United States v. Radix Laboratories, Incorporated, and Premchand Girdhari

963 F.2d 1034
CourtCourt of Appeals for the Seventh Circuit
DecidedMay 15, 1992
Docket91-2718, 91-2719
StatusPublished
Cited by14 cases

This text of 963 F.2d 1034 (United States v. Radix Laboratories, Incorporated, and Premchand Girdhari) is published on Counsel Stack Legal Research, covering Court of Appeals for the Seventh Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
United States v. Radix Laboratories, Incorporated, and Premchand Girdhari, 963 F.2d 1034 (7th Cir. 1992).

Opinion

HARLINGTON WOOD, Jr., Senior Circuit Judge.

Radix Laboratories, Incorporated and Premchand Girdhari, president of Radix Laboratories, Incorporated, pled guilty to and were sentenced on violations of 21 U.S.C. § 331(a), which prohibits the introduction or delivery for introduction into interstate commerce of adulterated or misbranded drugs. Additionally, Girdhari pled guilty to and was sentenced on a violation of 18 U.S.C. § 1001, prohibiting the making of false statements to any department or agency of the United States. Radix Laboratories, Incorporated was fined $50,000. Girdhari was sentenced to a one-year prison term and fined $50,000. Both Radix and Girdhari appeal these sentences. The district court did not abuse its discretion in imposing the sentences, which are well within the statutory maximum, and the government’s conduct in this case does not constitute reversible error. 1 We therefore affirm.

FACTS

From the late 1970s to 1991, Radix Laboratories, Incorporated (“Radix”) manufactured and sold animal drug products. Premchand Girdhari was the corporation’s president. On January 9, 1991, Radix and Girdhari were charged in a 21-count indictment with one count of conspiring to defraud the Food and Drug Administration (“FDA”), a violation of 18 U.S.C. § 371, four counts manufacturing adulterated animal drugs in violation of 21 U.S.C. § 331(b) and 331(k), ten counts distribution of adulterated animal drugs, violations of 21 U.S.C. § 331(a) and 331(b), four counts dis *1036 tribution of misbranded drugs in violation of the same section and subsections and two counts making false statements to the United States, violations of 18 U.S.C. § 1001. 2 Prior to trial Radix and Girdhari pled guilty but to substantially fewer counts than were charged in the indictment. Radix pled guilty to one count distributing a misbranded drug, a felony violation under 21 U.S.C. §§ 331(a) and 333(b). Girdhari pled guilty to one count of distributing an adulterated animal drug with the intent to defraud and mislead, 21 U.S.C. §§ 331(a), 333(b) and 18 U.S.C. § 2, and he pled guilty to one count of making a false statement to the FDA, a felony violation of 18 U.S.C. § 1001. All of the defendants’ offenses occurred prior to November 1, 1987, so the United States Sentencing Guidelines did not apply.

Subsequent to the guilty pleas, the prosecution submitted a letter and exhibits to the probation office detailing the violations to which Radix and Girdhari pled guilty as well as background material concerning the enforcement of FDA regulations and a factual summary of other violations committed by Radix and Girdhari. The defendants were not convicted on the other violations. The probation office included the government’s letter in the presentence report. In the letter the government sought to demonstrate that Radix and Girdhari had trampled on and regularly flouted FDA animal drug regulations over a period of several years. The factual summary in the letter was divided into three sections and described events that took place at Radix facilities between 1983 and 1991.

The first section of the factual summary describes events that took place between 1983 to January 1986. During those years, the Radix facility was located on Esmond Road in Eau Claire, Wisconsin. FDA inspections of the Esmond Road facility revealed gross . manufacturing deficiencies. After an April 1983 inspection, the FDA concluded that the manufacture of sterile products was virtually impossible at the Esmond Road facility, though Radix products produced there were labeled “sterile.” Moreover, Esmond Road production records did not allow the tracking of a particular raw material through the manufacturing process into the hands of the veterinarian customer as required by the Federal Food, Drug, and Cosmetic Act. See 21 U.S.C. § 351(a)(2)(B); see also 21 C.F.R. 211.80(a) and 211.184. Tracking was impossible at the Esmond Road plant since production records did not exist. It was during this time Girdhari was told by the FDA that if Radix made drugs only for the Eau Claire Animal Hospital, a local hospital which was part owner of Radix at that time, Radix did not need to register with the FDA as a drug manufacturer due to an exemption from registration for veterinarians. See 21 C.F.R. 207.10. Girdhari decided to capitalize on the exemption and sell a drug called “Cal-Plex” to a customer in South Dakota. In April 1985 Girdhari claimed he had not sold the product to any customer except Eau Claire Animal Hospital. This false statement provided the basis for Girdhari’s guilty plea to one violation of 18 U.S.C. § 1001. The prosecution’s letter details numerous other falsehoods Girdhari made to the FDA during inspections in September 1985, November 1985 and January 1986.

Girdhari and Radix dispute little of the government’s factual summary of events occurring at Esmond Road: “It is without a doubt that the Esmond Road facility was not appropriate for manufacturing parenteral (injectable) drugs.” Moreover, Gir-dhari does not address the government’s assertions concerning falsehoods to the United States other than the one to which Girdhari pled guilty. Consequently, there was little discussion of the 1983 to January 1986 occurrences at the sentencing hearing.

Girdhari and Radix dispute much of the summary regarding the next time period covered in the government’s letter, January 1986 to March 1987, after Radix was moved to a new facility at International *1037 Drive in Eau Claire. The primary basis for the January 1986 through March 1987 summary is four affidavits of former Radix employees. The four employees were hired at different times in 1986. Two of the employees were fired on October 23, 1986. All of the affidavits were taken in January of 1987.

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Bluebook (online)
963 F.2d 1034, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-radix-laboratories-incorporated-and-premchand-girdhari-ca7-1992.