IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF TEXAS
HOUSTON DIVISION
______
The Association of American )
Physicians & Surgeons, Inc., )
Congressman Ron Paul, M.D., )
Dawn Richardson, )
Rebecca Rex and )
Darrell McCormick, )
)
Plaintiffs, )
)
vs. ) Civil Action No. H-01-2963 (SL)
)
UNITED STATES DEPARTMENT OF )
HEALTH AND HUMAN SERVICES )
AND TOMMY G. THOMPSON, AS )
SECRETARY OF THE U.S. )
DEPARTMENT OF HEALTH AND )
HUMAN SERVICES )
)
Defendants. )
______)
MEMORANDUM OF POINTS AND AUTHORITIES
IN OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS
Andrew Schlafly, Esq. Karen Tripp
AAPS General Counsel Attorney-in-charge
939 Old Chester Road Texas Bar No. 03420850
Far Hills, NJ 07931 Southern District Bar No. 2345
(908) 719-8608 (phone) P.O. Box 1301
(212) 214-0354 (fax) Houston, Texas 77251-1301
(713) 658-9323 (phone)
(713) 658-9410 (fax)
ATTORNEYS FOR PLAINTIFFS
January 11, 2002
ii
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TABLE OF CONTENTS
Page
TABLE OF EXHIBITS …...iii
TABLE OF AUTHORITIES iv
MEMORANDUM OF POINTS AND AUTHORITIES IN OPPOSITION TO DEFENDANTS’ MOTION TO DISMISS 1
STATEMENT 1
A. Nature and Stage of the Proceeding 1
B. Statement of the Issues 3
C. Summary of the Argument 4
FACTUAL BACKGROUND 7
A. HIPAA Provides Limited Delegation to HHS. 7
B. Proposed Regulation and AAPS’s Comments 8
C. Final Regulation Extends Far Beyond Proposed Regulation 9
ARGUMENT 9
I. THE LIMITATIONS ON PATIENTS’ OWN ACCESS, AND PROVISIONS FOR GOVERNMENT ACCESS WITHOUT MEANINGFUL PROTECTIONS, ARE UNAUTHORIZED, UNCONSTITUTIONAL, AND UNDEFENDED HERE.. 10
A. The Limitations on Plaintiffs’ Own Access are Unauthorized and Unjustified. 10
B. The Broad Access to Medical Records Granted to Government is Unconstitutional. 13
II. PLAINTIFFS HAVE STANDING TO ASSERT THEIR FOURTH AND FIRST AMENDMENT CLAIMS. 16
A. Plaintiff AAPS’s Members Have Standing to Sue In Their Own Right Because They Have Suffered, and Continue to Suffer, Injury in Fact from the Privacy Rule. 18
B. Plaintiff AAPS’s Purposes Are Germane to this Litigation. 20
III. PLAINTIFFS’ CLAIMS ARE RIPE FOR REVIEW. 22
A. The Issue Is Fit for Judicial Determination. 23
1. Defendants’ Lack of Statutory Authority To Issue the Challenged Regulation Is a Purely Legal Issue. 24
2. The Unconstitutionality of the Privacy Rule Is a Purely Legal Issue. 25
3. HHS’s Issuance of the Rule Constitutes Final Agency Action. 28
4. Deferral Would Serve No Purpose to Either HHS or the Court Because HHS’s Position Concerning Privacy Reguations Has Crystallized. 30
B. Although Plaintiffs Need Not Demonstrate Hardship Because Their Challenge Is Fit for Judicial Determination, Deferring Review Would Create Hardship. 32
IV. PLAINTIFFS HAVE STANDING FOR THEIR TENTH AMENDMENT CLAIM, AND WHETHER THE PRIVACY RULE EXCEEDS COMMERCE CLAUSE AUTHORITY IS AN ISSUE OF FACT. 33
A. Plaintiffs Have Standing to Assert a Tenth Amendment Claim. 33
B. Whether the Privacy Rule Exceeds Commerce Clause Authority is an Issue of Fact Unsuitable for Disposition on the Pleadings. 35
V. THE PRIVACY RULE EXCEEDS HHS’S SCOPE OF AUTHORITY UNDER HIPAA. 36
A. The Plain Language of the Statute is Limited to Electronic Transactions. 37
B. The Secretary’s Extension to Non-Electronic Information Violates HIPAA. 39
C. Congressional Inaction Does Not Imply Endorsement of the Privacy Rule. 43
D. The Delegation of Authority to HHS Lapsed Under HIPAA. 44
VI. THE PRIVACY RULE VIOLATES THE REGULATORY FLEXIBILITY ACT AND THE PAPERWORK REDUCTION ACT. 44
A. The Secretary Failed to Comply with the Regulatory Flexibility Act. 45
B. The Secretary Failed to Comply with the Paperwork Reduction Act. 47
VII. CONCLUSION 48
TABLE OF EXHIBITS
EXHIBIT A AAPS v. FDA & HHS, Civ. No. 00-02898 (HHK)
(D.D.C. Oct. 25, 2001)
EXHIBIT B Florida Statute Section 456.057
EXHIBIT C California Health & Safety Code Section 123110
EXHIBIT D Missouri Statute Section 191.227
EXHIBIT E Robert A. Phillips and John Hoey, “Constraints of interest: lessons at the Hospital for Sick Children,” 159 Canadian Med. Assoc. J. 955-57 (1998)
EXHIBIT F “A Doctor’s Drug Trials Turn into Fraud,” New York Times, May 17, 1999, at A1
EXHIBIT G Declaration By Gregory N. Laurence, M.D.
EXHIBIT H Declaration By Patient Dawn Richardson
Declaration By Patient Rebecca Rex
Declaration By Melvin E. Edwards
EXHIBIT I Wash. Gas Light Co. v. Public Serv. Comm’n, 508 A.2d 930 (D.C. 1986)
EXHIBIT J Declaration By Beverly B. Nuckols, M.D.
Declaration By Philip M. Catalano, M.D.
Declaration By Melissa Kline Clements, M.D.
Declaration By Gary S. Mirkin, M.D.
EXHIBIT K California Constitution Article I, Section I
EXHIBIT L California Civil Code Section 56 et seq.
EXHIBIT M Florida Constitution Section 23
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