Although I have never made it official, I have been doing a series of posts on warnings as a result of some research I have done lately for a case. It started with an analytical framework for warnings, followed by some commentary on the duty to warn and the "obvious risk" posed by cell phone use while driving, and then a more detailed post on when the duty to warn arises.
As stated in a prior post, Gardner v. Q.H.S., Inc., 448 F.2d 238 (4th Cir. 1971) supports that the duty to warn arises when (a) the reasonably foreseeable risks of a product – either from its intended use or from the environment in which it is used – pose a potential danger, and (b) the user may not realize the potential danger. In such cases, the manufacturer and supplier has a duty to warn the user. Gardner, 448 F.2d at 242-43.
The question that follows is: how does a plaintiff prove this duty in the context of a manufacturer seller? A plaintiff must produce evidence from which a jury can conclude that a manufacturer or seller has reason to believe that a warning is necessary. Livingston v. Noland Corp., 293 S.C. 521, 525, 362 S.E.2d 16, 18-19 (1987) (holding that supplier and manufacturer had no way of knowing and no reason to foresee that failed refrigerator compressors would be unreasonably dangerous unless a warning was provided). Gardner also addressed this issue by discussing the means by which to determine foreseeability and whether a duty to warn arises. As stated by the court:
Where the issue is one of foreseeability, evidence of what has actually been experienced in the same or comparable situations constitutes proof of the greatest probative value. The only other way foreseeability can be proved is by expert testimony and in most instances it, too, will depend upon actual experience developed by laboratory or everyday experience.Id. at 244. In this context, the court in Gardner determined that depositions and complaint letters of other product users who had similar experiences with the hair rollers at issue were admissible to show the manufacturer’s knowledge of the problem. Id. The court also believed that certain expert testimony should have been admitted to show the nature of the danger. Id.
Gardner's analysis correlates with my own experience in warnings cases concerning the method of proof. There are multiple sources of information that should be reviewed to determine if there is an actual or potential risk with a product, creating a duty to warn:
- Interviewing manufacturer and/or seller representatives about the product and whether there was any knowledge of an actual or foreseeable risk, and when the individuals had this knowledge. From an efficiency standpoint, this is usually my first source (if I represent the manufacturer/seller).
- After interviews, reviewing internal company documents relating to prior incidents involving the product and the risk at issue, adverse event reports (in drug/medical device cases), testing of the product (and their results), memoranda and emails concerning any risks with the product, and other documents. This is typically where a plaintiff is trying to find a "smoking gun" where the manufacturer or seller indicates knowledge of a potential issue.
- Review of non-company documents and information, such as scientific literature concerning the product, case reports in literature of the potential risk at issue, trade literature, information from any regulatory bodies (FDA, CPSC, etc.), recall information, etc. Evaluating this information is important because even if there was not anything in the company documents or interviews to indicate knowledge of a potential risk, these sources can inform as to whether the company should have known of a potential risk. Although it may vary depending on the jurisdiction, companies frequently are held to the standard of being an "expert," meaning they are expected to know about the most current literature and findings concerning their product.
- Interviews and consultation with industry and scientific experts. These individuals, in my experience, usually provide their opinion -- putting together all of the above information -- as to whether there was a duty to warn.
These sources only focus on the duty to warn, and not the adequacy of the warning (which involves other sources of information that should be reviewed, and other kinds experts, including regulatory and human factors experts). Furthermore, the above list is certainly not exhaustive by any means. However, whether there was a duty to warn can be a simple issue (e.g., warning that a surface is hot) or a contentious one (whether a pharmaceutical manufacturer should have warned of a potential, disputed risk in its labeling), and all this information is important with regard to proving any duty to warn.