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Hansen v. Baxter Healthcare Corporation

December 15, 1999

STEVEN HANSEN, SPECIAL ADMINISTRATOR OF THE ESTATE OF ANDRINA HANSEN, DECEASED,
PLAINTIFF-APPELLEE,
V. BAXTER HEALTHCARE CORPORATION,
DEFENDANT-APPELLANT.



The opinion of the court was delivered by: Justice Wolfson

APPEAL FROM THE CIRCUIT COURT OF COOK COUNTY. HONORABLE RANDYE A. KOGAN, JUDGE PRESIDING.

In the 1880s, in Germany, Otto Luer came up with the idea of a six per cent taper as a way of putting a stopper in a bottle, keeping it there, and then getting it out again. Many years later, Luer's taper was used by hospital equipment manufacturers to ensure that one piece of iv-set tubing would fit into another.

This case is about the iv-sets manufactured by Baxter Healthcare Corporation (Baxter). And it is about the injuries and death suffered by Andrina Hansen (Andrina) when Baxter's iv-set tubing came apart.

Andrina's estate and her survivors sued Baxter under a products liability theory. The jury found for the plaintiffs and returned a total verdict of $18,047,000.

Baxter raises several issues on appeal. We find sufficient evidence to support the jury's verdict as to liability and damages. We do, however, reduce the judgment to reflect a $2,800,000 set-off of a pre-trial settlement.

FACTS

In March 1991, Andrina was admitted to Mt. Sinai Hospital for stomach ulcer surgery. In preparation for surgery, Dr. Ricky Maddox (Dr. Maddox) inserted a catheter into Andrina's jugular vein. This catheter would allow doctors to transfuse blood or other fluids to Andrina. Andrina's catheter was connected to an i-v tube manufactured by Baxter.

Baxter designs, manufactures, and distributes i-v sets to hospitals nationwide. I-v sets include tubing and connectors which link segments of tubing to medical devices or catheters placed into a patient's circulatory system. In 1991, Baxter offered two types of connectors: "friction fit" or "luer slip" connectors and "luer lock" connectors.

A luer slip connector consists of a tapered, "male" fitting which slips into a wider, "female" fitting to create a secure, leakproof connection. Baxter defined a luer slip connector as a product which, "*** when properly inserted, must provide a reasonably secure friction fit that will not leak or easily slide out of the catheter ***."

A luer lock connector consists of a luer slip connector with a threaded collar on the male fitting and a threaded flange on the female fitting which screw together to create a more secure connection. Baxter defined a luer lock connector as a product which "*** would provide a secure lock such that non-intentional separation of the Luer adapter from catheter *** could not occur."

Industry standards require luer slip connectors withstand five and one-half pounds of separation force before disconnecting, and luer lock connectors must withstand eight pounds of force.

Luer slip connectors have been used for more than 40 years, and luer lock connectors were introduced within the last 20 years. After luer lock connectors became available, i-v set producers, including Baxter, made all female fittings with flanges so these fittings could accommodate either luer slip or luer lock male fittings. At the time of Andrina's injury, Mt. Sinai used only luer slip connectors.

Dr. Henry Roztoczynski (Dr. Roztoczynski) successfully performed Andrina's surgery on March 7, 1991, and described her condition following surgery as excellent. Dr. Norbert Strohmayer (Dr. Strohmayer) assisted Dr. Roztoczynski with the surgery and saw Andrina on his morning rounds the day after her surgery. She was responsive with good vital signs.

Later that morning, Dr. Strohmayer and Dr. Maddox heard a commotion and rushed to Andrina's room. The attending nurse, Colleen Golden (Golden), announced Andrina was having a seizure. As Dr. Strohmayer administered valium to stop the seizure, he noticed blood pooling on Andrina's pillow. Andrina's catheter had become disconnected from the i-v tube. As a result of this disconnection, an air embolism occurred. Air entered into Andrina's catheter and traveled to her brain, causing brain damage. Andrina became paralyzed. She died on June 4, 1995.

In 1991, Andrina's son, Thomas Hansen (Thomas), filed a medical malpractice claim against Mt. Sinai and Golden. Thomas later added survival and wrongful death claims against Baxter based on a products liability theory. Shortly before trial, all defendants except Baxter settled for $2,880,000. The trial court allocated 85% of the settlement, $2,448,000, to Thomas' wrongful death claims and 15% of the settlement, $432,000, to his survival claims.

On December, 24, 1997, Thomas filed an amended complaint against Baxter alone, presenting survival and wrongful death claims under both products liability and negligence theories. These claims proceeded to trial.

At trial, Dr. Roztoczynski testified he received a telephone call at home around 11:00 a.m. on the morning after Andrina's surgery and proceeded to the hospital. At the hospital Dr. Roztoczynski spoke with the intensive care unit chairman, Dr. Philip Zaret, and read Andrina's records. Dr. Roztoczynski learned Andrina's seizure began when Golden raised her from a prone to a sitting position. Dr. Roztoczynski described Golden's reaction:

"Well, what happened, the nurse during the dangling [of] the patient as I said from flat to upright position patient becomes dizzy. Suddenly, you know, [Andrina] was short of the breath and becomes hypotensive so [Golden] knew that something happened.

And in this time she was not exactly sure what's happened so she call [sic] Dr. Strohmayer, who came and he immediately find [sic] out that the patient had dislodged of [sic] IV tubing from the central venous catheter. And he put the patient in the left side position to put the right side up, he did the [head-below-feet] Trendelenburg position and start aspiration of the air which was inserted through the syringe."

Baxter did not object to this testimony.

Dr. Roztoczynski said the luer slip connector came apart when Golden moved Andrina because "*** when the nurses would dangle [the patient's feet off the bed] under the tension [the] catheter got disconnected ***." Dr. Roztoczynski acknowledged luer slip connectors can easily disconnect. He testified he had seen such disconnections a "few times" and "quite often so many times" before Andrina's accident, though these previous disconnections carried less severe consequences.

While on staff at Our Lady of Resurrection Hospital two to three months before Andrina's accident, Dr. Roztoczynski noticed the hospital had started using luer lock connectors. Dr. Roztoczynski said he began using luer lock connectors "because I thought they were safe. *** [W]hen I saw this I said that's a great modernization to this [luer lock connectors], what we had before." Dr. Roztoczynski advocated luer lock connectors:

"*** if you have a patient and the patient needs to be moved from one place to move and some tension is happened [sic], you know, taking the patient out of the bed and the tension will happen. These things happen many times, believe me. If you just have this kind of thing [luer lock connectors], and I'll say that this only one to prevent it just to change it for the luer lock adaption [sic], this thing will not happen."

However, Dr. Roztoczynski testified he never mentioned luer lock connectors to his colleagues at Mt. Sinai.

Dr. Maddox testified he was a second year surgical resident at the time of Andrina's accident. Dr. Maddox said he placed a catheter into Andrina's jugular vein on the night of her surgery. But Dr. Maddox conceded he did not mate the i-v tubing with the catheter: "I usually don't put the IV tubing in myself unless it's a trauma situation. But in situations like this I would let the nurses know *** that that is correct procedure using the catheter." Dr. Maddox agreed the nurses would start the i-v--"get it all going and deliver the patient to surgery."

On the morning after Andrina's surgery, around 10 a.m., Dr. Maddox was in the intensive care unit discussing other patients when Golden announced an emergency situation. According to Dr. Maddox, he interpreted Golden's comment as "*** either [Andrina's] having a seizure or she's dropping blood pressure." When he entered Andrina's room, she was lying prone on her bed and she was unresponsive. Dr. Maddox said Dr. Strohmayer placed Andrina in the Trendelenburg position: "The reason was that the nurse's comment initially was that she was having a seizure, and we wanted to make sure that there was no cerebral event." Dr. Maddox said he was not familiar with luer lock connectors at the time of Andrina's accident.

Dr. Strohmayer testified he heard a commotion coming from Andrina's room on the morning after her surgery, and he hurried to her room. According to Dr. Strohmayer, Golden was in Andrina's room. Dr. Strohmayer said he asked Golden what had happened:

"If I remember the sequence correctly, she said she had sat up the patient and when the patient was sitting up, the patient became dizzy and then had a seizure and at that point we put her back to bed. And I think I got there when we were in the process of putting her back to bed. I don't know if she was already in the bed or getting in the bed; it was in that time frame."

Baxter did not object to this testimony.

Dr. Strohmayer testified he gave Andrina medication to stop her seizure and noticed blood pooling around her shoulder. Dr. Strohmayer then realized Andrina's i-v tubing had disconnected from her catheter and immediately reconnected them. Dr. Strohmayer was concerned Andrina had an air embolism. At trial he explained:

"At this point there was nothing else, she had been doing very well, so it would have to be some sort of acute event. The only thing that had happened within the past few minutes which could account for an acute event was the patient had--well, we saw the disconnected IV and she had been moved in and out of the bed, so we figured logically something happened during the transfer."

Dr. Strohmayer testified Mt. Sinai probably used luer slip connectors for all i-v's at the time of Andrina's accident. Although he did not focus his attention on i-v connectors, Dr. Strohmayer also knew about luer lock connectors at this time. He had seen both luer slip and luer lock connectors at other hospitals. Dr. Strohmayer did not read any medical literature about luer slip disconnections and did not remember specific instances of previous disconnections, but he suspected "*** it happened a few times." He said, "I'm sure we'd seen them in IVs get disconnected because people are moving and they pop out ***." Dr. Strohmayer acknowledged luer lock connectors were less likely to disconnect during patient movement and understood luer lock connectors provided more secure connections: "I just knew that it was screwed on so it's going to be harder to take off."

Dr. Donald Kuhlman (Dr. Kuhlman), an attending neurologist at Mt. Sinai in 1991, testified he consulted with Andrina's doctors after her accident. Dr. Kuhlman said he received Andrina's history when he arrived at the intensive care unit: "I got the history that there was a woman who had undergone an ulcer operation and seemed to be doing fine until they sat her up at the edge of the bed when she began having a seizure and became unresponsive. *** I was also told that they noticed that her central line had become disconnected ***." Baxter did not object to this testimony. Dr. Kuhlman noted raising Andrina from a prone position could be significant to the disconnection because "*** that movement there is something which could have jostled things loose."

Dr. Edmund Donoghue, Cook County Chief Medical Examiner, testified the i-v disconnection caused an air embolism, which in turn caused brain damage to Andrina.

Cynthia Schiavo Pullinger (Pullinger), a group product manager for Baxter's i-v products at the time of Andrina's accident, was called by Thomas as an adverse witness. Pullinger acknowledged luer lock connectors "*** could potentially be more secure. It's called a luer lock so it locks on." But she insisted both luer slip and luer lock connectors were safe products:

"You have customer preference. And if a customer prefers one versus the other, they're both safe products, so you offer them what they want, you know, clinically what they decide that they need. So it's just like anything else. You ...


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