Godfrey v. Secretary of Health and Human Services

CourtUnited States Court of Federal Claims
DecidedAugust 19, 2015
Docket10-565
StatusUnpublished

This text of Godfrey v. Secretary of Health and Human Services (Godfrey v. Secretary of Health and Human Services) is published on Counsel Stack Legal Research, covering United States Court of Federal Claims primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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Godfrey v. Secretary of Health and Human Services, (uscfc 2015).

Opinion

In the United States Court of Federal Claims No. 10-565V (Filed: August 19, 2015)* *Opinion originally issued under seal on July 29, 2015

) MEGAN L. GODFREY, ) ) Petitioner, ) Vaccine Petition; Intervening Federal ) Circuit Decision; Koehn v. Sec’y of v. ) Health and Human Servs., 773 F.3d ) 1239 (Fed. Cir. 2014); Remand to SECRETARY OF HEALTH AND ) Special Master HUMAN SERVICES, ) ) Respondent. ) )

Clay Ragsdale, Birmingham, AL, for petitioner.

Jennifer Reynaud, United States Department of Justice, Civil Division, Washington, DC, with whom were Benjamin C. Mizer, Acting Assistant Attorney General, Rupa Bhattacharyya, Director, Torts Branch, Vincent J. Matanoski, Assistant Director, and Catherine E. Reeves, Assistant Director.

OPINION

Pending before the court is Megan L. Godfrey’s (“Ms. Godfrey” or “petioner”)

petition for review of the June 11, 2014 decision of Chief Special Master Vowell (“chief

special master”) denying Ms. Godfrey’s claim for compensation under the National

Childhood Vaccine Injury Act of 1986, 42 U.S.C. § 300aa-1 to -34, as amended

(“Vaccine Act”). Godfrey v. Sec’y of Health and Human Services, No. 10-565, 2014

WL 3058353 (Fed. Cl. June 11, 2014) (“Decision”). Petitioner alleges that the single dose of the Gardasil human papillomavirus

(“HPV”) vaccine she received on August 22, 2007, “substantially contributed” to her

development of juvenile ankylosing spondylitis (“JAS”).1 An entitlement hearing was

held on December 10, 2012. The chief special master, applying the test set forth in

Althen v. Sec’y of Health and Human Servs., 418 F.3d 1274, 1278 (Fed. Cir. 2005),

determined that petitioner had not met her burden of proof to show causation-in-fact.

Specifically, the chief special master found that the medical theory presented by

petitioner—which posited that the HPV vaccine could have “triggered” petitioner’s JAS

in a manner similar to other environmental triggers—was not a sufficiently plausible

theory to show that the vaccine could actually “cause” petitioner’s JAS as required under

the Althen standard. The chief special master also found that the dose of HPV vaccine

given could not have caused or triggered petitioner’s JAS symptoms. The chief special

master further determined that petitioner had failed to establish a temporal relationship

between receipt of the vaccination and her JAS diagnosis, in that it was not clear when

the petitioner contracted JAS due to the staggered onset of symptoms.

Petitioner seeks reversal of the chief special master’s decision, arguing that the

chief special master erred in rejecting petitioner’s expert’s opinion that the HPV vaccine

can trigger or cause JAS and that a single dose of the vaccine could have triggered

petitioner’s JAS. Petitioner argues that she presented a viable, legally-probable medical

1 JAS is the juvenile form of ankylosing spondylitis, and typically causes peripheral arthritis and peripheral enthesopathies. Dec. at 11 (citing Pet.’s Ex. 52 at 2, Pet.’s Ex. 57 at 2, 4). JAS commonly affects the pelvis, heels, knee joints, and hip joints. Id. (citing Pet.’s Ex. 56 at 575).

2 causation theory and established a proper temporal reaction, both of which petitioner

argues the chief special master improperly disregarded. In support of her petition, Ms.

Godfrey relies extensively on the recent decision of the Federal Circuit in Koehn v. Sec’y

of Health and Human Servs., 773 F.3d 1239 (Fed. Cir. 2014). Koehn also involved a

claim of injury from the HPV vaccine and discusses the testimony of the two principal

experts that appeared in this case. Petitioner argues that the Koehn decision dictates

reversal of the chief special master’s decision rejecting a finding of causation in this case

due to the Federal Circuit’s criticism of the analysis in that case. Respondent argues that

Koehn does not undermine the chief special master’s decision because the relevant

discussion is dicta and this case is factually distinct because, unlike Koehn, it involves a

disease with a strong genetic component. Therefore, the government argues that the

decision of the chief special master should be affirmed.

For the reasons set forth below, the court finds that Koehn raises issues that are

best addressed by the chief special master in the first instance. Specifically, there are

several statements in the Koehn decision which suggest that the chief special master’s

grounds for rejecting petitioner’s causation theory should be re-examined. Accordingly,

the court GRANTS IN PART petitioner’s motion and REMANDS the case for further

consideration regarding whether the Koehn decision warrants a different outcome.

I. BACKGROUND

A. Procedural History

On August 10, 2010, Ms. Godfrey filed a petition under the Vaccine Act.

Additionally, petitioner filed her medical records, medical literature, and an expert report

3 from David Axelrod, M.D. (“Dr. Axelrod”), a clinical immunologist. On September 26,

2011, the government filed an expert report from Carlos D. Rose, M.D. (“Dr. Rose”), a

pediatric rheumatologist. On October 26, 2011, the government filed medical literature,

an expert report from Burt Zweiman, M.D. (“Dr. Zweiman”), an immunologist, and a

Vaccine Rule 4(c) report recommending against awarding compensation.

A Vaccine Rule 5 status conference was held on November 5, 2011, at which the

chief special master noted deficiencies in Dr. Axelrod’s report. Thereafter, on April 24,

2012, petitioner filed an expert report from Michael J. McCabe, Jr., Ph.D. (“Dr.

McCabe”), a toxicologist/immunologist. On June 18, 2012, the Secretary filed a

responsive expert report from Dr. Zweiman addressing Dr. McCabe’s report.

An entitlement hearing was held on December 10, 2012.2 At the hearing,

petitioner presented testimony from Dr. McCabe, while the government presented

testimony from Drs. Rose and Zweiman. On June 11, 2014, the chief special master

issued a decision denying compensation. The chief special master determined that

respondent’s experts were entitled to greater weight based on both their qualifications and

their testimony that petitioner’s causation theory was not supported by the medical and

scientific literature. On July 11, 2014, petitioner timely filed a petition for review in this

court. The petition was stayed pending the appeal in Koehn. Supplemental briefs were

2 Petitioner initially indicated that she wished to file an expert report from Anthony Turkiewicz, M.D., her treating rheumatologist. The chief special master denied a postponement of the hearing, but granted leave to file an affidavit. On January 18, 2013, petitioner gave notice that no affidavit would be filed.

4 filed following the resolution of that appeal. Oral argument on the petition for review

was held on July 14, 2015.

B. Facts

Ms. Godfrey was born on August 1, 1989. Dec. at 6. Her medical records

indicate that she was generally healthy through age 18. Id. Her family medical history

included Crohn’s disease (father) and rheumatoid arthritis (paternal grandparents and

paternal aunts and uncles). Id. at 6; Pet.’s Exs. 7 at 182, 8 at 9. She participated in

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