At the end of the term, the Supreme Court, in Ruan v. United States, 2022 WL 2295024,142 S. Ct. 2370 (2022), vacated the convictions of a couple of alleged “pill mill” doctors under the Controlled Substances Act upon finding that the government’s proof in their criminal trial did not meet the standard required by 21 U.S.C. §841’s “knowingly or intentionally” scienter (that’s legal Latin for the degree of intent required for a crime or tort) requirement for illegal drug distribution.  The Supreme Court stated, with respect to the statute’s language:

[T]he more unreasonable a defendant’s asserted beliefs or misunderstandings are, especially as measured against objective criteria, the more likely the jury  will find that the Government has carried its burden of proving knowledge.  But the Government must still carry this burden.  And for purposes of a criminal conviction under §841, this requires proving that a defendant knew or intended that his or her conduct was unauthorized.

*          *          *          *

We conclude that §841’s “knowingly or intentionally” mens rea applies to the “except as authorized” clause.  This means that in a §841 prosecution . . ., the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.

Ruan, 2022 WL 2295024, at *9-10 (citations and quotation marks omitted).  Ruan rejected the government’s arguments for an objective reasonableness standard, given the express terms of the statute.  Id. at *8.  So proof of subjective knowing intent is what the statute requires.

We’re not criminal lawyers, nor do we specialize in the Controlled Substances Act.  But just to see how far Ruan’s reach may extend, we searched for the statutory language that the Court interpreted – “knowing or intentionally” (specifically < knowing! or intentional! >) – in our sandbox, the FDCA.

We found two FDCA provisions where both the Ruan terms appeared in close proximity, the same way they did in the statute Ruan interpreted:

Section 333(b)(7), concerning the penalties for prescription drug-related offenses, provides, with respect to the most serious punishments:

(7) Notwithstanding [other limits], any person that knowingly and intentionally adulterates a drug such that the drug is adulterated . . . and has a reasonable probability of causing serious adverse health consequences or death to humans or animals shall be imprisoned for not more than 20 years or fined not more than $1,000,000, or both.

(Emphasis added).

Section 355a(b)(3), concerning who the FDA can permissively punish with debarment (that is, exclusion from participation in government programs) provides:

(D) the person has engaged in a pattern of importing or offering for import –

*          *          *          *

(ii)        adulterated or misbranded drugs that are –

*          *          *          *

(II)       knowingly or intentionally falsely designated in an authorized electronic data interchange system as a product that is regulated by the Secretary.

(Emphasis added).

Quite a few other FDCA sections contain some variant of one or the other of the two scienter terms interpreted in Ruan.  Importantly, the FDCA (unlike the statute in Ruan) actually defines “knowing” to mean “that the person, with respect to information” either “has actual knowledge” or “acts in deliberate ignorance or reckless disregard” of whether the information is true or false.  21 U.S.C. §321(bb).  Thus, as to FDCA sections using “knowing,” this statutory definition, rather than the more muscular scienter requirement Ruan imposed on prosecutorial proofs, would control.  However, the FDCA does not define “intent” or “intentionally,” so in that respect Ruan can’t be distinguished where the FDCA uses those terms.

The two biggies, of course, are the definitions of “drug” and “device” found in 21 U.S.C. §321.  A “drug” is an “article” that, among other things, is “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals, or “intended to affect the structure or any function of the body of man or other animals,” or “intended for use as a component of any article [described above in this subsection].”  Id. §321(g)(1) (emphasis added).

A “device” is something that, among other things, is:

(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(C) intended to affect the structure or any function of the body of man or other animals, and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

Id. §321(h)(1) (emphasis added).

Congress also used this same passive voice of “intend” in the definitions of “cosmetic,” “pesticide chemical,” “food additive,” “color additive,” “new animal drug,” “animal feed,” “dietary supplement,” antibiotic drug,” “single-use device,” and “tobacco product,” among other things.  21 U.S.C. §§321(i), (q)(1)(B)(ii), (s), (t)(1), (v), (w), (ll)(1), (rr)(1).

Significantly, Congress has not used the term “intended use” in the FDCA to define either drugs or devices.  We have discussed before how the FDA has, by regulation, defined “intended use” of both drugs and devices to include, as “intended,” levels of scienter that are far less than the Ruan definition of subjective knowledge.  See, e.g., 21 C.F.R. §§201.128, 801.4.  Whether Ruan imperils the FDA’s efforts to define “intent” to include behavior that isn’t “intentional” is anyone’s guess.

Under “prohibited acts,” several provisions of 21 U.S.C. §331 employ variants of “knowing” or “intentional” in criminalizing certain conduct:

  • Section 331(w), prohibiting “[t]he making of a knowingly false statement in any statement, certificate of analysis, record, or report required or requested under section 381(d)(3) of this title” – having to do with importation of drug components.
  • Section 331(gg), prohibiting “[t]he knowing failure to comply with paragraph (7)(E) of section 374(g) of this title [concerning pharmacy compounding]; the knowing inclusion by a person accredited under paragraph (2) of such section of false information in an inspection report . . .; or the knowing failure of such a person to include material facts in such a report.
  • Section 331(jj)(1), prohibiting “knowingly submitting a false certification under” 42 U.S.C. §282(j)(5)(B), pertaining to applications for National Institutes of Health human studies.
  • Section 331(yy), prohibiting “[t]he knowing and willful failure to comply with the notification requirement under section 350f(h),” pertaining to consumer notifications of adulterated food sold by chain grocery stores.
  • Section 331(ccc)(2), prohibiting “the intentional falsification of a prescription” for a pharmacy compounded drug.
  • Section 331(ddd)(1), prohibiting “[t]he manufacture or the introduction or delivery . . . of a rinse-off cosmetic that contains intentionally-added plastic microbeads.

(Emphasis added).

In addition to the provision already discussed above, §333 concerning “penalties” contains several other subsections employing variants of “knowing” or “intentional” in determining fines or criminal sentences for FDCA violations:

  • Section 333(b)(1), imposing fines and prison time for “drug marketing violations,” for: (1) “knowingly importing a drug” in violation of reimportation requirements, (2) “knowingly selling, purchasing, or trading a drug or drug sample or knowingly offering to sell, purchase, or trade a drug or drug sample,” (3) “knowingly selling, purchasing, or trading a coupon, knowingly offering to sell, purchase, or trade such a coupon, or knowingly counterfeiting such a coupon” redeemable for certain prescription drugs, and (4) “knowingly distributing drugs in violation of” FDCA drug wholesaling requirements.
  • Section 333(b)(6), imposing fines and prison time on a drug manufacturer or importer that “knowingly fails to comply with a requirement” concerning importation of drugs from Canada.
  • Section 333(b)(8), imposing fines and prison time on anybody that “knowingly making, selling or dispensing, or holding for sale or dispensing, a counterfeit drug.
  • Section 333(e), imposing fines and prison time on anybody that “knowingly distributes, or possesses with intent to distribute, human growth hormone for any use in humans” other than a governmentally approved use.
  • Section 333(9)(B), imposing enhanced penalties on anybody “who intentionally violates a requirement” pertaining to adulterated tobacco products.

(Emphasis added).

In addition to the provision already discussed above, §335a also authorizes “temporary denial of approval” of an abbreviated drug application (that is, an ANDA for a generic drug) submitted by someone who, in submitting other ANDAs, “has knowingly made or caused to be made a pattern or practice of false statements or misrepresentations.”  21 U.S.C. §335a(f)(1)(B)(ii) (emphasis added).

Under “civil penalties,” several provisions of 21 U.S.C. §335b employ “knowingly” in authorizing civil fines for certain conduct concerning ANDAs:

  • Section 335b(a)(1), fining anybody that “knowingly made or caused to be made, to [any HHS personnel], a false statement or misrepresentation of a material fact.”
  • Section 335b(a)(4), fining anybody that “knowingly failed to disclose, to [any HHS personnel], a material fact which such person had an obligation to disclose relating to any [generic] drug.”
  • Section 335b(a)(5), fining anybody that “knowingly obstructed an investigation . . . into any [generic] drug.”
  • Section 335b(a)(6), fining any ANDA holder that “knowingly” hired any “debarred” person for any purpose.

(Emphasis added).

Section 342(a) defines “adulterated food” to include food “intentionally subjected to radiation” other than as provided under the FDCA (emphasis added).  The same definition is employed in 21 U.S.C. §343-3(b) requiring “radiation disclosure statements.”

Section 360eee(8)(B), concerning supply chains for drug distribution, defines an “illegitimate product” to include a drug that “is intentionally adulterated such that the product would result in serious adverse health consequences or death to humans” (emphasis added).  Section 360eee(21) similarly defines a “suspect product” as a drug that “is potentially intentionally adulterated such that the product would result in serious adverse health consequences or death to humans” (emphasis added).  In a “transaction statement” as defined in §360eee(27), a distributor must certify that it “did not knowingly ship a suspect or illegitimate product,” “did not knowingly provide false transaction information,” and “did not knowingly alter the transaction history.”  Id. §360eee(27) (D, F-G) (emphasis added).

Thus, it appears to us:  First, that the same subjective intent standard likely applies with full force to FDCA-based liability under the two FDCA provisions that contain both of the same terms construed in Ruan, with the exception of the FDCA’s statutory definition of “knowing” being controlling should there be any divergence.  Second, it is also likely that the Ruan standard applies to prosecutions under FDCA provisions containing the undefined term “intentional.”  Third, the FDCA definition of “knowing” should prevail in prosecutions under provisions containing only variants of that term – to the extent Congress defined it differently than the Supreme Court’s holding in Ruan.

Finally, on a broader scale, query whether there is any way to reconcile Ruan with the so-called “Park Doctrine” that allows executives of FDA-regulated companies to be charged criminally for corporate wrongdoing without any actual knowledge at all?  At least with where the FDCA expressly imposes intent-based scienter requirements, let’s just say that we have serious doubts about the continued viability of the Park Doctrine.

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