Medical devices have helped to revolutionize modern medicine. Some devices are simply improvements on old tools, while others are new innovations that change the face of health care. While medical devices can help to improve medicine, they can also pose a serious risk to patient health. Companies more interested in profit than safety rush devices through testing procedures. The result is a market flooded with defective and dangerous medical devices. Dangers are only known after hundreds or thousands of patients suffer an injury or die because of the defective device.
Have you been injured because of a defective medical device? You have the right to hold the company that designed or sold that product responsible for the harm you’ve suffered. At Citywide Law Group, our personal injury lawyers can help you recover the money you need and deserve. Call today to schedule a free consultation with our Los Angeles defective medical device attorneys. We’ll review your case and answer any questions you have.
How Defective Medical Devices Get to You in Los Angeles
Medical devices must be approved by the FDA before they can be sold and used in the United States. There are two ways for products to get approval: rigorous testing and 510(k).
The first involves rigorous testing and documentation by the company seeking Premarket FDA approval. The company must provide the FDA with evidence to show that a medical device is effective and safe for use. Since the FDA receives thousands of new applications every year, it can be difficult to review each one with the care and attention it deserves.
As a result, a great deal of trust is placed with the companies that are seeking approval. Some take advantage of this and cut corners in design and manufacturing. Test results may be biased, incomplete, and/or not in line with scientific methods. Devices may appear to be safe simply because the company behind it claims it is. As a result, dangerous devices get approved by the FDA.
Medical devices may not have to go through a rigorous testing and approval process if a company opts to the use 510(k) process. Under 510(k) a medical device can be approved if a company can show that its product is substantially equivalent” to one or more devices that are already approved for use by the FDA. Instead of showing that the new device is effective and safe, the company must simply convince the FDA that it is simply an improvement on an existing product. This allows companies to bypass important testing processes that help to identify potential problems and issues.
Common Types of Defective Medical Devices
There are three categories of medical devices: Class I, Class II, and Class III. Class I devices are identified as “low risk” and include products like floss and exam gloves. Class II devices are identified as being slightly riskier than Class I devices. These include products like infusion pumps and motorized wheelchairs. Class III devices are identified as “life-sustaining” and pose the greatest risk to patient health. These include products like pacemakers and cerebellar stimulators.
Any class of medical device can pose a threat to patient health if it is defective. However, Class III medical devices, which are subject to the strictest scrutiny, are most likely to cause significant injury and/or death if they are defective.
The following medical devices have been shown to pose a threat to patient health and safety:
- Surgical mesh
- Retrievable IVC filters
- Hip implants
- Knee implants
- Shoulder implants
- Heart valve implants
- Heater/cooler units for cardiopulmonary bypass
- Pain pumps
- Insulin pumps
- Power morcellators
- Internal birth control (i.e., NuvaRing), and more.
If you use any of these medical devices and notice odd symptoms it is important to seek medical attention immediately.
Product Liability and Defective Medical Devices
In California, companies that design, manufacture, and/or sell medical devices have an obligation to make sure that those products are safe for consumer use. If a medical device is defective, the company can be held strictly liable for any harm that results. This means that you don’t necessarily have to prove that the company was negligent, or that they knew the product was defective.
There are three primary grounds on which you can file a product liability lawsuit: design defect, manufacturing defect, and failure to warn.
Medical devices must not pose more of a danger to consumers than they would expect. The risks of a device must also not outweigh the benefits. A design defect exists when the product is dangerous because of how it was originally designed.
Example: Lawsuits have argued that certain transvaginal mesh products contain a design defect because they deteriorate in the body rapidly. A consumer using transvaginal mesh would expect for the device to be strong and rigid in the body to perform its intended function. The design of the product called for faulty materials that caused injury.
Defects can also exist if a medical device is not manufactured according to its precise specifications. A manufacturing defect could affect one device on the manufacturing line or an entire batch.
Example: A company designs a robotic surgical device that requires a very specific computer chip. Without the chip, the device will not work as intended. An error during the manufacturing process causes some of the devices to be completed without the chip. Since the product was not manufactured as intended, a manufacturing defect exists.
Failure to Warn
A company has an obligation to warn consumers about any known risks that may be associated with a particular medical device. If a company does not provide a warning about a risk that they knew or should have known about, they can be liable for failure to warn. It’s important to note that a company may satisfy the obligation if all known risks are relayed to physicians who use and prescribe the devices.
Example: A company designs and sells a medical implant device. The company cuts corners and doesn’t put the device through a rigorous testing process. As a result, it fails to identify a serious health risk that is associated with product use. A patient receives the implant and suffers a life-changing injury because of the undisclosed risk. The company may be liable for damages for their failure to warn.
Why It’s Important to Work With a Personal Injury Lawyer
If you’ve been injured because of a defective medical device it is important to speak with an experienced personal injury lawyer. Product liability cases, particularly those filed against large companies, can be very difficult to navigate.
Your case will require an extensive investigation into your injury as well as the product’s history. You’ll also be met with resistance from the defendant. These companies have invested millions of dollars in their medical devices. They are prepared to contest any allegations that these money-making products are defective or dangerous.
Hiring an attorney with experience handling these types of complex cases will help you level the playing field.
Here’s what you can expect when you hire our Los Angeles defective medical device attorneys to handle your case:
- Investigation: We’ll carefully investigate your case and find evidence to show that the medical device is responsible for your injury.
- Expert Help: We’ll work closely with medical, scientific, and technology experts to determine precisely why the product was defective.
- Other Victims: We’ll search for other victims who may have also been injured because of the defective medical device. Testimony from other victims can help incredibly helpful as you demand compensation.
- Analyzing Damages: How much are your injuries and suffering worth? Our attorneys will identify all of your damages and make sure that they are valued properly. We’ll pursue compensation for medical bills, lost wages, pain and suffering, disfigurement, disability, and any other damages you’ve sustained.
- Identifying All Defendants: More than one person (or company) can be responsible for causing your injury. We’ll determine the precise cause of your injury and determine who may have contributed. This could include hospitals, doctors, medical staff, or others who may have been involved.
Our goal is to help you recover the money you deserve after an unexpected injury. Companies rush medical devices to market and put consumers like you at risk. The injuries you sustain can change your life forever. We know how important a financial award can be and will aggressively pursue money on your behalf. Call us today to schedule your free case assessment.
Call Our Los Angeles Defective Medical Device Lawyers
Have you been injured because of a defective medical device? Do you want to file a lawsuit against the company responsible for designing and selling the product? Citywide Law Group can help you maximize the financial award you receive. Contact our Los Angeles defective medical device lawyers today to schedule a free consultation. We will review your case, explain your legal options, and help you understand your rights. Call today to get started.