A Victory for States' Rights

The Supreme Court issued its ruling in Wyeth v. Levine. In a nutshell, the story is that Wyeth, a drug manufacturer makes the medication Phenergan, an anti-nausea medication that can be administered via the "IV Push" method. This method of administration involved injecting the medication directly into the vein of the patient, which differs from the "IV Drip" method which would involved placing the Phenergan into a solution which would then drip (like you see with all the sick patients at the hospital, that kind of bag). Unfortunately for Levine, this medication was administered to her via the IV Push method, which carries the risk of the medication inadvertently being injected into arterial blood or "migrating" to the artery through a process called "perivascular extravasation," and, as a result, she developed gangrene which resulted in her losing her arm - a painful blow to a musician. The trial court in Vermont found that had there been an adequate warning on the label of this risk, that this injury would not have occurred (ed. note: or that the decision would have been an informed one by the client). Wyeth appealed on the premise that because the FDA (A Federal Executive Branch office) approved the medication, that approval pre-empted any state failure to warn claims. This, of course, is patently absurd.

in a 6-3 decision, the Court held that "Federal law does not pre-empt Levine’s claim that Phenergan’s label did not contain an adequate warning about the IV-push method of administration." Ironically, Chief Justice Roberts, Justice Scalia, and Justice Alito were the dissenters - who opined that the Executive Branch can pre-empt state law (strict constructionist? Only when it serves their position).

Essentially, what Wyeth said was that it was impossible to comport with both FDA regulations AND state law, which is absurd. he FDA's "Changes being effected" regulation would allow Wyeth to add a stronger warning about the drug's risks in advance of a supplement application being approved - probably to protect from potential injury to American Citizens who would be placed in harm's way between when the risk became known (a causal connection is NOT required) and when the label change could be effected.

While I have read the Opinion, it is 80 pages long and it's a little late this evening to do an adequate summary.

Understand that Wyeth conceded that But For their label being inadequate, the injury would not have occurred. They also conceded that the inadequate label was also the proximate cause of the injury. Their ONLY leg to stand on was the pre-emption argument after the jury found for the Plaintiff. The ramifications of this could have had lasting, damaging effects for people who use pharmaceuticals (i.e. Everybody) had the Court held in favor of pre-emption.

The approach to the decision was based on two pre-emption "cornerstones." from the opinion:

First, “the purpose of Congress is the ultimate touchstone in everypre-emption case.” Medtronic, Inc. v. Lohr, 518 U. S. 470, 485 (1996) (internal quotation marks omitted); see Retail Clerks v. Schermerhorn, 375 U. S. 96, 103 (1963). Second, “[i]n all pre-emption cases, and particularly in those inwhich Congress has ‘legislated . . . in a field which the States have traditionally occupied,’ . . . we ‘start with the assumption that the historic police powers of the States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.’” Lohr, 518 U. S., at 485 (quoting Rice v. Santa Fe Elevator Corp., 331 U. S. 218, 230 (1947)).

In other words, the presumption is that the States traditionally have the power unless it clearly states in the Federal Act that Congress intended the States' rights to be pre-empted. Wyeth argued (and this is somewhat rich) that this presumption doesn't apply here because the Federal Government has regulated drug labeling for over a century. That doesn't touch on whether the label was adequate, and clearly doesn't touch on whether remedies were available to Wyeth. Moreover, it ignores the fact that the presumption exists out of respect for State Sovereignty. The dissenters, those Strict Constructionist ardent fans of stare decisis they are, adopt a position strikingly opposite that of precedent, and argue that when the claim is one of an implied conflict pre-emption, the presumption against the pre-emption should not apply. This is would be akin to saying that there should be times that strict scrutiny should be presumed to be pre-empted, hypothetically, a law that prohibits people who are registered Libertarians from voting (a fundamental right). In a word, that's absurd.

This is already a very long post, and I don't want it to go on too much longer. You have the holding, you have the facts, and you have a bit of what Wyeth's premise was. Now it's time to (briefly) discuss the potential ramifications to you and me had the Court sided with those Strict Constructionists. The primary problem would be that it would create an enormous shield for drug companies to protect them from liability for harmful and potentially deadly products. It also would create a situation in which drug companies would be tempted to not be as forthcoming with facts about potential harmful side effects in order to get the indication approved so they can start selling their drug sooner. It would encourage the withholding of information necessary for the FDA to allow for an accurate label, and would provide no incentive for the drug companies to remedy potential harm from side effects discovered after their mad rush to get the drug approved for sale as quickly as possible.

For those who might argue that this just encourages more litigation, I have a couple things to say - first - the drug companies can avoid their problems a couple different ways, first and foremost is to change the label or send out the DHCP letters as soon as possible and not try to use fancy math to hid the dangers posed by the drug. Second, don't push the approval so hard. In a related vein, it should be noted that had this case gone the other way, it could have dried up the litigation in this arena, but it also would have dried up the defense in this arena as well. This is probably why the attorneys for Wyeth, who aren't stupid, had been trying to get this holding to be reserved to the facts in this case - in other words, the cases would have continued regardless. Wyeth's attorneys didn't want to put themselves out of a job either.

That's a long summary, and I didn't touch on Justice Thomas's concurring opinion, which is very well written and supports the position that the three dissenters claim to advocate. But, it's important that this holding came out as it did, for all Americans, not just those whose last name is Inc., LLP, or the like.