Product Liability and Medical Devices

The medical device industry rakes in millions of dollars each year for products that are poorly tested due to a lack of strict regulations. According to a recent article in the New York Times, approximately one in 10 Americans have at least one medical device in their bodies, such as stents, pacemakers, heart valves, and more. On one hand, these devices are medical miracles that have improved and lengthened the lives of many. On the other hand, many are harmed because they have no guarantees about how safe the devices prove in the long run, nor how well they actually work.

The Food and Drug Administration (FDA) requires testing any medical products, whether drugs or devices, before they are approved, but most medical devices have not undergone any clinical testing because of two loopholes:

• 501k pathway – Manufacturers bring devices to market by saying the new product is “substantially equivalent” to a device that is already being used on the market.
• Supplement pathway – Manufacturers bring devices to market by telling the FDA that they made a small change to a device that is already on the market.

If you have had medical issues with any implanted medical devices, or someone you love has died because of a faulty device, contact an experienced products liability lawyer at The Florida Law Firm in Tampa. Call 813-463-8880 to schedule a free consultation.

What Types of Injuries Are Associated With Defective Medical Devices?

The types of injuries associated with defective medical devices vary based on the location of the implant, but some examples of common implants and their accompanying injuries can include:

• Cochlear ear implants that caused severe electric shocks in the heads of children resulting in convulsions, vomiting, and permanent ear damage
• Breast implants that ruptured and caused illness
• Metal-on-metal hip replacements causing fractures, dislocations, pain, and more
• Faulty pacemakers and defibrillators recalled because they may lead to death

Who Can Be at Fault?

If you are injured by a defective medical device, several parties may be held liable. This isn’t about choosing one responsible party—any party that takes part in bringing the product to market and may be held accountable in a medical device product liability claim. An attorney can help identify potentially responsible parties, and devise the best way to pursue compensation in a product liability case. Common defendants include:

Manufacturer

This is most likely a large firm that was involved in the design or marketing of the defective device.

Laboratory

While most devices have not undergone medical trials, they have been sent to a testing laboratory. If the lab is independent of the manufacturer they may also hold liability.

Medical Device Sales Representative/Retailer

Most medical device companies employ sales representatives who travel around to hospitals and recommend devices to doctors. The representative that recommended your implant may be liable in a lawsuit. If you purchased your device from a retailer or pharmacy, they may also be held liable.

Hospital and Doctor

If your doctor recommended your medical device, and also failed to warn you of dangers or provide you with instructions, he or she may be held liable as well. The hospital also may be liable by association depending on the facts of the case.

What Kind of Damages Might Be Recovered When a Medical Device Injury Occurs?

The most common awarded damages in products liability claims include:

• Medical expenses associated with your injury including hospitalization, ambulance rides, surgery, x-rays and other scans, medication, and physical therapy
• Future medical costs that are related to your device including long-term care and rehabilitation
• Pain and suffering caused by your defective device
• Lost wages because you missed work as a result of your injury
• Loss of future wages because of long-term damage caused by your defective implant that prevents you from working

Product Liability Lawyer in Tampa, Florida

If you live in the Tampa area, and you or a someone close to you has been injured because of a defective medical device, let a skilled attorney who specializes in products liability worry about the details of the case. Call The Florida Law Group at 813-463-8880 or contact us online to schedule a free consultation.