When it comes to matters of health and well-being, medical devices play a pivotal role in diagnosing, treating, and improving the lives of countless patients worldwide.
However, not all medical devices are created equal, and unfortunately, defects can occasionally lead to severe consequences for the patients who have placed their trust in these products.
Defective medical devices can cause substantial harm, ranging from serious injuries to life-threatening complications. In these situations, seeking justice and fair compensation becomes crucial for the affected individuals and their families.
This is where defective medical device lawyers step in.
At The Fakhouri Firm Accident and Injury Lawyers, our experienced attorneys can serve as invaluable allies to you and your family as you navigate the complexities that come with filing a defective medical device claim.
To schedule a free initial consultation to discuss your case and the types of damages you may have been entitled to, simply call 312-999-9990 or contact us online today.
Why Work With a Defective Medical Devices Attorney?
A defective medical devices attorney is a specialized legal professional who focuses on representing individuals who have been harmed or injured by faulty (or malfunctioning) medical devices. These attorneys possess in-depth expertise at the intersection of law, medicine, and product liability regulations.
Similarly, defective medical device cases are typically initiated by individuals who have suffered harm or injury due to the use of “faulty (or malfunctioning) medical products.” These cases encompass a broad range of medical devices, including implantable devices like pacemakers and artificial joints, as well as diagnostic tools, surgical instruments, and consumer medical equipment.
Because the scope of these cases is so broad, they often involve various issues like design defects, manufacturing errors, or failure to provide adequate warnings or instructions to users. When a medical device fails to function as intended or poses unforeseen risks, patients and their families may face significant physical, emotional, and financial hardships.
Personal Injury Claims Involving a Defective Medical Device
When a medical device that’s been designed to improve your health and well-being instead causes harm, the consequences can be devastating for you and your family.
Personal injury cases involving defective medical devices are filed by individuals who have suffered injuries or health complications due to the use of a faulty product. In such cases, the injured parties may be entitled to seek compensation for the physical, emotional, and financial hardships they endure.
What Kinds of Injuries Warrant a Defective Medical Device Claim?
Defective medical devices can lead to a wide range of injuries and health issues, depending on the nature of the device’s flaw. That said, any injury that was caused by a defective medical device can be considered ‘claim-worthy’ if your attorney can establish that your injury was caused by another party’s negligence.
These days, defective medical devices often cause the following types of injuries:
- Infections: Defective medical devices, such as implants or surgical instruments, may lead to infections if they are not sterile or if they cause damage to tissues and allow bacteria to enter the body.
- Device Failures: Malfunctioning medical devices can lead to serious consequences. For example, a faulty cardiac device like a pacemaker could fail to regulate the heartbeat, potentially resulting in a life-threatening cardiac event.
- Organ Damage: Some medical devices may cause unintended damage to internal organs or tissues during procedures or while in use. Organ perforations, lacerations, or punctures can lead to severe complications.
- Nerve Damage: Defective medical devices, particularly those used in surgical procedures, can inadvertently damage nerves, leading to chronic pain, loss of sensation, or even paralysis.
- Adverse Reactions: Medical devices that contain materials or substances patients are allergic to may trigger allergic reactions or severe immune responses.
- Migration or Dislocation: Implantable medical devices, such as joint replacements or surgical mesh, may migrate or dislocate from their intended position, causing pain, instability, or further complications.
- Blood Clots or Embolisms: Some medical devices can increase the risk of blood clots or embolisms, which may lead to serious health issues, such as stroke or pulmonary embolism.
- Bone Fractures: Defective orthopedic implants or devices used in bone surgeries can lead to fractures, compromising the structural integrity of the bone.
- Chronic Pain and Discomfort: Certain medical devices may cause chronic pain, discomfort, or unpleasant sensations that significantly impact a patient’s quality of life.
- Toxicity and Allergic Reactions: Medical devices made from certain materials, such as metals or plastics, may release toxic substances into the body, leading to dangerous reactions or long-term health issues.
It is important to note that the specific injuries and complications resulting from a defective medical device may vary widely depending on the device’s type and intended purpose. In fact, in some situations, you may only develop a serious health problem from your defective medical device months after it’s been removed.
Even in these situations, your attorney can still legally help you hold the negligent party accountable.
What Is the Discovery Rule?
Traditionally, plaintiffs must file a defective medical device claim within a set timeframe. This timeframe is referred to as the statute of limitations and will vary from state to state.
In many states, the statute of limitations for personal injury claims, including defective medical device cases, ranges from one to three years from the date the injury was discovered.
That said, the Discovery Rule recognizes that in certain cases, it may not be immediately apparent to the injured party that their injury was caused by a defective medical device.
Consequently, the Discovery Rule extends the starting point of the statute of limitations to the date when the plaintiff discovered or reasonably should have discovered both the existence of their injury and its connection to the defective medical device.
This means that the clock for the statute of limitations does not start ticking until the plaintiff knows, or should have known, about the link between the device and their injury.
Federal Rules and Regulations on Defective Medical Devices
While local regulations may come into play at the state or county level, there are several overarching federal rules and regulations that govern all defective medical device cases across the country.
The Role of the Food and Drug Administration (FDA)
The Food and Drug Administration (FDA) plays a crucial role in regulating medical devices, as it is this team’s job to ensure these devices operate safely and effectively for their intended patients. The FDA’s care involves a comprehensive approval process, monitoring post-market safety, and facilitating recalls when necessary.
FDA Approval Process for Medical Devices
Before a medical device can be marketed and sold in the United States, it must undergo a rigorous evaluation and approval process by the FDA.
This process will vary depending on the device’s classification, with higher-risk devices requiring more extensive scrutiny. Manufacturers must submit pre-market approval applications, which include detailed information about the device’s design, materials, intended use, and potential risks.
The FDA assesses the device’s safety and efficacy based on scientific evidence and clinical data. If the device meets the FDA’s standards, it receives clearance or approval for specific medical indications.
Recalls and Safety Alerts
Despite the FDA’s thorough review process, some medical devices may exhibit unforeseen defects or safety issues after entering the market. In such cases, the FDA can initiate a recall to remove or correct the defective devices.
Recalls are categorized based on the potential risk to patients, ranging from voluntary recalls by the manufacturer to mandatory recalls ordered by the FDA.
Additionally, the FDA issues safety alerts to inform healthcare providers and the public about potential risks associated with certain medical devices. These alerts aim to raise awareness and prompt appropriate actions, such as device modifications or patient monitoring.
The Role of the Consumer Product Safety Commission (CPSC)
The Consumer Product Safety Commission (CPSC) collaborates with the FDA to enhance the safety of medical devices used by consumers. While the FDA focuses on devices used primarily by healthcare professionals, the CPSC monitors devices intended for consumer use.
That said, the CPSC and FDA still work in tandem to address safety concerns related to medical devices. They share information, coordinate investigations, and pool resources to address potential risks associated with both professional and consumer medical devices.
Recalls and Reporting Requirements
Similar to the FDA, the CPSC has the authority to issue recalls for defective medical devices intended for consumer use. The CPSC sets standards and guidelines for manufacturers, distributors, and retailers to report safety issues related to consumer medical devices.
Timely and accurate reporting enables the CPSC to take swift action when safety hazards are identified. By overseeing the approval process, monitoring post-market safety, and coordinating with the CPSC, the FDA plays a vital role in safeguarding patients from the risks of defective medical devices.
Additionally, the CPSC’s involvement enhances overall safety measures for medical devices accessible to consumers, contributing to a safer and more reliable healthcare landscape.
Can I File a Defective Medical Device Case Against a Recalled Product?
If you have experienced harm or injury due to a medical device that has been recalled, you may wonder whether you can still file a defective medical device case. The short answer is yes; you can typically pursue a legal claim even if the device has been subject to a recall.
At their core, recalls are intended to remove defective devices from the market and address the potential risks they may pose. Here are some key points to consider when filing a defective medical device case against a recalled product:
- A Recall Does Not Invalidate Liability: A recall does not absolve the manufacturer or other parties involved from their liability for any injuries caused by the defective device. The fact that a recall was issued may actually strengthen your case, as it indicates that the device was indeed found to have safety issues.
- The Cause of Injury Matters: To pursue a successful defective medical device case, you must demonstrate that the recalled product directly caused your injuries. The recall alone may not be sufficient evidence; you will need to establish a link between the device and your specific harm.
- Act Promptly: It’s crucial to take prompt action if you believe you have a defective medical device claim. The statute of limitations for filing a lawsuit starts from the date of injury discovery, which may be different from the date of the recall announcement. Delaying the process could jeopardize your ability to seek compensation.
- Work with an Experienced Attorney: Filing a defective medical device case can be complex, especially when dealing with recalled products. An experienced defective medical device lawyer can help you navigate the legal process, gather evidence, and build a strong case to ensure your rights are protected.
- Consider Class Action Lawsuits: In some cases, a recall may lead to class action lawsuits, where a group of affected individuals collectively file a claim against the manufacturer. Joining a class action may be an option, but it’s essential to weigh the pros and cons with the guidance of your attorney.
Class Action Lawsuits vs. Individual Lawsuits
Class action lawsuits and individual lawsuits are two different approaches for pursuing compensation in defective medical device cases. Below, we’ll review the key features of each type of lawsuit:
Class Action Lawsuits:
- In a class action lawsuit, a group of individuals who have been harmed by the same defective medical device collectively file a single lawsuit against the manufacturer.
- Class members share similar claims, injuries, and allegations, making it more efficient to litigate as a group rather than pursue individual cases.
- Class actions can help distribute legal costs among many plaintiffs and may yield a stronger negotiating position against the defendant.
- If successful, the compensation is divided among all class members based on their injuries and damages.
- Joining a class action lawsuit means surrendering the right to file an individual lawsuit for the same injuries.
- In an individual lawsuit, a single plaintiff files a lawsuit against the manufacturer for their specific injuries caused by the defective medical device.
- Individual lawsuits offer greater control over the legal process and allow for more personalized arguments and evidence presentation.
- Compensation in an individual lawsuit is specific to the plaintiff’s unique damages and injuries.
- Individual lawsuits may be preferred when your injuries are especially severe or when the circumstances surrounding the case differ significantly from those of other potential claimants.
All in all, regardless of whether you’re considering a class action or individual lawsuit if you’ve experienced an injury from a defective medical device, our team is here to help.
Our Experienced Medical Device Accident Law Firm Is Ready to Help You
At The Fakhouri Firm Accident and Injury Lawyers, our experienced defective medical device attorneys have the legal know-how you’ll need to navigate every case from claim to close.