Cerrone v. Hhs

CourtCourt of Appeals for the Federal Circuit
DecidedJuly 29, 2025
Docket24-1281
StatusPublished

This text of Cerrone v. Hhs (Cerrone v. Hhs) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Cerrone v. Hhs, (Fed. Cir. 2025).

Opinion

Case: 24-1281 Document: 39 Page: 1 Filed: 07/29/2025

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, Farm- ington Hills, MI, argued for petitioner-appellant. Also rep- resented 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. ______________________ Case: 24-1281 Document: 39 Page: 2 Filed: 07/29/2025

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. Cer- rone 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. Case: 24-1281 Document: 39 Page: 3 Filed: 07/29/2025

CERRONE v. HHS 3

On May 19, 2016, Mr. Cerrone returned to the emer- gency 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 vac- cine 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 periodi- cally experienced acute exacerbation of his symptoms. App. 5. B On August 28, 2017, Mr. Cerrone filed a petition seek- ing compensation under the Vaccine Act for his alleged vac- cine-related injury. App. 1. The case was assigned to the Chief Special Master of the National Vaccine Injury Com- pensation Program, who heard expert testimony from Da- vid 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 immunolo- gist, 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 be- tween 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 non- threatening. App. 47. Dr. Rosenstreich explained that there are similarities between the viral proteins in the vac- cines and the proteins in Mr. Cerrone’s body relevant to Case: 24-1281 Document: 39 Page: 4 Filed: 07/29/2025

UC, and that Mr. Cerrone’s immune system may have mis- takenly 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 trig- gered Mr. Cerrone’s UC through other less immunologi- cally 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 pos- ited 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 de- creased stamina and stability was an early manifestation of systemic inflammation. Id. Dr. Rosenstreich further testified that the fact that Mr. Cerrone’s condition wors- ened after his second HPV vaccine supported the theory that an immune reaction caused Mr. Cerrone’s disease, be- cause immune responses to a second vaccine exposure typ- ically 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 im- mune 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. Case: 24-1281 Document: 39 Page: 5 Filed: 07/29/2025

CERRONE v. HHS 5

Dr. Rosenstreich’s opinion, a delay of that length was con- sistent with the pertinent medical literature. Id. Dr. Santoro, Mr. Cerrone’s other expert, is a gastroin- testinal physician. App. 16. He did not testify live but sub- mitted 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 pe- diatric gastroenterologist. App. 17. He explained that UC is considered an autoimmune disease that has a largely un- known etiology, although genetic, environmental, autoim- mune, 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 pro- gression, however, he disagreed that Mr. Cerrone’s vac- cinations were the likely cause of his disease. App. 18. Dr. Liacouras focused on Mr. Cerrone’s disease pro- gression as documented in his medical records, noting that no gastrointestinal bleeding was recorded until February 13, 2016. App. 18. Dr. Liacouras discounted Mr.

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