The purpose of a medical device is to help the patient. Even the most profit-driven medical device manufacturers develop and market their products with the goal of making a patient’s life better. Unfortunately, some of these devices malfunction and can cause great harm. This can happen when a device fails, is used improperly, or used off-label.
When you or a loved one suffers damages from a defective medical device, you need an aggressive and experienced legal team on your side. With over 30 years of experience and a strong record of winning large settlements for our clients, the defective medical device lawyers at GoldenbergLaw are here to help you get the justice you deserve.
To schedule a free consultation with our Minneapolis product liability attorneys, please contact GoldenbergLaw online or by calling 877-544-1757 today. We serve victims of dangerous medical devices living in the Twin Cities, surrounding areas of Minnesota, and throughout the nation.
- Defective Medical Devices: An Overview
- The FDA’s Role
- Defective Medical Device Warnings
- Common Defective Medical Devices
- Liability in Defective Medical Device Claims
- Contact GoldenbergLaw
Defective Medical Devices: An Overview
The costs of defective drugs and medical devices are great. In some cases, injuries caused by defective medical devices lead to more intensive surgeries than were originally necessary – just to correct the new damage caused by the defect. Some harms caused by defective medical devices also result in death. Fatal injuries caused by defects have been on the rise in the past decade. This increase has led to devices being pulled off the market, class action lawsuits, safety concerns and liability issues.
There are a variety of reasons for an increase in medical device lawsuits. Two of the leading reasons are:
- Human error
- Placing profit over people
Patents, research, development, testing and government approval take time and money. Companies may sometimes hide negative information to move the process quickly towards approval. Once a device is approved, the company gains more time with their product on the market, reaping the benefits of their development costs.
There is increased pressure on the government to approve new medical devices for patient use. Lobbyists for companies may put pressure on the FDA to approve medical devices quickly, allowing them to start making money on these products as soon as possible. There is also pressure on the FDA to reform the approval process to make it easier to bring new devices onto the market.
Any of these reasons may contribute to the poor planning and development that can result in the release of defective medical devices.
If you have been injured by a defective medical device, our product liability attorneys are here to help. Call GoldenbergLaw at 877-544-1757 to schedule a free consultation and learn more.
The FDA’s Role
The FDA oversees the research, development, manufacturing and marketing of medical products. Once a product receives approval, the FDA also monitors it for unexpected risks and makes sure the warning labels, marketing and other information given to the public is accurate.
Manufacturers must conduct testing and present their findings to the FDA to show their product is safe and effective for the public. The manufacturer’s evidence is evaluated and scrutinized to ensure it has been conducted while following FDA testing guidelines. In addition, the FDA has a set of Good Manufacturing Practices which manufacturers must follow to receive approval.
While the government requires drug and medical device manufacturers to perform adequate tests on their products, there are ways to bypass more stringent testing – and medical device manufacturers know all the tricks to rush a product to market. If a device is similar enough to an existing model, the FDA allows a fast-track approval process that can miss key dangers.
The testing process used to receive market approval from the FDA generally only tests short-term risks, making long-term defects difficult to detect. For this reason, the FDA monitors medical devices once they are on the market as well. When a dangerous defect or risk is discovered, the instrument is recalled or warning is issued.
It is important to remember that neither a recall nor a warning act as shields against liability. When a company makes a defective medical device, they may be liable for injuries regardless of how many warnings have been issued. Our Minneapolis defective medical device attorneys will review your claim free of charge to determine if and how you were warned of potential risks – and help you understand how these warnings may impact your ability to file suit.
Defective Medical Device Warnings
Manufacturers of medical devices have a legal duty to warn doctors of potential risks associated with their products. The risks must also be updated when necessary to make the warnings complete and clear. Once a warning has been updated, it typically becomes the doctor's responsibility to weigh the potential risks against the benefits of using the medical product. If the doctor fails to do so and their patient is injured as a result, the doctor may be liable for failing to inform their patient of known risks.
The duty to warn may include:
- Disclosing information about likely risks
- Making a patient aware of possible dangers
- Placing warnings of dangerous side effects on literature and labels
Medical device warnings allow doctors and patients to know of all potential risks, enabling informed decisions regarding care.
When there was a failure to warn, you must show that the lack of warning caused your injury, which is often difficult to establish. This is but one reason you need an experienced product liability attorney on your side as soon as possible following your injury. Contact GoldenbergLaw today to schedule a free consultation and learn more.
A Look at some of the Most Common Defective Medical Devices
Some of the most common defective medical devices are:
- C-QUR hernia mesh
- Zimmer Nexgen knee implant
- Artificial hip replacements
- Depuy ASR Hip System
- Stryker hip replacement components
- Medtronic Infuse BMP
- Medtronic Paradigm pump
- Bair Hugger surgical blanket
- Zimmer Persona Trabecular knee implant
The FDA approves medical devices for sale, but it does not guarantee that a particular product is safe. Medical device defects are often categorized as either design defects (which are part of the basic design of the product) or manufacturing defects (which occur as an unintended consequence of the manufacturing process). Whether a claim is based on strict liability or negligence depends on the type of defect involved and the warnings that were given (or not given). Our experienced product liability lawyers will carefully assess your claim, identify which type of defect is present, and fight tooth and nail for the full compensation you deserve.
Liability in Defective Medical Device Claims
The liability for injury caused by a defective medical device depends on the individual facts of your case. If the defect is in the design, development or manufacturing of the medical product, the manufacturer may be liable. Generally, if claims are against the manufacturer they will be for strict liability or negligence. Strict liability focuses on whether the medical product is unreasonably unsafe to consumers. Negligence cases focus on development, manufacturing and quality control of a medical product. It must be determined whether the manufacturer was responsible for the defect and the injury that occurred.
If the medical product is not shown to be defective or unreasonably unsafe due to manufacturing, the physician may be at fault. The best way to determine who is liable for your injury is through a one-on-one consultation at our Minneapolis office. Your consultation is free of both obligation and charge, allowing you to ask questions freely and gain a full understanding of your options before choosing the path you feel is best for your needs.
Contact our Defective Medical Device Attorneys
If you have any questions, or if you would like to speak with one of our Minnesota defective medical device attorneys, please do not hesitate to call our downtown Minneapolis office toll-free at 877-544-1757. If you prefer, you may e-mail or fill out the form on the Contact Us page of this web site, and a representative from our office will be in touch with you shortly. We serve victims of defective medical devices living throughout the nation.