In the

United States Court of Appeals

For the Seventh Circuit

Nos. 00-1523 & 00-2679

United States of America,

Plaintiff-Appellee,

v.

Baldev R. Bhutani and 

ALRA Laboratories, Incorporated,

Defendants-Appellants.

Appeals from the United States District Court

for the Northern District of Illinois, Eastern Division.

No. 93 CR 585--John F. Grady, Judge.

Argued April 5, 2001--Decided September 12, 2001

 Before Bauer, Ripple, and Evans, Circuit

Judges.

 Bauer, Circuit Judge. A jury found

defendants Baldev Raj Bhutani, Neelam

Bhutani, and ALRA Laboratories, Inc.

guilty of various violations of the

Federal Food, Drug, and Cosmetic Act

("FDCA"), 21 U.S.C. sec. 301 et seq. The

defendants moved for a new trial, which

the district court granted, finding that

the government violated Brady v.

Maryland, 373 U.S. 83 (1963). The

government appealed, and in United States

v. Bhutani, 175 F.3d 572 (7th Cir. 1999)

we reversed and remanded the case for

sentencing. On remand, the defendants

again moved for a new trial, which the

district court denied. Assuming

familiarity with our first opinion, we

consider the appeal by the defendants

(Neelam does not appeal) from that

denial. For the following reasons, we

affirm.

A.

 The defendants believe that the

government’s position in the first appeal

contradicted its trial theory and that

the government’s appellate position is

newly discovered evidence, and that if

the jury had heard the government’s

appellate theory it would have decided
the case differently. Specifically, they

contend that at trial the government said

that the defendants had added sodium

hydroxide to decomposed Lactulose in

hopes of concealing its medical

ineffectiveness, but on appeal admitted

that the Lactulose was medically

effective by iterating that it was within

the accepted pH range before the addition

of sodium hydroxide. On remand, the

district court agreed with the defendants

that the government had changed its

theory, but the district court refused to

entertain the argument, believing that it

was foreclosed from doing so since we had

held otherwise in our first opinion in

this case.

 The government counters that its focus

at trial was not that the Lactulose was

outside of the acceptable pH range or

medically ineffective, but rather the

fact that the defendants added sodium

hydroxide to the Lactulose lots because

they wanted the 1986 lots to have a pH

similar to the 1988 lots so that they

could bear the same expiration date and

be sold. The government’s position was

that the defendants masked the fact that

the Lactulose was degrading and past its

expiration date in order to make money.

 We agree with the government. A second

read of the trial transcript reveals that

the government’s position at trial and on

appeal has been consistent. The

government did not show at trial that the

Lactulose was outside the accepted pH

range or medically ineffective; rather it

admitted that the pH was at all times

within range, but that it was dropping,

which signaled degradation, and in order

to mask any degradation the defendants

raised the pH by adding sodium hydroxide

so that the fact that it was being sold

past its expiration date could not be

detected. The medical efficacy of the

Lactulose was only mentioned by the

government to explain the significance of

expiration dating to the jury. The

government wanted to explain why

expiration dates are imposed in order to

counter the defense theory that the

defendants did not intend to put an

adulterated product on the market because

Lactulose could be stable and medically

effective beyond the artificially imposed

expiration date assigned by the

"paperwork bureaucracy" known as the FDA.

The defense again mischaracterizes the
thrust of the government’s case and

regurgitates its argument from the last

appeal, the only difference being that in

the first appeal they argued that the

newly discovered evidence was the U.S.P.

recommendation, see 175 F.3d at 578-79,

and here they point to the government’s

switch in theories. This supposed

difference does not affect our decision.

There is no new evidence that would have

altered the outcome of this case.

B.

 The defendants submit that reversal is

justified because the district court

abused its discretion, see United States

v. Butler, 71 F.3d 243, 250 (7th Cir.

1995), by permitting the government to

elicit impermissibly prejudicial

testimony from Dr. John Senior, offered

as an expert in gastroenterology and

liver disease, see Trial Tr. at 1691

(December 28, 1995), about the medical

consequences of taking ineffective

Lactulose. The defendants claim that Dr.

Senior testified that patients could die

from ingesting ineffective Lactulose.

Before Dr. Senior testified, the district

court had admonished the government to

avoid introducing this sort of testimony.

The defendants believe that the

government violated this admonition.

 Contrary to the defendants’

characterization of Dr. Senior’s

testimony, the transcript reveals that he

did not testify in an impermissibly

prejudicial manner. Dr. Senior explained

that Lactulose works as a substitute

liver for patients with liver disease,

and that Lactulose would be ineffective

if it had degraded into its component

parts because the separate sugars would

be absorbed into the small intestine

before reaching the colon. He also

testified that it would be impossible for

a physician to know that Lactulose had

degraded to the point of ineffectiveness,

and therefore a physician might

erroneously determine that the Lactulose

was ineffective for a patient for some

other reason.

 The sole mention of the possibility of

death from ingesting ineffective

Lactulose was not presented by the

government, but was elicited on crossexamination by the defense:
Q. [Mr. Branding, Attorney for ALRA] And

[Lactulose] doesn’t cure the underlying

liver disease, does it?

A. Of course not.

Q. It’s only--

A. It’s only a compensation for a failed

organ.

Q. It’s used to treat the symptoms?

A. It’s used to treat--it’s not just

symptoms. It’s a whole syndrome that may

kill. It’s not just symptoms.

 Encephalopathy due to liver failure

may be fatal. It’s not just symptoms.

Trial Tr. at 1710-11 (December 28, 1995).

The testimony defendants complain about

was never offered, and thus there was no

abuse of discretion by the district

court.

C.

 The defendants argue that Count Four,

which charged that the defendants "[o]n

or about August 12, 1988 . . . with

intent to defraud and mislead, failed to

establish and maintain accurate drug

manufacturing batch production records

for the generic drug product, Lactulose

Syrup USP" in violation of 21 U.S.C. sec.

331(e), along with the correlating

conspiracy charge in Count One, failed to

state a crime for which they could be

convicted.

 In 1938, Congress enacted the FDCA

pursuant to its authority to regulate

interstate commerce in order to protect

the public from dangerous food and drug

products. In 1962, Congress amended the

FDCA, adding sec. 355(j) to require drug

manufacturers to establish or maintain

records about the manufacture and testing

of drugs. See The Drug Amendments of

1962, Pub. L. No. 87-781, sec. 103(a), 76

Stat. 780. Thereafter, the failure to

establish or maintain records under sec.

331(j) was a prohibited act under sec.

331(e) and subject to the imposition of

criminal penalties under sec. 333, such

as imprisonment, fine, or both.

 In 1984, Congress amended the FDCA and

the federal patent laws to help make
available more low cost drugs by creating

an abbreviated procedure for FDA approval

of generic drug applications. See Drug

Price Competition & Patent Term

Restoration Act of 1984, Pub. L. No. 98-

417, sec. 101, 98 Stat. 1585; see also

National Ass’n of Pharm. Mfrs., Inc. v.

Ayerst Labs., 850 F.2d 904, 907 (2d Cir.

1988). Congress enacted this new

abbreviated drug approval process under

sec. 355(j) and redesignated the old sec.

355(j) concerning recordkeeping as sec.

355(k). However, Congress did not alter

sec. 331(e). Thus, sec. 331(e) still

instructed that the failure to establish

or maintain records under sec. 355(j) was

subject to criminal penalties, even

though the new sec. 355(j) did not

require recordkeeping. Whether

intentional or not, the penalties for

failing to establish or maintain records

had been in effect eliminated.

 In 1990, Congress passed a short,

technical amendment, which stated:

"Section 301(e) of the Federal Food,

Drug, and Cosmetic Act (21 U.S.C. sec.

331(e)) is amended by striking out ’or

(j)’ and inserting in lieu thereof ’or (k).’"

Vaccine & Immunization Amendments of

1990, Pub. L. No. 101-502, 104 Stat.

1285. Thus, by simply replacing "(j)"

with "(k)," sec. 331(e) again clearly

subjected violators to the same criminal

penalties as they had been for more than

two decades prior to 1984 for failing to

establish or maintain records.

 However, there was a gap between 1984

and 1990 where under the plain statutory

language the failure to establish or

maintain records under sec. 355(k) was

not subject to criminal penalties. This

time gap is of import to this case; the

defendants’ conduct charged under sec.

331(e) occurred in August of 1988, which

raises the delicate question of whether

their convictions for these violations

may stand, given that the plain language

of the statute did not penalize their

conduct. As noted, the defendants argue

that under the plain language of the

statute they cannot be penalized for

failing to establish and maintain

records. The government argues that the

elimination of the penalty was a

scrivener’s snafu, and criticizes the

defendants’ hyper-technical and illogical

reading of the statute. This question has

all of the trappings of a law school
hypothetical, but with real-world

consequences, so although the defendants’

brief fails to support this argument with

case law discussion or even citation, we

nonetheless address this important issue

of criminal law and statutory

construction.

 Generally, courts strictly construe

criminal statutes against the government

and in the defendant’s favor. See Barrett

v. United States, 423 U.S. 212, 218

(1976); 3 Norman J. Singer, Sutherland

Statutory Construction sec. 59.03 (5th ed.

1992). This is so to ensure that people

are fairly warned about what sort of

conduct may expose them to criminal

penalties and what sort of penalty may be

imposed. See United States v. Bass, 404

U.S. 336, 348 (1971); 3 Sutherland Statutory

Construction sec. 59.03. But, in strictly

construing a statute, courts ought

notdeprive it of the obvious meaning

intended by Congress, nor abandon common

sense. See United States v. Moore, 423

U.S. 122, 145 (1975); 3 Sutherland Statutory

Construction sec. 59.06.

 Some courts have upheld the imposition

of criminal penalties despite the

presence of a typographical error in the

statute. See United States v. Lacher, 134

U.S. 624, 625-32 (1890) (upholding

conviction for embezzling a letter

containing an article of value under 18

U.S.C. sec. 318 even though after

revision of the statute the wording was

alteredbecause "the intention to impose a

penalty on [the] commission [of the

offense] cannot reasonably be denied;

and, although the apparent grammatical

construction might be otherwise, the true

meaning, if clearly ascertained, ought to

prevail"); United States v. Graham, 169

F.3d 787, 790-91 (3d Cir. 1999)

(upholding a defendant’s sentence for

illegally reentering the United States

after finding that Congress intended that

the actual term of imprisonment imposed

determines whether a defendant is

classified as an "aggravated felon" under

8 U.S.C. sec. 1101(a)(43) despite the

fact that the statutory section was

"obviously missing a crucial verb");

United States v. Warren, 149 F.3d 825,

827-28 (8th Cir. 1998) (affirming the

defendant’s sentence of 151 months for

manufacturing 32,000 grams of

methamphetamine under 21 U.S.C. sec.

841(b)(1) even though "[a]t the time of
[the] offense, because of a typographical

error, the same amount of a quantity of a

mixture--100 grams--was listed as

triggering both the five-year and the

ten-year mandatory minimum sentences,"

because Congress intended drug

trafficking penalties to be graduated

according to drug quantity); United

States v. Rossetti Bros, Inc., 671 F.2d

718, 720 (2d Cir. 1982) ("Plainly,

Congress did not intend its

recodification [of the Interstate

Commerce Act] to reduce the reach of

[its] penalty, but intended merely to

transplant that section, renumbered, into

the recodified portion . . . .

Congressional drafters unfortunately

overlooked [this], but, when construed in

light of the intent of Congress and in

light of common sense, that section

clearly applies to the regulations here

in question."); United States v.

Scrimgeour, 636 F.2d 1019, 1021-24 (5th

Cir. Unit B 1981) (reversing dismissal of

indictment under 18 U.S.C. sec. 1623(d)

for making false declarations before a

grand jury because in finding Congress’

intention in enacting the statute, the

court believed Congress inadvertently

used an "or" in the statute but meant to

use "and"); United States v. Moore, 613

F.2d 1029, 1039-45 (D.C. Cir. 1979)

(same); United States v. Babcock, 530

F.2d 1051, 1053-54 (D.C. Cir. 1976)

(holding that, in light of "an

inadvertent change" by Congress when

reorganizing and renumbering the statute,

2 U.S.C. sec. 441(b) was not to be

interpreted to mean that a misdemeanor

violation under sec. 440 precluded being

sentenced to imprisonment); cf. Whitfield

v. Scully, 241 F.3d 264, 272 (2d Cir.

2001) ("Although the statute refers to

[28 U.S.C.] sec. 1915(a)(2) for the

manner of payment, we have recognized

that this reference is a typographical

error (as it makes the statute

unintelligible) and that the actual

process for payment of costs is instead

described in sec. 1915(b)(2)."); Estate

of Kunze v. C.I.R., 233 F.3d 948, 953

(7th Cir. 2000) ("The erroneous crossreference in [26 U.S.C. sec.

7430(c)(4)(D)] to a misnumbered

subparagraph in (4)(A) can hardly be

construed to have changed the legislative

intent . . . or to have affected the

substantive rights of the parties. The

import of the subsection remains clear,

in spite of the typo."); In re Chateaugay
Corp., 89 F.3d 942, 952 (2d Cir. 1996)

(agreeing with other courts that the

improperly renumbered subsections in 11

U.S.C. sec. 507 were the result of

typographical errors by Congress rather

than substantive changes in the law).

 However, some courts have held

otherwise. See United States v. Faygo

Beverages, Inc., 733 F.2d 1168, 1170 (6th

Cir. 1984) (recognizing that Congress

unintentionally eliminated a penalty

section in recodifying the

InterstateCommerce Act, but holding that

the defendant was not subject to criminal

penalty for his conduct because "it would

be unreasonable to require persons

confronted with the plain language of a

criminal statute to go beyond that

statute in order to determine whether

Congress really meant what it clearly

said"); United States v. RSR Corp., 664

F.2d 1249, 1253-55 (Former 5th Cir. 1982)

(noting that Congress inadvertently

changed a penalty section in recodifying

the Interstate Commerce Act, but holding

that the defendant was not subject to

criminal penalty for his conduct, stating

"although this is what Congress clearly

meant to say, intended to say, and wanted

to say, still Congress did not say it").

 While the plain language of the FDCA

clearly prohibited the failure to

establish or maintain records, criminal

penalties were not clearly imposed.

Nevertheless, we agree with the reasoning

found in the former set of cases rather

than the latter because strictly reading

and applying the FDCA as it was at the

time of the offense in question would put

the plain language at odds with the

statute’s purpose and intent. There is no

indication in the legislative history

that in amending the FDCA Congress

intended to eliminate the penalties. The

Law Revision Counsel of the House of

Representatives, who prepares and

publishes the U.S. Code, even placed a

footnote in the 1988 edition of the U.S.

Code in sec. 331(e) after the

proscription on failing to keep records

under sec. 355(k), and noted that sec.

335(j) had been redesignated as sec.

355(k). Thus, it seems that the failure

to cross-reference the sections was

interpreted as a mere typo by the Law

Revision Counsel. Also, we agree with the

government that Congress would not have

eliminated the penalties for failing to
establish or maintain records in this

part of the statute while retaining the

penalties for failing to do so under

other sections. Furthermore, the

government points out that the 1984

amendments broadened the recordkeeping

requirements in the redesignated sec.

355(k), and that Congress would not have

intentionally broadened the requirements

and at the same time have eliminated the

penalties for not complying with the

requirements.

 Finally, the defendants do not argue

that because of the typographical error

they lacked notice; nor could they since

they maintained records believing that

they were required to (although they did

so inadequately, as this case reveals)

under the FDCA. Therefore, we hold that

the failure to establish or maintain

records under sec. 355(k) was subject to

criminal penalties despite the

typographical error in sec. 331(e)

between 1984 and 1990.

D.

 Baldev Bhutani also raises several

challenges to his sentence imposed under

U.S.S.G. sec. 2F1.1 (2000). "The district

court’s choice of which guideline to

apply is a question of law, and we review

this choice de novo," United States v.

Andersen, 45 F.3d 217, 219 (7th Cir.

1995); we review factual determinations

for clear error, see United States v.

Vitek Supply Corp., 144 F.3d 476, 490

(7th Cir. 1998).

 First, the defendant finds error in the

district court’s choice of guideline to

apply, claiming that he ought to have

been sentenced under sec. 2N2.1(a) rather

than sec. 2F1.1. Section 2N2.1(a) covers

violations of statutes and regulations

dealing with, among other things, drug

products, and assigns a base offense

level of six to such violations; however,

subsection (b)(1) instructs: "[i]f the

offense involved fraud, apply sec. 2F1.1

(Fraud and Deceit)." Section 2F1.1 "also

has a base offense level of six, but

provides for substantial increases in

offense level based on the amount of

loss." Andersen, 45 F.3d at 219.

Bhutani’s argument turns on the notion

that sec. 2N2.1(a) applies because his

wrongs were "knowing, technical"

violations of the FDCA, and not as
serious as those of other companies that

have been prosecuted. This argument is

without merit as there is substantial

evidence of fraud in this case. See,

e.g., id. at 219-20.

 Second, he submits that sec. 2N2.1(b)(1)

does not apply to his case since it was

made effective on November 1, 1992, but

"the offenses of conviction all occurred

prior to November 1, 1992." This is of no

matter since "judges must apply the

Guidelines in force when a defendant is

sentenced." United States v. Perez, 249

F.3d 583, 584 (7th Cir. 2001) (per

curiam). Bhutani was sentenced on

February 15, 2000, and subsection (b)(1)

was then in effect, thus it is

applicable.

 Third, the defendant disputes how the

district court measured loss. As noted,

sec. 2F1.1 assigns a base offense level

of six, which is increased based on the

amount of loss attributed to the fraud.

In calculating the loss, the district

court is not required under the

Sentencing Guidelines to "compute the

loss with precision; the court need only

make a reasonable estimate of the loss

based on the information available."

United States v. Duncan, 230 F.3d 980,

985 (7th Cir. 2000); see U.S.S.G. sec.

2F1.1, cmt. 9. If it has been shown that

the victims of the fraud suffered a loss

and a more precise way of measuring the

loss is unavailable, the amount of the

defendant’s gain may provide a reasonable

estimate of the loss. See Andersen, 45

F.3d at 221.

 Directing us to United States v.

Chatterji, 46 F.3d 1336 (4th Cir. 1995),

the defendant maintains that his gain was

not the appropriate measure because there

was no actual loss to consumers as none

of the drugs were shown to be medically

effective and there was no evidence that

anyone fell ill or died. He argues that

the calculation should not be based on

whether the consumers got what they

bargained for, but rather ought to be

based on whether the consumers got

medically effective drugs. 

 In Chatterji, the defendant, sentenced

under U.S.S.G. sec. 2F1.1, submitted two

abbreviated new drug applications to the

FDA, which were approved. See id. at

1338-40. The defendant had submitted

false batch records in its application
for one of the drugs, and for the other

had changed the formula by adding more of

an inactive ingredient after its

application had been approved without

seeking further FDA approval. The

district court held that loss should be

measured by the defendant’s gain from the

sale of the drugs because the defendant’s

fraud voided the FDA approval, thereby

stripping the drugs of market value. See

id. at 1340. The Fourth Circuit, over

dissent, reversed, finding that the

defendant’s gain was not the appropriate

measure of loss because consumers got

medically effective drugs that were

exactly what they purported to be. See

id. at 1340-43.

 Relying on United States v. Marcus, 82

F.3d 606 (4th Cir. 1996), the government

in our case argues that there was loss to

consumers because consumers paid for-FDAapproved drugs, but received drugs that

were not manufactured according to the

FDCA and FDA regulations; therefore, the

government argues that the amount of the

defendant’s gain is an appropriate

measure of loss. 

 In Marcus, the defendant, sentenced

under sec. 2F1.1, had obtained FDA

approval to manufacture a drug, but

changed the formula by adding two

additional inactive ingredients without

obtaining additional FDA approval. See

id. at 607-08. The district court found

that the defendant’s gain was the

appropriate measure of loss because the

drug did not meet FDA specifications, and

therefore, had no value. See id. at 608.

The court distinguished Chatterji, which

the Fourth Circuit affirmed, reasoning

that the formula modification in

Chatterji "was merely an insignificant

change that implicated only the shelf

life of the drug," and not the safety or

medical efficacy; however, the formula

modification here had a bearing on the

medical effectiveness, which would

require additional testing to determine

whether the drug was still safe and

effective. Id. at 610.

 In this case, the district court agreed

with the government’s position and

reasoned:

I find the analysis in the Marcus case

from the Fourth Circuit to be persuasive.

I understand that the defendants believe
Marcus is distinguishable on the basis

that the defendant there agreed that

there was an issue as to whether the drug

involved there was the bioequivalent of

the patented drug.

 I don’t regard that as a distinguishing

feature of the case, because whether the

defendants stipulate to it or not, and

certainly they do not in this case, I

find that there was an issue as to

whether these drugs had been properly

manufactured.

 I’m not saying that there was an issue

as to whether they would be injurious to

health or necessarily even an issue as to

whether they would be effective for their

pharmaceutical purpose. What I find,

rather, is that there was an issue as to

whether they had been manufactured in

such a way that the consumers of those

drugs were being sold something other

than what they thought they were buying.

 I don’t think that any consumer of any

of those drugs would have bought those

drugs had the consumer known what had

happened to them.

* * *

 And I think the essence of the loss here

to the consumers was the same thing fact

[sic] that the Marcus case was talking

about, namely, the fact that they didn’t

get the FDA-approved manufactured drugs

that they thought they were getting.

 And I emphasize that I don’t think

Marcus applies only in the situation

where the drugs could be dangerous. . . .

Sentencing Hr’g Tr. at 23-24 (February15,

2000). The district court based the

amount of loss on the defendant’s gain,

which it estimated at over $200,000,

thereby assigning Bhutani a base offense

level of fourteen. See U.S.S.G. sec.

2F1.1(b)(1)(I).

 While we do not agree with the district

court’s reading of Marcus or his reliance

on it, we wholly adopt the core of its

rationale. Indeed, we find the district

court’s reasoning to be more sound than

that in Chatterji and Marcus./1 The

medical effectiveness of the drug or its

dangerousness after adulteration ought

not be the core of the inquiry; rather,
the district court was justified in

determining that there was a loss because

consumers did not get what they bargained

for. We agree with the district court’s

decision that there was indeed loss to

consumers because consumers bought drugs

under the false belief that they were in

full compliance with the law.

 However, the defendant points out that

in Andersen we held that the defendant’s

gain was not the appropriate measure of

loss when there was "no clear evidence

that customers or consumers suffered any

loss." 45 F.3d at 221. We so held, in

part, because the drugs in that case were

sold in hand-labeled containers and the

customers were aware that the drugs were

not FDA approved. See 45 F.3d at 221.

That is not so here; here consumers

bargained for FDA-approved drugs that

were in compliance with the law. This

they did not get. We agree with the

district court’s determination of what

constitutes loss in this sort of case,

and that the defendant’s gain is the

appropriate measure of that loss.

E.

 The bulk of the defendants’ brief is

tinged with hyberbole, lamenting that

they ought not to have been prosecuted

because what they may have done was not

so bad compared to what others have done

and that their industry is overregulated

by the FDA. The judiciary is not the

branch to hear these beefs; rather, they

ought to be raised with Congress, who

makes the law, and prosecutors, who have

broad discretion in instituting criminal

proceedings. Furthermore, many of the

disputes are no more than an invitation

to reweigh the evidence based on the

defendants’ attempt to retry this case on

appeal. We are at ease with the jury’s

work in weighing evidence and assessing

credibility and will not engage in

second-guessing. The other arguments of

the defendants are equally without merit

and we shall not address them further.

AFFIRMED.

FOOTNOTE

/1 We decline the defendant’s invitation to apply

United States v. Maurello, 76 F.3d 1304 (3d Cir.

1996) by analogy to this case. We also find our

decision in Vitek Supply inapplicable because it
dealt with whether loss to competitors and downstream consumers was to be included in the loss

calculation. See 144 F.3d at 490-92.