COVID-19, Duty to Warn, and Potential Product Misuse
Under the law of most, if not all, U.S. jurisdictions, product manufacturers are required to provide product-related warnings associated with foreseeable uses of their products. The law in most of these jurisdictions also extends the duty to warn to reasonably foreseeable misuses of a company’s products. But, generally speaking, misuses that are not reasonably foreseeable do not require a warning – product manufacturers are not required to dream up and warn against every theoretical possible misuse of their products. While the duty to warn with respect to life sciences products may also be influenced by regulatory and/or statutory requirements, these general common-law principles governing failure to warn claims are not inapplicable to life sciences companies.
One of the predictable, but positive, responses to COVID-19 has been the search for effective ways to combat the spread of the virus and to treat those who have become infected. Americans are creative, and it is therefore no surprise that some have suggested novel uses of existing products or medications in the fight against COVID-19, while others have (mis)interpreted public and/or media comments to suggest (mis)using some products in otherwise-dangerous ways.
Americans are also litigious, and another predictable result of COVID-19 will undoubtedly be a rise in legal claims. Many of those claims are easy to anticipate, such as a plaintiff claiming to have been exposed to and infected by COVID-19 due to the negligence of someone else or the failure of a particular product.
But what of a person who attempts to use a product or medication as a novel treatment or prophylaxis for COVID-19, only to become injured by the product or medication itself? Recent news stories, for example, have included reports of increased calls to poison control centers about internal exposures to various cleaning products, as well as reports of people ingesting chloroquine-containing products intended to treat aquariums. Should the manufacturer of the product or medication have foreseen this, and included warnings with respect to the potential dangers of such a use? Or would the use be considered an unforeseeable misuse, such that the manufacturer would not be held liable for failing to warn against it?
As with most legal questions, there are arguments to be made on both sides. However, manufacturers of some products have proactively issued public statements or press releases, warning consumers against (mis)using their products in certain potentially injurious ways. Whether this turns out to have been prudent prescience that helps avoid future failure-to-warn claims remains to be seen, but product manufacturers may wish to consider this potential risk among the many others presented by the current COVID-19 situation.