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A defective device is one that has a defect or flaw. In the age we live in, we make use of a wide variety of devices, for a wide variety of purposes. These devices make our lives easier, and in some cases, better. In the healthcare sector particularly, the use of medical devices is changing how we access health.
According to the World Health Organization (WHO), a medical device is an instrument intended by the manufacturer to be used, alone or in combination for human beings for specific medical purposes. The purpose can include one or more of the following:
Medical devices have revolutionized the healthcare industry. The role they play in the diagnostic and therapeutic care of patients cannot be overemphasized.
Despite this though, there are many cases of defective medical devices that cause injuries and sometimes death. One would expect that since these devices are there to make lives easier and better, they should be put through the most stringent of tests, to ensure that they are safe for use. The reality though is often different.
A device can be termed defective in one of three ways. It can either have a design defect, a manufacturing defect, or a marketing defect. The dangers and injuries inherent in using defective devices are wide-ranged. They include:
According to Electrical Safety First, about 1380 fatalities and injuries were caused by electrical fires in 2015/16, with an average of 27 a week and 4 a day. The leading causes of these fires were defective cookers and ovens.
Consumer Reports, in its May 2012 publication, says that most medical implants have never been tested for safety.
“Medical devices often aren’t tested before they come on the market. “What they’re doing is conducting clinical trials on the American public,” says Dan Walter, a political consultant from Maryland. His wife was left with heart and cognitive damage from a speciality catheter cleared without testing. The device malfunctioned during a procedure to treat an abnormal heartbeat.
There’s no systematic way for the government, researchers, or patients to spot or learn about problems with the devices. “A coffee maker or toaster oven has a unique serial number so if a problem is found, the company can contact you to warn you. Your artificial hip or heart valve doesn’t,” says Diane Zuckerman. (Ph.D., President of the National Research Center for Women & Families). “Your doctor is supposed to notify you of a problem but may not be able to if he has retired or passed away. Without major changes in the system, there’s not much that patients can do to protect themselves”, she adds.
The FDA receives reports of deaths, serious injuries and malfunctions associated with medical devices. It classifies medical devices into three categories:
However, manufacturers have been able to worm their way out of carrying out adequate testing on their devices before releasing them to the public. There are a number of loopholes in the FDA regulations which they are able to take advantage of.
These loopholes, unfortunately help pour money into the coffers of corporate giants in the medical device industry, while people suffer. They are responsible for an increasing number of patients being harmed by these devices yearly.
While you may not be able to protect against being outfitted with a defective medical device, you can most definitely hold the manufacturers liable. You may not be able to prevent the injury, but you can definitely get justice for your injuries.
In order to file an action for a defective device, you need to first establish liability. You have to pinpoint the nature and cause of the defect or failure. Defects in product liability include:
A design defect occurs when the device is inherently dangerous. Take, for example, the notorious artificial hip model, the metal-on-metal hip, ASR XL made by Johnson & Johnson.
The design of the model was distinctive because both of its components - the ball at the top of the femur and the socket liner inside the pelvis – were made of chrome-cobalt.
This design was however defective because the chrome-cobalt nature of the balls caused a marked increase in blood chromium and cobalt levels. These then gave way to a lot of other medical problems.
A manufacturing defect occurs when the defect arose as a result of inadequately managed manufacturing processes. The quality of the defective device is thus non-conforming to the original prototype.
A marketing defect occurs when the marketers are quite aware of the risks inherent in using a device but still push the device. They don’t inform the prospective user of all risks involved. The user is thus unable to make an informed decision.
In filing an action for a defective device, you should name everyone in the chain of production of the device.
When filing a defective device claim, the most important element of the case is the device itself. You must keep the device in the same condition as it was when you were injured. This might be a bit complicated in cases where the defective device was an internal medical device.
A surgeon would normally not return a defective device to the patient after it has been removed. Most times, it is usually disposed of immediately. If this happens, you just might have lost the chance to file your claim.
The defendants in a defective device suit have a right to have the device examined by their experts. If you as the plaintiff, interfere with that right, however innocently, the defendants can push for the lawsuit to be dismissed - and they would be within their rights to do so.
To avoid this, you should contact a lawyer before you take any steps towards removing the device. They will in turn consult with your doctor and ensure that nothing happens to the device.
Multidistrict litigation (MDL) is a group of lawsuits filed in one common location against a common defendant. It is very different from a class action lawsuit. A class action is a single lawsuit with several similar claimants. MDL on the other hand, involves several lawsuits and several claimants.
In cases involving such widely used products as defective devices, it is possible for hundreds or even thousands of individuals to be affected. When they are so affected, many cases will be filed in court, and this may terribly stress the judicial system. MDL suits are adapted to ensure that the judicial system can deal with the stress.
Besides, MDL suits can be very important for you as a claimant. The disadvantage of a class action suit is that all the claimants share the settlement equally, degree of injuries notwithstanding. This means that a claimant with major injuries that might require surgery or extensive treatments would get the same amount as a claimant with a very minor injury. Obviously, this would not be right for you. MDL lawsuits allow you to maintain your own individual action.
The US Judicial Panel on Multidistrict Litigation decides when several lawsuits should be consolidated in an MDL. When this happens, all suits filed will be heard in just one federal district and before one judge. This will last throughout pre-trial proceedings and discovery. Any case that continues beyond these stages will be returned to its original district for full hearing.
The benefits of multidistrict litigation include:
Having an experienced and diligent legal team in your corner is even more important than having evidence for your lawsuit. A qualified defective devices lawyer will help you understand the procedure involved in recovering compensation for you. They will go toe to toe with giant medical corporations to get you the compensation you deserve.
At Oshan and Associates, we will fight for your right to justice unrelentingly and with the deepest of compassion for your suffering. Get in touch with us on 206-355-3880 or click here to schedule a free consultation.
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ALTON Rogers
February 06, 2024
I HAD A JOHNSON AND JOHNSON DEBUY KNEE DEVICE Revision Surgery on May 25th 2022.The 1st Surgery was 2019.The device came loose