When we go to a hospital or a doctor’s office, we expect to receive safe and effective treatment. However, sometimes these medical devices can be defective and cause severe harm to the patients who rely on them. In such cases, legal action may be necessary to hold the manufacturer accountable for the damages. Here are some key things that you need to know if you have been harmed by a defective medical device.
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What Are Medical Devices?
Medical devices are instruments, machines, implants, or other tools used in the diagnosis, treatment, or prevention of a medical condition. They range from simple devices like thermometers or blood pressure cuffs to complex devices like pacemakers, artificial joints, or surgical robots. Medical devices can significantly improve patients’ health outcomes, but they can also pose risks if they are defective or malfunction.
What Is a Defective Medical Device?
A defective medical device is a tool that does not work as intended, or that causes harm to the patient when used as intended. Defective medical devices can have design flaws, manufacturing errors, or marketing defects. Design flaws occur when the device was not properly designed or tested, and it fails to perform as intended. Manufacturing errors happen when the device is correctly designed, but an error occurs during production, leading to defects or malfunctions in the finished product. Marketing defects are when proper warnings or instructions were not provided to the healthcare provider or patient along with the device, resulting in improper use or injuries.
Examples of Defective Medical Devices
Some examples of defective medical devices that have led to legal action include:
- Metal-on-metal hip implants that corroded or broke down, causing infections, tissue damage, and other complications.
- Transvaginal mesh implants that caused severe pain, bleeding, and infection due to erosion or migration into the bladder or rectum.
- Power morcellators that spread undetected cancerous tissue during laparoscopic hysterectomies, causing the cancer to spread.
- IVC filters that migrated, fractured, or perforated vital organs or blood vessels, leading to severe bleeding or even death.
- Breast implants that ruptured or leaked, causing chemical toxicity and autoimmune diseases.
The Legal Basis for Filing a Defective Medical Device Lawsuit
If you have been injured by a defective medical device, you may be eligible to file a lawsuit against the manufacturer or other responsible parties. A lawsuit for a defective medical device can be based on one of several legal theories:
- Negligence – the manufacturer had a duty to produce a safe and effective device, but failed to do so, causing harm to the patient.
- Strict liability – the device was defective in design, manufacturing, or warning, and caused harm to the patient, regardless of whether the manufacturer was negligent.
- Breach of warranty – the manufacturer’s representation or promise about the device was untrue or misleading, leading to harm to the patient.
- Fraud – the manufacturer provided false or incomplete information about the device, leading to harm to the patient.
Steps You Should Take If You Have Been Injured by a Defective Medical Device
If you have been injured by a defective medical device, there are several steps you should take to protect your health and your legal rights:
Seek medical attention immediately. Your health should be your top priority. You should get the care you need to treat your injuries and prevent further harm. Be sure to keep all records of your medical treatment, including bills and statements.
Preserve any evidence related to the device. Keep the device itself, any packaging, instructions, or labels. Take photographs of your injuries and any indications of device malfunction. If possible, talk to any witnesses who were present when the injury occurred.
Contact a lawyer who specializes in defective medical device lawsuits. An experienced lawyer can provide you with information about your legal rights and help you navigate the complicated legal process. They can also help you gather evidence, negotiate with the manufacturer, and represent you in court.
File a report with the FDA. Reporting the adverse event to the FDA helps improve patient safety by alerting regulators and manufacturers to possible defects or risks associated with the device.
The Outcome of a Defective Medical Device Lawsuit
If you win a lawsuit for a defective medical device, you may be able to recover damages for:
- Medical expenses related to your injuries.
- Lost wages or income.
- Pain and suffering.
- Loss of consortium or companionship.
- Punitive damages.
However, the outcome of a defective medical device lawsuit can be unpredictable and may take years to resolve. In some cases, the manufacturer may offer a settlement to avoid a trial. In other cases, a trial may be necessary to determine liability and damages.
Conclusion
Medical devices can improve the lives of millions of people, but defects can cause harm and medical issues. If you or someone you love has been injured by a defective medical device, you have legal rights to pursue justice. By taking the right steps, preserving evidence, seeking medical attention, and contacting a lawyer, you can protect yourself and help others avoid similar harm in the future.