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Claims involving defective medical devices
1. Claims Involving Defective
Medical Devices
Defective Medical Devices
The advancement of technology in the medical field has resulted in
many people to depend on medical devices to better their health. In
the federal law, medical devices are defined as devices used by medical
2. practitioners to treat disease, injuries, or disabilities. These medical
devices encompass
Contraceptive devices such as IUD
Stents: Usually drug-coated tubes inserted into an artery to
prevent blockage
Defibrillators: tiny electronic devices that are implanted in the
patientβs heart to maintain a normal heart rate (pacemakers)
Implants: synthetic devices implanted in a patientβs impaired
body part such as a hip or shoulder to restore their function
The US Food and Drug Administration oversees all the medical
devices that hit the market and make the public aware of any defects
with the products. The FDA uses the premarket notification process or
the 501 (k) clearance process, which ensures that manufacturers of
medical devices seek approval for new products by stating their
substantial equivalent. Despite the strict regulations put in place by
the FDA, Federal and State Laws, many people still end up suffering
injuries by defects in the products. Should a defective medical device
3. injure you, the constitution allows you to file a lawsuit against both the
manufacturer and the medical provider.
Types of Defective Product Claims Involving Medical Devices
Under the strict product liability claims, medical devices just like any
other products must be free from any medical defects. Defective
product liability in βOklahoma claimsβ fall under three major categories
and liability claims should be based on one of them.
Design Defect: Defectively designed medical devices are those that are
properly manufactured but have unreasonable designs likely to cause
injury. Sometimes, medical devices may have been in the market for a
long time but due to mishandling and breakdowns, the device causes
injury to the patient. In some case, the victim may claim that the
manufacturer was aware of the defect, but out of negligence
deliberately concealed it or delayed taking the product off the market.
Manufacturing Defect: These are defects occurring from improperly
manufacturing processes. Defectively manufactured devices arise from
errors of omission at the manufacturing facility, during shipping or in
4. the hospital or doctorβs office. If the defect occurs anywhere between
the factory and the place where you received the device, the liability
falls on the manufacturer. Any member of the chain of distribution
(manufacturer, wholesaler, and retailer) may be held liable for the
defect. The law imposes liability on each party that reaps the rewards
from the sale of a dangerously defective product.
Marketing Defects: Marketing defects in medical devices are
considered to involve any recommendations, warnings or instructions
regarding the use of the specific device by a potential defendant. The
manufacturer has a legal liability to warn patients of foreseeable and
non-obvious dangers likely to occur from the use of the device.
Additionally, manufacturers should provide adequate information
regarding the appropriate use of the device, failure to which they are
liable. The manufacturer, doctor, hospital or sales representatives may
provide wrong marketing information, hence are all held liable should
an injury occur.
Proof of Claim
5. Defective product liability in Oklahoma is based on the ruling of
Kirkland v. General Motors Corp. 1, 1974 where the plaintiff must
prove three major claims.
1. That the defective device was the cause of the injury and a mere
possibility that it might have caused the injury is not enough
2. That the defect existed in the product if the action was against
the manufacturer at the time the product left the manufacturerβs
control and possession. If the action is against the retailer (in this
case the medic), the plaintiff must be able to prove beyond
reasonable doubt that the product was defective at the point of
use or consumption at the time it left the retailerβs possession or
control.
3. That the defect caused unreasonable danger (under Section 36)
to him
When medical devices are manufactured or marketed defectively,
there could be another person who has already sustained similar
injuries. It is thus important to seek help from a personal injury
6. attorney to see if there is a class action lawsuit already initiated with
similar injuries.
Potential Defendants Defective Product Claims Involving Medical
Devices
When filing a lawsuit for involving βdefective medical devicesβ, it is
important to include all potential defendants in your claim. A βpersonal
injury Attorney in OKCβshould be able to help you identify every
person or entity involved in the chain of distribution of the defective
medical devices. The following forms of people or entities that might
be liable for the defective device
Manufacturer: Mostly entities involved with the technical
development of the new medical device that caused harm to the
defendant.
7. Testing Laboratories: Any laboratories involved in the testing of
medical devices, especially if they are independent of the
manufacturer.
Medical sales representatives: Manufacturers use sales representatives
as the link between them and members of the medical community to
introduce and make recommendations regarding potential
applications. The sales representatives may be held liable for the
device that caused injury.
Doctor: The medical practitioner who recommended the medical
device may be held liable for failing to inform the defendant of the
potential risk and damages or provide adequate instructions on the
use of the medical device.
Retailer: Though the majority of the medical devices are delivered to
patients through hospitals, those obtained from pharmacies and drug
stores hold the retailer or hospital liable in the event they cause harm
to the patient.
8. Recoverable Damages
If you suffer injury from a defective medical device, your personal
injury βAttorney in OKCβ will help you file a lawsuit against the
manufacturer or the medical practitioner. However, you must ensure
to keep the device in the same condition it was at the time of inflicting
the injury. If the device is lost or tampered with, it becomes difficult to
prove claim resulting in a dismissal of the lawsuit. If you are successful
with the lawsuit, the court can award you punitive or compensatory
damages.
Punitive damages
The award of punitive damages by Oklahoma courts is usually based
on the case of Thiry v. Armstrong World Industries, where the
Supreme Court held that plaintiffs could claim exemplary or punitive
damages as an element of damage in a product liability action. The
aim of punitive damages is to punish the defendants where they acted
wrongfully and deter others from acting in a similar manner.
9. Compensatory damages
Oklahoma courts have always followed the general tort principle in
which, if a defendant suffers injury from the wrongful act or omission
of another is entitled to fair and just compensation equivalent to the
loss sustained. Compensatory damages are aimed at restoring the
defendant back to the position he/she was before the injury occurred.
Compensatory damages do this by attaching a monetary value to the
economic and noneconomic losses suffered by the defendant.
Assessing the various types of damages, which one is entitled to,
requires considerable legal expertise. Depending on your case, you
require an experienced product liability βattorney on OKCβ, who will
help you in gathering the facts to file a successful lawsuit.