This is an important medical device products liability case. The legal issues are framed in terms of defect design and failure to warn, but the real issue in the case is the legal dilemma created when a company introduces a safer product - can the new and old products both exist in the market place, or does the safer product mean that the old product is de facto defective?
The technology at issue in this case was IV tubing sets with friction fit couplings, and the new technology was IV tubing sets with Luer-lock connections. The incident occurred in 1991, and the Luer-lock IV sets had been available for about 20 years at that time, according to the evidence in the case. (See the lower court decision for a more detailed discussion of the facts: Hansen v. Baxter Healthcare Corp., 309 Ill.App.3d 869, 723 N.E.2d 302 (Ill.App. 1 Dist. 1999)). Plaintiff was admitted to the hospital for stomach ulcer surgery, and had a central venous line started to allow infusion of blood and other fluids as necessary. While recovering from the surgery, the friction fit IV connector on the central line came apart and she suffered an ultimately fatal air embolism. Her estate and survivors sued the hospital, physicians, and Baxter Healthcare Corp, the manufacturer of the tubing. There was no evidence of a manufacturing defect, i.e., the connector was made correctly, it just came apart due to patient movement or from some other external movement. Plaintiff settled with the medical care providers for $2,880,000. While the Supreme Court opinion is silent on the theories against the medical care providers, they included negligence in not properly handling (taping) the connections, in not realizing there was a disconnect, and in using a friction fit connection instead of a Luer-lock connection on a central line. At trial, plaintiff's claims against Baxter were:
(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.
The jury rendered a general verdict for plaintiff for $18,047,000. 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. Baxter appealed to the Illinois Supreme Court, arguing that the appellate court erred in finding that the jury's verdict could be supported under a defective-design theory. Plaintiff cross-appealed, arguing that the court should reverse the appellate court's finding that Baxter had no duty to warn the medical profession of dangers inherent in its product.
Plaintiff's experts supported plaintiff's theories, but the most effective testimony came from defendant's own personnel, who were called as adverse witnesses:
"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."
"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."
Plaintiff was able to rebut the testimony that Baxter did not develop the Luer-locks for safety reasons from the patent application for the Luer-lock: "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." This evidence that the Luer-lock connections were safer, and that such safety was critical for central lines, is the heart of plaintiff's case. Plaintiff first argued that Baxter had a duty to warn about the dangerous of using the friction fit connectors. More fundamentally, plaintiff argued that since the incremental cost of the Luer-locks was so low, and since they posed no additional risks to offset their benefits, that they rendered the friction fit connectors defective and therefore such connectors should no longer be marketed. Baxter countered that it should be able to rely on the learned intermediary defense, in that the medical community knew of the risks of friction fittings disconnecting and that there had been published studies on the risks this posed to patients with central venous lines. The appeals court agreed, finding that Baxter had made a sufficient showing that the risks were well known and it was the hospital's negligence and not Baxter's failure to warn which resulted in the improper use of the friction fitting.
The appeals court next turned to the defect design theory. It found that the plaintiff's case could be reduced to a simple claim: the friction fitting was defective because it could and did come apart due to patient movement. The court reviewed the standards for design defect claims in Illinois, then focused on the traditional key to a design defect case, the alternative design. In most cases the plaintiff has to hypothesize about possible alternative designs, which the defendant can then attack as too expensive, as posing other risks, or as not feasible at the time the product was marketed. In this case, however, the same manufacturer sold an alternative design which cost only pennies more and was, in some ways, even simpler to use correctly. Based on this, the court found that using either of the tests for defective design - consumer expectations or risk/ benefit - the jury could properly find that the friction fit connectors were rendered defective by the Luer-lock connectors.
The Supreme Court disagreed with the appeals court on the duty to warn claim. It found that there was sufficient conflicting testimony on what the defendant medical care providers, and medical care providers in general knew, about the risks of disconnection that the issue could properly go to the jury. In considering the design defect claim, the court analyzed Baxter's claim that it was improper to use a consumer expectations test for a medical device. It found that such connectors were purchased and used by nurses, without physician supervision. The court held this non-physician use of medical devices was properly judged by a consumer expectations test, rather than a "physician expectations" test. (While the court did not explain this "physician expectations" test, it is clearly a version of the learned intermediary, which most courts have not extended to nursing decisions.) The court next addressed Baxter's claim that a risk/benefit test should not have been used because the product was simple and the risks were easily appreciated and avoided. The court disagreed, referring to the patent application claim that these Luer-locks were needed for safety, and thus the product was intended as safety device. If such a device were needed, if the device were cheap and posed no additional risk, and if it were still not in universal use, it could be assumed that the dangers were not obvious and thus the risk/benefit calculation was merited.
This case deals with a common problem in biotechnology: is
it legally justifiable to continue selling a less safe product when it has been
superseded by a safer product with no significant disadvantages? More
generally, is it legally justifiable to sell products with important safety
devices as options? This is an important case for products liability lawyers,
medical device manufacturers, and purchasers of medical equipment.
The Law, Science & Public
Health Law Site
The Best on the WWW Since 1995!
Copyright as to non-public domain materials
See DR-KATE.COM for home hurricane and disaster preparation
See WWW.EPR-ART.COM for photography of southern Louisiana and Hurricane Katrina
Professor Edward P. Richards, III, JD, MPH - Webmaster
The Law, Science & Public
Health Law Site