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Hansen v. Baxter Healthcare Corporation

January 25, 2002

STEVEN HANSEN, SPECIAL ADM'R OF THE ESTATE OF ANDRINA HANSEN, APPELLEE
v.
BAXTER HEALTHCARE CORPORATION, APPELLANT



The opinion of the court was delivered by: Justice Kilbride

UNPUBLISHED

Plaintiff's decedent, Andrina Hansen, suffered an air embolism because an intravenous (IV) tube became detached from a catheter inserted into her jugular vein. The embolism caused brain damage and paralysis; Andrina died a little more than four years later.

The administrator of Andrina's estate filed medical malpractice claims, in the circuit court of Cook County, against the hospital and one of her treating nurses. He later added survival and wrongful-death claims based on a products liability theory against the manufacturer of the IV tube and connecting devices, Baxter Healthcare Corporation (Baxter). Shortly before trial, the plaintiff settled all claims against the medical malpractice defendants for a total of $2,880,000. The administrator then filed an amended complaint against Baxter alleging products liability and negligence theories.

Following trial, plaintiff dismissed the negligence claims and the matter was submitted to the jury on only the products liability theory. The jury awarded plaintiff $18,047,000. The award was reduced by a partial setoff of the amounts paid by the settling defendants.

On appeal, the appellate court found that the evidence was sufficient to justify the verdict based on a defective-design theory. The appellate court further found that the jury's verdict could not be sustained on the theory that Baxter breached its duty to warn of its products' inherent dangers. However, because the jury reached a general verdict, unchecked by any inconsistent answers to special interrogatories, the appellate court refused to disturb the verdict except to reduce the judgment amount by the full amount of the settlements. 309 Ill. App. 3d 869.

Baxter appeals to this court, primarily arguing that the appellate court erred in finding that the jury's verdict could be supported under a defective-design theory. Plaintiff cross-appeals, arguing that we should reverse the appellate court's finding that Baxter had no duty to warn the medical profession of dangers inherent in its product. We affirm the judgment of the appellate court.

BACKGROUND

Baxter designs, manufactures and distributes IV tubing sets to hospitals nationwide. These IV sets are prescription medical devices used to deliver fluids, such as blood products, medicines, or nutrients. An IV set consists of tubing and a connector, allowing it to be attached to other sections of tubing or to a catheter inserted into a patient's venous system.

There are two types of connectors: "friction-fit" and "Luer-lock." The friction-fit type consists of two mating tapered fittings. A medical professional must push the ends of the two fittings together with sufficient force to maintain a leak-proof connection. The Luer-lock type is similar to a friction-fit connector but also has a threaded collar that screws onto the hub of the catheter. In its patent application, Baxter stated that the Luer-lock was designed to overcome the problem of inadvertent disconnection that occurs with friction-fit connectors. Baxter continued to distribute both friction-fit and Luer-lock connectors to hospitals.

In March 1991, Andrina was admitted to Mt. Sinai Hospital for treatment of stomach ulcers. Following successful surgery, fluids were administered intravenously to Andrina through her jugular vein. This procedure is known as a "central line" application. Unfortunately, the Baxter friction-fit connector used to connect the IV tube to a catheter came apart, causing Andrina to suffer a seizure. She also suffered an air embolism resulting in brain damage, paralysis and, ultimately, death.

The administrator's complaint alleged, inter alia, that: (1) the tubing was unreasonably dangerous because it was designed, manufactured, and sold without a Luer-lock connection; (2) the friction-fit connection failed when the product was used in a reasonably foreseeable manner; and (3) Baxter failed to warn of the likelihood of unintentional disconnection and the need to use tubing equipped with the Luer-locking device.

At trial, plaintiff called Baxter employees as adverse witnesses to establish the propensity of the friction-fit connectors to disconnect unintentionally and to prove that Luer-locking devices provided a more secure connection. According to Margaret Foss, a registered nurse and Baxter vice-president, Baxter was aware at the time Andrina was injured that friction-fit connectors sometimes failed due to patient movement. Foss admitted that this could cause air embolisms in central line applications. She conceded that friction-fit connectors were inadequate for central line use and that, in such instances, medical professionals should use Luer-locks. She testified, however, that Baxter did not encourage sales representatives to recommend Luer-locks for central line applications. Instead, Baxter simply made both products available to its customers.

Baxter's sales representatives provided similar testimony. For example, one representative admitted that she knew prior to Andrina's injury that friction-fit IV sets could unintentionally disconnect and should not be used in central line applications.

Birenda Lal, Baxter's chief engineer in charge of the IV product line, was called as an adverse witness. He testified that friction-fit connectors could accidentally disconnect. He also stated that friction-fit connectors were being used in central lines and agreed that an air embolism could result if they became disconnected. For this reason, he recommended using Luer-locks in central line applications. He added, however, that Baxter did not advise hospitals to use one product or the other, and Baxter had not developed and marketed Luer-locks to prevent accidental disconnections or to increase patient safety. Rather, the Luer-lock mechanism was a competitive response to industry demands. Lal testified that adding Luer-locks to all connectors was technically feasible and would add between three and five cents to the cost of each unit. He believed that Baxter would put locking collars on all their connectors if customers demanded it.

Neil Sheehan testified as plaintiff's expert witness without objection. Sheehan is a mechanical engineer and had worked for several companies that developed and sold IV components. Sheehan had personally designed and, in some cases, patented medical devices, including IV equipment. He explained that the main problem with using a friction-fit connector was that the amount of force needed to disconnect it depended on several factors, including (1) the force used to connect it; (2) its composition; (3) the method used to sterilize it; and (4) variations in molding. Thus, the strength of the connection varied as different persons used different friction-fit connectors at different times. Generally, however, if the connection was made with less force, it was more likely to fail.

Sheehan also described the technical aspects of the Luer-lock. He stated that a Luer-lock prevents the accidental disconnection of IV lines and that it is four to five times stronger than a friction-fit. In order to disconnect a Luer-lock without unscrewing it, the components would have to be pulled apart with great force until the threads on one component tore. Sheehan testified that air embolisms can be avoided by using Luer-locks and that Luer-locks should always be used in central line applications. In his opinion, the friction-fit connector became obsolete once the Luer-lock became available.

In addition, Sheehan stated that is was foreseeable that friction-fit connectors might be used in a central line application. He opined, however, that a friction-fit connection was not a safe design in any application and that it was especially hazardous when used in a central vein. He also believed that if medical personnel had used a Luer-lock connector, Andrina's injury would have been prevented.

Dr. William Schumer, chief of surgery at Mt. Sinai Hospital, testified that decisions regarding the purchase of medical supplies were made by a nursing products committee. He said that Luer-locks were not used at Mt. Sinai prior to the incident, and he believed that most hospitals did not use them at that time. He stated that he assumed friction-fit connectors were safe because they were readily available in the market.

The chair of the nursing products committee at Mt. Sinai testified that the hospital staff relied on product manufacturers to advise them of the appropriate uses for their products.

The nurse responsible for the actual purchase and distribution of medical supplies at Mt. Sinai stated that at the time of Andrina's injury she did not know the difference between a friction-fit connector and a Luer-lock connector. She also noted that at that time she did not know that friction-fits should not be used in central line applications.

Dr. Ricky Maddox, a second-year resident in general surgery at Mt. Sinai at the time of Andrina's operation, testified that he placed the catheter in Andrina's jugular vein. Although he knew about using friction-fit connectors on IV tubing, he was unfamiliar with Luer-lock connectors. He did not learn of them until after Andrina was injured, when they began to be used exclusively at Mt. Sinai Hospital.

Dr. Henry Roztoczynski, Andrina's surgeon, testified that he was aware that friction-fit connectors could unintentionally disconnect and that Luer-lock connectors were safe to use in central lines. He never mentioned Luer-lock connectors to his colleagues at Mt. Sinai ...


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