Court filing
Motion for Leave to File Amicus Brief (AAPS) — Apter v. HHS
Filed September 29, 2022 in Apter v. Department of Health and Human Services; one of 66 filings from this case.
Record facts
| Court | U.S. District Court for the Southern District of Texas (Galveston Division) |
|---|---|
| Filed | 2022-09-29 |
U.S. District Court for the Southern District of Texas (Galveston Division) · No. 3:22-cv-00184 · Doc. 29 · 2022-09-29 · Docket on CourtListener
Full text
IN THE UNITED STATES DISTRICT COURT
FOR THE SOUTHERN DISTRICT OF TEXAS
GALVESTON DIVISION
ROBERT L. APTER, M.D., FACEP; MARY
TALLEY BOWDEN, M.D.; and PAUL E.
MARIK, MBBCh, M.MED, FCCM, FCCP,
Plaintiffs,
v.
DEPARTMENT OF HEALTH AND HUMAN
SERVICES; XAVIER BECERRA, in his
official capacity as Secretary of Health and
Human Services; FOOD AND DRUG
ADMINISTRATION; and ROBERT M.
CALIFF, M.D., MACC, in his official capacity
as Commissioner of Food and Drugs,
Defendants.
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Case No. 3:22-cv-184 (JVB)
UNOPPOSED MOTION FOR LEAVE TO FILE AMICUS CURIAE BRIEF OF
THE ASSOCIATION OF AMERICAN PHYSICIANS AND SURGEONS
Andrew L. Schlafly
SD Texas Bar ID NJ04066
939 Old Chester Rd.
Far Hills, NJ 07931
Tel: 908-719-8608
Fax: 908-934-9207
Email: aschlafly@aol.com
Counsel for Amicus Curiae
Association of American Physicians and Surgeons
Case 3:22-cv-00184 Document 29 Filed on 09/29/22 in TXSD Page 1 of 6
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By analogy with the FED. R. APP. PROC. 29, the Association of American Physicians
and Surgeons respectfully requests leave to file their accompanying amicus curiae brief in
support of plaintiffs here. Plaintiffs have consented to this motion while defendants have
indicated that they do not oppose it.
I.
IDENTITY AND INTEREST OF AMICUS CURIAE1
Amicus curiae Association of American Physicians and Surgeons (“AAPS”) is a
national association of physicians. Founded in 1943, AAPS has been dedicated to the
highest ethical standards of the Oath of Hippocrates and to preserving the sanctity of the
patient-physician relationship. AAPS has been a litigant in federal courts. See, e.g.,
Cheney v. United States Dist. Court, 542 U.S. 367, 374 (2004) (citing Ass’n of American
Physicians & Surgeons v. Clinton, 997 F.2d 898 (D.C. Cir. 1993)); Ass’n of American
Physicians & Surgeons v. Mathews, 423 U.S. 975 (1975). In addition, the U.S. Supreme
Court has expressly made use of amicus briefs submitted by AAPS in high-profile cases.
See, e.g., Stenberg v. Carhart, 530 U.S. 914, 933 (2000); id. at 959, 963 (Kennedy, J.,
dissenting); District of Columbia v. Heller, 554 U.S. 570, 704 (2008) (Breyer, J.,
dissenting). Over the span of more than a decade, the Fifth and Third Circuits have
expressly cited an amicus brief by AAPS in the first paragraph of one of its decisions. See
1 The undersigned counsel certifies that counsel for the Amicus authored this motion and
accompanying brief in whole; no counsel for a party authored this motion and brief in any
respect; and no person or entity – other than Amicus, its members, and its counsel –
contributed monetarily to this motion and brief’s preparation or submission.
Case 3:22-cv-00184 Document 29 Filed on 09/29/22 in TXSD Page 2 of 6
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Texas v. United States, 945 F.3d 355, 369 (5th Cir. 2019); Springer v. Henry, 435 F.3d
268, 271 (3d Cir. 2006). AAPS was the plaintiff in a decision relied upon by the
government here in its pending motion, which reinforces AAPS’s interest in this case.
(Govt Mot. 13)
Amicus AAPS members have direct and vital interests in the issues here,
particularly the interference by the FDA with the practice of medicine.
II.
AUTHORITY TO FILE THE AMICUS CURIAE BRIEF OF AAPS.
As now-Justice Samuel Alito observed while serving on the U.S. Court of Appeals
for the Third Circuit, “I think that our court would be well advised to grant motions for
leave to file amicus briefs unless it is obvious that the proposed briefs do not meet Rule
29’s criteria as broadly interpreted. I believe that this is consistent with the predominant
practice in the courts of appeals.” Neonatology Assocs., P.A. v. Comm’r, 293 F.3d 128,
133 (3d Cir. 2002) (citing Michael E. Tigar and Jane B. Tigar, Federal Appeals –
Jurisdiction and Practice 181 (3d ed. 1999) and Robert L. Stern, Appellate Practice in
the United States 306, 307-08 (2d ed. 1989)). Then-Judge Alito quoted the Tigar treatise
for the statement that “‘[e]ven when the other side refuses to consent to an amicus filing,
most courts of appeals freely grant leave to file, provided the brief is timely and well-
reasoned.’” 293 F.3d at 133.
This motion for leave to file an amicus brief is timely because it is filed (along
with the accompanying brief) within seven days of the filing of the brief that Amicus
supports, as filed by plaintiffs on September 23, 2022.
Case 3:22-cv-00184 Document 29 Filed on 09/29/22 in TXSD Page 3 of 6
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III.
REASONS WHY THIS AMICUS CURIAE BRIEF IS DESIRABLE
AND WHY THE MATTERS ASSERTED ARE RELEVANT TO THE
DISPOSITION OF THIS CASE.
The accompanying amicus curiae brief by AAPS will be beneficial to this Court’s
resolution of the issues raised for the following reasons, as more fully explained in the
accompanying brief:
A. Off-Label Prescribing Is Necessary to Effective Medical Treatment, and the
FDA’s Interference Is Illegal.
As expressly recognized by the Supreme Court, “courts, several States, and the
‘FDA itself recognize the value and propriety of off-label use.’” Buckman Co. v.
Plaintiffs’ Legal Comm., 531 U.S. 341, 350 (2001) (quoting Beck & Azari, “FDA, Off-
Label Use, and Informed Consent: Debunking Myths and Misconceptions,” 53 Food &
Drug L. J. 71, 76-77 (1998)). The Supreme Court added that “‘[o]ff-label use is
widespread in the medical community and often is essential to giving patients optimal
medical care, both of which medical ethics, FDA, and most courts recognize.’”
Buckman, 531 U.S. at 351 n.5 (quoting Beck & Azari, 53 Food & Drug L. J. at 72,
emphasis added).
Despite the clarity of federal law and common practice on this issue of off-label
prescribing, the FDA continues to illegally interfere with it as explained more fully in
plaintiffs’ Amended Complaint and brief in opposition to defendants’ motion to dismiss.
See also Exh. 6 to plaintiffs’ Amended Complaint (FDA: “You are not a horse. Stop it
with the #ivermectin. It’s not authorized for treating #COVID.”). That statement by the
Case 3:22-cv-00184 Document 29 Filed on 09/29/22 in TXSD Page 4 of 6
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FDA of “not authorized” is misinformation of the worst kind. The FDA does not
specifically authorize the use of approved-as-safe medication for virtually any new use
deemed effective by physicians licensed to practice by their state medical boards.
B. FDA’s Unjustified Overreach Has Propagated into Court Decisions and State
Medical Board Actions.
The FDA’s unauthorized and unjustified disparagement of physicians prescribing
ivermectin has wrongfully influenced multiple courts and state medical boards, as
explained in the accompanying amicus brief.
C. Legal Standing Exists to Challenge Devastating, Unauthorized Falsehoods by
Government.
The government seeks to avert substantive review here by challenging the legal
standing of plaintiffs. (Govt Mot. 11-17) But AAPS, as an association of physicians
many of whom having been treated Covid-19 patients since early 2020, can attest that the
impact of defendants’ actions beyond their authority has been causing real harm to
practicing physicians, including plaintiffs.
Similarly, the strong disparagement by the FDA of using ivermectin to treat
Covid-19 is sufficient to justify standing by plaintiffs here, as treating physicians, to
object to that unauthorized disparagement. Standing exists regardless of how the ultimate
merits of this case may be resolved.
WHEREFORE, Amicus AAPS respectfully requests that its unopposed motion for
leave to file its accompanying amicus curiae brief be granted.
Case 3:22-cv-00184 Document 29 Filed on 09/29/22 in TXSD Page 5 of 6
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Dated: September 29, 2022
Respectfully submitted,
/s/ Andrew L. Schlafly
Andrew L. Schlafly
Attorney-in-charge
State of N.J. Bar ID 04066-2003
SD Texas Bar ID NJ04066
939 Old Chester Rd.
Far Hills, NJ 07931
Tel: 908-719-8608
Fax: 908-934-9207
Email: aschlafly@aol.com
Counsel for Amicus Association of
American Physicians and Surgeons
CERTIFICATE OF WORD AND PAGE COUNTS
I hereby certify that the total number of words in this document, exclusive of
sections properly omitted from this count, is 1,005 words as indicated by Microsoft
Word, and that its page length is no more than 5 pages. I further certify that this
document is in size 13 Times New Roman font.
/s/ Andrew L. Schlafly
Andrew L. Schlafly
CERTIFICATE OF SERVICE
I hereby certify that on this September 29, 2022, I caused service of all the parties
of the foregoing document through operation of the Court’s CM/ECF system.
/s/ Andrew L. Schlafly
Andrew L. Schlafly
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