Jump to full article: The Wall Street Journal Interactive Edition, 2009-06-08
Author: MARK H. BERLIND
Intro: However, in a little-noticed provision, the bill also expressly provides that "no provision of this chapter . . . shall be construed to modify or otherwise affect . . . the liability of any person under the product liability law of any State." In other words, the regulatory regime that the legislation would establish can't protect companies from tort liability -- even if they rigorously follow every FDA rule.
This is a bizarre pairing of almost total government involvement in an industry without any government responsibility for, or even modest protection from, the damage claims sure to be generated by that industry for following the law.
The FDA legislation builds on the precedent recently established by the Supreme Court in Wyeth v. Levine. In Wyeth, the Court ruled 6-3 that even if the FDA has approved a drug, the drug maker can still be sued by patients in state court. The majority argued that a litigant is still entitled to claim that the company should have used a stronger warning label than the FDA had required.
But as Justice Samuel Alito observed in his dissenting opinion, "the real issue is whether a state tort jury can countermand the FDA's considered judgment."
The president has proclaimed a "new era of responsibility" for America. But these recent FDA developments -- in which government determines the rules, the business community takes the blame, and trial lawyers take their cut -- seems anything but.
Like elevating the rights of unions over those of secured lenders, the FDA tobacco legislation disturbingly suggests that only those disfavored by the administration will actually be held responsible for anything at all. And it's no secret that the trial bar -- among Mr. Obama's most generous campaign supporters -- has already earned billions from tobacco litigation.
If we truly believe in "responsibility" for businesses, government officials, trial lawyers and ordinary citizens, then regulatory compliance should provide a strong defense against tort claims.
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