A medical device is defined by the Food and Drug Administration (FDA) as any machine, instrument, apparatus, or similar device that is intended to prevent, treat, diagnose, cure a disease, or influence the structure or function of the human body. Medical devices are frequently used in hospitals, emergency rooms, and doctor’s offices to provide treatment and therapy to patients. When a device malfunctions, the results can range widely from simply giving incorrect data to causing severe injuries. For example, if a patient needs a controlled dose of insulin or a specific charge from a pacemaker, a defect could cause serious illness or death.
Medical devices require regular checks and maintenance to ensure proper functioning, and devices that are implanted into a patient’s body need regular monitoring. Despite these safety protocols, errors or defects can occur.
If you or a loved one has experienced illness or death due to a malfunctioning medical instrument, you need guidance from a Tulsa medical device errors attorney to seek compensation in your personal injury, product liability, or wrongful death lawsuit.
Medical devices must be manufactured properly, tested for correct function, and then regularly monitored and maintained to minimize errors that can bring catastrophic injuries to a patient. Different devices will cause different problems, depending on the type of device and how it is used.
Examples of injuries that can occur from a defective medical device include:
Medical devices can malfunction for a number of reasons besides improper maintenance or monitoring. They may have been made poorly or have been marketed unethically. When a device is faulty from the manufacturer, a victim is able to pursue a product liability claim against the company that made the device.
Specifically, there are four main ways a product can be subject to this type of case:
The FDA reports over 5.4 million cases of what they term “adverse events” involving medical devices over the last ten years. These reports involve devices such as knee and hip implants, vaginal mesh, hernia mesh, spinal disc replacements, and pacemakers. In addition to the faulty design concerns already noted, a medical device may fail for other reasons.
A ruling in 2002 called the Medical Devices User Fee and Modernization Act paved the way for the FDA to authorize something called the “least burdensome route” for device approval. This allows manufacturers to skimp on conducting sufficient clinical studies of their devices and simply file a document of modifications showing their product is comparable in safety and effectiveness to other products already on the market.
Records showing a company’s failure to properly test and perfect a product can be a significant factor in proving their liability in a lawsuit.
Likewise, many manufacturers rarely conduct appropriately randomized and controlled trials of their medical devices. The FDA allows something called a “reasonable assurance” standard, which means medical device testing is less rigorous than drug testing, even if a device is meant to treat the same condition as a medication. As more people in the US age, more manufacturers are rushing products to market without proper testing. It is not uncommon for items in heavy demand, such as hip or knee replacement devices, to be brought to market in a few months, with little to no actual implantations done to assess their performance.
When someone suffers injuries or death from a malfunctioning medical device, the case is usually pursued as a special type of personal injury lawsuit, known as a product liability claim. When pursuing a product liability case against the manufacturer of a medical device, the plaintiff must provide evidence that the device was defectively designed, was damaged, failed to perform as expected, or was defectively marketed. Once this evidence is gathered, the victim’s lawyer can work to determine which parties are liable.
Liability can be claimed when the plaintiff and their attorney are able to demonstrate that the manufacturer, a distributor, or some other party:
In some instances, a manufacturer may have recalled a medical device. Regardless of whether this has occurred, it is still possible to take legal action against the parties responsible when the device has injured a patient. Because of the complexities and burden of proof required, it is critical to engage a skilled medical device errors lawyer to ensure all avenues of compensation are explored.
It is also important to consider that manufacturers will use their significant financial resources to fight any claim against them. This will include investigating whether the patient used the device properly, and following all instructions and any warning labels.
They will work to rebut any claim of their culpability.
Further, if there was a recall issued for the device and the patient failed to contact the manufacturer or return the device, the plaintiff may not have a valid claim to pursue.
Oklahoma’s civil code prescribes a 2-year window to file personal injury, product liability, or wrongful death lawsuits. Claimants have two years to file their case from the date of the error or from the date when the victim first became aware of the medical device error that caused their illness, injury, or death.
When the victim and their medical device errors attorney have compiled the necessary evidence to pursue a personal injury or product liability claim, the next step is to calculate a fair and equitable amount of damages to seek. Damages are meant to provide compensation to a plaintiff and their family for injuries, loss, or death suffered as a result of a malfunctioning medical device. Damages can include both economic and non-economic items, such as:
In situations where the responsible parties have caused significantly heinous injury or loss to a patient, the court may award punitive damages. These damages are meant to inflict extreme financial punishment to a manufacturer, distributor, or other party, making an example of the defendant. Punitive damages serve as a warning to the defendant and any other party who may engage in the same actions. This type of award may also be accompanied by orders from the judge regarding procedures or policies the defendant must honor going forward.
When you or a loved one is injured by a faulty or misused medical device as a result of receiving care in Oklahoma, a qualified Tulsa medical device errors attorney is important to understand the complicated laws that govern this type of case.
Legal professionals reduce stress for victims and their families by gathering evidence, demonstrating culpability, and detailing the appropriate list of damages.
When a product is consistently defective and has affected hundreds or thousands of people, a class action lawsuit may be filed. However, this puts victims at the whim of a single court, often with awards that are extremely low once they are distributed to all participants in the class. Another approach is to join a mass tort type of suit, which functions like class action claims but allows each participant to file their own case.
Oklahoma Statutes Section 76.101 and 76.103 cover product liability claims against manufacturers. Interpreting how this law affects your case is best handled by skilled legal counsel who have experience in pursuing these types of claims for maximum compensation.
When a faulty medical product leaves you or a loved one with illness, injury, or death, bring your case to the experienced Tulsa medical device errors attorneys of Graves McLain. Contact us for a free consultation today online or by phone at 918-359-6600.
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