What Is Considered a Defective Medical Device?
A defective medical device is any device used for diagnosis or treatment which does not meet safety requirements and/or fails to perform as intended.
This could include devices that are:
- Insufficiently labeled
- Contaminated with foreign substances
- Lacking proper operating procedures or disclaimers
- Have parts that are missing
- Have incorrect instructions
- Have design defects
Common examples of defective medical devices include faulty hip replacements, hip implants, knee and breast implants, hernia mesh, transvaginal mesh, defibrillators, pacemakers, and other implantable items.
Defective medical devices can be hazardous and lead to serious injury or wrongful death if misused.
Annually, the Food and Drug Administration (FDA) receives hundreds of thousands of reports associated with medical devices, such as potential fatalities, injuries, or malfunctions.
To help ensure patient safety, manufacturers and healthcare providers must adhere to safety protocols when testing, manufacturing, distributing and using medical devices.
If you or a loved one have wrongfully suffered due to a faulty product, having an experienced defective medical device lawyer handle your case can make all the difference.
How Do I Know if I Have a Defective Medical Device Case?
To determine if you have a defective medical device case, consider the following:
- Have you experienced unexpected medical issues, physical discomfort, chronic pain, health problems, or a decreased quality of life after using a medical device?
- Has the device caused side effects or harm to your health due to its design, manufacture, or labeling?
- Was the device implanted in your body or used externally? It is important to understand if it was surgically implanted as this may give rise to additional legal remedies.
- Has the device injured you or someone close to you? If so, what specific injuries have taken place?
- Has the device manufacturer released information about known issues with its product?
- Are there any pending class action lawsuits related to similar products, such as those that are part of larger recalls or warnings from regulatory agencies such as the U.S. Food and Drug Administration (FDA)?
In addition to evidence of harm or injury, having records about when and where the device was purchased can also be helpful.
As the biggest medical device market globally, the United States accounts for 40% of worldwide revenue and sales from medical devices.
Nearly 1 in 10 Americans—or approximately 32 million people—have had a medical device implanted.
FDA figures indicate 80,000 deaths and 1.7 million casualties directly related to medical devices over the past decade.
With such alarming numbers, it’s crucial for individuals who believe they’ve experienced an issue with their medical device to seek professional advice about their legal rights and remedies.
When to Consult a Defective Medical Device Lawyer
When considering whether or not to seek legal action after being affected by a defective medical device, you must remember that time is of the essence. Consult a defective medical device lawyer as soon as possible if you think you or a family member has become a victim.
An experienced defective medical device attorney from Frantz Law Group can guide you through filing a claim against the at-fault party.
Our qualified lawyers will guide you through the process of seeking the support you need for your physical and emotional injuries caused by a faulty product. They will assess your situation and advise you of your legal rights and options to seek the compensation and justice you deserve.
Filing a Defective Medical Device Lawsuit
When planning to file a defective medical device lawsuit, you will need to gather evidence of the defective product, including information about the device and any reports or complaints filed against the manufacturer. Make sure to include medical bills, records, and other documentation demonstrating the injuries and losses caused by the faulty medical device.
You should contact a qualified attorney who is experienced in filing product liability claims. This type of lawyer will understand applicable laws and regulations concerning medical devices’ manufacturing, marketing, and distribution.
Your lawyer will be able to assess whether it would be beneficial to pursue the case and how to move forward with your medical device claim.
If the case has merit, you and your lawyer will then file a complaint (lawsuit) against the manufacturer and/or supplier of the defective device.
At this stage, discovery may occur where both parties can request documents and ask questions under oath to determine all facts related to the case.
Additionally, an expert witness may be necessary for cases involving complex medical devices or technologies requiring specialized knowledge. Expert witnesses can provide valuable testimony regarding a particular situation and can help strengthen a plaintiff’s case in court.
The next step is either settlement or trial, depending on what is decided among the parties involved.
How Much Are Defective Medical Device Settlements Worth?
Defective medical device settlements can be worth from hundreds of thousands to millions of dollars.
On average, medical malpractice cases result in recoveries of almost almost $680,000. Similarly, product liability cases involving defective medical devices yielded an average payout of nearly $750,000.
However, some defective medical device settlements and jury verdicts have resulted in multi-million dollar payouts due to the severity of the complications caused by the defective devices.
For example, in the United States, the following defective medical device settlements were paid out:
- $1.4 million for a defective surgery scalpel
- $1.5 million for a wrongful death case
- $5.1 million for a defective surgical tool
In addition to financial compensation for medical expenses and pain and suffering, product liability lawsuits may also result in changes to the design or labeling of a device so that future patients are not exposed to similar risks.
Calculating Your Losses
When evaluating possible compensation you are entitled to receive in a defective medical device settlement, consider both tangible and intangible damages caused by the defective product. This includes things like lost wages and medical expenses as well as pain and suffering that was experienced due to the faulty device.
The more documentation you have of your losses, the easier it will be to determine an amount that adequately compensates you.
For example, bills and receipts for medical treatment, pay stubs to establish lost wages, and medical records to show your physical or mental suffering can all help prove the true extent of your damages.
Additionally, consulting with an experienced medical device attorney can help you better understand what types of losses are compensable in a settlement and how much they may be worth.
The lawyer may also need to consider intangible harms like pain and suffering, which are often calculated by looking at the severity and duration of your injury.
For example, if you experienced long-term physical or emotional trauma due to manufacturing defects, a court or jury may award higher compensation than if you suffered short-term harm.
An attorney can also use their experience to negotiate a higher settlement amount with the defendant. With sufficient evidence and legal representation, victims of defective medical devices may be able to secure fair compensation for their injuries.
Add Multiple Defendants
Adding multiple defendants to a lawsuit involving defective medical devices can significantly increase the settlement amount. Each defendant can be held liable for their share of the damages and compensation you may be awarded in the case.
Multiple defendants can help establish more culpability and liability against each party, giving you leverage when negotiating higher settlement amounts.
Here’s a pro tip: identify the parties involved in the distribution chain from when the device was manufactured until it reached you. This will help you determine other potential defendants—most of which are large companies:
- Medical device manufacturers that designed or assembled the device
- Distributors and retail suppliers, including drugstores and the pharmacy
- Sales representatives who recommended or sold the device to your doctor or other medical professionals
- Doctors who prescribed the device to you
Having an attorney assess each individual involved in this process is key to ensuring that all those responsible are named defendants in your case.
Get the Compensation You Deserve with Frantz Law Group
If a defective medical device has injured you, you might well be entitled to the compensation you need to recover. Frantz Law Group understands this, and our catastrophic injury attorneys are dedicated to helping victims get the justice they deserve.
Our legal team is knowledgeable and experienced in handling complex cases involving defective medical devices. We thoroughly investigate the incident and aggressively pursue all avenues of legal recourse to maximize the likelihood of our client obtaining a financial recovery.
Our services include seeking damages for past and future medical care, lost wages, pain and suffering, mental anguish, and more.
At Frantz Law Group, we understand that no amount of money can undo what has happened. That is why our law firm utilizes years of legal experience combined with cutting-edge technology to build strong cases that maximize our clients’ financial recoveries.
Our attorney-client relationship also includes compassionate guidance throughout the process. Victims can focus on their physical and emotional healing without worrying about navigating the legal system alone or incurring large costs for legal representation.
Contact Frantz Law Group today for a free consultation with one of our experienced personal injury lawyers. With our help, you can get the compensation you need to begin your journey toward healing and justice.