Durk Pearson v. Michael Leavitt, in his official capacity as Secretary of the U.S. Department of Health

UNPUBLISHED
UNITED STATES COURT OF APPEALS
FOR THE FOURTH CIRCUIT
No. 05-1937
DURK PEARSON; SANDY SHAW,
Plaintiffs - Appellants,
versus
MICHAEL LEAVITT, in his official capacity as
Secretary of the U.S. Department of Health and
Human Services; LESTER M. CRAWFORD, in his
official capacity as Acting Commissioner of
the U.S. Food and Drug Administration; UNITED
STATES FOOD AND DRUG ADMINISTRATION; U.S.
DEPARTMENT OF HEALTH & HUMAN SERVICES; UNITED
STATES OF AMERICA,
Defendants - Appellees.
Appeal from the United States District Court for the District of
Maryland, at Greenbelt. Alexander Williams, Jr., District Judge.
(CA-04-3600-AW)
Argued: May 22, 2006 Decided: June 23, 2006
Before WILKINSON and TRAXLER, Circuit Judges, and Richard L.
WILLIAMS, Senior United States District Judge for the Eastern
District of Virginia, sitting by designation.
Affirmed by unpublished per curiam opinion.
ARGUED: Jonathan Walker Emord, EMORD & ASSOCIATES, P.C., Reston,
Virginia, for Appellants. Matthew Miles Collette, UNITED STATES
DEPARTMENT OF JUSTICE, Civil Division, Appellate Section,
Washington, D.C., for Appellees. ON BRIEF: Michelle C. Gayeski,

-- 1 of 9 --

2
EMORD & ASSOCIATES, P.C., Reston, Virginia, for Appellants. Peter
D. Keisler, Assistant Attorney General, Rod J. Rosenstein, United
States Attorney, Douglas N. Letter, UNITED STATES DEPARTMENT OF
JUSTICE, Civil Division, Appellate Section, Washington, D.C., for
Appellees.
Unpublished opinions are not binding precedent in this circuit.
See Local Rule 36(c).

-- 2 of 9 --

3
PER CURIAM:
Durk Pearson and Sandy Shaw (“Appellants”) sought and were
denied declaratory and injunctive relief to preclude the Food and
Drug Administration (“FDA”) and the Department of Health and Human
Services (“HHS”)(collectively “Appellees”) from taking action to
prevent Appellants from selling a report published by the United
States government that suggests that dietary supplements containing
S-adenosyl-L-methionine(“SAMe”) were a possible treatment for
various diseases. Appellants claimed that the potential for FDA
enforcement of its regulations chilled their constitutionally
protected First Amendment free speech rights. Finding that there
is not a sufficient factual basis upon which to make a
determination of Appellants’ claims, we agree with the district
court’s ruling that the controversy is not ripe and accordingly
affirm the dismissal of the claim under Rule 12(b)(6) of the
Federal Rules of Civil Procedure.
I.
Durk Pearson and Sandy Shaw are formulators of dietary
supplements containing SAMe. Appellants receive royalties from
distributors who are licensed to sell their products. SAMe is an
amino acid created within human cells by the energy molecule ATP
and the amino acid methionine. SAMe plays a role in many of the
biochemical reactions in the human body. SAMe has been the subject

-- 3 of 9 --

4
of research by privately funded organizations and by federal
government agencies.
In October 2002, the Agency for Healthcare Research and
Quality (“AHRQ”), a division of HHS, published a report entitled
“S-Adenosyl-L-Methionine for the Treatment of Depression,
Osteoarthritis, and Liver Disease”(the “Report”). The Report
summarized the conclusions of various published studies examining
the effect of SAMe on the treatment of depression, osteoarthritis,
and liver disease. The Report concluded that supplements
containing SAMe are more effective than placebos in the treatment
of depression and osteoarthritis but were no more effective in
treating liver disease. The Report was made available to the
public on at least seven different websites.
In 2004, Appellants wrote a prologue to the Report, touting
its findings and explaining the role of SAMe in bodily processes.
Appellants intended to sell a bound volume consisting of their
prologue and the Report (collectively the “Publication”) to the
general public through their licensees.
Appellants refrained from selling the Publication because of
fear of prosecution by the FDA. Specifically, Appellants feared
that the FDA, under their administrative enforcement policy, would
use the Publication as evidence of the “intended use” of the
dietary supplements and reclassify Appellants’ SAMe-containing
dietary supplements as “new drugs” under the Food Drug and

-- 4 of 9 --

5
Cosmetics Act (“FDCA”), thus prohibiting sale of the Publication to
consumers.
In November 2004, Appellants brought this action seeking a
declaration that the potential enforcement of FDA regulations was
a violation of their First Amendment right to free speech.
Appellants also sought to enjoin Appellees from declaring the
Publication as evidence of an intent to sell the SAMe-containing
dietary supplements as “new drugs” and from taking any action to
prohibit Appellants’ licensees from selling the Publication to the
public. At the time the action was filed, the FDA had not
threatened or implemented any procedures to either prohibit the
sale of the Publication or to prosecute Appellants for FDA
violations.
Appellants moved for summary judgment and Appellees moved to
dismiss or, in the alternative, for summary judgment. The district
court ruled that there was not a sufficient factual record upon
which to make a determination regarding the validity of Appellants’
claims and that the case was not ripe, and granted Appellees’
motion to dismiss. This appeal followed.
II.
Ripeness requirements are relaxed in First Amendment cases
because of the potential chilling effect of unconstitutional
restrictions on free speech. Forsyth County v. Nationalist

-- 5 of 9 --

6
Movement, 505 U.S. 123, 129-30 (1992). To withstand a ripeness
challenge, a plaintiff must demonstrate “a live dispute involving
the actual or threatened application of [a statute or policy] to
bar particular speech.” Renne v. Geary, 501 U.S. 312, 320 (1991).
But without a factual record of an actual or threatened action
resulting in the suppression of free speech, no ripe, justiciable
controversy exists. Woodall v. Reno, 47 F.3d 656, 656 (4th Cir.
1995); see Jordahl v. Democratic Party of Virginia, 122 F.3d 192,
198 (4th Cir. 1997).
In evaluating the ripeness of a claim for judicial review,
courts must consider (1) the fitness of the issues for judicial
decision and (2) the hardship to the parties of withholding court
consideration. Abbott Labs v. Gardner, 387 U.S. 136, 149 (1967);
overruled on other grounds by Califano v. Sanders, 430 U.S. 99
(1977). Regarding administrative agency cases, this court has held
that a claim is not ripe for review unless the issues to be
considered are purely legal ones and the agency rule giving rise to
the claim is final and not dependent on future uncertainties or
intervening agency rulings. Charter Fed. Sav. Bank v. Office of
Thrift Supervision, 976 F.2d 203, 208 (4th Cir. 1992). If certain
critical facts that would substantially assist the court in making
its determination are contingent or unknown, the case is not ripe
for judicial review. Arch Mineral Corp. v. Babbitt, 104 F.3d 660,
665-66 (4th Cir. 1997).

-- 6 of 9 --

7
Appellants have offered insufficient evidence to demonstrate
the fitness for judicial review that ripeness requires. Appellants
claim that the FDA will use their Publication as evidence of the
“intended use” of their SAMe containing supplements. However, the
record is devoid of any evidence that would support this
contention. There is no indication of who will sell the
Publication, how the Publication will be marketed, the purpose for
which the Publication will be used, or the way in which it will be
distributed. These factors are a necessary part of the analysis of
the “intended use” of a product. In United States v. An Article of
Drug Consisting of 250 Jars etc. of U.S. Fancy Pure Honey, etc.,
218 F. Supp. 208, 209-11(E.D. Mich. 1963), aff’d, 344 F.2d 288 (6th
Cir. 1965), the court found that jars of honey were unapproved
drugs because booklets containing statements about the honey’s
disease-treating capacity were sold adjacent to the jars of honey.
In United States v. 24 Bottles ‘Sterling Vinegar & Honey,
etc.’(Balanced Foods Inc.), 338 F.2d 157(2d Cir. 1964), the Second
Circuit held that booklets claiming the curative power of honey
were not evidence of intended use because they were shelved with
other publications and were not marketed with the honey in any way.
Accordingly, any determination of “intended use” must be grounded
in a fact-based inquiry and cannot be based on speculative
contentions. Appellees have neither threatened nor taken action
against Appellants. There has been no final agency determination

-- 7 of 9 --

8
of the Publication as evidence of intended use. Because Appellants
have not shown such action on the part of Appellees, there is no
issue to decide and judgment must be deferred.
In a ripeness inquiry, hardship is determined by considering
(1) the immediacy of the threat and (2) the burden imposed upon the
party compelled to act under threat of enforcement of the
challenged law. Charter, 976 F.2d at 208-09. The threatened harm
must be “immediate, direct, and significant.” West Virginia
Highlands Conservancy, Inc. v. Babbit, 161 F.3d 797, 800 (4th Cir.
1998)(citations omitted). Appellants’ complaint meets none of
these requirements. Appellants allege harms relating to the loss of
free speech, the right to sell the Publication via their licensees,
and the loss of royalties from sales of the Publication and their
SAMe dietary supplements. These alleged losses are not immediate,
Appellants have not undertaken any campaign to sell the
Publication, and the FDA has not made a final determination
regarding the Publication as evidence of the “intended use” of
Appellants’ product. These issues prevent the court from making a
determination as to whether an immediate threat exists that
requires the injunction that Appellants seek. Any losses or
hardship suffered by Appellants would be contingent on these
factual circumstances.

-- 8 of 9 --

9
For the foregoing reasons, we conclude that the instant matter
is not ripe for disposition and the district court’s decision is
AFFIRMED.

-- 9 of 9 --