Medical Negligence - May 20, 2024

What to Do After a Medical Device Failure: A Comprehensive Guide for Georgia Residents 

Medical devices play a crucial role in enhancing the quality of life for millions of people. From pacemakers to hip replacements, these devices are designed to improve health and well-being. However, when a medical device fails, it can lead to severe injuries, additional surgeries, and even life-threatening complications. Knowing what steps to take after a medical device failure is essential for protecting your health and legal rights.

At T. Madden & Associates, P.C., we specialize in representing victims of medical device failures throughout Georgia. This comprehensive guide will help you understand the steps to take after a medical device failure, the types of medical devices that commonly fail, relevant laws in Georgia, and how to seek compensation for your injuries.

Types of Medical Devices That Commonly Fail

Medical devices can range from simple tools to complex machinery. Some devices are more prone to failure than others due to design flaws, manufacturing defects, or inadequate testing. Here are some commonly failing medical devices:

1. Hip and Knee Replacements

These devices are designed to alleviate pain and improve mobility. However, defects can lead to loosening, fractures, and severe pain, often requiring additional surgeries. Common brands include:

• DePuy Synthes (a subsidiary of Johnson & Johnson): Known for the DePuy ASR and Pinnacle hip implants, which have faced numerous recalls and lawsuits due to high failure rates. 
• Stryker: Stryker’s Rejuvenate and ABG II modular-neck stems have been associated with corrosion and fretting, leading to recalls and legal actions. 

2. Pacemakers and Defibrillators

These life-saving devices regulate heart rhythms. Failures can lead to heart attacks, arrhythmias, and other serious health issues. Common brands include:

• Medtronic: Medtronic has issued recalls for several models of its pacemakers and defibrillators due to battery and wiring issues.
• Boston Scientific: Known for the recall of its INGENIO pacemakers and CRT-Ps (cardiac resynchronization therapy pacemakers) due to premature battery depletion.

3. Insulin Pumps

Used by diabetics to manage blood sugar levels, insulin pumps can malfunction, leading to incorrect dosages and severe health complications. Common brands include:

• Medtronic: Medtronic’s MiniMed insulin pumps have faced recalls due to issues with incorrect insulin dosing. 
• Animas (a subsidiary of Johnson & Johnson): Animas OneTouch Ping and Animas Vibe have been associated with delivery malfunctions and subsequent recalls. 

4. Surgical Mesh

Often used in hernia repairs, surgical mesh can cause infections, pain, and organ perforation if it fails. Common brands include:

• Ethicon (a subsidiary of Johnson & Johnson): Known for its Physiomesh and Prolene Hernia System, which have faced recalls and numerous lawsuits. 
• C.R. Bard: Bard’s Kugel hernia mesh patches have been recalled due to a high risk of complications. 

5. Breast Implants

Defective breast implants can rupture, causing pain, infection, and the need for corrective surgeries. Common brands include:

• Allergan: Allergan’s BIOCELL textured breast implants have been linked to a rare form of cancer, leading to a global recall. 
• Mentor (a subsidiary of Johnson & Johnson): Mentor’s silicone and saline breast implants have faced scrutiny for various complications. 

6. Intrauterine Devices (IUDs)

IUDs are used for birth control, but defects can lead to device migration, perforation of the uterus, and severe pain. Common brands include:

• Mirena (by Bayer): Mirena IUDs have been associated with device migration and perforation, leading to numerous lawsuits. 
• Paragard (by CooperSurgical): Paragard IUDs have faced legal actions due to breakage during removal, causing injuries. 

7. Dialysis Machines

Used for patients with kidney failure, malfunctioning dialysis machines can cause contamination, infections, and other severe complications. Common brands include:

• Fresenius Medical Care: Fresenius has faced recalls for its dialysis machines due to issues with potential contamination and software malfunctions. 
• Baxter International: Baxter’s dialysis products have been subject to recalls for various defects, including potential contamination and malfunctions. 

Immediate Steps to Take After a Medical Device Failure

If you experience a medical device failure, it is crucial to take the following steps to ensure your health and protect your legal rights:

1. Seek Immediate Medical Attention

Your health is the top priority. Contact your healthcare provider or go to the emergency room if necessary. Inform them of the device failure and follow their medical advice.

2. Preserve the Device

If possible, keep the failed medical device and any related packaging, instructions, or labels. This can be crucial evidence in your case.

3. Document Everything

Keep a detailed record of your symptoms, medical treatments, and any additional surgeries or procedures required due to the device failure. Take photographs of any visible injuries or complications.

4. Report the Failure

Notify the Food and Drug Administration (FDA) about the device failure. The FDA has a reporting system for adverse events related to medical devices, which can help identify patterns and prevent further incidents.

5. Contact a Personal Injury Lawyer

Engage a qualified personal injury lawyer in Georgia with experience in medical device failures. At T. Madden & Associates, P.C., we offer free consultations to discuss your case and guide you through the legal process.

Legal Rights and Protections in Georgia

Georgia law provides several protections for individuals injured by defective medical devices. Understanding these laws can help you navigate the legal landscape and ensure you receive the compensation you deserve.

Product Liability Laws

In Georgia, medical device manufacturers can be held liable for injuries caused by defective products under product liability laws. This includes defects in design, manufacturing, and failure to provide adequate warnings or instructions.

Types of Product Defects

• Design Defects: Flaws in the design of the device that make it inherently unsafe. 
• Manufacturing Defects: Errors that occur during the manufacturing process, resulting in a defective product. 
• Marketing Defects: Failure to provide adequate instructions or warnings about the risks associated with the device. 

Legal Theories for Product Liability

• Strict Liability: Under strict liability, a manufacturer can be held liable for a defective product regardless of whether they were negligent. 
• Negligence: To prove negligence, you must show that the manufacturer failed to exercise reasonable care in the design, production, or marketing of the device. 
• Breach of Warranty: This involves a violation of the terms of an express or implied warranty. For instance, if the device does not perform as promised, the manufacturer may be held liable. 

Statute of Limitations

The statute of limitations for product liability claims in Georgia is typically two years from the date of injury. It is crucial to file your claim within this timeframe to preserve your right to compensation.

Comparative Negligence

Georgia follows a modified comparative negligence rule, which means that if you are partially at fault for the incident, your compensation may be reduced by your percentage of fault. However, if you are found to be 50% or more at fault, you may be barred from recovering any damages.

Medical Malpractice

If a healthcare provider’s negligence contributed to the device failure, you might have a medical malpractice claim in Georgia. This can include improper implantation, failure to monitor the device, or not addressing known risks. The statute of limitations for medical malpractice in Georgia is generally two years from the date of injury or death, but there are exceptions, so timely consultation with an attorney is essential.

Federal Regulations and FDA Oversight

The FDA regulates medical devices to ensure they are safe and effective. However, despite rigorous testing and approval processes, some defective devices still make it to the market. When this happens, the FDA may issue recalls or safety alerts. Manufacturers are also required to report any adverse events related to their devices to the FDA.

Preemption of State Law Claims

In some cases, federal law may preempt state law claims. This typically occurs when a medical device has received premarket approval (PMA) from the FDA. However, there are nuances, and a skilled attorney can help determine if preemption applies to your case.

Types of Compensation Available

Victims of medical device failures may be entitled to various types of compensation, including:

Medical Expenses

This covers all medical costs related to the device failure, including emergency care, surgeries, hospital stays, medications, rehabilitation, and any future medical needs.

Lost Wages

If your injuries prevent you from working, you can claim compensation for lost income, including future earning potential if your ability to work is permanently affected.

Pain and Suffering

Compensation for pain and suffering addresses the physical pain and emotional distress caused by the device failure and your injuries.

Loss of Consortium

If the device failure negatively impacts your relationship with your spouse or family, you may be entitled to compensation for loss of companionship and support.

Punitive Damages

In cases where the manufacturer’s conduct was particularly egregious, punitive damages may be awarded to punish the defendant and deter similar behavior in the future.

How T. Madden & Associates, P.C. Can Help

At T. Madden & Associates, P.C., we are dedicated to helping victims of medical device failures throughout Georgia. Our experienced legal team can:

Investigate the Failure

We conduct thorough investigations to gather evidence, identify liable parties, and build a strong case on your behalf.

Work with Medical Experts

Our attorneys collaborate with medical experts to understand the extent of your injuries and the impact of the device failure on your health.