Supreme Court Rules To Limit Liability Claims Regarding FDA Approved Products
A recent Supreme Court ruling could limit patient safety when it comes to medical devices and pharmaceuticals. The Supreme Court ruled in late February that patients injured by certain defective medical devices, which have been approved by the Food and Drug Administration, cannot sue the product's manufacturer.
This is because federal regulations preempt state-based product liability claims when challenging the design or labeling of medical devices that clear the FDA's approval process. Preemption basically refers to the way that courts deal with conflicting regulations between federal and state governments on the same issue; meaning, when both court systems rule on the same subject matter in a different way, federal law will displace the state regulation.
In this case, the plaintiff alleged that her husband was injured by a faulty balloon catheter that burst during heart surgery. The man died. Medtronic, the manufacturer, said the FDA-approved product had been used improperly.
Although the FDA has thorough processes for approving medical devices and medication warnings, the FDA's recent issues, concerning lack of funding and resources, have some wondering about their ability to monitor the industry adequately.
The main issue in controversy is in relation to whether all similarly situated product liability claims will eventually follow this precedent in being regulated by federal law. The problem with such is that states generally have retained the power to regulate these matters. The longstanding difference between state and federal government roles relate to "police powers," which are matters dealing with health, safety, and general welfare. These powers have fundamentally been retained by states under the 10th Amendment.
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