Can Injured Plaintiff Bring a Lawsuit over a Medical Device Approved by the Government?


Charles and Donna Riegel sued the medical device manufacturer Medtronic after a 'balloon catheter' failed during surgery, requiring an emergency coronary bypass procedure. Medtronic argued that the Riegels could not bring their product liability lawsuit under state law, because the Food and Drug Administration (FDA) had approved the device.

In 1976, the United States Congress passed the Medical Device Amendments to the FDA's authority to regulate food, drugs, and cosmetics. The Medical Device Amendments require the FDA to conduct a Pre-Market approval study of medical devices. Once a medical device is approved by the FDA, such approval is a defense to claims that the device was designed improperly.

Medtronic argued that the Pre-Market Approval law preempts state laws regarding medical devices. State laws may be preempted by federal laws when Congress passes a law stating directly that the federal law overrides state laws on the same topic or the federal law so broadly deals with the same topic that state law would simply interfere.

The district court, as well as the Second Circuit Court of Appeals, agreed with Medtronic. Most of the federal circuit courts have agreed with the Second Circuit, but a few have not. Because of the conflict in the federal circuit courts, the United States Supreme Court agreed to hear the case.

The FDA generally does not do its own pre-market research, but merely reviews the research performed by a medical device manufacturer. The FDA also does not, yet, perform studies on devices after they've been put on the market, nor does the FDA require the companies to do such post-market research.

The Riegels reminded the Supreme Court that it generally does not find a federal law to preempt state lawsuits unless the Congress expressly says so. The Riegels also argued that because the federal law did not allow a plaintiff to be awarded damages in federal court, state courts must be open to the plaintiff.

Medtronic countered that the medical device pre-market approval law is sufficient to protect the safety of the public; allowing lawsuits in state courts would end up making it impossible to design a device that could meet the approval of all the states.

Justice Ginsberg stated that she thought the federal medical device approval law did not preempt state lawsuits, but only prohibited states from creating their own pre-market approval processes. The Riegels argued that the federal law forbids states from adding their own approval requirements, but does not preempt state lawsuits when a device fails.

The Court will issue its opinion by June 2008. If the Court forbids awarding damages in state lawsuits over medical devices that are defective, even though approved by the FDA, one has to wonder what motivation a medical company would have for assuring its devices are safe and effective.

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