Court Opinion

ID: 4211311
Source: CourtListenerOpinion
Date Created: 2017-10-12 18:00:51.683977+00
Date Added: 2024-06-11T07:47:41.519530
License: Public Domain

In the

       United States Court of Appeals
                   For the Seventh Circuit
                       ____________________

No. 17-1483
SIDNEY HILLMAN HEALTH CENTER OF ROCHESTER and
TEAMSTERS HEALTH SERVICES AND INSURANCE PLAN LOCAL
404,
                                   Plaintiffs-Appellants,
                                   v.

ABBOTT LABORATORIES and ABBVIE INC.,
                                                 Defendants-Appellees.
                       ____________________

           Appeal from the United States District Court for the
             Northern District of Illinois, Eastern Division.
                  No. 13 C 5865 — Sara L. Ellis, Judge.
                       ____________________

  ARGUED SEPTEMBER 12, 2017 — DECIDED OCTOBER 12, 2017
                ____________________

      Before EASTERBROOK, KANNE, and WILLIAMS, Circuit Judg-
es.
    EASTERBROOK, Circuit Judge. The Food and Drug Admin-
istration has approved the use of Depakote (divalproex so-
dium) to treat seizures, migraine headaches, and some con-
ditions associated with bipolar disorder. Physicians are free
to prescribe it to treat other conditions, called off-label uses,
2                                                 No. 17-1483

but a drug’s manufacturer can promote it only as suitable for
uses the FDA has found to be safe and effective. Abbott La-
boratories, which makes Depakote, encouraged intermediar-
ies to encourage Depakote’s off-label uses while hiding its
own involvement. This promotion, for conditions including
schizophrenia, dementia, and attention deficit hyperactivity
disorder (ADHD), was detected, and prosecution followed.
In 2012 Abbott pleaded guilty to unlawful promotion and
paid $1.6 billion to resolve the criminal case and settle qui
tam actions that had been filed against it under the False
Claims Act, 31 U.S.C. §§ 3729–33. The next year saw the
transfer of Depakote sales in the United States to AbbVie, a
fraternal corporation, but for simplicity we ignore AbbVie.
    Two welfare-benefit plans that paid for some of Depako-
te’s off-label uses filed this suit in 2013 seeking treble dam-
ages under the civil-liability provision in the Racketeer In-
fluenced and Corrupt Organizations Act, 18 U.S.C. §1964.
They asked the district court to certify a class comprising all
third-party payors of drug expenses. (The parties call them
TPPs; we prefer Payors.) The district court dismissed the suit
as untimely. 64 F. Supp. 3d 1146 (N.D. Ill. 2014). Civil RICO
actions must be commenced within four years after injury
was or should have been known. Agency Holding Corp. v.
Malley-Duff & Associates, Inc., 483 U.S. 143 (1987); Rotella v.
Wood, 528 U.S. 549 (2000). The judge observed that off-label
promotion began in 1998 and the first qui tam suit was filed
in 2007. But the qui tam suits began under seal, which lasted
until 2011, and alleged that Abbott had concealed its role in
the off-label promotions. These considerations led us to re-
mand so that the parties could explore through discovery
when a reasonable Payor first should have understood that
it was paying for drugs that had been prescribed in response
No. 17-1483                                                      3

to an undercover marketing campaign. Sidney Hillman Health
Center of Rochester v. Abbott Laboratories, Inc., 782 F.3d 922
(7th Cir. 2015).
    Discovery did not occur. Nor was a class certified. In-
stead the district judge dismissed the complaint on a differ-
ent ground, this time ruling, see 192 F. Supp. 3d 963 (N.D. Ill.
2016), that the plaintiffs could not hope to show proximate
causation, another of RICO’s requirements. See, e.g., Hemi
Group, LLC v. New York City, 559 U.S. 1 (2010); Anza v. Ideal
Steel Supply Corp., 547 U.S. 451 (2006); Holmes v. Securities In-
vestor Protection Corp., 503 U.S. 258 (1992). The judge ob-
served that the improper marketing was directed at physi-
cians and concluded that tracing loss through the steps be-
tween promotion and payment would be too complex.
     To the extent the district judge believed that it is never
permissible to base RICO damages on injury to one person
caused by wrongs against another, the decision conflicts
with Bridge v. Phoenix Bond & Indemnity Co., 553 U.S. 639
(2008). The plaintiffs in Bridge alleged that defendants had
conspired to submit multiple bids in an auction whose rules
limited to one the number of bids allowed to any person or
group. Plaintiffs contended that the extra bids did not harm
the auctioneer but diminished their own chances of profita-
ble transactions. The Court held that a RICO recovery is pos-
sible when a wrong against A directly injures B. Our plain-
tiffs say that their situation is identical: unlawful sales tactics
don’t injure doctors, who do not use or pay for the drugs
they prescribe, but directly injure Payors. The Supreme
Court several times has stated in RICO litigation that the ini-
tially injured person can recover, and indeed that “[t]he gen-
eral tendency of the law, in regard to damages at least, is not
4                                                   No. 17-1483

to go beyond the first step,” Holmes, 503 U.S. at 271–72, quot-
ed with approval in Hemi Group, 559 U.S. at 10. Plaintiffs in-
sist that Payors are the “first step” and so are entitled to pro-
ceed with the suit.
    Payors part with money, to be sure, but it is not at all
clear that they are the initially injured parties, let alone the
sole injured parties.
    The relators in the qui tam actions alleged, as did the
criminal prosecutor, not simply that Abbott promoted De-
pakote for unapproved uses, but also that Depakote was not
effective, or even was harmful (compared with placebos or
other drugs), for some of those uses. Abbott commissioned
studies that it hoped would show the benefits of Depakote
for additional maladies, and the relators asserted that one of
these studies was discontinued because Depakote was harm-
ing the patients, while the result of another was suppressed
because it showed no benefit compared with a placebo. Ac-
cording to the qui tam suits, however, Abbott went right on
marketing Depakote for off-label uses. This description of
the conduct implies that the Payors are not the only, or even
the most directly, injured parties.
     Patients suffer if they take Depakote even though it is
useless to them and may be harmful. They suffer adverse
health effects if Depakote (a) aggravates their medical condi-
tions, (b) produces side effects not justified by medical bene-
fits, or (c) dissuades them from taking drugs that would alle-
viate their conditions. Many patients also incur financial
loss. Filling prescriptions usually entails out-of-pocket costs
to patients even when health insurance or welfare-benefit
plans cover most of the expense. The patients’ health and
financial costs come first in line temporally; that pharmacies
No. 17-1483                                                   5

then send bills to Payors, which cover the remainder of the
expense, does not make those Payors the initial losers from
the promotional scheme to which Abbott pleaded guilty.
   Physicians also may lose, though less directly. People
with medical conditions such as schizophrenia or ADHD
want help. If a physician prescribes an ineffective medicine
and so does not provide that help, patients may turn else-
where. Physicians affected by off-label promotions thus may
lose business and revenue.
    Plaintiffs contend that Payors bear the principal costs of
off-label promotions, because they pay for most of the cost of
the drugs, but comparing the patients’ health costs (and out-
of-pocket co-pays) with the Payors’ costs may be difficult.
    And those difficulties are compounded by other possibil-
ities.
    First, some off-label uses of Depakote may be beneficial
to patients. That makes it hard to treat all off-label prescrip-
tions as injury to the Payors, which if they did not pay for
Depakote would have paid for some other drug that physi-
cians would have prescribed in lieu of Depakote—a drug
that might have helped patients less yet cost the Payors
more. It would not be proper to calculate damages by as-
suming that all off-label prescriptions are improper.
   Second, whether or not any given off-label prescription
for Depakote helped the patient (compared with another
drug), some physicians were apt to write such prescriptions
whether or not Abbott promoted off-label uses. We know
that the number of off-label prescriptions grew once Abbott
began its campaign, but off-label prescriptions did not start
from zero. To calculate damages it would be necessary to
6                                                   No. 17-1483

determine the volume of off-label prescriptions that would
have occurred in the absence of Abbott’s unlawful activity.
That may not be an easy task.
    Third, some physicians doubtless were proof against the
campaign of disinformation. They may not have changed
their prescribing practices at all, or they might have changed
them but done so in response to information that Abbott did
not influence. The medical literature contains not only dou-
ble-blind clinical studies but also case studies and even an-
ecdotes that affect physicians’ prescribing practices. For
some physicians, these may have dominated over anything
Abbott did. Disentangling the effects of the improper pro-
motions from the many other influences on physicians’ pre-
scribing practices would be difficult—much more difficult
than following the one-step causal link in Bridge.
    Plaintiffs tell us that they can estimate the effects of Ab-
bott’s promotion by using a regression analysis. If the inten-
sity of Abbott’s efforts differed in different parts of the coun-
try, it may be possible to see how much additional Depakote
was prescribed in the more promotion-intensive areas. This
would enable a statistical inference linking the volume of
off-label sales to the amount of promotion and could in prin-
ciple address the problems that we labeled “second” and
“third” above.
   But there are some big ifs. Did the intensity of Abbott’s
promotion differ regionally? If yes, how much of the differ-
ence was offset by information that flowed from one region
to another through medical meetings or publications? Did
any remaining difference affect Depakote’s sales for off-label
uses by enough to allow a statistically significant inference,
or did other things, such as word of mouth in the profession,
No. 17-1483                                                   7

and published reports, make the national experience more
uniform? We asked plaintiffs’ counsel at oral argument
whether a study of this kind is in the record. Counsel said no
and asserted that this is because the case was dismissed on
the complaint—yet, if such a study had been conducted, it
could have been attached to the complaint or submitted any
time after the suit’s filing. We also asked whether such a
study has been published. Again the answer was no. The ab-
sence of data leaves a serious problem in showing plausible
causation, which is required even at the complaint stage.
And notice that the only kind of problems a regression anal-
ysis could address would be those we labeled “second” and
“third” above. It would not address the question whether
patients suffered medical losses or out-of-pocket costs via
co-pays, or whether physicians lost business by prescribing
an ineffective or harmful drug, or what to do about patients
whose off-label use of Depakote made them healthier.
    Hemi Group rejected, as too indirect or contingent, a claim
by New York City based on a seller’s failure to file reports
that would have helped the City collect taxes. The immedi-
ate cause of loss was buyers’ failure to pay those taxes, the
Court observed, and the failure to file reports just took away
one tool for collection. The causal chain in our case is longer
than the one Hemi Group deemed too long. The immediate
effect of wrongful off-label promotion is on physicians’ con-
duct. Some physicians will change, to some degree, which
drugs they prescribe for what conditions; some patients will
be affected for good (health benefits) or ill (health and finan-
cial losses) by the physicians’ decisions; finally some of the
financial costs will be borne by Payors, who are made worse
off to the extent Depakote is more expensive than the drug
that otherwise would have been prescribed (whatever drug
8                                                  No. 17-1483

that should have been) but better off to the extent that De-
pakote is cheaper than that alternative drug.
    Five other courts of appeals have considered the extent to
which Payors can recover under RICO for wrongs commit-
ted while marketing pharmaceuticals. Sergeants Benevolent
Association Health and Welfare Fund v. Sanofi-Aventis U.S. LLP,
806 F.3d 71 (2d Cir. 2015), and UFCW Local 1776 v. Eli Lilly &
Co., 620 F.3d 121 (2d Cir. 2010), hold that there are so many
layers, and so many independent decisions, between promo-
tion and payment that the causal chain is too long to satisfy
the Supreme Court’s requirements. Two other circuits agree
and deem this so straightforward that they have issued non-
precedential decisions. United Food & Commercial Workers
Health & Welfare Fund v. Amgen, Inc., 400 F. App’x 255 (9th
Cir. 2010); Southeast Laborers Health & Welfare Fund v. Bayer
Corp., 444 F. App’x 401 (11th Cir. 2011). See also Ironworkers
Local Union 68 v. AstraZeneca Pharmaceuticals, LP, 634 F.3d
1352, 1370 (11th Cir. 2011) (Martin, J., concurring) (agreeing
with the Second Circuit).
    In re Avandia Marketing, Sales Practices & Product Liability
Litigation, 804 F.3d 633 (3d Cir. 2015), agrees with the Second
Circuit’s position as a rule but held that recovery under
RICO is possible when misrepresentations are made directly
to Payors, leading them to add certain drugs to their formu-
laries, which means that they pay more per prescription than
they would otherwise. Finally, In re Neurontin Marketing &
Sales Practices Litigation, 712 F.3d 21 (1st Cir. 2013), while
agreeing with the Third Circuit about the consequences of
misrepresentations directly to Payors, implies disagreement
with the other four circuits about the possibility of Payors’
recovery for misrepresentations made to physicians. The
No. 17-1483                                                    9

implication of Neurontin may be short of a holding, but to
the extent there is a conflict the Second Circuit has this right.
Like it, we hold that improper representations made to phy-
sicians do not support a RICO claim by Payors, several lev-
els removed in the causal sequence. Public prosecution
avoids these problems, so Abbott’s criminal conviction and
$1.6 billion payment were the proper remedies.
                                                      AFFIRMED