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Wyeth is a pharmaceutical manufacturer and Levine is a person injured by an Intravenous Push (IV Push) of Wyeth's drug Phenergan, used to get immediate relief of serious nauseous symptoms [Of three ways to get a drug quickly into one's system, the IV Push is the quickest. Slower, but often effective, are Intramuscular injection (IM--usually in the arm, leg, or butt) or IV Drip--where the liquid "drips" into a vein from a hanging IV bag]. The issue in this case, like that in Altria, is whether FDA approval of the labeling of a drug precludes states from enforcing more stringent requrements on a pharmaceutical manufacturer than the FDA requires. In this case, the FDA approved labeling for Phenergan that included IV Push, but required Wyeth to give extensive warnings (two-page) that a misapplication of the IV Push could lead to gangrene. The Vermont Supreme Court, the court immediately below in this case, decided that such labelling was insufficient but that Wyeth could, under federal law, have gone beyond this and banned use of such a method because of the dangers of the method going awry. Since Wyeth didn't do this, they were subject to lawsuit under common law tort theories of negligence. Indeed, at trial (and affirmed on appeal), Mrs. Levine was awarded more than $8,000,000 against Wyeth. Surely this is an amount that would catch the attention of the Supreme Court as well as many others.

Because I have gone through the "pre-emption analysis" on the similar case from October (Altria), I will only review a little of the history of FDA oversight of prescription drugs in this country, so that you can see how the pre-emption issue develops. Though each case has its own horrors, the cases are made common because of their common rootage in the FDA's authority over drug approval and labeling.

Getting A Drug Through The FDA

The Federal Drug Administration's (FDA) power to ensure safety of drugs and labelling dates back to the 1938 Federal Food, Drug and Cosmetic Act, in which Congress charged the FDA to (a) serve as the sole gatekeeper for deciding whether a drug is safe for its labeled uses and includes "adequate directions for [such] use"; and (b) seize drugs it finds are inadequately labeled or dangerous when used as intended. 21 USC sec. 321 et seq. Marketing a prescription drug with a label that is not FDA-approved is a federal crime.

Twenty-four years later, the FDA was authorized by Congress to go one step further--to ensure that safe drugs are effective for their labeled use (codified as amended at 21 USC sec. 355(b)). This significant expansion of FDA's regulatory oversight recognized that the use of any drug entails some risk and that marketing approval should rest on the FDA's scientific determination that a drug's overall health care benefits outweighs its risks. This observation is important because it shows that the FDA would now be actively involved in a "balancing" test with respect to the approval and labeling of drugs. Going further, from a congressional report in 1962, "the determination of safety is in th elight of the purposes of the new drug provisions, considered by [FDA] to be inseparable from consideration of the drug's effectiveness."

It is helpful to pause at this point because here, in a nutshell, is the issue in this and thousands of other cases. The FDA approves drugs and requires labeling to list known risks. Some of those risks may be pretty substantial but as long as the drug is approved and the labeling lists those risks, drug manufacturers want to be "off the hook" for screw-ups in the application of their medications. Indeed, health care professionals and hospitals can be sued (and were successfully sued in this case--with a high six-figure settlement) for poor administration of the drug, but the manufacturers wanted to escape tort liability for their drug as long as the FDA approved it and the labeling.

Here is what the FDA said about its work in a 1962 Congressinal hearing on drug approval:

"Every time the scientists on our staff allow a new drug to come to market, they have to take the sum total of scientific knowledge that they can muster about the drug, and reach a conclusion as to whether or not the good that the drug will do, the lives it will save or the suffering that it will prevent, outweighs the known side-effects."

Well, the process for seeking approval of a new drug is, as you must imagine, pretty voluminous. I won't go into that now, but the statute cited above, along with regulations at 21 CFR sec. 314, go into it in detail. Suffice it to say that part of the approval process is also an approval of the label. The label must contain "a summary of the essential scientific information needed for safe and effective use of the drug," inculding a description of "clinically significant adverse reactions," "other potential safety hazards," "limitations in use imposed by them,...and steps that should be taken if they occur." Thus, the FDA has authority over drug approval and labeling language.

One other thing you should know--which is relevant in this case. There is a provision of the law, called the "CBE provision" ("change being effected") that allows, in extra-ordinary cases, manufacturers to initiate interm post-approval labeling changes pending FDA approval. This is meant to operate only when scientifically significant, newly discovered information demands changes to protect the public regarding safety concerns or give more accurate data about dosage issues. In other words, there is a provision in the law which would allow a company to "do the right thing" while FDA approval is pending. The VT Supreme Court decided that Wyeth could have used this provision to discontinue the IV Push method of Phenergan application in this case.

Conclusion

So, we return to the basic pre-emption question. Should a drug company be liable for the administration of its product under state tort law, whether through a common law theory or consumer protection statutes, when it has complied with the safety and labeling requirements of the law as administered by the FDA? I wouldn't be surprised if the Court would reach out and protect the drug-makers here, in the interests of uniformity of judgments, though this kind of decision certainly won't "solve" the issue. It comes down, ultimately, to what kind of oversight we want the federal government to have on the drug-manufacturing and approval business, how "out there" we want to be on their approval of new drugs or chancy applications of existing drugs, etc. It is a terribly difficult balancing act, and the Court, in this case, will show how it joins the balance.

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