Medical devices can be quite diverse; from sophisticated computerized and Wi-Fi-capable medical equipment to the most basic of medical supplies such as gloves or tongue depressors. The US Food and Drug Administration (FDA) sets requirements and oversees the Current Good Manufacturing Practice (CGMP) relative to medical devices. The FDA also evaluates the efficacy, function, and safety of medical devices before they are marketed to and used by the public and healthcare community. The Medical Device Reporting program (MDR) requires reporting to the FDA any incidents where a medical device may have contributed to or caused a serious injury or death, as well as any other deficiencies that might constitute a "defective medical device."
If the FDA determines that there is a problem with a medical device a recall can be implemented. Reasons include violation of FDA standards and/or regulations, or devices that are otherwise defective or a risk to the health of the intended user/recipient. The FDA uses a three-level system classifying the risk of harm from a medical device:
The Safe Medical Devices Act of 1990 (the SMDA) was enacted on Nov. 28, 1990. This law was precipitated by an FDA finding that a significant number of medical device recalls were required secondary to faulty product design. One study on defective medical devices recalled by the FDA found that product malfunction and manufacturer errors account for the majority of recalls.
Some categories of medical devices recalled in recent years include those used in the following fields of medicine:
We have come to rely upon and trust the integrity of medical devices used in our healthcare, and consider them generally to be safe, beneficial, and not a source of risk or harm. However, due to defective design, inadequate warnings and/or testing, improper use, or other shortcomings in medical products, many hazards exist which could result in significant injury to a patient, and even death.
If you have been injured - or suspect you have been injured - by a defective medical device, the best course of action is to speak with a knowledgeable personal injury lawyer as soon as possible. You may have a claim for compensation for your injuries, whether the device has been recalled or not. Damages you may be able to recover may include medical expenses, lost wages, lost future earning potential, pain and suffering, and other losses based upon the facts in the case.
You have a right to know what medical devices were used in your surgery or medical treatment, and which party made the decision to use the specific device. Our attorneys are well-versed in product liability matters. We can analyze the details found in your medical records and help you obtain information about your treatment, and determine who can be held accountable for the impact on your life. Potentially liable parties may include:
To recover compensation for your injuries, it may be necessary to file a lawsuit to pursue damages. This can be done as a:
To win a case and recover compensation for injuries caused by a defective medical device, you must show that:
For purposes of product liability, the device may have been defective in any of several different ways:
It is important to note that there is a time limit imposed by law on claims for injury from defective medical devices. In the state of New Jersey, the statute of limitations is two years from the date of injury (or from the date you became aware of the injury). If you fail to file within that timeframe, you may be forever barred from recovering compensation.
Blume Forte Fried Zerres & Molinari has been serving the people of New Jersey since 1929. If you or a loved one has suffered injury, a worsened health condition, or died because of a defective medical device, you can contact us to evaluate your potential claim and possibly pursue compensation for applicable damages. Our firm has represented numerous clients who were injured due to defective medical devices. Contact one of our skilled New Jersey product liability lawyers at (973) 635-5400 for a no-cost consultation and case evaluation.
If you need to consult a New Jersey personal injury attorney, you need to contact Blume Forte Fried Zerres & Molinari. The initial consultation is always free.