Riegel v Medtronic - a Clash Between Ethics and Law

A year ago today, on February 20, 2008, the Supreme Court decided Riegel v Medtronic by an 8-1 decision, with Judge Ginsburg as the sole dissenter. Riegel concluded that the Medical Device Amendments of 1976 meant that "no State 'may establish or continue...with respect to a device...any requirement' relating to safety or effectiveness that is different from, or in addition to, federal requirements."

The decision means that FDA approval of a device preempts the rights of individuals to sue for damages caused by the device and similarly preempts the rights of states to enact more stringent standards than required by the FDA.

Riegel may be good law (8 justices thought so), but it's bad ethics.

Today's New York Times reported that Representatives Henry Waxman, chairman of the House Energy and Commerce Committee, and Frank Pallone Jr., head of its health subcommittee, plan to introduce legislation that would nullify Riegel. A similar Senate bill, sponsored last year by Senators Kennedy and Leahy, is expected to be reintroduced in the next few months.

The core issue is the relative priority we give to competing values. Getting FDA approval for a device - especially at the highest (Tier III) level - is very demanding in time and cost. Device manufacturers argue that allowing post approval tort claims against them and allowing states to impose higher safety standards will impede bringing new devices to market. They're invoking the potential benefit of new devices as the key value.

Critics of Riegel give more weight to safety concerns. Here's what the Times article reports:

The lawmakers, as well as patient advocates and others, say the Supreme Court’s medical device decision has left patients legally powerless against what they criticize as spotty oversight of products by the F.D.A.

“Consumers face the worse of all possible worlds,” said David C. Vladeck, a professor at Georgetown University Law Center and a medical industry watchdog. “The F.D.A. has shown itself incapable of keeping dangerous products off the market, and now the Supreme Court has said patients can’t sue companies for redress.”

Providing benefit and avoiding harm are fundamental health care values. The question for ethical reflection is - when push comes to shove with regard to oversight of medical devices, which should prevail?

The answer comes from the adjoining article in this morning's Times, headlined "Guilty Pleas in Inquiry Into Stryker’s Marketing." The article reports that two former Stryker sales representatives have pleaded guilty to charges that they had promoted off-label use of the products even though they knew that such use had earlier caused problems in some patients. One claimed - all too plausibly - that Stryker's compensation system encouraged the fraudulent practices.

Even apart from criminal fraud we know that the FDA is not able to conduct adequate post marketing surveillance. Tort liability and the potential for states to set their own requirements are necessary for public safety. Sadly, the revelations of corrupt corporate practices have undermined trust in self regulation by device and pharmaceutical manufacturers.

Riegel v Medtronic tells us what the law says about medical devices. But Representatives Waxman and Pallone, and Senators Kennedy and Lahey understand that good ethics and sound public policy require a change in the law.