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What Criteria Define a Medical Device as Defective in Legal Terms?

To hold a manufacturer, seller, or designer liable for injuries a defective product caused, you need to prove how it was defective. This means you need to understand what criteria define a medical device as defective in legal terms. Essentially, your injury must have resulted from a:

  • Manufacturing defect
  • Design defect
  • Failure to warn
  • Breach of warranty

Proving a product is defective is difficult, but you aren’t alone. Our defective medical device lawyers in Dallas can handle the process for you.

Manufacturing Defects 

These are flaws that creep into the device during its production process, potentially turning an essential medical instrument into a danger when used for its intended purpose. Imagine, for instance, using a syringe designed to deliver life-saving medication, only to find it leaking due to improper sealing. Such defects not only compromise the device’s functionality but also pose significant health risks to you, the user.

Design Defects

These are inherent flaws in how a medical device is conceptualized and developed. A hip replacement that promises to restore your mobility but carries a design that significantly increases the risk of implant failure is a glaring example. Design defects often stem from a failure to adequately anticipate or test how the device operates under real-world conditions, leaving you vulnerable to unexpected and sometimes catastrophic failures.

Failure to Warn

A lack of warnings about how to safely use a device is another critical concern. Consider an electronic medical device that comes into your hands without clear, comprehensive instructions for something as basic as safe battery replacement. The absence of such guidance can lead to misuse or accidents, endangering your health or even life. It’s a scenario where the device itself might function correctly, but the lack of proper communication puts you at risk.

Breach of Warranty

A breach of warranty comes into play when a medical device fails to live up to its promises regarding safety and efficacy. Whether these assurances are explicitly stated (express warranty) or implied by the device’s nature and marketing (implied warranty), their violation can lead to harm. You rely on these warranties when choosing medical devices, expecting them to perform safely and effectively. A breach not only undermines this trust but can also expose you to unanticipated medical complications.

In navigating the complex landscape of medical devices, these criteria serve as your guideposts. They empower you to make informed decisions, demand accountability, and ensure that the devices you depend on for your health and recovery adhere to the highest standards of safety and reliability.

Examples of Defective Medical Devices

It can be difficult to determine what type of defect your case falls under. Some examples include:

Manufacturing Defects

  • A blood glucose meter giving inaccurate readings due to faulty assembly, leading to potential mismanagement of diabetes
  • A robot-assisted surgical device that malfunctions during surgery

Design Defects

  • A knee implant prone to early wear and tear because of its material composition, risking premature failure and necessitating revision surgery
  • A hernia mesh designed with synthetic nondegradable mesh that adheres to nearby organs and tissue

Failure to Warn

  • An electric wheelchair lacking adequate instructions on its weight limit, posing a risk of collapse and injury
  • A failure to warn about the potential for more wear-and-tear from a metal-on-metal hip implant

Breach of Warranty

  • A heart monitor that consistently fails to detect arrhythmias, despite the manufacturer’s guarantee of high sensitivity and accuracy
  • A dental implant system that is guaranteed to last a lifetime but starts to deteriorate after just a few years, necessitating expensive and painful corrective procedures

Proving a Medical Device Is Defective

Navigating the intricate process of proving a medical device is defective can be a daunting endeavor. It requires a nuanced understanding of both medical and legal complexities that you, as an individual, might find overwhelming. This is where the knowledge and experience of a lawyer from our firm becomes incredibly important.

Our defective product lawyers have years of experience in medical device litigation and are adept at dissecting the multifaceted nature of such cases. We understand that proving a device is defective involves demonstrating one of several key factors: manufacturing flaws, design defects, inadequate warnings, or breaches of warranty. Our approach is thorough, leveraging expert testimonies, scientific analysis, and an exhaustive review of medical records to build a compelling case on your behalf.

Once we establish the type of defect, we just need to prove that the defect caused your injuries and losses.

We recognize the emotional and physical toll that a defective medical device can impose. Thus, our commitment extends beyond legal representation; we strive to ensure your story is heard and that justice is served. With us, you’re not just hiring a lawyer; you’re partnering with a dedicated advocate who will navigate the legal system’s intricacies to safeguard your interests and well-being. Trust in our firm to handle the process meticulously, giving you the space to focus on your recovery and peace of mind.

Who Might Be Liable in a Defective Medical Device Case?

Your liable party depends on the type of defect but could include the:

  • Medical device manufacturer
  • The defective device’s designer
  • Whoever sold the defective medical device
  • Whoever marketed the device

Regardless of who we hold liable, we will fight for every dollar you deserve for medical bills, lost wages, pain and suffering, and your other losses.

Our Defective Medical Devices Are Here to Get You the Compensation You Need

When you turn to a medical device for help, you place immense trust in its ability to improve your health, not compromise it. Discovering that this trust has been betrayed due to defects or negligence is not only disheartening but can lead to significant injuries and losses. You deserve compensation for the hardships you’ve endured.

At Loncar Lyon Jenkins, we understand the gravity of your situation and are committed to fighting for the justice you deserve through a product liability claim. Don’t navigate this challenging time alone. Contact our defective product lawyers today for a free consultation. Let us help you take the first step towards healing and compensation.

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Author

Ted Lyon

Born in Terrell, Texas, Attorney Ted Lyon, a partner of Loncar Lyon Jenkins, attended East texas State University, now Texas A&M at Commerce, where he obtained his undergraduate degree in political science. Working as a police officer, Attorney Lyon paid his way through undergraduate school, followed by attendance at the Southern Methodist University School of Law. Learn More

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