When an individual becomes ill or injured, a medical device may be a recommended or necessary part of his or her treatment process. The term “medical device” refers to any type of device used to treat a medical condition, injury, or disability. When a medical device does not work as intended or causes injury, it must be removed. This causes additional physical, financial, and emotional stress for victims and their families.
If you or a loved one has suffered due to a defective medical device, the experienced Kansas City medical device injury attorneys at Cullan & Cullan can fight on your behalf to obtain the compensation you need. Because our team includes lawyers who are also medical doctors, we have a unique and invaluable understanding of the medical and legal implications of defective medical devices. We can provide more effective representation as a result.
To discuss your needs with a qualified attorney, call (816) 253-8606. Your consultation is free!
Product Liability Claims Involving Medical Devices
There are different types of product liability claims that can result from defective medical devices:
- Manufacturing Defect: For example, a part of the device or a component may be faulty because it was not properly manufactured or assembled.
- Defective Design: This means that a dangerous or faulty design may cause injury or harm to patients using them.
- Defective Marketing: This may mean a failure on the part of the manufacturer to provide adequate warnings about the risks involved, or falsely marketing a device as “safe” when in fact it presents several dangers.
Types of Defective Medical Devices
There are many types of defective medical devices. Often, these devices cause similar injuries to large groups of people. They can also lead to similar but slightly different injuries in large groups. Often, defective medical device litigation involves class actions or mass torts.
Some examples of defective medical devices include:
- Hernia mesh
- Bair Hugger
- DePuy hip implants
- IVC filters
- Proton pump inhibitors
- Essure birth control implant
- Mirena IUD
This list is not exhaustive. Any medical device can be defective—and the consequences can be disastrous. If you or a loved one suffered injuries as a result of a defective medical device, contact our firm to speak with an attorney.
FDA Approval Process
All medical devices must be approved for use by the Food and Drug Administration (FDA). Some medical devices are approved through a process known as the 510 (k) approval, in which the FDA can give a product its stamp of approval if there are other “substantially similar” products in the market that have already been approved by the agency.
For example, many transvaginal mesh devices were approved through this process. Manufacturers are not required to test their devices and provide additional data to obtain such an approval from the FDA. With a 510 (k) clearance, the medical device manufacturer can sell their products without first passing through the Premarket Approval (PMA) process that mandates clinical trials and other studies relating to the use, safety, and potential risks presented by the device.
Proving Liability in a Defective Medical Device Injury Claim
To prove your claim, you must show that you were injured, that the medical device was defectively designed, manufactured, or marketed, and that the defective device was the cause of your injury. You must also prove that you sustained damages and losses as a result of the faulty medical device. Injured victims can seek compensation for damages including medical expenses, lost wages, cost of revision surgery, pain and suffering, disabilities, and emotional distress.
At Cullan & Cullan, our team of medically trained Kansas City product liability attorneys have the experience and resources to help those who have suffered injury or worse due to defective medical devices. You may be eligible to receive compensation from the at-fault party.
Contact us at (816) 253-8606 for your free consultation.