Wrongful Deaths in Medical Trials
When a patient agrees to participate in a medical trial, she should not have to worry that she will sustain fatal injuries as a result of her participation. However, according to a recent article in Fortune Magazine, a drug trial for an Alnylam Pharmaceuticals medication has been shut down following the death of 18 participants. When a patient agrees to participate in a drug trial, what exactly does she agree to? And when a participant in a drug trial suffers fatal injuries as a result of her participation, can her survivors file a wrongful death lawsuit?
Learning More About Clinical Trials and Patient Participation
Before we get into the facts of the recent drug trials and the participant deaths, what should you know about clinical trials? According to a fact sheet from the National Institutes of Health (NIH), clinical trials can take many different shapes, including those for new drugs aimed at treating current diseases. Specifically, the type of clinical trial in the Alnylam Pharmaceuticals case was a “treatment trial,” which is defined as a clinic trial to “test new treatments, new combinations of drugs, or new approaches to surgery or radiation therapy.” As the NIH fact sheet clarifies, “the goal of [these] clinical trials is to determine if a new test or treatment works and is safe.”
Yet clinical trials cannot simply expose patients to all sorts of unethical risks of harm. As the NIH explains, patients must first give informed consent to participating in the trial, and then most clinical trials must be approved and monitored by an Institutional Review Board (IRB). The point of the IRB is to “ensure that the risks are minimal and are worth any potential benefits.”
Alnylam’s RNA Interference Technology and Revusiran
Now that you have a bit more knowledge about clinical trials, we should move onto the specific treatment trial at issue here. What was the drug being tested by Alnylam, and can family members of injured patients seek compensation through a wrongful death lawsuit? As a report from CNBC explains, the trial involved an “experimental therapy for a rare genetic condition that can cause heart failure.” The drug being tested is known as revusiran, and it involves a type of technology called RNA interference (or RNAi). This kind of technology “prevents genes from making their designated proteins.” In the instance of revusiran, drugmakers designed it to “target the gene involved in producing the abnormal protein which causes amyloidosis.”
Amyloidosis is a frequently under-diagnosed heart condition that can be fatal, and the American Heart Association estimates that it is only diagnosed in between six and ten Americans per million every year. Yet the current incarnation of the drug intended to treat the condition may be more harmful than the condition. More patients not taking the placebo died while they were participating in the study. As a result, safety monitors recommended that the drugmaker suspend the study.
Patient Deaths and Wrongful Death Lawsuits in Aurora
In some cases of patient death, the survivors may be able to file a wrongful death claim. In Illinois, these lawsuits are governed by the Wrongful Death Act. Generally speaking, survivors must file a claim within one year of the date of the patient’s death. As such, it is important to reach out to an experienced Aurora wrongful death lawyer as soon as possible if you believe you have a claim. Contact Woodruff Johnson & Evans today to discuss your case.