Okay, a few days off due to computer and car troubles, and back at it

Last Monday, while we were all wrapped up with the looming election, the Supreme Court heard oral arguments in a case that could further limit - in fact, essentially invalidate as a principle - the ability of states to set tougher health and safety standards than the federal government.

Nearly a year ago, the Supreme Court ruled in Riegel v. Medtronic that manufacturers of FDA-approved medical devices were immune from common-law suits based on state law principles because federal law expressly preempted them - that is, the law said that no interpretation of liability could be stricter than that established by the feds.

Now comes Wyeth v. Levine. Another health-related industry, in this case pharmaceuticals in the form of Wyeth Laboratories, is trying to expand on that argument - and as in Riegel, it is doing it with the support of the Department of Injustice. What Wyeth is arguing for in this case is implied preemption. In essence, Wyeth is saying that even though federal law regarding warning labels on drugs contains no express preemption clause, suits based on state law are preempted anyway. Why? Well, because ... they just are. I mean, the FDA declares itself to be the supreme authority on safety issues and who is a mere jury, a mere state, to question them? The lowest common denominator consumer protection established by the FDA, Wyeth and the DOI are saying, is not a minimum the company must meet but a maximum anyone is able to enforce.

The issue comes to the Court in near-melodramatically tragic packaging: Diana Levine, a bass player and author of children’s music in Vermont, visited a clinic [in April 2000] to receive treatment for headache-related nausea but wound up developing tissue deterioration and gangrene in her arm, ultimately leading to its amputation. The cause? Clinic staff attending to Ms. Levine had administered the antihistamine Phenergen using a delivery technique known as an “IV push,” inadvertently injecting the drug into one of Ms. Levine’s arteries in the process. Although both Wyeth (the drug’s manufacturer) and the FDA were aware that the “IV push” created a risk of inadvertent arterial injection and gangrene, the FDA had nevertheless approved labeling for Phenergen that warned against – but did not prohibit – IV push administration.

Levine sued Wyeth, asserting that it hadn't provided adequate warnings about the dangers, dangers which, again, were known, of getting an IV injection of Phenergen. She won; the jury awarded her $6.7 million.

Wyeth appealed to the Vermont Supreme Court and lost again. So it turned to the feds and the likely-more-pleasant venue of a right-wing, corporate-friendly, SCOTUS. You can get more detail about the legal arguments advanced by both sides at the second link above, but one argument made by Wyeth struck me:

The company insists that it would be impossible to satisfy both the labeling requirement of the FDA and the demands of Vermont’s common law on the grounds that the labeling required by the FDA was binding on the company and it could use no other wording. A provision of the Food, Drug and Cosmetic Act which specifically allowed companies to toughen label warnings applies only, Wyeth claims, to newly-discovered risks - an argument rejected by both the original trial judge and the Vermont Supreme Court. The thing is, Wyeth and the FDA both acknowledge that the risks of IV push delivery, specifically including what befell Diana Levine, were known at the time of labeling. Wyeth claims that prevented the company from issuing a stricter warning (because the risk was not "newly-discovered"). So what it's actually saying, then, is that the FDA required Wyeth to knowingly conceal or downplay known dangers related to Phenergen. Which is, to say the least, a rather bizarre argument and would seem, logically, to be one unlikely to be taken seriously - but of course logic has little to do with regulatory law and even less to do with the current SCOTUS.

This whole mess looks to me like another classic case - and no, this sort of thing did not start with the Bush administration - of a regulatory agency coming to be an ally of the industry it's supposed to regulate.

The implications run well beyond the immediate issue, well beyond even the pharmaceutical industry as a whole. As an article in the Wall Street Journal on Tuesday pointed out,

[b]ecause other federally regulated industries are in a similar situation - Congress hasn't indicated whether federal oversight is intended to complement or supplant parallel state laws - business hopes the court will rule in favor of pre-emption that can be applied to other fields.

In other words, the hope is that, as I said at the top, SCOTUS will set a precedent here that will essentially invalidate the entire idea that any state government, that any common law, can set a higher standard for public safety and protection that some federal agency or another. What is particularly - I don't know whether to call it galling, frustrating, or bitterly amusing - is that at least some of these same voices, including some who have filed amicus briefs in Wyeth and I specifically include the US Chamber of Commerce and the radical right-wing Washington Legal Foundation (which recently issued a report claiming that "business civil liberties" are being "eroded" by a "growing trend to criminalize normal business activities"), have in other circumstances decried federal regulation for inhibiting states' abilities to be "creative" and "flexible."

Speaking of amicus briefs, who filed them is often revealing. In this case, Wyeth is being supported basically by the drug companies and the DOI along with, as noted, the US CofC and the WLF. Levine is being supported by two former FDA commissioners, the National Conference of State Legislatures, 18 members of Congress, the medical associations of Texas, California, and North Carolina, Consumers Union, and a whole bunch of other people and groups - including 47 states.

The WSJ reported that some Justices seemed skeptical of Wyeth's claims.

"As a textual matter, as a logical matter, as a semantic matter, I don't agree," said Justice Anthony Kennedy.

Justice David Souter said that "Wyeth could have gone back to the FDA at any time and said, either based on experience or just our rethinking of the data that we have, we think the label ought to be changed to say, 'Don't use IV push.'" ...

Justice Samuel Alito suggested that the facts in the case suggested the FDA label was inadequate.

So it is possible that the worst will not happen. But as I've already said, logic has little to do with it. My own prediction is that the decision, not expected for some time, will follow the same course as previous decisions: Wyeth will win but it will be based on some technicality that will unlock to door to a wider application of preemption but not swing it open. People on both sides will issue statements looking for ways to minimize the apparent impact, but for different reasons: the one side will want to hide the actual effect the better to advance their selfish interests, done best by stealth; the other side will want to try to head off that advance by yielding as little ground as possible.

Nonetheless, it will be another victory for the corporations, another loss for public resistance, another case that will be used as precedent to unlock still another door. So hopefully, the Dimcrats will follow through on a promise to change the law and restore the right to sue that is being continually stripped away.

Footnote: Seth Waxman, representing Wyeth before the Supreme Court, was Bill Clinton's solicitor general. And the circle keeps goin' 'round.