Godfrey v. Secretary of Health and Human Services

United States Court of Federal Claims·Decided August 19, 2015·No. 10-565·Unpublished

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).

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

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.

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 athletics during high school, including as a member of the school’s cheerleading team. Dec. at 6 & n.12.

On August 22, 2007, petitioner received HPV and meningococcal conjugate vaccines. Id. at 6; Pet.’s Ex. 2 at 1. Four months later, on December 19, 2007, petitioner presented to her pediatrician, Mark Woods, M.D., complaining of sharp intermittent left hip pain that had been ongoing for three months. Dec. at 6; Pet.’s Ex. 3 at 1. She reported no injury and an X-ray of her hip was negative. Pet.’s Ex. 3 at 1. She received an MRI on December 28, 2007, which revealed “[b]ilateral femoral benign fibrous dysplasia, greater on the left side than the right, and left-sided sacroiliitis, which the radiologist thought could be inflammatory.” Dec. at 7; Pet.’s Ex. 8 at 86.

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