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ELIZABETH A. STRANGE

First Assistant United States Attorney District of Arizona

ADAM R. SMART

Assistant U.S. Attorney

N.C. State Bar No. 31797

Two Renaissance Square

40 N. Central Ave., Suite 1800

Phoenix, Arizona 85004-4408

Telephone: (602) 514-7500

Facsimile: (602) 514-7760

Email: adam.smart@usdoj.gov

Attorneys for United States 

Department of Health and Human Services

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF ARIZONA

ThermoLife International, LLC,

Plaintiff, 

v. 

United States Department of Health and Human Services,

Defendant.

CV-17-04049-PHX-JJT

ANSWER

The United States Department of Health and Human Services (“Defendant”), by and 

through counsel, herein answers the Complaint filed by ThermoLife International, LLC

(“Plaintiff”) on November 2, 2017. 

1. The allegations in the first sentence in paragraph 1 of the Complaint contain 

Plaintiff’s characterizations of its Complaint, to which no response is required. To the 

extent a response to these allegations is required, Defendant states that the Complaint and 

the referenced FOIA request speak for themselves. Defendant respectfully refers the Court 

to them for full, complete, and accurate statements of their content. Defendant states that 

it lacks knowledge or information sufficient to form a belief as to the truth of the allegation 

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concerning when the referenced FOIA request was sent and, therefore, denies it. Defendant 

denies the allegations in the second sentence of paragraph 1.

2. Defendant lacks knowledge or information sufficient to form a belief as to 

the truth of the allegations in paragraph 2 of the Complaint and, therefore, denies them.

3. With respect to the allegations in paragraph 3 of the Complaint, Defendant 

admits that it is an agency of the Executive Branch of the United State Government within 

the meaning of 5 U.S.C. § 552(f)(1).

4. Paragraph 4 of the Complaint sets forth conclusions of law as to which no 

response is required. To the extent a response to these allegations is required, Defendant 

admits that 5 U.S.C. § 552(a)(4)(B) provides district courts with jurisdiction to “enjoin the 

agency from withholding agency records and to order the production of any agency records 

improperly withheld from the complainant,” and that 28 U.S.C. § 1331 provides district 

courts with “original jurisdiction of all civil cases arising under the Constitution, laws, or 

treaties of the United States,” but denies that any agency records were improperly withheld 

from Plaintiff in this matter. Unless specifically admitted, the remaining allegations are 

denied.

5. Paragraph 5 of the Complaint sets forth conclusions of law to which no 

response is required. To the extent a response to these allegations is required, Defendant 

admits that venue lies in this District, but denies that Plaintiff is entitled to any relief in this 

matter.

6. The allegations in paragraph 6 of the Complaint are irrelevant to the 

resolution of the claim set forth in the Complaint. To the extent a response to these 

allegations is required, Defendant admits the allegations in paragraph 6.

7. The allegations in paragraph 7 of the Complaint are irrelevant to the 

resolution of the claim set forth in the Complaint and, in any event, set forth conclusions 

of law as to which no response is required. To the extent a response to these allegations is 

required, Defendant states that the referenced Bill and statutes speak for themselves. 

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Defendant respectfully refers the Court to them for full, complete, and accurate statements 

of their content.

8. The allegations in paragraph 8 of the Complaint are irrelevant to the 

resolution of the claim set forth in the Complaint. To the extent a response to these 

allegations is required, Defendant lacks knowledge or information sufficient to form a 

belief as to their truth and, therefore, denies them.

9. The allegations in paragraph 9 of the Complaint are irrelevant to the 

resolution of the claim set forth in the Complaint. To the extent a response to these 

allegations is required, Defendant states that the referenced Bill speaks for itself. 

Defendant respectfully refers the Court to it for full, complete, and accurate statements of 

its content. 

10. The allegations in paragraph 10 of the Complaint are irrelevant to the 

resolution of the claim set forth in the Complaint. To the extent a response to these 

allegations is required, Defendant states that the referenced Bill speaks for itself. 

Defendant respectfully refers the Court to it for full, complete, and accurate statements of 

its content.

11. The allegations in paragraph 11 of the Complaint are irrelevant to the 

resolution of the claim set forth in the Complaint. To the extent a response to these 

allegations is required, Defendant states that the referenced bills speak for themselves. 

Defendant respectfully refers the Court to them for full, complete, and accurate statements 

of their content.

12. The allegations in paragraph 12 of the Complaint are irrelevant to the 

resolution of the claim set forth in the Complaint. To the extent a response to these 

allegations is required, Defendant lacks knowledge or information sufficient to form a 

belief as to their truth and, therefore, denies them, except admits that the United States 

Food and Drug Administration is one of Defendant’s operating divisions. 

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13. The allegations in paragraph 13 of the Complaint are irrelevant to the 

resolution of the claim set forth in the Complaint. To the extent a response to these 

allegations is required, Defendant lacks knowledge or information sufficient to form a 

belief as to their truth and, therefore, denies them.

14. With respect to the allegations in paragraph 14 of the Complaint, Defendant 

admits only that Kercsmar & Feltus PLLC submitted a FOIA request to FDA by letter

dated May 29, 2015, and that a copy of the request is attached to the Complaint as Exhibit 1. 

To the extent paragraph 14 purports to describe the contents of the FOIA request, 

Defendant states that the document speaks for itself and no response is required. Defendant 

respectfully refers the Court to the document, which is attached as an exhibit to the 

Complaint, for full, complete, and accurate statements of its content. Defendant denies the 

remaining allegations in paragraph 14.

15. To the extent that paragraph 15 of the Complaint purports to describe the 

contents of the FOIA request, Defendant states that the document speaks for itself and no 

response is required. Defendant respectfully refers the Court to the document, which is 

attached as an exhibit to the Complaint, for full, complete, and accurate statements of its 

content. To the extent that paragraph 15 purports to characterize the time frame of the 

request, Defendant denies it. 

16. To the extent that paragraph 16 of the Complaint purports to describe the 

contents of the FOIA request, Defendant states that the document speaks for itself and no 

response is required. Defendant respectfully refers the Court to the document, which is

attached as an exhibit to the Complaint, for full, complete, and accurate statements of its 

content. To the extent that paragraph 16 purports to characterize the time frame of the 

request, Defendant denies it. 

17. To the extent that paragraph 17 of the Complaint purports to describe the 

contents of the FOIA request, Defendant states that the document speaks for itself and no 

response is required. Defendant respectfully refers the Court to the document, which is 

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attached as an exhibit to the Complaint, for full, complete, and accurate statements of its 

content. 

18. With respect to the allegations in paragraph 18 of the Complaint, Defendant 

admits that FDA received the referenced FOIA request on June 4, 2015, and that a copy of 

the FOIA request is attached to the Complaint as Exhibit 2. 

19. Defendant denies the allegations in paragraph 19 of the Complaint.

20. With respect to the allegations in paragraph 20 of the Complaint, Defendant 

admits only that FDA sent a letter, dated December 11, 2015, to Kercsmar & Feltus PLLC, 

and that a copy of the letter is attached to the Complaint as Exhibit 3. To the extent that

paragraph 20 purports to describe the contents of the letter, Defendant states that the 

document speaks for itself and no response is required. Defendant respectfully refers the 

Court to the document, which is attached as an exhibit to the Complaint, for full, complete, 

and accurate statements of its content

21. With respect to the allegations in paragraph 21 of the Complaint, Defendant 

admits only that FDA sent an email dated April 7, 2016, at 8:50 a.m., to Kercsmar & Feltus 

PLLC, and that a copy of the email is included in an email chain attached to the Complaint 

as Exhibit 4, but denies that Exhibit 4 contains the complete email. To the extent that 

paragraph 21 purports to describe the contents of the email, Defendant states that the 

document, which is attached as an exhibit to the Complaint, except for its missing content,

speaks for itself and no response is required. 

22. With respect to the allegations in paragraph 22 of the Complaint, Defendant 

admits only that Kercsmar & Feltus PLLC sent an email dated December 20, 2016, at 

3:21 p.m., to FDA, and that a copy of the email is included in an email chain attached to 

the Complaint as Exhibit 5. To the extent that paragraph 22 purports to describe the 

contents of the email, Defendant states that the document speaks for itself and no response 

is required. Defendant respectfully refers the Court to the document, which is attached as 

an exhibit to the Complaint, for full, complete, and accurate statements of its content. 

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23. With respect to the allegations in paragraph 23 of the Complaint, Defendant 

admits only that FDA sent an email dated December 21, 2016, at 10:17 a.m., to Kercsmar 

& Feltus PLLC, and that a copy of the email is included in an email chain attached to the

Complaint as Exhibit 6. To the extent that paragraph 23 purports to describe the contents 

of the email, Defendant states that the document speaks for itself and no response is 

required. Defendant respectfully refers the Court to the document, which is attached as an 

exhibit to the Complaint, for full, complete, and accurate statements of its content. 

24. With respect to the allegations in paragraph 24 of the Complaint, Defendant 

admits that Kercsmar & Feltus PLLC sent a letter dated October 23, 2017, to FDA, and 

that a copy of the letter is attached to the Complaint as Exhibit 7. To the extent that 

paragraph 24 purports to describe the contents of the letter, Defendant states that the 

document speaks for itself and no response is required. Defendant respectfully refers the 

Court to the document, which is attached as an exhibit to the Complaint, for full, complete, 

and accurate statements of its content.

25. With respect to the allegations in paragraph 25 of the Complaint, Defendant 

admits only that FDA sent an email dated October 24, 2017, to Kercsmar & Feltus PLLC, 

and that a copy of the email is attached to the Complaint as Exhibit 8. To the extent that 

paragraph 25 purports to describe the contents of the email, Defendant states that the 

document speaks for itself and no response is required. Defendant respectfully refers the 

Court to the document, which is attached as an exhibit to the Complaint, for full, complete, 

and accurate statements of its content. 

26. The allegations in paragraph 26 of the Complaint set forth legal conclusions 

to which no response is required. To the extent a response is required, Defendant admits 

only that, as of November 2, 2017, FDA’s Center for Drug Evaluation and Research had

not released documents in response to Plaintiffs’ FOIA request and denies the remaining 

allegations in paragraph 26.

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27. The allegations in paragraph 27 of the Complaint are ones of incorporation 

to which no response is required. To the extent a response is required, Defendant repeats 

and incorporates its responses to the allegations in paragraphs 1-26 of the Complaint as if 

fully set forth herein.

28. Defendant denies the allegations in paragraph 28 of the Complaint.

29. Paragraph 29 of the Complaint sets forth legal conclusions to which no 

response is required. To the extent a response is required, Defendant admits that Plaintiff 

has exhausted the applicable administrative remedies with respect to the FOIA request at 

issue.

30. Defendant denies the allegations in paragraph 30 of the Complaint.

With respect to Plaintiff’s prayer for relief, Defendant denies that Plaintiff is entitled 

to any of the relief requested.

DEFENSES

The Complaint fails to state a claim on which relief can be granted because no 

agency records have been improperly withheld from Plaintiff.

FIRST AFFIRMATIVE DEFENSE

All proceedings with respect to the pending FOIA request should be stayed pending 

further order of this Court to be issued after the FOIA request reaches, in the normal course 

of business, the front of the processing queue to which it is assigned.

SECOND AFFIRMATIVE DEFENSE

Some of the information requested by Plaintiff is exempt from disclosure under 

FOIA.

Wherefore the Defendant requests that the Complaint and action be dismissed, that 

Plaintiff take nothing thereby, and that Defendant recover its costs and such other relief as 

the Court may deem appropriate.

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Respectfully submitted this 18th day of January, 2018.

ELIZABETH A. STRANGE

First Assistant United States Attorney District of Arizona

s/Adam R. Smart

ADAM R. SMART

Assistant U.S. Attorney

OF COUNSEL:

ROBERT P. CHARROW

General Counsel

REBECCA K. WOOD

Chief Counsel

Food and Drug Administration

ANNAMARIE KEMPIC

Deputy Chief Counsel, Litigation

LESLIE COHEN

Associate Chief Counsel

United States Department of Health 

and Human Services

Office of the General Counsel

Food and Drug Administration

10903 New Hampshire Ave.

WO Bldg. 32, Rm. 4301

Silver Spring, MD 20993

(301) 796-0551

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CERTIFICATE OF SERVICE

I hereby certify that on January 18, 2018, I electronically transmitted the attached 

document to the Clerk’s Office using the CM/ECF System for filing which served a copy 

of the attached document and Notice of Electronic Filing to the following CM/ECF 

registrant:

Gregory B. Collins

Julia A. Wagner

Kercsmar & Feltus PLLC

7150 East Camelback Road, Suite 285

Scottsdale, Arizona 85251

Attorneys for Plaintiff

s/ M. Beickert

Office of the United States Attorney

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