A clinical trial for an aggressive cancer treatment has raised questions about the liability for companies managing these test treatments. Nearly two dozen patients were involved in the testing for JCAR015, a new option referred to as a “rocket” treatment for those adult patients diagnosed with relapsed acute lymphoblastic leukemia. Unfortunately, five of those patients suffered swelling of the brain shortly after receiving a dose of the chemotherapy medication fludarabine.
Although fludarabine was later removed from the testing protocol, other patients suffered similar symptoms in a near mirror-image timeline months later, raising concerns again about the safety risks of such treatments.
U.S. Laws and Clinical Trials
The case law surrounding this issue can be quite confusing, which is why it’s recommended that anyone injured in a clinical trial, or family members who have lost their loved one in a recent clinical trial, consult with a lawyer first. Federal laws in the U.S. do not require that researchers pay out participants who have been harmed in these trials, but the law does outline that the consent forms used in these trials detail whether or not compensation would be available for injuries related to the research. The wording in most consent forms, however, can be vague. In addition, a consent form on which a patient would give up his or her right to sue in the event of negligence would probably not hold up in court.
However, the surge of clinical trials in the U.S. today means that more individuals are being injured and expressing their concerns about compensation. A rising number of lawyers are helping to represent the interests of injured victims of family members of patients who have lost their lives. A consent form in and of itself does not entirely absolve the research project managers and developers from all liability.
While prescription drugs and other treatments may benefit some patients, being rushed to market can come at a significant cost. If it is later learned that a company sped up the process of properly investigating any and all concerns before or during human testing, this could be presented in a legal claim on behalf of the victim.
Why You Need to Get Help with Your Juno Therapeutics Case
The issues involved in bringing forward a negligence claim like this are notoriously complex. Family members of patients who passed away in the recent Juno Therapeutics clinical trial may have the right to pursue a wrongful death lawsuit. If this applies to you or someone you know, it is best to avoid speaking with or signing any agreements from the study managers until you have had the opportunity to talk directly with a lawyer. With many complex legal issues at play regarding victim and family member rights in clinical trials, the wording of the consent form and the management of the study are critically important in determining next steps.
Given that a rising number of states have passed “right to try” laws, or those laws that encourage patients to go outside the scope of traditional medicine to pursue experimental treatments, it is likely that the legal precedents will continue to be defined as more cases come forward.
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