Before legal drugs are approved by the United States Food and Drug Administration (FDA) and put on the market, they are usually put through clinical trials by the manufacturer. In a clinical trial, the company seeks to discover how the medicine reacts in humans, and how well it treats the target condition. Unfortunately, it is not uncommon for subjects in the trial to experience unexpected side effects, and sometimes end up in a worse condition than before. Because of the consent forms and other documents clinical trial participants sign when entering the trials, it may become more difficult to seek compensation when injured.
Generally, when a person enters a drug clinical trial, he is already suffering from the disease or condition that the test is seeking to cure. So, when the person suffers injuries during or after the test, it may be difficult to attribute the injuries to the test as opposed to the disease itself. Injuries during the test could include a rapid increase in the development of the disease, or a development of new symptoms not previously experienced. In some cases, a person participating in a clinical test may die.
Participants are usually required to sign numerous forms and contracts when joining a clinical trial. Among these forms are consent forms where the participant agrees to receive the treatment provided in the clinical trial and acknowledged that experimental nature of the treatment. Under federal law, participants in a clinical trial must be informed of the benefits and the side effects or danger involved in taking the medication. Therefore, the consent form may inform the potential participant that if he is injured, he will receive treatment for the injury, and no other form of compensation.
Signing a consent form or a contract for a clinical trial does not mean that if the participant is injured as a result of negligent conduct he cannot choose to file a lawsuit that is separate from the offered compensation. Therefore, before deciding whether to pursue a claim to not, an injured participant should consult with an experienced attorney.
Before signing up for a clinical trial, it is important to ensure that the trial is legitimate and approved by the FDA. In addition, make sure that you have consulted with your physician and have been advised of the dangers of participating in the trial as well as the benefits. Patients must also remember that they are free to leave the clinical trials in most cases, even before the trial is over. If they notice adverse side effects, they should immediately consult their doctor.
Contact an Experienced Personal Injury Attorney
When a participant realizes that he has been injured in the test, it is important to consult with an attorney right away. Trying to get compensation directly from the organization or company running the trial may not be as effective, and may result in you getting a smaller settlement than you are entitled to. Call us at Vocelle & Berg, LLP, in Vero Beach, Florida for a free consultation with a personal injury attorney.
Resource:
fda.gov/ForPatients/ClinicalTrials/ucm20041753.htm