Warning: Additional Warnings May Be Required.

• Author: Zeigler, Jessie

Manufacturers face a fractured landscape of increasingly stringent, overlapping, and conflicting rules and rulings governing how they must warn against the risks associated with their products. This is true of manufacturers of various consumer products, commercial products, food, pharmaceuticals, and other products who produce for a national or global marketplace and find themselves subject to different regulatory schemes depending on where their products are offered, sold and/or used. Rules born from case law impose additional, and varying, obligations upon them. Because it is not generally feasible to create different warning labels for different areas of the country or world, such varying laws impose a high burden on manufacturers across industries. And where laws conflict, it is not always possible to standardize warnings at the strictest standards. As a result, a bad rule or case can impact how the manufacturer addresses warnings across the globe.

This article sets forth recent developments and notable lawsuits across certain industries with regard to warning labels, focusing particularly on the sometimes conflicting requirements imposed on manufacturers by inconsistent regulations and/or court rulings.

1. Increased Warning Requirements

   1. The Risks of Products Manufactured by Other Companies: Do Jelly Makers Have to Warn About Peanut Allergies?

      Manufacturers may be liable for warning consumers against the risks associated not only with their own products, or even with products that are required for use of their products, but even with products that could foreseeably be used with their own products. At least that is the law in Tennessee right now.

      Last year, the United States Supreme Court recognized in a maritime case that "[t]hree approaches have emerged" on how to apply a 'duty to warn' principle "when the manufacturer's product requires later incorporation of a dangerous part ... in order for the integrated product to function as intended." (1) The first, which the Court dubbed "the foreseeability rule" states that "[a] manufacturer may be liable when it was foreseeable that [it]s product would be used with another product or part, even if [it]s product did not require use or incorporation of that other product or part." (2) The second, the "bare metal defense," shields any manufacturer that "did not itself make, sell, or distribute the part or incorporate the part into the product ... even if the product required incorporation of the part and the manufacturer knew that the integrated product was likely to be dangerous for its intended uses." (3)

      The third approach, imposes a duty to warn when a product "requires incorporation of a part ... the manufacturer knows or has reason to know that the integrated product is likely to be dangerous for its intended uses." (4)

      The United States Supreme Court adopted the third approach, holding that a manufacturer can be liable if a court finds "it should have known" that its product would be used with another product. This rule requires a manufacturer to find all the products that are likely to be used with its product and determine what risks those products might pose, but the Court noted it was "most appropriate" for the maritime context, because maritime law "has always recognized a special solicitude for the welfare" of sailors. (5) The Court rejected the foreseeability rule even in this special context, finding it "would sweep too broadly," imposing "a difficult and costly burden on manufacturers, while simultaneously overwarning users." (6)

      The application of these three approaches in different jurisdictions shows the challenge that manufacturers face. The Air & Liquid Systems case arose in the asbestos context, but it could be applied to a variety of component products. The Court's holding could have standardized the moderately stringent third approach, or led courts to adopt the bare metal defense, recognizing the third approach as appropriate only in contexts necessarily more protective--like maritime law. Instead, at least in one jurisdiction, a state appellate court has adopted the most restrictive rule, and its language seems to apply broadly across the product liability landscape.

      Last year, the Tennessee Court of Appeals cited Air & Liquid Systems outside of the maritime context, and even in this less less-restrictive context, adopted the foreseeability approach rejected by the Supreme Court, holding that manufacturers in Tennessee are liable for the...