Common Defenses in Defective Medical Device Lawsuits and How to Counter Them Effectively

Defective medical device lawsuits are complex and challenging, often involving high stakes for both plaintiffs and manufacturers. Manufacturers typically employ a variety of defenses to mitigate their liability and protect their interests. Understanding these common defenses and how to counter them effectively is crucial for plaintiffs seeking justice and compensation for their injuries. At Mainor Ellis, our Las Vegas Defective Medical Device Injury Lawyers ensure our clients understand the primary defenses used by manufacturers in defective medical device lawsuits and strategies for countering these defenses.

Common Defenses Used by Manufacturers

Manufacturers often argue that federal law preempts state law claims. Under the Medical Device Amendments of 1976 to the Federal Food, Drug, and Cosmetic Act, devices that receive premarket approval (PMA) from the FDA are subject to rigorous scrutiny. Manufacturers claim that once a device has been approved by the FDA, state-law claims challenging the safety and effectiveness of the device are preempted. This means that plaintiffs cannot sue for defects because the federal approval should theoretically ensure the device’s safety.

The Learned Intermediary Doctrine defense posits that manufacturers fulfill their duty to warn about the risks associated with a medical device by informing the prescribing physician, rather than the patient directly. The physician, considered a “learned intermediary,” is responsible for conveying this information to the patient and making informed decisions about the use of the device. Therefore, manufacturers argue that they should not be held liable if the physician fails to properly inform the patient or misuses the device.

Manufacturers may claim that the injury resulted from the plaintiff’s misuse of the device rather than a defect. This defense suggests that the device was used in a manner not intended by the manufacturer, and such misuse caused the injury. Common examples include failing to follow instructions for use, using the device for an off-label purpose, or tampering with the device.

Strategies to Counter These Defenses

To counter preemption defenses, plaintiffs can argue that their claims are based on state requirements that parallel, rather than conflict with, federal regulations. Demonstrating that the manufacturer failed to comply with FDA requirements can also weaken the preemption defense.

Plaintiffs can counter the Learned Intermediary Doctrine defense by showing that the manufacturer did not adequately inform the physician of the risks or that the warning provided was insufficient or misleading. Evidence that the physician was not properly educated about the device’s dangers can also undermine this defense.

To counter product misuse defenses, plaintiffs should provide evidence that they used the device as intended and according to the instructions. Expert testimony can help establish that the injury was due to a defect rather than misuse.

Seek Legal Assistance Today

Navigating defective medical device lawsuits requires strategic legal expertise. By understanding and effectively countering the common defenses used by manufacturers, plaintiffs can strengthen their cases and improve their chances of obtaining fair compensation for their injuries. At Mainor Ellis in Las Vegas, Nevada, we are here to support our clients in presenting the best case possible and ensuring justice is served.

Source:

ncbi.nlm.nih.gov/pmc/articles/PMC1200796/