What laws govern medical device injury lawsuits?

In Pennsylvania, medical device injuries are regulated by both state and federal law. The Pennsylvania Unfair Trade Practices and Consumer Protection Law (UTPCPL) protects consumers from deceptive marketing and false advertising of medical devices. Additionally, Pennsylvania’s Medical Outcomes Research and Evaluation (MORE) Act requires medical device manufacturers to provide accurate testing and labeling information for their products. At the federal level, medical device manufacturers must comply with the Food and Drug Administration (FDA), which approves all medical devices before they can be marketed or sold in the United States. The FDA also requires medical device manufacturers to report any safety issues or recalls to them. Injury lawsuits related to medical device injuries are typically handled in the state court system as either a product liability or negligence lawsuit. Product liability lawsuits are based on claims that the manufacturer of the device was negligent in its design, manufacture, or labeling of the product, and resulted in the plaintiff’s injury. Negligence lawsuits may also be used in medical device injury cases where the manufacturer failed to provide adequate warnings or instructions, or where a health care provider was negligent in the use of the device. In either type of case, the plaintiff must prove that the defendant failed to use reasonable care, resulting in injury or illness. Finally, the Pennsylvania Supreme Court has declared that a medical device manufacturer can be held liable for punitive damages in cases of gross negligence or wanton and willful misconduct. Punitive damages are awarded to punish the defendant in a lawsuit for egregious behavior and to deter similar behavior from happening in the future.

What laws govern medical device injury lawsuits?

Related FAQs

Related Blog Posts