Flores v. Secretary of Health and Human Services

115 Fed. Cl. 157, 2014 WL 1155959
CourtUnited States Court of Federal Claims
DecidedMarch 21, 2014
Docket1:10-vv-00489
StatusPublished
Cited by71 cases

This text of 115 Fed. Cl. 157 (Flores 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.

Bluebook
Flores v. Secretary of Health and Human Services, 115 Fed. Cl. 157, 2014 WL 1155959 (uscfc 2014).

Opinion

OPINION AND ORDER

SWEENEY, Judge

Petitioner seeks compensation under the National Childhood Vaccine Injury Act of 1986 (“Vaccine Act”), 42 U.S.C. §§ 300aa-l to -34 (2006), alleging that she sustained a spinal cord stroke caused by a human papil-lomavirus (“HPV”) vaccination. In a September 28, 2013 decision, the special master denied petitioner’s request for compensation. Before the court is petitioner’s motion for review of the special master’s decision. For the reasons set forth below, the court denies petitioner’s motion for review and sustains the decision of the special master.

I. BACKGROUND

A. Medical History

Petitioner’s medical history is not in dispute, and can be briefly summarized. 2 On April 28, 2008, when she was fourteen years old, petitioner received her first HPV vaccination. She received her second HPV vaccination on June 27, 2008. The following day, she began to experience several symptoms, including left-sided weakness, severe headache, and shortness of breath. She then developed flaccid paralysis of her extremities and slurred speech. When the emergency medical service arrived at her house, petitioner developed bradycardia and suffered a cardiac arrest. She was taken to the emergency room at Mt. Sinai Hospital, and was subsequently transferred to Rush University Medical Center (“Rush”).

At Rush, petitioner underwent an extensive medical workup and was given a working diagnosis of transverse myelitis. That diagnosis changed after two neurologists, Drs. Tilwalli and Stefofski, examined petitioner on August 6, 2008. As described by the special master:

Dr. Tilwalli, a neurology fellow, opined that given Valeria’s quick onset, absence of inflammatory markers, and lack of response to anti-inflammatory treatment, he favored a vascular etiology. He also noted that he thought Valeria’s HPV vaccination was too close to symptom onset to induce an inflammatory response. Similarly, a neurologist, Dr. Stefofski, opined that Valeria’s quick symptom onset “strongly favors a vascular etiology over immune mediated/inflammatory (definitely too soon for Gardasil or even for a remote preceding myelitogenie trigger).” He also noted that due to the lack of response to corticosteroids and cyclophosphamide, he doubted an autoimmune etiology.

*160 Flores, 2013 WL 5587390, at *4 (citations omitted). Ultimately, it was determined that petitioner had experienced a spinal cord stroke.

On August 7, 2008, petitioner was transferred from Rush to the Rehabilitation Institute of Chicago. Her physical condition did not improve; she continued to require total assistance for mobility and all activities of daily living. In addition, she had been on continuous ventilation during her stay at Rush and remained on the ventilator during her rehabilitation. Petitioner was discharged from inpatient rehabilitation on December 16, 2008. Since that time, she has shown some improvement-she has begun to feel some sensation in her extremities and exhibited voluntary movement in two fingers. However, she remains dependent on a ventilator.

B. Procedural History

Petitioner’s father filed a petition for compensation under the Vaccine Act on July 29, 2010, claiming that the HPV vaccine caused his daughter’s spinal cord stroke. Upon reaching the age of majority, Ms. Flores was substituted as petitioner. After the submission of medical records and expert reports, the special master convened an evidentiary hearing, during which he heard the testimony of three expert witnesses. Petitioner offered the testimony of neurologist Douglas A. Kerr, M.D., Ph.D., and respondent offered the testimony of pediatric neurologist Peter M. Bingham, M.D., and pediatric hematologist Joan Cox Gill, M.D. Posthearing briefs were filed, and the special master issued a decision on September 12, 2013.

In his decision, the special master noted that all three experts agreed that petitioner had suffered a spinal cord stroke, which was caused by a blood clot that had become lodged in a spinal cord vessel, depriving petitioner’s spinal cord of oxygen and causing permanent injury. Where the experts disagreed, the special master explained, was on the cause of the blood clot. Dr. Kerr opined that the blood clot was caused by the HPV vaccine. Specifically, he asserted that petitioner had a genetic predisposition to blood clotting involving multiple genes; that petitioner’s first HPV vaccination sensitized her immune system; that the second HPV vaccination elicited an exuberant, rapid immune response; and that the immune response resulted in petitioner’s blood clot, either through inflammation or platelet aggregation. Drs. Bingham and Gill, on the other hand, found it improbable that the HPV vaccine could be connected to petitioner’s blood clot. Dr. Bingham explained that there was neither clinical evidence of inflammation, nor a noted connection between the HPV vaccine and spinal cord strokes or blood clots. Dr. Gill asserted that there was no clinical evidence of inflammation or platelet aggregation, and that a clotting response via inflammation would have taken at least four days to develop.

The special master initially found that petitioner was unable to establish that she had a genetic predisposition to blood clotting. Because this genetic predisposition was a critical factor of the theory of causation advanced by Dr. Kerr, the special master concluded that petitioner could not establish that Dr. Kerr’s theory was probable. Although this conclusion, on its own, was sufficient to deny petitioner’s request for compensation under the Vaccine Act, the special master addressed other aspects of Dr. Kerr’s theory. First, he noted that Dr. Kerr’s theory was premised on petitioner’s spinal cord stroke originating from a blood clot in a vein (venous thrombosis), but that the evidence supported a finding that the blood clot originated in an artery (arterial thrombosis). Second, the special master held that petitioner failed to demonstrate that the HPV vaccine can contribute to the type of inflammation that causes blood clots and strokes or that petitioner’s second HPV vaccination did contribute to her blood clot or stroke. Similarly, the special master concluded that petitioner had not shown that she had experienced platelet aggregation or that any platelet aggregation contributed to her blood clot or stroke.

In addition to addressing specific elements of Dr. Kerr’s theory of causation, the special master discussed some of the medical literature submitted by the parties. He held that the Slade article, relied upon heavily by Dr. Kerr, did not offer “significant support” for *161 the proposition that the HPV vaccine can contribute to strokes. The special master also concluded that other medical literature added “slightly” to the reasons to reject Dr. Kerr’s theories of causation.

At the close of his decision, after concluding that the lack of an identifiable cause of petitioner’s spinal cord stroke did not offer “significant support”' for her theory that the HPV vaccine caused the stroke, the special master analyzed petitioner’s case under the test for causation set forth in Althen v.

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Bluebook (online)
115 Fed. Cl. 157, 2014 WL 1155959, Counsel Stack Legal Research, https://law.counselstack.com/opinion/flores-v-secretary-of-health-and-human-services-uscfc-2014.