United States v. Mohammed F. Azeem, United States of America v. Muhammed Z. Mannan

983 F.2d 1057, 1993 U.S. App. LEXIS 9009
CourtCourt of Appeals for the Fourth Circuit
DecidedJanuary 14, 1993
Docket92-5319
StatusUnpublished

This text of 983 F.2d 1057 (United States v. Mohammed F. Azeem, United States of America v. Muhammed Z. Mannan) is published on Counsel Stack Legal Research, covering Court of Appeals for the Fourth 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. Mohammed F. Azeem, United States of America v. Muhammed Z. Mannan, 983 F.2d 1057, 1993 U.S. App. LEXIS 9009 (4th Cir. 1993).

Opinion

983 F.2d 1057

NOTICE: Fourth Circuit I.O.P. 36.6 states that citation of unpublished dispositions is disfavored except for establishing res judicata, estoppel, or the law of the case and requires service of copies of cited unpublished dispositions of the Fourth Circuit.
UNITED STATES OF AMERICA, Plaintiff-Appellee,
v.
Mohammed F. AZEEM, Defendant-Appellant.
UNITED STATES OF AMERICA, Plaintiff-Appellee,
v.
Muhammed Z. MANNAN, Defendant-Appellant.

Nos. 92-5319, 92-5320.

United States Court of Appeals,
Fourth Circuit.

Argued: October 28, 1992
Decided: January 14, 1993

Appeals from the United States District Court for the District of Maryland, at Baltimore. John R. Hargrove, District Judge. (CR-91-132-HAR)

H. Elliot Wales, for Appellants.

Lawrence G. McDade, Assistant Director, Office of Consumer Litigation, UNITED STATES DEPARTMENT OF JUSTICE, for Appellee.

Milton A. Bass, Jacob Laufer, BASS & ULLMAN, for Appellant Azeem.

Raymond A. Bonner, Assistant United States Attorney, for Appellee.

D.Md.

AFFIRMED.

Before MURNAGHAN, NIEMEYER, and HAMILTON, Circuit Judges.

PER CURIAM:

OPINION

Mohammed Azeem and Muhammed Mannan were indicted by a federal grand jury on charges of making false statements to the Food and Drug Administration (FDA) during the generic drug approval process (Counts 2 and 3) and of conspiring to make such statements (Count 1). On February 12, 1992, Azeem was convicted on all three counts and Mannan on counts 1 and 3. Not limited by the Sentencing Guidelines because of the dates of the offenses, the district judge sentenced Azeem to three years for each count, running concurrently, andmMannan to four months in a work release center. Both have appealed their convictions and sentences. A plethora of issues has ensued.

Superpharm Corporation developed, manufactured, and sold generic drugs, chemical copies of innovator or brand name drug products. After the patent on a new drug has expired, other pharmaceutical firms can market generic versions of that drug, on demonstration to the FDA, in an Abbreviated New Drug Application (ANDA), that the product with respect to which representation has been made will be bioequivalent to the original product. Bioequivalence is demonstrated through a series of tests in the laboratory and on human subjects. In addition, the company making application must demonstrate manufacturing expertise, as evidenced by its research, records, and test results.

Mohammed Azeem and Muhammed Mannan were Superpharm employees. Azeem was Vice President of the Corporation and was responsible for all technical services, including Research, Product Development, and Regulatory Affairs. Near the end of his employment by Superpharm, Azeem was absent from work for many weeks due to illness and a kidney transplant. He was hospitalized from late February to late March 1986. After that time, he initially returned to work on a limited schedule. Then, in July 1986, he was dismissed along with his subordinate Liaquat Hossain.

Shortly before his completion of graduate degrees in pharmaceutical marketing,1 Mannan began employment in February 1985 as a technician in Superpharm's Research and Development Department under the direction of Liaquat Hossain (the government's key witness). He was responsible for manufacturing pilot batches utilizing formulas given to him by Hossain; he also prepared batch records submitted to the FDA in support of ANDAs and maintained inventory cards showing raw material usage.

The evidence supporting the indictment against Azeem and Mannan focused on Superpharm testing and ANDA submission of five generic drugs: diazepam, ibuprofen, lorazepam, hydralazine, and propranol. The government also introduced evidence, pursuant to Federal Rule of Evidence 404(b), relating to other generic drug products not specified in the indictment, but developed by Azeem prior to Mannan's involvement. Since Azeem and Mannan have challenged the sufficiency of the evidence presented, we must look at the specific, alleged actions taken by them.

DIAZEPAM (supporting Count 1-conspiracy)

On July 11, 1985, Superpharm submitted ANDAs, signed by Azeem, for three separate strengths of Diazepam (brand name "Valium"). A production batch record for pilot batches of each strength was submitted with the ANDA; each trial batch had a weight of 3.2 kg. Based on its policy of only accepting pilot batches between approximately 10 and 300 kg, the FDA would not accept the data supporting the ANDA and mailed Superpharm a deficiency letter explaining that fact.

Testifying pursuant to a plea agreement, Hossain told the jury that, after receiving the deficiency letter, Azeem directed him to produce new batch records, using the same lot numbers as before and altering the batch size to roughly 10 kilograms. Hossain expressed concern that the FDA would notice the inconsistency, but Azeem indicated that he would take care of it. Hossain passed Azeem's order on to Mannan, in whose handwriting the fraudulent batch records were created. The only material difference between the two sets of records, one of 3.2 kg and one purporting to be of 10 kgs, was the stated batch size. Tripling the batch size in the original batch records, Mannan filled out new records indicating that a 9.6 kg batch size was involved even though he had not, and could not,2 produce batches of that size. On November 1, 1985, Azeem submitted the three fraudulent batch records to the FDA.

Also in connection with Diazepam, Mannan prepared a handwritten, raw material inventory card. Even though Mannan did not begin employment until February of 1985, his initial entries were dated prior to that time. Inventory cards are required by law for controlled substances and subject to audit by the DEA. The government contended that Mannan falsified entries on the card in order that the raw material withdrawals would comport with the fraudulent large batch records he created at the direction of Azeem and Hossain.

IBUPROFEN (supporting Count I-conspiracy)

Superpharm submitted an ANDA, signed by Azeem, for Ibuprofen (brand name "Motrin") on September 6, 1985. In response, the FDA mailed a deficiency letter, noting the absence of accelerated stability data. On November 4, 1985, Azeem replied by submitting a stability data summary indicating passing tests had been conducted on three lots in April, May, June, and July of 1985.

Hossain, however, testified at trial that Azeem again had submitted falsified information to the FDA, backdating stability test results. The chemist conducting the stability studies on Ibuprofen, Roberto Batuigas, did not begin testing the lot represented in Azeem's summary until July 18, 1985 and finished in September.

LORAZEPAM (supporting Count I-conspiracy)

On April 26, 1986, Superpharm submitted an ANDA, signed by Azeem, for Lorazepam (brand name "Ativan") together with a summary of dissolution data.

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983 F.2d 1057, 1993 U.S. App. LEXIS 9009, Counsel Stack Legal Research, https://law.counselstack.com/opinion/united-states-v-mohammed-f-azeem-united-states-of-america-v-muhammed-z-ca4-1993.