The U.S. Food and Drug Administration (FDA) receives several hundred thousand reports every year of consumer injuries and deaths with suspected links to defective medical devices. It also announces recalls of dozens of potentially dangerous medical devices annually. If you know or suspect you have suffered harm from a defective medical device, you could have grounds for a product liability claim against its manufacturer.
An experienced lawyer from Hardison & Cochran can help you file a product liability claim to seek accountability and compensation for what you’ve suffered. Here’s what you need to know about the process for a defective medical product lawsuit in North Carolina.
Product Liability and Medical Devices
The term “product liability” refers to the responsibility that manufacturers, distributors, and sellers have for any harm their products cause. When it comes to a medical device, this means the manufacturer and the retailers are responsible for the safety and effectiveness of these devices. If a medical device fails and causes harm in North Carolina, the injured party can pursue a product liability claim against the manufacturer and other responsible parties.
Medical device defects fall into three broad categories:
- Design defects occur when a medical device is inherently unsafe due to its design. Even if manufactured correctly, a device with a design defect poses a risk to users. For example, a poorly designed implant might break easily inside a patient’s body and cause internal harm.
- Manufacturing defects happen during the production process. These defects are not present in a device’s design but occur when mistakes arise during manufacturing. For instance, this type of defect might lead to a contaminated batch of syringes that cause dangerous infections.
- Marketing defects, also known as failure-to-warn defects, involve inadequate instructions or warnings about a medical device’s risks. For instance, if a manufacturer fails to provide proper usage guidelines for surgical tools, patients can suffer preventable harm from misuse.
Examples of Defective Medical Devices
Two recent recalls highlight the pervasive issue of medical device defects.
Teleflex and Arrow International have recalled specific intra-aortic balloon catheter kits due to a manufacturing defect that might cause balloon implants to twist in the body, preventing total inflation. This defect could lead to potential harm, including blood loss, artery tearing, unstable blood pressure, heart ischemia, or death. The recall follows reports of 322 complaints, 31 injuries, and three deaths.
Hologic, Inc. recently recalled its BioZorb Marker, a radiographic marker that marks soft tissue for radiography and other procedures. BioZorb initiated the recall due to reported complications such as pain, infection, rash, device migration, erosion, and the need for additional medical treatment to remove the devices. There have been 71 reported injuries related to this issue.
Other common types of medical device defects include those affecting:
- Pacemakers
- Hip implants
- Insulin pumps
- Surgical mesh
- Defibrillators
- Breast implants
- Heart valves
- Dialysis machines
- Cochlear implants
- Stents
- Infusion pumps
- Oxygen concentrators
- IV tubing
- Blood glucose meters
- Ventilators
- Prosthetic limbs
- Hernia mesh
- Contact lenses
Using defective medical devices can lead to severe health problems. Affected patients might suffer from infections, pain, and other preventable complications. Some defective devices can fail to perform as intended, causing additional injuries or worsening existing conditions. In severe cases, defective devices can result in permanent disability or death. Patients might require additional surgeries or treatments to correct issues related to the faulty devices, leading to increased medical costs and emotional distress.
How to File a Product Liability Claim in North Carolina
To file a product liability claim in North Carolina, you must establish three key elements:
- You must prove that the product was defective. This could mean demonstrating a design flaw, manufacturing defect, or inadequate warnings about potential risks.
- You must demonstrate that the defect existed when the product left the manufacturer’s control. This means establishing that the product was faulty before you or your provider received it.
- You must show that the defect caused you harm by linking your injury directly to the defect.
It’s worth noting that you have three years from the date of your defective medical device injury to file a product liability lawsuit. If it takes time to discover your injury, the three-year filing window does not begin until you know about or should reasonably know about the defect-related injury.
However, North Carolina has a statute of repose for product liability lawsuits, which is 12 years from the product’s initial sale date. This means even if you discover the defect-related injury after a long period, you cannot file a claim more than 12 years after the product was initially sold.
Proving a Defective Medical Device Claim
A lawyer can help you prove each element of your product liability claim by gathering and presenting compelling evidence. This might include medical records, expert testimonies, and product documentation showing that the product was defective. They can also trace the defect back to the manufacturing process to demonstrate that the issue existed before you received the product.
Additionally, your lawyer can connect your injury to the defect through medical reports and expert analysis. Expert witness testimony is essential in many product liability cases, as these seasoned professionals can review medical records to interpret complex jargon and identify links between device malfunctions and preventable patient injuries.
How a Product Liability Lawyer Can Help
An experienced defective medical device lawyer can provide valuable assistance with your product liability claim in North Carolina. Among the ways a lawyer can help include:
- Gathering evidence to support your claim
- Investigating the history of the defective product
- Consulting medical experts to link your injury to the defect
- Interviewing witnesses to corroborate your story
- Analyzing product design and manufacturing processes
- Calculating the full value of your product liability claim
- Completing and filing necessary claim paperwork on time
- Identifying and complying with all legal requirements
- Negotiating with insurance companies on your behalf
- Representing you in court if the case goes to trial
- Never charging you any fees unless they recover compensation for your claim
With a knowledgeable lawyer’s help, you can recover several types of compensation from a successful product liability claim. This could include compensation for:
- Past and future medical expenses, including hospital bills, surgeries, and ongoing treatment costs
- Lost wages and earning capacity if your injury prevents you from working
- Pain and suffering, which covers the physical and emotional distress resulting from your injuries
Contact a North Carolina Product Liability Attorney Now
If you have suffered a defective medical device injury in North Carolina, contact Hardison & Cochran today to help you pursue compensation. Our team can help you understand your rights and handle the process of filing your product liability claim. Reach out to us now for a free initial consultation, and let’s work together to demand the compensation and accountability you deserve.
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