Medical Devices Injury Law
Millions of people suffering from various conditions such as heart disease, arthritic or injured hips and knees, backs and other ailments have come to rely on medical devices to relieve their pain and to give them an opportunity to experience a normal and pain free life. The medical device industry is massive, with companies reaping billions in profits each year with many devices being rushed to market after pressuring the FDA to approve their products without the standard and lengthy clinical approval process.
Unfortunately, profits often take precedence over safety and efficiency. In the medical device industry, this fact has come true all too often. Some of the medical devices that have been recalled or are the subject of class action or multi-district litigation (MDL) in recent years include:
- DePuy orthopedic devices including the Articular Surface Replacement (ASR) XL Acetabular system and LCS Duofix Femoral Component
- Zimmer Durom Cup (metal hip implant) and NexGen CR Flex (artificial knees)
- Stryker Rejuvenate and ABG II modular-neck hip stem systems
- Transvaginal mesh (for pelvic organ prolapse and stress urinary incontinence)
- Mirena intrauterine device
- NuvaRing birth control device
- INFUSE bone grafts by Medtronic (used in spinal fusions for people with degenerative bone disease or arthritis)
These and other medical devices fail because of a flaw in the manufacturing process, initial design or in how and to whom the product is marketed. Product liability principles apply to any product defect that is deemed unreasonably dangerous for its intended use or which is marketed for uses that have not been approved by the FDA.
Users of flawed medical devices report serious infections, life-threatening blood clots, leakage, metal toxicity, necrosis (premature cell death), bone dissolution and leakage of metal ions that cause complications in the heart, thyroid gland and nervous system.
One manner of demonstrating liability is if a product has been recalled. Recalls can be by the manufacturer or ordered by the FDA. The premise is that a product has a defect that is in violation of FDA standards. There are three categories of product recalls pursuant to the FD& C Act:
- Class I Recall. This is most serious with there being “the reasonable possibility that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
- Class II Recall. Exposure to a defective device has the possibility of causing adverse health consequences that are temporary and can be remedied by medical procedure. This category is also appropriate if severe health consequences are remotely possible.
- Class III Recall. This category concerns the least harmful products. It is used if a product does violate FDA standards but its use is unlikely to cause any harmful health consequences.
A recall under the first two categories enables you to consider filing an injury claim if you did suffer an adverse consequence that can be linked to the medical device so long as you used the device as it was intended and you have provable damages. A recall is powerful evidence of the device’s flawed nature.
Many of these claims are the subject of class action or MDL suits. If you were injured by a medical device, promptly contact a medical devices injury attorney. You may choose to become part of the class or MDL litigants or you may opt out and pursue the matter individually. The benefit of being involved in a mass tort action is that lawyers are able to share information gathered through discovery, any court rulings generally will apply to all claims and the costs are shared.
Retain a Medical Devices Injury Attorney
Medical device litigation is a complicated area of law that requires legal practitioners to have the resources to deal with litigation and the experience and knowledge to contend with the medical issues involved to prove liability and causation. Even if your claim is part of a class action or MDL, your medical devices attorney can present medical support that the device caused your claimed injuries and that your damages are substantial. You are entitled to such damages as:
- Past and future medical expenses
- Past and future income loss
- Lost earning capacity
- Permanent impairment
- Emotional trauma
- Pain and suffering
In Massachusetts, you have 3 years from the date you discovered your injury to bring a claim against the manufacturer or supplier of the medical device. Immediately contact a medical devices injury lawyer if you suspect that your medical device has caused you injury or is the subject of a recall.