CourtsUnited States Court of Appeals for the Third Circuit1963UNITED STATES of America v. 60 28-CAPSULE BOTTLES, MORE OR LESS and 47 7-Capsule Bottles, more or less, of an article of drug labeled in part: -UNITROL A TRUE APPETITE DEPRESSANT ONE CAPSULE WORKS ALL DAY, Republic Drug Company, Buffalo, New York-Each Capsule Contains: Phenyl Propanolamine Hydrochloride 75 Mg. In a Special Base that Provides for Timed Disintegration of the Contents Over a Period of Approx. 6 to 10 hours. This Capsule is Equal to One tablet of 25 Mg. Potency Taken 3 Times Daily-R 9229 (Other Codes: 9131: R 9172): and one Counter Display Carton reading in part: Safe Easy Reducing Plan: one window banner reading in part: Lose Weight up to 14 lbs. in 14 days Unitrol . . . Thats All Nysco Laboratories, Inc., Claimant-Appellant

UNITED STATES of America v. 60 28-CAPSULE BOTTLES, MORE OR LESS and 47 7-Capsule Bottles, more or less, of an article of drug labeled in part: -UNITROL A TRUE APPETITE DEPRESSANT ONE CAPSULE WORKS ALL DAY, Republic Drug Company, Buffalo, New York-Each Capsule Contains: Phenyl Propanolamine Hydrochloride 75 Mg. In a Special Base that Provides for Timed Disintegration of the Contents Over a Period of Approx. 6 to 10 hours. This Capsule is Equal to One tablet of 25 Mg. Potency Taken 3 Times Daily-R 9229 (Other Codes: 9131: R 9172): and one Counter Display Carton reading in part: Safe Easy Reducing Plan: one window banner reading in part: Lose Weight up to 14 lbs. in 14 days Unitrol . . . Thats All Nysco Laboratories, Inc., Claimant-Appellant

United States Court of Appeals for the Third Circuit1963-12-03No. No. 14437

325 F.2d 513

Summary · law.co

Holding. The district court properly applied the fair preponderance of the evidence standard in determining that the drug product was misbranded, and the judgment of condemnation is affirmed while the motion to remand is denied.

The United States brought a civil forfeiture action against Unitrol, an appetite suppressant drug product, alleging it was misbranded in violation of federal law. The defendant appealed the district court's condemnation order on multiple grounds, including a challenge to the evidentiary standard applied at trial. The defendant argued that the government should have been required to prove misbranding by clear and satisfactory evidence rather than the lower civil standard of preponderance of the evidence.

The appellate court rejected the defendant's evidentiary standard argument. Although an earlier case contained language suggesting a higher standard was required, that language was not essential to that decision, and moreover it arose under an older statute. Current appellate precedent interpreting the modern Federal Food, Drug, and Cosmetics Act of 1938 uniformly applies the preponderance standard in misbranding cases. The court found this approach sound given the public health interests at stake.

The court also examined the defendant's factual challenges to the district court's findings and found substantial documentary and testimonial evidence supporting the trial court's conclusions. The defendant's motion for remand based on newly discovered evidence was denied as the evidence presented did not meet the threshold for relief.

Summary generated by law.co from the public-domain opinion. The opinion text itself is public domain.

Key issues

Appropriate evidentiary standard in drug misbranding forfeiture cases
Whether preponderance of evidence or clear and satisfactory evidence applies under the 1938 Act
Sufficiency of evidence supporting findings of misbranding

Procedural posture

The defendant appealed a district court judgment condemning drug products as misbranded under federal law, challenging the evidentiary standard used and the sufficiency of the factual findings.

Authorities cited

No cited authorities resolved to law.co cases yet.

Opinion · public domain

majority opinion

PER CURIAM.

This is an appeal from a judgment of the district court condemning certain articles of drug as misbranded within the meaning of 21 U.S)C. § 352(a) (1958 ed.). The appellant contends that the district court erred in holding that the burden of proof on the United States in a misbranding action requires only that it prove its contention by a fair preponderance of the evidence. It is asserted that our decision in Van Camp Sea Food Co. v. United States, 82 F.2d 365 (C.A. 3, 1936), rejects that standard in cases of this type and requires a higher degree of proof on the part of the government, i. e., that it establish its case by clear and satisfactory evidence.

There is language in Van Camp which purports to adopt the rule urged by the appellant. However, it appears from an analysis of the opinion in that case that this language was not decisional, for the court premised its dismissal of the libel on the following supposition:

“But assuming for present purposes the instructions of the court were right and that in a forfeiture case the preponderance, as in a civil case, is all that is required, did the proofs make out such a case that it could be submitted by [sic] a jury to find there was a preponderance? The answer to this question requires the critical study of the proofs, which we now try to make.” 82 F.2d at 366.

Thus the court’s expression of agreement with the “clear and satisfactory evidence” test was not essential to its decision. Moreover, the holding in Van Camp was based on a construction of the Food and Drugs Act of 1906, whereas the instant action was brought under the Federal Food, Drug, and Cosmetics Act of 1938, 21 U.S.C. §§ 301, 392 (1958 ed.). The appellate cases considering the question under the 1938 Act adopt the fair preponderance of the evidence criterion. United States v. Wood, 226 F.2d 924 (C.A. 4, 1955); United States v. 449 Cases, Containing Tomato Paste, 212 F.2d 567, 573, 45 A.L.R.2d 846 (C.A. 2, 1954); United States v. 5 Cases, More or Less, Containing “Figlia Mia Brand,” 179 F.2d 519, 524 (C.A. 2), cert, denied, 339 U.S. 963, 70 S.Ct. 997, 94 L.Ed. 1372 (1950). See also, C. C. Co. v. United States, 147 F.2d 820, 824 (C.A. 5, 1944). Because of the public interest in cases of this kind, we think that the rationale of these decisions is unassailable. Accordingly, we hold that the district court applied the proper evidentiary standard to the case at bar.

The appellant also makes a broad frontal attack on the findings of the district court, asserting that they are clearly erroneous. However, an examination of the record convinces us that there is a plethora of evidence both documentary and testimonial to support the district court’s factual determinations.

The appellant has also filed a motion to remand this case to the district court on the basis of newly discovered evidence, but the evidence cited to support the motion is not of sufficient character as would justify the granting of such relief.

The judgment of the district court will be affirmed, and the motion to remand will be denied.