Appendix — Whalen v. Roe

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APPENDIX

Suprene Court of the United States

OCTOBER TERM, 1975

Ropert P. WHALEN, as Commissioner of Health of the

State of New York,

Appellant,

against

RicHarp Ror, an infant by Rospert Rog, his parent; JoHn

Dor, an infant by Mary Dor, his parent, James Mog, an

infant by Micuarrt Mog, his parent; JANE Por, MattHEw

T. Bropy, Israri L. ScoMreReER AND Emprre State Parysi-

cians GvItp, Ixc.,

Appellees,

and

Grorck Patient, Martua Patient, Geratp L. Lustic, and

THe AmerRICAN FEDERATION OF PHysIcIANS AND DENTISTs,

Intervenor-A ppellees.

Ox AppeaAL From THE Unitep States District Court

FOR THE SovrHerN District or New YorK

ED, SN SRR 3 TEN I a a a ETD

JURISDICTIONAL STATEMENT FILED

DECEMBER 15, 1975

PROBABLE JURISDICTION NOTED

FEBRPARY 23, 1976

INDEX

PAGE

Relevant Docket Entries—District Court .......... la

Complaint (Roe, 73 Civ. 1303) .........eeeee eee ees 9a

Complaint (Patient, 73 Civ. 1431) .........---.+5+. l4a

Affidavit of A. Seth Greenwald ............-0e seers 19a

Affidavit of Robert Whelan, M.D. ..........-..+055: 22a

Sample Prescription ..........6+eeeeee cece ee eeees 29a

Order Denying Plaintiffs’ Motions, etc. ...........- 30a

Opinion Denying Plaintiff's Motion for an Order

Convening a Three-Judge Court, etc. ........-. 32a

Opinion of United States Court of Appeals ........ 4la

Notice of Motion to Dismiss Complaint ............ 54a

Affidavit of A. Seth Greenwald, in Support of Motion 56a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion) ........-..++seeeeees 57a

pT POCO PETIT er TTT TTT eTTTT TT TTT TTT Tt Tt 77a

Stipulation (Legislative History) .........--.++++ 8la

Chester Hardt Memorandum ...........-seeeeeees 83a

Pre-Trial Order on Consent ........:.eeeeeeeeeeee 89a

Exhibit B, What You Should Know About Triplicate

Prescriptions .......:eeeeeeeee serene eeeeeeeee 105a

Transcript of Proceedings 12/2/74 ......----+++++. 110a

Trial Deposition of Dr. Joseph Martin Rosenberg .. 216a

Trial Deposition of Joseph Jules Wasserman ....... 295a

Trial Deposition of State of New York by Joseph

L. Cammizzaro ........cccecccccccccccnrccsces 363a

ii INDEX

PAGE

Notice of Motions to Amend the Pre-Trial Order ... 516a

Affidavit of A. Seth Greenwald, in Support of Motion 518a

Exhibit A, Defendant’s Amended List of Trial Ex-

Bite... ccccccccesseeseesesecesuneneenenaam 521a

Order Substituting Defendant ..........-++-+++++5 523a

Final Order and Judgment (Reproduced at Juris-

dictional Statement p. 14a) ......-..-eeeeeeees 524a

Notice of Appeal (Reproduced at Jurisdictional

Statement p. 18a) .......- cece eee e eee eee e eens 524a

Opinion Denying Stay, Justice Marshall (Reproduced

at Jurisdictional Statement p. 39a) .......----- 524a

Relevant Docket Entries—District Court.

DATE

3/29/73

4/ 5/73

4/ 6/73

4/10/73

73 Civ. 1303 and 73 Civ. 1431

73 Civ. 1303 (Roe v. Ingraham)

PROCEEDINGS

Filed Complaint and issued Summons (73

Civ. 1303).

Filed Affidavit of A. Seth Greenwald; Assist-

ant Attorney General, etc.

Filed Memorandum of Law in support of

Plaintiff’s Motion for a Three Judge Court.

Filed Memorandum of Law in opposition to

convening a Three Judge Court and to dis-

miss the Complaint.

Filed Plaintiff’s Order (ret. 4/6/73).

Filed Plaintiff’s Order to Show Cause and

Temporary Restraining Order (ret. 4/6/73).

Filed Plaintiffs Orper. Ordered that: Plain-

tiff’s motion for an order convening a three

judge court pursuant to 28 U.S.C. Sec. 2281

and 2284 is denied; Plaintiff’s motion for a

preliminary and permanent injunction is

denied; the complaint is dismissed for want

of substantial federal question; and the tem-

porary restraining order granted on 3/29/73

is dissolved. Execution stayed until 4/9/73

to permit plaintiff to seek a stay and to per-

fect a new appeal Carter, J. M/N.

Filed Opinion #39394 Motions for prelim-

inary and permanent injunctions are denied

and temporary restraining order is dissolved.

Complaints are dismissed for want of substan-

tial federal question. So Ordered. Carter, J.

M/N.

Relevant Docket Entries—District Court.

DATE

4/ 9/73

6/18/73

6/21/73

6/25/73

6/ 8/73

8/27/73

10/16/73

7/ 3/74

PROCEEDINGS

Filed Notice of Appeal.

Filed Defendant’s Notice of Motion to Dis-

miss (ret. 6/25/73).

Filed Memorandum of Law for Defendant to

Dismiss Complaint with attached Second In-

terim Report.

Filed Plaintiff’s reply memorandum in sup-

port of motion for a preliminary ipjunction

and in opposition to Defendant’s motion to

Dismiss.

Filed Opinion and true copy of USCA man-

date: Ordered that the District Court Order

dismissing th complaint is reversed with in-

structions; costs taxed against appellee (no

bill of costs attached) (Also in 73 Civ. 1431

RLC) (Entered 7/14/73) M/N.

Filed opinion #39786—heard before a Three

Judge Panel—The defendant’s motion to dis-

miss is denied. The motion for preliminary

injunction is denied and the restraining order

heretofore entered is vacated. So Ordered.

Judges Feinberg (Cir. Judge), Wyatt and

Carter. M/N

Filed defendants Answer to complaint (also

73-1431).

Filed Stipulation and Order that, for pur-

poses of the above entitled action, the docu-

ments indicated herein constitute the legisla-

tive history of the sections in Article 33 of the

New York Public Health Laws, ete. Carter, J.

Relevant Docket Entries—District Court.

DATE

11/21/74

11/22/74

11/27/74

12/ 2/74

12/ 3/74

12/ 3/7

1/20/75

PROCEEDINGS

Filed consent pretrial order—Carter, J.

Filed consent pretrial order (#2) Carter, J.

Filed Defendant’s trial memorandum.

Filed order that the trial (Three Judge Court;

Feinberg, (J. Wyatt, J. and Carter, J.) will

be held on 12/2/74. Ordered that the parties

shall submit trial memoranda by 11/27/74.

Original to be filed with the Clerk of the

Court, copies thereof delivered to each mem-

ber of the Three Judge Court—Carter, J.

M/N

Filed Plaintiffs’ and Intervenors’ Trial mem-

orandum.

Filed order designating the following judges

in addition to Judge Carter, to hear and de-

termine cause: Wilfred Feinberg, C.J. and

Inyer B. Wyatt, J—Kaufman, Ch. J.—C.A.

Filed consent pretrial order that 73 Civ. 1431

shall be consolidated for trial and tried jointly

with this proceeding—Carter, J.

Filed Plaintiffs’ memorandum of law in sup-

port for a preliminary injunction.

Filed reply memorandum in support of plain-

tiffs’ motion for a preliminary injunction and

in opposition to defendant’s motion to dismiss

the complaint.

Filed Plaintiffs’ memorandum in support of

motion for a Three Judge Court and T.R.O.

Relevant Docket Entries—District Court.

DATE

1/29/75

2/28/75

3/28/75

4/ 1/75

4/11/75

4/22/75

PROCEEDINGS

Filed Defendant’s memorandum of law in

opposition to motion to convene a Three Judge

Court and to dismiss.

Filed Transcript of Record of Proceedings

dated December 2, 1974—(also in 73 Civ.

1431).

Filed Defendant’s post trial memorandum

(also for 73-1431).

Filed Plaintiffs’ post trial brief with proposed

Findings of Fact and Conclusions of Law

(also for 73-1431).

Filed Intervenors’ post trial memorandum of

law.

Filed Plaintiffs’ reply post trial brief.

Filed Defendant’s affidavit and notice of mo-

tion to amend pre-trial order as indicated and

for judgment in favor of defendant on the

close of plaintiffs’ prima facie case, etc. (re-

turnable 4/25/75).

Filed deposition of Joseph A. Bonacci on

12/6/74 M/N.

Filed deposition of State of New York by

Joseph L. Cannizzaro on 12/5/74 M/N.

Filed Plaintiffs’ affidavit in opposition to cer-

tain portions of defendant’s motion to amend.

Filed deposition of Dr. Jerry Martin Rosen-

berg taken on 12/4/74.

Filed deposition of Joseph Jules Wasserman,

a witness taken on 12/4/74.

Relevant Docket Entries—District Court.

DATE

4/22/75

7/28/75

8/13/75

9/17/75

10/ 3/75

PROCEEDINGS

Filed transcript of record of proceedings

dated 12/2/74 (copy and not certified).

Filed memo endorsed on defendant’s motion

to amend pre-trial: Defendant’s motion to

amend pretrial order to include exhibit A-N

inclusive is granted. Defendant’s motion to

exclude the testimony of Joseph Wasserman

and to grant judgment to defendant at the

close of plaintiffs’ prima facie case is denied.

So Ordered—Carter, J. (for 73-1303 and 73-

1431).

Filed Opinion #42959 Three Judge Court

holding that so much of sections 3331(b),

3332(2) and 3334(4) of the New York Public

Health Law as requires reporting to a state

authorities. The names and addresses of

patients who receive Schedule II drugs and

medication is an unconstitutional interference

with plaintiffs’ rights of privacy guaranteed

under the 16th Amendment. The decision

makes unnecessary an evaluation of the state

measures to insure confidentiality. Settle

order and notice. Judges Feinberg, Wyatt

and Carter. M/N.

Filed Plaintiffs’ affidavit of Michael Lesch in

support of Plaintiffs proposed judgment.

Filed affidavit and order substituting Robert

P. Whalen Commissioner of Health of the

State of New York as defendant in place of

his predecessor, Hollis 8S. Ingraham. Carter,

Relevant Docket Entries—District Court.

DATE

10/ 9/75

10/20/75

10/21/75

11/ 5/75

PROCEEDINGS

Filed Final Order and Judgment that sections

3331(6), 332(2)(a) and 333(4) of the New

York Public Health Law, insofar as they re-

quire disclosure to the State of New York the

identity of patients receiving prescriptions

for Schedule II controlled substances are de-

clared unconstitutional, ete. Defendant’s are

enjoined from enforcing said provisions.

Paragraphs 3 and 4 of this judgment are

stayed on condition that defendant timely file

a notice of appeal to the U.S. Supreme Court.

Feinberg, C. J., Wyatt, J. & Carter, J. Judg-

ment entered—Clerk M/N.

Filed Defendant’s notice of appeal to the

U.S. Supreme Court.

Filed order (with letter attached) that De-

fendant’s letter of 10/16/75 is treated as a

motion for further stay of the order of

10/9/75. Motion for a further stay is denied

—Feinberg, C.J., Wyatt, J. and Carter, J.

M/N.

Filed letter by Supreme Court of the U.S.

Office of the Clerk, dated 10/30/75, forward-

ing copy of opinion by Justice Marshall dated

10/28/75.

Filed copy of Justice Marshall’s memoran-

dum opinion of 10/28/75, denying the applica-

tion for a stay in this action.

Relevant Docket Entries—District Court.

DATE

4/ 4/73

4/12/73

4/19/73

6/ 8/73

10/16/73

11/27/74

12/ 2/74

2/28/75

3/28/75

4/ 1/75

73 Civ. 1431 (Patient v. Ingraham)

PROCEEDINGS

Filed complaint and issued summons (73 Civ.

1431).

Filed Plaintiffs’ notice of appeal.

Filed transerpit of record proceedings dated

April 6, 1973.

Filed Notice to Docket Clerk that record on

appeal has been certified and transmitted to

USCA on 4/19/73.

Filed opinion and true copy of USCA man-

date—same as 73-1303; reversing order of the

District Court and ordering a Three Judge

Court.

Filed Defendant’s answer to complaint.

Filed order—same as 73-1303; setting trial

date and date for submitting memoranda.

Filed order—same as 73-1303, designating

members of Three Judge Court.

Filed consent pretrial order—same as 73-1303,

ordering consolidation with 73-1303, Carter, J.

Filed transcript of record of proceedings

dated 12/2/74.

Filed Defendant’s post trial brief (73-1303).

Filed Plaintiffs’ post trial brief (73-1303).

Filed Plaintiffs’ post trial memorandum of

law.

Relevant Docket Entries—District Court.

DATE

8/13/75

9/17/75

10/ 8/75

10/21/75

PROCEEDINGS

Filed Opinion #42959—same as in 73-1303

hoiding the challenged sections of the N Y

Public Health Law, to be unconstitutional as

a violation of the Right to Privacy.

Filed affidavit of Michael Lesch in support of

plaintiff’s proposed judgment. (73-1303)

Filed Final Order and Judgment—same as

73-1303.

Filed order that Defendant’s motion for a

stay is denied. (73-1303)

Complaint (Roe, 73 Civ. 1303).

UNITED STATES DISTRICT COURT

SourHERN District or New York

Ricuarp Ror, an infant, by Robert Roe, his parent, Joun

Dor, an infant, by Mary Doe, his parent, James Mog,

by Michael Moe his parent, Jane Pos, MatrHew T.

Bropy, Israzt L. Scumierer and EMPIRE State Puy-

stoians Gump, Inc.,

Plaintiffs,

against

Hous S. Ixcranam, as Commissioner of Health

of the State of New York,

Defendant.

,™

Plaintiffs, by their attorneys Shea Gould Climenko &

Kramer and Solomon Z. Ferziger, for their complaint

herein, allege as follows:

1. This is a civil action brought by the plaintiffs, on

their own behalf and on behalf of all others similarly

situated, for a temperary and permanent injunction

against enforcement of those provisions of Article 33 of

the New York Public Health Law (referred to herein-

after as the “Act”) which require physicians to record, on

prescriptiton forms to be filed with the State of New York,

the identity of patients using medications set forth in

Schedule II of Section 3306 of the Act (referred to herein-

after as “Schedule II controlled substances”) and to declare

such requirement violative of the Fourteenth Amendment

of the United States Constitution.

9. Jurisdiction is conferred upon this Court pursuant

to 28 U.S.C. Sections 1343(3), 2281, 2201 and 2202.

10a

Complaint (Roe, 73 Civ. 1303).

3. Each of the individual plaintiffs is a citizen of the

United States, a resident of New York State and at least

one resides in the Southern District of New York.

4. Plaintiffs Richard Roe, Joe Doe and James Moe (who

are infants appearing by their parents) and Jane Poe are

patients regularly receiving prescriptions for medications

listed on Schedule II of Section 3396 of Article 33 of the

New York Public Health Law. The aforesaid plaintiffs

are suing under fictitious names to avoid public disclosure

of their identity.

5. Plaintiffs Matthew T. Brody and Israel L. Schmierer

are physicians who, in the course of their practices, pre-

scribe for recognized medical purposes, drugs listed on

Schedule IT of Section 3306 of Article 33 of the New York

Public Health Law.

6. Plaintiff Empire State Physicians Guild, Inc. is a

Membership Corporation organized and existing under the

laws of the State of New York.

7. Defendant Hollis S. Ingraham is Commissioner of

Health of the State of New York and is sued herein in that

capacity.

8. On June 8, 1972, Governor Nelson A. Rockefeller

signed into law, Laws of New York 1972, Chapter 878,

entitled “An Act to amend the public health law and the

penal law, in relation to controlled substances and danger-

ous drugs, and repealing articles thirty-three, thirty-

three-A and thirty-three-B of the Public Health Law, and

section 220.00 of the penal law in relation thereto.” (The

text of the Act is set forth herein as Appendix A.) By its

terms the Act becomes effective on April 1, 1973.

lla

Complaint (Roe, 73 Civ. 1303).

9. The Act on its face and as construed and applied

by defendant requires (1) that, except as expressly au-

thorized by a provision for emergency oral prescriptions,

all Schedule II controlled substances may be prescribed or

dispensed only upon an official New York State prescrip-

tion (Section 3338(2)); (2) that such prescription shall be

prepared in triplicate and the original and both copies

shall contain, inter alia, the name, address and age of the

ultimate user for whom the substance is intended (Section

3332(2)); (3) that if a physician dispenses the substance,

he shall keep the original prescription and forward two

copies to the Department of Health (Section 3331(6)) and

if a physician prescribes the substance, he shall retain one

copy of the prescription, transmit the original and one copy

of the pharmacist who retains the original and files the

copy with the Department of Health (Section 3333(4)) ;

and (4) that the Department of Health may make disclos-

ure of the information contained on such prescriptions to,

inter alia, any “person who by virtue of his office is en-

titled to obtain such information” (Section 3371(1)(a)).

10. In or about January 1973, the Commissioner of

Health promulgated certain rules and regulations with re-

spect to controlled substances pursuant to authority there-

fore in the Act.

11. The Act on its face, and as construed and applied,

violates the Fourteenth Amendment of the United States

Constitution in that, by requiring disclosure of the identity

of certain patients it invades the patient’s right of privacy

and confidentiality, infringes on the doctor’s right to pre-

scribe treatments for his patients solely on the basis of

medical considerations and discriminates against persons

suffering from certain diseases by requiring their identifi-

cation to a governmental agency as a condition to receiv-

ing medical treatment for their illnesses.

12a

Complaint (Roe, 73 Civ. 1303).

12. This suit involves a genuine case of controversy be-

tween plaintiffs and defendant.

13. The plaintiffs have no plain, speedy or adequate

remedy at law and will suffer irreparable injury unle:s a

preliminary and permanent injunction is granted.

Wueneror:, plaintiffs pray that the following relief be

granted:

1. That a three-judge court be convened as provided in

298 U.S.C. Sections 2281 and 2284 to declare unconstitu-

tional and enjoin the enforcement of Sections 3331(6),

3332(2) (a) and 3333(4) of the Act insofar as they require

disclosure to the State of the identity of patients using

Schedule II controlled substances.

2. That the defendant, his agents, servants and em-

ployees

(a) be enjoined from distributing New York State

prescription forms requesting the identity of patients

receiving prescriptions for Schedule II controlled sub-

stances ;

(b) be enjoined from accepting for filing New York

State prescription forms containing the identity of

patients receiving prescriptions for Schedule II con-

trolled substances ;

macists to complete and file prescription forms con-

taining the identity of patients receiving prescriptions

for Schedule II controlled substances ; and

(d) be ordered to destroy any New York State pre-

scription forms previously filed containing the identity

of patients receiving prescriptions for Schedule Il

13a

Complaint (Roe, 73 Civ. 1303).

controlled substances and any records made there-

from.

3. That an injunction, pendente lite, be granted to the

plaintiffs against the defendant, his agents, servants and

employees for the relief sought in paragraphs 2(a), (b)

and (c) hereinabove and ordering that defendant, his

agents, servants and employees deposit in the registry of

this Court any New York State prescription forms pre-

viously filed containing the identity of patients receiving

prescriptions for Schedule II controlled substances and

any records made from such forms.

4. That the plaintiffs be granted such other and further

relief as the Court may deem just and proper.

Dated: New York, New York, March 28, 1973.

Suea Goutp CLimenko & KRAMER

By MicHaeL Lescu

A Member of the Firm

and

Sotomon Z. Ferzicer, Esq.

Attorneys for Plaintiffs.

l4a

Complaint (Patient, 73 Civ. 1431).

UNITED STATES DISTRICT COURT

SouTHERN District or New York

Georce Patient, MartHa Patient, Geratp L. Lustie and

Tue AMERICAN FEDERATION OF PHYSICIANS AND DENTISTS,

Plaintiffs,

—against—

Hous S. [ncranam, as Commisioner of iealth

of the State of New York,

Defendant.

. 4

Plaintiffs, by their attorneys, Norwick, Raggio & Jaffe,

as cooperating attorneys for the New York Civil Liberties

Union, for their complaint, allege as follows:

1. This is a civil suit by the plaintiffs, on their own

behalf and on behalf of others similarly situated, for a

temporary and permanent injunction against enforcement

of those provisions of Article 33 of the New York Public

Health Law (referred to hereinafter as the “Act”) which

require physicians to record, on prescription forms to be

filed with the State of New York, the identity of patients

using medications set forth in Schedule II of Section 3306

of the Act (referred to hereinafter as “Schedule II con-

trolled substances”) and to declare such requirement viola-

tive of the Fourteenth Amendment of the United States

Constitution.

2. Jurisdiction is conferred upon this court pursuant to

28 U.S.C. 1331, 1343(3), 2281, 2201 and 2202 as well as

—

15a

Complaint.

by 42 U.S.C. 1983 and by the Commerce Clause of the

United States Constitution, Article 1, Section 8 and by

the Fourteenth Amendment of the United States Consti-

tutior..

3. The amount in controversy in this action is in excess

of $10,000.

4. Each of the individual plaintiffs is a citizen of the

United States, a resident of New York State and at least

one resides in the Southern District of New York.

5. Plaintiff George Patient is a patient regularly re-

ceiving prescriptions for medication listed on Schedule II,

namely, Hycodan and Percodan, in treatment for his con-

ditions resulting from his status as a post-operative can-

cer patient. Plaintiff Martha Patient is a patient regu-

larly receiving prescriptions for medication listed on

Schedule If, namely Demerol, in treatment of a migraine

condition. These plaintiffs are suing under fictitious

names to avoid pvblic disclosure of their identity.

6. Plaintiff Lustig is a physician who in the course of

his practice prescribes for recognized medical purposes

drugs listed on Schedule IT and who has preseribed Sched-

ule II drugs for plaintiff George Patient.

7. Plaintiff American Federation of Physicians and

Dentists is an unincorporated association of physicians

and dentists.

8. Defendant Hollis S. Ingraham is Commissioner of

Health of the State of New York and is sued herein in that

capacity.

9. On June 8, 1972, Governor Nelson A. Rockefeller

signed into law, Laws of New York 1972, Chapter 878, en-

l6a

Complaint.

titled ‘‘An Act to amend the public health law and the

penal law, in relation to controlled substances and dan-

gerous drugs, and repealing articles thirty-three, thirty-

three-A and thirty-three-B of the Public Health Law, and

section 220.00 of the penal law in relation thereto.’’ (The

text of the Act is set forth herein as Appendix A.) By its

terms the Act becomes effective on April 1, 1973.

10. The Act on its face and as construed and applied by

defendant requires (1) that, except as expressly authorized

by a provision for emergency oral prescriptions, all Sched-

ule II controlled substances may be prescribed or dis-

pensed only upon an official New York State prescription

(Section 3538(2)); (2) that such prescription shall be pre-

pared in triplicate and the original and both copies shall

contain, inter alia, the name, address and age of the ulti-

mate user for whom the substance is intended (Section

3332(2)); (3) that if a physician dispenses the substance,

he shall keep the original prescription and forward two

copies to the Department of Health (Section 3331(6)) and

if a physician prescribes the substance, he shall retain one

copy of the prescription, transmit the original and one

copy to the pharmacist who retains the original and files

the copy with the Department of Health (Section 3333(4) ) ;

and (4) that the Department of Health may make dis-

closure of the information contained on such preseriptions

to, inter alia, any ‘‘person who by virtue of his Office is

entitled to obtain such information’’ (Section 3371(1)(@N.

11. In or about January 1973, the Commissioner of

Health promulgated certain rules and regulations with

respect to controlled substances pursuant to authority

therefor in the Act.

12. The Act on its face, and as construed and applied,

violates the Fourteenth Amendment of the United States

l7a

Complaint.

Constitution in that, by requiring disclosure of the identity

of certain patients it invades the patient’s right of privacy

and confidentiality, infringes on the doctor’s right to pre-

scribe treatments for his patients solely on the basis of

medical considerations and discriminates against persons

suffering from certain diseases by requiring their identifi-

cation to a governmental agency as & condition to receiving

medical treatment for their illnesses.

13. The Act on its face conflicts with, is inconsistent

with and overlaps federal law and federal regulation and

is thus void, being in conflict with the commerce power

of the United States government and the laws and regu-

lations enacted by the United States pursuant thereto.

Wuenrerore, plaintiffs pray that the following relief be

granted:

1. That a three-judge court be convened as provided in

28 U.S.C. 2281 and 2284 to declare unconstitutional and

enjoin the enforcement of Section 3331(6), 3332(2) (a) and

3333(4) of the Act in so far as they require disclosure to

the State of the identity of patients using Schedule I

controlled substances.

29. That the defendant, his agents, servants and em-

ployees

(a) be enjoined from distributing New York State

prescription forms requesting the identity of patients

receiving prescriptions for Schedule IT controlled sub-

stances ;

(b) be enjoined from accepting for filing New York

State prescription forms containing the identity of

patients receiving prescriptions for Schedule II con-

trolled substances ;

SL o_- i-_—_——_ nc -_- <<

18a

Complaint.

macists to complete and file prescriptiton forms con-

taining the identity of patients receiving prescriptions

for Schedule II controlled substances; and

(d) be ordered to destroy any New York State

prescription forms previously filed containing the

identity of patients receiving prescriptions for Sched-

ule II controlled substances and any records made

therefrom.

3. That an injunction, pendente lite, be granted to the

plaintiffs against the defendant, his agents, servants and

employees for the relief sought in paragraphs 2(a), (b)

and (c) hereinabove and ordering that defendant, his

agents, servants and employees deposit in the registry of

this Court any New York State prescription forms previ-

ously filed containing the identity of patients receiving

prescriptions for Schedule II controlled substances and

any records made from such forms.

4. That the plaintiffs be granted such other and further

relief as the Court may deem just and proper.

Dated: New York, New York, April _, 1973.

Norwick, Racecio & JAFFE

A Member of the Firm

19a

Affidavit of A. Seth Greenwald.

UNITED STATES DISTRICT COURT

SovuTrHERN District or New York

As.

Ricuarp Rog, an infant by Roserr Rog, his parent, JoHn

Dor, an infant by Mary Dor, his parent, James Mog, an

infant by Micnaet Moe, his parent, Jane Pog, MatTTHEW

T. Bropy, Israe, L. Scuurerer, and Empre State Puy-

sictans GuiLp, INc.,

Plaintiffs,

against

Hous S. IxcranaM, as Commissioner of Health

of the State of New York,

Defendant.

Srate or New York t ss ;

County or New York

A. Sern GREENWALD, being duly sworn, deposes and says:

I am an Assistant Attorney General in the Office of Louis

J. Lefkowitz, Attorney General of the State of New York,

attorney for defendant and make this affidavit to present

several pertinent procedural] considerations to the court.

The institution of the law suit with fictitious names

raises the question considered in Roe v. State of New York,

49 F.R.D. 279, 8 A.L.R. Fed. 670 (S.D.N.Y. 1970). Since

the “Roes”, “Does” and “Moes” are the real parties in

interest the Court and the defendant should be given the

names of same to insure the existence of actual contro-

——

20a

Affidavit of A. Seth Greenwald.

versy. This can be accomplished by the filing of an affidavit

containing the true name and identity of the fictitious

plaintiffs. This was done in Doe v. Lavine, 72 Civ. 2517

(S.D.N.Y.). After this is done, your deponent has no ob-

jection to taking whatever steps necessary to insure con-

tinued anonymity.

It should be pointed out that Dr. Schmierer may well

have named severa! of the infant plaintiffs in his affidavit.

Mentioned therein are Howard Goldstein and James

Maiorana.

II.

On March 29, 1973, this Court issued a general tempo-

rary restraining order against defendant. However this

is not a class action and plaintiffs make none of the re-

quired recitals in their complaint, except that it is on

“behalf of all others similarly situated” (par. “1”). In

all other respects it fails to comply with Rule 23, F.R.C.P.

In particular we wonder whether the representative par-

ties adequately represent the class. 23(a)(4). The partys’

attorney must be qualified, experienced and generally able

to conduct the proposed litigation. Eisen v. Carlisle ¢

Jacquelin, 391 F. 2d 555, 562 (2d Cir. 1968). We do not

contend plaintiffs’ attorneys are not but, on the other hand,

they have not so affirmatively stated.

In view of the lack of a class action, Rule 23, the t.r.o.

should immediately be limited to plaintiffs’ prescriptions

and no others. Also no pharmacists are represented so

that the plaintiffs should not purport to seek relief on their

behalf.

In sum, this action should not be treated as a class action

unless there is compliance with Rule 23.

2la

Affidavit of A. Seth Greenwald.

II.

In view of the confusion engendered by the original t.r.o.

with the subsequent modification, we urge that this action,

if it is to be dismissed, be done with expedition. If, as we

contend, the public health is endangered by the continua-

tion of any restraints on the law, this Court should not

extend the t.r.o. and quickly decide the case. We believe

that at this time the plaintiffs have not shown any harm

by letting the law go into complete operation. They only

express conjectures and vague fears in the distant future.

If they are, by chance, successful, full relief can be ren-

dered at that time. However at this time there is no need

for relief since it is not the recording of data that is a

possible invasion of privacy but the ultimate revelation of

same. Of course, we contend this will not occur and if the

plaintiffs took the effort to fully investigate defendant’s

proposed procedures they would have been aware of this.

Rather they have acted out of fear, unsupported by facts.

WuHeEreEFoRE, your deponent respectfully requests that

plaintiffs’ motion be denied, the temporary restraining

order dissolved, and the complaint dismissed with all pos-

sible dispatch.

(Sworn to by A. Seth Greenwald, April 4, 1973.)

22a

Affidavit of Robert Whalen, M.D.

UNITED STATES DISTRICT COURT

SouTHERN District or New York

—

Ricwarp Rog, et al.,

Plaintiffs,

Hoiuis S. Incranam, M.D.,

Defendant.

State or New York t ss '

County or New York

Rosert Wuaten, M.D. being duly sworn deposes and

says:

Deponent is the Second Deputy Commissioner of the New

York State Department of Health and in such capacity has

the direct responsibility under the Commissioner of Health

for Department policy relating to controlled substances.

Chapter 878 of the Laws of 1972 enacting a new Article

33 to the Public Health Law was signed by Governor Rocke-

feller June 8, 1972.

The legislation was the result of extensive investigation

by the Temporary Commission to Evaluate the Drug Laws

into pertinent medical practice, extent of abuse, and ave-

nue of diversion of legal drugs. Hearings were conducted

throughout the State and the opinions of hundreds of ex-

perts were solicited.

The Department has proceeded to implement the provi-

sions of the law including the requirement of a triplicate

prescription. The procedural steps are as follows:

Upon the application by a practitioner, official New York

State prescription forms are issued in groups of one hun-

23a

Affidavit of Robert Whalen, M.D.

dred serially numbered forms. For prescribing or dis-

pensing a Schedule II substance, the practitioner will use

the triplicate form. If he dispenses the substance, he will

keep the original and forward two copies to the Department.

If he prescribes the substance, he will give the patient the

original and one copy. ‘The patient will take both the

original and the copy to the pharmacy. The pharmacist

filling the prescription will sign his name upon the original

and the copy and will note the date of delivery, and the

registration number of the pharmacy. He will then, by the

fifteenth of the following month, send the endorsed copy to

the Department. He will retain the original for five years.

Once the Department has received the copies, it will be

able to compile data which will uncover irregularities such

as forgeries, fraudulent obtaining of Schedule II sub-

stances, and thefts of prescription blanks and the.r misuse

by unauthorized persons. The information received by the

Department will show if a patient has obtained prescrip-

tions by going from doctor to doctor, or if stolen prescrip-

tions are being used. This procedure will also indicate

where there is a possibility of over-preseribing or over-

dispensing of Schedule II drugs.

Drug abusers operate in part through legitimate medical

channels. Prescriptions are raised and refilled repeatedly

and ficititious patient names are used. Individual patients

go to more than one physician for drug prescriptions to be

used for nonmedical needs and there are instances of over-

prescribing.

At the time this proceeding was commenced over 23,000

practitioners had submitted orders and been mailed tripli-

cate prescription forms. Such forms have been ordered by

and mailed to approximately 300 institutions in New York

State.

The requirement for a triplicate prescription is one part

of the broad control mechanism of narcotics, depressants,

stimulants and hallucinogens provided for in Article 33.

24a

Affidavit of Robert Whalen, M.D.

The need for contro] has long been recognized and pol-

icies relating to socially condemned drugs date back at

least to the Federal Harrison Anti-Narcotie Act of 1914,

which required that doctors be registered under the Act

and made the manner of securing drugs a matter of record.

The original goal was to make the entire process of dis-

tribution in America a matter of record. A series of Fed-

eral acts continued such controls, the most recent of which

is the Federal Controlled Substances Act of 1970. A simi-

lar pattern prevailed in the states with a Uniform Nar-

eotics Act enacted in most of the states. Controls in New

York State go back to about World War I and a basic Uni-

a Narcotic Drug Act was enacted in New York State in

Txat the Uniform Narcotic Drug Act, as enacted in New

York State in 1933, requires that the full name and address

of the patient be on the prescription. This requirement

has existed until the present time in both the Public Health

Law (Public Health Law § 3301 (32) and in the Federal

Regulations (21 CFR 4306.05). The identity of the pa-

tient on the label has also been a requirement of both the

State and Federal Laws.

Tuat there is a need for control has been thoroughly

documented. To review the statements and acts of Presi-

dent Nixon aud Governor Rockefeller would be to repeat

generally known information as to abuses and efforts made

to curb such abuses. It would be difficult to envision a sys-

tem of controls that would be effective which did not re-

quire a physician to identify the patient for whom a drug

is prescribed.

Information as to the identity of patients has always

been required and has been available as limited by the stat-

ute. Records required by the control provisions existing

prior to April 1, 1973 are confidential and are only open to

inspection by “federal, state, county and municipal officers,

208

Affidavit of Robert Whalen, M.D.

whose duty it is to enforce the laws of the state or of the

United States relating to narcotic drugs”. The law effec-

tive April 1, 1973 does not make available information that

was not available prior to April 1 and, as a matter of fact,

places a greater cloak of confidentiality over this informa-

tion. Public Health Law § 3371 prohibits disclosure by

Department personnel except (1) pursuant to judicial sub-

poena or court order, (2) to agencies licensing persons au-

thorized to deal in controlled substances and (3) to another

person who by virtue of his office is entiled to obtain such

information. This last exception is to allow disclosure in-

ternally within the Department to those with a controlled

substance responsibility. The Temporary Commission to

Evaluate the Drug Law stated in its interim report that

“this would relate primarily to intra-departmental commu-

nications”. The section further provides that where such

information is disclosed in a proceeding the court shall in-

sure that such information is not made public.

The Department is experienced in dealing with confiden-

tial data and gathers information, reports and statistics in

such diverse areas as venereal disease, tuberculosis, cancer

and medical rehabilitation and is the custodian of birth,

death, fetal death, marriage and dissolution of marriage

records. All Department staff and persons with duties re-

quiring access to Department records are instructed to

treat as confidential any information or data received or

developed in the performance of their duties. Utmost care

will be taken with respect to triplicate prescriptions to in-

sure that only Department personnel with specific Con-

trolled Substances functions have access to the information.

The pharmacists are provided with preaddressed en-

velopes to mail to the Department the copies of the pre-

scriptions. The copies received by the Department, as well

as the tapes or punch cards produced from them will be

given special handling and kept in locked, secured areas

26a

Affidavit of Robert Whalen, M.D.

while not in use, with access thereto strictly cireumscribed

by the Commissioner. There will be no massive print out

of patient names but, on the contrary, the availability of

such information will be severely limited. Attached are

detailed statements of Department procedures and policies

on both security and confidential information.

Deponent has read the papers in this proceeding and it

would appear that in many instances affiants are reading

or interpreting the statute incorrectly.

The identity of the patient is required in the case of ad-

dicts and habitual users. The practitioner is not required

to file the original and a copy of the individual official pre-

scription required by Public Health Law § 3331 (6) for the

treatment of addiction maintenance because § 3355 of the

Public Health Law has specific reporting requirements for

maintenance programs including the identity of the patient

and the amount of drugs administered or dispensed. There

is no discrimination between addicts and habitual users on

the one hand and others for whom drugs may be prescribed.

The purpose of collecting copies of the prescriptions

centrally is to increase the efficiency of the controls man-

dated by Article 33. The filing of the prescription does

not indicate the medical condition for which the drug was

prescribed, is not a recording of illness, does not impair

the patient-doctor relationship and certainly does not re-

sult in ridicule, abuse or blackmail.

The affidavits of the physician in support of the injune-

tion support a medical use for the drugs prescribed. That

Schedule IT drugs have a medical use is not in question.

The schedules as set forth in the Public Health Law range

from Schedule I, having no currently accepted medical use

and a high potential for abuse to Schedule V which has a

currently accepted medical use and a low potential for

abuse. Schedule IT drugs have a currently accepted medi-

cal use with severe restrictions and a high potential for

abuse requiring strict controls.

27a

Affidavit of Robert Whalen, M.D.

A similar multiple prescription procedure has been in

effect in California since 1940, in Illinois since 1958 and in

Idaho since 1967. Experience indicates that computer

accessibility of such information uncovers such irregulari-

ties as forgeries, fraudulent obtaining of narcotic drugs,

theft of prescription blanks and their misuse by unauthor-

ized persons and other abuses. To the best of deponent’s

knowledge no litigation in those states has questioned the

disclosure of the identity of the person for whom the pre-

scription is written.

The availability of such information to another person

who by virtue of his office is entitled to obtain such infor-

mation, as provided for in Public Health Law § 3371,

heavily relied on by petitioners, is only to allow disclosure

internally within the Department as set forth earlier in

this affidavit.

It is unlawful for any person to administer or dispense

a controlled substance except as expressly allowed by Arti-

cle 33 of the Public Health Law. Specifically provided

for to enable Schedule IT controlled substances to be ad-

ministered or dispensed is the official triplicate prescrip-

tion. The elimination of such provision would prevent

such substances from being administered or dispensed in

the State of New York, there being no statutory alterna-

tive, and would create a vacuum.

The temporary restraining order has created confusion

among practitioners and pharmacists. Many are under

the mistaken belief that they need not comply with the

triplicate prescription requirements of Article 33. Profes-

sional confusion is to the detriment of the health care needs

of the citizens of New York State.

This affidavit is made in opposition to the request of the

plaintiffs fora preliminary injunction and in opposition

to the continuance of the temporary restraining order.

(Sworn to by Robert P. Whalen, M.D., April 3, 1973.)

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30a

Order Denying Plaintiffs’ Motions, etc.

UNITED STATES DISTRICT COURT

SouTHERN District or New York

73 Civ. 1303 (RLC)

Ricuarp Roe, an infant by Roserr Roe, his parent, Jonn

Dor, an infant by Mary Dor, his parent, James Mor, an

infant by MicHart Mog, his parent, Jane Por, MarrHew

T. Bropy, Israzen L. Scumrerer and Emprme Srarte

Puysicians Gump, Inc.,

Plaintiffs,

—against—

Ho.us 8S. Iyeranam, as Commissioner of Health of

the State of New York,

Defendant.

ORDER

Plaintiffs having applied for an order convening a three

judrge court, pursuant to 28 U.S.C. §§ 2281 and 2284, on

the ground that plaintiffs seek an interlocutory and perma-

nent injunction restraining the enforcement, operation and

execution of a state statute by restraining the action of

an officer of such state upon the ground of the unconstitu-

tionality of such statute and for an order enjoining de-

fendant, his agents, servants and employees from en-

forcing those provisions of Article 33 of the New York

Public Health Law, and this Court having previously

granted an order restraining enforcement of certain pro-

visions of Article 33 of the New York Public Health Law

pending determination of plaintiffs’ application for an

order convening a three judge court and for a permanent

injunction ;

3la

Order Denying Plaintiffs’ Motions, etc.

Anp defendant having opposed said motion, it is hereby

Orperep that plaintiffs’ motion for an order convening

a three judge court pursuant to 28 U.S.C. §§ 2281 and 2284

be, and it hereby is, denied; and it is further

OrpereD that plaintiffs’ motion for preliminary and per-

manent injunction is denied and complaints dismissed for

want of a substantial federal question.

Orperep that the temporary restraining order granted

herein on March 29, 1973 be and is hereby dissolved.

Execution stayed until 12 noon on Monday, April 9, 1973

to permit plaintiff to seek a stay and to perfect their

appeal to the United States Court of Appeals.

Dated: New York, New York

April 6, 1973

s/ Rospert L. Carter

U.S.D.J.

32a

Opinion Denying Plaintiff's Motion for an Order

Convening a Three-Judge Court, etc.

Richard Ror, an infant by Robert Roe, his

parent, et al., Plaintiffs,

and

George Patient et a!., Intervenors,

Hollis S. Incranam, as Commissioner of

Health of the State of New York,

Defendant.

No. 73 Civ. 1303.

United States District Court,

S. D. New York.

April 10, 1973.

Rosert L. Carter, District Judge:

OPINION

The plaintiffs have made a narrow attack upon the com-

prehensive New York Controlled Substances Act, N.Y. Pub-

lic Health Law 43300 et seq. (McKinney’s Consol. Laws,

ce. 45 Supp.1972), which attempts to regulate virtually all

facets of the use and distribution of drugs in this state for

which a prescription is required. The plaintiffs object only

to those sections, specifically §4 3331(6),* 3332(1), (2)(a),?

***§ 3331 Scheduled substances administering and dispensing

by practioners.

oe e * * *

6. A practitioner dispensing a substance which may be pre-

scribed only upon an official New York state prescription must

at the time of such dispensing prepare an official New York pre-

scription in the manner set forth in subdivision two of section

(footnte continued on following page)

——

33a

Opinion Denring Plaintiff’s Motion for an Order

Convening a Three-Judge Court, etc.

(4),* 3338(2),* which, in combination, require physicians

and pharmacists to file with the state copies of prescrip-

tions for certain drugs which are described in detail in the

(footnote continued from preceding page)

thirty-three hundred thirty-two of this article. The practi-

tioner shall retain the original for a period of five years and

shall file the two copies with the department by not later than

the fifteenth day of the next month following the month in

which the substance was delivered... .”’

2 **§ 3332 Making of official New York state prescriptions for

scheduled substances.

1. No substance for which an official New York state pre-

scription is required may be prescribed by a practitioner ex-

cept on an official New York state prescription, and in good

faith and in the course of his professional practice only.

2. Such prescription shall be prepared in triplicate, written

with ink, indelible pencil or, apart from the practitioner’s signa-

ture, typewriter. The original and both copies must contain

the following:

(a) the name, address, and age of the ultimate user for

whom the substance is intended... .”’

®‘*§ 3333 Dispensing upon official New York state prescription.

1. A licensed pharmacist may, in good faith, and in the

course of his professional practice, sell and dispense to an ulti-

mate user controlled substances for which an official New York

state prescription is required only upon the delivery to such

pharmacist, within thirty days of the date such prescription

was signed by an authorized practioner, of the original and one

copy of such official New York state prescription.

4. The endorsed original prescription shall be retained by

the proprietor of the pharmacy for a period of five years. The

endorsed copy of such prescription shall be filed with the de-

partment by not later than the fifteenth day of the next month

following the month in which the substance was delivered.’’

* “§ 3338 official New York state prescription forms.

e e & * e

2. Except as expressly authorized by section thirty-three

hundred thirty-four, substances listed in schedule II may be

prescribed or dispensed only upon an official New York state

prescription. ...”’

34a

Opinion Denying Plaintiff’s Motion for an Order

Convening a Three-Judge Court, etc

statute under the heading of “Schedule IT” drugs, § 3306.

Concededly, although the statute does not require it, the

state will enter the information it receives, including the

name of the patient for whom the drug is prescribed, into

a computer file. It is this mechanized collation of data,

pursuant to which the state will have on file the names and

addresses of patients who are users of prescribed drugs,

that constitutes the gravaman of plaintiffs’ complaint.

On March 29, 1973 the plaintiffs’ petitioned this court for

an order to show cause on a motion to convene a three

judge court pursuant to 28 U.S.C. §§ 2281, 2284 on the

ground that plaintiffs sought preliminary and permanent

injunctions restraining the implementation of ceriain sec-

tions of the New York Controlled Substances Act (which

was to become effective on April 1, 1973), which were al-

legedly constitutionally infirm, The plaintiffs further

sought a temporary restraining order which would stay

implementation of the Act pending determination of the

merits. The cou:t heard all counsel and signed the order®

setting oral argument for Friday, April 6, 1973.

* Counsel for plaintips George Patient, et al., petitioned this

court on April 3, 1973 to intervene in the principle action. There

being no objection by counsel in the Roe action, the motion was

granted on April 6, 1973 and reference to ‘‘plaintiffs’’ hereinafter

includes the intervenors.

° The temporary restraining order did not enjoin the implementa-

tion of the entire act. Rather it ordered, in substance, that the de-

fendant was restrained from:

1. filing or processing prescription forms identifying the

patients receiving Schedule II drugs;

2. requiring physicians or pharmacists from filing prescription

forms identifying the patients receiving Schedule II drugs;

and ordered that the defendant retain in a secure place uny pre-

scription forms received during the pendency of the temporary re-

straining order.

35a

Opinion Denying Plaintiff’s Motion for an Order

Convening a Three-Judge Court, etc.

Plaintiffs make a two pronged attack on the legislation.

First, it is argued that the statute is an unconstitutional in-

vasion of the patient’s right to privacy, and second, that

the statute creates classifications which do not comport with

the dictates of the equal protection clause.

I consider first the equal protection argument. The law

in this complex area is currently in a state of flux, see, e. g.,

Gunther, The Supreme Court 1971 Term foreword: In

Search of Evolving Doctrine on a Changing Court, 86 Harv.

L.R. 1 (1972), as evidenced by such cases as James v.

Strange, 407 U.S. 128, 92 S.Ct. 2027, 32 L.Ed.2d 600 (1972) ;

Weber v. Aetna Casualty and Surety Co., 406 U.S. 164, 92

S.Ct. 1400, 31 L.Ed.2d 768 (1972); Stanley v. Illinois, 405

U.S. 645, 92 S.Ct. 1208, 31 L.Ed.2d 551 (1972); Eisenstadt

v. Baird, 405 U.S. 438, 92 S.Ct. 1029, 31 L.Ed.2d 349 (1972) ;

and Reed v. Reed, 404 U.S. 71, 92 S.Ct. 251, 30 L.Ed.2d

225 (1971).

The Court of Appeals in this Cireuit has recently char-

acterized the appropriate test as “whether the legislative

classification is in fact substantially related to the object

of the statute.” Boraas v. The Village of Belle Terre (2d

Cir. 1973), 476 F.2d 806 at 814. —

Applying this test I find no constitutional infringement

that can be said to pose a substantial federal question. It

is of course true, that patients legitimately receiving

Schedule IT drugs are treated differently than those who

are either receiving Schedule III, IV or V drugs, those re-

ceiving no drugs at all, or those who are classified as ad-

dicts. But this is only improper if the treatment afforded

Schedule II users does not substantially further the ends

of the statute.

It is rarely easy to pinpoint with precision a statute’s

“purposes.” Here the goal is obviously at least in part to

contro] certain illegal drug uses by doctors, pharmacists

36a

Opinion Denying Plaintiff’s Motion for an Order

Convening a Three-Judge Court, etc.

and patients. The plaintiffs intimate that the more lenient

reporting standards required of Schedules III, TV and V

users make the statute underinclusive and therefore void.

This conclusion however results from a misstatement of

purpose rather that a defect in the statute. As explained

in the Memorandum of Assemblyman Chester Hardt,

Chairman of the Temporary State Commission to Evaluate

the Drug Laws, the state, by choosing to rely on voluntary

and virtually unreviewed compliance with the law as it per-

tains to the less dangerous drugs of Schedules III, TV and

V, sought not only to control drugs effectively but also to

limit the intrusion into personal affairs. Thus restricting

the new reporting requirements to Schedule II users in

fact was consonant with the legislative goals.

The plaintiffs also contend that the statute, by imposing

stricter confidentiality requirements to an addict’s records’

than it does to the records of a Schedule IT drug user,’ is

*“§ 3356 Central registry confidentiality.

1. The department shal] establish a central registry as

part of which the following information shall be assembled :

(a) the name and other identifying data relating to each

reported addict;

(b) the status of each addict awaiting admission to an ap-

proved program or programs;

(ce) the status of each addict in an approved program.

2. Identifying data in such registry with respect to an in-

dividual addict shall be available only to a practitioner at-

tempting to ascertain the status of an addict seeking treatment

ae or admission to a program with which he is asso-

ciated.”

*“§ 3371 Confidentiality of certain records, reports, and in-

formation.

1. No person, who has knowledge by virtue of his office of

the identity of a particular patient or research subject, a

(footnote continued on following page )

37a

Opinion Denying Plaintiff’s Motion for an Order

Convening a Three-Judge Court, etc.

irrational and unconstitutional. The Controlled Sub-

stances Act deals at some length with distributions of

drugs to addicts, Title V, §§ 3350-3356, and attempts to

make provision for the effective treatment and rehabilita-

tion of addicts in “maintenance programs.” It is well

known that addicts have generally been quite reluctant to

participate in drug programs. One can well assume that

active police surveillance of these programs would gen-

erate additional hostility among the addict population.

The legislature, recognizing that addicts would be particu-

larly reluctant to join treatment programs if their records

were available to the police, imposed especially rigid con-

fidentiality standards for addicts’ files. It is evident, there-

fore, that § 3356 rationally promotes a valid and legitimate

state interest and that the differing treatment afforded

Schedule IT users and addicts does no violence to any stric-

tures imposed by the equal protection clause.

The only remaining question is whether the system de-

vised does in fact further the objectives of the statute. The

(footnote ne from preceding page)

ufacturing process, a trade secret or a formula shall dis-

ee ee 8 ee tees except :

(a) to another person who by virtue of his office is en-

titled to obtain such information; or

(b) pursuant to judicial subpoena or court order in a

criminal] investigation or proceeding; or

va to an department of government, or official

cuiteteal @ wand regulate, license or otherwise supervise a

mn who is authorized by this article to deal in controlled

a Se Se a SS ae ee oo Ss

by or before such agency, department or board

2. In the course of any enafinn Gham auth totems,

tion is disclosed, except when necessary to effectuate the right

of a party to the proceeding, the court or presiding officer

shall take such action as is necessary to insure that such in-

— or record or report of such information is not made

public,”

38a

Opinion Denying Plaintiff's Motion for an Order

Convening a Three-Judge Court, etc.

conclusion that it does seems unavoidable. Through the

use of this system the state will more effectively be able to

investigate and control such drug related abuses as for-

geries, prescriptions to fictitious persons, patients receiv-

ing dangerous drugs from a number of different doctors,

and similar activity. Based upon the evidence presented

to me, especially the affidavit of Dr. Robert Whalen, Sec-

ond Deputy Commissioner of the New York State Depart-

ment of Health and the Interim Report of the Temporary

State Commission to Evaluate the Drug Laws, I can only

conclude that the system of reporting required by the stat-

ute directly and substantially effectuates the state’s legit-

imate interests as expressed by the Act.

The right to privacy, to which I now direct my attention,

is more difficult primarily because the issue has only re-

cently clearly emerged as a basic constitutional considera-

tion. It is not necessary here to expound upon the his-

torical antecedents and the current flowering of that right.

We are all aware of course that Griswold v. Connecticut,

381 U.S. 479, 85 S.Ct. 1678, 14 L.Ed.2d 510 (1965) solidified

privacy’s constitutional status and that since that decision

numerous extensions of its essence have occurred. See,

e. g., United States v. United States District Court, 407

U.S. 297, 92 S.Ct. 2125, 32 L.Ed.2d 752 (1972), Stanley v.

Georgia, 394 U.S. 557, 89 S.Ct. 1243, 22 L.Ed.2d 542 (1969)

and, to some extent, the recent decisions of Roe v. Wade,

410 U.S. 113, 93 S.Ct. 705, 35 L.Ed.2d 147 (1973) and Doe

v. Bolton, 410 U.S. 179, 93 S.Ct. 739, 35 L.Ed.2d 201 (1973).

The case at bar, however, is significantly distinguishable

from each of those cases and from any case cited to the

court by counsel. The fundamental thrust of this lawsuit

might be made clearer by briefly discussing what is not in-

volved here.

First, this is not a case where the state has launched a

broad scale invasion into the doctor-patient relationship re-

39a

Opinion Denying Plaintiff’s Motion for an Order

Convening a Three-Judge Court, etc.

quiring the publication of the entire medical history and

treatment record. Indeed, contrary to plaintiffs’ sugges-

tion, even the illness for which a Schedule IT drug is pre-

seribed need not be revealed.

Second, the statute on its face does not permit unre-

stricted divulgence of even the limited information col-

lected. In fact § 3371 confines disclosure to the extent con-

sistent with the purposes of the Act. I have also been pre-

sented with the memorandum of Assemblyman Hardt and

the affidavit of Commissioner Whalen, both of whom ap-

pear to be taking all necessary steps to maintain the

security of the computerized information.

Finally, this is not a case where the plaintiffs have been

able to prove actual abuse of the reporting and computeriz-

ing process and consequentiy to argue facial unconstitu-

tionality based upon pragmatic or historical evidence; that

is that such process necessarily and inevitably results in

abuse.

In order to further appreciate the essence of plaintiffs’

privacy argument, it is necessary to consider the status of

the law prior to April 1, 1973. Insofar as the issues in-

volved in this lawsuit are concerned, the only effective dis-

tinction is that the new statute requires sending a copy of

each prescription for Schedule II drugs to Albany to be

computerized. Previously prescriptions required the name

of the patient, N.Y. Public Health Law § 3301(32) (McKin-

ney 1971) (repealed 1973), the pharmacist was required to

keep a copy of the prescription, 7d. at § 3322, and law en-

forcement officials had complete access to the druggists

prescription files, Jd. at 4§ 3322(1)(c), 3334. In short, the

state had the power to learn all that it may now require to

be revealed. The only difference is that now the state has

developed the means to make effective use of that basic

power which remains unchallenged.

40a

Opinion Denying Plaintiff’s Motion for an Order

Convening a Three-Judge Court, etc.

I must confess, however, that plaintiffs’ claims fall upon

sympathetic ears. I share with the plaintiffs a deep con-

cern about the ultimate consequences of overzealous data

collection and instant data retrieval. I recognize the dan-

gers in a society which permits the government to know

the intimacies of its citizens’ lives and especially the conse-

quences to those people against whom such information is

maliciously or malevolently used. And I realize the poten-

tial for individual harm consequent upon errors of fact be-

coming imprinted upon unforgiving tapes.

Yet computers, computer banks—the new technology—

are facts of present day life. Courts can be no more ef-

fective than Canute in turning back the tide. It cannot be

contended, at least not seriously, that governmental use of

this new technology is constitutionally impermissible. And

that is the fundamental and basic question which is being

raised.

It may well be that courts will be required to establish

guidelines and set standards but that is not this case. I do

not believe that the United States Constitution proscribes

state use of computer lists which contain the names of pa-

tients as is provided for under this statute.

The motions for preliminary and permanent injunctions

are denied and the temporary restraining order is dis-

solved. The complaints are dismissed for want of a sub-

tantial federal question.

So ordered.

4la

Opinion of United States Court of Appeals.

Ricwarp Rog, an infant, by Robert Roe,

his parent et al., Plaintiffs-

Appellants,

George Patient et al., Intervenors-

Appellants,

Vv.

Hollis S. Incranam, as Commissioner

of Health of the State of New York,

Defendant-Appellee.

Nos. 947, 948, Dockets 73-1562, 73-1582.

United States Court of Appeals,

Second Circuit.

Argued May 4, 1973.

Decided May 24, 1973.

Before Frrennvy, Chief Judge, Hays, Circuit Judge, and

JameEson,® District Judge.

Frienb.y, Chief Judge:

This appeal from an order of the District Court for the

Southern District of New York, 357 F.Supp. 1217 dismiss-

ing complaints in actions under the civil rights statute, 42

U.S.C. § 1983, as jurisdictionally implemented by 28 U.S.C.

§ 1343(3), relates to the New York State Controlled Sub-

stances Act, N.Y.Laws 1972, ch. 878, amending N.Y. Public

Health Law §§ 3300-96, effective April 1, 1973, McKinney’s

Consol.Laws, ¢c. 45.

The Controlled Substances A represents a comprehen-

sive effort by the State, aimed primarily at controlling the

* Of the United States District Court for the District of Mon-

tana, sitting by designation.

42a

Opinion of United States Court of Appeals.

abuse caused by diversion of lawfully manufactured and

prescribed dangerous drugs into unlawful uses. Broadly

speaking, the scheme of the statute is to classify each such

drug in one of five schedules, see Public Health Law § 3306,

depending on the degree of harm its abuse may cause and

the extent of its lawful medical uses, with restrictions im-

posed on distribution of the drug varying in accordance

with the schedule in which it is placed. Schedule I lists

drugs with a high potential for abuse, for which there is

no generally recognized medical use, including certain

opiates and opium derivatives, various hallucinogenic sub-

stances, and marijuana; § 3330 forbids prescribing any

such substance except for strictly limited purposes detailed

in Title ITI. Schedule II lists substances having a high

potential for abuse leading to severe psychological or

physical dependence, but having accepted medical use in

some cases; included in this schedule are such major nar-

cotics as cocaine, concentrated codeine, morphine, Demerol,

and other opiates, and the amphetamines. Schedule II

drugs may be prescribed and dispensed only in the manner

hereafter described. Schedules III, IV and V list other

drugs of medical utility having progressively less severe

effects on the central nervous system; these may be pre-

scribed and dispensed in less onerous ways unnecessary

here to detail.

Plaintiffs’ complaints are particularly directed at the

procedure established for the prescription of Schedule II

drugs. Section 3338(2) directs that, except for emergency

oral prescriptions,’ substances listed in Schedule II may

be dispensed only upon an official New York State pre-

scription form. These forms, to be prepared and issued

>The procedure for these, detailed in § 3334, ultimately re-

sults in the same filing with the Department of Health of a copy of

the prescription bearing the name of the patient about which plain-

tiffs complain.

43a

Opinion of United States Court of Appeals.

by the Department of Health in groups of 100, are to be

in triplicate and serially numbered, § 3338(1). So far as

here relevant, the prescription must contain the name, ad-

dress and age of the patient; the name, address, registra-

tion number, telephone number and handwritten signature

of the prescribing practitioner; specific directions for use;

and the date upon which the prescription was actually

signed, § 3332(2). When the practitioner also dispenses,

he must retain the original for five years and file the two

copies with the Department of Health not later than the

fifteenth day of the month following that in which the sub-

stance was delivered, § 3331(6). When dispensing is to be

done by a pharmacist, the practitioner must retain a copy

for five years, § 3332(4), the pharmacist must retain the

original for a like period, and the pharmacist must file a

copy endorsed with the date of delivery, the registration

number of the pharmacy, and his signature, with the De-

partment of Health not later than the fifteenth day of the

month following that in which the substance was delivered,

§ 3333. The information contained in the prescriptions

filed with the Department of Health is afforded some de-

gree of confidentiality by § 3371, which provides:

1. No person, who has knowledge by virtue of his

office of the identity of a particular patient or research

subject, a manufacturing process, a trade secret or a

formula shall disclose such knowledge, or any report

or record thereof, except:

(a) to another person who by virtue of his office is

entitled to obtain such information; or

(b) pursuant to judicial subpoena or court order

in a criminal investigation or proceeding; or

official board authorized to regulate, license or other-

wise supervise a person who is authorized by this

44a

Opinion of United States Court of Appeals.

article to deal in controlled substances, or in the course

of any investigation or proceeding by or before such

agency, department or board.

2. In the course of any proceeding where such in-

formation is disclosed, except when necessary to effec-

tuate the rights of a party to the proceeding, the court

or presiding officer shall take such action as is neces-

sary to insure that such information, or record or

report of such information is not made public.

This action against the Commissioner of Health was

brought by three infants reeciving prescriptions for medi-

cations listed under Schedule II, two physicians who pre-

scribe drugs listed under that schedule, and the Empire

State Physicians Guild, Inc. A post-operative cancer

patient who receives Hycodan and Percodan, both Schedule

II drugs, a woman suffering from migraine who receives

Demerol, a physician who prescribes for one of these pa-

tients, and the American Federation of Physicians and

Dentists were permitted to intervene as plaintiffs and also

to file a separate complaint. Alleging that the compelled

disclosure to the Department of Health of the identity of

patients for whom Schedule II drugs have been prescribed

unconstitutionally invades the patient’s right to privacy,

infringes on the doctor’s right to prescribe treatment

solely on the basis of medical considerations, and discrim-

inates against persons suffering from certain diseases by

requiring their identification to a governmental agency as

a condition to receiving medical treatment, plaintiffs

sought temporary and permanent injunctive relief and

asked that a three-judge court be convened, 28 U.S.C.

§ 2281, to consider their complaint. An affidavit support-

ing the application for a temporary restraining order

annexed a Memorandum to members of the New York

Legislature from the Chairman of the Temporary State

45a

Opinion of United States Court of Appeals.

Commission to Evaluate the Drug Laws, which had pro-

posed the New York State Controlled Substances Act.

This Memorandum was submitted because, in addition to

elaborating the reasons thought to require the strict con-

trol of Schedule II substances, it demonstrated that infor-

mation from the official prescription would be ceded into

a computer. The report explained that the computer

would be asked certain questions at regular intervals.

These questions, which “will be formulated at the highest

administrative level,” would relate to physicians who had

“prescribed and dispensed a greater amount of a Schedule

II substance than could possibly be justified by the nature

of their practice” and to “situations arising from lost or

stolen prescriptions.” The Memorandum stated, however,

that the proposed plan would not “make use of massive

print-outs of patients’ names,” or, indeed, disclose identify-

ing data about any patient ‘‘unless, based upon previous

reports, it is clear that such patient has been using stolen

or forged prescriptions.’

The district court issued a temporary restraining order

against the Commissioner’s accepting for filing or process-

ing forms containing the identity ef patients receiving pre-

scriptions for Schedule IT drugs or requiring physicians or

pharmacists to file such forms, and directing the Commis-

sioner to maintain in a sealed vanit such forms as were re-

ceived. It also set an early hearing on the motion to con-

vene a three-judge court. The State responded with a

?The motion for a temporary injunction was also supported

by affidavits of parents of the infant plaintiffs, objecting to the

names of their children and the medications they are receiving

being disclosed to the state and recorded in the state’s data bank,

and affidavits of physicians asserting that the disclosure require-

ment would make them reluctant to prescribe, and patients reluc-

tant to accept, Schedule II drugs, thus causing non-medical con-

siderations to interfere with the doctors’ determination as to the

appropriate medica] treatment.

46a

Opinion of United States Court of Appeals.

motion to dismiss the complaint. It submitted an affidavit

of Dr. Robert Whalen, Second Deputy Commissioner of the

Department of Health. This developed the reasons, dis-

cussed below, which were thought to require the filing of

the prescriptions with the patients’ names on them. Dr.

Whalen alleged that similar multiple prescription proce-

dures had been in effect in three other states, for consider-

able periods, with beneficial effects. He also said that the

exception in §3371(1)(a) allowing disclosure “to another

person who by virtue of his office is entitled to obtain such

information” was “to allow disclosure internally within the

Department to those with a controlled substance respon-

sibility.” Annexed to his affidavit were a manual of the

State Commissioner of Health entitled “Security of Com-

puter Systems,” another manual of the State Commissioner

of Health dealing generally with confidential information,

and a policy statement dealing specifically with security

from unauthorized disclosure of information obtained by

the Department of Health under the Controlled Substances

Act. Relying in part on this affidavit, which the district

judge took to demonstrate that the Department of Health

was “taking all necessary steps to maintain the security of

the computerized information,” he found no substantial

constitutional question and dismissed the complaint for

lack of federal jurisdiction. He continued the temporary

restraining order for three days to allow plaintiffs to seek

a further stay from this court after filing notice of appeal,

and another panel of this court continued so much of it as

required the Commissioner to retain prescriptions received

in a sealed vault pending an expedited appeal.®

*It is clear that the modified restraining order does not relieve

physicians and pharmacists from performing the duties imposed

on them by the statute under attack. The Commissioner is at

liberty to announce this if he deems it desirable.

47a

Opinion of United States Court of Appeals.

In the face of recent strong advocacy of the abolition of

the three-judge court requirement in constitutional cases,‘

a unanimous Supreme Court has just defined the standard

permitting a single judge to dismiss a complaint seeking

an injunction on the ground of unconstitutionality in the

most limiting terms the Court has ever used. in Goosby v.

Osser, 409 U.S. 512, 516, 93 S.Ct. 854, 858, 35 L.Ed.2d 36

(1973) it said:

Section 28 U.S.C. § 2281 does not require the conven-

ing of a three-judge court when the constitutional at-

tack upon the state statutes is insubstantial. “Consti-

tutional insubstantiality” for this purpose has been

equated with such concepts as “essentially fictitious”

Bailey v. Patterson, 369 U.S. 31, 33, 82 S.Ct. 549, 551,

7 L.Ed.2d 512 (1962), “wholly insubstantial,” ibid, “ob-

viously frivolous,” Hannis Distilling Co. v. Baltimore,

216 U.S. 285, 288, 30 S.Ct. 326, 327, 54 L.Ed. 482

(1910), “obviously without merit,” Ex parte Poresky,

290 U.S. 30, 32, 54 S.Ct. 3, 45, 78 L.Ed. 152 (1933).

The limiting words “wholly” and “obviously” have

cogent legal significance. In the context of the effect

of prior decisions upon the substantiality of constitu-

tional claims, those words import that claims are con-

stitutionally insubstantial only if the prior decisions

inescapably render the claims frivolous; previous de-

cisions which merely render claims of doubtful or

questionable merit do not render them insubstantial

for the purposes of 28 U.S.C. § 2281. A claim is insub-

stantial only if “its unsoundness so clearly results

*See Report of the Study Group on the Caseload of the Su-

preme Court 28-30 (1972); 1970 Report of the Proceedings of the

Judicial Conference of the United States, at 78-79; Burger, The

State of the Federal Judiciary—1972, 58 A.B.A.J. 1049, 1053

(1972).

48a

Opinion of United States Court of Appeals.

from the previous decisions of this court as to fore-

close the subject and leave no room for the inference

that the question sought to be raised can be the subject

of controversy.” Ex parte Poresky, supra, 290 U.S. at

32, 54 S.Ct., at 4; see also Levering and Garrigues Co.

v. Morrin, supra, 289 U.S. 108, 105, 53 S.Ct. 549, 550,

77 L.Ed. 1062 (1933); Hannis Distilling Co. v. Balti-

more, supra, 216 U.S. at 288, 30 S.Ct. at 327; MeGilvra

v. Ross, 215 U.S. 70, 80, 30 S.Ct. 27, 31, 54 L.Ed. 95

(1909).

Despite the severity of this standard, we should have lit-

tle difficulty in sustaining the district court if plaintiffs’

attack had been limited to the discrimination between the

disclosure requirements applicable to prescriptions for

drugs in Schedule II and those applicable to drugs in

Schedules III, 1V and V. It is apparent that the limitation

of the central filing requirement to Schedule II drugs was

designed for the specific purpose of confining the resulting

intrusion into privacy to those drugs whose unlawful dis-

tribution entails the greatest danger to patients and the

public. The legislative purpose in making the differentia-

tion being thus permissible, indeed, laudable, the courts

will not assume the task, for which they are conspicuously

unfitted, of inquiring whether every drug was properly

placed by the Legislature in one schedule rather than an-

other. Lindsley v. Natural Carbonic Gas Co., 220 U.S. 6’,

78-79, 31 S.Ct. 337, 55 L.Ed. 369 (1911); Metropolis

Theater Co. v. City of Chicago, 228 U.S. 61, 69-70, 33 S.Ct.

441, 57 L.Ed. 730 (1913). The district court likewise was

clearly correct in dismissing the plaintiffs’ claim that the

Act’s imposition of stricter confidentiality requirements

upon the records of addicts participating in drug mainte-

nance programs than on the information relating to Sched-

ule II drug prescriptions denied them equal protection of

49a

Opinion of United States Court of Appeals.

the laws. As the district judge pointed out addicts have

understandably been reluctant to bring their drug use to

the light of day, and the state could reasonably have be-

lieved that only the strictest confidentiality, including pro-

tection from disclosure to law enforcement authorities,

would encourage them to join treatment programs.

This, however, was only a part, indeed a relatively minor

part, of plaintiffs’ complaints. The patients’ main attack

is that the requirement of filing with the Department of

Health is an impermissible invasion of a constitutional

right to privacy with respect to the status of their health

and the medical treatment they are receiving, and the phy-

sicians contend that the danger of disclosure impairs a con-

stitutional right to make their decisions solely on the basis

of medical considerations.°

The concept that privacy may be a constitutional right

enjoying protection against governmental intrusions other

than those banned by specific provisions of the Bill of

Rights, notably the First and Fourth Amendments, see

Stanley v. Georgia, 394 U.S. 557, 564-566, 89 S.Ct. 1243, 22

L.Ed.2d 542 (1969); Katz v. United States, 389 U.S. 347,

351-353, 88 S.Ct. 507, 19 L.Ed.2d 576 (1967), was first

explicitly stated in Griswold v. Connecticut, 381 U.S. 479,

85 S.Ct. 1678, 14 L.Ed.2d 510 (1965).° That decision, along

with Eisenstadt v. Baird, 405 U.S. 488, 92 S.Ct. 1029, 31

L.Ed.2d 349 (1972), can be viewed as forecasting recogni-

'The standing of the physicians seems to be established by

Griswold y. Connecticut, 381 U.S. 479, 481, 85 S.Ct. 1678, 14 L.Ed.

2d (1965), and Doe v. Bolton, 410 U.S. 179, 185, 93 S.Ct. 739, 35

L.Ed.2d 201 (1973). However, since their claims are less impres-

sive than those of the patients, we will confine our discussion of the

merits to the latter.

® There are passages in Skinner v. Oklahoma ex rel. Williamson,

316 U.S. 535, 536, 541 (majority opinion of Douglas, J.), 546-547,

62 S.Ct. 1110, 86 L.Ed. 1655 (concurring opinion of Jackson, J.)

(1942), which may be regarded as harbingers.

50a

Opinion of United States Court of Appeals.

tion of a constitutional right of men and women to decide,

free of governmental interference, whether to minimize the

risks of conception from sexual] intercourse, although

Griswold focused on the provision of the Connecticut stat-

ute proscribing the use of contraceptives and the attendant

horrors of enforcement in the case of married persons, 381

U.S. at 485-486, 85 S.Ct. 1678, and Eisenstadt was rested

on the equal protection clause. Roe v. Wade, 410 U.S. 113,

152, 93 S.Ct. 705, 35 L.Ed.2d 147 (1973), went further and

held that a woman’s right to terminate her pregnancy was

a “fundamental” constitutional right, subject to regulation

only on the basis of a “compelling” state interest, which

was found not to exist during the first trimester and to ex-

ist only in a limited degree in the second. Doe v. Bolton,

410 U.S. 179, 93 S.Ct. 739, 35 L.Ed.2d 201 (1973), took a still

further step by recognizing a pregnant woman’s constitu-

tional right to make the abortion decision on the basis of

advice from her own physician without the approval of a

hospital committee or the concurrence of other doctors.

Although, as we recently indicated in Rosenberg v.

Martin, 478 F.2d 520, at 524 (2 Cir. 1973), the right to

privacy which thus far has been granted constitutional pro-

tection relates only to “the most intimate phases of per-

sonal life,” having to do with sexual intercourse and its

possible consequences, it is not “obvious” that the right will

be thus confined. Indeed, the Court’s recognition in Roe

v. Wade, supra, 410 U.S. at 153, 93 S.Ct. at 727, that the

right to privacy is “founded in the Fourteenth Amend-

ment’s concept of personal liberty and restrictions upon

state action” itself suggests that the right may not be so

closely cabined. See, for an adverse criticism, Ely, The

Wages of Crying Wolf: A Comment on Roe v. Wade, 82

Yale L.J. 920 (1973). As Mr. Justice Stewart stated in his

concurrence in Roe, 410 U.S. at 169, 93 S.Ct. at 735, quoting

Mr. Justice Harlan’s dissenting opinion in Poe v. Ullman,

367 U.S. 497, 548, 81 S.Ct. 1752, 6 L.Ed.2d 989 (1961), the

dla

Opinion of United States Court of Appeals.

liberty guaranteed by the due process clause “is a rational

continuum which, broadly speaking, includes a freedom

from all substantial arbitrary impositions and purposeless

restraints, ... and which also recognizes, what a reasonable

and sensitive judgment must, that certain interests require

particularly careful scrutiny of the state needs asserted to

justify their abridgement.”

If there is anything “obvious” about the constitutional

right to privacy at the present time, it is that its limits

remain to be worked out in future cases. Should the con-

stitutionally protected zone of privacy be extended beyond

the area already recognized, the individual’s interest in

keeping to himself the existence of his physical ailments‘

and his doctor’s prescriptions for them would lie rather

close in the continuum.’ If New York had passed a statute

directing that all prescriptions, or even all prescriptions

for Schedule II drugs, must be published in the press, we

do not think the State would have seriously contended,

still less that the district judge would have held, that a

constitutional attack was “obviously frivolous.” That is

enough to show that the quetsion whether the right of

privacy here asserted by the patients does enjoy some de-

gree of constitutional protection is a substantial one. As-

7 While the State correctly points out that the prescription form

does not require a description of the illness, plaintiffs counter that,

at least for some of the drugs in Schedule II, many members of the

public know the ailments for which such drugs are commonly pre-

scribed. To take perhaps the most obvious examples, most informed

people would associate lange dosages of Demerol with an ailment

causing serious pain. It is immaterial that the ailment usually is

not one that should arouse any emotion toward the victim save sym-

pathy; most people simply do not want their ailments to be gen-

erally known.

* Indeed, there is language in Doe v. Bolton, supra, 410 U.S. at

194, 93 S.Ct. 739, from which it could be argued that the Court has

already taken the step of extending constitutional protection to the

privacy of the doctor-patient relationship.

52a

Opinion of United States Court of Appeals.

suming that such a constitutionally protected right does

exist, the plaintiffs have raised a further question whether

the impairment of that right was justified by some larger

interest which the State is entitled to pursue.

The right to privacy in matters such as those here at

issue surely is not absolute. This is shown by the rulings in

Roe v. Wade, supra, 410 U.S. at 152, 93 S.Ct. 705, per-

mitting restrictions on the abortion decision during the sec-

ond trimester of pregnancy and prohibition of it during

the third. Also, we do not read the portion of Doe v. Bolton,

supra, 410 U.S. at 198, 93 S.Ct. 739, striking down Georgia’s

“two doctor concurrence” requirement as meaning that a

state is wholly without power to regulate the practice of

medicine or the activities of physicians except by profes-

sional censure, deprivation of licenses, or enforcement of

the criminal law. Indeed, plaintiffs seem to concede that

their constitutional rights were not violated by the previous

New York laws, which required prescriptions for narcotic

drugs to bear the full name and address of the patient, and

the name, address, registration number and signature of

the physician, former Public Health Law §3301(32) (Mc-

Kinney 1971); required pharmacists to retain copies of

prescriptions for two years, former Public Health Law

§ 3322(1)(¢); and allowed inspection of them by state and

federal law enforcement authorities as well as the Depart-

ment of Health, former §§ 3322(1)(c), 3334(1).

New York has advanced powerful arguments in support

of the requirement of central filing of prescriptions for

Schedule II drugs. The most important are that only by

such filing, now complemented by the computer’s ability to

answer appropriate inquiries, can the State readily detect

a number of serious abuses—the same patient going from

doctor to doctor and thereby obtaining quantities of

Schedule II drugs greater than his legitimate medical

needs; over-prescription by doctors; and the theft or

53a

Opinion of United States Court of Appeals.

forgery of prescriptions. Each of these abuses leads

to an individual’s possession of quantities of these dan-

gerous drugs which would be seriously harmful if used

and afford the opportunity for sale into illicit drug

channels. Without questioning the seriousness of the

problem, plaintiffs respond that these abuses could be

adequately controlled without central filing, or by cen-

tral filing without patient’s names, and that the added

efficiency is not worth the price in terms of risk of

disclosure,

On this last point something turns on how great the risk

is. While the Constitution does not condemn a state to

using ineffective means in dealing with a problem as seri-

ous as the use of the opiates and stimulants listed in

Schedule II, it may well condition use of a more effective

means which involves a danger to constitutionally-protected

privacy on the taking of all reasonable precautions to limit

the risk. The complaints, and other m .terial of which we

may take judicial notice, are not conclusive on this score.

Although Dr. Whalen may be correct in asserting that

4 3371(1)(a) was intended only to allow disclosure of

prescription information to Department of Health officials

working in the area, the statutory language is so open-

ended that full exploration of how confidentiality is in fact

being preserved may be required. If it were clear that the

State had taken or proposed to take effective steps, by

regulation or otherwise, to limit access to the patients’

names on the prescription forms as rigidly as is consistent

with accomplishment of the asserted statutory purpose, the

grounds for constitutional attack might disappear. But

the district court was not entitled to dismiss the complaint

on the basis of the State’s assertions that it has already

done this. The Supreme Court stated long ago in Ex parte

Poresky, 290 U.S. 30, 32, 54 S.Ct. 3, 4, 78 L.Ed. 152 (1933),

that “The existence of a substantial question of constitu-

54a

Notice of Motion to Dismiss Complaint.

tionality must be determined by the allegations of the bill

of complaint.” See also Goosby v. Osser, supra, 409 U.S.

at 521, 93 S.Ct. 860 n. 7. Looking at these allegations, and

also at the Memorandum of the Temporary State Commis-

sion to Evaluate the Drug Laws which was annexed to the

moving affidavit of plaintiffs’ counsel, and the various state

manuals, as we think we may, we do not believe that, under

the strict test announced in Goosby v. Osser, supra, the

complaint could properly have been dismissed without fur-

ther exploration of the degree of need for central! filing in-

cluding the patients’ names on the one hand, and the ade-

quacy of the provisions to protect against malicious or

careless disclosure on the other.

The order of dismissal is therefore reversed, with in-

structions to the district judge to request the convening of

a three-judge court under 28 U.S.C. §4 2281 and 2284. The

temporary restraining order, as modified by this court, is

continued pending the hearing before such a court and for

such further period, if any, as that court may then direct.

Notice of Motion to Dismiss Complaint.

[SAME TITLE]

Sims:

PLEASE TAKE NoTIcE, that upon the annexed affidavit of

A. Seth Greenwald, sworn to June 18, 1973, the various

summons and complaints, the prior affidavit of Robert P.

Whalen, M.D., sworn to April 3, 1973, the proposed reg-

ulation on confidentiality, and all the prior submissions

and proceedings, the undersigned will move this Court on

55a

Notice of Motion to Dismiss Complaint.

June 25, 1973 at 4:30 P.M., in Rooin , United States

Courthouse, Foley Square, New York, New York, for an

order pursuant to the Federal Rules of Civil Procedures,

Rules 12(b)(6) dismissing the complaints upon the ground

that they fail to state a claim upon which relief may be

granted, and that they are moot by virtue of the promul-

gation of the amended regulation 10 NYCRR § 80.107,

suspension of any inspection pending determination of this

motion, and for such other and further relief as may be

just and proper.

Dated: New York, New York

June 18, 1973

Yours, ete.,

Louis J. Lerxowitz

Attorney General of the

State of New York

Attorney for Defendant

A. SerH GREENWALD

Assistant Attorney General

To: Suea, Govutp, CLIMENKO

& Kramer, Esqs.

Norwick, Raccio & Jarre, Esqs.

56a

Affidavit of A. Seth Greenwald, in Support of Motion.

[SAME TITLE]

Strate or New York t ss :

County or New York

A. Seta Greenwap, being duly sworn, deposes and

says:

I am an Assistant Attorney General in the office of Louis

J. Lefkowitz, Attorney General of the State of New York,

attorney for defendant.

I have already made objection to plaintiffs’ use of fic-

titious names in this action in my affidavit of April 4, 1973

and reiterate that plaintiffs should be required to disclose

their actual identities with any protections the Court con-

siders necessary.

As to any preliminary injunction it should not extend

beyond the actual plaintiffs as this is not a class action.

In any event no modification of the order of the Court of

Appeals is warranted since it is unnecessary.

As to the motion to dismiss, it would appear that there

are no issues beyond those presented by the complaint and

opposing papers. The defendant has established thorough

security it proposes to use with the triplicate prescriptions

when the system is implemented, if permitted by this

Court. Together with the new regulation, it is submitted

that only issues of law are presented by this case and the

questions raised by the Court of Appeals are essentially

moot.

WHEREFORE, your deponent respectfully requests that

the complaint be dismissed.

(Sworn to by A. Seth Greenwald, June 18, 1973.)

57a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion.

(36 F. Supp. 536)

Richard Roe, an infant, by Robert Roe,

his parent, et al., Plaintiffs,

and

George Patient et al., Intervenors,

Hollis S. Incranam, as Commissioner

of Health of the State of New York,

Defendant.

No. 73 Civ. 1308.

United States District Court,

S. D. New York.

Aug. 23, 1973.

OPINION

Rosert L. Carter, District Judge.

Statute Under Attack:

This action challenges the constitutionality of certain

provisions of the New York State Controlled Substances

Act (the “Act”), New York Laws 1972, ch. 878, N.Y. Public

Health Law § 3300 et seq. (McKinney’s Consol. Laws, c. 45,

Supp. 1972) effective April 1, 1973, as amended, New York

Laws 1973, ch. 97, ch. 163, ch. 728. The Act attempts a

comprehensive regulation of all facets of the legitimate

drug trade—research, manufacture, medical prescription,

wholesale and pharmaceutical distribution—in an effort to

prevent and discover any diversion of this trade to illegiti-

mate use.

58a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion.

The provisions of the Act apply to “controlled sub-

stances”—those drugs warranting regulation—which are

described in detail in § 3306. Furthermore, that section

classifies the regulated drugs into “schedules” depending

upon the extent to which the drugs may be lawfully pre-

scribed for medical purposes and the dangers inherent in

their misuse. Thus, Schedule I drugs “are all highly abus-

able substances which have no current medical use or lack

accepted safety for use in treatment under medical super-

vision in this country.” Interim Report of the Temporary

State Commission to Evaluate the Drug Laws (“Interim

Report”) at 13.1. These drugs may not be prescribed, dis-

tributed or possessed for any purpose other than the

strictly limited use described in Title ITI, §§ 3324-3329, per-

taining to research and related activities, § 3330.

Schedule IT contains “those substances which have a high

potential for abuse, but also have an accepted or restricted

medical use. Abuse of a Schedule II substance may lead

to severe physiological dependence.” Interim Report at

13. Schedules ITI, [TV and V list those drugs having an ac-

cepted medical use but a potential, though in decreasing

degree, for psychological and/or physiological dependence

consequent to misuse.

The Act requires that an official New York State pre-

scription form’ be used to prescribe or dispense Schedule

The Temporary State Commission to Evaluate the Drug Laws

was created in 1970 to investigate the problems arising under exist-

ing drug laws and to recommend changes in the law. New York

Laws 1970, ch. 474, as amended by New York Laws 1971, ch. 7.

The Committee’s recommendations as contained in the Interim Re-

port were adopted by the legislature virtually without modification.

* These forms are to be prepared and issued by the Department

of Health, numbered serially, prepared in triplicate and issued to

practitioners in groups of one hundred at a cost of $10 per group

(10¢ per triplicate form), § 3338.

59a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion.

IT drugs, § 3338(2)*, except in cases of emergencies § 3334.

This triplicate form must contain the following informa-

tion: the name, address and age of the patient; the name,

address, registration number, telephone number and hand-

written signature of t' physician, directions for use (e. g.,

dosage, frequency of dosage and maximum daily use), and

date the prescription was signed, § 3332.

In the event the drug is actually administered or dis-

pensed by the prescribing physician, the doctor must re-

tain a copy of the form in his files for a period of five

vears and file the original and one copy with the Depart-

ment by the fifteenth day of the month following the month

in which the drug was dispensed, § 3331(6). If, however,

the prescription is to be dispensed by a pharmacist, the

doctor shall keep one copy of the form in his files for a

period of five years and deliver to the patient the original

and one copy, § 3332(4). The drug user will deliver those

two forms to the pharmacist who, upon filing the prescrip-

tion, shall endorse the original and copy with the date of

delivery, the pharmacist’s registration nimber and his

signature, § 3333(3). The original of the form will be re-

tained by the pharmacist for five years and the copy must

be filed with the Department of Health by the fifteenth day

of the month following the month in which in which the

drug was dispensed, § 3333(4).

The confidentiality of the records collected pursuant to

the above procedures is protected as provided for in the

statute, $3371. That section states:

1. No person, who has knowledge by virtue of his

office of the identity of a particular patient or research

* The statute authorizes the Commissioner of Health to require

any particular Schedule III or IV drug to be prescribed or dis-

pensed only upon an official prescription form, § 3338 (3), but the

court has no knowledge that such discretionary power has been ex-

ercised or that notice of an intention to do has been given and

issues concerning these schedules are not before us.

60a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion.

subject, a manufacturing process, a trade secret or a

formula shall disclose such knowledge, or any report

or record thereof, except:

(a) to another person who by virtue of his office is

entitled to obtain such information; or

(b) pursuant to judicial subpoena or court order

in a criminal investigation or proceeding; or

official board authorized to regulate, license or other-

wise supervise a person who is authorized by this arti-

cle to deal in controlled substances, or in the course

of any investigation or proceeding by or before such

agency, department or board; or

(d) to a central registry established pursuant to

this article.*

*The statute requires that addict maintenance programs be

approved by the Commissioner, § 3352, pursuant to specific statu-

tory standards, § 3353. Such programs are required to maintain

certain records pertaining to addicts who are either in or have

applied for admission to the program, © 3354 and the program

must file monthly reports with the Department summarizing its

activity in the preceding month, § 3355. The Department is re-

quired to maintain a “central registry” which, by drawing from

the reports submitted pursuant to § 3355 and § 3372 (requiring

individual physicians to report the name and other identifying

information of any person found to be an addict), will be a cen-

tralized repository of information pertaining to the status of ad-

dicts and applicants for admission to maintenance programs, § 3356.

That section provides:

1, The department shall establish or cause to be established

a central registry as part of which the following information

shall be assembled:

(a) the name and other identifying data relating to each

reported addict ;

(footnote continued on following page )

waits lal

6la

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion.

2. In the course of any proceeding where such in-

formation is disclosed, except when necessary to effec-

tuate the rights of a party to the proceeding, the court

or presiding officer shall take such action as is neces-

sary to insure that such information, or record or

report of such information is not made public.

Pursuant to its statutory authority, the Department of

Health has promulgated regulations in respect of confiden-

tiality as follows:

No person who by virtue of his office has knowledge

of any records required by article 33 of the Public

Health Law or this Part shall disclose such knowledge,

or any report or record thereof, except:

(a) to another person who by virtue of his office is

entitled to obtain such information;

(b) pursuant to judicial subpoena or court order

in a criminal investigation or proceedings; or

official board authorized to regulate, license or other-

wise supervise a person who is authorized by this

(footnote continued from preceding page)

(b) the status of each addict awaiting admission to an ap-

proved program or programs;

2. Identifying data in such registry with respect to an

individual addict shall be available only to:

(a) a practitioner attempting to ascertain the status of an

addict seeking treatment with him or admission to a program

with which he is associated ;

(b) an agency, department of government, or commission

established pursuant to the mental hygiene law and authorized

to gather such information.

62a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion.

article to deal in controlled substances, or in the

course of any investigation or proceeding by or before

such agency, department or board. 10 N.Y.C.R.R.

§ 80.107°

The Issue to be Decided:

Although the Act does not specifically so provide, it is

alleged by plaintiffs and conceded by the state, that the

Department of Health will, upon receipt of the prescrip-

tion forms, enter the information received into a computer.

This anticipated procedure is the focus of plaintiffs’ com-

plaint.

° The Attorney General has informed the court that in response

to the Court of Appeals decision in this case, discussed below,

these regulations were amended to read as follows:

No person who has knowledge by virtue of his office of the

identity of a particular patient or research subject, a manu-

facturing process, a trade secret or a formula shall disclose

such knowledge, or any report or record thereof, except:

(a) to another person who by virtue of his office as an em-

ployee of the department is entitled to obtain such informa-

tion; or

. * * o *

(d) to a central registry established pursuant to this article.

The Act authorizes the Commissioner of Health to promulgate

regulations thereunder provided that a 21-day period is allowed

for public response, § 3308. Furthermore, New York law requires

that a copy of any proposed regulation must be admitted to the

legislature at least 21 days before its adoption. N.Y. Executive

Law § 10l-a (MeKinney’s Consol.Laws, ¢. 18, 1972). Immediately

after adoption by the Department the regulation must be sent to

‘the Secretary of State for inclusion in the official compilation of

rules and regulations. N.Y. Executive Law §102 (McKinney

1972). We have been advised that the new confidentiality regula-

tion was submitted to the legislature in early June, 1973, and was

formally promulgated by the Department of Health on July 2,

1973, effective upon filing with the Department of State.

63a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant's Motion.

The origina] plaintiffs in this action include three infants

(by their parents) and one adult receiving Schedule IT

drugs, two named doctors who prescribe such drugs, and

the Empire State Physicians Guild, Inc. The plaintiffs

complain of a violation of their constitutionally protected

rights, 42 U.S.C. § 1983 and assert that the jurisdiction of

the court is founded upon 28 U.S.C. § 1343(3). They allege

that the reporting provisions of the Act

by requiring disclosure of the identity of certain pa-

tients . . . invades the patient’s right of privacy and

confidentiality, infringes on the doctor’s right to pre-

scribe treatment for his patients solely on the basis of

medical consideration and discriminates against per-

sons suffering from certain diseases by _ juiring their

identification to a governmental agency as a condition

to receiving medical treatment for their illness. Com-

plaint, Para. 11.

Shortly after the commencement of the action a post-

operative cancer patient and an individual suffering from

migraine headaches, both of whom receive Schedule II

drugs as medication, the physician prescribing such drugs

for one of these patients, and the American Federation of

®*The physicians are not here merely asserting the rights of

their patients but claim independent violation of protected con-

stitutional rights. Their standing to sue is established by Doe v.

Bolton, 410 U.S. 179, 93 S.Ct. 739, 95 L.Ed.2d 201 (1973). See

also, Roe v. Ingraham, 480 F.2d 102, (2d Cir. 1973) at n. 5. Al-

though it is unclear from the complaint, the Physicians Guild is

apparently suing on behalf of its doctor members. Inasmuch as its

claims are only repetitive, we may assume proper standing exists.

Griswold v. Connecticut, 381 U.S. 479, 85 S.Ct. 1678, 14 L.Ed.2d

510 (1965), NAACP vy. Alabama, 357 U.S. 449, 78 S.Ct. 1163, 2

L.Ed.2d 1488 (1958); Pierce v. Society of Sisters, 268 U.S. 510,

45 S.Ct. 571, 69 L.Ed. 1070 (1925).

64a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion.

Physicians intervened and filed a separate complaint.’ The

intervenor plaintiffs repeat verbatim the language of the

original complaint (quoted above) alleging that the Act is

constitutionally infirm. In addition, the intervenors claim

that the Act

on its face, conflicts with, is inconsistent with and over-

laps federal law and federal regulation and is thus void,

being in conflict with the commerce power of the United

States government and the laws and regulations en-

acted by the United States pursuant thereto. Com-

plaint, Para. 13.

Both complaints, in identical laguage, ask for preliminary

and permanent injunctive relief and the determination of

these issues by a three-judge court pursuant to 28 U.S.C.

§ 2281.

All of the patient-plaintiffs—the three children and adult of

the original complaint and the intervenor cancer patient and mi-

graine sufferer—are identified in each complaint only by fictitious

names ostensibly to protect their identities. This procedure is not

explicitly authorized by the federal rules. However, it was given

implicit recognition by the United States Supreme Court in Roe

v. Wade, 410 U.S. 113, 93 S.Ct. 705, 35 L.Ed.2d 147 (1973) and

Doe v. Bolton, 410 U.S. 179, 93 S.Ct. 739, 35 L.Ed.2d 201 (1973).

The inherent problems which this procedure poses, most notably the

possible inability to fix res judicata effect, mandate that it be used

sparingly. Here, however, if plaintiffs are required to reveal their

identity prior to the adjudication on the merits of their privacy

claim, they will already have sustained the injury which by this

litigation they seek to avoid. See N.A.A.C.P. v. Alabama, 357 U.S.

449, 78 S.Ct. 1163, 2 L.Ed.2d 1488 (1958). Under such circum-

stances it is permissible to proceed by pseudonym but only if these

fictitious names are actually representative of real and specific ag-

grieved individuals. Plaintiffs’ attorneys have represented to the

court that these preconditions have been met.

65a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant's Motion.

Prior Court Proceedings:

By Order to Show Cause filed on March 29, 1973, the

same date as the filing of the complaint, plaintiffs requested

a temporary restraining order enjoining the implementation

of the Act which was to become effective on April 1, 1973.

The District Court, after hearing all counsel in chambers,

and based upon a number of supporting affidavits and their

exhibits, issued a temporary restraining order enjoining

the defendant from filing or processing any prescription

forms containing a patient’s name, from requiring physi-

cians or pharmacists to file such prescription forms with

the Department, and requiring placing under seal any form

received until dissolution of the order.®

On April 6, 1973, the district court heard oral argument

on plaintiffs’ motion to convene a three-judge court and de-

fendant’s motion, made on April 3, 1973, to dismiss the ac-

tion. The court, D.C., 357 F.Supp. 1217, dismissed for lack

* The order provided that it be:

ORDERED, that, pursuant to 28 U.S.C. Section 2284(3) and

Fed.R.Civ.P.R. 65, pending determination of plaintiffs’ ap-

plication for a preliminary injunction, defendant Hollis S.

Ingraham, his agents, servants and employees, be and they

hereby are restrained from

(a) accepting for filing or processing New York State pre-

scription forms containing the identity of patients receiving

prescriptions for Schedule II controlled substances as set forth

in Section 3306 of Article 33 of the Act; and

(b) requiring physicians or pharmacists to file prescription

forms containing the identity of patients receiving preserip-

tions for Schedule II controiled substances as set forth in Sec-

tion 3306 of Article 33 of the Act; and

it is further OrperEp that defendant, his agents, servants and

employees shall retain in a sealed vault or other equally secure

place any prescription forms received by them during the

pendency of this temporary restraining order.

66a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion.

of a substantial federal question both in respect of the claim

of denial of equal protection and infringement of plaintiffs’

right of privacy.®

The Court of Appeals reversed the order of dismissal.

Roe v. Ingraham, 480 F.2d 102 (2d Cir. 1973). While agree-

ing that plaintiffs’ equal protection claims were properly

dismissed, the court concluded that “the question whether

the right of privacy here asserted by the patients does en-

joy some degree of constitutional protection is a substantial

one.” Id. at 108. Assuming that right extended to the cir-

cumstances of this case, the district court would be re-

quired to determine whether its invasion was justified. Such

a determination would require a factual investigation of

the “need for central filing including the patients’ nanies

on the one hand and the adequacy of the provisions to pro-

tect against malicious or careless disclosure on the other.”

Id. at 109. For these reasons the Court of Appeals directed

the district judge to request the convening of a three-judge

court to make such a determination.

In stating that the plaintiffs’ claim was “substantial”

the Court of Appeals used that word as applied to the

power of a single judge to dismiss a complaint seeking an

injunction against an allegedly unconstitutional state law.

Its decision means only that the complaints are “sub-

stantial” in that they are not “essentially fictitious”,

“wholly insubstantial”, “obviously frivolous”. Goosby v.

Osser, 409 U.S. 512, 516, 93 S.Ct. 854, 858, 35 L.Ed.2d 36

® The trial court continued the temporary restraining order for

three days to permit plaintiffs an opportunity to seek a further stay

from the Court of Appeals. That court continued the order only

insofar as it required the Commissioner to seal the prescription

forms he receives pending appeal. Thus, doctors and pharmacists

were required to perform all of their obligations under the Act.

This modified order was continued by the three-judge court and

remains in effect at this time.

67a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion.

(1973) (citations omitted). Whether the complaints are

sufficiently substantial to defeat a motion to dismiss and

whether plaintiffs are entitled to a preliminary injunction

upon the determination of a statutory court of three judges,

are wholly different problems.

Hearing Before This Court:

On remand, this statutory court was convened, as pro-

vided by 28 U.S.C. § 2281, and on June 25, 1973 heard oral

argument on the plaintiffs’ motion for a preliminary in-

junction and defendant’s motion to dismiss.

Preliminary Injunction:

In order to prevail on a motion for preliminary injunc-

tive relief, the moving party must demonstrate a clear

showing of probable success on the merits and the possi-

bility of irreparable injury. Gulf & Western Industries,

Inc. v. Great Atlantic & Pacific Tea Co., Inc., 476 F.2d 687

(2d Cir. 1973). However, “where the balance of hardship

tips decidedly toward the party requesting the temporary

relief”, Dino De Laurentiis Cinematograficia S.p.A. v.

D-150, Ine., 366 F.2d 373, 375 (2d Cir. 1966), the burden of

demonstrating probable success on the merits is reduced if

the moving party “has raised questions going to the merits

so serious, substantial, and difficult as to make them a fair

ground for litigation and thus for more deliberate investi-

gation.” Checker Motors Corp. v. Chrysler Corp., 405 F.2d

319, 323 (2d Cir.) cert. denied, 394 U.S. 999, 89 S.Ct. 1595,

22 L.Ed.2d 777 (1969), accord Exxon Corp. v. City of New

York, 480 F.2d 460 (2d Cir. 1973), Gulf & Western Indus.

Inc. v. Great Atlantic & Pacific Tea Co., Inc., supra.

68a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion.

In order to determine the extent to which plaintiffs’

claims measure up to these standards it is obviously neces-

sary to consider, in some depth, the substantive content of

the right of privacy.”

The Right of Privacy:

The plaintiffs assert that the state’s systematic collection

of all prescriptions for Schedule II drugs, which by statu-

tory command must contain the patient’s name, and the

subsequent computerization of this information, violate

their constitutionally protected right of privacy. While

the Constitution does not specifically proclaim any general

right of privacy, certain provisions of the Bill of Rights

have been held to confer a guarantee of privacy. As early

as 1885 the United States Supreme Court recognized that

the Fourth and Fifth Amendments insure “the sanctity of

a man’s home and the privacies of life.” Boyd v. United

States, 116 U.S. 616, 630, 6 S.Ct. 524, 29 L.Ed. 746 (1885).

Yet, for many years the Court would not go beyond the

specific strictures of the Constitution to protect individual

privacy.’

In Katz v. United States, 389 U.S. 347, 88 S.Ct. 507, 19

L.Ed.2d 576 (2%67) in which an electronic listening device

was attached to the outside of a telephone booth, the Court

abandoned the trespass concept of Fourth Amendment

10 In their briefs and on oral argument before the three-judge

court plaintiffs abandoned the equal protection claim which they

had pressed in the earlier proceedings, and that issue, therefore, is

no longer a question in this litigation.

11 See, e. g., Olmstead v. United States, 277 U.S. 438, 48 S.Ct.

564, 72 L.Ed. 729 (1928), in which the Court concluded that wire-

tapping is not a “search” within the meaning of the Fourth

Amendment. Ultimately, the limitations imposed by Olmstead

were lightened.

69a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion.

violation and chose instead to protect “the privacy upon

which [the individual] justifiably relied.” ia. at 353, § 88

S.Ct. at 512. Even here, however, the protection of an as-

pect of individual privacy derived not from any general,

unspecified rights, but rather, from a specific provision of

a guaranteed freedom.

The First Amendment has also been interpreted to en-

compass certain privacies necessarily included within the

scope of its specific mandates. Thus, in NAACP v. Ala-

bama, 357 U.S. 449, 78 S.Ct. 1163, 2 L.Ed.2d 1488 (1958)

the Court, in protecting the integrity of the membership

lists of a private organization, recognized the “freedom to

associate and privacy in one’s associations,” id. at 462, 78

S.Ct. at 1172, which emanates from the’ guarantees of

speech and assembly. Watkins v. United States, 354 U.S.

178, 77 S.Ct. 1173, 1 L.Ed.2d 1273 (1957), in limiting the

scope of congressional committee questioning of individ-

uals, made note of the need “to insure that the Congress

does not unjustifiably encroach upon an individual’s right

to privacy nor abridge his liberty of speech, press, religion

or assembly.” Id. at 198-199, 77 S.Ct. at 1185. Similarly,

the First Amendment has been held to include a correlative

right to receive information and ideas. Thus, the attempt

to criminalize the mere private possession of obscene ma-

terial was found to be unconstitutional. Stanley v. Geor-

gia, 394 U.S. 557, 89 S.Ct. 1243, 22 L.Ed.2d 542 (1969).

These rights of privacy discussed above are only exam-

ples of the protection afforded pursuant to specific provi-

sions of the Bill of Rights. The plaintiffs here, however,

do not contend their claim is derived from any particular

section of the Constitution. Rather, they assert an inde-

pendent right of privacy first given cognizance by the

United States Supreme Court in Griswold v. Connecticut,

381 U.S. 479, 85 S.Ct. 1678, 14 L.Ed.2d 510 (1965). Al-

70a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion.

though sharply divided over the exact origins of such a

right, a majority of the Court recognized the existence of

a constitutionally protected “zone of privacy” which

shielded the individual from unreasonable personal intru-

sions by federal or state governments. This principle has

been reasserted in a number of subsequent cases. See, e. 9.,

Eisenstadt v. Baird, 405 U.S. 438, 92 S.Ct. 1029, 31 L.Ed.2d

349 (1972); Roe v. Wade, 410 U.S. 113, 93 S.Ct. 705, 35

L.Ed.2d 147 (1973); Doe v. Bolton, 410 U.S. 179, 93 S.Ct.

739, 35 L.Ed.2d 201 (1973). Each of these cases involved

instances of sexual conduct, and as recently noted in this

Cireuit, “the right to privacy which thus far has been

granted constitutional protection relates only to ‘the most

intimate phases of personal life’ having to do with sexual

intercourse and its possible consequences. ...” Roe v. In-

graham, supra 480 F.2d at 107, quoting Rosenberg v. Mar-

tin, 478 F.2d 520, 524 (2d Cir. 1973).

Plaintiffs’ claims, therefore, raise novel and serious ques-

tions with potentially far-reaching consequences as to the

permissible reach of the protection afforded by the right

of privacy as an independent constitutional guarantee. In

order to decide the motion before us, however, we need not,

at this time, fully define the limits of that right.

Plaintiffs have conceded the constitutionality of the New

York law as it existed prior to the effective date of the

Controlled Substances Act. Pursuant to the provisions of

that now repealed statute—the Narcotic Drug Control Act,

New York Laws 1953, ch. 879, 44 3300-3366, as amended—

all prescriptions were required to bear the patient’s name,

New York Laws 1961, ch. 206, § 3301(32), the pharmacist

dispensing the prescribed drug had to retain the prescrip-

tion in his file for a period of two years, New York Laws

1953, ch. 879, § 3322, subd. 1(c), and the pharmacist’s files

had to be maintained “so as to be readily accessible for in-

7la

Opinion of Three-Jud nti

ge Court Denying Plaintiffs’

and Defendant’s Motion. ,

spection by any public i

oe of this pobre _ —

; t is evident, therefore, that the nat i

tion required to be revealed by individual er

users remains essentially the same. Under the old law

however, the accumulation of records began and ended with

the individual pharmacist, without any attempt at central-

ization. Now, of course, although the prescription infor-

mation remains the same, the data is transmitted to a

single data-collection facility. Plaintiffs’ complaints, there-

fore, go only to this centralized collection of information

( record-keeping”) rather than to the nature of the in-

formation obtained in the first place (“reporting”)

This essential distinction between reporting and record-

keeping in respect of infringement of constitutional pro-

scriptions was most recently noted in Stark v. Connally

347 F.Supp. 1242 (N.D.Cal. 1972), appeal pending 41 L.W.

3509 (1973). In that case the plaintiffs challenged the ure.

visions of the Bank Secrecy Act, 31 U.S.C. §§ 1051-1122

The record-keeping provisions of the statute required

banks to keep the customary ledger records of individual

accounts and microfilm copies of all checks, drafts or other

instruments drawn on, presented for payment to, or re-

ceived for deposit by the bank. The reporting provisions

gave the Secretary of the Treasury virtually unlimited

power to require the reporting of all business and individ-

ual financial transactions, regardless of size.

It was only as to the reporting provisions relating to

domestic transactions that the court found the statute

transgressed constitutional guarantees of privacy, and then

only because of the particularly broad discretion given to

** See, also, New York Laws 1953, ch. 879, § 33 i

mitted access to the files b i Babe Ryne

forcement of the federal | A = a

72a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion.

the Secretary to require submission of information about

all aspects of every financial transaction. Thus, Stark

would support plaintiffs’ position here only if the New

York State Commissioner of Health had been given broad

powers to delve into intimate details of the individual s

medical history. In fact, the extent of the reporting pro-

visions, namely, the insertion of the patient’s and doctor s

names on a prescription, are here not deemed offensive,

and thus Stark supports defendant’s contention that the

Act does not unconstitutionally encroach upon plaintiffs

i rivacy.

ga soe for the defendant is Thom v. New

York Stock Exchange, 306 F.Supp. 1002 (S.D.N.Y. 1969),

affd. 425 F.2d 1074 (2d Cir.), cert. denied 398 US. 905, 90

S.Ct. 1696, 26 L.Ed.2d 64 (1970). There plaintiff chal-

lenged a New York law requiring all persons employed by

member firms of national security exchanges to be finger-

printed as a condition of employment, N.Y. General Bus.

1972), claiming that the statute was, inter alia, an uncon-

stitutional invasion of his right to privacy. The court

noted that the plaintiff did not contest the state’s right to

investigate employees of national security firms but only

objected to being fingerprinted.

But fingerprinting under the statute is only a means

of verifying the required information as to the exist-

ence or nonexistence of a prior criminal record. It

involves no additional intrusion into the personal lives

of the employees and applicants. The submission of

one’s fingerprints is no more an invasion of privacy

than the submission of one’s photograph or signature

to a prospective employer, which the Stock Exchange

rules still require. Jd. at 1009 (Footnote omitted.)

73a

Opinion of Three-Judge Court Denying Plaintiff s’

and Defendant’s Motion.

Thom emphasizes once again the underlying fallacy of

plaintiffs’ argument. Any invasion of privacy which occurs

under this statute would appear to result from the original

insertion of a patient’s name on the prescription and its

delivery to the pharmacist rather than the subsequent cen-

tralized collection of these documents. Furthermore, the

plaintiffs have been unable to produce any evidence, either

by affidavit, scientific study, official document or otherwise,

which provides even the slightest hit of actual, or even

likely, injury which will result to the plaintiffs if the drug

reporting system becomes operational.*® Indeed, the

** The plaintiffs argue that the very act of coding a patient’s

name into a centralized computer would result in the unwarranted

invasion of a constitutionally protected right to privacy. At oral

argument this proposition was supported primarily by counsel’s

reference to the general threat of privacy posed by ever-increasing

capacity of data-collection systems and computer informational

transfer on the one hand, and the more specific harm flowing to

particular individuals consequent to the perpetuation of incorrect

data and the unauthorized divulgence of private information.

Plaintiffs’ fears are shared by many and have within the last

few years generated considerable literature. The seminal work is

Westin, ‘‘Privacy and Freedom’’ (1967) in which the author, as

Chairman of the Special Committee on Science and Law of The

Association of the Bar of the City of New York, first defined pri-

vacy as ‘‘the claim of individuals, groups, or institutions to deter-

mine for themselves when, how, and to what extent information

about them is communicated to others.’ 7d. at 7, After examin-

ing the ‘‘new tools for invading privacy’’ he concludes that the

governing institutions of our society have been remiss in maintain-

ing the balance of privacy in this country and that without imme-

diate action we are threatened with subjugation to the tools of

science. Interestingly enough, Westin, five years later, has ¢o-

authored, as Project Director of the Project on Computer Data-

banks of the Computer Science and Engineering Board of the

National Academy of Sciences, the only thorough study of the

actual manner in which operating computer systems have influenced

individual privacy. Westin and Baker, ‘‘Databanks in the Free

(footnote continued on following page)

74a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion.

Memorandum of Assemblyman Chester Hardt, Chairman

of the Temporary State Commission to Evaluate the Drug

Laws, to Members of the Legislature, which was submitted

as an exhibit to plaintiffs’ moving papers, reflects favor-

ably on defendant’s position. This memorandum, along

with the Interim Report and the affidavit of Dr. Robert

Whalen, Second Deputy Commissioner of the New York

State Department of Health, all demonstrate 1) that the

state perceives itself to be in the throes of a crisis situation

resulting from the rampant illegal use of drugs; 2) that

the diversion of legal drugs to illicit use is a substantial

contributing factor in this dangerous situation; 3) that the

responsible state officials have engaged in serious, pro-

tracted and extensive study and research, including the

solicitation of advice and recommendations from various

representatives of special interest groups and the public

at large, all of which resulted in the proposed legislation;

and 4) that the methods ultimately decided upon appear on

their face to be reasonably calculated to effectuate the

purposes for which they were established, namely, to effec-

tively monitor the ebb and flow of the legal drug trade so

as to identify sources and methods of diversion.”

(footnote continued from preceding page)

Society: Computers, Record-Keeping and Privacy’’ (1972). This

study, like its predecessor, does not make light of the awesome

capabilities of the computers. Yet, it concludes that: ‘‘Our find-

ing is that [the earlier prediction that computers would destroy

practical boundaries of privacy] does not fit the computerized

record systems in existence in 1970-72.’’ Id. at 243.

14 Plaintiffs argue that other states have adopted less restrictive

legislation which does not require the centralized collection of pa-

tients’ names. The validity of the New York law is not undercut

by the existence of different laws elsewhere, particularly when the

enactment of the instant statute was preceded by extensive re-

search and study which demonstrates the state’s attempt to con-

struct a statutory scheme responsive to local needs.

Heese

75a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion.

The constitutional right of privacy, obviously, is not an

absolute bar to all government action that intrudes into

one’s personal life. The critical question is whether the

objective which the regulation seeks to accomplish is neces-

sitated by a subordinating state interest justifying the

degree and consequences of the resulting personal instru-

sion. See, e. g., Roe v. Wade, supra, 410 U.S. at 153, 93

S.Ct. at 727; Roe v. Ingraham, supra 480 F.2d at 108. In

seeking a preliminary injunction the burden is on the

plaintiffs to demonstrate a probability of success or at

least the existence of a serious and substantial question

warranting further deliberation. Robert W. Stark, Ine. v.

New York Stock Exchange, 466 F.2d 743, 744 (2d Cir.

1972), Inmates of Attica v. Rockefeller, 453 F.2d 12 (2d

Cir. 1971).

In order to obtain preliminary injunctive relief, the

plaintiffs are bound to show, at the very least, a substantial

legal foundation for their claim that the reporting provi-

sions of the statute violate their right of privacy and that

the consequences of the resulting intrusions are not justi-

fied when considered against the state’s interest. How-

ever, the plaintiffs have not produced any evidence which

demonstrates conclusively, or even supports inferentially,

the conclusion that, assuming the right to privacy will be

extended to cover this case, the competing interests of the

state are not sufficient to overcome whatever injury they

may suffer. It is this lack of proof which, at this stage

of the proceedings, causes plaintiffs’ success on the merits

to be insufficiently probable and their claim to be decidedly

insubstantial.

Having reached this conclusion, it is not necessary to

decide the question of irreparable injury or tipping of the

balance of hardships. It should be noted, however, that

the state’s efforts are directed against a very real and

pressing emergency requiring immediate and effective re-

76a

Opinion of Three-Judge Court Denying Plaintiffs’

and Defendant’s Motion.

sponse. The injury to the state and its people resulting

from any delay in implementation of programs designed

to deal with this problem may be quite significant. On the

other hand, there is no evidence of any immediate injury

threatening the plaintiffs other than the computerization

of their names at the Department of Health and even

this injury is easily susceptible to remedy, should the

plaintiffs ultimately prevail, merely by ordering the state

to destroy its records and erase the tapes.

Motion to Dismiss:

The defendant’s motion to dismiss, subject as it is to

the most favorable reading of plaintiffs’ complaint, cannot

be sustained. The discussion above demonstrates only

that at this time the plaintiffs have not met the heavy,

burden required to convince this court of the propriety of

a preliminary injunction. On the other hand, the plain-

tiffs ought to be allowed to explore more fully the outer

reaches of the right to privacy itself and to submit the

necessary intensive and detailed analysis of the competing

interests of the state and the individual. Specifically, the

plaintiffs must be afforded the opportunity to demonstrate

that the computerization of names is not necessary for

the accomplishment of the state’s goals, that the controls

developed by the state are inadequate to protect against

unauthorized disclosure of the computerized information

and that the injury to the plaintiffs resulting from the

implementation of this system of centralized filing is suffi-

ciently serious to overcome any competing state interest.

The motion to dismiss is denied. The motion for pre-

liminary injunction is denied and the restraining order

heretofore entered is vacated.

So ordered.

on Oe

77a

Answer.

UNITED STATES DISTRICT COURT

SouTHEeRN District or New York

Ricwarp Rog, an infant, by Roserr Roz, his parent, et al.,

Plaintiffs,

against

Houuis 8. Incranam, as Commissioner of Health

of the State of New York,

Defendant.

73 Civ. 1303

GeorGE Patient, et al.,

Intervenors,

against

Hous 8S. Incranam, as Commissioner of Health

of the State of New York,

Defendant.

73 Civ. 1431

dé.

. 4

Defendant for his answer to the complaints herein, re-

spectfully alleges:

As To 73 Crv. 1303

Frrst: Denies as to paragraph “1” that plaintiffs bring

this action “on behalf of all others similarly situated . . .*

There is no request pursuant to Rule 23 for a class action

order.

78a

Answer.

Szconp: Denies knowledge or information sufficient to

form a belief as to paragraphs “3”, “4” and “5”.

Turrp: Denies knowedge or information sufficient to

form a belief as to paragraph “6” except as otherwise ap-

pears from the records of the Secretary of State of the

State of New York.

FourtH: Denies so much of paragraph “Y” as to phy-

sicians’ dispensing, Public Health Law § 3331(6) since the

statute has been amended; and as to P.H.L. § 3371(1) (a),

in that regulations have been issued by defendant further

regulating disclosure of confidential information.

FirtH: Denies each and every allegation contained in

paragraphs “11”, “12” and “13”. As to “12”, the action in-

volves a hypothetical state of fact, contemplating improba-

ble violations of law and statute.

As To 73 Civ. 1431

SrxtH: Denies as to paragraph “1” that plaintiffs bring

this action “on behalf of others similarly situated .. .”

There is no request pursuant to Rule 23 for a class action

order.

SeventH: Denies so much of paragraph “2” which al-

leges jurisdiction pursuant to 28 U.S.C. 1331, the Com-

merce Clause, U.S. Const., Cert. 1, § 8.

EicHtH: Denies as to paragraph “3” that the amount

in controversy is in excess of $10,000.

Nrxta: Denies knowledge or information sufficient to

form a belief as to paragraphs “4”, “5”, “6” and “7”.

79a

Answer.

TentH: As to paragraph “10”, see paragragh “Fourtn”

herein.

ELEVENTH: Denies paragraphs “12” and “13”,

AS TO BOTH ACTIONS—FOR A FIRST SEPARATE

AND COMPLETE DEFENSE

TweLrrH: The plaintiffs fail to present an actual case

or controversy.

For A SECOND SEPARATE AND COMPLETE DEFENSE

THIRTEENTH: The complaint(s) fail to raise a substan-

tial question within the jurisdiction of this Court.

For A THIRD SEPARATE AND COMPLETE DEFENSE

FourtEENTH: The complaint(s) fail to state a claim

upon which relief may be granted.

For A FOURTH SEPARATE AND COMPLETE DEFENSE

FirreentH: The need for filing of the specified official

prescriptions is established by the legislative history and

such a determination is solely within the discretion of the

legislature. A court cannot look behind or review this

discretion.

SrxtrentH: The State has a legitimate interest in pro-

tecting public health to require filing. Hypothetical injury

to plaintiffs is inadequate to overcome this interest.

80a

Answer.

For A FIFTH SEPARATE AND COMPLETE DEFENSE

SEVENTEENTH: The statute itself and regulations pro-

mulgated by defendant are adequate to protect against un-

authorized disclosure of computerized information, assum-

ing any right of privacy applies to prescriptions.

EIGHTEENTH: Unauthorized disclosure is a violation of

criminal statutes and not to be presumed.

Wuererore, it is respectfully requested that the com-

plaint(s) be dismissed.

Dated: New York, New York

~ ptember 26, 1973

Louis J. LerKow1Tz

Attorney General of the

State of New York

A. Seta GreeNwALD

Assistant Attorney General

Attorney for Defendant

8la

Stipulation (Legislative History).

[SAME TITLE]

Ir 1s Heresy StipuLaTeD AND AGREED by and between the

undersigned that, for purposes of the above entitled action,

the following documents constitute the legislative history

of the sections in Article 33 of the Public Health Law at

issue herein:

1. Reporting of Sales of Dangerous Drugs, Second

Interim Report of the Temporary State Commission to

Evaluate the Drug Laws (Albany, N.Y. April 5, 1971) ;

2. Proposed New York State Controlled Substances

Act and Revision of the Penal Law, Interim Report of

the Temporary State Commission to Evalulate the

Drug Laws (State of New York—[1972] Legislative

Document No. 10) ; and

3. Memorandum of Chester R. Hardt, Chairman

of the Temporary State Commission to Evaluate the

Drug Laws (Appendix to Court of Appeals, pp. 40a-

44a),

and

Ir 1s FurtHer STrPuLaTeD AND AGREED that the foregoing

is without prejudice to the right of any party to offer tapes,

82a

Stipulation (Legislative History).

transcripts, exhibits or other material referred to in the

document described in paragraph “2” hereinabove.

Dated: New York, New York

June 20, 1974

SHea Govtp Ciuimenko & Kramer

By Micuae. Lescx

A Member of the Firm

and

Sotomow Z. Ferzicer, Esq.

Attorneys for Plaintiffs

Louis J. Lerxowrrz, Esq.

Attorney General

Assistant Attorney General

Attorney for Defendant.

So OrpDERED :

“ee ve eeeeeeeeeeeeeeeeenene

83a

Chester Hardt Memorandum.

State oF New York

Temporary State CoMMISSION

EvaLuaTE THE Druc Laws

STATE CAPITOL, ROOM 250

ALBANY, NEW YORK 12224

(510) 472-8511

To: MEMBERS OF THE LEGISLATURE

From: Chester R. Hardt, Chairman

Re: TRIPLICATE Prescriptions; New York State

ConTROLLED Suspstances Act; EFFECTIVE

Aprit 1, 1973.

Many of you have received communications from medical

practitioners concerning the New York State Controlled

Substances Act particularly the triplicate prescription re-

quirement for Schedule II Substances. To assist you in

replying, I have prepared the enclosed memorandum which

should enable you to respond to these inquiries.

If my office can be of further assistance to you, please

let us know.

The triplicate prescription provision is but one facet of

the comprehensive system of control against diversion of

lawfully manufactured, distributed, prescribed and dis-

pensed psychoactive drugs enacted by the Legislature

and the Governor in 1972. Public Health Law licensing

provisions have been tightened, specific rules regarding

safeguards for dispensing methadone have been enacted,

and greater preventive enforcement authority has been

given to the State Health Department.

84a

Chester Hardt Memorandum.

The triplicate prescriptiton concept was first proposed

by our Commission in its Interim Report of April 5, 1971.

Initial reaction appeared favorable, and the Commission

proposed triplicate prescriptions as part of the system to

control the illicit flow of drugs with a medical use in its

next draft report, circulated to medical societies and all

interested parties throughout the State in September of

1971. Hearings were held in major cities, and both invited

and volunteer speakers were heard from every aspect of

every discipline involved. Alternative proposals were

actively solicited. The reaction of ail of the experts, most

of the laymen, and all of the government agencies con-

tacted was that voluntary cooperation to stem the tide of

illicit therapeutic drug traffic was not possible in this

State.

However, when all of the evidence was in, the Commis-

sion did not recommend that all dangerous drugs require

a triplicate prescription. We believed, and we still believe,

that there continues to be room for voluntary curtailment

of the prescribing and dispensing of controlled substances,

particularly the short-acting barbituates, which are still

in Schedule III. We believe that if the terrible epidemic

of short-acting barbituate abuse in Southern California is

averted in New York State, the triplicate prescription pro-

vision will not be extended to these substances. With re-

gard to those drugs now in Schedule II, however, such as

morphine and amphetamines, the evidence at our hearings

was clearly that if we did not already have an epidemic

with these drugs, we were on the threshold of one.

At the outset, multiple prescriptions will be required

only for Schedule IT substances. These include the major

narcotics, such as pure opium, pure codeine, morphine,

Demerol and Dilaudid. Also included are the ampheta-

mines, including methamphetamine, and amphetamine-

like substances, such as Ritalin and Preludin. There is a

85a

Chester Hardt Memorandum.

likelihood at this time that methaqualone (Quaalude) will

also be included. Subject to exception from the multiple

prescription requirement will be certain compounds con-

taining amphetamines whose other ingredients vitiate the

stimulant effect of the amphetamines. These substances

represent a small fraction of the drugs dispensed or pre-

scribed in the usual course of a physician’s practice.

This requirement was conceived, by the Legislature and

the Governor, as an integral part of the Controlled Sub-

stances Act. The reason is that the relationship between

prescribing practices and general patterns which create a

climate hospitable to drug abuse has been firmly estab-

lished by the overwhelming preponderance of evidence re-

ceived by our Commission. Up to 30 per cent of all those

addicted to heroin since 1970 began their drug abuse by

misuse of prescribed medications. The drug dependence

and illness resulting from the over-preseribing of stimu-

lants has been documented at every level of government

and by nearly all responsible professionals. For example,

a recent NIHH study revealed that although general

practitioners represent but 30 per cent of all physicians,

they account for 41 per cent of all prescriptions for psycho-

active drugs. The stimulants, Ritalin and Preludin, were

not originally contained in the federal Schedule IJ. Our

Commission petitioned the federal government to include

Ritalin and Preludin in their Schedule II, just as we have

done in our Schedule II, based upon the experience of

almost uncontrollable abuse of these amphetamine-like

substances in Sweden following the prescription of am-

phetamines in that country. The Federal government did,

indeed, add these substances to their Schedule II at our

behest.

Here is how the multiple prescription system will work

in New York State. Upon prescribing or dispensing a

Schedule II substance, the practitioner will use an official

86a

Chester Hardt Memorandum.

New York State form instead of a sheet from his usual

prescription pad. Official forms will be provided by the

New York State Department of Health. If the physician

dispenses the substance, he will keep the original and

forward two copies to the Department. If he prescribes

the substance, he will give or mail to the patient the

original and one copy. The patient will take both the

original and the copy to the pharmacy. The pharmacist

filling the prescription will sign his name upon the origi-

nal and the copy and will note the date of delivery, and

the registration number of the pharmacy. Once a month,

he will send his accumulated endorsed copies to the Depart-

ment. He will retain the original for five years.

Although official prescriptions are not refillable, such a

prescription may authorize the dispensing of a maximum

30-day supply of the substance in question. All regular

prescriptions for controlled substances in Schedules III,

IV and V, including phenobarbital, may be refilled five

times in any given six month period of time.

Prescriptions, including official prescriptions, may be

mailed to long-term or invalid patients. Telephone pre-

scriptions may be filled for all controlled substances, even

for Schedule II narcotics, by phamacists, providing the

pharmacist makes a reasonable attempt to verify the

identity of the person representing himself to be a doctor,

for example, by a callback, and providing that the physician

follow up the oral prescription with an official or a written

prescription, as the substance in question may require.

The New York State Controlled Substances Act

materially tightens restrictions on divulging confidential

information. Under present law, confidentiality of patient

records simply does not exist with regard to law enforce-

ment personnel who may inspect such records at will.

Nothing relating to patient records may be disclosed under

the new law, even in the course of a criminal] investigation,

87a

Chester Hardt Memorandum.

except upon a judicial subpoena. Moreover, under the new

law measures must be taken in any administrative proceed-

ing, against a practitioner, to seal exhibits and to delete the

patient’s name.

With regard to data processing techniques that will be

used in connection with multiple prescriptions, the system

will work as follows: information from the official prescrip-

tion will be coded into a computer. The prescription copy

itself will be kept separately in a coded batch. The batch

number will be in the computer. At regular intervals,

certain specific questions will be asked of the computer.

These questions will be formulated at the highest

administrative level and no question may be asked of the

computer that has not been previously approved by the

Department. The questions will relate to physicians who

have prescribed and dispensed a greater amount of a

Schedule IT substance than could possibly be justified by the

nature of their practice. The computer will also be asked

to report on situations arising from lost or stolen prescrip-

tions.

It is extremely important that you make note of the fact

that, unlike many private health insurance programs that

presently employ data processing techniques for deter-

mining costs and eligibility of patients, our proposed plan

will not make use of massive print-outs of patients’ names.

The computer will not disclose identifying data about any

patient unless, based upon previous reports, it is clear

that such patient has been using stolen or forged prescrip-

tions.

Law enforcement officials in both California and Illinois

have been consulted in considerable depth about the use

of multiple prescriptions, since they have been using them

for a considerable period of time. They indicate to us that

they are not only a useful adjunct to the proper identifica-

tion of culpable professional and unscrupulous drug

88a

Chester Hardt Memorandum.

abusers, but that they also give a reliable statistical indica-

tion of the pattern of drug flow throughout their states:

information sorely needed in this state to stem the tide

of diversion of lawfully manufactured controlled sub-

stances. Our independent investigation of these systems

in California and Illinois has failed to reveal one single

case of the invasion of a patient’s right to privacy, despite

the fact that these other systems make use of massive com-

puter print-outs of patients’ names, which we do not.

The people of the State of New York have time and

again been demonstrated to be the most susceptible of all

the people in the United States to drug abuse. It is the

most deeply felt conviction of those involved in helping to

curb drug abuse in this state that the multiple prescription

requirement will be a safe and useful implement in this

effort.

89a

Pre-Trial Order on Consent.

[SAME TITLE]

On October 24, 1974, the attorneys for the parties to

this action appeared before the Court at a pre-trial con-

ference pursuant to Rule 16 of the Federal Rules of Civil

Procedure and, as a result thereof, the following action

has been taken:

I. Stipulation of Facts

The parties stipulate that the following facts are not

in dispute in this action. Each party reserves the right

to object to the materiality of any such stipulated facts

and its relevancy to the issues:

A. Manner In Which The Triplicate

Prescription Forms Are Used By

Physicians and Pharmacists

1. Prior to April 1, 1973, the effective date of Arti-

cle 33 of the Public Health Law and at all times there-

after, prescription forms for Schedule II drugs have

been sent to all qualified physicians who ordered such

forms.

2. Annexed hereto marked “Exhibit A” is the list of

Schedule II drugs which appears in Article 33 of the

Public Health Law. Annexed hereto marked “Exhibit

B” is a letter from the Commissioner of Health to phy-

sicians instructing them how to obtain and use the forms

and setting forth a list of some of the drugs, together

with their trade names. The Commissioner of Health

is authorized to reschedule Schedule III drugs or Sched-

ule IV drugs as Schedule II drugs (see § 3338(2)), but

90a

Pre-Trial Order on Consent.

no such re-schedulings had been made as of February 11,

1974. There has been statutory reclassification. (See

Chapter 97, Laws of 1973, a copy of which is annexed

hereto marked ‘‘Exhibit “*C”.)

3. Acting under Article 33 of the Public Health Law,

the Department of Health requires a physician dispens-

ing a Schedule II drug to keep one copy of the prescrip-

tion and mail the original and remaining copy in a pre-

addressed envelope provided by the State of New York

State Department of Health, Bureau of Controlled Sub-

stances, Licensing and Evaluation, 845 Central Avenue,

Albany, New York 12206. A physician who only prescribes

the drug but who does not dispense is required to keep

one copy of the prescription form and give the original

and copy to the patient, who must take them to a pharma-

cist in order to have the prescription filled. The phar-

macist is required to keep the original prescription form

and to send the remaining copy to Albany. (See §§ 3337

and 3333.)

4. The copy of the prescription form that is sent to

Albany contains (a) the name, address, telephone number

and BNDD number (now known as DEA number)* of

the prescribing practitioner, (b) the date on which the

prescription was issued, (c) the name, age and address

of the patient, (d) the name and amount of the drug

prescribed, (e) the maximum daily dosage thereof, (f)

the signature of the practitioner, (g) the prescription

number issued by the pharmacy, (h) the date the prescrip-

*‘*BNDD number’’ refers to the number given by the Fed-

eral Bureau of Narcotics & Dangerous Drugs (“BNDD”), now

known as The Drug Enforcement Administration (‘‘DEA’’), to

all practitioners who prescribe and/or dispense drugs and to phar-

macists who dispense drugs.

91a

Pre-Trial Order on Consent.

tion was filled, (i) the Schedule II substance NDC num-

ber,* (j) the pharmacy BNDD number and (k) the sig-

nature of the dispenser. A sample copy of such a form

is annexed hereto marked “Exhibit D”’’.

B. Organization of Bureaus of Department of

Health Which Process or Use The Forms

5. Dr. Arthur G. Baker, Associate Commissioner of

Health for Community Health Services, is charged with

overall responsibility for the triplicate prescription pro-

gram. Two bureaus under his jurisdiction have responsi-

bilities relating to the triplicate prescriptions—the Bureau

of Narcotic Control (‘‘BNC’’) and the Bureau of Con-

trolled Substances, Licensing and Evaluation (“BCSLE”).

The BNC, under its director, John J. Bellizzi, is respon-

sible for conducting investigations concerning alleged vio-

lations of the Public Health Law relating to controlled

substances. There are 24 narcotic investigators in BNC,

distributed throughout the state as follows: 2 each in Buf-

falo, Rochester, Syracuse, White Plains and Albany, and

the remaining 14 in New York City. The BCSLE, under

its director, Joseph L. Cannizzaro, is responsible for proc-

essing of the prescriptions and security and retention of

the prescriptions. BCSLE was formed after enactment of,

and for the purpose of implementing, the triplicate pre-

scription legislation. Twenty-four of its employees are

principally concerned with such implementation. In addi-

tion, the Office of Electronic Data Processing (‘‘OEDP’’),

a unit which is part of the Department of Health but not

under Dr. Baker’s jurisdiction,* participates in the proc-

essing of the prescription blanks by transferring the in-

*‘“NDC”’ refers to National Drug Code.

* At the trial, further evidence on this subject will be offered

by defendant.

92a

Pre-Trial Order on Consent.

formation from the prescription blanks to dises to tapes

which can be ‘‘read’’ by the computer. In April 1973, the

director of OEDP was Harold Gottheim. The director of

OEDP since March 1974 has been Joseph Bonacci. Imple-

mentation of the triplicate prescription law necessitated

the hiring of 14 additional key punch operators and one

additional computer operator.

C. Processing of the ‘‘Cashed’’ Prescription

Blanks in Albany

6. In Albany, the prescriptions are received in the mail

room of BCSLE, at 845 Central Avenue. They are taken

unopened to a receiving room where they are opened,

coded, put into batches of 100 each and logged by approxi-

mately nine clerks. Since April 1, 1973, the effective date

of the law, prescription forms have been received at the

rate of approximately 25,000 per week or over 100,000 per

month.

7. The batches are then taken into a ‘‘ processing room’’

which is part of the OEDP, where the information on the

triplicate forms is keypunched onto discs and subsequently

the information on the discs is transferred to magnetic

tapes.

8. The prescription forms which have not yet been

processed are stored overnight in a locked cabinet. Those

which have already been processed are stored in a locked

vault. The magnetic tapes containing triplicate prescrip-

tion information are kept in a locked cabinet in an area of

the processing room separate and apart from all other

tapes and discs.

93a

Pre-Trial Order on Consent.

D. Development of a Format for Presentation

of the Information Contained On the Tripli-

cate Prescription Forms Filed in Albany

9. Prior to the enactment of the statute on June 8, 1972,

no one from the Department of Health was asked to testify

about the need for identifying information as to patients

using Schedule II drugs. Although Bellizzi has been head

of enforcement in New York since 1958, he was not con-

sulted by the legislature about the need for triplicate

prescriptions until after the statute was enacted.

10. After June 8, 1972, the Department of Health began

to consider how the triplicate prescription information

could be used. Bellizzi was sent to California and Lllinois,

two states which had triplicate prescription statutes, and

found that the two principal areas of benefit were in de-

terring forgeries and over-prescriptions of the drugs.

Thereafter, no memorandum was prepared by the Depart-

ment of Health setting forth the questions to be answered

by the system until memoranda dated June 20, 1973,

October 11, 1973 and October 23, 1973, all of which were

prepared more than one year after the statute had been

enacted. However, from April 1973 to September 1973, the

Department of Health was restrained from processing the

prescription forms by this Court, the United States Court

of Appeals for the Second Circuit and the United States

District Court for the Western District of New York. The

June 20, 1973 memorandum, prepared by Mr. Bellizzi for

Commissioner Whelan, did not mention the possibility of

apprehending patients who go from doctor to doctor to ob-

tain excessive amounts of Schedule II drugs as a potential

benefit of the system. The October 11, 1973 memorandum

also did not mention the problem. The October 23, 1973

memorandum was divided into 18 questions to be answered

monthly on a first priority basis, 25 additional questions

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to be answered monthly, 3 questions to be answered

quarterly, one question to be answered semi-annually and

5 questions to be answered on an ‘‘on request basis”.

None of the 15 questions to be answered on a ‘‘first priority

basis” contained any request for information as to patients

who go from doctor to doctor in order to obtain excessive

amounts of Schedule II drugs.

11. Thereafter, on November 29, 1973, three schedules

were prepared showing the information to be derived

from the system (copies thereof are annexed hereto marked

“Exhibit E”, “Exhibit F’’ and ‘Exhibit G’’) and, in early

December 1973, a further memorandum was prepared de-

scribing the format of the information to be obtained in

greater detail. (A copy thereof is annexed and marked

“Exhibit H”). According to Dr. Baker, the four basic

purposes of the system were as follows:

(a) To facilitate study of the practicing habits of

those practitioners who use an unusually large number

of prescriptions. Dr. Baker plans to obtain a list of

such physicians and then a printout of the types of

drugs prescribed or dispensed by such physicians and

to refer that information to the Bureau of Narcotic

Control which will pursue an audit of such physician’s

practices to ascertain whether such usage was proper.

(b) To obtain the information contained on Exhibits

EK, F, and G.

may present a problem of abuse. Dr. Baker plans to

follow the same process of investigating physicians

who prescribe these drugs as is described in subpara-

graph 1lli(a) above.

(d) To ascertain instances in which patients appear

to be obtaining more than a 30-day supply of a con-

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Pre-Trial Order on Consent.

trolled substance, possibly by obtaining prescriptions

from more than one physician.

12. The only information from the computer which Dr.

Baker contemplates would contain the names of any

patients is a print-out of patients who have obtained more

than a 30-day supply of a Schedule II drug in a 30-day

period. The only reason given by Dr. Baker for the above

print-out is that it will assist in the identification and in-

vestigation of persons who, using the same name, go from

doctor to doctor to obtain an illicit supply of Schedule II

drugs. The number of case reports of such violations was

as follows from January 1, 1969 to May 12, 1974:

1974 — 1 case

1973 — None

1972 — None

1971 — 1 case

1970 — 1 case

1969 — 1 case

E. Print-outs Now Being Produced

By the State’s System

13. As presently in effect, the following print-outs are

produced by the state’s system:

(a) “Practitioner RX Transaction Record Edit Er-

ror Listing.” This print-out sets forth errors which

occurred in the process of transferring the information

from the prescription form as filed in Albany to the

computer tape on which the information is stored or

to deficiencies contained on the prescription.

(b) ‘‘Schedule II substances dispensed and proc-

essed in month... .”

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This shows, inter alia:

(i) The number of prescriptions filled and the

average number of prescriptions per practitioner;

(ii) The number of prescriptions dispensed by

practitioners ;

(iii) The number of prescriptions dispensed by

pharmacies.

(d) “Report of duplicate prescriptions processed in

month. . . .” This shows when two prescriptions with

the same number were filled. While the purpose of

this print-out was to detect possible forgeries or

counterfeits, all duplications uncovered have resulted

from errors in processing.

(e) “Unmatched BNDD numbers.” This print-out

was designed to show prescriptions filled where the

practitioner’s BNDD number listed on the prescription

did not match the BNDD number shown on Depart-

ment of Health records for the practitioner. It too

was designed to protect against possible forgeries,

but, in April 1974, “in the process of being modi-

fied.’’*

(f) “Patients with prescription total in excess of

30-day supply processed in month... .” This is the

print-out designed to ascertain the identity of patients

who go to more than one doctor to obtain an excess of

a 30-day supply of Schedule II drugs within a 30-day

period. Originally, this print-out did not contain

patients’ names, but, in April 1974, it was being al-

tered so that patients’ names would be included a

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