App developers may face product liability and other tort claims if apps do not function as intended. Here’s how they can protect themselves.
Elizabeth Curtin and Jana Wozniak
In the more than five years since Apple’s “There’s an app for that!” advertisements first entered the collective mind of consumers, mobile applications have grown exponentially. Health-related apps, in particular, have surged in number and diversity. Today, health-related apps run the gamut from prevention and early detection to diagnosis and treatment. While the success of health-related apps is no secret, developers may be less aware of the potential legal risks associated with these apps.
App developers will first want to consider whether their apps are actively regulated by FDA, and seek regulatory advice to understand and align themselves with FDA’s position. Whether an app is a medical device depends on the intended use of the app. Even if the app meets the statutory definition of medical device, FDA has stated that it intends to exercise enforcement discretion (meaning that it does not intend to enforce statutory requirements) for apps it considers to pose a low risk to human health.
In its February 9, 2015, guidance on mobile medical applications (superseding the September 2013 guidance), FDA provided insight on its views and specific examples of how its authority may apply to mobile medical apps. FDA defines a mobile medical app as a mobile app that meets the statutory definition of device, and is used as an accessory to a regulated medical device or intended to transform a mobile platform (such as a smartphone or tablet) into a regulated medical device.
The agency provided examples of the types of mobile medical apps that are the focus of its regulatory oversight, and ones over which it intends to exercise enforcement discretion. For example, apps that “control the delivery of insulin on an insulin pump by transmitting signals to the pumps from the mobile platform” would be among the types of apps on which FDA is focused. By contrast, FDA views apps that help patients “self-manage their disease or conditions without providing specific treatment or treatment suggestions” as low risk. According to the guidance, FDA intends to exercise enforcement discretion over this type of low-risk app.
In a separate draft guidance, released January 20, 2015, FDA discussed “general wellness” products, described as products that help maintain or encourage general health or healthy activity, or promote, track, and encourage choices to help reduce disease risks. According to the draft guidance, FDA does not intend to determine whether low-risk general wellness products are regulated medical devices or, if they are devices, whether the applicable regulatory requirements are met.
FDA appears posed to take a hands-off, or nearly hands-off, approach to apps that pose a low risk to health. But whether an app is considered a medical device or the subject of FDA’s enforcement focus, app developers that make unsubstantiated claims may find themselves in the spotlight of the Federal Trade Commission (FTC). In 2015, the FTC announced a settlement with marketers of two apps related to melanoma, the deadliest form of skin cancer. According to the FTC, both apps claimed to provide an “automated analysis of moles and skin lesions for symptoms of melanoma and to increase consumers’ chances of detecting melanoma in its early stages.” The FTC alleged that the claims were deceptive, and the marketers lacked adequate evidence to support such claims. In a press release on the FTC Web site, the director of the FTC’s Bureau of Consumer Protection reiterated that “[a]pp developers and marketers must have scientific evidence to support any health or disease claims that they make for their apps.”
In the litigation arena, app developers may face product liability and other tort claims if apps do not function as intended. At its most basic level, product liability is the legal theory that allows an injured person to seek damages from the manufacturer or seller of a product that purportedly caused the injury. By definition, product liability applies to products, which brings to mind tangible items, like a toaster or a car. Product liability does not apply to services, such as medical care or legal advice. So what does this mean for health-related apps?
The most analogous comparison is to software and computer programs, and there is precedent for product liability claims involving software failure that causes personal injury. For example, injured plaintiffs have brought claims against the manufacturers of an airplane ground proximity warning system for its alleged role in a plane crash, and a computerized energy management system blamed for the inaction of an exhaust fan that led to toxic fume inhalation.
Product liability claims involving health-related apps are likely to fall into one of two categories:
- Design defect, which would involve allegations that the app was defectively created.
- Failure-to-warn/Warnings defect, which would involve allegations that the app warnings or instructions did not adequately warn about the potential risks of the app. This type of claim could also involve allegations that the consumer was not instructed on the proper use of the product.
Here are some examples of how a health-related app could potentially result in product liability litigation:
Diagnosing Disease. Imagine an app intended to diagnose a viral skin condition that, if untreated, can spread and become disfiguring. The app is advertised to help consumers identify the skin condition but advises (briefly) to “see a doctor for diagnosis.” Imagine next that a consumer used the app, decided he did not have the condition, and did not see his doctor. The consumer then finds himself with an advanced case of the condition and suffers scarring, so he sues the app developer. He might claim design defect, that the app is inherently faulty because it did not accurately diagnose the condition. He could allege that the defective design led to the failure to diagnose his condition and his disease progression. He might also claim failure to warn, alleging that the warnings did not adequately communicate that the app was not a replacement for a doctor’s visit.
Failure to Remind. If a pharmaceutical manufacturer marketed an app that reminded patients to take their medication on an appropriate schedule, and it malfunctioned such that a patient failed to take his medication on time and experienced side effects, the patient might claim design defect, or allege that the developer or pharmaceutical manufacturer failed to warn of the consequences of relying too heavily on the reminder app.
Faulty Monitoring. If an app is intended to monitor a body function, such as heart rhythm, and the person experiences irregularities not detected by the device, this could result in design defect or failure-to-warn claims, just as would be expected with any similarly functioning medical device.
If the app falls into a category FDA deems low risk, this will not dispose of a product liability claim, but it may support the developer’s defenses.
Product liability claims are not the only legal claims that could arise from the malfunction of a health-related app. Other legal claims, which are often paired with product liability claims, include the following:
- Breach of Implied or Express Warranty. Warranties are statements concerning a product in a commercial transaction.
- Misrepresentation. Misrepresentation claims that misstatements were made about a product, and that the product user or purchaser acted in reliance on those statements.
- Violation of State Consumer Protection Laws. Many states have consumer protection laws that provide remedies for defective products. Such laws may not require physical injury but may require economic injury. The applicability of state law will depend on where the app was used and purchased, among other things.
These claims may seem far-fetched for health-related apps, but with the widespread use and increasing number of these apps, the likelihood for litigation increases. The following are tips for health-related app developers to mitigate these litigation risks:
- Identify and inform consumers of potential risks associated with the use of the app.
- Provide clear instructions for safe use of the app.
- Clearly state (and do not overstate) the app’s intended use. If appropriate, clearly state what the app does not do (e.g., “This app does not diagnose disease or replace the opinion of your medical provider.”).
- Utilize experts to ensure appropriate communication of warnings, disclaimers, and instructions.
- Obtain regulatory advice on how FDA classifies your app and your regulatory obligations.
- Conduct legal, medical, and regulatory review of advertising and promotional messaging of the app, and document review of same.
- Promptly detect “bugs” and timely release updates.
- Implement a process for documenting and investigating consumer complaints.
- Validate and verify design changes and corrections.
- Stay abreast of regulatory and legal developments with health-related apps because what you don’t know, can hurt you.
|Don't miss the digital health innovation tour at MD&M East in New York City on June 10, 2015.|
Elizabeth Curtin is a partner in the Product Liability Group at Sidley Austin LLP in Chicago. Reach her at [email protected]
Jana Wozniak is a partner in the Product Liability Group at Sidley Austin LLP in Chicago. Reach her at [email protected].
[image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]