Going Paperless: What Manufacturers Need to Know Before Digitizing Warnings

Faegre Drinker Biddle & Reath LLP
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Faegre Drinker Biddle & Reath LLP

By the time the COVID-19 pandemic began, society was well into the so-called “Digital Age,” relying heavily on electronic communications, apps, websites, and the like to go about daily activities. Everything from ordering food to taking the bus to work could be achieved and tracked through a simple app. During the pandemic, the reliance on electronic mediums went from preferable to necessary, as many businesses shut down and transitioned to a remote or online-only presence.

The escalation of the digital age has led some manufacturers to consider electronic warnings for their products, through the manufacturer’s website, by providing a QR code, or by recommending (or requiring) the consumer to download an app. Even the American National Standards Institute (ANSI) has bought into digital warnings. ANSI’s Z535 standards provide guidance for product manufacturers related to the size, content, and location of warnings. Recently, ANSI created a subcommittee on warnings in electronic media and is in the process of developing a new standard, ANSI Z535.7, for safety information in electronic media. This new standard is expected to be published by December 2022. The FDA has also recently utilized electronic means to communicate information regarding the COVID-19 vaccines. In October 2021, the FDA published three Consumer Fact Sheets for the three currently authorized vaccines on its website and included a QR Code linked to the “most recent” COVID-19 Vaccine Fact Sheets.

Of course, there are many benefits to the publication of warnings and other safety information electronically. Warnings that exist in electronic form, either online or in an app, cannot be lost or discarded by the consumer. Electronic warnings can also be updated to provide new or additional safety information, and that information could be (at least theoretically) communicated to the consumer instantly using push notifications, text messages, or emails. Providing information in electronic form may also be easier for the consumers to digest, as electronic communications and web-based apps have become more familiar to many consumers than printed information.

However, providing warnings via an electronic medium is not as easy and instantaneous as it may sound. There are a number of implications that manufacturers of consumer products, medical devices, pharmaceuticals, and other products must consider before going paperless with their warnings.

For example, in the context of consumer products, there may be purchasers without smartphones or who are otherwise not tech savvy. If the manufacturer of a product has gone digital, it must provide a means for the consumer to access the warning and safety information outside of the digital context (for example, by calling a customer service number and requesting the information to be mailed). However, the steps necessary to obtain a hard copy of the warning information may be a barrier to some customers receiving the pertinent safety information. Additionally, providing a QR code on the product or product packaging does not guarantee that the consumer will take the necessary steps to scan the code and read the linked information. Whether the consumer does not see or understand the QR Code, or sees and ignores it, the manufacturer risks that the safety information will not actually reach the consumer. Further, manufacturers must also consider the transfer of a product to another consumer. On-product warnings have the best chance of being viewed by any user of the product (versus just the original purchaser), and manufacturers should consider keeping the most important safety warnings directly on the product.

In addition to the above considerations, manufacturers should also be cognizant of consumer protection laws, which place limitations on a manufacturer’s collection and use of consumer information. A web-based app, for example, may require the consumer to input his or her name and email address, and such activity is likely to be governed by federal or state consumer protection laws.

For medical devices or drugs, there are additional challenges posed by a move to primarily digital labeling. First and foremost, FDA’s regulations and processes governing labeling changes have not evolved to deal with the new possibility of updating a product labeling in a purely digital form. Therefore, changes made to labeling would have to comply with FDA’s regulations and guidance documents before being digitally implemented.

In the litigation context, the drug/device package insert is central to a failure to warn claim. Companies would need processes to track which version of a digital label was in effect at a particular date. Additional investigations would be needed to determine the relevant labeling because the date of manufacture may not be the sole consideration in identifying the relevant label. For instance, if a QR code landing site was updated after manufacture, the relevant date could be the date of use of the product. For home use devices or over-the-counter drugs, determining the date a patient first used the medical product could be even more challenging without the help of pharmacy or medical records.

Thinking through multiple aspects of a company’s processes related to updating digital labeling will be crucial to developing a robust (and hopefully defensible) system. Imagine a scenario in which some of the company’s products are changed digitally to include positive information such as new medical journal articles, but less positive changes are made much more slowly (and perhaps for very good reasons, such as submitting information/applications to FDA before implementing a change). Not implementing digital labeling uniformly across products could become central to painting an unflattering portrait of a manufacturer in litigation.

While digital labeling could bring many benefits in increasing product education to consumers, patients, and doctors, a company should thoughtfully consider the ways their current processes would be impacted and the complications that could follow in the event litigation occurs. The future of product warnings and safety information may very well be digital, but additional guidance and legislation is needed before industries pivot to paperless.

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