Medical Device Complications - Caress Worland Law Group

Each year, large corporations introduce hundreds of new medical devices to the U.S. market. This sort of innovation is exciting. And, when products are effectively used and safely designed, they are of great benefit to patients across the United States. On the other hand, the rapid pace of innovation means that, while the Food and Drug Administration (FDA) is responsible for testing and approving these devices based upon their safety and efficacy, it simply often cannot keep pace with the rate of innovation. In recent years, the approval process for medical devices has been accelerated as multinational manufacturers motivated by the desire for profit have pushed harder and harder for faster device approval and less rigorous testing. As a result, in many cases the FDA now approves prostheses, implants, and other devices on the basis that they are “substantially similar” to existing devices.

Unfortunately, while this approach allows doctors quicker access to new and often much-needed medical devices, it also means that unsafe devices are finding their way to patients. With increasing frequency, we are seeing cases of patients suffering injuries and other complications due to the use and implantation of untested and unproven medical devices. Of course, there are many well-known cases of FDA-approved medical devices harming patients as well. And patients who receive these devices from their health care providers can face a lifetime of pain, limitations, and financial struggle. If you are facing these struggles, you shouldn’t face them alone. We’re here to help. Our attorneys have decades of experience in cases involving medical device complications. Call (317) 255-5400 for a free and confidential consultation with one our highly experienced Indianapolis defective medical device attorneys.

Our Indianapolis defective medical device lawyers represent clients who have experienced complications related to all types of medical devices. This includes everything from equipment operated by specialists in medical facilities to artificial joint replacements implanted during surgical procedures. All of these devices have two things in common: (i) they are intended to improve patients’ health; and (ii) when designed, manufactured, or used improperly, they have the potential to cause serious injury or death.

Defibrillator
Hip implant or replacement
Home blood test
Intrauterine device (IUD)
IVC blood clot filter
Oxygen machine
Pain pump
Robotic surgery equipment
Transvaginal patch or mesh
X-ray, CAT scan, MRI, or other diagnostic testing equipment
Any other dangerous or defective medical device

As a result of our vast experience handling cases involving all sorts of medical device failures, we are knowledgeable and informed about the intended purposes (and defects) of a wide variety of medical devices, including those mentioned above, and more. We can help you understand what went wrong and how to begin taking the steps toward making it right.

From inadequate research and development to errors in manufacturing and implantation, there are various issues that can lead to medical devices causing patients harm. Typically, claims involving medical device defects and complications will be based upon one or more of the following four types of issues:

1. Design Defect

Even when a medical device receives FDA approval, this does not necessarily mean that the device is safe for its intended use. The FDA’s testing methods and protocols are limited, and it often is not until a device has been used on numerous patients that an issue is discovered. Stated simply, a product should not have more of a risk than a normal, reasonable consumer would expect. Unfortunately, some products do. If your device was manufactured according to specification and it still caused you harm, you may have a claim for financial compensation based upon a design defect. We can help you to assess your circumstances and see if you are owed compensation.

2. Manufacturing Defect

In some cases, a device will be appropriately designed but is not manufactured according to the design specifications. This can either be a widespread problem (e.g., if a machine is improperly tooled or there is a deficiency in the manufacturer’s quality control process) or an issue with an individual device. In either case, you are entitled to just compensation and it is important that you discuss your case with an attorney promptly.

3. Failure to Warn

A common issue with many consumer-oriented medical devices is what is known as “failure to warn.” Failure to warn is essentially a labeling defect, where the manufacturer or seller fails to provide notice of a medical device’s potential complications or limitations. If certain risks associated with a medical device would not be obvious to a health care provider or patient making use of the device, these risks must be disclosed on the device’s packaging or on the device itself. Failures to warn give patients and their families with the same legal rights as design and manufacturing defects.

4. Medical Negligence

It is also possible for a medical device to cause complications not because it is defective, but because it is used or implanted improperly. Medical negligence is among the leading causes of death in the United States, and each year hundreds of thousands of patients suffer severe harm due to their health care providers’ mistakes. If you have been the victim of any of these situations, you are entitled to compensation. To best fight for that compensation, you need an attorney who understands the complex law pertaining to these sorts of claims. Often, constitutional law, tort law, and other areas of legal practice may intersect, and you need an attorney who understands the law and can use that knowledge to put forth the best arguments for you to receive the compensation you deserve. Our team at Caress Worland Law Group has the knowledge and experience to do exactly that. When our Indianapolis defective medical device lawyers investigate your case, in addition to determining whether you have a claim for a product defect, we will also thoroughly assess whether you have grounds to pursue a claim for medical malpractice. If you do, then we will help guide you through that process as you seek to assert your rights under the law.

Q: How can you prove that my medical device (or my loved one's medical device) was defective?

Proving that a medical device is defective isn’t easy. It requires a comprehensive investigation conducted by individuals who are experts in the relevant technology, experienced physicians who can link the defect to your or your loved one’s injury or medical condition, and attorneys who know what it takes to prove a defective medical device claim. At Caress Worland Law Group, we have been handling cases involving medical device complications for decades. We work with trusted experts who are at the top of their professions, and we rely on our extensive experience to make sure we seek maximum compensation on behalf of our clients. It is also important to note that product defect cases are governed by the law of “strict liability.” This means that proof of negligence is not required. If the evidence shows that (i) a medical device was defective and (ii) this defect led to you or your loved one’s injury, you are entitled to just compensation for all of your injury-related losses.

Q: What should I do if I believe that I have a claim for a medical device defect or medical malpractice?

If you are concerned about a possible medical device complication, there are several steps you can take to help protect your legal rights:

See a doctor promptly (contact us if you would like a referral)
Keep the device and any packaging (if you have it)
Collect copies of your medical bills, statements of benefits, receipts, and any other documentation relating to your treatment or your purchase of the device
Start keeping a log of your condition’s impact on your life (including days you miss from work, hours spent at your doctor’s office or the hospital, and your daily pain levels and limitations)
Consult with an experienced local attorney about filing a claim for financial compensation (you will want an attorney who has experience in product liability and medical malpractice claims)

Q: Can I file a product liability claim if my medical device has not been recalled?

Yes, while you can certainly check to see if your device has been recalled, a recall is not a necessary precursor to filing a claim for financial compensation.

Q: How long does it take to win financial compensation for a medical device complication?

This is not an easy question to answer, because everyone’s situation is unique. Product liability and medical malpractice cases both involve a number of unique complexities. As a result, they tend to take longer than other types of personal injury and wrongful death claims. In most cases, patients and their families can expect their cases to take anywhere from two to four years. While this may sound like a long time – perhaps longer than you want to wait – it is important to keep the long-term impacts of your injuries or your loved one’s untimely death in mind. You could be facing a lifetime of pain and suffering, and your loss of income, medical expenses, and other financial and non-financial losses could easily add up to hundreds of thousands (if not millions) of dollars. If you need financial help in the interim, there are options available and we can help you evaluate the options that are available.

If you believe that you may have a claim for a medical device defect or medical negligence, or if you are not sure and would like to find out, we invite you to schedule a complimentary initial consultation at our law offices in Indianapolis, IN. To speak with one of our experienced Indianapolis defective medical device attorneys in confidence, please call (317) 255-5400 or tell us your concerns online today. We look forward to listening to your story and to helping you begin the process of fighting for the compensation you deserve.