some had dried blood on them. They were malodorous and "very nasty."

At the beginning of Muir's employment with Davol, his supervisor told him he could handle the catheters with his bare hands because they had been EtO sterilized. At first, Muir did not use any type of gloves. However, in 1978, once he saw the condition of some of the catheters, he began using gloves.

The only type of gloves Muir used in his examinations were latex exam gloves. At times, water would migrate inside the gloves. Occasionally, the gloves would rip and tear. The catheters were sometimes wet and slippery from the lubricant. About once a month, Muir stuck himself with the scissors or a needle when the catheter he was examining slipped. Muir would simply place an adhesive bandage over the wound, put on another glove, and continue his examination. Sometimes the balloon of the catheter was inflated with water and would not deflate. If Muir touched the outside of the balloon, it would explode and "blow" its contents all over him. He learned by trial and error how to deflate the balloon to avoid such an explosion. Muir was not concerned about his exposure to the catheters and his wounds because he believed the catheters were sterilized.

A blood test in 1986 revealed abnormalities in Muir's liver function and in his white blood cell count. Muir did not have another abnormal blood test until January 25, 1990. That test indicated slightly high liver enzymes, slightly low white blood cell count and a reverse in the percentage of granulocytes to lymph/monos. Muir's family physician, Dr. Jeanne Campbell, described this condition as lymphocytosis. Another test taken January 29, 1990, indicated Muir's white blood cell count was borderline low and showed continued lymphocytosis. Dr. Campbell sent Muir a letter on April 30, 1990, asking him to return to the office for a follow-up on the abnormal tests. Muir did not return to the office until October 26, 1990. The blood test taken that day indicated a slightly low white blood cell count and lymphocytosis.

In 1991, Muir was diagnosed with non-insulin dependent diabetes. On October 17, 1991, he was given a blood test which revealed abnormalities in his enzymes, low white blood cell and red blood cell counts, low hematocrit, high mean corpuscular hemoglobin, and continued lymphocytosis. Dr. Campbell testified the nature of Muir's problem was not clear, but that "[a]t this point [she] would have expressed a low level of concern."

Muir returned to Dr. Campbell on March 12, 1992, complaining of a three week episode of fatigue. Blood work was repeated. His white blood cell count and red blood cell count were both low. Muir's hemoglobin and hematocrit were markedly low and the persistent lymphocytosis was more marked than it had been before. His red blood cells were unusually large and he had an unusually great amount of hemoglobin per cell. That abnormality occurs in individuals with vitamin B12 and folic acid deficiencies, and certain types of bone marrow and liver disorders. Dr. Campbell became extremely concerned. She consulted another doctor and tested Muir's B12 level, which was normal. She repeated the hematocrit four days later and found it had dropped significantly. Dr. Campbell then referred Muir to Dr. Elizabeth Christian on March 19, 1992, for a bone marrow biopsy. Dr. Christian stated Muir's bone marrow test was hard to read. He presented with pancytopenia, a depression of the red blood cells, white blood cells, and platelets, indicative of either aplastic anemia or myelodysplasia. According to Dr. Christian, myelodysplasia and aplastic anemia are bone marrow disorders. She later determined Muir suffers from myelodysplasia. To treat anemia, Muir was given two units of packed red blood cells at the end of March. The blood donors for these transfusions tested negative for hepatitis C.

In an antibody test taken April 10, 1992, Muir tested positive for the hepatitis C antibody. Dr. Christian discussed this diagnosis with Muir on April 21, 1992. At the time of Muir's diagnosis, she was of the opinion that the hepatitis C was causing the pancytopenia. A percutaneous liver biopsy taken in November of 1992 indicated Muir had chronic active hepatitis consistent with hepatitis...