1



# In the United States Court of Federal Claim s

OFFICE OF SPECIAL MASTERS

No. 00

- 736V
Filed: October 31, 2013 ; Re

- Filed: November 1, 2013 1

* * * * * * * * * * * * * *
WILLIAM JOE WINNER and ROXAN * TO BE PUBLISHED DEHESH WINNER, as Next Friend s of, *

W.D.W

. , a minor, * Special Master

* Hamilton

- Fieldman Petitioners, *

*

v. *
* Decision on the Record, Dismissal of
SECRETARY OF HEALTH * Claim for Insufficient Proof; Failure to AND HUMAN SERVICES, * Submit Expert Report; Hepatitis B

* Vaccine, DTaP Vaccine, Hib Vaccine ; Respondent. * Immune Deficienc ies

. * * * * * * * * * * * * * *

Brian Robert Arnold , Dallas, TX, for Petitioners.
Alexis Babcock , Washington, DC, fo r Respondent.

DISMISSAL DECISION 2

On December 8, 2000 , William Joe Winner and Roxa n Dehesh Winner (“Petitioners”) filed a petition for Vaccine Compensation under the National Vaccine

1 This Decision has been reissued to r eflect the amended case caption a s state d in the undersigned ’ s Order of November 1, 2013.

2 Because this published decision contains a reasoned explanation for the action in the case, the undersigned intends to post this decision on the United States Court of Federal Claims’ website, in accordance with the E

- Government Act of 2002, Pub. L. No.
1 07

- 347 § 205, 116 Stat. 2899, 2913 (codified as amended at 44 U.S.C. § 3501 note (2006)). As provided by Vaccine Rule 18(b), each party has 14 days within which to file a motion for redaction “of any information furnished by that party (1) that is trade s ecret or commercial or financial information and is privileged or confidential, or (2) that are medical files and similar files the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). In the absence of such motion, the entire decision will be available to the public. Id.2

Injury Compensation Program, 42 U.S.C. §300aa

- 10, et seq

. 3 ( “Program”), on behalf of their son, W.D.W . Pet ition (“Pet”) at 1. Petitioners filed Amended Petitions in this case and ultimately alleged in the Fourth Amended Petition that W.D.W. suffered an adverse reaction as a result of an initial hepatitis B vaccine he received on December 9, 1997, as
well as other subse quent vaccines he received, “e specially the DtaP, HIB, and Hep

- B vaccines he received on June 10, 1998.” Fourth Amended Pet. at 5

. Petitioners specifically argue that with each successive set of vacc ines W.D.W. received, he suffered
“a dverse reactions, multiple physical and health problems and injuries such as fever, nausea, pain, irritability, loss of appetite, fatigue, tiredness, diarrhea, pain, inflammation, swelling and redness at injection site, as well as severe allergic reactions such as significant rashes and hives on his body, difficulty breathing, pain, etc...” Id. Petitioners also allege that in the alternative, W.D.W. “suffered an aggravation of a pre

- existing medical condition (weakened im mune system and intolerance to vaccines) as a result of
said vaccines.” Id. at 8.

After a review of the petition and supporting documents, Respondent’s counsel
filed a “Motion T o Dismiss For Failure to Prosecute, ” asserting that W.D.W

. ’ s records do not demonstrate a causal association between his vaccines and alleged injuries; additionally, Respondent argued that Petitioners have not provided a medical expert report addressing their burden under Althen

, and the case has been pending for almost 13

years. Resp’t’s Motion at 7 , ECF No.76 . Respondent requests that the undersigned
dismiss the above

- captioned petition. Id. Petitioner s did not oppose Respondent’s Motion; this case is now ripe for decision.

I

PROCEDURAL HISTORY

On December 8, 2000, Petitioner s filed a p etition for vaccine compensation along
with the Affidavit of Brian R. Arnold, Attorney

, and medical records labeled Exhibits 1 through 1 2

. 4 Petitioners alleged that W.D.W. suffered mercury poisoning as a result of a

3 National Childhood Vaccine Injury Act of 1986, Pub L. No. 99

- 660, 100 Stat. 3755. Hereinafter, for ease of citation, all “§” references to the Vaccine Act will be to the pertinent subparagraph of 42. U.S.C. §300aa (2006).

4 Documents accompanying the pe tition were filed in the following order : Exhibit
1

- Affidavit of Brian R. Arnold, Attorney for Petitioner, Prenatal Records, Exhibit 2

- Dr. Kuhl’s Pediatrician Records, Exhibit 3

- Normal Regional Hospital Records

- Darius,
Exhibit 4

- Normal Regional Hospital

- Roxan, Exhibit 5

- Marshall Regional Hospital,
Exhibit 6

- Shawnee Regional Hospital Records, Exhibit 7

- Sooner Start Program, Exhibit
8

- Texas’ Early Childhood Intervention Program, Exhibit 9

- Harrison County Co

- op,3

hepatitis B vaccination W.D.W. received within 24 hours of his delivery on December 9, 1997, as well as subsequent vaccines that he received. 5 Pet. at 2

- 4. T h e case was assigned to Chief Special Master Golkiewicz. Notice of Assignment, ECF No. 2. Respond ent’s counsel, Traci R. Manning, made an appearance on December 19, 2000. Notice, ECF No. 4.

Special Master Golkiewicz issued an Order on January 31, 2001, directing
Petitioners to file the expert report and curriculum vitae (“CV”) of Dr. Holme s, Petitioner’s expert, or to file a status report by March 2, 2001. Order, ECF No. 5. On March 20, 2001, April 24, 2001, May 14, 2001, June 20, 2001, August 8, 2001, August 22, 2001, October 9, 2001, and February 4, 2002, Petitioners filed status reports

reg arding their status in ret aining an expert. Filings, ECF Nos. 7

- 14. No expert report was
filed on any of the above

- mentioned dates

.

On May 13, 2002, Chief Special Master Golkiewicz issued an Order stating that a committee of petitioners’ counsel, respond ent’s representatives, and special masters had been formed to determine how to most efficiently process autism/thimerosal injury cases, and pursuant to the agreement of that committee, the Petitioners in this particular case
could delay indefinitely the fi ling of medical records relating to this case until the
committee determine d a procedure for resolving the general “causation” issue involved in these related cases. Order, ECF No. 17. Additionally, Chief Special Master Golkiewicz suspended the filing of R espondent’s Rule 4(c) Report. Id.

On July 29, 2002, the case was reassigned to Special Master Hastings. Order, ECF
No. 19. On this same date, Petitioners opted to join the Omnibus Autism Proceeding (“OAP”)

, and a stay was issued, “pending the completion of a general inquiry by the Office of Special Masters regarding the possible causal relationship between certain vaccinations and autistic spectrum disorders (“ASDs”). ” Order at 1, July 29, 2002.

On Febru ary 5, 2007, the case was reassigned to Special Master Campbell

- Smith. Order, ECF No. 21. Special Master Campbell

- Smith ordered

, on January 15, 2008, that
Petitioner s file within 90 days all medical records from the period of the vaccinee’s birth through either, whichever date was later, the date of petition filing or the date of the vaccinee’s initial diagnosis of autism, autism spectrum disorder, a speech or language delay related to an autism diagnosis, or any similar neurological disorder related to an

Exhibit 10

- Oklahoma Hearing Evaluation, Exhib it 11

- Oklahoma Eye Exam, Exhibit 12

- Dr. Amy Holmes & Dr. Stephanie F. Cave Medical Records

- Mercury Removal.

5 Additional vaccines cited in the original petition are as follows: DTaP, Hib, Hep

- B, and OPV administered on February 16, 1998, DTaP, Hib, OPV administered on April 9, 1998, DTaP, Hib, and Hep

- B administered on June 10, 1998 , and MMR administered on July 7, 1999. Pet. at 1

- 3.4

autism diagnosis; Respondent would then have 45 days, subsequent to Petitioners’ filings, to file a Statement Regarding whether the Claim should Proceed in the OAP. Order, ECF No. 22.

Respondent’s counsel filed a “ Statement Regarding Jurisdiction and Appropriateness of Proceeding withi n the Omnibus Autism Proceeding ” on June 2, 2008. Statement, ECF No. 24. Respondent noted that the record indicate d that this case was filed prior to the expiration of the relevant statutory limitations period, and involve d a diagnosis of autism spectrum disorder; therefore, Respondent d id not oppose further processing of this case in the Court’s Omnibus Autism Proceed ing. Id. at 3.

The OAP was ongoing for several years, and has been summarized in Program
decisions as follows:

Ultimately, the Petitioners’ Steering Committee [“PSC”], an organization formed by attorneys representing petitioners in the OAP, litigated six test cases presenting two different theories on the causation of ASDs. The first theory alleged that the measles portion of the measles, mumps, rubella vaccine could cause ASDs. 6 That theory was presented in three separate Program test cases during

sev eral weeks of trial in 2007. The second theory alleged that mercury contained in thimerosal

- containing vaccines could directly affect an infant’s brain, thereby substantially contributing to the causation of ASD. That theory was presented in three additio nal test cases during several weeks of trial in 2008. Decisions in each of the three test cases pertaining to the PSC’s first theory rejected the petitioners’ causation theories. Cedillo v. Sec’y of Health & Human

Servs. , No. 98

- 916V, 2009 WL 331968 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d , 89 Fed. Cl. 158 (2009), aff’d , 617 F.3d 1328 (Fed. Cir. 2010); Hazlehurst v. Sec’y of Health & Human Servs. , No. 03

- 654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d

, 88 Fed. Cl. 473 ( 2009 )

, aff’d , 604 F.3d 1343 (Fed. Cir. 2010); Snyder v. Sec’y of Health & Human Servs. , No. 01

- 162V, 2009 WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d , 88 Fed. Cl. 706 (2009).

Decisions in each of the three “test cases” pertaining to the PSC’s second theory also rejected the petitioners’ causation theories, and petitioners in each of the three cases chose not to appeal. Dwyer v.

6 Other decisions have described the first theory as follows: “The MMR vaccine
and thimerosal

- containing vaccines can comb ine to cause autism.” King v. Sec’y of
Health & Human Servs. , 2010 WL 892296, at *8; see also Order, Mar. 15, 2010 at 1

- 2.5 Sec’y of Health & Human Servs. , No. 03

- 1202V, 2010 WL 892250 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); King v. Sec’y of Health &

Human Servs

. , No. 03

- 584V, 2010 WL 892296 (Fed. Cl Spec. Mstr. Mar. 12, 2010); Mead v. Sec’y of Health & Human Servs. , No. 03

- 215V, 2010 WL 892248 (Fed. Cl. Spec. Mstr. Mar. 12, 2010). Thus, the proceedings in these six test cases are concluded.

See Douglass v. Sec’y of Health & Human Servs. , No. 04

- 427V, 2012 WL 2108883, at *1 (Fed. Cl. Spec. Mstr. Apr. 10, 2012 ) ( footnote omitted).

On February 2, 2011, Special Master Campbell

- Smith or dered that Petitioners file
an Amended P etition that was fully c ompliant with §§ 300aa

- 11(c) and which clearly explain ed the theory of vaccine causation in this case. Order, ECF No. 26. Petitioners
filed th eir Amended Petition on March 2, 2011. Amended Pet., ECF No. 27. The Amended Petition allege d that W.D.W. sustai ned a “Table Injury” as a result of the Hep

B vaccine he received as well as other subsequent vaccines listed in the petition. Id.

On August 4, 2011, Respondent’s counsel issued a new notice of appearance

, substituting Alexis Babcock as counsel for Respondent . Notice, ECF No. 30. Chief Special Master Campbell

- Smith ordered on Au gust 10, 2011, that Petitioners’

outstan ding medical records and a Second Amended P etition, clarif ying the legal theory
on which P etitioner desire d to proceed

, would be due b y September 9, 2011. Order, ECF
No. 31. Petitioners’ counsel failed to file the required documents.

Chief Special Master Campbell

- Smith issued an “ Order T o Show Cause ” on September 19, 2011, ordering Petitioners to show cause on or before October 19, 201 1, why the case should not be dismissed for failure to prosecute or for failure to establish a compensable vaccine claim. Order, ECF No. 32. On October 19, 2011, Petitioners filed a Response to Chief Special Master Campbell

- Smith’s Order to Show Cause. Re sponse, ECF No. 33. Chief Special Master Campbell

- Smith then ordered Petitioners to file amended pleadings by October 26, 2011. Order, Non

- PDF, Oct. 19, 2011.

On October 25, 2011, Petitioners filed medical records. Filings, ECF Nos. 34

- 35.
Petitioners ad ditionally filed the affidavits of Roxan Winner and William Joe Winner. Filings, ECF Nos. 36, 37. On October 26, 2011, Petitioners filed a Second Amended Petition for Vaccine Compensation, alleging that W.D.W. “ sustained an adverse reaction and injury as a result of the initial Hep

- B vaccine h e received on December 9, 1997 . . . as well as other subsequent vaccines listed herein that he r eceived, especially the DtaP, HIB

, and Hep

- B vaccines he received on June 10, 1998.” Second Amended Pet

. at 4, ECF No.
38. The Second Amended Petition alleged that “ w ith each successive set of vaccines

W.D.W. received, he suffered adverse reactions, multiple physical and health problems and injuries such as fever, nausea, pain, irritability, loss of appetit e, fatigue, tiredness,6

diarrhea, pain, swelling, and redness at the injection site, as well as severe allergic reactions such as rash, hives, difficulty breathing, pain, etc. . . .” Id.

On August 6, 2012, Petitioners filed a Third Amended Petition for Vaccine Compensation. Third Amended Pet

. , ECF No. 58. On September 6, 2012, Petitioners filed a Fourth Amended Original Petition for Vaccine Compensation. Fourth Amended Pet., ECF No. 60.

In the Fourth Amended Petition, Petitioners allege, among othe r things, that

W .D.W. suffered a vaccine injury after receiving a Hepatitis B vaccine on December 9, 1997, and again after administration of D T aP , H ib , and Hepatitis B vaccines on June 10,
1998. Fourth Amended Pet. at 7

- 8. In the alternative, P etitioners allege aggravation of a

pre

- existing condition. Id. at 8. During a status conference with the parties on September 19, 2012, Chief Special Master Campbell

- Smith noted that t he challenge for P etitioners would be causally connecting W.D.W ’s alle ged injuries to his vaccinations

, since

P etitioners appear to rely on a mechanism of causation that implicates the thimer osal component in the vaccines. Order at 2, ECF No. 61. The theory of thimerosal

- induced harm to a vaccinee’s immune system was careful ly considered and rejected in the OAP

test cases

. Id. at 1

- 2

. Chief Special Master Campbell

- Smith advised P etitioners’ counsel that any theory presented now must be different from the one advanced in the OAP or must involve previously unconsidered evidenc e. Id. Petitioners’ counsel stated that he was waiting for an opinion letter from Dr. Seshagiri Rao, one of W.D.W

. ’s treating physicians, to address the issue of causation. Id.

From October 19, 2012, through February 15, 2013, Petitioners filed four motions for extensions of time to file an expert report. Motions, ECF Nos. 62, 63 , 64, 66

.

On March 4, 2013, the case was reassigned to the undersigned. Order, ECF No.
67. On March 15, 2013

, Petitioners’ counsel filed a fifth motion for an e xtension of t ime to file an expert report. Motion, ECF No. 68. On March 26, 2013, the undersigned held a

status conference with the parties to establish a timeline for the filing of Petitio ners’ expert report; the undersigned ordered that on or before March 27, 2013, Petitioners’
counsel was to provide medical records to Dr. Rao’s office, and on or before May 2, 2013, Petitioners’ counsel was to file an expert report or a status report, indi cating the
status of Petitioners’ retention of an expert . Order, ECF No. 69.

Petitioners filed a Status Report on May 2, 2013, indicating that Dr. Rao was unable to file an expert report by the deadline due to illness. Report, ECF No. 70. A
status conf

erence was thereafter conducted on May 16, 2013, to discuss the status of Petitioners’ expert report. Order, ECF No. 71. The undersigned informed Petitioners’ counsel that on or before July 18, 2013, Petitioners’ counsel should file an expert report

or st atus report, indicating the status of expert retention

. Id.7

On July 18, 2013, P etitione rs filed a status report indicating that they were advised by Dr. Rao’s assistant that Dr. Rao would not be providing a report. Report, ECF No. 72.
A status conferenc e was conducted on Thursday, July 25, 2013, and again on August 27,
2013

, and September 25, 2013, to discuss the status of Petitioners’ progress in obtaining an expert report. Order, ECF No s . 73, 74, 75. During the se status conference s , the undersigned ord ered that Petitioners’ counsel was to file an expert report by noon on September 30, 2013

, and that if Petitioners’ counsel fail ed to do so, Respondent’s counsel

was to file a dispositive motion. Id.

Petitioners’ counsel failed to file an expert report by September 30, 2013; therefore, Respondent’s coun sel filed a “Motion T o Dismiss F or Failure T o Prosecute. ” Motion, ECF No. 76.

II

DISCUSSION

To receive compensation under the Program, Petitioners must prove either 1) that

W.D.W. suffered a “Table Injury”

- i.e., an injury falling within the Vaccine Injury Table

corresponding to one of his vaccinations, or 2) that W.D.W. suffered an injury that was actually caused by a vaccine

. See § 300aa

- 13(a)(1)(A) and § 300aa

- 11(c)(1).

Petition ers’ original petition alleged that W.D.W. suffered from a Table encephalopathy. However, that allegation is not included in the Fourth Amended Petition; the undersigned therefore deems it abandoned. In addition, the medical records do not support the occ urrence of a Table encephalopathy. Petitioners must proceed with a theory supporting causation

- in

- fact.

To establish vaccine causation, Petitioners must satisfy all prongs of the test established by the court in Althen v. Sec’y of Health & Human Serv s. , 418 F.3d 1274, 1278 (Fed. Cir. 2005). To satisfy the first prong of the Althen test, Petitioners must provide “a medical theory causally connecting the vaccination and the injury.” Id. ( quoting Grant v. Sec’y of Health & Human Servs. , 956 F.2d 1144 , 11 48 (Fed.
Cir. 1992) ) . Petitioners’ theory must show that it is more likely than not that the vaccine(s) W.D.W. r eceived can cause the injuries Petitioners allege the vaccines caused. Moberly v. Sec’y of Health & Human Servs.

, 592 F.3d 1315, 1324 (Fed. Cir. 2010).

To satisfy the second prong of the Althen test, Petitioners must establish “a logical sequence of cause and effect showing that the vaccination was the reason for the injury.”
Althen , 418 F.3d at 1278. That is, Petitioners must show by preponderan t evidence (more likely than not) that the vaccine(s) W.D.W. received did cause the injuries they allege they caused. See Capizzano v. Sec’y of Health & Human Servs. , 440 F.3d 1317 , 1326 (Fed. Cir. 2006).8

Finally, to satisfy the third prong of Althen , Petitioners must produce preponderant evidence of “a proximate temporal relationship between vaccination and injury.” Althen

, 418 F.3d at 1278. This prong helps to establish the connection between the causal theory of prong one and the m ore fact

- based ca use and effect arguments of prong two by demonstrating, “ t hat the onset of symptoms occurred within a timeframe from which, given the medical understanding of the disorder’s etiology, it is medically acceptable to
infer causation

- in

- fact.” de Bazan , 539 F. 3d 1347, 1352 (Fed. Cir. 2008).

The undersigned is not authorized to make a finding of causation based on the claims of a Petitioner alone, unsubstantiated by medical records or a medical opinion. See 42 U.S.C. §300aa

- 13(a)(1)(B). Although Petitioners s ought and received several
extensions of time with in which to file an expert report , as of September 30, 2013, no report had been filed. A review of the record in this case provides no other evidence demonstrating that W.D.W

. ’ s medical condition s were vaccine

- caused. Without such evidence, Petitioners cannot meet their burden of proof under the three

- prong test of
Althen

. The undersigned therefore GRANTS Respondent’s Motion to Dismiss.

III

CONCLUSION

The undersigned is sympathetic to the fact that W.D.W. suffers from numerous medical problems . However, under the law

, the undersigned can authorize compensation only if a medical condition or injury either falls within one of the “Table Injury” categorie s, or is shown by medical records or a competent medical opinion to be vaccine

caused. No such proof exists in th is record. Thus, this case is dismissed for insufficient proof. The Clerk shall enter judgment accordingly. 7

IT IS SO ORDERED.

/s/ Lisa Hamilton

- Fieldman
Lisa Hamilton

- Fieldman Special Master

7 To preserve whatever right Petitioners may have to file a civil action in another court, they must file an “Election to File a Civil Action” which rejects the judgment from this court within 90 days of the date judgment was filed.