Medical devices, such as pacemakers and prosthetics, can potentially improve patients’ lives and assist health care professionals in diagnosing and treating serious medical conditions. However, the U.S. Food and Drug Administration's (FDA) approval process does not always guarantee the safety and effectiveness of these devices. Studies have linked certain types of medical devices to numerous injuries and deaths, highlighting the significant risks and harm associated with these products.
Were you injured, or was someone you love harmed or killed by a dangerous or defective medical device? You may be entitled to compensation for your injuries and losses. At Peterson & Associates, P.C., our experienced team of Kansas City medical device injury attorneys can help you navigate the complex legal landscape and fight for the recovery and justice you deserve. We have a proven track record of success in holding negligent manufacturers, distributors, and health care providers accountable. Here's what you need to know.
Understanding the FDA Medical Device Approval Process
Bringing new medical devices to market through the FDA’s traditional premarket approval (PMA) pathway is lengthy and expensive. A standard PMA application costs more than $322,000, involves vast amounts of paperwork, and requires manufacturers to demonstrate the safety and efficacy of their products. From concept to approval, it takes an average of three to seven years for medical devices on the PMA pathway to reach the market.
Unfortunately, the FDA only makes manufacturers complete this rigorous process for new life-supporting or lifesaving devices it considers high-risk. Other medical devices can gain FDA clearance through premarket notification (PMN).
Also known as the 501(k) pathway, PMN allows manufacturers to get their products on the market faster and for considerably less money by claiming they’re substantially similar to those already available. Though this shortcut is supposed to reduce bureaucratic red tape and get essential devices to patients more quickly, when abused, dangerous or defective products can make it onto the market with little to no testing.
When this happens, the FDA may recall a defective device to protect the public.
Dangerous or Defective Medical Devices Can Cause Severe Harm
Studies have linked dangerous or defective medical devices to serious injuries, such as:
- Cobalt poisoning due to wear and tear of metal-on-metal artificial hips
- Inadequate or excessive insulin delivery from implantable pumps
- Infections and other complications caused by contaminated or poorly designed surgical implants
- Severe burns or electrical shock from faulty defibrillators or pacemakers
- Perforations, tears, or other damage to organs or tissues caused by defective surgical tools, mesh implants, or IVC filters
- Blood clots or other cardiovascular problems caused by defective heart valves or stents
- Nerve damage, paralysis, or other neurological problems caused by faulty spinal cord stimulators or other neuromodulation devices
- Severe allergic reactions, infections, or other complications caused by poorly designed or contaminated medical tubing or catheters
- Vision loss, blindness, or other eye problems caused by defective intraocular lenses or laser surgery devices
- Hearing loss, tinnitus, or other ear problems caused by defective cochlear implants or hearing aids
Potentially Liable Parties in Dangerous or Defective Medical Device Cases
Patients typically see several health care professionals before being prescribed a particular medical device, making it difficult to determine who’s responsible for your injuries and losses. For example, the prescribing physician may be liable if they knew the device was risky but failed to plainly explain those risks to the patient. Other potentially liable parties include hospitals, medical device distributors, or sellers.
However, the manufacturer is frequently held liable for medical device injuries due to defects, inadequate warnings, or misleading marketing. Medical device manufacturers are legally responsible for ensuring their products are safe, meet FDA standards, and include warnings of possible risks or side effects. Patients have a right to know the risks associated with a particular medical device so that they (and their doctors) can make informed health care decisions.
How Our Kansas City Medical Device Injury Attorneys Can Aid Your Recovery
Dangerous or defective medical device cases can be complex and complicated. Whether you’re located in Missouri, Kansas, or elsewhere in the United States, Peterson & Associates, P.C.’s highly skilled medical device liability lawyers can provide the aggressive and effective representation you need to recover fair compensation. When you’re injured, results matter. We’ve collected more than half a billion dollars for our clients, including $141,100,000 in compensation for a client for a defective product claim. Additionally, because we handle cases on contingency, if you don’t get paid, we don’t get paid. Injured? Peterson & Associates, P.C. is here to help!
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