Litigation encompasses controversial cases addressing legal issues. The case that will be discussed further, namely Hansen v. Baxter, highlights the importance of awareness of the legal and ethical issues when entering the market.
In March 1991, Andrina Hansen was admitted to Mt. Sinai and was diagnosed with a stomach ulcer. Surgery was scheduled for treatment, and after its successful outcome, the patient was administered fluid intravenously through the jugular vein (Brief – Hansen v. Baxter Healthcare, n.d.). This procedure is known in medicine as the “central line” insertion (Tse & Schick, 2021). Despite the successful operation, the friction connector used to administer the fluid to Hansen fell apart, causing her to have a seizure. The connector belonged to the Baxter company, which is why the company faced legal repercussions later.
During the initial investigation, it was found that the pipe was dangerous since it was produced without a Luer-lock. This lock was also a product of the Baxter company, which did not warn its customers (mainly large clinics and hospitals) about the possible dangers of using a friction fit tube. Initially, the plaintiff filed a lawsuit based on the negligence of the hospital doctors. Later, the charges were filed against Baxter when the victim accused the organization of wrongdoing regarding the product or service liability theory (Brief – Hansen v. Baxter Healthcare, n.d.). After the first procedural hearings, the estate manager of the deceased Andrina decided to dismiss the claim against the hospital staff, and the jury considered this case only on the theory of product liability and its quality.
Despite Baxter’s appeal after the jury decided in favor of the plaintiff, the court did not change its decision. There were reasons for this: according to patent law and the application, Luer-locks were necessary and were a guarantor of safety during such medical procedures (Brief – Hansen v. Baxter Healthcare, n.d.). The circumstance leads to the logical conclusion that since the product was conceived as a necessary protective device, its use should be recommended. This means that the tube should initially be sold with a Luer-lock instead of the old friction connector. As a result, the solution would not be financially unprofitable, both for the manufacturer and for medical institutions. Moreover, it is essential to point out that Baxter failed to acknowledge the consumer rights of the medical institutions purchasing their products, namely, the right to safety and information (HG, 2022). Failure to disclose the safety issues correlating with the lack of the Luer-lock directly violates the aforementioned rights.
The court’s decision in favor of Baxter’s responsibility to recommend the protective device can also be explained through the theory of design defects in the product. In this case, a batch of goods is defective, which creates hazardous risks (Catenazzo & Paulssen, 2019). As a result, the manufacturer could have claimed that redesigning and investing in the manufacturing of a new batch would be time and cost-consuming. However, even if the circumstances were to fit the aforementioned framework, Baxter would be at a disadvantage, and it would become more challenging for the company to appeal against the court’s decision. Moreover, as the healthcare industry is a field in which ethical considerations are primordial, Baxter’s failure to maintain transparency and value safety highlights the duties the organizations did not adhere to.
This case describes the general problem of modern biotechnology and medicine from the perspective of consequences versus business strategy. From a legal perspective, a company is entitled to diversify a product by selling components rather than sets. However, the ethical circumstances and consumer rights create an environment in which companies are limited in advancing such techniques. Thus, it is inevitable that jeopardizing one’s well-being both from a legal and moral perspective is frowned upon, which has been exemplified in the jury’s decision in favor of the plaintiff.
References
Brief – when do new medical devices render old ones defective? (n.d.).
Catenazzo, G., & Paulssen, M. (2019). Product defects are not created equal: prioritizing production process improvements. Production Planning & Control, 31(4), 1–16.
HG. (2022). Consumer Rights – Consumer Protection Law. HG Legal Resources.
Tse, A., & Schick, M. A. (2021). Central Line Placement. StatPearls Publishing.