As genomic testing moves into the mainstream, there is an increased risk of lawsuits against healthcare providers. Medical malpractice claims could arise from the use, failure to use, or misuse of genomic information by healthcare providers. A recent review by Marchant and Lindor explored the risk of genomic malpractice. They summarize actual lawsuits over the years and outline potential areas for litigation moving forward.
According to the review, the number of lawsuits related to genetic testing has been relatively stable over time, with about 12 per year, despite increased use of these tests by healthcare providers. Yet, with >75,000 genetic testing products on the market and in a largely unregulated environment, the potential for growth in genomics malpractice cases is there.
The good news is that educating healthcare providers about the validity and proper use of genetic tests could mitigate the risk of genomic malpractice.
Potential areas of genomic malpractice
The vast majority of genomic malpractice cases to date have involved prenatal genetic testing. In more recent years as clinical applications have expanded, cases involving diagnostic, susceptibility and pharmacogenomic testing have emerged.
Marchant and Lindor outline several situations where genomic malpractice either has occurred or may occur in the future.
Failure to offer genetic screening despite indications that it was warranted
The failure to offer a test usually occurs because healthcare providers may be unaware of genetic tests currently available for early diagnosis and prevention of disease or are not up to date on recent genetic testing guidelines.