State Law Claim For Defective Artificial Hip

In a decision that could have a wide-ranging impact on claims for defective medical products, a federal court in Illinois has ruled that federal law does not preempt certain state law claims for injuries caused by defective medical devices.

The case involved the "Trident" artificial hip, manufactured by Stryker Corporation. Artificial hips are medical devices that are regulated by the Food and Drug Administration (FDA). The FDA informed Stryker that its Trident hip failed to meet the FDA's standards, but the hips continued to be implanted into patients. When one of these hips failed, the patient sued under Illinois law. Stryker argued that the patient's state law claims were preempted by the Federal Food, Drug, and Cosmetic Act.

The court disagreed, finding that while federal law preempts state law if the device manufacturer meets federal standards, it does not protect the manufacturer from state law claims if the manufacturer fails to meet those standards. Under this rule, state law cannot be used to force manufacturers to do more than the FDA requires (thus undermining the FDA's regulatory control), but if the evidence shows that the device maker did not follow federal law, allowing state law to be enforced would not require the manufacturer to do anything it is not already supposed to be doing.

Stated another way, federal law preempts state law if the federal law is followed, but state law may be used to complain about a failure to follow federal law when it harms the person using the medical device.

As the use of medical devices becomes more widespread, the quality of these devices becomes ever more important. This decision makes clear that while manufacturers who follow federal law are protected from lawsuits, those who do not may be held accountable.

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