What is an Adverse Event Report?
If you are dealing with a possible medical malpractice lawsuit, one of the key documents that you need is the adverse event report. Your hospital will send an adverse event report to you, and you should make a copy for your lawyer. Remember, you have the right to pursue a medical malpractice lawsuit if you were the victim of negligence.
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Medically speaking, an "adverse event" is any negative health change (usually unexpected), and the term is most commonly associated with a clinical trial. This could be the side effect of a drug, an unrelated incident, or even death. In a clinical trial, patients typically sign a waiver that says they will not sue their doctors or hospitals for any adverse events that may occur, since it is a new and voluntary procedure or medication. All clinical trial adverse events are reported, by law, to the Food and Drug Administration, which will ultimately decide the validity of a treatment option for mainstream use.
Adverse events that happen outside of clinical trials can also occur. When the adverse event due to use of a drug or medical device is classified as "serious" and was unexpected, it has to be reported to the FDA and the Council for International Organizations of Medical Sciences in order to help others around the world from having the same problem. Keep in mind, though, that adverse events aren't limited to drug side effects. Anything unexpected or unnecessary and negative to your health is considered to be an adverse effect.
Adverse event reporting is not highly organized on a federal level for non-serious or known side effects. However, there are state laws in many locations that require hospitals to report adverse events. For example, as of July 2007, hospitals in California have five days to report to the California Department of Health Services certain adverse events, including death after a low-risk surgery, surgery on the wrong patient or the wrong side of the body, falls, contaminated drugs, burns while in the hospital, suicide attempts while in the hospital, and surgical devices unintentionally left in the body. Other states have similar laws. Hospitals with too many adverse events may have accreditations revoked or may even be investigated for potential closing or administration changes.
Pennsylvania became the first state to pass a law requiring hospitals to send adverse event reports to patients, giving them the details of exactly what happened. When something happens to you due to someone's negligence, whether it be the fault of a doctor, an entire hospital, a pharmacist, a drug manufacturer, etc., you have the right to pursue legal action. This is where the adverse event report will come into play. There are statutes of limitations for personal injury or wrongful death lawsuits, so you need to talk to a lawyer as soon as possible, even if you have not received your adverse event paperwork in the mail yet. During the discovery process, you lawyer can request this information so you have it on hand.
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In some cases, especially when dealing with a dangerous drug side effect, those who have filed adverse event reports with a manufacturer can band together to file a class action lawsuit. This happens when a number of people all have the same complaint against a single entity and the judge hears all the cases at once. Adverse event reporting helps connect the people who are all dealing with the same problems. Your lawyer can talk to you about potential class action lawsuits and why it may or may not be a good idea. In any case, don't discard the adverse event report the hospital sends you, even if you believe it is inaccurate or incomplete. It is an important document for your upcoming lawsuit.
