Where Personalized Medicine and Litigation (Might) Collide

Legal consequences abound at every corner in healthcare. Each month this blog discusses examples of what those consequences can be.

Over the next few months I intend to write about new technologies and how these might impact healthcare providers in terms of litigation. This month I want to discuss personalized medicine. Bear in mind that with all of these new technologies, the discussion will invariably involve—at some point—the creation, storage, and transmission of at least some electronically stored information (ESI).

Here is one definition of personalized medicine, from the US Food and Drug Administration (FDA):

Personalized medicine has a fairly broad definition, but, essentially, we’re talking about using genetic or other biomarker information to make treatment decisions about patients. These could include decisions about who should get certain kinds of therapies or specific doses of a given therapy, or who should be monitored more carefully because they’re predisposed to a particular safety issue. The terms genetics, pharmacogenetics, personalized medicine, and pharmacogenomics have been used interchangeably to mean the study of genetic variations and their influence on the way people respond to medications.

Personalized medicine made the news recently when, on April 6, 2017, the FDA allowed the marketing of 23andMe’s genetic health risk tests for ten diseases or conditions. According to a news release from the FDA, “These are the first direct-to-consumer (DTC) tests authorized by the FDA that provide information on an individual’s genetic predisposition to certain medical diseases or conditions, which may help to make decisions about lifestyle choices or to inform discussions with a health care professional.”

Let’s track the path of a hypothetical test from a consumer to a healthcare provider:

  1. The test is marketed by the manufacturer as being effective for the identification of a certain condition.
  2. The test is taken using a device provided by the manufacturer and the results are reported back to it through an app installed on a consumer’s smart phone.
  3. A consumer purchases the test from the manufacturer and installs the app on her phone.
  4. The consumer self-administers the test and the result of the test is reported back to the manufacturer through the app.
  5. The result is analyzed by the manufacturer and a certain condition is identified that is itself reported back to the consumer through the app.
  6. The consumer reviews what was reported back and transmits the identification of the condition to her healthcare provider who used the report, among other things, to prescribe a course of treatment for the condition.
  7. The condition was one that, in fact, the consumer did not have. The healthcare provider made a misdiagnosis based on, among other things, the report from the manufacturer. As a result of the treatment, the consumer suffered a serious and likely permanent decline in her health.
  8. The consumer commences a civil action against the manufacturer and the healthcare provider based on the adverse effect.

Considering these hypothetical facts (all of which we will assume to be true for this exercise), what causes of action or claims might the consumer assert?

  1. A medical malpractice claim against the healthcare provider based on the misdiagnosis or the provider’s unreasonable reliance on the analysis in making the diagnosis.
  2. A product’s liability claim against the manufacturer based on a defect in the design or manufacture of the test.
  3. Another product’s liability claim against the manufacturer based on a defect in the analysis.

This does not exhaust the possible claims. For example, there might be evidence that the app did not record the test results accurately or that there was some error in transmission of the test to the manufacturer. That error might implicate the internet service provider responsible for the transmission.

What does all this portend? First, there will be increasing volumes and varieties of ESI as personalized medicine becomes common and matures. Second, whatever ESI is created through personalized medicine, that ESI will be used to diagnose and treat patients and will become part of a record—whether or not part of an official electronic health record—and will become the subject of information governance. Third, the ESI may need to be preserved for pending or anticipated litigation and the failure to do so may have adverse consequences for the healthcare provider.


**Editor’s note: The views expressed in this column are those of the author alone and should not be interpreted otherwise or as advice.

Ron Hedges, JD, is a former US Magistrate Judge in the District of New Jersey and is a writer, lecturer, and consultant on topics related to electronic information. He is a Senior Counsel with Dentons US LLC. 

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