CAN A PRODUCT BE ADEQUATELY DESIGNED, EVEN IF IT IS UNDISPUTEDLY STILL DANGEROUS?
Sometimes the black letter law passed by the legislature is unclear. The legislature can’t anticipate every possible fact scenario when they pass a law, so it lay to the courts to interpret the law and give guidance to what it means. This interpretation is called case law. When the court decides a certain meeting to the law it essentially answers a legal question. Lawyers and other courts then can rely on that ruling when they have a similar issue in their case. The following case answers the question above.
Savina v. Sterling Drug, Inc., 247 Kan. 105, 795 P.2d 915 (1990).
This case addresses the following issues:
Can a product be adequately designed, even if it is undisputedly still dangerous?
When are warnings adequate for an undisputedly dangerous product?
This case revolves around injuries caused by a metrizamide, a chemical used to create contrast in x-rays of the spine. Id. at 106. The court determined that Kansas law recognized an exception to design defects for “unavoidably unsafe products” that, even when properly prepared, are inherently dangerous and “cannot be designed more safely.” Id. at 115. However, such products do require adequate warnings to avoid liability. Id. at 124.
In this case, the Plaintiff was to undergo a specific type of spinal x-ray—a myelogram—which required metrizamide to be injected into his spinal cord. Id. at 106. Unlike other contrasting fluids, metrizamide is not removed after the procedure, but instead left in the spine to be absorbed into the blood stream. Id. Upon being injected with the substance, Plaintiff felt burning and tingling in his feet and legs. Id. at 108. As it turns out, the warnings provided by the drug’s manufacturer—Defendant—were severely outdated and limited. Id. at 110. Notably, permanent paralysis was not mentioned as a potential side effect, though it was a known, albeit very rare, side effect of metrizamide. Id. The trial court granted summary judgment for the Defendant, finding that the product fit within the unavoidably unsafe product exception and contained adequate warnings because the side effect experienced by Plaintiff was too rare to warrant warnings. Id. at 113.
The court began by noting that a product can be defective under Kansas law in three ways: defectively designed, defectively manufactured, or defective based upon inadequate warnings. Id. However, it was unclear if Kansas law recognized “comment k” products, named after the comment within the Restatement (Second) of Torts. Id. A comment k product is one that is still unsafe but cannot be made any saver without losing its usefulness. Id. After considering the nature of modern pharmaceuticals, the court determined that this exception is a necessary evil. Id. at 116. However, simply because the product is a prescription drug does not place the product into this exception, but is decided on a case-by-case basis. Id.
However, even an unavoidably unsafe product can be defective through inadequate warnings. Id. at 120. Whether warnings are sufficient is generally a question for the jury to determine, based upon what a “reasonable consumer” would expect from the product. Id. at 123-24. In this case, the court found that permanent paralysis was an extreme and severe side effect, and could easily be beyond what a reasonable consumer would expect. Id. at 124. Thus, failure to warn about this potential harm could make the product defective. Id. This was supported by the testimony of several doctors who found the side effect extreme and the type of danger that should be explicated stated, even if it is rare. Id. The court thought there was sufficient evidence in this case to put before the jury, so the case was remanded for a decision as to whether the warnings contained on the substance were sufficient. Id. at 129.