Cerrone v. Hhs

Court of Appeals for the Federal Circuit·Decided July 29, 2025·No. 24-1281·Published

Opinion

United States Court of Appeals for the Federal Circuit

NIKKO CERRONE, Petitioner-Appellant

v.

SECRETARY OF HEALTH AND HUMAN SERVICES,

Respondent-Appellee

2024-1281

Appeal from the United States Court of Federal Claims in No. 1:17-vv-01158-EGB, Senior Judge Eric G. Bruggink.

Decided: July 29, 2025

GARY A. KROCHMAL, Gary A. Krochmal, PLLC, Farmington Hills, MI, argued for petitioner-appellant. Also represented by AMBER WILSON, Wilson Science Law, Washington, DC.

ELEANOR HANSON, Torts Branch, Civil Division, United States Department of Justice, Washington, DC, argued for respondent-appellee. Also represented by C. SALVATORE D’ALESSIO, LARA A. ENGLUND, MALLORI BROWNE OPENCHOWSKI, HEATHER LYNN PEARLMAN, YAAKOV ROTH.

2 CERRONE v. HHS

Before MOORE, Chief Judge, LOURIE and BRYSON, Circuit Judges.

BRYSON, Circuit Judge.

Nikko Cerrone filed a petition for compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10–300aa-34 (“Vaccine Act”), claiming that the administration of certain vaccines caused him to develop ulcerative colitis (“UC”), a type of inflammatory bowel disease (“IBD”). The special master assigned to his petition denied his claim for compensation, and the Court of Federal Claims upheld that decision. We affirm.

I

A

On October 7, 2015, Mr. Cerrone, who was sixteen years old at the time, visited his primary care physician complaining of jaw and ear pain. At that visit, he received the Gardasil human papillomavirus (“HPV”) vaccine, the Flumist influenza vaccine, and the Hepatitis A vaccine. App. 2. No reaction to the vaccines was recorded on that day or for the remainder of 2015. Id. However, Mr. Cerrone later stated in an affidavit that in November 2015 his stamina and stability decreased, and in December 2015 he first experienced blood in his stools. Id.

On February 10, 2016, Mr. Cerrone returned to his physician complaining of a sore throat and congestion. App. 3. At that visit, he received a second dose of the HPV vaccine. Id. Although his medical records from that visit do not mention any gastrointestinal issues, he visited the emergency room three days later, complaining that he had been experiencing blood in his stools for three weeks and that his symptoms had worsened in the past several days. Id. Mr. Cerrone then underwent various diagnostic tests, and on March 24, 2016, he was diagnosed with UC. Id.

CERRONE v. HHS 3

On May 19, 2016, Mr. Cerrone returned to the emergency room to be treated for UC symptoms, and he reported that he had been experiencing symptoms for five months. App. 4. He began treatment for UC at around that time. Id. On June 24, 2016, he returned to his physician for more testing and received his third dose of the HPV vaccine. Id. No reaction to that vaccination was documented, and Mr. Cerrone has not alleged that the third dose of the HPV vaccine exacerbated his symptoms. Id.

On October 3, 2016, Mr. Cerrone was further evaluated for UC. Id. At that time, he reported that his symptoms had begun in December 2015. Id. Since October 2016, Mr. Cerrone has received treatment for UC and has periodically experienced acute exacerbation of his symptoms. App. 5.

B

On August 28, 2017, Mr. Cerrone filed a petition seeking compensation under the Vaccine Act for his alleged vaccine -related injury. App. 1. The case was assigned to the Chief Special Master of the National Vaccine Injury Compensation Program, who heard expert testimony from David Rosenstreich and John Santoro on behalf of Mr. Cerrone and from Chris Liacouras and Neil Romberg on behalf of the respondent. Id.; see App. 5–28.

Dr. Rosenstreich is a licensed clinician and immunologist , with a focus on allergies. App. 5–6. He testified that Mr. Cerrone’s UC was caused by the three vaccines that Mr. Cerrone received on October 7, 2015. App. 5. Dr. Rosenstreich based that opinion on the theory of molecular mimicry, which is the theory that molecular similarities between different kinds of cells can cause the immune system to react similarly to both despite one (a foreign agent) being threatening and the other (the host’s own cells) being nonthreatening . App. 47. Dr. Rosenstreich explained that there are similarities between the viral proteins in the vaccines and the proteins in Mr. Cerrone’s body relevant to 4 CERRONE v. HHS

UC, and that Mr. Cerrone’s immune system may have mistakenly attacked those proteins. App. 8. Although Dr. Rosenstreich testified that any of the three vaccines could have triggered the molecular mimicry in Mr. Cerrone’s case, he focused on the HPV vaccine. Id.

As an alternative to his molecular mimicry theory, Dr.

Rosenstreich testified that the vaccines could have triggered Mr. Cerrone’s UC through other less immunologically specific mechanisms, and he offered some examples of such mechanisms. App. 9. Dr. Rosenstreich supported his opinions by reference to various journal articles, the HPV vaccine package insert, case reports, and reports from the Vaccine Adverse Event Reporting System. 1 App. 9–11.

Dr. Rosenstreich testified that his causation theory was consistent with Mr. Cerrone’s medical history. He posited that Mr. Cerrone was likely susceptible to UC, either genetically or as a result of environmental factors. App. 13. According to Dr. Rosenstreich, Mr. Cerrone’s report of decreased stamina and stability was an early manifestation of systemic inflammation. Id. Dr. Rosenstreich further testified that the fact that Mr. Cerrone’s condition worsened after his second HPV vaccine supported the theory that an immune reaction caused Mr. Cerrone’s disease, because immune responses to a second vaccine exposure typically manifest more quickly and robustly than responses to the first exposure. App. 14. Finally, Dr. Rosenstreich explained that his causation theory was consistent with the 81-day delay between Mr. Cerrone’s vaccination and the onset of blood in his stools because it takes time for the immune response to cause such severe damage. App. 15. In

1 The Vaccine Adverse Event Reporting System is a database maintained by the Centers for Disease Control and Prevention that compiles information from the public about reactions to immunizations. App. 11 n.28.

CERRONE v. HHS 5

Dr. Rosenstreich’s opinion, a delay of that length was consistent with the pertinent medical literature. Id.

Dr. Santoro, Mr. Cerrone’s other expert, is a gastrointestinal physician. App. 16. He did not testify live but submitted a report and affidavit. Id. The special master found his opinions to be largely duplicative of Dr. Rosenstreich’s opinions. Id.

Dr. Liacouras, who testified for the respondent, is a pediatric gastroenterologist. App. 17. He explained that UC is considered an autoimmune disease that has a largely unknown etiology, although genetic, environmental, autoimmune , and bacterial factors are all possible explanations. App. 17. He did not dispute Mr. Cerrone’s UC diagnosis. Based largely on the timing of Mr. Cerrone’s disease progression , however, he disagreed that Mr. Cerrone’s vaccinations were the likely cause of his disease. App. 18.

Dr. Liacouras focused on Mr. Cerrone’s disease progression as documented in his medical records, noting that no gastrointestinal bleeding was recorded until February 13, 2016. App. 18. Dr. Liacouras discounted Mr. Cerrone’s self-reported decreased stamina and stability, because those symptoms have many possible causes unrelated to UC. App. 19. Given the delay between the vaccinations and the onset of Mr. Cerrone’s UC symptoms, Dr. Liacouras concluded that it was unlikely that vaccines caused Mr. Cerrone’s UC. Id. Dr. Liacouras also based his opinion on a review of the relevant medical literature, which he described as suggesting that vaccines are not commonly associated with the development of UC. Id.

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