With the advancements of technology and artificial intelligence, the past decade has witnessed a number of new drug discoveries and several milestone innovations in medical devices. In order to be sold in the United States drugs and medical devices must be approved by the Food and Drug Administration (FDA). However, approval does not ensure the safety of a medication or medical device. In reality, a product flaw, incomplete labelling, or insufficient warnings might result in bodily, psychological, or emotional harm.
A disastrous surgical operation; prolonged pain and weakness; an inability to return to work or resume regular activities – these are just a few of the potential problems that might arise as a result of hazardous medicines or medical equipment. Defective medical products can have a significant negative influence on your life and the lives of your loved ones. In many situations, the damage generated by particular medications or devices is more debilitating than the condition that led to their administration in the first place.
Despite strict standards and testing on medical products, these devices can fail or be defective, proving dangerous or life-threatening in some cases. There can be unexpected issues with medical devices used in the treatment of patients - faults can occur in either the design, manufacture or application of the device. If you or a loved one have suffered medical device complications requiring hospitalization or corrective surgery, you may be entitled to compensation for medical costs and other expenses. To read more about this, please click here.
Every year, drug companies introduce new life-saving medications to the market. Despite new drugs going through a rigorous Food & Drug Administration (FDA) approval process, serious side effects may go undetected in clinical trials. In fact, many FDA-approved drugs have been linked with serious medical complications. If you have had serious complications or were hospitalised as a result of an adverse drug event, or if a family member died as a result of prescribed drug-related complications, you may be entitled to financial compensation for medical expenses, lost income, pain and suffering, and other costs incurred due to these devastating side effects.
Drug Recalls, Warnings & Alerts
In recent years, several drugs and dietary supplements have been linked to serious health problems, clearling outweighing their potential benefits. According to the Journal of the American Association, adverse drug reactions resulting from correctly administered Federal Food and Drug Administration (FDA)-approved prescription drugs are responsible for over 100,000 deaths per year in the United States making it the fourth leading cause of death in the United States.
There are also typically over 2 million annual occurrences of non-fatal, but serious, reactions, and millions of complications and disabilities related to the unexpected effects of drugs and a variety of products.
The Food and Drug Administration (FDA) is responsible for ensuring the safety of a variety of products, including drugs, medical devices and foods. A RECALL is an action taken to remove a product from the market. Recalls are conducted by FDA request or on the initiative of the manufacturer. In many recall situations (Class I Recall) there may be a reasonable probability that the use of or exposure to a product will cause serious injury or death. A Class II Recall is a situation where use or exposure to a product may cause temporary or medically reversible injury. The recall of a defective or harmful consumer product is sometimes publicized in newspapers and in news broadcasts. This may be especially true when a recall involves drugs, medical devices, foods or other products regulated by the FDA. The FDA seeks publicity about a recall only when it believes the public needs to be alerted about a serious hazard.
The FDA expects companies to take full responsibility for product recalls, including follow-up checks to assure that recalls are successful. FDA guidelines call on manufacturers to develop contingency plans for product recalls. After a recall is completed, the FDA makes sure that the product is destroyed or suitably reconditioned and investigates why the product was defective.
A SAFETY ALERT is issued in situations where a medical device or product may present an unreasonable risk of substantial harm. In some cases, these situations are also considered recalls.