In the United States Court of Federal Claims 

OFFICE OF SPECIAL MASTERS

No. 15-160V 

Filed: December 15, 2015 

For Publication 

************************************* 

ADAN GOMEZ and RAQUEL AYON, * 

on behalf of the Estate of JOEL GOMEZ * 

 * 

Petitioners, * 

 * 

 v. * 

 * 

SECRETARY OF HEALTH * 

AND HUMAN SERVICES, * 

 * 

 Respondent. * 

* 

************************************* 

Jeffrey T. Roberts, Newport Beach, CA, for petitioners. 

Darryl R. Wishard, Washington, DC, for respondent. 

MILLMAN, Special Master

ORDER DENYING PETITIONERS’ MOTION FOR DISCOVERY ON A NON-PARTY 

VACCINE MANUFACTURER1

 

On February 20, 2015, petitioners filed a petition under the National Childhood Vaccine 

Injury Act, 42 U.S.C. §§ 300aa-10¬34 (2012) (“Vaccine Act”), on behalf of the estate of Joel 

Gomez alleging that the Gardasil vaccine caused their son, Joel Gomez, to develop myocarditis, 

which led to his death. On November 2, 2015, petitioners filed a motion requesting the Court’s 

authority to issue a subpoena on the manufacturer of the Gardasil vaccine, Merck & Co., Inc. 

(“Merck”). Petitioners seek answers to interrogatories and the production of documents by Merck 

regarding the production, testing, and safety of Gardasil. Petitioner’s motion does not meet the 

standard for discovery in the Vaccine Program. Therefore, petitioners’ Motion for Discovery is 

DENIED. 

1 Vaccine Rule 18(b) states that all decisions of the special masters will be made available to the public 

unless they contain trade secrets or commercial or financial information that is privileged and confidential, 

or medical or similar information whose disclosure would constitute a clearly unwarranted invasion of 

privacy. When such a decision is filed, petitioners have 14 days to identify and move to redact such 

information prior to the document’s disclosure. If the special master, upon review, agrees that the identified 

material fits within the banned categories listed above, the special master shall redact such material from 

public access.

Motion for discovery on a nonparty vaccine manufacturer; 

discovery; Gardasil

 
PROCEDURAL HISTORY

On February 20, 2015, petitioners filed a petition under the Vaccine Act, alleging that 

their son’s receipt of the Gardasil vaccines on June 19, 2013 and August 19, 2013 caused him to 

develop myocarditis, which led to his death on August 20, 2013. See Pet. at ¶¶ 8-9, 11. 

 The initial status conference was held on April 16, 2015. During the status conference, 

petitioners’ counsel raised the issue of requesting discovery on Merck. The undersigned 

discussed a ruling she had recently published in Phillips-Deloatch v. Sec’y of Health and Human 

Services, No. 09-171V, 2015 WL 1950107 (Fed. Cl. Spec. Mstr. Apr. 9, 2015), in which she 

denied petitioner’s request for authority to subpoena Merck regarding the Gardasil vaccine. 

 On June 22, 2015, respondent filed her Rule 4(c) Report. Resp’t’s Rep. She agreed that 

petitioners’ son had myocarditis, but disagreed with petitioners’ view that the Gardasil vaccine 

caused the condition, noting the coroner stated Joel’s myocarditis had been present for at least 

several days or even weeks. Id. at 8. Respondent argued that an autopsy of his liver and his 

elevated heart and respiration rates prior to his vaccination suggest that Joel Gomez likely had a 

“chronic, multi-symptom condition that may have contributed to or caused his death.” Id. at 8-9. 

 On October 16, 2015, petitioners filed their expert report. Petitioners’ expert, Dr. Sin 

Hang Lee, concluded that “the most plausible cause of death for [Joel Gomez] is cardiac failure 

brought about by a surge of myocardium-depressing cytokines . . . released from the 

macrophages activated by the HPV L1 gene DNA fragments present in the vaccine product” 

after petitioner’s second dose of Gardasil. Pet’r’s Rep. at 9. 

 On October 27, 2015, respondent filed a status report requesting that petitioners file Dr. 

Lee’s CV and the medical literature he cited in his report. Respondent’s counsel also requested 

the slides Dr. Lee examined when writing his report. 

 A telephonic status conference was held on October 28, 2015. The undersigned reviewed 

Dr. Lee’s expert report with the parties, and noted that the report was well-written and thorough. 

 On October 30, 2015, petitioners filed a Motion for Discovery under the heading 

“Additional Documentation.” The undersigned struck the filing on November 2, 2015 because it 

was filed under the incorrect docket heading. Petitioners refiled their motion under the correct 

heading, “Motion for Discovery,” on November 2, 2015. In their motion, petitioners ask the 

Court for its authority to submit sixteen interrogatories to Merck about the production, testing, 

manufacture, and side effects of Gardasil, as well as possible adverse effects of Gardasil on the 

cardiac health of vaccinees. Petitioners also ask for authority to request Merck to produce 

documents regarding clinical studies of Gardasil, and documents showing that Gardasil can 

cause adverse effects on vaccinees’ hearts. 

 Respondent filed her response to petitioner’s motion on November 19, 2015. Petitioners 

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filed their reply to respondent’s response on November 24, 2015, which the undersigned struck 

for being filed under the wrong heading. The petitioners refiled their reply on the same day. 

Respondent filed a sur-reply on November 30, 2015, noting that the U.S. Court of Federal 

Claims had published an Order on a similar issue on the same day she filed her reply November 

24, 2015. See Sur-Reply at 1; Halverson v. Sec’y of HHS, No. 15-227V, 2015 WL 7445510 

(Fed. Cl. Spec. Mstr. Oct. 29, 2015). 

 The matter is now ripe for adjudication. 

FACTS

 Joel Gomez received his first dose of the Gardasil vaccine on June 19, 2013. He received 

his second dose of the vaccine on August 19, 2013. He had no major health issues prior to his 

vaccinations, although he had previously visited his pediatrician after experiencing pain in his 

chest after running and had elevated pulse and respiratory rate during several visits to his 

doctors, despite the fact that he trained extensively for high school football. See med. recs. Ex. 

3, at 11; id. at 8; id. at 6; id. at 2. He had also visited the doctor due to a low white blood cell 

count. Id. at 6. On August 20, 2013, the day after his second Gardasil vaccine, Joel Gomez was 

found unresponsive in bed. Med. recs. Ex. 5. He was taken to the San Gabriel Valley Medical 

Center Emergency Room in full cardiac arrest. Med. recs. Ex. 13. After performing an autopsy, 

Dr. Ribe noted that Joel had myocarditis. Med. recs. Ex. 10. The cause of death was listed as 

unknown. Id. at 6. 

EXPERT REPORTS

On June 22, 2015, respondent filed her Rule 4(c) Report, which concludes that Joel’s 

myocarditis was not related to his receipt of the Gardasil vaccine. See resp’t’s rep. at 8. 

Respondent’s view, without having the pathology slides examined by an expert pathologist, is 

that Joel may “have had disease processes within his lungs and liver.” Id. She bases this belief 

on the coroner’s findings that Joel had extremely heavy lungs, which she states are unlikely to 

have become so heavy shortly after his Gardasil vaccination, and the fact that Joel had “portal 

inflammation and fibrosis with piecemeal necrosis of the liver.” Id. Respondent also notes that 

Joel’s heart and respiration rates were high, which is abnormal for a healthy adolescent 

undertaking heavy football training. Id. 

Petitioners filed their expert report on October 16, 2015. Their expert, Dr. Sin Hang Lee, 

states that Joel most likely had a healing myocardial infarct, not viral myocarditis, because Joel 

did not have flu-like symptoms in the weeks before his death. Med. recs. Ex. 15, at 4. 

Additionally, slides of the left ventricle of the heart indicate that the myocardial infarct was a 

few weeks old and in the process of healing. Id. Because Joel was able to participate in football 

practice without complaining of shortness of breath or chest pain, Dr. Lee believes the 

myocardial infarct was not the primary cause of Joel’s death. Id. at 4-5. Instead, Dr. Lee states, 

Joel’s death was caused by cardiac failure produced by a “surge of myocardium-depressing 

cytokines . . . released from the macrophages activated by the HPV L1 gene DNA fragments 

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present in the vaccine product after the injection of the second dose of Gardasil.” Id. at 9. The

first dose of the Gardasil vaccine caused cytokines to surge through his body, leading Joel to 

develop a myocardial infarction, which was in the process of healing at the time of his death. Id. 

The second Gardasil vaccination caused a new surge of cytokines which led to an episode of 

hypotension, resulting in Joel’s death from “left heart failure due to insufficient blood perfusion 

to the heart muscle and brain.” Id. 

DISCUSSION

1. Discovery Standard 

Discovery is not a matter of right in the Vaccine Program. A special master’s authority 

to direct discovery is outlined in the Vaccine Act, which provides: 

(B) In conducting a proceeding on a petition a special master— 

(i) may require such evidence as may be reasonable and necessary,

(ii) may require the submission of such information as may be 

reasonable and necessary,

(iii) may require the testimony of any person and the production of any 

documents as may be reasonable and necessary, 

(iv) shall afford all interested persons an opportunity to submit relevant 

written information— 

. . . and 

(v) may conduct such hearings as may be reasonable and necessary.

There may be no discovery in a proceeding on a petition other than the discovery 

required by the special master.

42 U.S.C. § 300aa-12(d)(3)(B). Thus, the plain language of the statute indicates that the special 

master may require discovery of evidence that is “reasonable and necessary” to the proceedings 

in a case. “Reasonable and necessary” has been interpreted to mean that

the special master should require production if the master concludes that, given 

the overall context of the factual issues to be decided by the master, he or she 

could not make a fair and well-informed ruling on those factual issues without the 

requested material. Requiring the requested testimony or document production 

must also be “reasonable” under all the circumstances, which means that the 

special master must consider the burden on the party who would be required to 

testify or produce documents. That is, the importance of the requested material 

for purposes of the special master’s ruling must be balanced against the burden on 

the producing party. 

In re Claims for Vaccine Injuries Resulting in Autism Spectrum Disorder or a Similar 

Neurodevelopmental Disorder, 2004 WL 1660351, at *9 (Fed. Cl. Spec. Mstr. July 16, 2004) 

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(emphasis in original) (hereinafter “Omnibus Autism Proceeding”); see also Werderitsh v. Sec’y 

of HHS, No. 99-319V, 2005 WL 3320041, at *4–*5 (Fed. Cl. Spec. Mstr. Nov. 10, 2005). 

Special masters have generally refrained from granting extensive discovery. See

Omnibus Autism Proceeding, 2004 WL 1660351 (Special Master Hastings denied a motion 

seeking discovery from Merck); In re Claims for Vaccine Injuries Resulting in Autism Spectrum 

Disorder or a Similar Neurodevelopmental Disorder, 2007 WL 1983780 (Fed. Cl. Spec. Mstr. 

May 25, 2007) (three special masters denied a motion for discovery of vaccine safety 

information held by the Vaccine Safety DataLink Project); Werderitsh, 2005 WL 3320041 

(Special Master Sweeney denied petitioner’s request for access to information from the Vaccine 

Adverse Event Reporting System); Schneider v. Sec’y of HHS, No. 99-0160V, 2005 WL 318697 

(Fed. Cl. Spec. Mstr. Feb. 1, 2005), aff’d, 64 Fed. Cl. 742, 746 (Fed. Cl. 2005) (Special Master 

Edwards denied discovery of the vaccine manufacturer’s information about the manufacturing 

and testing of hepatitis B vaccine). 

Petitioners’ Motion for Discovery requests the authority to require Merck to answer 

interrogatories and produce documents in possession of the vaccine manufacturer. As discussed 

in the Omnibus Autism Proceeding, vaccine manufacturers are not exempt from discovery in the 

Vaccine Program: “[T]he statutory language plainly does not exempt anyone from being 

potentially required to provide testimony or documents, stating that a special master may ‘require 

the testimony of any person and the production of any documents.’” Omnibus Autism 

Proceeding, 2004 WL 1660351, at *6 (quoting 42 U.S.C. § 300aa-12(d)(3)(B)(iii)). Moreover, 

Congress included “trade secret[s] or commercial or financial information” as a category of 

information to be excluded from disclosure in Vaccine Program decisions, which suggests 

Congress may have anticipated a vaccine manufacturer would submit information in a vaccine 

claim. See id. (discussing § 300aa-12(d)(4)(B)). These statutory provisions thus support that a 

special master has the authority to require a vaccine manufacturer to provide information. 

In summary, the relevant inquiry is whether the information requested by petitioners is 

“reasonable and necessary” for the undersigned to make a “fair and well-informed decision” on 

whether Gardasil vaccine caused Joel Gomez’s death. 

2. Analysis 

To carry their burden of proof, petitioners must show by preponderant evidence: “(1) a 

medical theory causally connecting the vaccination and the injury; (2) a logical sequence of 

cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of 

a proximate temporal relationship between vaccination and injury.” Althen v. Sec’y of HHS 418 

F.3d 1274, 1278 (Fed. Cir. 2005). As the Federal Circuit stated in Grant v. Secretary of Health 

& Human Services, 956 F.2d 1144, 1149 (Fed. Cir. 1992), without more, “evidence showing an 

absence of other causes does not meet petitioner’s affirmative duty to show actual or legal 

causation.” 

 Petitioners ask the Court for authority to subpoena Merck because they believe Dr. 

Lee’s expert opinion “could be further assisted” by information from the vaccine manufacturer. 

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Pet’r’s Mot. at 1. However, petitioners’ claims are already supported by an expert report that is, 

as the undersigned noted during the October 28, 2015 status conference, extremely thorough and 

well-written. Therefore, any information petitioners may obtain from Merck is not necessary for 

petitioners to go forward with their claim. 

Petitioners state in their reply to respondent’s response to their Motion for Discovery that 

Dr. Lee “has already provided a persuasive medical theory as to Gardasil causing the death of 

Joel Gomez,” and that they have met their evidentiary burden, but they say that does not mean 

they “should discontinue seeking stronger evidence” to assist the special master. Pet’rs’ Reply, 

at 2. As another Special Master stated recently in Halverson, petitioners’ burden is “a 

preponderance of the evidence standard, not scientific certainty.” Halverson v. Sec’y of HHS, 

No. 15-227V, 2015 WL 7445510, at *5 (Fed. Cl. Spec. Mstr. Oct. 29, 2015). Petitioners are not 

required to produce epidemiological evidence to prevail. Capizzano v. Sec’y of HHS, 440 F.3d 

1317, 1325 (Fed. Cir. 2006). Petitioners appear to want this information simply to bolster their 

case against respondent. It is not reasonable for petitioners to request information from Merck 

solely to provide stronger evidence for a case they are already able to make without that 

information. Therefore, the information requested by petitioners is not reasonable or necessary 

for the undersigned to make a “fair and well-informed decision” on whether Gardasil vaccine 

caused Joel Gomez’s death. The undersigned has studied petitioners’ motion and finds it does 

not adequately make a reasonable showing of why burdening Merck with a discovery request is 

reasonable and necessary. 

CONCLUSION

The record does not contain a persuasive reason to require production of information and 

documents from Merck & Co., Inc. Petitioners’ Motion for Discovery is DENIED. 

IT IS SO ORDERED. 

Dated: December 15, 2015 /s/ Laura D. Millman 

 Laura D. Millman

 Special Master

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