If you or a loved one were injured from a medical device or healthcare product, you may be entitled to recover compensation from a medical device injury lawsuit or settlement.
Full Answer
Is a medical device design a defective design?
A medical device isn't usually classified as having a defective design. A manufacturing defect occurs when a product is manufactured in a way that deviates from the design, which usually means the product doesn't perform as intended, and someone is injured as a result.
How are medical devices regulated?
Medical devices are regulated by the U.S. Food and Drug Administration (FDA). The FDA often works with manufacturers to initiate and announce necessary medical device recalls. The most important element of proving a medical defect case is often the product itself.
What is an example of a medical device?
Certain radiation-emitting electronic products that have a medical use or make medical claims are also considered medical devices. Examples of these include diagnostic ultrasound products, x-ray machines and medical lasers. The following steps may be helpful when trying to determine if a product is regulated by the FDA as a medical device.
What if my product is not a medical device?
If your product does not meet the definition of a medical device, it may be regulated by another Center within the FDA. If you believe your product is regulated by another Center, you may contact that at Center to discuss the products they regulate.
How to know how much a medical device settlement is worth?
Speaking with a knowledgeable medical device attorney is the only way to truly gauge how much your medical device settlement is worth. To learn more about your legal options in medical device lawsuit cases, call or contact us at PhillyLaw in Philadelphia today to schedule a free consultation of your case.
What is medical device compensation?
Compensation for medical device claims includes payment for both economic and noneconomic damages. Economic damages refers to out of pocket expenses incurred by the victim as a result of their medical device. This can include medical expenses, lost wages, rehabilitation, and the loss of future income and benefits.
Who is Liable in a Medical Device Case?
The most common people and entities held liable in a medical device case include the following:
What happens if a medical device is not properly tested?
If a medical device manufacturer did not properly test its product before releasing it to the market or had knowledge of potential defects the manufacturer can be held liable for damages. Some device manufacturers will release devices to the public knowing that some will be defective, and they deserve to be held accountable for their actions.
What is medical device?
A medical device refers to any device that helps patients treat a disease, illness, injury, or disability. Some medical devices can be small, while others replace entire body parts. Some medical devices can be purchased and used by the patient at a local store, while others require surgery or outpatient treatment in order to place the device correctly.
Who is liable for defective medical devices?
If the retailer sold you the defective medical device that caused you real harm, the retailer may also be held liable for the damages that result from the defective medical device.
Can medical devices cause damage?
Medical devices can cause damage for a number of reasons, and if you have been injured by a medical device you may have a viable claim for compensation.
What is a defective medical device settlement?
Defective medical device settlements compensate victims for the actual money they have lost because of their injuries, as well as for intangible harms. For example, you might be able to receive money for the following as part of a settlement:
How to maximize medical device compensation?
One way to maximize your compensation is to add as many defendants as possible. In a lawsuit involving defective medical devices, you might be able to sue any of the following:
What are some of the most important medical inventions?
Medical devices save countless lives. Some of the greatest medical inventions of the recent past include pacemakers, defibrillators, and insulin pumps.
Can a doctor be legally liable for a defective device?
Doctor. A doctor could be legally liable for failing to warn you about the dangers of defective medical devices. Doctors usually have malpractice insurance that can pay out a settlement.
What is defective medical device settlement?
Defective medical device settlements are designed to reimburse plaintiffs for their economic losses and intangible harms.
What is improperly designed medical device?
The medical device was improperly designed. The device contained hazardous materials or was negligently manufactured. The device manufacturer or distributor failed to warn about possible risks and hazards. The promotion and marketing of the device was deceptive, fraudulent or misleading. The device had known defects and safety concerns ...
Why is the FDA 510k process so bad?
The FDA’s 510 (k) process has received considerable criticism in that new devices can enter the stream of commerce without pre-market inspections or testing so long as they are substantially equivalent to a predicate device already being sold.
What is FDA recall?
FDA medical device recalls. Medical device recalls are intended to address a defect in the product, a health risk or a violation of FDA laws. When the FDA learns that a device manufacturer intends to remove a device or make a correction, it assesses the dangers and classifies the recall according to relative degree of risk.
What happens when a defective medical device causes fatal harm?
When a defective medical device causes fatal harm, surviving relatives may bring a wrongful death claim to recover compensation for benefits and wages the deceased would have earned.
How do medical devices affect your life?
Defective medical devices can destroy your health, your happiness and your livelihood . Some patients have had to endure multiple revision surgeries to repair perforated organs, others have lost their mobility and are permanently unable to work due to chronic pain and ongoing complications.
What is a class I medical device?
Class I: There is a reasonable probability that a medical device will cause serious health problems or death. Class II : A device may cause temporary health problem or there is a slight possibility it will cause serious health problems or death. Class III: A product is not likely to cause any injury or health problem.
Who regulates medical devices?
Medical devices are regulated by the U.S. Food and Drug Administration (FDA). The FDA often works with manufacturers to initiate and announce necessary medical device recalls.
What are the medical malpractice claims made against?
Unlike medical malpractice claims, which are made against a health care professional, product liability claims over defective medical devices are made against the manufacturers or sellers of these products.
How does a recall affect a product liability claim?
Usually a defective device needs to be removed and replaced, and in most instances the patient needs to undergo additional care to treat complications. Medical devices are regulated by the U.S. Food and Drug Administration (FDA).
How does product liability differ from medical negligence?
Product liability in the health care setting differs from medical negligence in that medical negligence focuses on whether the defendant health care provider's actions were reasonable when measured against the medical standard of care, while product liability focuses on whether the product (the medical device) was defective or dangerous.
How to prove a medical defect?
The most important element of proving a medical defect case is often the product itself. If you believe you've been injured by a defective medical device , it's crucial to preserve it to the extent possible. If the device is used externally, like a thermometer, that's a pretty easy task. Put the device in a drawer and don't take it apart or otherwise handle it until you give it to your lawyer.
What is design defect?
A design defect occurs when the product is manufactured as designed, but is deemed unreasonably dangerous. A medical device isn't usually classified as having a defective design.
What is a marketing defect?
A marketing defect usually refers to a problem with the product's instructions or advertising. An example of a marketing defect is a manufacturer's failure to warn patients and care providers about hidden dangers associated with a hip implant device.
Does settlement money count as income?
It will come as no great surprise that the answer is almost universally yes . Settlement money counts as income, and the amount, including any interest on the award, must be declared accordingly. Now, as with all matters related to taxes, exceptions exist.
Is class action settlement money taxable?
So, class action settlement money will, in general, be taxable.
Is a settlement from a lawsuit tax free?
The criteria for this exemption are pretty specific. An individual needs to have received the award as compensation for physical injury or sickness and/or emotional distress caused by physical injury or sickness (punitive damages remain taxable even in these circumstances.) The physical / emotional injury also needs to be the result of a wrongful act. So, if you suffered a back injury at work because of faulty equipment, and you sued the product’s maker for negligent design, any settlement money you received may be tax-free. Equally, if the injury leads directly to emotional distress – anxiety, for example – the money may be tax-free because of this direct link.
Is the IRS vigilant about physical injury?
The link to a physical injury is crucial, and the IRS is likely to be vigilant about these things. Take, as an example, the class action lawsuit filed by motorists caught up in New Jersey’s “Bridgegate” scandal.
Is back injury compensation tax free?
So, if you suffered a back injury at work because of fault y equipment, and you su ed the product’s maker for negligent design, any settlement money you received may be tax-free. Equally, if the injury leads directly to emotional distress – anxiety, for example – the money may be tax-free because of this direct link.
Is settlement money taxable?
If you’re the victim of discrimination and, say, lose your job, and this leads to emotional distress, any settlement money you receive will remain taxable. Under that “other sources” category, you may wonder about lawsuit settlement money.
Is emotional distress taxable?
If you’re the victim of discrimination and, say, lose your job, and this leads to emotional distress, any settlement money you receive will remain taxable. Why? While emotional distress that’s linked to a physical injury can qualify settlement money as being tax-exempt, emotional distress in and of itself does not. The link to a physical injury is crucial, and the IRS is likely to be vigilant about these things. Take, as an example, the class action lawsuit filed by motorists caught up in New Jersey’s “Bridgegate” scandal. Drivers were stuck for hours in traffic jams, and a class action lawsuit is seeking compensation for a number of damages, including emotional distress. Should the plaintiffs win their case and receive compensation, it will be taxable at the normal income rate. No physical harm, no tax-free settlement money.
