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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 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 patient’s heart to maintain a normal heart rate (pacemakers)
- Implants: synthetic devices implanted in a patient’s 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 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 Oklahoma claims 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 the hospital or doctor’s 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
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.
- That the defective device was the cause of the injury and a mere possibility that it might have caused the injury is not enough
- That the defect existed in the product if the action was against the manufacturer at the time the product left the manufacturer’s 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 retailer’s possession or control.
- 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 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 defective medical devices, it is important to include all potential defendants in your claim. A personal injury Attorney in OKC should 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.
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.
If you suffer injury from a defective medical device, your personal injury Attorney in OKC 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.
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.
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 attorney on OKC, who will help you in gathering the facts to file a successful lawsuit.