Medical Product and Device Defects

A product liability case is an offshoot to injuries which are caused by defective or harmful medical appliances, organ transplants, equipment, surgical implants, prosthetic devices, surgical equipment, diagnostic equipment, hospital supplies, and visual and hearing aids. Any of these products can be the cause of a product liability lawsuit if it caused injury to individual(s).

First Issue: The Statute of Limitation

One of the main points in cases of this nature is the statute of limitations or simply the time limit for taking a lawsuit. All states permit a set period of time to ring a lawsuit, however, there are many cases that involve defective medical products where this important period of time can slip away between the individual’s exposure to the defective product and the individual’s knowledge of the injury. Because of this, there are many states that have accepted a rule where the time set for bringing the lawsuit does not start to apply at the time of the injury, hence, when the injured person becomes aware or should have known of the resulting disease or other harmful consequence.

Knowing the Difference: Medical Malpractice or Product Liability

Similar to other product liability cases, the plaintiffs in medical lawsuits bring out the issue of the manufacturer’s or other provider’s failure to alert consumers about the probable risks of their products. There were many instances when manufacturers of these types of products can perform their responsibility by giving the warnings to the doctors, nurses, or other medical staff who will be using these products, and this responsibility is passed to those professionals and experts to provide sufficient information to the individual or consumer. There is a thin line between the product liability action which involve a defective medical device and a medical malpractice action, and it is an experienced lawyer in this area who is capable of helping both the plaintiffs and defendants determine which of these laws apply.

The Regulation and the US FDA

The Food and Drug Administration or FDA controls the safety and effectiveness of medical devices. The amount of control the US FDA has over the manufacturers will depend on how the products or goods are manufactured are to cause an injury. FDA has designed and set the standards and practices for the manufacturers to adhere to. The proof of adherence or compliance may boost the case of the defendant that the injury was not through their negligence, hence, the failure to follow can strengthen the plaintiff’s claim that the injury-causing product was defective. FDA also sets the labeling requirements for particular medical products. However, the compliance of the manufacturers with these requirements does not relieve the manufacturers from “failure to warn” liability.

The individuals who are filing lawsuits about the safety of the medical devices which are approved by federal authorities may face more stern legal procedures, after a decision is handed down by the US Supreme Court in February 2008. In the Riegel v. Medtronic Inc, the Court declared that the Medical Device Amendments of the 1976 stops most of the state law claims in challenging the safety or the effectiveness of the medical device that was granted the market approval from the US Food and Drug Administration.

Obtaining Legal Assistance for a Defective Product Injury

The product liability actions are usually complicated and setting legal faults always need the help and testimony of professionals. There are many theories under which the plaintiff might raise a claim, and many defenses that might beat and crushed the claim. Furthermore, each state has its own laws and particular regulations and decrees that will affect the product liability action. Thus, it is very important to consult an experienced lawyer if you or any of your family members experiences an injury which is caused by a defective product.


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