Defective Medical Devices

Medical devices are used to ease pain, help with disabilities and save lives. However, when these devices are flawed they may cause serious injury and death. Some medical device defects may include faulty design or insufficient manufacturing quality and are considered instruments used for treatment, diagnosis or prevention of disease or injury. The FDA categories of devices are complex and widely varied and many of the adverse effects of medical devices are preventable. If you believe you may have a claim for injuries caused by a medical device, contact our firm today to schedule a consultation with an attorney to discuss your options.

What is a defective medical device?

A defective medical device is an instrument that is flawed in design, manufacture, inadequate instructions or insufficient warnings. The likely risk of injury caused by the medical device is great compared to its possible benefits. According to federal statute, a medical device is a recognized instrument or apparatus that is intended for use in a humans or animals to cure, treat or prevent a disease or ailment and does not reach its intended purpose.

Types of Defects

There are different types of defects associated with medical devices. Some instruments may be considered unavoidably unsafe products. A device is unavoidably unsafe when it cannot be made completely safe, but its value and benefits surpass the potential risks. It is determined that in order to continue to research and develop new medical products, it is necessary to make unavoidably unsafe products available on the market. These are available as long as they have adequate warnings and are not deemed defective due to faulty manufacturing.

Another defect may be in warnings to physicians and to consumers. The prescribing physician must be warned of any dangerous potential risks associated with a medical device. The doctor then weighs the potential risks against the benefits of the medical product. The physician may be considered the “informed intermediary” between the manufacturer and the patient. Warnings are made in accordance with the FDA in the Physicians Desk Reference and package inserts on medical products. The doctor is knowledgeable in medicine and uses that knowledge to consider the warnings, how the warnings may affect their patient and to proceed as they best see fit. The manufacturers have a legal duty to warn doctors of potential risks associated with a drug or medical device. The risks must also be current and updated when necessary as to make the warnings complete and clear. Manufacturers do not have a duty to warn the patient of any risks. The doctor receives the warning and will explain any potential risks to their patients.

As with drugs, the FDA also tests medical devices and give approval before they are on the market for consumers. Some defects may come from inadequate testing and rushing the approval process to get a product on the market. Pressure on the government to approval new medical devices comes from companies as well as from the public. Things may be missing during testing as a result. There are also defects that do not become apparent until a product is in use for a period of time. These long-term defects are difficult to determine during short-term testing to approve a device for consumer use. For this reason, the FDA monitors medical devices once they are on the market. When a dangerous defect or risk is discovered, the instrument is recalled.

Common Defective Medical Devices

There have been common defective medical devices in the news the past decade. The categories of those devices are as follows: Cardiology (pacemakers, heart valves and stints), Contraceptive devices (IUDs), Cosmetic (breast, penile implants), Orthopedic (bone and joint screws, rods and plates), Surgical Tools and Therapeutic devices (catheters and tubing). These devices are used to help people and save lives every day. Although they are commonly used, it is important to be aware of what medical devices you are using and keep up to date on any negative issues that may come up over time with prolonged use of any instrument. Some medical devices that have been found as defective are as follows:

• Artificial disk
• Artificial knee joints
• Artificial hip replacements
• Composix Kugel Mesh Patch (hernia repair)
• Defibrillators (ICD)
• Heart stents
• Heart valves
• Implantable contraceptives and intrauterine devices
• Infusion pumps
• Medicine pumps
• ObTape Sling
• Pacemakers
• Silicone implants

While it is important to ask your doctor about any medical device you are using and rely on the news to keep up to date on any problems with medical devices, it is also important to monitor how you are feeling. If something has changed or you have any concerns about your medical care, bring those concerns and questions to your doctor. However, if you believe you have been injured by a faulty medical device it is important to seek legal assistance. If you believe you may have a claim for injuries caused by a medical device, contact our firm today to schedule a consultation with an attorney to discuss your options.

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