The provision of the 1995 tort reform statute providing immunity from liability for the manufacturer of any FDA-approved drug, discussed here last month, provides some more food for thought about some of the doctrinal underpinnings of the judicial principle of textualism and about the art of crafting legislation.
Recall that the statute provides that a product manufacturer is immune in such a circumstance except where:
- the defendant intentionally withheld information from or misrepresented information to the FDA, or
- the defendant bribed an FDA employee to secure or maintain approval of the drug.
The precise wording of MCL 600.2946(5) is:
(5) In a product liability action against a manufacturer or seller, a product that is a drug is not defective or unreasonably dangerous, and the manufacturer or seller is not liable, if the drug was approved for safety and efficacy by the United States food and drug administration, and the drug and its labeling were in compliance with the United States food and drug administration's approval at the time the drug left the control of the manufacturer or seller. However, this subsection does not apply to a drug that is sold in the United States after the effective date of an order of the United States food and drug administration to remove the drug from the market or to withdraw its approval. This subsection does not apply if the defendant at any time before the event that allegedly caused the injury does any of the following:
(a) Intentionally withholds from or misrepresents to the United States food and drug administration information concerning the drug that is required to be submitted under the federal food, drug, and cosmetic act, chapter 675, 52 Stat. 1040, 21 U.S.C. 301 to 321, 331 to 343-2, 344 to 346a, 347, 348 to 353, 355 to 360, 360b to 376, and 378 to 395, and the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted.
(b) Makes an illegal payment to an official or employee of the United States food and drug administration for the purpose of securing or maintaining approval of the drug.
This provision evinces a legislative policy that a drug which has been subjected to the approval process of the FDA and has passed its scrutiny may not be determined by trial courts to be unreasonably unsafe, unless one of the two specified exceptions applies. Both exceptions cover unlawful acts which would interfere with the otherwise orderly process of FDA approval, and the sense and intention behind them is pretty clear. But is it wise to include such arcane and unusual occurrences within the statute? When has it ever been shown that an FDA official has been bribed?
What of other actions which can also interfere with the approval process? If a drug manufacturer were to order a hit on a witness providing information to an FDA Regulatory Decision Team or Working Group, or pay a witness to alter his testimony and thereby secure the approval of the drug, would the courts be precluded from considering this equally culpable misconduct in determining whether to apply the statutory immunity?
A simple truth is that the endeavor to predict the ways that devious minds can work mischief is always an imperfect process. The effort by the legislature to anticipate some types of misconduct tends to lead to the conclusion that other types of misconduct would not justify withholding the protection of the statute from manufacturers and sellers, under the familiar priniciple of expressio unius est exclusio alterius (the specification of some things implies the exclusion of others).
There are alternatives. The courts could fashion a judicial public policy exception to the statute, under which such misconduct on the part of a defendant would nullify the protection afforded by the statute. Or the statute could expressly say that misconduct of a defendant would nullify its protection, and leave it to the courts to fill in what that means.
The first approach -- creating judicial exceptions to statutory provisions, based on the judicial perception of the injustice of simply applying the law as written -- is precisely that which textualism rejects. The textualist holds that courts do not have the authority to overrule, nullify, or create ad hoc exceptions to statutory enactments. If the legislature is to decide that a certain course of action is prohibited, or encouraged, only the legislature has the power to define how far its decision should extend. The courts, he urges, simply do not have that power.
The second approach -- creating a broadly-worded exception, expressly subject to having its exact borders determined by judicial interpretation -- seems much more sensible. This could be accomplished if the statute were drafted to read:
This subsection does not apply if the defendant at any time before the event that allegedly caused the injury procures or encourages the approval of the United States food and drug administration by any wrongful or illegal act, including but not limited to the following:
(a) Intentionally withholding from or misrepresenting to the United States food and drug administration information concerning the drug that is required to be submitted under the federal food, drug, and cosmetic act, chapter 675, 52 Stat. 1040, 21 U.S.C. 301 to 321, 331 to 343-2, 344 to 346a, 347, 348 to 353, 355 to 360, 360b to 376, and 378 to 395, if the drug would not have been approved, or the United States food and drug administration would have withdrawn approval for the drug if the information were accurately submitted.
(b) Making an illegal payment to an official or employee of the United States food and drug administration for the purpose of securing or maintaining approval of the drug.
The use of the familiar phrase "including but not limited to" would make it clear that the exclusio alterius rule would not apply. The inclusion of the examples would invoke another legal Latinism, ejusdem generis -- the specification of examples means that the general principle is intended to apply to matters similar to the examples, and not to those which are dissimilar. This formulation of the statute would leave it to the courts to deterimine which actions by the defendant were sufficiently culpable to justify the application of the exception, subject to the use of the qualifying phrase "wrongful or illegal act".
This type of formulation would provide an exception to the general rule of immunity, but give the courts the authority to determine whether the exception should apply when a new act of despicable corruption that the legislature failed to anticipate is uncovered.
The justification behind this more flexible rule is that the courts are better able to determine, on an ad hoc basis, when and where such an exception should be applied, and that the legislature does not always have the ability to make an accurate prediction about what kinds of legal and factual wrinkles its enactments are likely to encounter.
9:46:41 PM 
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