*1 Verispan, INC. HEALTH IMS Plaintiffs, Appellees,
LLC, Hampshire AYOTTE,
Kelly New A. Defendant, General,
Appellant.
No. 07-1945. Appeals, Court
United States Circuit.
First 9, 2008.
Heard Jan. 18, 2008. Nov.
Decided *2 Technology, Health Information
anee for LLC, amici curiae. Surescripts, Lane, and Bell, II, Garry R. Don L. *3 P.A., for on brief Spellman, & Ransmeier Stores, Drug of Chain Association National curiae. amicus Getman, Stacey, Donáis, Schul- Craig S. Steere, PA, Popeo, and J. Daniel thess & Washington for Samp on brief Richard A. Foundation, amicus curiae. Legal Miller, Rein, Joshua Andrew M. Bert W. LLP, and Turner, Rein John Wiley S. for Healthcare for Coalition on brief Kamp Communications, amicus curiae. Starr & Judge, Wadleigh, J. Stephen Peters, Donald Earl Chil- Ayer, B. Donald for III, Day on brief and Jones dress Attor- Lombardi, Assistant E.B. Laura Inc., Health, curi- amicus Kluwer Wolters Head, General, Richard W. whom ney with ae. brief, General, was on Associate appellant. SILER,* for LIPEZ, SELYA, and Before Judges. Circuit Stacy with whom Fiil-Flynn, Sean M. Schus- and Michael Canan, Vignery, Bruce SELYA, Judge. Circuit AARP, Community brief,
ter, were on pre- of brand-name spiraling cost Legislative Association Catalyst, National great con- scription drugs is matter Prices, Drug National Prescription on every level. New government cern Med- Alliance, Hampshire New Physicians this es- to curb attempted has Hampshire Policy Society, and ical innovative by enacting calating problem Choices, amici curiae. companies affected Certain legislation. Ngo on Melissa Rotenberg and Mark legisla- challenged Hampshire’s New have Privacy Information brief for Electronic challenge raises and that response, tive Privacy Law and Experts and 16 Center that lie questions constitutional important curiae. Technology, amici cy- of free at the intersection Julin, whom Patricia R. with Thomas The tale follows. berspace. & Acosta, Milberg, Hunton Michelle representatives, sales Pharmaceutical Bassett, Jeffrey LLP, P. James
Williams “detailers,” industry argot known in Ash, P.A., Reno, Mark Spear, Orr & C. by promoting pre- livelihood earn their Blount Dorsett Anderson and Smith interactions drugs in one-on-one scription brief, LLP were on Jernigan & Mitchell in this A tool valuable physicians. appellees. endeavor, omnipres- through available knowl- technology, is Keville, computerized Bernstein, ence of Terri D. S. William pre- physician’s each individual edge Manatt, Phillips, LLP Phelps & informational history. scribing With Initiative, Alli- National brief for EHealth * Circuit, designation. sitting by Of the Sixth
asset, detailers are able target particu- combating this novel threat to the cost- lar physicians shape pitches their sales effective delivery of care, health New accordingly. Convinced that this detailing Hampshire has acted with as much fore- technique physicians induces to prescribe thought and precision as the circumstances expensive brand-name in place of permit and the Constitution demands. equally but effective less costly generic New drugs, Hampshire enacted a law that I. BACKGROUND
among other things prohibited certain The raw facts are largely undisputed. physicians’ transfers of prescribing histo- Modern-day detailing begins when a pre- *4 ries for use in detailing. See 2006 N.H. scription is filled.1 moment, At that the § Laws at N.H.Rev.Stat. codified pharmacy stores its computerized data- Ann. 318:47-f, §§ 318-B:12(IV) 318:47-g, base a potpourri of (2006) (the information about the Law). Prescription Information transaction, such as the name of the pa- A duo of data miners promptly challenged tient, the identity of the prescribing the physi- law as invalid on grounds. various cian, the drug, its dosage, and the quantity The district court found that it worked an dispensed. toDue the complex abridgement unconstitutional relation- of free ships that mark the delivery speech of enjoined health its care enforcement. See products and services in Health Ayotte, twenty-first IMS Inc. v. 490 F.Supp.2d century, (D.N.H.2007) this information quickly (D.Ct.Op.). finds its This way into databases, other appeal ensued. including those of insurance carriers and pharmacy bene- pages follow, In the explain we why fits managers. we not persuaded regulated data transfers embody pro- restrictions on plaintiffs case, IMS Health speech. view, tected In our portions of Inc. LLC, and Verispan, are in the busi- the law at issue here regulate conduct, not of ness data mining. For present pur- speech. stereotypical Unlike commercial poses, that means that purchase data speech, new information is not filtered into of type kind above, described ag- the marketplace with the possibility of entries, gregate group by them pres- stimulating better informed consumer criber, and cross-reference each physi- (after all, choices physicians already know cian’s prescribing history with physician- histories) their own and the specific information available through the societal flowing benefits prohibit- from the American Medical Association. The final ed pale transactions in comparison product prescriber’s enumerates the iden- negative produced. externalities un- This tity and speciality, the drug prescribed, usual combination of features removes the and kindred information. scope of challenged portions of the statute from the enterprise is mind-boggling: these two proscriptions of the First Amendment. record, alone group, and organize There is a second basis for our decision. several billion prescriptions each year. To Even if the Prescription Information Law protect patient privacy, prescribees’ names amounts to a regulation protected are encrypted, effectively eliminating proposition with which we dis- ability particular match —a prescriptions agree passes constitutional muster. particular with patients. —it description detailing Our Rowe, owes much to Corp. Health F.Supp.2d precise provided by accounts two (D.Me.2007); district 157-65 Op., Ct. D. courts, including the court below. See IMS F.Supp.2d at 165-74. office, herself usually by presenting cian’s information collections massive
These helpful purveyor non-profit certain utility for great have The detailer institutions, and research. information pub- (e.g., educational entities armed with office physician’s to the comes enforcement and law groups, lic interest physi- to educate concern, and offers handouts Hampshire’s New agencies). pharma- latest about the his staff use: cian and commercial frankly however, is with words, In other developments. cological phar- the mined exploitation holding out the open doors use detailers whose detailers companies, maceutical and efficient of a convenient promise physicians. drugs to marketing init up- receiving practice-related means war- detailing art of point, At this dates. in- Detailing rants further elaboration. Withal, precious, time is physician’s by phar- visits one-on-one tailored volves way their manage must and detailers representatives sales maceutical reluctance to natural physicians’ around This is time- staffs. and their physicians presentations. work, promotional make time suit- consuming expensive *5 end, distribute typically detailers bioe- To lower-priced marketing of ed to physicians and array gifts to an of small (drugs are drugs generic quivalent lunches, staffs, complimentary host their indistinguishable pharmacologically From drug samples. out free pass for save counterparts brand-name their physi- a time, invite a detailer will absorp- time to of in rates differences potential confer- all-expense-paid an to attend associ- cian tion). margins profit higher en- speaking a accept or to lucrative ence drugs leaves with brand-name ated gagement. to brand- open field solicitation personal manufacturers, who in the
name very little freebies cut ice. Most of these $4,000,000,000on roughly spent year 2000 however, highly are samples, The free detailing.2 astounding: is Their sheer volume prized. an estimated year in engage drug manufacturers Brand-name $1,000,000,000 drug samples flowed in free in- For situations. detailing several That flood of physicians. a man- from detailers stance, where detailing employed is to of- physicians enables free medications encourage prescription seeks ufacturer pa- charge to selected drugs free of against fer drug as brand-name patented a of thus tolerate de- Many physicians competitor's tients. a drugs, against or as generic reap the harvest of tailing in order to a means visits drug, or as patented brand-name bring.3 samples that these visits loyalty brand maintaining a physician’s drug has a patent on brand-name after its office, physician’s detailers Once inside expired. impressively an mounting capable marketing pitch. and intense sophisticated pres- habits physician’s If a ongoing an works to establish the detail- detailer opportunity, appropriate an ent and, relationship physician with the physi- to the gain access attempts er Nevertheless, physi- significant number of availability 3. ready of reliable Because of visits, year detailing flatly 2000 as a convinced parties used the cians refuse figures, the purposes. It year illustrative or a waste of benchmark are either unethical both evidence that dear from anecdotal time. gross detailing and the incidence in- expended in its service have amounts intervening years. creased in the cases, most detailers’ regu- visits become a ternet pharmacy or other entity, similar lar occurrence. For example, average for any commercial purpose, except for primary care physician interacts with no purposes limited of pharmacy reim- twenty-eight fewer than detailers each bursement; formulary compliance; care week and the average specialist interacts management; utilization review with fourteen. health care provider, the patient’s insur- ance provider or agent either; frequency
Given the exchanges, these health research; care or as otherwise it is surprising that prescriber-identifi- provided by law. Commercial purpose able information can be an invaluable asset includes, but to, is not limited advertis- to the detailer. That information enables ing, marketing, promotion, activi- physicians detailer zero who ty that could used to influence sales regularly prescribe drugs, competitors’ or market share of a physicians who are prescribing large quan- product, influence or evaluate the pre- drugs tities of particular conditions, scribing behavior of an individual health and “early adopters” (physicians with a care professional, or evaluate the effec- openness demonstrated to prescribing tiveness of a professional pharmaceutical just have come onto the mar- detailing sales force. ket). The information allows the also de- tailer to promotional tailor her message in § N.H.Rev.Stat. Ann. 318:47-f.
light of physician’s prescribing history. The statute further provides that noth- ing contained in this language should be II. THE LEGISLATIVE RESPONSE *6 prohibit read to the dispensing prescrip- of time, In Hampshire the New legislature tion to a patient, medications the transmis- moved to combat what it perni- as a saw sion of prescription information either be- cious of detailing. 4, effect January On prescribe!' tween a and a pharmacy or 2006, bill, a which would become the Pre- between pharmacies, the pre- transfer of scription Law, Information was introduced scription records evident to a pharmacy’s in the House Representatives. of Hear- change in ownership, the distribution of ings before the House and Senate fol- management care patient, materials to a or lowed. Those hearings goals made the of the like. Id. The statute explicit makes proposed the pellucid: statute the protec- that nothing the above-quoted language privacy interests, tion of the safeguarding should be “prohibit collection, read to patient health, of and cost containment. use, transfer, sale patient of pres- and Testimony taken at the hearings indicated criber code, de-identified data zip geo- that the of last these was the bill’s driver. graphic region, or medical specialty for course, commercial purposes.” due proposed Id. passed bill Last —but chambers, surely both signed by provides was least—it gover- both criminal nor, penalties and and civil 30, took effect on June 2006. In violations. Id. 318:55, §§ part relevant it provides: 358-A:6. Records prescription relative to informa- III. THE LITIGATION
tion containing patient-identifiable and prescriber-identifiable shall not be Within a month of the effective date of transferred, licensed, used, or sold the Prescription Law, Information any pharmacy benefits manager, insur- initiated this constitutional chal- ance company, electronic transmission lenge. They filed a civil action in the intermediary, retail, order, mail or In- United States District Court for the Dis- enjoined its and tion Law unconstitutional naming the Attor- Hampshire, trict of New The court did Id. capacity as the enforcement. in her official ney General in- declaratory and other constitution- plaintiffs’ not reach the seeking and defendant alleged complaint challenges. al junctive relief. Their use transfer and statutory ban on timely appeal followed. issues This information prescriber-identifiable of novo review. See Bose engender de raised of Speech Free Clause transgressed Union, 485, 466 U.S. v. Consumers Corp. Amendment, vague- was void First (1984); 1949, L.Ed.2d 502 104 S.Ct. Clause. ness, the Commerce and offended Phoenix, Inc., 456 F.3d Mandel v. Boston discovery and a expedited period A Cir.2006). (1st 198, 209 The district trial ensued.
four-day bench under advisement the matter court took STANDING IV. re- thoughtful subsequently wrote every “Standing is a threshold issue Pre- in which it concluded script Delahanty, Berner federal case.” regulated Law Information scription (1st Cir.1997). It direct- bears F.3d Op., 490 conduct. D. Ct. speech, not adjudicate ly upon power a court’s ap- Accordingly, at 174-75. F.Supp.2d Consequently, we first ad- dispute. Id. test constitutional plied the conventional issue that standing dress an issue —an whether speech, inquiring for commercial of the conduct upon the nature touches (i) govern- supported law substantial point focal serve our should (ii) interest, directly advanced ment inquiry. (iii) than interest, was extensive more Id. at to serve interest. necessary sought improve Hampshire has New & Elec. (citing Cent. Gas Hudson between detail- quality interactions Comm’n, Corp. v. Pub. Serv. by regulating upstream physicians ers and (1980)). 65 L.Ed.2d prescriber-identifiable in- transactions between data miners those formation governmen- The district court found information to use in put would who support tal interests advanced *7 detailing. The directs our attention state 178-81 & n. 13. insufficient. Id. at law transactions, prohibited upstream to these to cost contain- specific reference With comprise the relevant claiming they ment, that the state the court maintained plain- present purposes. conduct for non- substituting prove failed to had demur, that the relevant positing tiffs con- generic drugs for brand- bioequivalent of the downstream inter- composed duct is generally would be advanta- name physicians detailers and actions between at patients’ health. Id. 180-81. geous to interactions that because is those court also said cost containment to affect. The legislature intended district of the satisfy prong the third could not point. on this court sided with many oth- Hudson test so because Central Op., F.Supp.2d 490 See D. Ct. curtailing regulatory options existed er would involve re- detailing of which —none three sets of The record reveals id. at 181-83 speech. See strictions here. transactions are interwoven These education, gift continuing (listing medical (i) acquisition the data miners’ of include bans, of the state’s possible revisions phar- prescriber-specific information program). Medicaid (ii) others; miners’ the data macies and (now processed) end, of that declared the rele- sale information In the the court companies for use de- Informa- of the portions vant
49 (transfers tailing purposes other are assert rights base). of their customer (iii) exempted); and the use of that infor- We think so concluding the court by pharmaceutical mation company detail- sight lost of jus narrowness promote particular ers to products phy- tertii exception. I, See Sprits Wine & 418 Hampshire sicians. New regulate chose to F.3d at 49 (characterizing the exception as first and second of these transactional “isthmian” refusing to allow franchisor subsets, not model, the third. Given this to assert First Amendment rights of fran- basic of principles jurisprudence standing chisees).
help us to
preliminary
resolve this
dispute.
The exception is
practical
rooted in
party ordinarily
no standing
has
“A
it,
considerations. Under
litigant
will be
to assert
the First
rights
Amendment
of permitted to raise a third party’s rights
parties.”
third
Retailers,
Wine & Spirits
only when three criteria are met: the third
(Wine
Inc. v.
I),
Rhode Island
Spirits
&
party has suffered a constitutional injury
(1st
36,
Cir.2005);
418 F.3d
49
accord Eu
fact,
litigant
enjoys a close relation
Educ.,
litt ex rel Eulitt v. Me. Dep’t
386
ship with
party,
the third
and an obstacle
(1st
Cir.2004).
F.3d
351
pharma
No
exists to the
party
third
assertion
his or
detailer,
ceutical company,
physician
or
rights.
her own
Ohio,
See
v.
499
Powers
party
in this case.4 It follows that unless
400, 410-11,
U.S.
111 S.Ct.
113
they can
within
exception
come
some
(1991)
L.Ed.2d 411
(citing Craig, 429 U.S.
general
jus
principle,
teriii
the plain
451).
lack
tiffs
standing to assert
the First
The inapplicability
rights
Amendment
of the exception
of the participants in
is evident. There is
targeted
no
downstream
indication
(third-stage) in
record that pharmaceutical
words,
companies,
teractions.
In
they
other
de-
cannot
tailers,
physicians
rights
assert the
incapa
somehow
pres-
detailers to use
ble of or inhibited from vindicating
criber-identifiable information in
their
communi
own rights.
cating
face-to-face
such
physicians,
absence
nor can
barrier,
Craig
pertain.
does not
assert
Eu
rights
physicians
See
litt,
352-53;
386 F.3d at
receive that
see
Singleton
information
also
during such inter
v.
West,
114-16,
U.S.
FCC,
actions.
Inc.
Wulff
Cf.
(10th
(1976).
Cir.1999) (consider
L.Ed.2d
F.3d
ing
commercial
rights where the
course,
Of
the Court has indicated some
plaintiff directly sought to
use
informa willingness
third-party
to relax
standing in
tion for its own marketing).
*8
the First Amendment context. See Kow
Tesmer,
the district
convinced
alski v.
125, 130,
543 U.S.
125
court that
exception
Craig
564,
(2004).
down in
laid
S.Ct.
vindication Crawford —remains 1610, 1623, 170 -, has and no court 128 S.Ct. U.S. necessary prerequisite; Raich, (2008); the hin- to write v. willingness L.Ed.2d 574 Gonzales exhibited a standing 2195, test as L.Ed.2d out of 125 162 drance element 545 S.Ct. U.S. (2005). convenience.5 See general a matter 49; I, Richard at 418 F.3d Spirits
&Wine
Facial
Fallon, Jr.,
As-Applied
H.
CONDUCT?
OR
Y. SPEECH
Party Standing,
Third
Challenges
a
requires
issue
determination
The next
(2000);
1321,
see
1359-64
Harv. L.Rev.
challenged portions
not the
of whether or
Osediacz,
(noting
n. 2
at 140
414 F.3d
also
regu-
Law
Information
...
limited relaxation
“[e]ven
a
The state offers
speech.
protected
late
controversial”). Thus,
miners
the data
prob-
nuanced
simplistic solution to this
explain
rights
their own
must assert
the law falls under
lem: it asseverates that
infringed by
oper-
rights are
how those
cover-
exception to
Amendment
First
Law.
Prescription Information
ation of the
Vopper,
age limned
Bartnicki
analysis
we restrict our
proceed,
As we
1753,
51
the First Amendment allowed absolute
illegal
conduct
merely because the conduct
prohibition
only
of the former but
allowed
initiated,
was in part
evidenced, or carried
prohibition of the latter when the discloser
out means of language,
spoken,
either
participated
had
in the interception.
Id. at written,
printed.”
or
v. Forum
Rumsfeld
529, 121
It carefully
S.Ct. 1753.
distin-
Acad. & Inst. Rights,
(FAIR),
Inc.
547
guished the situation at hand from other
47, 62,
1297,
U.S.
126 S.Ct.
164 L.Ed.2d
situations in which valid
prohibited
laws
(2006)
156
(quoting Giboney
Empire
the use
illegally
of
intercepted wire com- Storage
Co.,
490,
Ice
502,
&
336 U.S.
69
10,
munications. See id. at 527 n.
121
684,
(1949)).
various
transferred information can
not,
give
intended to
immunity
every
be barred or
independent
restricted for
possible
language.”
use of
Frohwerk v.
(licensing agreements
reasons
a prime
States,
204,
United
206,
249 U.S.
39 S.Ct.
example), they
prohibited
cannot be
mere-
(1919).
aggregating, manipulating, obscene, and transfer- lewd and profane, the libel- ring particular data for one purpose only. ous, insulting words”); and the or ‘fighting’ brings This vividly to mind Chief Justice Thompson Ctr., see also v. W. States Med. Roberts’s admonition that “it has never
been an abridgement (2002) deemed of freedom L.Ed.2d (explaining that false of speech or press to make a course of misleading speech may commercial *10 52 view, explana- natural In our the most without constitutional completely
barred
that this com-
phenomenon
for this
tion
concern).
derives from a
exceptions
of de facto
plex
speech-relat
of
species
There are other
underlying
that
laws are
felt sense
effectively
beyond
lie
regulations
ed
of the First
inoffensive to the core values
These
First Amendment.
reach of the
because
Amendment—inoffensive
trade,
in restraint of
agreements
include
and,
regulate conduct
to the
principally
see,
Eng’rs v.
Soc’y
e.g., Nat’l
of Prof.
all,
they regulate speech at
extent
679, 697-98,
States,
98
U.S.
435
United
comprises items of
putative speech
(1978);
1355,
commu
L.Ed.2d 637
55
S.Ct.
It
is this
informational value.
nugatory
see,
crimes,
e.g.,
of
in furtherance
nications
that dis-
unusual combination of features
498,
684;
69 S.Ct.
Giboney, 336 U.S.
them out-
places
these laws and
tinguishes
work
creating hostile
statements or actions
Amendment.
the ambit of the First
side
see,
environments,
City
v.
e.g., O’Rourke
of
62
Chaplinsky, 315 U.S. at
Cf.
(1st
Cir.2001);
Prov.,
735
235 F.3d
of First
(explaining inapplicability
by an em
of benefits made
and promises
fighting
words because
Amendment
see,
election,
e.g.,
during a union
ployer
value
slight
words are “of such
social
these
Co.,
Packing
v.
NLRB Gissel
step
truth that
benefit that
as a
618-20,
1918,
Neutrality, and to detailers for pharmacies to data miners Bark, Sup.Ct. Rev. That Didn’t promoting dispensation of purpose reason, the Justices have but for whatever fit expensive drugs) of brand-name within why necessary to address never deemed portions integument. challenged prohibitions or how these content-based conduct, principally regulate of the statute scru manage escape First Amendment challenged por the extent that the and to Thus, loom as tacit but tiny. these laws speech, all impinge upon tions suzerainty to the of unexplained exceptions of scant societal value. speech is Spir & the First Amendment. See Wine say challenged elements We I, at 53. its 418 F.3d princi- Information Law have labored to formulate theo- Scholars regulate provi- conduct because those pally why Amendment immuni- ries about First ability only to restrict sions serve See, e.g., M. ty exists in such cases. Neil aggregate, compile, miners to Richards, Privacy and Reconciling narrowly Data transfer information destined Amendment, view, 52 U.C.L.A. L.Rev. the First ends. In our defined commercial (2005); Sehauer, conduct, 1149, 1165-74 Frederick on the not the this is a restriction Boundaries the First Amendment: of the data miners. Wine & speech, Cf. I, Preliminary Exploration (viewing “provision Constitu- F.3d at 49 Spirts A services, Salience, including designing advertising 117 Harv. L.Rev. tional (2004). advertisements, efforts, arranging place- for their Despite these 1777-84 media, licensing the ment in various mystery. a doctrinal matter remains
53
use of trade
common
names” as conduct
plaintiffs’
The
true complaint, of
course,
words,
than
In
speech).
rather
other
is that in banning
this
this use of their
data,
drying
we risk
up
is a
situation
which information itself
for
market
their services. To that concern
commodity.
repeat:
a
we
plaintiffs,
has become
The
“the First amendment
safeguard
does not
who are
the business of harvesting,
against changes in commercial regulation
refining,
selling
and
commodity,
this
ask
previously
render
profitable informa
inus
essence to rule that because their
tion
I,
valueless.”
Spirits
Wine &
418
of,
product is information
say,
instead
beef
case,
F.3d at
48.
we
an
offered
jerky, any regulation constitutes a restric-
example of the closure of a tax loophole
tion
speech.
think
We
that such an
rendering tax-shelter
information worth
interpretation stretches the
fabric
less. See id.
It is the same here:
First
beyond any
Amendment
rational
seller of information can not be heard to
measure.
complain
speech
that its
infringed by
is
a
advance
related
two
theo-
law making
profitable
the most
use of that
why
ries as to
their
processing
information
(“The
illegal.
information
See id.
First
First,
speech.
constitutes
they analogize Amendment’s core concern is with the free
their situation to that of a newspaper, not-
of a message
transmission
or
from
idea
ing
they,
speaker
listener,
like a
not
newspaper, collect
with the speaker’s
ability
concern,
profit.”).
to turn a
public
it,
information of
analyze
Second,
they
distribute
for
fee.
Although speech, protected
not,
liken this case to those in which the Su-
implicated by
Prescription
Information
preme Court has struck down commercial Law, it
primarily
consists
of communica-
ground
restrictions on the
tions between detailers and doctors—but
speech contributes to the efficiency of the
no detailer or doctor
plaintiff
is a
here.
marketplace. The response to
Therefore,
both of
adjudication
an
of that
aspect
arguments
these
is rooted in the con-
the law
await a proper plaintiff.
must
duct/speech distinction:
the plain-
While
add, moreover,
We
that the fact that this
lip-synch
tiffs
the mantra of promoting the
can be freely
information
transferred to
information,
free
flow
the lyrics do not
anyone
non-detailing
purposes renders
fit the tune.6 The Prescription Informa-
apart
this case a world
statutes
simply
tion Law
prevent
does not
in-
have been struck
down
the interest of
formation-generating
activities.
“providing]
forum where ideas and in
plaintiffs may
gather
still
analyze
formation flourish.”
tion of (striking challenged portions of the law survive 771-73, at U.S. scrutiny. challenge advertisement of of modest level prohibiting statute down must, drugs). Speech the Free Clause under price information therefore, fail. the detailing pushed has Pharmaceutical uncharted waters. marketing into
art of AMENDMENT FIRST SCRUTINY VI. sales, maximizing drug of In the service odyssey we could end our Although as a histories prescribing use detailers here, to us that path open there is another customers targeting potential of means if the to the same distinction. Even leads tipping and as a tool precisely more treated as Prescription Information Law is in their favor. bargaining power of balance speech, it is protected a on restriction behav- such, detailing physician affects As This, then, constitutional. nonetheless physi- likelihood that increases the ior and ground for our constitutes an alternative (more the detailers’ prescribe cians will decision. Hampshire The New drugs. expensive) advantage bar- legislature found acquisi- Assuming, arguendo, (chiefly of invidious because gaining power tion, manipulation, prescriber- and sale of drug prices) inflationary impact its compass comes within the identifiable data integ- compromised that it determined Amendment, Prescription of the First decisionmaking. Conse-
rity
physician
of
Law would have to survive
Information
sought to level the
legislature
quently,
scrutiny
regulation
as a
intermediate
but,
eliminating speech
by
field not
playing
Florida Bar v.
speech.
commercial
See
rather,
ability
eliminating the detailers’
by
It, Inc.,
618, 623, 115
For
515 U.S.
Went
informational asset—
particular
to use a
(1995).
2371,
As
On behalf of the Informa- Law, tion New Hampshire cites gov- three category The first embodies evidence ernmental maintaining patient interests: showing that detailing increases the cost of prescriber privacy, protecting citizens’ prescription drugs. The second involves a health from the adverse effects of skewed showing that prescribes’ histories en- prescribing practices, and cost contain- hance detailing. the success of The final sake, simplicity’s ment. For we restrict category encompasses evidence indicating analysis our to the third of these interests. that, notwithstanding escalating these problems Fiscal have caused entire civi- costs, detailing does not contribute to im- crumble, lizations to so cost containment is proved patients’ Drawing health. these assuredly most governmental substantial inferences, the stripping state reasons that such, interest. As cost containment suf- ability detailers of the prescribes’ use fices to satisfy prong the first of the Cen- histories as a marketing tool will decrease tral Hudson test. the quantities (relatively of expensive) question
The next brand-name drugs dispensed, law di- increase the —whether rectly advances that quantities interest —is not so cut (relatively inexpensive) ge- and dried. To succeed on prong of neric drugs dispensed, and thus reduce incrementally when plaintiffs re- comes more successful costs. The contain overall positive physician-specific effects with the aid of pursued spond with evidence by prescribers’ prescribing histo- histories —is less formidable. detailing enhanced Still, noting analogies opine that the state has Dr. Avorn drew ries will ebb fol- that health care costs his- proven that detailers armed with generic increased substitution lowing enjoyed significant marketing ad- tories drugs. leverage, for brand-name in- vantage, resulting greater drugs, of brand-name creased sales unarguable: point The state’s initial correspond- costs—all with no higher detailing use pharmaceutical companies addition, ing patients. a for- benefit drugs, and promote sale brand-name *14 detailer, relying personal experi- mer on than significantly more drugs those cost ence, kinds of testified about various counterparts.7 Detailing generic their leverage prescribing that histories afford- inducing physi works: that it succeeds (e.g., ability target phy- to ed detailers of prescribe larger quantities cians to prescribing large quantities ge- sicians (even clear if the drugs brand-name seems ability in on a drugs, neric to zero not). See, is magnitude exact of that effect choices, customary physician’s prescribing Hon Manchanda & Elisabeth e.g., Puneet ability punish physicians and the to who ka, Direct-to- The and Role of Effects display allegiance particular fail to to the Pharmaceuti Physician Marketing in drugs). brand-name Each of these wit- Review, 5 Industry: integrative cal An emphasized prescribing nesses histo- Pol’y L. & Ethics Yale J. Health helped ries the detailer to become more (2005); Wazana, Ashley Physicians and presentation in her and to fo- adversarial Industry: the Pharmaceutical Is a Gift physician’s cus on the weakness of the Am. Gift?, Ever Just a 283 J. Med. Ass’n drug (2000). opposed erstwhile of choice as pharma fact that the The drug. clinical virtues of the detailed A over industry spends ceutical promotional published brochure IMS $4,000,000,000annually detailing bears many for detailers’ use corroborated efficacy. loud to its witness claims, newspa- these as did a submitted at trial testimony The adduced rein- per part legisla- article that formed of the conclusions. forced these common-sense history tive underlying the Avorn, professor Dr. Harvard Jerome Kowalczyk, Liz Information Law. See specializing pharmacoe- Medical School Drug Companies’ Reports Outrage Secret pidemiology pharmacoeconomics, de- Doctors, Globe, May Boston detailing sub- showing scribed studies Al. stantially physicians’ rates of increases drugs. This ac- prescribing brand-name plaintiffs deny pre- The did not testimony president count echoed scribing detailing histories made more effi- Hampshire president-elect of the New did, however, They try to cast cacious. Society. Medical detailing helpful as a and informative ac- view, tivity. prescribing In their histories support The evidence in of the second physi- step detailing target be- enable detailers both to progression —that course, primary targeted detailing employed situation is not the state's concern 7. Of only promote compet- the sale of brand-name differential between because cost drugs generic drugs, in lieu of but also to likely sig- ing drugs to be brand-name is less encourage prescribers particu- to choose one nificant. lar brand-name over another. The latter detailing tended dramatical- likely from an edu- effect most to benefit dans ly prescription craft market- of brand- and to to increase cational interaction (and, thus, physician’s message pre- tailored to name the cost of ing offered the testi- plaintiffs scription drugs) conferring any without practice. Wharton, a distin- mony corresponding public of Dr. Thomas health This benefit. char- cardiologist, support Avorn, guished opinion was of Dr. and Dr. detailing Dr. found acterization. Wharton Wazana’s article reached the same conclu- interactions highly Wazana, informative produce supra, sion. See at 375. The is elevat- in which “the level of discourse record contains evidence of wide- also testimony indicated that the Other ed.” chan- spread incidents'—Vioxx and calcium availability permit- histories prominent nel blockers are two exam- more physicians to inform ted detailers ples pointed in the same direction. —that Finally, negative information. quickly Finally, study the record contains a evidence anent the adduced found that 11% of statements to detailers’ identifying target- purported value physicians demonstrably were inaccurate.8 “early adopters.” ing Ziegler, Singer, P. See M.G. Lew & B.C. Accuracy Drug *15 determined that the The district court of Information Representatives, Pharmaceutical Sales cost containment interest state’s asserted (1995). 273 J. Am. Med. Ass’n 1296 satisfy prong failed to the second The court based Hudson test. Central highly suggestive the face of this on its conclusion that this determination evidentiary predicate, the district court’s reasoning final link in the chain of was prove demand that the state that the sub appears missing: General “[t]he generic drugs stitution of for brand-name health care cost sav- to assume that drugs higher would not lead to net health that from a ban on the use ings will result subjected care costs the state to a level of can be prescriber-identifiable scrutiny exacting required far more than is compromising patient achieved without speech. City Ren for commercial See Op., F.Supp.2d D. at 180. care.” Ct. Inc., Theatres, Playtime ton v. flawed, the court assumption This was (1986) 925, L.Ed.2d 29 106 S.Ct. wrote, drugs some- because brand-name (permitting city rely experiences to on better than their patients times served Amusements, localities); Nat’l different thus, counterparts; possible it was generic rely (permitting town to F.3d at 742 generic drug prescrip- that an in increase complaints, “constabulatory con residents’ care, patient en- might compromise tions incidents,” and com pattern cern with a costs, new medical and overwhelm gender sense). provided compe mon The state at any savings. Id. 180-81. increases the detailing tent evidence that drugs, that showing prescription that of brand-name Admittedly, the state’s drugs expen tend to be more pres- health care costs would lessen should brand-name sive, possession prescrib that detailers’ to detailers was criber histories be denied heightens this exorbitant ef though ing But even there histories overwhelming. not fect, many aggressively drugs detailed point, was no direct evidence on cheap- far no benefit vis-a-vis their testimony provide to present state did unrebutted study by response non-sequitur. The fact that cer- plaintiffs responded is a 8. The to this citing Drug prohibited by the federal Food and Administra- law is not a tain behavior is regulations prohibiting false medical ad- engage tion guarantee persons in it. will not § That vertisements. See 21 C.F.R. 202.1. detailing and that from the first state to refuse detailers counterparts, er generic prescribing access to histories is to de- scan- had contributed much: that simply mand too evidence does public health endangering dals both requires exist. The First Amendment against coffers. Viewed public and the states to assess their own realis- interests the fact that some de- background, tically only steps to take reasonable produce su- tailed brand-name interests; furtherance of it these discerned flimsy a cases is too perior results some require Augean does not feats in order to hang a conclusion that hook on which to regulations restricting sustain commercial prescription of brand-name decrease speech. yield a net unlikely to drugs would be costs. diminution in health care While The short of the matter is while ironclad, the district
state’s
is not
position
legislature
state
does not have unfettered
of a far
objection
partakes
court’s
truthful,
suppress
discretion “to
nonmis-
conjecture.
greater degree of
leading
paternalistic purposes,”
information for
at
Liquormart, 517 U.S.
is more a mat-
analysis,
In the last
this
there is in this area “some
prediction.
Just as
policy
ter of
than of
legislative judg
room for the exercise of
drugs produce superior
some brand-name
ment,”
id.
relative to the law’s effect on net health
We legitimate regulatory goals merely because all, degree. ter deference is matter objector an can hypothesize alternative Here, we to the Hampshire defer New efficacy measures doubtful that would legislature only question on the narrow leave unencumbered. it (hypo- whether is sensible to conclude instance, In this thetically) outlays that net medical the district court seems will to have decrease as a result of the withdrawal of overestimated the extent to which geared histories from detailers. Giv- alternatives described were record, legislative accomplish objective. en the contents of the the state’s we believe that deference is order. Information Law was a tar- geted legislative response particular to a probe point We need not more problem proven that had resistant to a end, deeply. we conclude that the number of different regulatory ap- adequately state demonstrated that proaches. The three measures embraced Prescription Information Law is reason- by the district court improvement were no ably calculated to advance its substantial on those ineffectual approaches. reducing interest overall health care Hampshire. costs within New The first of the measures comprises a This leaves the third Central Hudson gifts ban on between physi- detailers and question: regulation whether is no cians. Such a measure target would *17 necessary more extensive than to serve the legislature harm that never deemed state’s interest cost containment. The central to its aims. Some studies do indi- Supreme explained Court has this cate that detailers’ gifts pre- influence requires standard “in restriction to be behavior, scribing but the Hampshire New proportion reasonable to the interest only legislature gift-giving saw such Edenfield, served.” U.S. 113 pernicious when it occurred within the recently, S.Ct. 1792. More ap- Court context of a high-intensity pitch sales plied gloss, stating a that “if the Govern- possible by possession made a detailer’s ment could achieve its interests a man- physician’s history. a prescribing More- speech, ner that does not restrict or that over, such a ban would have unintended speech, restricts less the Government must consequences; necessarily it would cut off Thompson, do so.” samples physicians the flow of free S.Ct. 1497. dispense receive from detailers and often Invoking indigent patients. to Thompson, Hampshire the district court New was Hampshire’s goal constitutionally attempt reg- concluded that New entitled to to cost containment could have detailing killing golden been achieved ulate without measures, by three goose. alternative none of an comprises patient’s symp- envi- attend to the individual
The second measure toms, a ac- physicians diagnosis, prescribe educate to make campaign to sioned possible. cordingly. Detailing provably phy- skews drugs whenever prescribe generic prescribing as a matter sicians toward more brand- suggested measure fails This drugs by highlighting strengths com- name simple Pharmaceutical economics. $4,000,000,000per year drugs pa- brand-name unrelated to the panies spend over marketing jug- Inserting condition. one Against that tient’s individual detailing. step would need to commit more laborious into the decisionmak- gernaut, the state put ing process may physicians pre- to across a con- incline to enormous resources ground scribe fewer brand-name and more trary message. It is not speech regula- generic drugs; nothing a commercial but it will do striking down distorting cam- correct for or efface the factors tion that some counter-informational cost, physician’s might previously restore introduced into paign, regardless of Hampshire prescribing habits. The New equilibrium marketplace to the of ideas. legislature Prescription Infor- enacted de P.R. Assocs. v. Tourism See Posadas only Co, mation Law not to lower costs but (1986). prevent exerting also to detailers from so L.Ed.2d 266 physicians’ prescrib- much influence over hinges The third measure on the ing habits. thought that it would be workable for New sum, plain- we find that neither the Hampshire program to retool its Medicaid nor the district court has identified an tiffs non-preferred drugs so that as ex- —such Prescription alternative to the Information pensive drugs for which non- brand-name promises goals Law that to achieve the bioequivalent generic substitutes exist— restricting speech. the law without Conse- only dispensed upon physician’s would quently, Prescription we hold that the In- D. pharmacist. consultation with See Ct. formation Law is no more restrictive than This Op., F.Supp.2d suggested at 182. necessary accomplish goals. those in- impracticability, measure fails for coming too completeness, and for late inqui- That ends our First Amendment prescription process. Implementing above, ry. For the reasons elucidated we day out of a would take extra time doctor’s challenged portions hold that and, events, in all make no would inroads Law Information survive the patients. respect privately insured Thus, rigors scrutiny. of intermediate finally, represents And this third measure if provisions even one assumes that those remedy attempt compro- a crude implicate to some extent commercial physicians mised habits of af- speech, they do not violate the First explain briefly. ter the fact. We *18 Amendment. Physicians prescribe medications for in- VII. VOID FOR VAGUENESS dividuals on basis of a multitude of generic A drug' Terming factors. or not numerous undefined words —-whether bioequivalent rarely capable phrases Prescription of Information —will being recommended amorphous ambiguous, plain- across board as a Law drug for a substitute brand-name because tiffs contend that' the statute is unconstitu- subtly each tionally vague.9 offers different situation- This contention need not advantages. specific physician The must detain us. plaintiffs passing Prescription
9. The mention that the Information Law is overbroad
61
statutory text is set out
pertinent
Hosp.,
Carlisle v. Frisbie Mem.
152 N.H.
II,
opinion,
supra
762,
405,
(N.H.2005).
in this
see
Part
earlier
A.2d
888
417
Consis-
purpose
and it would serve no useful
tent
that approach,
inquiring
an
court
say
It
repastinate
ground.
suffices to
“presume any
should not hesitate to
nar-
question virtually every-
rowing
practice
construction or
to which
thing
soup
meaning
to nuts-from the
fairly susceptible.”
the law is
City of
adjective
scope
of the
“identifiable” to the
Co.,
Lakewood v. Plain Dealer Publ’g
486
phrase
purpose.”
of
“commercial
750,
11,
2138,
770 n.
108 S.Ct.
100
They allege
pervasive imprecision
(1988) (internal
that this
L.Ed.2d 771
quotation
speech (especially since vi-
protected
chills
omitted);
Carhart,
marks
Stenberg
see
may trigger
olations of the statute
both
914, 944-45,
2597,
530 U.S.
147
penalties).
criminal and civil
See Reno v.
(2000);
Realtors,
L.Ed.2d 743
R.I. Ass’n of
ACLU,
2329,
Whitehouse,
(1st
26,
Inc. v.
199 F.3d
(1997).
Cir.1999).
pedantry, and the fact that a statute re- legislature’s avowed intent was to curtail quires interpretation per- some does not in New Hampshire what it viewed as the unconstitutionally vague. force render pernicious practice targeted detailing by Auth., Ridley Bay Transp. See v. Mass. pharmaceutical companies. sought It (1st Cir.2004). 390 F.3d That is the by prohibiting do so “for commercial case here. purpose” the dissemination and use of the may interpret
A federal court
state
data on
targeting
which
had come to de
by using
ap
law
the same method and
pend:
prescriber
keeping
histories.
proach
highest
that the state’s
court would
purpose,
with this narrow
the statute ex
Pharms.,
use.
Nat’l
Inc. v.
See
Feliciano-
coverage
every
cludes from its
almost
com
(1st
de-Melecio,
221 F.3d
241-42
Cir.
detailing;
mercial use other than
the listed
2000); see also Planned Parenthood
exemptions
“pharmacy
include
reimburse
Idaho,
Wasden,
Inc. v.
ment;
376 F.3d
formulary compliance; care man
(9th Cir.2004) (“Ordinarily, in
construing
agement;
utilization review
a health
statute,
state
we follow the state’s rules of
care provider,
patient’s
pro
insurance
statutory interpretation.”).
either;
agent
vider or the
health care
provided
research or as otherwise
law.”
law,
Hampshire
Under New
an in
§Ann.
N.H.Rev.Stat.
318:47-f.
quiring
court
legislative
consider
his
tory
clarifying
ambiguous
to aid in
an
position,
stat
As we understand the state’s
Aero.,
Hughes
categories
exceptions
ute.
v. N.H. Div.
these
to be
(N.H.2005).
N.H.
broadly
impinging upon
871 A.2d
construed
to avoid
objective
“in light
prescriber-identifiable
construe a statute
uses of
data that do
[it],
legislature’s
enacting
intent in
implicate
state’s core concern.
*19
in light
policy sought
example,
explic-
of the
to be For
General
statutory
itly
advanced
the entire
acknowledged
scheme.”
the court below that
Zannino,
they
develop
argu-
but
do
an
overbreadth
waived. See United States v.
is,
therefore,
1,
(1st Cir.1990).
Any
argument
ment.
such
F.2d
through
marketing
than
need
Information Law does not
other
direct
Prescription
selling prescriber-
activity
that
will
from
not be concerned
their
plaintiffs
bar the
pharmaceutical compa- offend the statute.
identifiable data to
recruiting physi-
nies for research or
reading
Prescription
This
narrow
of
participate
to
in clinical trials
cians
similarly
allay
Information Law
serves to
drugs.
that un-
newly developed
Given
pharmacies
and other
concerns
derstanding,
the fact
that data derived
subject
preseriber
sources of
data will be
later
be
from such research or trials
prosecution
improper
based on some
general marketing
companies’
used
long
downstream use of that data. As
uses into
permitted
cannot transform
impose
such entities
conditions on the
impermissible purpose.
ones that have an
require purchas-
data that
transfer
such
all, marketing and sales are the ulti-
After
law,
comply
ers to
with the terms of the
virtually
all research
purposes
mate
Thus,
request-
are safe.
when data is
by pharmaceutical companies.
done
As
myriad
ed for one of the
uses that are
long
companies
as the
do not undertake
permissible
Prescription
under the
Infor-
targeted detailing
Hampshire-
of New
Law,
chilling
mation
there should be no
trial participants
based clinical
—whose
effect.10
prescribing data was obtained for research
reasons,
reject
plain-
For these
we
purposes
is no violation of the Pre-
—there
tiffs’ contention that
the law is void for
scription Information Law.
vagueness.
this construction of
recognize
We
Prescription
Information Law is not VIII. DORMANT
COMMERCE
challenge,
inevitable. But this is a facial
CLAUSE
purpose
and the state’s articulated
nar-
Finally,
a
mount
Com-
interpretive
through
rows the
lens
which
challenge
Prescription
merce Clause
to the
problem.
we must view the
See Davis v.
They
Information Law.
maintain that the
FEC, -U.S.-,
128 S.Ct.
2770-
by regu-
statute violates the Constitution
(2008)
(noting
171 L.Ed.2d
that in
lating
wholly
Hamp-
conduct
outside New
challenges
facial
courts should
“extend[ ]
argument
unavailing.
shire. This
judgment
measure of deference to the
law”);
body
Clause,
legislative
ostensibly
enacted the
The Commerce
Grange v.
an
Repub.
grant
power Congress
Wash. State
Wash. State
affirmative
— U.S.-,
Party,
regulate
among
Commerce ...
“[t]o
Const,
(2008)
states,”
(explaining
§
63
(distinguishing
as-applied
Commerce
facial and
so-called “dormant
Com
der
scope
law),
depends upon
challenges
merce Clause
to federal
Clause”
—
denied,
U.S.-,
A
1738,
See id.
law
challenged statute.
cert.
(2008).
occurring
regulate
conduct
purports
wholly Hampshire). outside New So enacting the borders of the state. See K would, preted, among the statute other Pharms., S Inc. v. Am. Home Prods. from a things, prohibit the transfer of data (7th 728, Cir.1992); Corp., 962 F.2d 730 in, pharmacy manager benefits located McGlone, 448, N.H. State v. 96 78 A.2d say, Verispan, New York to a Delaware (N.H.1951). Second, 530 statutes Pennsylvania. firm headquartered Such given opposed should be a constitutional as regulation a direct of out-of-state transac- interpreta to an unconstitutional arguably assert, would, per se tions fairly possible. tion whenever See Arizo invalid under the dormant Commerce Arizona, English v. 520 nans for Official Mfrs., Auto. Clause. See Alliance 430 137 L.Ed.2d F.3d at 35. Nascimento, (1997); 38; 491 F.3d at part, urges For its the state us to inter- State, v. 110 N.H. see also Sibson pret governing only the law in-state (N.H.1969) (explaining that A.2d already transactions. As we have ex- to avoid a “a statute will be construed normally plained, federal court should rights conflict with constitutional whenever interpret using state law the same method reasonably possible”). course approach highest court of the Pharms., state would use. Nat’l See Here, Hampshire Attor the New at 241-42. F.3d ney charged General —the state official enforcing An its laws—has exhorted us to assertion that the Commerce with Law particular statutory Information Clause invalidates read only activity place takes presents challenge scheme a facial to that “relate domestically.” Appellant’s Reply Br. at generally statute. See United States (1st Cir.2007) Nascimento, narrowing is reason- 491 F.3d 13. This construction *21 tenet that laws it can aggregated accords with the where then be and sold able and to have extraterri presumed should not be legally others, may to not accomplish very any avoids torial effect. It also doubt much.11 But that does not make the At- constitutionality about law’s under the the torney interpretation General’s unreason- As the dormant Commerce Clause. Sev McGuire, 58; able. See 386 F.3d at In re wisely enth observed when con Circuit Morgan, A.2d at 109. There is no rule lacking fronted with a similar state statute legislature enacting forbids restriction, any geographic built-in prophylactic legislation prevent disfa- no to read the would make sense statute activity engage vored before individuals regulate out-of-state transactions when the activity. upshot doing so would be to annul the Pharms., statute. See K-S 962 F.2d IX. CONCLUSION go We need no further. For the reasons point. There is no need to belabor the above, elucidated we reverse the decision Hampshire We are confident that the New injunc- of the district court and vacate the Supreme interpret Court would the Pre- against tion enforcement of Prescrip- scription only Information Law to affect tion Information Law. light, domestic transactions. Seen this Reversed. plaintiffs’ dormant Commerce Clause challenge necessarily fails. This law LIPEZ, Judge, concurring Circuit profit result in a loss of to out-of-state data dissenting. closing aspect miners due to the of one Hampshire the New market their Although agree I majority with the wares, but that circumstance amounts nei- stand, the district court’s decision cannot regulating ther conduct outside the respectfully disagree majority’s with the “necessarily requiring] state nor to out-of- refusal to address First Amendment state commerce to be conducted according issue at majori- the core of this case. The II, Spirits in-state terms.” &Wine 481 ty focuses on the upstream so-called trans- F.3d at 15. acquisition, actions—the aggregation, and dissenting We add a coda. Our brother prescriber-identifiable sale of that, face, concedes the Attorney its activity concludes such —and General’s interpretation Prescrip- of the is not within purview of the tion Information Law obviates Com- First Amendment. That conclusion is self- merce problem. Clause He nevertheless point. evident and beside the In enacting suggests that interpretation leaves Prescription Information Confidentiali- is, the Act with “negligible impact” and (“the ty Act Prescription Act” or “the therefore, unreasonable. We fail to see Act”),12 Hampshire the New Legislature logic suggestion. regulate upstream chose to transac- sure, tions
To because it wanted to plau- General’s alter the mes- interpretation sage by pharmaceutical sible used In- detailers Law, permits formation which pursuing the routine downstream transaction with transfer of data to out-of-state professionals. words, facilities health care In other remains, however, question legislation 11. The whether 12. The did not include a formal purchasers statute; subsequently could adopted make use title for the I have a formula- aggregated data in Hampshire. New tion that blends the district court’s and the question That is not before parties' usage. us. *22 doctors, speech limit the cations between detailers and designed to the Act was majority justifica- The relies on accept those detailers. but also State’s standing to avoid doctrine of prudential allowing tion for the restriction without limitation violates deciding whether plaintiffs to establish the First view, my In Amendment. the First majori- Amendment values at stake. The unwise, unsup- and avoidance is wasteful ty’s standing principles use of is thus standing, and ana- ported by principles doubly wrong.
lytically flawed. A. The Prudential Policies of Third the issue
Consequently,
examining
after
Party Standing
I
the issue that we
standing,
address
the Act re-
addressing
should be
—whether
Boren,
190,
In Craig v.
429 U.S.
97 S.Ct.
speech
commercial
be-
protected
stricts
451,
(1976),
Supreme
In such a decision us doctors. But here the First Amendment forgo to consideration of the constitu- by issues raised exchanges between to tional merits order await the initi- physicians detailers and explored were ex- challenge ation of a new to the statute haustively. by injured parties imper- third would be
missibly
repetitive
to foster
and time- Moreover, the district court expressly
consuming litigation under the guise of
confronted the question
third-party
Moreover,
prudence.
caution and
inso-
standing before proceeding with the case.
far
applicable
as the
constitutional ques-
that,
parties
The court told the
if the State
pre-
tions have been and continue to be
sought to invoke standing as a barrier to
vigorously
“cogently,”
sented
and
action,
full resolution of the
stay
it would
jus
denial
standing
tertii
in deference
thirty days
the case for
to allow interven-
to a direct class suit can
no func-
serve
by
pharmaceutical
tion
company. The
purpose.
tional
explained:
court
(citation
193-94,
Id. at
Thus, third-party on standing. If I Craig, only as in prudential think there’s issue, issue with standing here, too, third-party doctrine is at standing, if plaintiff it, asked for I pragmatic paramount. considerations are give will days them 30 to amend to bring district court heard evidence from in a plaintiff new pharmacy company, about a dozen witnesses and considered which case it seems to me the voluminous third- other materials in preparing party standing argument disappears. thoughtful its comprehensive decision. Nothing in the extensive record even hints I didn’t think going we were to be were unable or unwilling talking about third-party standing today, protection whom the constitutional in the briefs really raised it’s
since
that,
aimed,
abstract, gener-
claim not be an
press
you
But if
want
now.
way.
it that
that the courts are neither
grievance
to deal with
alized
we’ll have
think
adjudi-
nor well
equipped
well
advised
added.)
Attorney General
(Emphasis
Joseph
Md.
H.
Sec’y
cate.”
State
press
that “we don’t intend
then said
Co.,
5,n.
Munson
467 U.S.
The issue was not
this time.”
that at
(1984);
This case illustrates the importance plaintiffs’ must consider the First Amend- pragmatism. reject There is no reason ment contentions before concluding that the district court’s proceed decision to upstream information “exchanges” that a pharmaceutical company without as a make speech possible worthy are not plaintiff unless that decision would result protection. First Amendment “generalized a trial of the grievance that equipped courts are neither well nor inconsistency This pervades majori- Munson, adjudicate,” well advised to ty’s decision. making judgments After 5, 104 U.S. at 955 n. reality S.Ct. 2839. The about the nature of the detailing transac- is that the court parties and the have tion and how increases the likelihood time, expended substantial resources and physicians prescribe will expen- more energy to address comprehensively the sive drugs, the majority asserts that “the First Amendment issue the heart of this legislature sought to playing level the field case. That issue vigorously has been tried *25 by eliminating but, rather, not speech by thoughtfully adjudicated. Given our eliminating the ability detailers’ a use authority to review the judg court’s entire particular informational prescribing asset — ment, it is imprudent to avoid that issue. particular histories —in a way.” (Empha- added.) sis majority Here the is charac- B. The Unavoidable Issue terizing speech the suppos- interest that is majority’s analysis The yet an- reveals edly beyond scope the opinion, of its why other reason its standing reliance on characterizing incorrectly. it very The is inappropriate. In the first of its part elimination of ability the detailers’ to use analysis, majority the finds no constitution- particular “a informational asset” restricts al in the flaw Act’s restriction on “certain message the they are allowed to dissemi- exchanges” information because those nate and implicates the free speech con- “are ... transfers the sorts ex- cerns of the First Amendment. changes by valued Supreme the Court’s First Amendment jurisprudence.” How- Moreover, in discussing its alternative ever, conclusion, to reach that majority the holding, which plaintiffs’ treats the up- considers the societal particu- benefits of a stream speech subject transactions as lar form of detailing very speech that —the the First Amendment rather than con- it beyond claims is scope the appeal. duct,14 majority the weighs the value of
My colleagues detailing, data, insist that regulated the limited based the scope of against review prevent Legislature’s “does not policy objectives consid- eration of New Hampshire’s and the interest harms identified govern- combating I detailing.” do not Again, understand ment. majority’s conclusion how the majority can it ways. have both the Act does not violate the First If constitutionality impact of the Act’s Amendment rests on a judgment about the majority actually never pharmacies identifies to data miners and from data specific speech component acquisition, of the miners to companies. aggregation and sale of information majority As the dis- major- tailers and doctors. detailing speech i.e., —that — covered, analysis. impossible it is to assess the con- off limits for
ity place purports stitutionality factoring to “sub- Act without majority points example, the For objective to Legislature’s specific in the record in the stantial evidence” speech limit the of the detailers. instances, detailers that, in several histories encour- with armed Moreover, there is no reason to think prescription aged the overzealous majority’s judgments about the drugs regard- costly brand-name more in a case change statute would where health conse- public both the less of plaintiff. pharmaceutical company was outcome of probable and the quences All of the relevant considerations were ex- By con- analysis. sensible cost/benefit They the district court. have plored trast, no evidence contains the record majority’s in the similarly explored been detailing, physi- that in the absence majority could not analysis because the generic prescribe have tended to cians upstream characterize the transactions pa- than their more often either merely making judgments conduct without patients’ pocket- their health or tients’ of the “downstream” about the value books warranted. and the doc- the detailers between ultimately concludes majority tors. demonstrated adequately “the state Thus, liti- practicalities both the of this Law is rea- Prescription Information gation and the nature of the First Amend- to advance its substan- sonably calculated ana- require ment that the case be issue health care reducing overall tial interest it and the district lyzed parties as the tried Hampshire.” costs within New proceed court decided it. therefore says Thus, majority does what my will analysis. Although discussion it evaluates doctrine forbids: standing *26 majority’s, the I have overlap at times on the impact on the law’s Act based of the present my complete view chosen prescribers. and speech between detailers governing law. The First record and the hardly surpris- majority’s approach is The impor- here is both question Amendment the Act’s speech that this was ing given close, fully explain and I wish to tant and majori- the surprising is is target. What end, I conclude that the dis- why, in the that reliance on ty’s appreciate failure to Prescrip- declaring in trict court erred where, misplaced is as standing principles tion Act unconstitutional. here, majority seeks to the issue that the ostensibly Although unavoidable. avoid is II. inquiry to limiting its First Amendment background of this recounting acquisi- transactions —the upstream case, heavily comprehensive I draw on the tion, prescriber- and sale of aggregation, of the facts set thoughtful recitation pri- in its and deciding identifiable data —and court. See IMS Health by in- out the district transactions mary holding that these 163, 165-74 F.Supp.2d Ayotte, Inc. v. 490 majority makes only, conduct volve (D.N.H.2007). largely un- value, Those facts are nature, judgments about the primarily contest parties disputed; occurs in of the consequences legal significance.15 their between de- the downstream transactions typically apply the de novo standard argue er than appellees that we should 15. The cases, see Bose applies in Amendment First error standard in review- the deferential clear 485, 514, Union, court, Corp. v. Consumers ing by the district rath- the facts found 70
A. Pharmaceutical companies tout the Sales Market- prod- virtues their in ucts television commercials and other
ing
media, typically urging
consumers
ask
prescriptions
More than three billion
are
their doctors for the
drugs.
advertised
year by
written each
doctors
other
However, the bulk of
drug companies’
licensed health
professionals, covering
care
promotional efforts
directly
are aimed
8,000
approximately
pharmaceuti-
different
physicians
prescribers.17
and other
products.
cal
prescriptions
These
are
primary method for
promotion
such
is de-
54,000
filled
approximately
phar-
retail
tailing,
usually
which
accompanied
is
macies;
2004,
in
such retail prescription
provision
drug samples
free
sales totaled
billion.16 In an effort to
$168
prescribers can
patients.18
distribute to
increase and protect
their share of this As inducements to increase their access to
market,
vast
pharmaceutical companies en- physicians who are sometimes reluctant to
in
gage
promotional
various
activities.
them,
meet with
detailers also frequently
public
familiar
most
with direct-to-
offer free meals and
gifts
other
to the
consumer
in
advertising,
which
drug
doctors and their staffs. As I shall ex-
(1984),
patients otherwise not have received. The cost of the samples 2. distributed annual- Samples and Other Perks ly by pharmaceutical representatives has samples Free courtesy gifts and rou- are been estimated at more than billion.22 $11 tinely given by part detailers as of their It visits, only is not patients sales they and who important are benefit tools in from drug companies’ largess, marketing. rely howev- Doctors Physicians er. receiving drug and other samples they can medical office staff patients distribute to members frequently who “good are unable to receive will” gifts afford high detailers, cost of some including medications.21 office Keeping supplies, meals, office open doors free en- and detailers conference travel sures that the will funding perks doctors have a contin- that are designed to en- — ued supply samples, courage and long-term some physi- with, relationships and cians are therefore reluctant loyalty toward, to restrict the detailers.23 Studies detailing. Even when drug cost is not an have shown that these sorts of gifts can During legislative process leading 21. management ol center testified at commit- statute, adoption president of the of the hearing tee Hampshire on the New law that New Hampshire Society, Medical Sa- Marc drug representative one bring offered to cof- dowsky, importance noted the samples of the bagels fee and every Tuesday the center " psychiatric practice: his exchange for prescriptions every 'two ” of the prescribe Some I medicines $8 a are Legislative (hereinaf- week.’ History, at 41 pill, pill. $8-10 patients I have are who Hist.) Legis. ter (testimony Carolyn Fi- stable on these medicines and then nocchiaro). job, lose their qualify don't for insur- A similar ance anecdote was carrying and I am described a in 2006 keep them to them is, York stable. That New Times giving I’m samples. them article that also I was includ- sign have to samples every Legislative for the ed get in the History. I in, time The article re- So, them. drug when reps ported come I that a manager district pharma- for a So, have to talk to them.... think company ceutical sent an e-mail to detailers kind important of an thing because these stating: people medicines can cost thousands of dol- goal "Our scripts is 50 or more per week year lars good and I have a number of territory. for each you If achieving citizens of New Hampshire giving that I am goal, yourself this ask if those doctors that samples free to.... you great have such relationships with are being you. fair to Hold them 22. accountable parties’ Second Stipu- Amended Joint time, lunches, all samples, lation ("Stipulation Facts") of Facts din- used ners, programs figure; past Family [consulting Kaiser ar- re- Foundation ported rangements] provided retail samples you value of have paid provided in 2004 get $15.9 was See billion. business!! You can do it!!" Indicators, Trends supra, Pear, Gardiner Harris & Robert Drug Maker's *29 Compete to in Lucrative Insulin Market Efforts example, As an a nurse-practitioner who 23. Times, are Scrutiny, Under N.Y. Jan. 2006. was the director a hospital-based of cholester- (citations omit- and, at 168-69 F.Supp.2d physicians,24 on effect have a subtle ted).25 to the are unrelated they typically because care, they have come of medical
provision Profiles Mining and Prescriber Data 3. consumer fire both particular under them- medical offices professionals enter and medical detailers advocates When and they equipped Research are products, Pharmaceutical market their selves. (“PhRMA”) in about America information only of not with detailed Manufacturers voluntary governing code attempting to sell but adopted they professionals knowledge health care about considerable interactions with also with prescriber inducements discourages such of their audience. Much supplied by information is provid- of is the value what either unless a crucial play who (less $100) companies, and and similar than ed is insubstantial in the flirtation be- role behind-the-scenes for the ben- primarily is the inducement representa- sales pharmaceutical in- tween the value of or patients, efit so-called These prescribers.26 and induce- tives minimal and is ducement orga- and companies collect mining” “data provider’s to the directly related isment and their information about doctors nize an occasional example, For practice. informa- converting patterns, under stethoscope acceptable gift of “thousands of sources” from gleaned tion to be it is not deemed the Code because pharma- which the commodity for into a benefits gift and the value of substantial sums.27 industry pays substantial ceutical contrast, unrestricted In an patients. entities, and other pharmacies retail may From to a local bookstore gift certificate insurers, data as acquire such regard- under the Code not be offered conduct, of the business part it does because value less its every phar- on miners obtain information to the and is unrelated patients benefit form, sale, including the The maceutical practice. professional’s health care drug, of the dosage and strength with re- distinctions similar Code draws and ad- and the name dispensed, amount and entertainment. spect to meals Stanford, on announced restrictions physicians and have Although show that studies 24. their staff gift- interactions between gifts toward and other "mostly negative” attitude have a industry. gifts report pharmaceutical that such also and the ing, the studies members Maine, among physi- states, feelings and reciprocal including Vermont "induce Some Honka, J. 5 Yale Minnesota, prohibit- & cians.” passed Manchanda laws have either 809; Ethics, also see L. & Pol’y, companies Health from ing gifts to doctors Loewenstein, A Social George Id.; & Jason Dana Me. gifts. see requiring disclosure Physicians on Perspective (dis- Science (2004) § Gifts tit. 2698-A Rev.Stat. Ann. 252, 252-54 Industry, J. Am. Med. Ass’n (1994) closure); (prohi- § 151.461 Minn.Stat. 9, 2003). (July (2007) § bition); tit. Vt. Ann. Stat. (disclosure). advocacy a health care consumer 25. Boston, Catalyst, Community group based plain- Facts states Stipulation of 26. The Profession, as a on Medicine and the Institute "are Verispan LLC and Inc. tiffs IMS Health University, an- at Columbia group a research information, leading providers the world's calling re- campaign nounced national pharmaceutical analysis and research doctors the interaction between strictions industries.” and healthcare Stephanie companies. pharmaceutical Saul, Drug A Move to Makers: Doctors Facts, these According Stipulation of Times, Ties, Cozy Feb. N.Y. End wholesalers, centers, are: including sources medical A CIO. number hospitals clinics. physicians, Yale, pharmacies, Pennsylvania University those at *30 prescriber. dress of the The information obtained shortly detailing after visits to identifying includes an code for each pa- assess whether the sales calls had an effect tient, although the patient is not personally on targeted prescribers’ drug choices. sources, identified. From other including The compensation detailer’s is sometimes Association, Medical American tied to the success of his or her efforts. plaintiffs obtain information about individ- This use prescriber-identified prescribers ual and their specialities.28 has sharp drawn fronts, criticism many on The data mining companies weave the including among physicians object who together information produce, to among both to the disclosure of information they databases, other “prescriber profiles”—in- deem confidential and to the hard-sell mes- reports dividualized on prescriptions sages by delivered detailers who being by particular written doctors. The know more about their prescribing information is then sold to habits parties third uses, various than do the including commercial doctors phar- themselves. maceutical marketing, and also provided AMA responded to the concerns at no charge nonprofit purposes, such initiating the Prescribing Data Restriction as academic and medical research.29 The Program (“PDRP”), which physi- allows data provide a historical of a physi- view cians to restrict access to their prescribing cian’s prescribing practices, allowing the data by pharmaceutical detailers. The pharmaceutical companies identify to doc- AMA also developed guidelines for the use tors who displayed willingness have to of prescribing data “to provide ethical try (the products new “early adopters”) guidance to the industry.” healthcare and to target drug doctors whose choices guidelines urge that companies, alia, inter they seek to change. knowledge With “[cjontinually reinforce pre- that use of the physicians’ prescribing history, the de- scribing data overtly to pressure or coerce tailers are able to tailor messages their physicians prescribe particular drug is those specific doctors’ circumstances —for absolutely an inappropriate use.” Neither example, emphasizing potential side the PDRP guidelines nor quelled have effects of a competitor’s prod- brand-name the concerns. The PDRP has been criti- uct that the detailer knows doctor has cized prescriber because information will been using, or highlighting the advantages only withheld if affirmatively doctors of the detailers’ branded drug over the out, opt opt-out and the choice must be generic alternative the doctor routinely every renewed years. three prescribes. Voluntary The detailer’s verbal message guidelines are seen favor of insufficient brand-name to offset may be furthered provision commercial free incentives samples to use the infor- medication, mation. encouraging states, what Some is ini- like New Hamp- tially a shire, “no-cost” switch to the more expen- legislation turned to to address the sive drug. companies reports also use concerns. 28. The Physician data, AMA’s Masterfile contains including to prod- “[d]etermine which educational, demographic, certification, li- license,” develop ucts to "[(Implement censing speciality information for more prescription programs,” recall and to acceler- 800,000 than active U.S. medical doctors and development ate the drugs new based more ninety percent than practicing osteo- "the needs and habits of those whose health pathic doctors. these new designed improve.” Facts, Stipulation of at 4-5. companies Pharmaceutical also have non- marketing prescriber-identified for the uses *31 data other access to the for preserve Statutory Re- Hampshire’s
B. New pur- commercial including other sponse uses— court the district agree poses.31 the prohibits Act narrowly are de- uses prohibited patient-identi- use of both or transmission not, does for the statute fined and for data prescriber-identifiable fiable and compa- pharmaceutical example, prohibit Violators purposes.30 commercial certain prescriber-identifiable using nies pen- civil criminal and to both subject See their own research. data for § In 318:55. Ann. N.H.Rev.Stat. alties. at 171.32 F.Supp.2d provides: part, the statute pertinent informa- prescription to relative Records History Legislative 1. and patient-identifiable containing tion legislation the introducing proposed In data shall not prescriber-identifiable hearing the Senate Committee at a before transferred, used, by sold licensed, or and Adminis- Departments on Executive manager, insur- any benefits pharmacy Rosenwald, tration, Cindy Representative transmission company, electronic ance explained co-sponsors, one of the statute’s order, In- retail, or intermediary, mail protect “It goals: two will had it entity, similar or other pharmacy ternet money for the save and will privacy except for purpose, any commercial for It state, and businesses. for consumers reim- pharmacy purposes the limited by prohibiting goals accomplish these will care bursement; formulary compliance; or patient of individual the or use sale by a review utilization management; marketing brand identity for prescriber patient’s insur- provider, health care at- A drugs.” written prescription name either; agent of or provider ance testimony, which included tachment to her research; as otherwise or health care will H.B. 1346 “What entitled section purpose law. Commercial provided alia, will, do,” the law inter states to, limited advertis- includes, is not but drug prescription reduce “[h]opefully activi- promotion, marketing, ing, & the State employers patients, costs for influence sales could be used ty that program.” Medicaid pharmaceutical of a share or market pre- or evaluate influence product, testified at sixteen individuals About individual health of an scribing behavior Depart- representative A hearing.33 or evaluate effec- professional, care Services, Human Health and ment of professional of a tiveness pri- Moore, both the emphasized Gregory force. sales detailing purposes vacy cost reduction prescriber He described legislation. the use of effect, prohibits the statute “trade secrets” physicians’ data pur- all prescriber-identifiable further stated: detailing, but seeks poses related prescriber in- companies use the could tical challenged the restric- have
30. Plaintiffs participate physicians to recruit data. patient-identifiable formation tions on trials. in clinical permits the continued use also 31. The Act data, categorized prescriber aggregated earlier, hearing comprehensive less 33.An region, geographic speciality, zip code and Committee House was held before the prescriber identification. without but Health, Environ- and the Human Services trial, Indeed, ment. day first counsel on the pharmaceu- agreed that General Department also that these believes who him rep came to see said *32 ultimately drive the cost of up activities this is a better anxiety, medicine for prescription drugs and the cost of health though even person asymptom- was aggregate. in the no other care Since atic at the time. this, passed legislation has it state like Sadowsky’s view, In there appar- was “no to quantify would be hard for us what ent requested reason” “ex- switch be, impact might but find it un- that I cept presumably that [the doctor] ha[d] likely drug companies are sending been effectively.” marketed to pur- into doctors’ offices details for the Among speaking against those the stat- pose selling cheaper doctors medi- ute was a representative of New fact, that, I’m cation. if confident Hampshire Association Drug of Chain doctor, you’re a that one of the best Stores, Trachy, Stuart who described the ways get your a into detailer office proposed legislation as “too and broad” you would be if switched to prescribing a opt observed that “the out program that generic drug a drug. over brand the AMA going is to be instituting should testifying Also in favor of legislation take care of the concerns that have we president-elect was Hamp- the New heard in specific terms of doctors being Society, shire Medical Dr. Seddon Savage, concerned that their prescribing is who said the law “will marketing deter out there.” A spokesman plaintiff manipulate practice intended to of indi- IMS, Hunkier, Robert stated that restrict- physicians
vidual that is intended in- ing prescriber-identifiable information crease market share for the individual would not lower health care costs because companies, possibly at the expense ap- “pharmaceutical companies in all will[] propriate making pa- decision for the likelihood reps continue send sales to all He further stated tients.” that “Numer- doctors ability without the specifi- to more ous studies have that ... shown [doctors’] cally hone right people with the making decision can be and sometimes is right message. likely It will incur more shaped by marketing efforts.” system.” costs to the pre- Hunkier also Savage’s general was rein- testimony dicted that the acknowledged beneficial forced comments from Marc Dr. Sa- data, uses of the including re- medical dowsky, psychiatrist a and the president of search, compromised would be because the Hampshire the New Society. Medical He information would no longer readily reported phone a a pa- conversation with available. Responding to complaints from tient primary who said that her care doc- doctors companies that more “know tor thought had a brand-name medicine about [their] behavior than might be better for her than generic [they] know,” Hunkier stated that IMS using. she Sadowsky was continued: working greater was toward access: “[W]e said, “Well, you’re doing fine on the think preferable that a pro- solution is to generic your co-pay and going is to go vide this doctors, information to to health month, up year. So, $40 it $500 and others researchers instead of turning entirely why clear to doing me we’re out the light taking away ... this.” I think that an everyone.” was The American Medical Associ- example primary physician care expressed ation opposition also leg- to the having been directly islation, marketed to commenting in a prepared state- really didn’t have a clinical reason for ment the PDRP “provide[] would doing it except that physicians was last they the tools need to re- highlighted detailing. ies on State want do not information strict Avorn, pro- testimony Jerry of Dr. legislatively-mandat- avoiding while shared whose Harvard Medical School have unintended fessor at could ed restrictions prescription focuses on the use research consequences.” outcomes, and who also their Legal Chal- Action and Legislative Hospital Brigham and Women’s works at lenge Pharmacoepidemiology in the Division Through *33 Pharmaeoeconomics.34 and by approved Act was The medical litera- testimony on the Avorn’s 2006, May and it took in Legislature testimony practitioners of ture and Four year. that 30 of on June effect experiences with specific recounted 2006, who and later, July IMS on weeks Attorney sought case, detailing, General in this complaint filed the Verispan of detailing general, and use show that the First Act violated that alleging in particular, data Clause, prescriber-identifiable the Commerce Amendment and brand- physicians prescribe influences and vagueness it void for that was and frequently than would drugs name more declaratory They sought overbreadth. decision-mak- with “evidence-based” occur the statute’s against relief injunctive and untainted the detailers’ ing that was Meanwhile, compliance enforcement. messages.35 The marketing data- Act, modified its Verispan with the Act advanced General asserted suppress identify and that it bases so could prescri- substantial interests the State’s from New data all prescriber-identifiable public health and cost-con- privacy, ber infor- before the prescriptions Hampshire tainment. parties. IMS to third mation was released prescriber-identifiable selling stopped
also behalf, elicited On their Hamp- New from information obtained testimony the beneficial considerable about parties. sources to third shire prescri- use of detailing and the aspects of target physicians. data to ber-identifiable four-day bench trial in Janu- a During Wharton, Jr., Dr. example, Thomas For 2007, the heard February court ary and Hospital, cardiology at Exeter of director witnesses, of most testimony ten live drug initiated testified that discussions A former detailer physicians. whom were very “a provide representatives company also plaintiff each representative of and a discussing the stimulating forum” for volu- also parties submitted testified. He also coronary of disease.36 materials, treatment including minous written is elevat- the “level discourse stated that describing stud- journal articles number of by the decisions influenced cal data-with as follows: explained those two fields 34. He from detailers. and communication” "contact study of the Pharmacoepidemiology is the Facts, 12; See, at Avorn Stipulation of e.g., large populations, as drugs in utilization 5; use, Declaration, Avorn Tes- wheth- consequences of that Kesselheim well as the and event; Session, pharma- and adverse timony, Day er a benefit or PM between connection is the coeconomics economics, what drug use and good is a lot of stated "there 36.Wharton cost[], they fit into health but how also education, stimulation, cross-ferti- intellectual might system what their benefits care and drug lization, upon the in a sense based all system. care save the health data, discussion, pre- presenting initiating rep we about know senting papers, some of which con- parties witnesses at times 35. The very we So it's which don’t. some prescribing decisions relied trasted educational, experience.” data-i.e., resulting informational decisions "evidence-based” replicable clini- solely from consideration ed” drug representative when knows his Hudson, Under Central truthful com- they habits: know “[I]f that mercial speech that does not promote un- I’m drug, a user of the they will direct lawful activity may “(1) only limited if they say what have to to me toward is in support of a substantial government brand-new that might information have (2) interest, ‘directly advances the govern- come out starting rather than with the (3) mental asserted,’ interest ‘is not they If basics. know that I’m a user of a more extensive than is necessary to serve drug, I would think are more ” Dia, that interest.’ El Inc. v. P.R. Dep’t likely to come if to me a new adverse Affairs, Consumer 413 F.3d effect is announced regarding that drug.” (1st Cir.2005) Hudson, (quoting Central Plaintiffs also emphasized the lack of evi- 2343). 447 U.S. at showing dence prescri- restriction of district court considered State’s assert- ber-identifiable would lead a de- ed interests in protecting prescriber priva- crease costs and attempted to *34 cy, promoting public health, and containing show that less efficient detailing would health care costs. It concluded that the result, potentially increasing pharma- record did not reveal a distinct privacy ceutical companies’ marketing and, costs interest supported that was by the Act and turn, increasing the cost of prod- their held that neither public health interest ucts.37
nor the
interest
containing health care
C. The District Court’s Decision
costs was directly
advanced
the statute.
30,
April
2007,
On
the district court
addition,
the court found a “funda-
ruled that the Prescription
impermis-
Act
mental flaw” in
Attorney
General’s
sibly restricted commercial speech and
argument
that the regulation was neces-
therefore violated the First Amendment.
sary
“pharmaceutical
because
companies
rejected
It
the Attorney
argu-
General’s
manipulate health
providers
care
by using
ment that
targeted
Act
only unpro-
prescriber-identifiable data to enhance the
tected factual
information rather
than
effectiveness
highly persuasive but
constitutionally protected speech and also
truthful
commercial
speech.”
490
rejected her contention that
the statute
F.Supp.2d at 181. Instead of restricting
regulated only non-speech “uses” of the
information,
such
stated,
the court
“if the
prescriber-identifiable data. Having con-
State is concerned that truthful detailing is
cluded
the Act
protected
restricted
causing health
providers
care
in-
make
commercial speech,
the court examined
advisable prescribing decisions,
whether the
‘the
Attorney
reme-
General had suffi-
dy to
justified
ciently
applied is
speech,
more
regulation
not en-
under the
”
forced
three-part
inquiry
silence.’
set out in
Id. (quoting Whitney
Central Hud-
v.
son
&
California,
Gas
Corp.
Electric
274
Public
U.S.
Ser-
Commission,
vice
(1927)
L.Ed.
(Brandéis, J.,
concur-
(1980).
The court also not the First implicate and found conduct does prong tral Hudson cost- health and Attorney advance its Gener- could Amendment. From the State interests, specifically the regulates containment perspective, the statute al’s of brand-name unnecessary prescription protected transaction and commercial restricting protected drugs, without Richards, generally Neil M. speech. See noted that State The court speech. Privacy Data and the First Reconciling aha, directly samples limit the could, inter Amendment, L.Rev. 52 UCLA and then- prescribers gifts given (2005) (concluding that restrictions on use staffs, providers care about educate health target advertise- of consumer data of their implications and cost the health regulation ments were “not decisions, health care require all, of informa- regulation but rather continuing edu- participate providers to activity deciding business tion use—the objective infor- offering programs cation trial, products”). to market At to whom advantages and disadvan- about the mation contended that the General choices, adopt a or of different tages not restrict the content of the Act did takes program pharmacy Medicaid advertising manufacturers’ account. into cost considerations ac- marketing messages, which she that the stat- the court held Accordingly, Amend- knowledges trigger would First “to the extent *35 not be enforced ute could Rather, scrutiny.38 legislature the ment or restrict the transfer purports that it to Attorney in the “unusual”—and the made Id. at data.” prescriber-identifiable use of permissible choice “to General’s view— plaintiffs’ the granted therefore It information,” of the strike at the source perma- and a declaratory relief request for Session, thereby regu- Day AM It reach their injunction. did not nent and use of a “com- lating the distribution argu- or Commerce Clause vagueness limiting speaker’s rather than modity” ments. message.39
III.
court,
argu-
I think this
Like the district
line
dividing
create a
attempts
ment
ar-
continues to
Attorney
General
factual context of
not exist in the
that does
Act
that the
gue
appeal
explicitly pro-
case.
the statute
and this
While
only the use of information
restricts
175;
Pharmacy v. Va.
Va. State Bd.
Attorney
points
see
General
out
38. The
of
(the
Council,
regulate
"speakers”
Act does
Consumer
Citizens
all,
companies)
(1976)
but re-
("Purely
48 L.Ed.2d
prescriber-
only the entities that sell
stricts
may
public
claim
of
interest
factual matter
prescription
parties.
other
data to
identifiable
Studios,
City
Inc.
protection.”); Universal
Cir.2001)
(2d
Corley,
446-47
273 F.3d
wisely
longer
Attorney
no
39. The
General
information,
("Even
advocacy,
dry
devoid of
inappli-
that the First Amendment is
contends
relevance,
expression, has
political
or artistic
Prescription Act
it tar-
because
cable to
protection.”)
Amendment
accorded First
been
As the district
gets only
information.
factual
Moreover,
precedent).
(citing Supreme Court
held,
truthful infor-
"the transmission of
court
regulates
pres-
directly
the statute
while
practices
concerning
mation
data,
Legislature’s ob-
criber-identifiable
providers
Hampshire’s
...
health care
of New
messages presented by
jective
restrict the
is to
exempt
review
from First Amendment
is not
physician
As
their
customers.
the detailers to
targets
merely
factual information
because it
my
objective
assess-
explain,
informs
beliefs, emotions,
viewpoints,
than
rather
regulation.
F.Supp.2d at
ment
types
expression.” 490
other
itself,
mercial transaction
rather than as a
prescriber-identifiable
hibits
“use” of
data,40
expression
limitation on the content of the
Legislature’s
one of the
desired
may
used to conduct that transac-
of the mar-
outcomes is the modification
West,
FCC,
tion. See U.S.
Inc. v.
182 F.3d
keting messages
by phar-
communicated
(10th Cir.1999)
See,
(finding
e.g.,
detailers.
Defen-
maceutical
prohibition
compa-
of telecommunications
in Support
dant’s Memorandum of Law
proprietary
nies’ use of customer
data for
Objection
its
to Plaintiffs Motion
Pre-
targeted marketing constitutes a restric-
(“By
liminary Injunction,
prohib-
at 30-31
protected
speech).
tion on
commercial
use,
license, transfer,
iting the
or sale of
prescriber-identifiable
prescription
I recognize
separate
that there are three
purposes,
prevents
for commercial
the Act
first,
commercial activities involved here:
pharmaceutical companies
using
miners,
the transfer of the data to data
physicians
into
pressure
information
including
plaintiffs,
from the entities
changing
prescriptions
from less
their
that acquire prescription information in
costly
to name brand
medications
ordinary
course
their businesses
unrelated to the clinical needs
reasons
(such
pharmacies
compa-
and insurance
patients.”).
attempted
The State has
to nies); second, the
transfer of the data
intention
expression-based
insulate this
aggregated form
from the
to the
scrutiny by
from First Amendment
direct-
and, third,
pharmaceutical companies;
ing
an
legislation
step
its
earlier
the marketing
of drugs
prescribers
de-
However, may
process.
communicative
tailers whose
pitches
sales
make use of the
requirements
not skirt the Constitution’s
data. To
in protecting
serve its interests
Indeed,
such fashion.
privacy, promoting public health and con-
impact
General seeks to minimize the
costs,
taining health
Legislature
care
by emphasizing
the Act
detailers
targeted
message
the content of the
com-
continue
mar-
to use
same face-to-face
municated
the third transaction. The
*36
keting approach
physicians,
with
notwith-
statute
message indirectly by
restricts that
standing
Prescription
the
Act. But if the
imposing restrictions on the first
two
acknowledges
State
that the form of mar-
transactions.41
pur-
Because the statute’s
(i.e.,
keting conduct remains the same
poses
transaction,
are linked to the third
detailers),
promotion by
face-to-face
it is
conclude—as did the district court—that
difficult
may
to see how the statute
impact
the assessment of the statute’s
solely
regulation
viewed
as a
of
com-
similarly
the
must be
focused.42 See IMS
prohibition
40.
purposes
comply
In addition to the catch-all
on
of our discussion. To
"use,”
statute,
noted,
statute,
previously
pro-
the
parties making
prescriber-
as
the
all
licensing,
hibits the
or
presumably
transfer
sale of the
identifiable available for sale
agreement
information.
by
must condition the sale on an
purchasers
ways
not to use the data in
expressly governs
prohibited
41. The
by
By restricting
Act
the Act.
the re-
type
by restricting
first
of transaction
marketplace,
con-
lease of the information
into
"any pharmacy
manager,
duct of
benefits
in-
message
State limits the content of the
company,
surance
ultimately
by
electronic transmission in-
communicated
the detailers.
retail,
order,
termediary,
mail
or Internet
pharmacy
entity.”
or
patient privacy
other similar
Whether
42.The State’s interest
is
Legislature
implicated
by
viewed the
as well
the first two transac-
—the
tions,
process
through
prescription
“middlemen” in the data transfer
which
data is
—as
"electronic
intermediaries]”
transmission
or
transferred to entities uninvolved in individu-
unclear,
patients'
“other similar
is
but I
entities]”
al
health care. That interest does
because,
properly
play
part
analysis
think
treated as such for
not
a
in our
as
(“The
They involve conduct in
tion at issue here.
Health,
law is
F.Supp.2d at 176
speech
is non-existent
impact
which the
propos-
at
squarely
speech
aimed
...
or, most,
using
example,
incidental —for
though it
at
even
transaction
a commercial
es
about a
unlawfully intercepted information
speech.”);
such
explicitly bar
not
does
competing prod-
a
321,
rival to create
312,
business
108 S.Ct.
Barry, 485 U.S.
Boos v.
(1988)
using illegally
uct or
recorded information
(noting that
1157,
L.Ed.2d 333
or for extortion.
Id.
im-
to trade
securities
the direct
focus on
“Regulations that
Here,
n.
By contrast, legislation whose
purpose
within
features
a different business struc-
regulate
conduct,
ture,
economic
which
described as
package
“franchised
only incidentally
speech, typically
affects
stores.” The State responded by amend-
does not raise First
ing
Amendment concerns.
statute to
specific
identify
con-
generally
See
v.
i.e.,
Forum
duct
sought
prohibit;
it defined
Rumsfeld
Inc.,
47,
Rights,
Acad. & Inst.
547 U.S.
the term “chain
organization”
store
to in-
(2006)
83
methods,
su-
regulate business
see
a claim
was to
case,
considered
we also
second
35, and,
in
as we observed
&
regu-
pra n.
Wine
that the
franchisees
Spirits’
Wine &
I,
Amendment
not
Spirits
on
“the First
does
improper
an
limitation
imposed
lation
changes
&
advertising.
safeguard
Wine
commercial
against
of their
the content
profit-
II,
previously
that render
regulation
F.3d at 6.
481
Spirits
at
valueless.” 418 F.3d
able information
issue
First Amendment
no
We found
48.
case,
first
we stat-
In the
either instance.
the
“prohibit
Here, however,
did not
not
regulation
Legislature
did
ed that
a fran-
advice
of
between
model or strate
simply prohibit
communication
business
liquor
A
of
Instead,
and the holders
Class
chisor
it restricted the substance
gy.
47,
only forbade
licenses,”
at
but
418 F.3d
messages being
communicated
business
Spirits’
&
implementation Wine
in their
sales
pharmaceutical detailers
provision
“[t]he
model. We concluded
previous
by curtailing information
pitches
licensing services is
advertising and
words,
ly available to detailers.
other
trans-
a commercial
proposes
speech
indirectly, the
targeted, albeit
the State
constitute
does not
action and therefore
detailers in order to achieve
speech of the
at
In the
speech.” Id.
49.
commercial
objectives.
regulation
Such a
multiple
its
case,
prohibi-
we observed
later
and
speech,
commercial
is a
on
limitation
advertise-
or common
tion on coordinated
consequently must bear the bur
the State
indi-
target speech; each
“does not
ments
demonstrating that
den of
satisfies
liberty to
licensee remains at
liquor
vidual
See, e.g.,
test.
Liquor
Central Hudson
44
prices
its
information about
disseminate
Island,
484,
mart,
v.
517 U.S.
Inc. Rhode
and to
retail stores
to other
products
(1996)
1495,
499,
or otherwise Such insider e.g., information communications — The Attorney General maintains that the securities, statements, about fraudulent or Prescription Act supports the State’s sub- speech that would violate intellectual stantial in protecting patient interests property routinely laws—are regulated prescriber privacy, promoting public without inquiry.48 First Amendment Al- health, containing health care costs. though the is about State concerned the Although plaintiffs the challenge do not potentially misleading effect of the infor- importance the public health and provided by mation prescri- detailers to interests, cost-containment contend bers, does characterize the mes- the evidence in the record fails to sages it seeks to categorically restrict as prove that directly either interest ad- Thus, untruthful deceptive. my analy- vanced required by statute as presumes sis Hampshire’s pro- New second prong of Central They Hudson. hibition on the prescriber-identifi- use of wholly reject General’s con- able data affects communications that are tention that the Act a privacy serves inter- such, truthful and otherwise lawful. As est. they may only be limited with adequate justification. I, too, accept as substantial the State’s asserted interests cost-containment and justify
To
speech
commercial
restric-
quality
However,
join
health care.
I
tion,
the State bears the burden of proving
district court in rejecting on this record
the three elements of the Central Hudson
(1)
prescriber privacy
test:
as a sufficient
support
the restriction is in
interest
of a
(2)
interest;
justify
government
substantial
it di-
Act. The State
rectly
interest;
advances the asserted
does not claim
an
in preventing
interest
(3) it is “not more extensive than
public
is neces-
disclosure of
prescriber-identifi-
speech subject
scrutiny
that,
agree
strict
rather than as
majority
with the
properly con-
regulation
speech subject
strued,
of commercial
exceeding-
terms of the statute are
scrutiny. Although
intermediate
the statute
that,
ly
understood,
narrow and
so
the Act
unquestionably
by limiting
affects content
impermissibly
does not
speech
burden
outside
communicate,
information the detailer
I
scope.
its
find no
applicable
merit in this view of the
targeted speech
standard. The
concerns the
Supreme
48. The
Court has treated as a
promotion
product
aof
classic context
—the
question
threshold
under the Central Hudson
speech.
for commercial
Content-based re-
test
speech
"whether the commercial
con-
speech
strictions on
subject
commercial
activity
cerns unlawful
misleading.”
or is
only to
scrutiny.
intermediate
See Naser Jew-
Ctr.,
Thompson v. W. States Med.
elers,
Concord,
(1st
Inc. v.
513 F.3d
strict chilling because it has a effect However, speech. non-commercial *40 not, data, public it could as the mine health and increase health and indeed able disclosed and care costs. allows the data to be statute Defen- myriad purposes. See
used for a Accordingly, join Id. I the district court in (con- Memorandum, at n. 10 Trial dant’s rejecting Attorney argument the General’s “attempt to that the law does not ceding Prescription justified by that the Act is data secret keep preseriber-identifiable privacy substantial interest.
entirely private”). I turn to consider whether thus the Pre-
Rather, Attorney explains the General narrowly scription provi- Act is a tailored interest privacy her brief that the State’s directly sion that advances the State’s sub- relationship,” “patient-physician in the is in quality stantial interests health care and Hampshire patients’ in New specifically cost-containment. expect that their rela- right
“reasonable Advancing B. the Interest tionship physician private, with the is pharmaceutical detailer is not ma- [that] Attorney General asserts prescribing be- nipulating physician’s prong Act satisfies the second Attorney contends havior.” The General of the Central Hudson test —that it ad- invisible that detailers have become “an vances the State’s interest —because it re- physician’s intruder in the examination prescribers duces the likelihood that will room.” unnecessarily expensive make and unwise However, choices. borrow the district court’s regulation any does not description Attorney well stated of the way privacy on the cognizable touch logic: General’s Although room. the statute examination patient-identifiable bars disclosure of infor- ... reasoning begins The chain with data, prescriber mation as well as major premise prescriber-iden- challenge prohibition do not tifiable data allows com- Thus, specific patient on the use of data. panies target providers health care patient identifying no information is is- marketing marketing for tailor mes- justification Any privacy sue in this case. sages ways detailing more make prescriber- in the must therefore reside Next, persuasive. it assumes that be- arguing identifiable data. Rather than data makes preseriber-identifiable cause data is [preseriber-identifiable] that “the inevitably detailing persuasive, more being exploited compromise patient pri- prescriptions leads to more brand- Attorney argues that vacy,” the General gener- drugs compared name when “pharmaceutical companies using only ic because branded alternatives make help persuade data to doctors to Finally, detailed. it assumes drugs are decisions.” 490 inadvisable pre- in the number of increase F.Supp.2d prop- at 179. The district court scriptions drugs written for brand-name depiction in this erly recognized flaw alternatives compared generic when privacy interest: public health and increases harms because branded General claims as a health care costs [W]hat than turn out to be more harmful protecting prescriber interest in often distinct always generic than alternatives and almost privacy nothing more a restate- Accordingly, a ban expensive. law can are more ment of her contentions preseriber-identifiable use of justified prevents pharma- because it public using prescri- marketing purposes promotes companies ceutical ways and contains health care costs ber-identifiable data in that under- health *41 companies prohibiting remedy required by was the the First prescriber-identifiable data using from Amendment. Id.
to the sale of brand-name promote I consider the showing State’s on each of drugs. the two interests in turn. F.Supp.2d at 180. 1. Quality Interest of Health accepted premise The district court Care detailing prescriber-identifiable that persuasive, data is more but found that the To Prescription validate the Act on the Attorney General had failed to establish a impact quality basis its on the of health detailing link any nega- between such care, Attorney General to needed show tive health or impact public on costs. detailing that with prescriber-identifiable concern, On the health the court found data professionals influences medical that it “counterintuitive and unproven” drugs choose that are less safe or less that, balance, drugs “brand-name are appropriate patients’ to meet needs than injurious public more to the health than the non-patented they alternatives would addition, In generic alternatives.” Id. prescribe. agree otherwise I with the dis- that unpersuaded court was the State’s trict court that no evidence the record public purpose health was served bar- supports newer, proposition ring prescriber target the use of data to drugs brand-name are generally less safe “early adopters” drugs of new because older, or effective than generic ones. “the record does not establish either that that, The record does contain evidence early likely adopters are more to be influ- times, physicians persuaded pre- are by detailing enced than other health care drugs scribe new that are less effective for providers generally or that new are patients. that, Dr. Avorn testified in the injurious public more to the health than wake extensive marketing hy- for new existing medications.” Id. pertension medications, known as calcium- Attorney blockers,
The court found the General’s channel many doctors switched position similarly “better, older, on cost-containment defi- prod- less-marketed cient. It that “[n]on-bioequivalent stated products ucts” to new gave patients generic always drugs are not as effective “less benefits in terms of preventing alternatives,” id., as brand-name and found strokes or heart disease.” The record did Attorney proven not, however, General had not support a conclusion that reductions health care norm; costs such rather, occurrences were the stemming newer, from reduced use of Attorney primarily General’s evidence expensive more medications “can be was showing directed toward detailing achieved without compromising patient routinely persuades health profession- care care.” Id. at It thus found that none prescribe patented als to when medications of the State’s asserted interests was ad- offer no benefit over cheaper generic Moreover, vanced words, Act. alternatives. Attorney other the extent that General General’s focus unnecessarily was on the successfully drew a connection high prices between paid functionally equivalent truthful, non-misleading detailing drugs. based on That pertinent circumstance is prescriber-identifiable data and “inadvisa- the cost-containment interest discuss in decisions,” ble prescribing section, the district the next rather than to an interest court opined less, speech, more in safe and appropriate health care. Session, evidence relevant to the interest PM (Testimony
Other of Dr. Avorn) (“[The quality health care showed that detail- drug companies] very *42 prescriber-identifiable data to tar- ers use conscious that the patent life is ticking then get early adopters, prescribe who away, and there’s a impetus tremendous promoted drugs new that sometimes turn on the part industry the to be able to out have harmful side effects. Howev- maximize their possible income as much as er, Attorney argument the General’s is not drug the minute the is released on the greater physicians that a number of be- market.”). While a few weeks or months early adopters targeted come because of delay in adoption drug- of a new might detailing; pharmaceutical it claims the difference, make a substantial financial the companies identify physi- use the data to Attorney General has not shown that it adopt cians who are inclined to already would have material consequences. health words, drugs. targeted new In other unsurprising It is that I find the Attor- likely among doctors would have been ney showing General’s on the State’s any users of in drugs first new event. health care interest inadequate Thus, possible adverse effect on health —or at undeveloped given justifica- least that pro- care from reliance on stemming — tion’s limited in only legislative role both the hibited data would arise from the in possible process difference time between an ear- and the Promoting quality trial. ly adopter’s alert from a detailer and the health care was not one of the pur- two physician’s notice from another source. poses of the law identified the Act’s provides The record no basis for conclud- sponsor when she legisla- introduced the that, case, ing ordinary that differ- tion,50and the district court noted that the significant ence time would have a legislative history contained no “substan- health effect.49 support tial pro- the view that it was measure, moted a public except as health
However, the
that
evidence did indicate
containing
to the extent
that
healthcare
to early adopters
economically
access
was
costs
has a positive public
itself
health
advantageous
for the
com-
Conference,
benefit.” Tr. of
April
Status
panies. By soliciting
possible
the earliest
11, 2006,
medications,
at 44.51 In a colloquy
use of new
with coun-
companies
can
trial,
advantage
maximize the financial
sel toward the end of the
the court
of their
rights
it
high-priced
exclusive
while their
observed that
did not see “one shred of
See,
drugs
patent-protected.
Day
record,
e.g.,
evidence in this
legis-
either
Foster,
noting
patients
co-sponsor,
during
It is worth
that some
inevi-
Senator
stated
49.
tably
exposed
trying
must be
to the risks of
Senate Floor Debate that
me what
"[t]o
drugs
through
by pa-
new
tients,
because it is
use
legislation is about is dollars and cents.”
testing,
after more limited clinical
problems
side effects and other
are detected.
reviewing
during
51.In
the State’s interests
addition,
weighed against
the risks must be
hearing;
mid-trial oral
the district court stat-
early adoption
drugs
the benefits of
legisla-
ed: “I didn't see
discussion in the
prove
“breakthrough” developments
to be
history
targeted detailing
tive
...
was
See,
Session,
e.g., Day
treatment.
AM
leading
prescription practices;
to unhealthful
Frankel);
(Testimony
Randolph
AM
injuring
patients by
that doctors were
their
(Part 2),
(recording
Session
at 15
State coun-
denying
therapies
them
would bene-
“obviously
sel’s observation that
sometimes
by giving
drugs
fit from or
them
that would
better”).
drug
newer
is
harm them....
a bill
This is
about costs. It's
safety.” Day
not a
Representative
In addition to
bill about
AM Session
Rosenwald’s
Act,
(Part 2),
purposes
statement about the
3-4.
prescrip-
trial” that
history
quormart,
or in the
517 U.S. at
lative
S.Ct. 1495
(“[T]he
ge-
higher-priced
tion
instead of
showing
State bears the burden of
unhealthy
healthy
or less
“produces
nerics
merely
regulation
that its
will advance
Hampshire.”
in New
anybody
outcomes for
interest,
its
but also that it will do so ‘to a
effectively
Additionally,
coun-
”)
degree.’
(quoting
material
Edenfield
limited
Attorney
tered the
General’s
show- Fane,
ing on adverse health effects with evidence
(1993)).
words,
tension. ... This distortion of — earlier, detailing as noted also is used influ- from the use of recommended in na- among competing ence the choice brand- guidelines tional was estimated to have in- drugs. testimony indicating name Sobelson's expenditures by creased health care around detailing the influence of in the brand-name $3 billion dollars alone.” [sic] Decla- setting supports equally an inference that it is ration, at 7. competition effective in the between brand- generic drugs. name and trast, prescriber-specific without informa- which he and his colleagues prescri- used tion, ber-specific data obtained pharmacy physicians records to choose for education-
it becomes less about the business and by al visits clinical knowing my pharmacists, more about the science of accompa- drug.... puts power of the de- nied [I]t mailed “unadvertisements.” He physician’s tail in the reported more hands be- targeted these interventions truly cause don’t know what his con- in 14 percent resulted a in inap- reduction perspectives cerns are or what his or propriate prescriptions,58 Declaration at are.... the power [I]t biases shifts significance and he saw in these results a equal footing. the conversation to more detailing: commercial (cid:127) A Boston Globe article included (known Our programs educational Legislative History reported similar infor- “academic detailing”) focused on improv- mation; representative a sales told his ing patient through care reducing exces- that, if understanding he learned that a sive use of inappropriate medications. competitor’s doctor was But when these techniques are used product, presentation his should focus on companies main goal simply whose Liz undermining product. Kowalc- product sales, increase impact zyk, Drug Companies’ Reports Secret Out- patients and on the health system care Doctors, Globe, rage May Boston quite are different. The studies we have at Al. cited indicate that more physician-specif- (cid:127) explained Plaintiff has IMS the bene- ic detailing will lead to prescrip- more fits of data-mining prescri- with focus on agents, tions of brand-name often with ber-specific “By using data-mining data: patient no additional benefit but at much solution, pinpoint IMS can prescribers who higher cost to patients and to state- are switching from one medication to an- programs, based insurance which will other. A sales can person use this model up continue to drive the cost of health target doctors who have switched from care in Hampshire. New drug they selling and to devise a *46 Id. at 10. specific message switching to counter that behavior.” Paul Jerry Kallukaran & Ka- trial, Avorn echoed these observations at gan, Mining Data at IMS HEALTH: explaining that prescriber-identified data Turned, How We a Mountain Data into important was to the success of his coun- Molehills, a New IMS Information-rich ter-detailing because “that’s how we knew Abstract. visit, to whom and we also knew what to
(cid:127) say to them because we knew what declaration, In both testimony his prescribing.” were In the declara- Dr. detailing Avorn stated that becomes tion, he that restricting stated access to less information-focused and a pow- more information, prescriber-specific persuasion “[mjaking erful tool of when the sales representative more difficult for manufacturers to tailor prescriber- is armed with ... specific joint marketing strategies their to individu- information. his declara- Kesselheim, Dr. physicians!,] actually encourage tion with he related the al would “counter-detailing” experience present physicians of his re- detailers to a more with School, search unit at Harvard Medical description product neutral that infra, suppressing As discussed cite this tive of cost-containment without counter-detailing speech. explain, counter-detailing success as evidence As I is not objec- comparable that the State could have achieved its alternative. expensive presentation of informa- showed more brand-name emphasize would times, will, Declaration, 11; drugs at be the better thera- promotion.” tion over acknowledged The court (Avorn peutic choice.59 Session, Day at 140 see also PM given deference” must be “substantial (“[I]f Testimony) rep my knows sales legislature’s predictive judgments to a history, they will market to me a quality record establishes that “[w]hen beyond way goes me in a well or at an extensive in- legislature conducted just me with the data. It’s not providing exper- vestigation, acquired considerable point. at that It’s not a really education area, incorporat- regulated tise field.”). playing level findings approved into the express ed (cid:127) prescriber-identi- assumption An (cit- F.Supp.2d statute.” 490 at 177 n. 12 detailing impacts drug choice is fiable FCC, ing Sys., Turner Broad. Inc. v. guidelines professional reflected in the U.S. 137 L.Ed.2d cautioning against using aggres- the data (1997)). However, ques- the court above, sively. As noted the AMA has Legislature’s tioned the extent of the in- adopted suggestive guidelines against the initiative, vestigation adopting before “prescribing overtly pres- data to use alia, noting, quickly inter that it acted af- physicians prescribe sure or coerce introduced, ter the bill was made no ex- particular drug.” Such indirect evidence press findings legisla- on the need for the supports the view that eliminat- State’s tion, and “cited no evidence as to how ing access to the information will de- effective the might prove restriction physicians crease the likelihood that will F.Supp.2d be.” 490 at 177. swayed targeted marketing pre- regulations sup am mindful that unnecessary expen- scribe more —and press carefully commercial must be drugs. sive—brand-name Nonetheless, evaluated. the district court held the a higher General
b. The
court’s evaluation
district
proof
required by
standard of
than is
Su
evidence
preme
precedent.
Court
While a state
that,
The district court concluded
not-
legislature “does not have the
dis
broad
evidence,
withstanding this
the State’s
truthful,
cretion to suppress
nonmislead-
showing
link
was insufficient to establish a
ing
paternalistic
purposes,”
information for
between the Act and cost-
Liquormart, 4
other
containment
because
evidence 116 S.Ct.
the Court’s commercial
reasoning
explained
59. The court
its
or better than a
well
brand-name alterna-
*47
may
cost-containment interest as follows:
patients,
tive for most
there
be some
patients
by taking
will
who
benefit
by
Attorney
I am also unconvinced
Yet,
branded medication.
a ban on the use
argument
Prescription
General's
that the
prescriber-identifiable
of
data affects both
directly promotes
Information Law
helpful
prescrib-
and harmful brand-name
containing
State's interest
in
health care
ing practices
way.
in the same
Because the
Attorney
appears
costs. The
General
to as-
Attorney
prove
has failed to
General
any
savings
sume that
health care cost
reductions in health care costs that
prescri-
will result from a ban
the use of
prescriber-
result from a ban on the
of
use
ber-identifiable data can be achieved with-
However,
identifiable data can be achieved without
compromising patient
out
care.
care,
compromising patient
I am unable to
proposition
is far from self-evident.
argument
endorse her
Non-bioequivalent generic drugs are not al-
justified
Law
ways
Information
can be
as
cost
as effective as brand-name alterna-
Moreover,
tives.
even
where non-
containment measure.
in cases
bioequivalent generic drugs
F.Supp.2d
will work as
490
at 180-81.
FCC,
speech
“recognize
ry
Corp.
cases
some room the
Commuc’ns
835 F.2d
(D.C.Cir.1987));
legislative judgment.”
of
Id. at
exercise
see Florida Bar v.
It, Inc.,
ments). showing data the extent of the influence of Broadcasting,
In Turner
ob- prescriber-specifie
Court
information on physi-
that,
record,
given the exhaustive
decision-making;
served
cians’
nor can she docu-
Congress’s findings were entitled to
money
“def- ment how much
the Prescription
in part
erence
because the institution is far Act will save the State or consumers. The
equipped
judiciary
better
than the
regulation
was the first of
its kind
country,
amass and evaluate the vast amounts of
and it had been in
effect
less
bearing upon legislative
questions.”
year
than a
when the district court invali-
(internal
U.S. at
S.Ct.
S.Ct.
3028,
(1989));
106
speech prohibit-
L.Ed.2d 388
Florida
“the amount of beneficial
Bar,
632,
quirement
require
This case does not
us to decide if
Booher,
Speech,
Scrutinizing Commercial
in
Thompson represents
departure
69, 77
Rts. L.J.
15 Geo. Mason U. Civ.
application
tailoring
Court’s
of the narrow
(2004);
Hoefges, Regu-
see also R. Michael
I
ex
prong
Central Hudson. As
shall
Advertising:
lating
Services
Professional
by
plain,
applied
majority
even as
and
Parameters
Current Constitutional
Thompson, Central Hudson’s narrow tai
the First Amendment Com-
Issues Under
Doctrine,
loring requirement
24
Arts
is satisfied here.
Speech
mercial
Cardozo
As
(2007)
953,
(noting that
Ent. L.J.
989
matter,
&
speech
an initial
the restriction on
arguably
pushed
“has
precedent
recent
imposed by
signifi
Act is
analy-
Hudson
prong
fourth
of the Central
cantly more limited than similar restric
the least-
than ever before to
sis closer
speech
on commercial
that have
tions
been
requirement
of strict
restrictive-means
by the
It
Supreme
considered
Court.
Erickson,
scrutiny”); Emily
constitutional
complete
marketing
neither a
ban on the
Telemarketing,
Advertising:
Disfavored
see,
advertising
product
price,
of a
or its
Speech
and the Commercial
Junk Faxes
360,
at
122
e.g.,
Despite the Act’s
alternatives.
Id.
maintain that it is broader than
objective
necessary to serve the State’s
proposal
non-speech
This
and the other
tailoring
that it thus fails the narrow
proposed by
alternatives
parties
reasons,
reject
multiple
test. For
*52
equivalency
the district court lack
with the
and conclude that the
plaintiffs’ contention
Prescription
accomplishing
Act
justifying
burden of
State has met its
goal.
State’s cost-containment
In re-
inadequacy of alter
Prescription Act. The
sponse to the
suggestion
district court’s
interests, the
satisfy
to
the State’s
natives
legislative changes
that
be made in the
communications, and the
private
context of
program,
Attorney
Medicaid
General
message
impact
sought
on the
to
limited
argues that such measures would not re-
that
be disseminated lead me
conclude
to the
spond
State’s broader concern that
has
“a ‘rea
Hampshire
New
established
physicians’ drug
patients
choices for all
abridgment
its
sonable fit’ between
by
distorted
pres-
the detailers’ access to
Liquormart,
...
goal,”
and its
addition,
criber-identifiable data.69 In
507, 116
1495.
517 U.S. at
Attorney
General maintains
formular-
by
ies also are
affected
Inadequacy
1.
of Alternative Measures
detailing, citing
physicians
evidence that
argue that
plaintiffs
The
State’s
request additions to such lists even when
objective
could
cost-containment
have
drugs
the added
have “little or no thera-
measures that
through
been achieved
did
advantage
peutic
existing formulary
over
protected speech
not
at all.
impact
The
supra, at 375.
Wazana,
drugs.”
that,
agreed
district court
and noted
example,
Legislature
could
The
have ad-
court’s other suggestions
requir-—
by
implement-
“properly
ing
dressed the issue
the State “to enter
the intellectual
ing”
Pharmacy Program
a Medicaid
that marketplace” with its own information
choices;
takes into account the
cost-effectiveness of
about proper
mandating
drugs.
F.Supp.2d
brand-name
participation
continuing
182.
medical edu-
pointed
Hamp-
The court
out that
programs;
limiting
New
cation
samples,
program requires
shire’s current
authori-
ingratiating gifts provided
meals and other
patients
zation for Medicaid
to obtain cer-
prescribers
similarly
detailers to
—are
tain drugs
regulations
and that state
allow imperfect.
argues
General
cost considerations to be taken into ac-
that the
comparable
State lacks
resources
count
deciding
drugs
directly
when
which
should to
detailing—
counter commercial
subject
to the authorization.
490 for which the pharmaceutical companies
result,
F.Supp.2d at
As a
spend
182.
the court
billions of dollars70-—and the district
prevent
concluded that the State could
un-
court at
testimony
trial noted Avorn’s
necessary expenditures
relying
on brand-name
programs
medical education
drugs by denying
requests
authorization
would be difficult because “it would be
expensive
for more
right
are no hard to find the
people and ...
testimony
plac-
rely
secondary impact
elicited
could not
on that
objective.
ing drugs
formulary
achieve its
on a Medicaid
list has
well,
spillover effect on “the cash market” as
argues
70. She further
that "such a solution
Session,
Day
(testimony
PM
at 29
of Hos-
simply
symptom,”
would
treat the
while the
Sadek,
president),
sam
IMS senior vice
but
statute "is an
treat
effort to
the disease itself.”
reasonably
the State
could conclude that it
Brief at 43.
scriptions
what the
other
disputes
would be
over
reasons
than the clini-
[t]here
content is.”71
patients”) (citing
cal needs of
Avorn Decla-
9-11).72
ration, at
acknowledge
suggestion
courtesy
prohibit
samples
the State
and Moreover, Avorn testified that the reme-
gifts
prescribers
easily
other
is not as
dies proposed
the district court “have
im-
prohibition
dismissed. That
could be
tried,
necessarily
been
Hamp-
New
plemented unilaterally and without ex-
shire, in particular,
nationally in
but
terms
pense
to the State. Like the
trying
freebies,
to restrict
trying
Act,
directly
such ban would be
aimed
provide doctors with other means of learn-
diminishing
persuasive
force
ing, requiring that
continuing
doctors take
above,
message.
detailers’
As described
*53
ed
opined
courses.” Avorn
that the Pre-
the record contains evidence that
the
scription Act
perks
physi-
have a subtle influence on
just
oh,
flippant,
was not
a
let’s see what
decision-making, increasing
cians’
their af-
happens with
It
this.
was more of a
finity
particular
representatives—
sales
sense of people
everything
have tried
and, presumably,
representatives’
for those
they
try
can
and we still have this mas-
fact,
drugs.
In
a number of states have
sive distortion of
pre-
what doctors are
that
passed
requiring
gifts
prescri-
laws
State,
scribing and what
and its
disclosed, and,
bers be
publicly
as
citizens,
paying
are
for drugs because of
data,
prescriber-identifiable
profes-
use of
very heavily
very
pro-
effective
guidelines
adopted
sional
have been
to re-
motional strategies
going
that are
on out
duce or eliminate such benefits.
there; and this
given
seemed
that
like—
intent, however,
in
While similar
a ban
those other
are probably
avenues
gifts
prescri-
on
and the ban on the use of
viable,
going to be
that this seemed to
interchangea-
ber-identifiable data are not
way
preserving
be a
company’s
achieving
goal
ble means of
the State’s
ability
give
me their best shot in their
cost-containment.
samples
gifts
The
argument,
sales
but not to
do so with
merely
preparatory step
in the mar-
knowledge
really
kind of
shouldn’t
keting process;
they may
while
increase
anything
teaching
to do with
me
have
prescribers’ susceptibility
to the sales
something....
pitch,
reasonably
the State
concluded that
I am thus satisfied that
the State has
it is the
pitch
sales
itself
has the most
possibility
eliminated the
that “alternative
troubling effect on the prescribers’ drug
regulation
forms of
that would not involve
urgently
choice-and is most
in need of
restriction on
would more
regulation.
Appellant’s
See
Brief at 42
likely
goal,”
to achieve the State’s
Li
(asserting
pharmaceutical companies
quormart,
Edmfield
respects,
In relevant
this case falls be-
by
public
tation
certified
accountants
tween
Although
Ohralik
Edenfield.
(“CPAs”) did not survive First Amend-
recipients
of the marketing messages
scrutiny. 507
ment
are,
Ohralik,
at issue here
highly
unlike
noting that
Although
face-to-face
professionals,
trained
in ques-
solicitor
commercial solicitation
have “detri-
tion—the
detailer —is
id.,
aspects,”
recog-
mental
the Court also
schooled in the art of persuasion, like the
that,
context,
nized
the commercial
“[i]n
lawyers
Edenfield,
in Ohralik.
Unlike
value,”
may have
solicitation
considerable
there is substantial evidence that the de-
Among
id. at
A CPA’s
leading.
advantage provided by pres-
The
objectivity,
advocacy.
dence and
not
may only
to re
eriber-identifiable
be
of a
is far
typical client
CPA
less
emphasis
presentation.
focus the
manipulation
than the
susceptible
But where the record
a real risk
shows
young
pro-
victim Ohralik. Fane’s
may
presentations
give
that “one-sided”
spective
sophisticated
clients are
and ex-
influence,”
appropri
“undue
the
marketers
perienced
un-
business executives who
speech
much clos
limiting
ateness of
veers
the
that a
derstand well
services
CPA
than
Li
er to Ohralik
See 44
general,
prospective
offers.
Edenfield.
498,
quormart,
U.S. only place transactions that take erns those as- “preventing legitimate interest plaintiffs’ and the Hampshire within New fraud, involve un- pects of solicitation that all of the conduct contention intimidation, overreaching, influence, due purports regulate Act occurs outside conduct’”) of ‘vexatious and other forms us, the record before we do State. On added). (emphasis evaluating adequate have an foundation implications for the that disconnect and its and Benefits Costs 3. Calculation analysis. I therefore Clause Commerce the alternative already have described remand this case to district would will have access ways prescribers in which court with instructions address no information helpful to the in the first in- Commerce Clause issue pharma- them from longer available to stance.74 Pre- a result of the ceutical detailers as interpre- General’s Under supra Act. Section IV.B.2.b. scription See Act tation of the statute-that reaches only a suppresses therefore The statute only that occur within New transactions speech. “On amount of beneficial small Hampshire-no problem Clause Commerce whole, then, challenged regulation ‘ Alliance Auto. would exist. See Mfrs. “carefully ... that [the State] indicated] (1st Cir.2005) Gwadowsky, 430 F.3d the costs and benefits associat- calculated” that, (explaining evaluating whether a imposed by ed with the burden extraterritorial impermissible statute has New prohibition.’” its Greater Orleans reach, obliged adopt any courts Ass’n, at 119 S.Ct. Broad. reasonable construction consistent with the Network, 507 U.S. (quoting Discovery Constitution). majority summarily Fox, (quoting at 113 S.Ct. narrowing construction “rea- deems 3028)); also see U.S. sonable,” that “it would make commenting West, Inc., 182 F.3d regulate no sense to read the statute to context, I conclude that the State In this upshot out-of-state transactions when the justify the limited has met its burden to doing to annul the statute.” so would be speech imposed restraint on commercial narrowing application Yet literal Prescription Act.73 *56 appear construction would to leave the Act negligible impact hardly a reason- with — y. able outcome. the plaintiffs’
There remains Commerce undisputed plain- It is that none of the part compa- Act. I challenge Clause to the place transactions take within New tiffs’ ny my colleagues challenge on that with Hampshire. The district court found that majority’s discussion of the because the all of their Verispan pre- “IMS and obtain issue, ready acceptance information, of the At- scription including and its informa- torney Hamp- statement about in prescriptions General’s tion on filled New Act, shire, scope computers of the further undermine that are located majority’s Hampshire.” decision. There is outside of New value of the trial, F.Supp.2d Attor- At the court de- puzzling disconnect between the 166. join majority's of the 74. The district court's First Amendment rul- discussion ing unnecessary it plaintiffs’ is uncon- made it to evaluate the contention that statute legal arguments concerning stitutionally vague, parties' other than its statement in challenges. invoking standing vagueness Clause footnote doctrine. and Commerce scribed the record factual on the Com- force.” Consequently, data would be question merce Clause as follows: outside New Hampshire before trans- action described the Act occurs. The undisputed It’s that prescriptions are district court’s factual summary suggests generated in the state. It’s undisputed prescriber-identifiable most the prescriptions are filled within leaves Hampshire New in permissible this the state. It’s undisputed that the phar- manner. they’re macies where filled based [are] (cid:127) undisputed state. It’s That understanding of the facts under-
pharmacy, a part of its prac- routine lies plaintiffs’ argument that the Act tices, unassociated the sale of this seeks prohibit to transfer, the licensing, pharmaceutical information to compa- use, or sale of data identifying New Hamp- IMS, nies or transfers the information prescribers shire wherever such activity the ordinary course of its business from occurs. Plaintiffs’ explained counsel their a data center in the state to data centers position during a colloquy with the court at outside the state. That the soft- IMS trial: Verispan
ware and software is to applied said, The State has this doesn’t apply it outside the state. That it is then outside of the state.... reply [0]ux to transferred from the [pharmacy] to IMS that has been ... if it prohibit doesn’t state, or Verispan outside the is these state, transactions outside of the thereafter sold com- then the really statute loses all of its panies and other clients outside the force and effectiveness. Because if Rite state. pharmacy Aid’s Hampshire New can parties agreed summary, transfer parent its in Pennsylvania variations, with some was parent and its can accurate and transfer to IMS or agreed also with the court’s Verispan Pennsylvania, understanding pro- that’s not that “the factual record that And bears hibited. then can they transfer it Commerce question Pfizer, Clause undisputed.” wherever headquar- Pfizer’s ters are outside of Hampshire; New undisputed facts, Given these however, if Pfizer can then use it outside of New much, it is unclear if any, how Hampshire for all of pur- these various activity that explicitly pro- statute poses that prohibited, are then there’s scribes occurs within New Hampshire. absolutely no force or effect to this stat- example, For the “routine” transfer of ute. And I think what the State is prescriber-identifiable information from a really arguing is that ... all these trans- local New Hampshire to the pharmacy state, fers outside of the pro- pharmacy’s headquarters out-of-state does hibited. appear prohibited the Act. *57 Arguably, that electronic would transfer This stops statement step one short of not impermissible be for an “commercial demonstrating the most critical flaw the alia, purpose” involving, inter Attorney “advertis- General’s narrowing construction — ing, marketing, promotion, activity or any of the If Act. her view of the Act were that could be correct, used to influence only sales not buy could Pfizer and use market share a pharmaceutical product, New Hampshire data outside of New influence or evaluate the prescribing be- Hampshire “for all these purposes various havior of an individual health profes- prohibited,” care that are the Act but also sional, or evaluate the of a effectiveness would no pose barrier to the use of such professional pharmaceutical detailing sales data by detailers inside Hampshire. New ... the laws of the State knowledge of Act does not the so because This would be Hampshire.... above, of New and, the as noted apply to detailers that the detailers suggest undisputed facts law, Hamp- the New this view of Under entities the data from routinely obtain embargo on the use of the an places shire information, ac- acquisition whose it before is data prescriber-identifiable General, not Attorney was cording to At- The by pharmacies. released first Hence, the detailers’ by the Act. restricted contemplates torney apparently General in New data prescriber-identifiable use of and simi- Hampshire pharmacies that New appear would doctors’ offices Hampshire license, permitted lar entities would be no violation of to involve they transfer, the information use or sell route toward its taking an indirect Act. condition that the only on the accumulate communica- regulating detailers’ goal of pro- for the not be used downstream data tions, the First to avoid presumably purposes. commercial hibited trig- that would be concerns Amendment However, I de- the disconnect speech, the by a direct restriction on gered lan- explicit scribed earlier remains. may accomplished not have Legislature im- appear guage of the Act does it intended. what original a restriction on pose such by Hampshire phar- transfers of data New course, Attorney General Of the state. The macies to entities outside the Act that her concession believe prescri- only Act the transfer proscribes to out-of-state transactions apply does not specified com- data for the ber-identifiable of her view problematic is not because by of data purposes. mercial The transfer using prescri- detailers from the Act bars beyond New Hampshire pharmacies New in their communica- ber-identifiable im- typically may not Hampshire’s borders if prescribers Hampshire with New tions prohibitions. Transactions plicate those Hampshire, in New originated that data occur involving purposes those commercial of whether the regardless downstream, and, so far as the farther information inside company purchased the shows, outside the state. primarily record Indeed, un- or outside of the state. Attorney Frankly, I am not sure that the derstanding scope suggested of the Act’s import of her understood the General comments dur- Attorney General’s in- regulates only Act statement with the district ing parties’ colloquy Nor, the state of given state transactions. court: record, majority’s do I understand here is we reality of the situation that, interpret- Act is statement when the pharmacies chain mov- have ... national proposes, General ed as the Hampshire, into the of New ing State “may profit in a loss of to out-of- result business, places their own setting up closing to the of one state data miners due hiring managers, es- hiring pharmacists, Hampshire market for aspect of the New of business tablishing place contrary, the stat- their wares.” To Hampshire and then obvi- State of New Hampshire appears impact ute’s New ously to abide the laws of agreeing only transac- truly governs if it negligible Hampshire of New when the State that occur within the state. tions in this place of business establish *58 Attorney General’s conces- state; Although in of their and then the course sidestep plain- business, attempt ... was an they’re collecting these sion challenge, there out of tiffs’ Commerce Clause They’re moving these data data. argument step that such a was state, may in full be an purpose, for whatever
105 unnecessary. regu- pages sixty-page When state statute their brief. The Attor- “wholly beyond lates commerce the bound- ney response equally General’s is I terse. state,” enacting usually aries of the is think it unwise to address the Commerce per Mfrs., invalid se. Alliance Auto. Clause cursory issue based on a briefing every impact 430 F.3d 35. Yet provides legal analysis neither nor prohibited. interstate commerce is “[T]he developed application of the law to the dormant Commerce is not abso- ] Clausef limited facts of record. Although par- conflicting legis- lute and in the absence of agreed ties at trial that the facts on the lation ‘the Congress, States retain au- Commerce Clause claim undisputed were thority general police powers under their and that no further evidence was needed regulate legitimate matters local con- it, to resolve do not address cern, though even interstate commerce evidence in meaningful way in Mgmt. be affected.’” Pharm. Care their briefs and the General does (1st Rowe, 294, Ass’n F.3d not address the evidence all. The dis- Cir.2005) (quoting Taylor, Maine v. 477 trict court did not reach the claim. 106 S.Ct. 91 L.Ed.2d Our comment similarly about a bare (1986)). Moreover, whether extrater- Commerce Clause claim in Spirits Wine & ritoriality impermissible every in- II guide also should sophis- us here: “This stance, or whether it transgresses the dor- ticated area of law requires ar- developed mant only Commerce Clause when the gumentation, evidentiary support.” challenged discriminatory statute is or 481 F.3d at (noting that the Supreme nature, protectionist appears an- to be Court had as a ‘critical “label[ed] consider- other relevant consideration. See Peter C. ation’ regarding extraterritorial reach Comment, Felmly, Beyond the Reach of claims the ‘overall effect of the statute on Clause, States: Dormant Commerce ” both local and interstate commerce’ Extraterritorial Regulation, State and the Inst., Inc., (quoting Healy v. Beer Federalism, Concerns 55 Me. L.Rev. 337 n. 105 L.Ed.2d (2003) (noting that recent Su- (1989))). I therefore would remand preme Court considering cases the dor- this case to the district court on the Com- mant Commerce Clause an in- suggest merce Clause issue. creased “focus on the territorial reach of legislation state ... in stark contrast long-established concentration on state VI. regulations discriminatory pro- that are I my summarize conclusions: nature”). tectionist prudential standing 1. The doctrine is enough have said to demonstrate the inapplicable in the circumstances of this complexity of the Commerce Clause issue case, where the core First Amendment inadequacy and the of the record. There vigorously litigated issue was compre- missing prescri- details about how the hensively court, considered the district generated by ber-identifiable data New and where the Information Hampshire pharmacies flows to corporate constitutionality Act’s cannot be assessed offices out of state and purpose of that addressing impact without its on the com- information parties appear flow. The munications between prescri- detailers and assumptions
have different about those de- bers; legal significance. tails and their More- over, plaintiffs’ argument on the Com- 2. The Act restricts commercial merce spans only Amendment, Clause two and one-half protected by that is the First *59 bears therefore Attorney General and the demonstrating the stat-
the burden test; Hudson
ute satisfies the Central has failed to the State Although
3. justified by substan- Act is
prove that the health quality privacy
tial interests
care, to show met its burden has in con- its interest directly
Act advances drugs and prescription
taining the cost necessary than extensive
is not more objective.
accomplish the Pre- majority, find
4. Like the sufficiently clear to withstand
scription Act con- challenge when
plaintiffs’ vagueness legisla- with its narrowly, consistent
strued precedent. history applicable
tive contention that plaintiffs’
5.
Act the dormant Commerce violates district be considered
Clause should instance. should
court the first We purpose. the case for
remand and EXCHANGE
SECURITIES
COMMISSION, Plaintiff,
Appellant, TAMBONE; Hussey, Robert
James
Defendants, Appellees.
No. 07-1384. of Appeals,
United States Court
First Circuit. Sept.
Heard 2007.
Decided Dec. 2008.
Rehearing Denied Feb.