Keeping Americans Safe from Faulty Medical Devices

“Who is best equipped to protect the consumer from dangerous drugs and medical devices: regulatory agencies or the courts?” Mark Agrast, Senior Fellow at the Center for American Progress, asked a panel of experts during his introductory remarks at the CAP-hosted event “Protecting America from Unsafe Drugs and Medical Devices: Federal Preemption or Consumer Protection?” on Wednesday. The panel included Georgetown Law Professor David Vladeck, Director of Federal Relations for American Association for Justice John Bowman, Arnold and Porter LLP Partner Robert Weiner, and Alliance for Justice President Nan Aron.

Last year’s Supreme Court case Riegel v. Medtronic held that a 1976 federal law that regulates medical devices expressly preempts common law claims challenging the safety or efficacy of FDA-approved medical devices. The decision “turned established law on its head in courts around the country,” Aron said as she introduced “Hit and Run,” a short documentary about the case. She posed a question to the audience on the issue of preemption, asking: “ Should the FDA’s approval of medical devices, such as a defibrillator, preclude individuals from getting access to the courts if they are harmed?”

The Medtronic ruling stands in contrast to the Court’s decision this March in Wyeth v. Levine that federal law did not preempt state tort suits about drug warning labels. “Wyeth was an enormous victory for consumers,” said Vladeck. “The ruling drives a stake through the heart of Bush’s “preemption by preamble” program … I think that Wyeth is a signal that this very ambitious program by the Bush administration to reshape American tort law through regulatory preamble is probably doomed to judicial invalidation.”

The panelists discussed legislation introduced by Reps. Frank Pallone, Jr. (D-NJ) and Henry A. Waxman (D-CA) and Sen. Edward M. Kennedy (D-MA), known as the Medical Device Safety Act, which would reverse Riegel and permit consumers to sue manufacturers of faulty devices in state court. Vladeck and Bowman, who favor the bill, argued that tort cases are an important “backstop” for federal regulation which not only deter manufactures from knowingly selling flawed devices and provide injured consumers with compensation, but also bring information to light of which may not have been available to the FDA.

In contrast, Weiner said, “I believe in regulation, but regulation by litigation is inefficient and inappropriate,” calling juries in tort cases “less democratic than the regulatory process.” In addition, Weiner asked whether it was fair to ask a device manufacturer to compensate injured parties when the company acted in accordance with the FDA’s instructions, and argued that the fear of civil liability can deter manufacturers from bringing new and innovative devices to the marketplace.

As an alterative to litigation, Weiner suggested an industry-wide, no-fault insurance-style system. But Bowman argued that such a system would not provide adequate compensation or take proper account of the circumstances of specific cases.

Ultimately, the panelists agreed that more effective regulation would help reduce the need for lawsuits but differed over whether, given the limited ability of the FDA to protect consumers from harm, the tort system is a help or a hindrance.

For more details on this event, please visit the events page.