Advances in genetic testing have opened the door to personalized medicine—letting doctors predict health risks, tailor treatments, and diagnose hereditary conditions. Yet with that promise comes a hidden danger: what if a genetic test is misinterpreted, misreported, or handled negligently? The consequences can be devastating—leading to unnecessary surgeries, incorrect treatments, emotional trauma, or delayed diagnosis of serious illnesses.
At Alan Ripka & Associates, we believe patients deserve accountability when innovations in diagnostics cause harm. In this blog, we’ll explore whether you can sue for injuries caused by genetic testing errors, the challenges involved, and how to pursue compensation when the results go wrong.
What Types of Genetic Testing Errors Cause Harm?
Before discussing liability, it’s important to understand the kinds of mistakes that might give rise to injury:
- Misinterpretation or misreporting of test results — A lab returns a “negative” result, but the variant was present; or a clinician misreads the report, leading to incorrect clinical decisions.
- Failure to order appropriate genetic tests when indicated by medical history or family risk.
- Laboratory handling errors — sample contamination, mislabeling, chain-of-custody failures or technical failures during sequencing.
- Delayed reporting or failure to communicate results to patients, leading to loss of “chance” for earlier intervention.
Any of these can lead to real damage: unnecessary surgeries, improper medication, missed opportunities for preventive care, or increased disease progression.
Legal Basis for Suing Over Genetic Testing Errors
If you believe you’ve been harmed by a genetic testing error, these are the primary legal theories under which a lawsuit may be possible:
Medical Malpractice / Professional Negligence
If a clinician or genetic counselor fails to act with the standard of care—by misinterpreting results, failing to order necessary tests, or failing to communicate results—you might claim medical negligence. Courts have recognized that physicians can be liable for wrong genetic interpretations.
Laboratory or Technical Malpractice / Product Liability
Genetic testing labs may be liable if their equipment or protocols are defective, or if they fail to maintain proper standards (e.g., under Clinical Laboratory Improvement Amendments, or CLIA).
Loss of Chance Doctrine
In some jurisdictions, you can recover damages not only for a full harm but also for a lost chance—i.e., the opportunity for earlier detection or better prognosis was lost because of the error.
Wrongful Birth / Wrongful Life Claims
In cases involving prenatal genetic testing, parents may claim that had correct testing been done, they would have made different decisions (such as termination or early interventions). These cases are controversial and vary greatly by jurisdiction.
Challenges You’ll Face in a Genetic Testing Injury Claim
Suing over genetic testing errors is often more complex than traditional medical malpractice. Here are the major hurdles:
Establishing Causation
You must show that the error directly caused or significantly worsened your injury or outcome. Because genetic conditions are often probabilistic, proving that the misinterpretation or delay changed your prognosis can be challenging.
Proving Standard of Care
Courts require expert testimony to define how a competent provider should have interpreted or ordered the test under similar circumstances. Given the evolving nature of genetics, what is “standard” may be contested.
Complex Scientific Evidence
Genetic data and variant classifications are highly technical. You’ll need genetics experts who can explain how an error occurred and its clinical impact in terms a judge or jury can understand.
Statutes of Limitation & Timing
Delays or nondisclosure may trigger timing issues. Some claim delays in disclosing results can toll (pause) the statute of limitations, but this depends heavily on jurisdiction.
Privacy and Genetic Discrimination Protections
Under the Genetic Information Nondiscrimination Act (GINA), use of genetic information by insurers or employers is restricted. However, GINA does not bar malpractice claims—it covers discrimination, not negligence.
Key Steps to Pursue a Claim
If you believe you have a case, here are crucial early steps:
- Collect all records — genetic test reports, lab communications, clinician notes, consent forms.
- Consult genetic and medical experts to review whether the test was indicated, interpreted properly, and communicated.
- Document how harm occurred — Did you receive wrong treatment? Was diagnosis delayed? Did you undergo unnecessary procedures?
- Consider your jurisdiction — genetic malpractice law is still developing; some states are more receptive than others.
- Engage experienced legal counsel familiar with medical-genetic cases to navigate both scientific and legal complexity.
Examples of Real Cases & Lessons
A prominent case involved a woman who underwent double mastectomy and hysterectomy after being told her genetic test was positive for cancer gene variants—only to later discover the test was negative. The lawsuit claimed misinterpretation led to unnecessary surgeries.
In academic literature, genetic malpractice claims are increasingly discussed. Some courts have considered loss-of-chance actions in genomic medicine.
These cases underscore the high stakes: bodily integrity, life-altering surgeries, emotional damage, and lifelong consequences.
What You Might Recover
If your case succeeds, possible damages may include:
- Medical costs (corrective surgeries, treatment of consequences)
- Past and future lost income
- Pain, suffering, emotional distress
- Costs of ongoing care or monitoring
- In wrongful birth cases, lifelong care and special education costs
Punitive damages may apply in rare cases involving gross negligence or recklessness.
Limitations & Defenses
Healthcare providers and labs often assert defenses such as:
- Informed consent — the patient was warned of possible uncertainty in genetic interpretation.
- Good faith judgment — the provider’s decision was reasonable under current scientific knowledge.
- Genetic uncertainty — variant classification is evolving, and many tests carry ambiguity.
- Comparative fault — arguing that you or another physician contributed to the harm.
Because genetics is in flux, defendants may claim that the error was within accepted limits of scientific uncertainty.
The Future of Genetic Testing Liability
As genetic medicine becomes more routine, courts and statutes will likely evolve to address its risks. Key drivers include:
- More standardized variant classification systems
- Enhanced regulation of labs under CLIA or FDA oversight
- Greater court receptivity to loss-of-chance claims in genomics
- Technological safeguards (automated checks, AI validations) reducing simple human interpretive errors
Patients and attorneys must stay ahead of these trends to hold negligent parties accountable.
Conclusion: You Can Seek Justice—Even in Genetic Harm
Genetic testing holds great promise, but with promise comes responsibility. When errors or misreporting result in harm, injured individuals may deserve redress. The path is complex, but not impossible. With expert analysis, legal strategy, and scientific evidence, a strong claim can be built.
At Alan Ripka & Associates, we are prepared to take on these challenging but vital cases. If you or a loved one have been harmed because of genetic testing errors, don’t wait.
📞 Call us today at (212) 661-7010 or visit AlanRipka.com to schedule a free, confidential consultation.
We will review your case, explain your legal options, and fight to hold negligent parties accountable.
