Mager v. Sec'y of Health & Human Servs.

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MICHAEL MAGER, as parent of VICTORIA MAGER, Petitioner, v. SECRETARY OF HEALTH AND HUMAN SERVICES, Respondent.

No. 14-820

United States Court of Federal Claims

June 20, 2023^[*]

Renee J. Gentry, Vaccine Injury Clinic, George Washington University Law School, of Washington, DC, for petitioner.

Zoe Wade, Trial Attorney, with whom were Darryl R. Wishard Assistant Director, Heather L. Pearlman, Deputy Director, C Salvatore D'Alessio, Director, Torts Branch, Brian M Boynton, Principal Deputy Assistant Attorney General, Civil Division, Department of Justice, all of Washington, DC, for respondent.

OPINION AND ORDER

RYAN T. HOLTE Judge

"[W]hile most of the Nation's children enjoy greater benefit from immunization programs, a small but significant number have been gravely injured." Cloer v. Sec'y of Health & Hum. Servs., 654 F.3d 1322, 1325 (Fed. Cir. 2011) (quoting H.R. Rep. No. 99-908, at 4 (1986)). The Vaccine Act "assure[s] parents that when their children are the victims of an appropriate and rational national policy, a compassionate [g]overnment will assist them in their hour of need." Boatmon v. Sec'y of Health & Hum Servs., 941 F.3d 1351, 1364 (Fed. Cir. 2019) (Newman, J., dissenting) (quoting statement of Sen. Edward Kennedy, S. Comm. on Labor & Human Res.). The pro-petitioner Vaccine Act does not require clarity or perfection in proving a vaccine injury. Indeed, "'[t]he purpose of the Vaccine Act's preponderance standard is to allow the finding of causation in a field bereft of complete and direct proof of how vaccines affect the human body,' even if the possible link between the vaccine and the injury is 'hitherto unproven.'" Porter v. Sec'y of Health & Hum. Servs., 663 F.3d 1242, 1261 (Fed. Cir. 2011) (quoting Althen v. Sec'y of Health & Hum. Servs., 418 F.3d 1274, 1280 (Fed. Cir. 2005)).

The current issue before the Court revolves around challenge-rechallenge-an inferred clinical determination of causality, generally accepted in the medical field and based on repeat adverse reactions to the administration of a pharmaceutical or biologic. Victoria Mager's first observed seizure occurred shortly after receiving the first dose of the HPV vaccine. The seizures subsided for several years until Ms. Mager received a second dose of the HPV vaccine, at which point her seizures returned-ultimately resulting in her death. Petitioner proffered the challenge-rechallenge paradigm as evidence of causation, and the Special Master found Mr. Mager was entitled to compensation under the Vaccine Act. Respondent moved the Court for review of the Special Master's Ruling Finding Entitlement alleging the Special Master erred by allowing the use of the challenge-rechallenge paradigm, among other things. The Court addresses some nuances of challenge-rechallenge as it applies to the Vaccine Act. For the following reasons, the Court denies respondent's Motion for Review.

I. Petitioner's Medical History and the Vaccination

The Court's recitation of the background facts draws from the Special Master's Decision Denying Compensation, ECF No. 189, the Court's Opinion and Order granting petitioner's 2021 Motion for Review, Mager v. Sec'y of Health & Hum. Servs., 158 Fed.Cl. 136 (2022), ECF No. 202, and the Special Master's Ruling Finding Entitlement to Compensation ("Ruling Finding Entitlement"), ECF No. 224.

Ms. Mager's health history was relatively normal before receiving the vaccination for the human papilloma virus ("HPV").^[1] Ms. Mager received the vaccine on 2 October 2007. Pet. at 1, ECF No. 1. Six weeks later, Ms Mager suffered a seizure and was taken to a nearby emergency room. Pet'r's Ex. 11 at 28, ECF No. 9-4. The admission notes from that visit state she experienced a seizure followed by a second seizure approximately four minutes later. Id. Her head CT scan, urine toxicology screen, and chest x-ray were all normal. Id. at 3-4, 13. An electroencephalogram ("EEG") "indicate[d] focal sites of cerebral hyperexcitability which can be associated with partial seizures/epilepsy." Id. at 17. Ms. Mager was prescribed Depakote, an anti-seizure medication, and discharged on 15 November 2007. Id. at 38.

In a follow-up visit on 12 December 2007, Ms. Mager's physician, Dr. Shafrir, noted that her parents recalled that "for a while [after her initial seizure], [Ms. Mager] was waking up with big cuts in her tongue at least twice and also complaining of soreness after waking up and it is possible that these might have been seizures." Pet'r's Ex. 11 at 75. Ms. Mager's stepmother also reported Ms. Mager's enuresis was resolved after she began taking her anti[-]seizure medication, Depakote. Id. Dr. Shafrir noted the EEG indicated an impression of "focal onset epilepsy" and "some frontal lobe dysfunction," and he recommended neuropsychological testing. Id. at 77.

Approximately two months later, Ms. Mager saw another pediatric neurologist, Dr. Koehn, who ordered another EEG-the results of which were normal. Pet'r's Ex. 6 at 22, ECF No. 8-7. Dr. Koehn noted, referring to the original abnormal EEG, that "[t]he first EEG pattern could represent a fragment/a more lateralized pattern of an underlying generalized discharge or it could in fact be a focal discharge. Therefore, leaving the possibility open for this to have been a primary or secondarily generalized seizure." Id. at 20. Although the medication appeared to control her seizure activity, Ms. Mager's father and stepmother noted undesirable side effects of the medication and requested she be weaned off Depakote. Id. at 24. Accordingly, Dr. Koehn agreed to gradually wean Ms. Mager from Depakote and referred her for neuropsychological testing. Id. at 28; see also Pet. at 1.

Shortly after seeing Dr. Koehn, Ms. Mager saw another physician, Dr. Waltonen, for neuropsychological testing. Pet'r's Ex. 6 at 6. Dr. Waltonen observed she had "a history of some type of learning difficulty at least in the speech and language area." Id. He also noted Ms. Mager had a family history of epilepsy and seizures on her maternal side. Id. at 2. He noted reports of "increasing problems with doing well in school" and Ms. Mager's teachers indicated she had "problems following directions." Id. at 1, 4. Ultimately, Dr. Waltonen concluded that "[o]verall, her examination does not reveal evidence of significant cognitive impairment with the exception of these very focal language findings." Id. at 6.

From April 2008 to October 2012, Ms. Mager did not experience any seizure activity and appeared to function normally. Her school records did not indicate any abnormalities. See Pet'r's Ex. 83, ECF No. 144-3. The results of sport physicals she received in August 2009 and March 2012 were normal. Pet'r's Ex. 10 at 15-17, ECF No. 9-3; Pet'r's Ex. 14 at 1-2, ECF No. 12-2. During a physical exam in January 2012, she reported she had not experienced seizure activity for four years. Pet'r's Ex. 10 at 18. Ms. Mager received her second HPV vaccination on 11 September 2012. Pet'r's Ex. 4 at 1, ECF No. 8-5. The following month, on 10 October 2012, she suffered a seizure and was taken to the emergency department of a nearby medical center. Pet'r's Ex. 7 at 9, ECF No. 8-8. Her evaluation, which included an [electrocardiogram], was normal. Id. at 13-14. She was diagnosed with a "[p]robable seizure" and discharged. Id. at 14.

In a visit with her primary care doctor the next month, she reported two additional seizures occurring on 19 October 2012 and 7 November 2012 after her ER visit. Pet'r's Ex. 9 at 39, ECF No. 9-2. Her doctor prescribed an anti[-]seizure medication, Depakote, and referred her to a neurologist. Id.

Neurologist Dr. Edgar saw Ms. Mager a couple months later in January 2013. Pet'r's Ex. 9 at 24-25. According to Dr. Edgar's note, "[t]he EEG is normal during wakefulness. During sleep there is activation of infrequent potentially epileptiform activity over the left frontal and bioccipital head regions, consistent with the patient's history of generalized seizures." Id. at 25. Dr. Edgar believed Ms. Mager suffered from primary generalized seizure disorder, and he noted the "age of onset at approximately 11 years of age suggests the possibility of juvenile myoclonic epilepsy, although no myoclonic seizures are reported." Id. at 31. He recommended Depakote, but due to Ms. Mager's objections, he directed her to begin weaning off Depakote and prescribed Keppra, an alternative anti[-]seizure medication, instead. Id. at 8.

Dr. Edgar observed during a follow-up appointment in July 2013 that Ms. Mager's compliance with her Keppra prescription was "less than ideal"; she had a sub-therapeutic level of the medication in her blood according to a test on 30 May 2013. Pet'r's Ex. 9 at 3. Ms. Mager wanted to stop using Keppra, but Dr. Edgar persuaded her to remain on the drug given her history of seizures. Id. at 4. Due to her age at the onset of her seizure condition, Dr. Edgar again noted "probable juvenile myoclonic epilepsy." Id.

Months later, on 11 January 2014, Ms. Mager was found unresponsive at a friend's house and was rushed to the emergency department of a nearby hospital where she was pronounced dead upon arrival. Pet'r's Ex. 8 at 2, ECF No. 8-9. The local police department reported a witness statement that Ms. Mager had been "missing a lot of doses of her medication," and her father reported that "she was having seizures more frequently." Pet'r's Ex. 13 at 2, ECF No. 9-6.

According to an autopsy, Ms. Mager suffered pulmonary edema and brain changes consistent with a seizure disorder. Pet'r's Ex. 16 at 10, ECF No. 18-2. There was subpial gliosis in sections of her brain. Id. at 16. A toxicology screen showed therapeutic levels of Keppra in her blood. Pet'r's Ex. 13 at 11. The cause of Ms. Mager's death was "seizure disorder"

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