The Supreme Court ruled yesterday that the FDA’s approval of a medication does not protect the drug’s maker from state-level lawsuits. This limits the scope of the preemption doctrine, the notion that when federal laws come into conflict with state or local laws, the federal laws win.
The case, Wyeth vs. Levine, revolved around a former violinist. She was injected with the anti-nausea medication Phenergan and, when the injection struck an artery, had to have an arm amputated. The musician sued Wyeth, the drug’s maker, and a jury awarded her $7.3 million. Lawyers for the Bush administration and Wyeth pointed out that the FDA had approved the medication, with a label warning of the drug’s dangers; this, they said, preempted actions at other levels of government.
The Court’s ruling to the contrary is both puzzling and disturbing. Puzzling because the Court appeared to rule last year, in the 8-1 Riegel decision, that the preemption doctrine applied to lawsuits over FDA-approved medical devices. Disturbing because it will weaken the FDA at a time when it needs bolstering.
Furthermore, the decision will likely discourage innovation: Manufacturers will face far-greater legal vulnerabilities under state rules, which can differ from the FDA’s already-strict standards. This decision will encourage manufacturers to be far more cautious, and to seek new products that minimize risk, rather than ones that maximize benefits.
Congress could reverse the decision by making preemption explicit in the law. It could apply preemption to the entire Food, Drug, and Cosmetic Act, which the Court’s opinion stated would have made a difference.
This idea would, in a perfect world, have some level of bipartisan support. Conservatives appreciate the tort-reform element of limiting costly lawsuits, while liberals should appreciate the display of confidence in a federal regulator. If we’re going to have an FDA, let its regulations be the final word. Otherwise, drug makers have to meet up to 50 different state standards, which could diminish the FDA, something liberals presumably do not want.
Alas, it is not so. Democrats in Congress, particularly Henry Waxman, are elated by this decision. Waxman consistently sought to undercut the Bush administration’s preemption efforts, of which I was a part, because he saw this approach as a giveaway to Big Pharma. It seems that dislike for pharmaceutical manufacturers and support for trial lawyers’ right to sue hold greater sway than the need to support federal safety monitors.
I hope that the tort-reform movement, with no current recourse in any of the three federal branches, can make some headway at the state level.
– Tevi Troy is the former deputy secretary of health and human services, and author of Intellectuals and the American Presidency.