Defective Medical Devices and Your Legal Rights

Jun 28, 2024 - Defective Medical Devices, Personal Injury by Cross & Smith

Medical devices play a crucial role in diagnosing, preventing, and treating various health conditions. However, when these devices are defective, they can cause severe harm, leading to physical, emotional, and financial distress. Understanding your legal rights is essential if you or a loved one has been affected by a defective medical device. Here’s an overview of the legal landscape surrounding defective medical devices, including types of defects, liability, and steps to take if you are affected.

Types of Defective Medical Devices

Medical devices are regulated by the federal Food and Drug Administration (FDA) and are classified as Class 1, Class 2, and Class 3 devices. Class 1 devices are simple, low-risk items like bandages and non-electric wheelchairs. Class 2 devices carry higher risk than Class 1 devices and include products such as powered wheelchairs and infusion pumps. Class 3 devices are more complex and invasive, and are often considered to be life-prolonging, and include such products as pacemakers and surgical robots. 

Defects in these devices can occur at any stage, from design and manufacturing to marketing. Here are the main types of defects:

1. Design Defects: These occur when a device is inherently unsafe due to its design, even if manufactured correctly. For example, a hip replacement implant that wears out prematurely can be considered a design defect.
2. Manufacturing Defects: These occur when a device is designed correctly but becomes dangerous due to errors in the manufacturing process. Contaminated surgical instruments or poorly assembled pacemakers are examples of manufacturing defects.
3. Marketing Defects: These involve improper labeling, insufficient instructions, or failure to warn about potential risks. An example is a medication infusion pump that does not include adequate warnings about the risk of overdose.

Legal Grounds for Making a Claim

Victims of defective medical devices can pursue legal action based on several grounds:

• Strict Liability: Under strict liability, a manufacturer can be held responsible for a defective product regardless of whether they were negligent. The plaintiff must prove that the device was defective, the defect caused the injury, and the device was used as intended.
• Negligence: This requires proving that the manufacturer failed to exercise reasonable care in designing, manufacturing, or providing adequate warnings for the device. The plaintiff must show that this negligence directly caused their injury.
• Breach of Warranty: A breach of warranty claim can be based on an express warranty, which is a specific promise made by the manufacturer, or an implied warranty, which is an assumption that the product is safe for its intended use. If a medical device fails to meet these warranties, the injured party may have grounds for a claim.
• Fraud and Misrepresentation: If a manufacturer knowingly provides false information or conceals crucial information about a device’s safety, they can be held liable for fraud or misrepresentation.

What Steps to Take if You’ve Been Injured By a Medical Device

If you believe you or a loved one has been harmed by a defective medical device, you should take the following steps to protect your legal rights:

1. Seek Medical Attention: Prioritize your health and safety by seeking immediate medical attention. Document all treatments and medical advice related to the injury.
2. Preserve the Evidence: Keep the defective device, packaging, instructions, and any related medical records. These items are crucial for proving your case.
3. Document Your Experience: Maintain a detailed record of your symptoms, medical visits, and any communications with healthcare providers or the device manufacturer.
4. Consult a Lawyer: Contact an experienced Tuscaloosa personal injury attorney to evaluate your case, explain your rights, and guide you through the legal process.
5. Report the Incident: Notify the U.S. Food and Drug Administration (FDA) through the MedWatch program. Reporting the defect can help prevent further injuries and contribute to regulatory actions against the manufacturer.

Potential Outcomes

Legal actions involving defective medical devices can result in various outcomes:

• Compensation: Victims may receive compensation for medical expenses, lost wages, pain and suffering, and other related costs. The amount depends on the severity of the injury and the circumstances of the case.
• Recalls and Safety Alerts: Successful lawsuits can prompt manufacturers to recall defective devices or issue safety alerts, potentially preventing further harm.
• Regulatory Actions: Lawsuits can lead to increased scrutiny from regulatory agencies like the FDA, resulting in stricter safety standards and regulations for medical devices.

Recent Medical Device Cases

Medical device cases can be brought individually or as class action lawsuits. Several recent high-profile medical device defect cases include the following:

• Litigation is ongoing against IUD manufacturer Paraguard for injuries allegedly caused to women by the company’s intrauterine device.  As of June 2024, there were 2,690 pending lawsuits. The Paragard IUD lawsuits claim a design flaw led to the IUD device breaking during removal. This meant that part of the device could remain lodged in the uterus or other internal organs, causing injuries.
• Hip Implants: Numerous lawsuits have been filed against manufacturers of metal-on-metal hip implants, including Johnson & Johnson and Biomet Orthopaedics. The lawsuits claim that the design flaw caused metallosis, a condition where microscopic metal particles from the implant are released into the body, damaging tissue and bone. Many victims received substantial settlements, and some devices were recalled.
• Transvaginal Mesh: Thousands of women sued several manufacturers of transvaginal mesh devices used for pelvic organ prolapse and stress urinary incontinence. The devices, manufactured by Johnson & Johnson and others, caused serious injuries, including chronic pain and organ damage. The litigation led to significant settlements and increased regulatory oversight. 

Contact a Tuscaloosa Personal Injury Attorney Today

Defective medical devices pose significant risks to patients, and understanding your legal rights is crucial if you have been harmed. By recognizing the types of defects, the legal grounds for claims, and the steps to take if affected, you can better navigate the complex legal landscape. 

Consulting with an experienced Tuscaloosa personal injury attorney and taking appropriate action can help you seek justice and compensation, while also contributing to the improvement of medical device safety standards for others.

Here at Cross & Smith, LLC we are experienced in preparing defective medical device injury claims,and presenting those claims to a jury. We’ll help you get the compensation you deserve.  Contact us today at (877) 791-0618 for a free confidential consultation.