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Analysis: A warning to the FDA


Amid much critical commentary about the way federal drug regulators are doing their job, a Supreme Court majority on Wednesday provided a ringing endorsement of lawsuits in state courts to fill in for lapses at the national level — in particular, lawsuits that claim drugmakers have not given doctors and patients enough warning about side-effects.  The six Justices who joined in upholding a verdict of nearly $6.8 million against the pharmacetical company Wyeth have sent their own warnings: to the industry, and to the Food and Drug Administration.

Justice John Paul Stevens’ opinion speaking for five Justices, and Justice Clarence Thomas’ separate opinion joining in the result, provided in combination a reinforcement of these ideas: that drug companies are primarily responsible for keeping their warning labels up to date and complete (and may pay for it if they don’t), and that the FDA not only needs to police the industry more closely — even if it lacks resources – but that it also had better have the clearest mandate from Congress before it tries to scuttle patients’ lawsuits in state courts.

Justice Stevens, conceding that “the FDA has limited resources to monitor the 11,000 drugs on the market,” wrote a lengthy — and telling — footnote recounting a whole series of studies lamenting the agency’s inability to use its drug approval authority to ensure that the pharmaceutical companies are doing all that they must do to warn doctors and patients about the risks of new drugs, and of the methods of administering them to patients.

And, by contrast, Justice Stevens had fervent praise for the function that patients’ lawsuits — based on state, not federal, law — may serve.  “State tort suits,” he wrote, “uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.  They also serve a distinct compensatory function that may motivate injured persons to come forward with information.”

When those lawsuits are based on claims (as in the Wyeth case) of manufacturers’ failure to warn about risks, Stevens added, they “lend force to the promise [of federal law] that manufacturers, not the FDA, bear primary responsibility for their drug labeling at all times.”

The main opinion also is notably critical of the FDA for abandoning, during the Bush Administration, what Stevens calls its long-standing view that “state law offers an additional, and important, layer of consumer protection that complements FDA regulation.”

Justice Thomas’ opinion took a markedly different approach, but comes out at the same place, practically.  He announced a firm new position that he would no longer support the idea that  state lawsuits seeking not just to protect patients but consumers in general can be blocked just because they seem to intrude on federal regulation by impliedly conflicting with it. Only if Congress, in language it actually puts into a federal law regulating business or commerce, expressly bars state lawsuits in the same field are those lawsuits preempted, according to Thomas’ newly declared position.

For the drug industry, Thomas’ approach would mean that no state court lawsuit challenging a drug’s label would be barred, since Congress in the 71-year history of federal drug regulation has never approved a direct preemption law of the kind that Thomas said would alone suffice.

While Thomas’ position appears to address the whole question of federal takeover of a field of commerce, and seeks to limit the scope of that dominance, it is unclear whether the Stevens opinion will also find application for industries other than those making pharmaceuticals.  Some of the language of that opinion seems to sweep broadly, on spelling out what Congress must do if it wants to make federal protection of consumers exclusive.  But the opinion also reads in many parts as if it were confined to drug regulation alone.

The FDA, those parts of the opinion make clear, cannot expect the Supreme Court — or federal courts in general — to take that agency’s word for it when it simply opines that U.S. oversight of the drug industry displaces anything the states may do.  The courts, Stevens wrote, will defer to this supposedly expert agency only when it can point to either a specific federal law that puts it solely in charge, or only when the agency writes a binding regulation that has “the force of law.”  And, to be able to get by with the latter approach, Stevens indicated, the agency must be able to point to specific authority granted by Congress.

The Court no doubt will have other federal-vs.-state regulation cases to sort out as time goes on, because consumer advocates are sure to try to make the most of the Wyeth ruling to support their lawsuits in state courts over what they claim are defective products.  Only Congress, by the obviously politically risky tactic of scuttling consumer complaints, would seem to be able to thwart that effort.