Tort Reform by Regulation: After The FDA Approves It, You Can't Sue It.

The Bush Administration is trying a new tactic in tort reform, one the New York Times reports as an acknowledged changed in government policy by the Justice Department. In essence, if the FDA has approved a product, consumers cannot sue regarding it.

The purpose is to prevent undermining public health by second guessing the FDA's government approval sanction. This applies to devices and drugs, based on reports of recent court cases. They have argued that Federal Law barred the claims because a device was produced to federal specifications.

They also acknowledged this was a change from a 1997 position, when they felt states could provide an additional protection to consumers. The administration is arguing that consumers benefit because the excessive litigation may cause withdrawal of approved products and "underutilization of beneficial treatments. The Bush administration is reported to assert their goal was to vindicate government authority to regulate medical products. Thsy also are trying to avoid a patchwork of court created standards across the country.

It is not clear how many cases this affects, or which. But it is apparently several, because Representative Maurice D. Hinchey (D), NY, asserted FDA lawyers had repeatedly intercede in civil suits. The article lists a series of drug and device cases, across the country.

This raises the question of what other regulatory relief can occur in Tort Reform and the Malpractice Crisis.