Sophisticated User Decision Helps

May 5, 2008
But it doesn't let manufacturers off the hook.

A recent California Supreme Court decision adopting the "sophisticated user" doctrine -- essentially a common sense rule that a manufacturer does not need to warn knowledgeable users of known risks -- is good news for manufacturers whose products carry risks that should be known to the professionals who use them. Yet, it does not eliminate the need for manufacturers to continue following best practices when it comes to product warnings and other customer communications.

On April 3, the California Supreme Court recognized the "sophisticated user" doctrine as a defense in product liability cases. The ruling in Johnson v. American Standard, Inc. solidified the prevailing assumption that explicit product warnings are not necessary if the user understands or should understand the risks or dangers inherent in using the product.

The specific case was brought by a trained, certified HVAC technician who claimed that his exposure to hazardous gas used in HVAC systems caused him to develop pulmonary fibrosis. He argued that the manufacturer of the product was negligent and liable for failure to warn him of those hazards.

The Supreme Court disagreed, upholding a lower court ruling that, because the technician was certified and had received training that included warnings about the hazard, he should have understood the risks and acted accordingly. The Supreme Court further recognized that the buying customer has the responsibility to ensure its employees who routinely use the products in their occupations understand any known risks and hazards, reasoning, "[t]he failure to provide warnings about risks already known to a sophisticated purchaser usually is not a proximate cause of harm resulting from those risks suffered by the buyer's employees or downstream purchasers."

This decision is welcome news for manufacturers who sell their products in California or are subject to toxic tort or mass tort lawsuits. While other states already utilize the "sophisticated user" doctrine, California has been a dangerous jurisdiction for manufacturers due to large jury verdicts and an increasing number of plaintiffs from other states seeking to file their lawsuits there. The Johnson decision helps to temper the likelihood that plaintiffs will bring similar suits there in the future as it is anticipated that this defense can be applied to other failure to warn claims, including those in toxic tort and mass tort lawsuits.

While manufacturers should hail the Johnson decision as an important tool against frivolous lawsuits, in no way should manufacturers believe it completely absolves them of responsibility when it comes to disclosure of product hazards and good communication with customers.

As the Supreme Court recognized, not all warnings lead to user safety and requiring manufacturers to warn of every conceivable risk would "invite mass consumer disregard and ultimate contempt for the warning process." Thus, it is important that product manufacturers follow best practices when warning about product hazards or risks and strive to maintain the balance between necessary warnings and overwarning.

To ensure that product warnings comply with best practices, a company should:

  • Review on a regular basis its existing warnings and ensure they reflect current safety, industrial hygiene, and medical knowledge;
  • Understand the laws, regulations and legal decisions, including foreign regulations if the product is sold outside the United States, governing use, warnings, training, labeling and disposal;
  • Check for published guidelines from state or federal agencies applicable to the product;
  • Adhere to industry standards, including those developed by trade associations and standards organizations;
  • Consult with legal, industry and human factors experts as necessary; and
  • Review and update any training programs and product documentation to reflect proper product use and handling instructions for the product's intended user.

Once the warnings have been updated, it is essential to retain good records. Companies should always document the sources used to advise customers about product safety, especially training programs, instruction manuals and sales literature. Further, companies should retain records of communications with customers, so if there is a need for documentation, "sophisticated user" status can be established.

While the Johnson case should give manufacturers doing business in California some comfort, the best protection is to follow best warning practices and retain documentation establishing the same.

Susan Barrett Harty is a partner in the Vorys Columbus office and a member of the litigation practice group. She develops strategies for the client's compliance with international hazardous material regulations, such as REACH, (Registration, Evaluation, Authorization and Restriction of Chemical Substances), RoHS (Restriction of Hazardous Substances Directive) and GHS (Globally Harmonized System of Classification and Labeling of Chemicals).

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