Court Opinion

ID: 3001466
Source: CourtListenerOpinion
Date Created: 2015-09-24 20:17:00.785569+00
Date Added: 2024-06-11T11:45:45.376036
License: Public Domain

In the
 United States Court of Appeals
               For the Seventh Circuit
                          ____________

Nos. 06-3612 & 06-3619
UNITED STATES OF AMERICA,
                                                   Plaintiff-Appellee,
                                  v.

ROSS A. CAPUTO and ROBERT M. RILEY,
                                             Defendants-Appellants.
                          ____________
            Appeals from the United States District Court
        for the Northern District of Illinois, Eastern Division.
                No. 03 CR 126—Ruben Castillo, Judge.
                          ____________
  ARGUED SEPTEMBER 10, 2007—DECIDED FEBRUARY 27, 2008
                          ____________

  Before EASTERBROOK, Chief Judge, and KANNE and EVANS,
Circuit Judges.
   EASTERBROOK, Chief Judge. An autoclave sterilizes
medical instruments quickly and cheaply. But some
instruments can’t stand the high temperatures and pres-
sures of an autoclave, so there is a demand for steri-
lizers that use lower temperatures and non-aqueous
sterilants. One system in widespread use relies on ethylene
oxide gas as the sterilant. That gas is toxic and hard to
handle, however, and Ross Caputo saw a business oppor-
tunity in these drawbacks. He designed a low-temperature
2                                   Nos. 06-3612 & 06-3619

system using a plasma of peracetic acid as the sterilant
and in 1990 asked the Food and Drug Administration to
approve this device, which his company AbTox Inc.
called the Plazlyte.
  Since 1976 it has been unlawful to sell a new medical
device without the FDA’s approval. The Medical Device
Amendments to the Food, Drug, and Cosmetic Act have a
grandfather clause covering devices that had been law-
fully sold on or before May 28, 1976, or are “substantially
equivalent” to them. 21 U.S.C. §360c(f)(1)(A)(ii). AbTox
asked the FDA to approve sales of a Plazlyte as “substan-
tially equivalent” to units that employ ethylene oxide as
the sterilant. We refer to “a” Plazlyte rather than “the”
Plazlyte because AbTox made at least two models. The first
had an interior volume of one cubic foot and used 10%
peracetic acid made by mixing water with a solution of
30% peracetic acid. The water and the 30% solution were
in separate bottles. This device used a two-cycle proce-
dure, applying gas plasma twice to sterilize the instru-
ments. The second model had an interior volume of
approximately five cubic feet, used 5% peracetic acid
from a single bottle (no dilution with water from a sec-
ond bottle), and ran just one cycle, at a different pressure
from the first model. We call the first model the small
Plazlyte and the second model the large Plazlyte.
  AbTox submitted the small Plazlyte for approval in 1990.
It also submitted only those tests that favored the
device’s effectiveness; others, less helpful to AbTox,
were concealed (or so a jury could conclude; we re-
count the evidence in the light most favorable to the
verdict). The agency’s staff doubted whether the Plazlyte
was equivalent to ethylene oxide systems and insisted on
limiting the uses to which it could be put. When the FDA
Nos. 06-3612 & 06-3619                                      3

signed off on the small Plazlyte in 1994, it approved the
device only for use with solid stainless-steel instruments.
If AbTox wanted to sell the Plazlyte to sterilize instru-
ments containing interior space that the gas plasma
might not fully penetrate (such as those with hinges or
lumens) or instruments made from materials that might
react chemically with peracetic acid (C2H4O3), an organic
peroxide, it had to file an application for approval as a
new device rather than one equivalent to a grandfathered
device. Any medical instrument containing plastic,
solder (usually made of lead, tin, or silver), or brass (an
alloy of copper and zinc) was outside the scope of the
FDA’s approval.
  A new and expensive machine (Plazlytes sold for
about $100,000) for sterilizing solid instruments made of
stainless steel had no prospect in the market. Autoclaves
are cheaper and don’t require the handling of acids.
Caputo understood that AbTox would never be able to
sell a single unit of the small Plazlyte for the limited use
approved by the FDA. Caputo (and his assistant Robert
Riley) did not try. Instead they immediately began pro-
moting the large Plazlyte as a replacement for ethylene-
oxide devices, and thus as suitable for general-purpose
sterilization. It had begun selling the large Plazlyte outside
the United States in 1993; thus, long before receiving
the FDA’s approval to sell the small Plazlyte, it knew
that the small device would never be marketed and that
the large Plazlyte would be promoted for use with many
kinds of instruments—though it did not tell the FDA
these things when negotiating the details of the limited
use that would be allowed to the small Plazlyte.
  Problems ensued when some hospitals used the Plazlyte
to sterilize brass instruments employed for procedures
4                                   Nos. 06-3612 & 06-3619

in the eye. The Plazlyte left a blue-green residue on some
of these instruments—and, although the instruments
were sterile, the residue (copper and zinc acetate) was
harmful to patients’ eyes. Some patients experienced
corneal decompensation, a severe condition that entails
loss of vision.
  In May 1995 the FDA found out what AbTox was telling
customers and reminded it about the limitations on the
scope of approval. This notice informed AbTox that the
Plazlyte as promoted was “misbranded”. AbTox then
sought the FDA’s approval to sell the large Plazlyte
to sterilize a wider class of instruments; when the FDA
rejected AbTox’s request for expedited decision and
told AbTox that it “may not market this device until
you have received a letter from the FDA allowing you to
do so”, AbTox went on promoting the large Plazlyte as
before. On September 27, 1996, the FDA sent AbTox
another instruction to stop selling the large Plazlyte; AbTox
failed to comply (though it did not tell the FDA so). The
agency never authorized AbTox to sell the large Plazlyte
for any use.
  The Centers for Disease Control opened an investiga-
tion to discover what was causing the eye injuries. Mean-
while, in January 1998, the FDA inspected AbTox’s facili-
ties and discovered that it was still selling the large
Plazlyte. The inspectors told AbTox to desist; it didn’t. In
April 1998 the FDA issued a warning to all hospitals,
telling them that the large Plazlyte was not an approved
device and at all events must not be used with any instru-
ments containing solder, copper, or zinc, or for any oph-
thalmic instruments. The FDA directed AbTox to recall
the devices; U.S. marshals seized its inventory; this crimi-
nal prosecution eventually followed.
Nos. 06-3612 & 06-3619                                      5

  The prosecutor threw the book at Caputo and Riley. The
indictment charged them with conspiring to defraud
the United States, 18 U.S.C. §371, mail fraud, 18 U.S.C.
§1341, wire fraud, 18 U.S.C. §1343, lying to federal agents,
18 U.S.C. §1001, and the delivery of misbranded devices,
21 U.S.C. §§ 331(a) and 333(a)(1). A jury convicted them
of these charges after an eight-week trial. Caputo has
been sentenced to 120 months’ imprisonment and Riley
to 72 months. Both were ordered to make restitution of
$17.2 million, the list price of all Plazlyte units ever sold.
  Defendants’ lead argument is that the Food, Drug, and
Cosmetic Act violates the first amendment by restricting
promotional materials to those uses that the FDA has
approved. The argument starts from the premise that
federal law allows customers of any approved medical
device or drug to put it to any use that the customer
sees fit. These “off-label uses” being lawful, the argument
goes, it must also be lawful to tell customers about them.
   Until the last 30 years, such an argument would have
been laughed out of court. Valentine v. Chrestensen, 316
U.S. 52 (1942), had held that “commercial speech”—that
is, speech promoting a product for sale—is not part of
the “freedom of speech” as that term was understood in
1789. But the Court overruled Valentine in Virginia Board of
Pharmacy v. Virginia Citizens Consumer Council, Inc., 425 U.S.
748 (1976), holding that the government cannot regulate
by ensuring ignorance among consumers. If it is lawful to
sell a product then, the Court held, it must be lawful to
inform consumers that the product is available to buy.
Consumers themselves must decide what to do; the
Constitution forecloses an enforced ignorance based on a
paternalistic view that informed consumers will make
mistakes. See also, e.g., Greater New Orleans Broadcasting
6                                   Nos. 06-3612 & 06-3619

Ass’n, Inc. v. United States, 527 U.S. 173 (1999); Rubin v.
Coors Brewing Co., 514 U.S. 476 (1995); Bolger v. Youngs
Drug Products Corp., 463 U.S. 60 (1983); R.H. Coase, Adver-
tising and Free Speech, 6 J. Legal Studies 1 (1977).
   For a time judges thought the Supreme Court’s new
understanding inapplicable to drugs (and, by implica-
tion, medical devices): Federal law allows vendors to tell
customers about all lawfully available drugs and devices,
after all, and thus avoids the precise problem presented
by Virginia Citizens Consumer Council. But federal law
does prohibit manufacturers from alerting consumers to
lawful off-label uses, and Thompson v. Western States
Medical Center, 535 U.S. 357 (2002), held that this limit is
unconstitutional in at least some applications. A federal
law allowed pharmacists to compound some drugs that
had been approved for stand-alone sales, creating sub-
stances that had not been subjected to the normal testing.
The legislation granting pharmacists this compounding
privilege attached conditions to the way they could
promote the compounded drugs. The Court held these
limits unconstitutional: if the compounded drug could
be sold, the Court held, then it could be freely promoted
for every lawful use. Western States Medical Center estab-
lishes that drugs are not a special case for first-amendment
analysis. (The Court once held that gambling is a special
case, see Posadas de Puerto Rico Associates v. Tourism Co. of
Puerto Rico, 478 U.S. 328 (1986), but the status of that rule
is doubtful. See 44 Liquormart, Inc. v. Rhode Island, 517
U.S. 484, 508–14 (1996) (plurality opinion).) The Court
suggested in Western States Medical that Congress either
adopt a substantive rule prohibiting compounding
(or, here, prohibiting off-label uses) or allow the FDA to
supply warnings via its own speech. Compelling private
Nos. 06-3612 & 06-3619                                      7

persons to toe the government’s line, or shut up, is uncon-
stitutional, the Court held. This is the doctrine that Caputo
and Riley propose to invoke in their defense.
   Whether Virginia Citizens Consumer Council and Western
States Medical Center apply to promotion by a product’s
manufacturer, which struck a bargain with the FDA in
the approval process by promising to limit its promo-
tion—a bargain that the private litigants in the earlier cases
had not struck—is a difficult question. The doctrine of
unconstitutional conditions places limits on the promises
that an agency may extract from those who seek approval.
And if a given use is lawful, and thus can be written
about freely in newspapers or blogs, and discussed
among hospitals that already have purchased a Plazlyte,
doesn’t it make a good deal of sense to allow speech by
the device’s manufacturer, which after all will have the
best information? Why privilege speech by the unin-
formed? The manufacturer has an incentive to slant the
speech in its favor and may withhold bad news, but many
listeners (especially professionals such as physicians)
understand this and can discount appropriately. That, at
any rate, is the anti-paternalist view of Virginia Citizens
Consumer Council and the cases that followed in its wake.
  Yet if a manufacturer’s promise to the FDA to avoid
speech about off-label uses is unenforceable, the FDA
may respond by withholding any approval of drugs or
devices that have questionable additional uses. AbTox’s
small Plazlyte would not have been approved at all,
had the FDA anticipated that approval would enable
AbTox to tout it (or its larger brother) for use with brass
ophthalmic instruments. Other firms, with no desire to
promote off-label uses (or, at least, no desire to pay for
the expensive tests needed to persuade the FDA to sanc-
8                                  Nos. 06-3612 & 06-3619

tion wider use), would be made worse off by their
inability to strike deals allowing the FDA to approve a
subset of all possible uses. Consumers who could benefit
from drugs or devices that would be excluded from the
market by the FDA’s response to a broad privilege to
tout off-label uses also would be made worse off. Doubt-
less the first amendment differs from Bentham’s felicific
calculus, but a court should hesitate before extending
an ahistorical reading of the Constitution in a way that
injures the very audience that is supposed to benefit from
free speech.
   Fortunately, we need not decide today whether a seller
of drugs or medical devices has a constitutional right to
promote off-label uses. Virginia Citizens Consumer Council
and its successors rest on the assumption that the law
allows the activity that the speaker seeks to promote.
Here that assumption holds only if AbTox lawfully
could sell the large Plazlyte for the (approved) use
with solid stainless-steel instruments. Unless the
machine itself could be sold lawfully, there were no
lawful off-label uses to promote. And the jury found, by
its verdicts on both the fraud-on-the-United-States
count and the misbranded-device counts, that the large
Plazlyte could not lawfully be sold. The jury concluded
not only that Caputo and Riley had lied to the agency
when seeking approval of the small Plazlyte but also
that the large Plazlyte differed enough from the small
one that new approval was essential. For current pur-
poses it is enough to concentrate on the latter conclusion.
(Defendants insisted at oral argument that the jury
could have convicted, under the instructions given,
without finding either lies to the FDA or sale of a never-
approved device. We have reviewed the instructions and
Nos. 06-3612 & 06-3619                                     9

conclude that, to convict on all counts as it did, the jury
had to find both.)
  Once the FDA certifies a medical device under the
grandfather clause, the seller may make modifications to
that device without obtaining fresh approval. The line
between a “modification” (no approval needed) and a
new device (which must be submitted independently
for approval) is drawn in 21 C.F.R. §807.81. There are
two principal inquiries: first, whether the changes “signifi-
cantly affect the safety or effectiveness of the device” and,
second, whether there is a “major change or modification
in the intended use of the device.” 21 C.F.R. §807.81(a)(3).
We doubt that the large Plazlyte could be described as
a “modification” of the small one; recall that the large
device had been placed on sale outside the United States
in 1993, the year before the FDA approved the small
device. “Modification” suggests a change in an approved
device, not a different device that was already on sale
before the approval. But suppose that this is wrong, and
suppose further that the large Plazlyte was as safe as the
small one notwithstanding the difference in the concen-
tration and number of applications of the sterilant. There
remains the rule that a “major change or modification
in the intended use of the device” requires fresh approval.
Promoting the large Plazlyte as suitable for use with
all medical instruments is a major change in intended
use, compared with using it for solid stainless-steel instru-
ments alone. This expansion of use caused the copper
and zinc acetates that injured patients. So the large
Plazlyte, with its expanded “intended use”, was not
covered by the FDA’s approval of the small Plazlyte and
could not lawfully be sold at all. That knocks out the
premise of Virginia Citizens Consumer Council and similar
cases. There was no lawful activity for speech to promote.
10                                   Nos. 06-3612 & 06-3619

  Caputo and Riley try to avoid this conclusion by arguing
that the Due Process Clause of the fifth amendment
disabled the FDA from keeping the large Plazlyte off the
market. The line between new and modified devices is too
vague to be enforceable, the argument goes. We grant that
phrases such as “significantly affect” and “major
change . . . in the intended use” are not self-defining. But
then no legal phrase is. Think of “material” (as in “material
misrepresentations are forbidden”), a staple of legal
discourse, or “unreasonable” (as in “unreasonable
danger to the health and safety of park users”, a phrase
deemed adequately specific in Thomas v. Chicago Park
District, 534 U.S. 316, 324 (2002)). The Supreme Court has
rejected vagueness challenges to the antitrust laws,
see Nash v. United States, 229 U.S. 373 (1913), which must
be an order of magnitude more ambulatory than
§807.81(a)(3), and has held that a rule cannot be deemed
unconstitutionally vague if it suggests a metric for decision.
See United States v. Powell, 423 U.S. 87 (1975). Section
807.81(a)(3) tells us what dimensions of difference mat-
ter, even though it does not give an exact answer to the
question “how much is too much”? (The statute in Powell,
which forbade the mailing of a firearm capable of being
concealed on the person, also omitted a quantitative
rule, but the Court held that its qualitative approach
suffices.)
  The uncertainty that is inevitable in legal standards (as
opposed to numerical rules) often is offset by notice, so
that people need not guess what is required of them. The
FDA gave AbTox notice, and to spare. It published in
March 1993 (before the small Plazlyte was approved) a
“Guidance” stating that any change in the sterilant or
chamber size of a sterilizer creates a new device that
Nos. 06-3612 & 06-3619                                   11

requires new approval. It sent letters, which AbTox
ignored. (The letters not only called attention to the 1993
Guidance but also restated the FDA’s view of AbTox’s
duties under the statute and regulation.) It sent an inspec-
tion team, whose directions AbTox spurned. There was
no such notice in United States v. Prigmore, 243 F.3d 1 (1st
Cir. 2001), a decision on which defendants heavily rely.
(And Prigmore did not hold the statute or regulations
unconstitutionally vague, either, though it did remand
for a new trial with jury instructions adequate to pin
down the meaning of the rules at issue there.)
  To say that the FDA showered interpretations and advice
on Caputo and Riley is not to say that the published
“Guidance” has the effect of a regulation, let alone that
AbTox was legally bound to comply with the letters. Only
the statute, regulations, and formal directives of the
agency (as opposed to its staff) have legal force. The
agency did not issue its cease-and-desist and recall orders
until April 1998. Until then Caputo and Riley were at
liberty to chart their own course, as their own legal advis-
ers counseled them. When they did this, however, they
took a risk and could not then say “we didn’t know” or
“the regulation left us scratching our heads.” The agency
comprehensively alerted AbTox, Caputo, and Riley to its
view of their legal obligations, and an agency’s inter-
pretation of its own regulations, no less than a judicial
opinion, may disambiguate them. When Caputo and
Riley chose to go their own way, the question on the table
for the court became simply who is right about the mean-
ing of the legal rules, not whether adequate notice
was given.
  Note that Caputo and Riley have not made an advice-of-
counsel defense, though no one gets into a multi-million-
12                                   Nos. 06-3612 & 06-3619

dollar medical-device business without legal counsel.
Perhaps they lied to their lawyers about what they
were doing and thus cannot present a defense that de-
pends on candor to counsel; or perhaps they decided to
avoid asking for advice about §807.81(a)(3) for fear of
what the answer would be; finally, they may have
asked and received a reply that they did not follow. The
attorney-client privilege prevents us from knowing which.
  Defendants did, however, argue that they acted “in
good faith.” They complain about the adequacy of the
instructions on this subject. That the district judge gave
any such instruction at all was unduly favorable to the
defense. This was at heart a fraud prosecution (and for
most counts nothing but a fraud prosecution), and there
is no “good faith defense” to fraud. A person who tells a
material lie to a federal agency can’t say “yes, but I
thought it would all work out to the good” or some such
thing. Intentional deceit on a material issue is a crime,
whether or not the defendant thought that he had a good
excuse for trying to deceive the federal agency or the
potential customers.
   The district judge did not abuse his discretion—the right
standard, see General Electric Co. v. Joiner, 522 U.S. 136
(1997)—in keeping out of evidence the proposed “expert”
testimony that defendants wanted to introduce. The
“expert” would have testified about the meaning of the
statute and regulations. That’s a subject for the court, not
for testimonial experts. See Bammerlin v. Navistar Interna-
tional Transportation Corp., 30 F.3d 898, 900 (7th Cir. 1994).
The only legal expert in a federal courtroom is the
judge. An advice-of-counsel defense might have got
something along these lines in through the back door, but
as we have explained no such defense was made.
Nos. 06-3612 & 06-3619                                13

  It came out after the trial that the jury’s foreman had
six misdemeanor convictions related to his use of heroin
and alcohol, to which he had been addicted. The district
judge held a hearing and concluded that this juror
had believed that questions asking the venire whether
anyone had been convicted of a crime sought informa-
tion about federal crimes only, and he had not been
convicted of a federal crime. The judge credited that
explanation, found that the juror had committed an
“honest mistake,” and added that, had the juror re-
vealed his convictions, they would not have supported
a challenge for cause. The juror testified, and the judge
found, that he had broken his heroin addiction through a
methadone program, had been “clean” for a year before
trial, and had been forthright about his problems when
asked; it was a newspaper report, based on that candor,
that led to the discovery after the end of the trial. The
district judge applied the right legal standard, see
McDonough Power Equipment, Inc. v. Greenwood, 464 U.S.
548 (1984); United States v. Warner, 498 F.3d 666, 684–88
(7th Cir. 2007), and did not abuse his discretion in con-
cluding that defendants are not entitled to a new trial.
After all, it is usually the prosecutor who wants to ex-
cuse potential jurors with criminal records, lest they
sympathize unduly with others facing the ordeal of a
prosecution and at risk of imprisonment. Caputo and
Riley do not give any reason for thinking that this juror
would have been slanted in the prosecutor’s favor.
  Riley contends that his conviction on Count 9, which
charged him with making two false statements to an
employee of the FDA, in violation of 18 U.S.C. §1001,
should be reversed because the instructions allowed the
jury to convict if either of two statements was false,
14                                   Nos. 06-3612 & 06-3619

while the evidence shows that one statement at most
was false. As a matter of law, one false statement is enough
for a conviction, so Riley’s line of argument fails under
Griffin v. United States, 502 U.S. 46 (1991), which holds
that a conviction is proper if the evidence established
beyond a reasonable doubt any of the ways in which
the crime might have been committed. Griffin holds that
a jury may be relied on to accept the supported possi-
bility and discard the unsupported one. (When the in-
struction contains a legal error, then the jury’s fact-finding
ability may lead it astray, but Riley does not contend
that the instruction allowed the jury to convict him on
Count 9 on a factually substantiated but legally incorrect
theory.)
  A brief discussion of sentencing brings this opinion to a
close. The district court calculated the loss at roughly
$17 million, the list price for all Plazlyte devices that
AbTox delivered. Application Note 3(F)(v) to U.S.S.G.
§2B1.1 says that defendants who sell goods without
required approvals receive no credit for their value, if any,
to the customers. List price thus was the right starting
point. Defendants say, however, that some machines
were sold at a discount and a few given away as demon-
strators, and that the judge should have used actual
transactions prices rather than list prices. That’s true in
principle, but defendants don’t say that using transac-
tions prices would have reduced the loss below $7 million.
A loss from $7 million through $20 million produces the
same offense level; there’s accordingly no need to deter-
mine with precision where within that span the loss falls.
(Despite United States v. Demaree, 459 F.3d 791 (7th Cir.
2006), which was released a month before defendants
were sentenced and holds that judges must use the Guide-
Nos. 06-3612 & 06-3619                                    15

lines in force on the date of sentencing, the district judge
used the 1997 version in which loss from $10 million
through $20 million produced the same number of levels.
That error was favorable to defendants, and as the prosecu-
tor has not taken a cross-appeal we need not discuss
it further.)
  Finding actual transactions prices was unnecessary to
know the “loss” for the purpose of §2B1.1, which does not
require more than an estimate. Restitution, by con-
trast, requires an exact figure; it is a substitute for civil
damages, though limited to direct losses rather than
consequential damages. See United States v. Behrman,
235 F.3d 1049 (7th Cir. 2000); United States v. Havens,
424 F.3d 535, 537 (7th Cir. 2005). So the restitution for a
Plazlyte with a list price of $100,000 but sold at a $20,000
discount is $80,000, not $100,000. And the restitution for
a machine given away as a demonstrator is nothing.
Likewise restitution for a machine that was invoiced at
$100,000, but never paid for in light of the recall (defen-
dants say that there were several in this category), is zero.
The district court must determine these figures one cus-
tomer at a time and not use the list-price shortcut that
is suitable when the only question is whether loss falls
within widely spaced bounds.
  Defendants propose a further adjustment for the value
the buyers obtained from the Plazlyte sterilizers. Some
hospitals may have used them principally for the ap-
proved purpose and found them entirely satisfactory;
others may have put them to off-label uses that did not
cause problems. But if a court is going to deduct for
the value of the machines in use, it should order restitu-
tion for the cost of compensating injured patients, the cost
to hospitals and the Centers for Disease Control of investi-
16                                   Nos. 06-3612 & 06-3619

gating the mysterious eye injuries, and so on; one can’t
have the subtractions for productive use without the
additions for harms caused by off-label uses. Defendants
do not propose to make restitution for these harms, so
they can’t obtain subtractions either.
  There remains one problem: What of the machines that
remained in service after the recall? A recall notice is (from
a customer’s perspective) an option rather than a com-
mand. Some hospitals returned their Plazlyte machines;
others junked them; but a few kept them and continued
using them, even purchasing extra sterilant from AbTox
to extend their lives. (The FDA allowed AbTox to sell
the peracetic acid to hospitals that certified their aware-
ness of the recall and the reasons behind it.) These cus-
tomers evidently believed that the machines were valu-
able—and, if hospitals took care to avoid certain kinds of
instruments, they continued to be safe. We think that no
restitution is owed to customers that, with full knowledge,
continued to operate Plazlyte machines for longer than
was necessary to replace them. (Hospitals that retained
the Plazlyte sterilizers only until they could secure
new, approved equipment should be grouped with hospi-
tals that returned them in the recall.) In principle hospitals
that kept their machines in long-term service are entitled
to compensation for a reduction in the value that Plazlyte
sterilizers would have on resale (not only because of
the blow to their reputation but also because spare parts
will be hard to come by), but unless that value (or its
proxy, the reduction in the machines’ expected useful lives)
can be determined, the judge should assume that the
hospitals that kept their Plazlyte machines for more than
a year after the recall notice will use them until they
wear out.
Nos. 06-3612 & 06-3619                                17

  The judgment of the district court is affirmed except
with respect to restitution. The award of restitution is
vacated and the case remanded for calculation, using
the principles in this opinion, of the amount that defen-
dants owe to each of AbTox’s customers.

                  USCA-02-C-0072—2-27-08