Mobile apps have become part and parcel of the daily life of people all over the world, with manufacturers developing apps that cater to diverse interests and needs. According to the App Association’s State of the App Economy, 4th edition, the app economy has grown from $1.9 billion in 2008 to $143 billion in 2016. It is interesting to note how quickly the market for medical and health apps has grown in keeping with the emergence of a highly tech-savvy and health-conscious population. Many of these apps collect, store, analyze and transfer the personal and medical information of individuals. Mobile apps have been developed keeping both patients and providers in mind and these enjoy huge popularity. However, there has also been a corresponding increase in product liability exposures, as product liability lawyers would know. Consumers have certain rights when they buy a product, and the most important among them is the right to be safe when using the product. If the product causes an injury to the consumer, a lawsuit arises seeking compensation for the injury and trauma. The injury has to be established via a detailed medical records review and the compensation available will be determined by the circumstances of individual claims. Typically, compensation can be sought for lost wages, medical expenses, pain and suffering, and reduced earning capacity.
Mobile Apps as “Products”
So are apps “products’ in the traditional sense? They are software and not tangible things or objects that come under the purview of products. According to the Ninth Circuit, ‘where the predominant factor of the software transaction is the exchange or provision of goods, and services such as employee training, repair and system upgrades are merely “incidental to sale,” the software is properly characterized as a good, the sale of which is governed by the UCC (uniform commercial code).’ Courts applying this predominant factor test consider that “mass-produced, standardized, or generally available software, even with modification and ancillary services included in the agreement, is a good that is covered by the UCC.” Going by this, apps that are standardized applications available to any mobile device through an online marketplace may be viewed as products.
Examples of popular mobile apps include:
- Prescription refill apps offered by major pharmacies
- Apps that remind contact lens wearers when to replace their lenses
- Heart and blood pressure monitor apps
- Blood sugar monitor apps
- CPR instructional apps
The risk of using these apps is that many of these do not have any authenticated data compared to accepted standards. It is not clear how these apps operate because such information is protected under patent. Another issue is that people depending on these apps may even forego the required medical treatment and end up facing serious health risks.
The Question of Mobile App Injury
If a mobile app causes an injury to a consumer, will the manufacturer be held responsible for it? Just as in the case of other products, are they required to warn the consumer of any indirect injury or distraction the app may cause? On September 25, 2013, the FDA issued its final guidance regarding how it plans to regulate mobile medical apps under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
- The FDA would focus on mobile medical apps whose functionality poses a risk to patient safety if the app malfunctions.
- Mobile apps that meet the definition of “device” and are used as an accessory to a regulated medical device, or used to transform a mobile platform into a regulated medical device will be regulated. The mobile app is a device if it is used for the diagnosis, cure, treatment or prevention of disease.
- However, some apps that have a medical/health focus but do not meet the definition of a “device” will not be regulated by the FDA. These include apps that are intended to be used as educational tools for medical training, those meant for patient education, those that are intended to automate general office operations in a healthcare setting, and those that provide electronic access to medical device instructions or labeling.
Mobile Apps May be Bound by Tort Liability Laws
Medical apps that are medical devices may be bound by the same laws of tort liability applicable to traditional medical devices – these would include strict products liability, negligence, misrepresentation and breach of express or implied warranty. Whether the FDA classifies them as high-risk or low risk, medical apps cannot eliminate the risk of liability totally. As “products,” regulated as well as non-regulated apps may be bound by applicable state consumer product laws that provide a private right of action for both economic and non-economic injuries caused by violations of federal or state consumer protection laws.
The FDA requires manufacturers of mobile medical apps to be compliant, the term manufacturer would include any entity/person that commences specifications, designs, labels or creates a software system/application for a regulated medical device. A person/entity that creates a mobile medical app by using existing off-the-shelf software and markets the product to function as a mobile medical app also falls within the definition of manufacturer.