VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_14-vv-00932 Package ID: USCOURTS-cofc-1_14-vv-00932 Petitioner: J.O. Filed: 2014-10-02 Decided: 2015-02-20 Vaccine: Hepatitis A and Menactra Vaccination date: 2013-02-22 Condition: Crohn's disease Outcome: dismissed Award amount USD: AI-assisted case summary: On October 2, 2014, petitioners Debi Oliveira and Tony Oliveira, on behalf of their minor son J.O., filed a petition alleging that the hepatitis A and Menactra vaccines administered on February 22, 2013, caused or significantly aggravated J.O.'s Crohn's disease. J.O. was born on November 9, 1999. The respondent, the Secretary of Health and Human Services, argued that J.O.'s Crohn's disease began before the vaccinations and that the petitioners failed to provide an expert medical report to support their claim of significant aggravation. Special Master Laura D. Millman presided over the case. The public decision does not describe the specific clinical story of J.O.'s Crohn's disease beyond what is contained in the medical records. Medical records indicated that J.O. experienced digestive issues, including diarrhea and weight loss, prior to his vaccinations. His personal care physician, Dr. Anthony Marinello, noted concerns about potential food allergies to milk and gluten based on J.O.'s prior complaints of adverse reactions to these foods. Approximately three months before his vaccination, J.O. began experiencing diarrhea associated with meals. He also reported dark red blood in his stool about a week before seeing an allergist on March 7, 2013, and had experienced vomiting two days prior to that. Despite attempting to gain weight by increasing his intake of milk, pasta, and wheat over the preceding six months, J.O. had been losing weight. Allergy testing for cow's milk and wheat was negative. On March 28, 2013, J.O. saw pediatric gastroenterologist Dr. Nikki Allmendinger, who noted similar symptoms, including daily diarrhea, occasional blood in stool, abdominal pain, and poor weight gain, despite increased caloric intake. Dr. Allmendinger diagnosed J.O. with disorder of the intestine, ulceration of the intestine, diarrhea, and blood in his stool on April 8, 2013, and subsequently diagnosed Crohn's disease on April 16, 2013. The petitioners' counsel, William E. Cochran, Jr., stated he was looking for a medical expert. The respondent's counsel was Lisa A. Watts. Special Master Millman granted the petitioners' oral motion to dismiss the case on February 19, 2015, finding that they failed to prove by a preponderance of the evidence that the vaccines caused or significantly aggravated J.O.'s Crohn's disease, as required by the National Childhood Vaccine Injury Act. The decision noted that the medical records did not substantiate the petitioners' claims and that no expert medical opinion had been filed. Subsequently, on April 14, 2015, the parties stipulated to an award for attorneys' fees and costs. Special Master Millman approved a total award of $15,201.40, consisting of $12,454.50 in attorneys' fees and $2,746.90 in attorneys' costs, payable jointly to J.O. and his parents and their counsel, Black McLaren Jones Ryland & Griffee, P.C. Theory of causation field: Petitioners alleged that hepatitis A and Menactra vaccines administered on February 22, 2013, to J.O. (born November 9, 1999) caused or significantly aggravated his Crohn's disease. The respondent argued that J.O.'s Crohn's disease symptoms, including diarrhea and weight loss, predated the vaccinations. Medical records from J.O.'s personal care physician and an allergist documented digestive issues and weight loss prior to February 22, 2013. A pediatric gastroenterologist diagnosed Crohn's disease on April 16, 2013, after colonoscopy revealed intestinal ulceration. Petitioners did not file an expert medical report to support their claim. Special Master Laura D. Millman dismissed the case on February 20, 2015, finding that petitioners failed to prove causation by a preponderance of the evidence, as required by the National Childhood Vaccine Injury Act, citing the lack of substantiating medical records and expert opinion. The theory of causation was considered off-Table. Attorneys for petitioners were William E. Cochran, Jr., and for respondent was Lisa A. Watts. On April 14, 2015, the parties stipulated to an award of $15,201.40 for attorneys' fees and costs, consisting of $12,454.50 in fees and $2,746.90 in costs, payable jointly to petitioners and their counsel. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_14-vv-00932-0 Date issued/filed: 2015-03-13 Pages: 5 Docket text: PUBLIC DECISION (Originally filed: 02/20/2015) regarding 14 DECISION of Special Master Signed by Special Master Laura D Millman. (tlj) Copy to parties. -------------------------------------------------------------------------------- Case 1:14-vv-00932-UNJ Document 15 Filed 03/13/15 Page 1 of 5 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 14-932V February 20, 2015 Not to be Published *************************************** J.O., a Minor, by his Parents, * DEBI OLIVEIRA and TONY OLIVEIRA, * * Petitioners, * * v. * Hepatitis A and Menactra vaccines; * causation or significant aggravation SECRETARY OF HEALTH * of Crohn’s disease; no expert witness; AND HUMAN SERVICES, * petitioner’s motion to dismiss granted * Respondent. * *************************************** William E. Cochran, Jr., Memphis, TN, for petitioners. Lisa A. Watts, Washington, DC, for respondent. MILLMAN, Special Master DECISION1 On October 2, 2014, petitioners herein sued on behalf of their son J.O. by filing a petition under the National Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-10-34 (2006), alleging that hepatitis A and meningococcal (“Menactra”) vaccines caused J.O.’s Crohn’s disease, or, in the alternative, significantly aggravated his preexisting Crohn’s disease. 1 Because this decision contains a reasoned explanation for the special master’s action in this case, the special master intends to post this decision on the United States Court of Federal Claims’ website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002). Vaccine Rule 18(b) states that all decisions of the special masters will be made available to the public unless they contain trade secrets or commercial or financial information that is privileged and confidential, or medical or similar information whose disclosure would constitute a clearly unwarranted invasion of privacy. When such a decision is filed, petitioners have 14 days to identify and move to redact such information prior to the document’s disclosure. If the special master, upon review, agrees that the identified material fits within the categories listed above, the special master shall redact such material from public access. Case 1:14-vv-00932-UNJ Document 15 Filed 03/13/15 Page 2 of 5 Under the Vaccine Act, “significant aggravation” is defined as “any change for the worse in a preexisting condition which results in markedly greater disability, pain, or illness accompanied by substantial deterioration of health.” 42 U.S.C. § 300aa-33(4). Crohn’s disease is defined as “one of the principal forms of inflammatory bowel disease, a chronic granulomatous disease of the gastrointestinal tract of unknown etiology; it can involve any part of the tract, but most often is found in the terminal ileum. Characteristics include scarring and thickening of the bowel wall that frequently leads to intestinal obstruction, abscesses, and fistula formation. There is a high rate of recurrence after treatment.” Dorland’s Illustrated Medical Dictionary 531 (32d ed. 2012) (“Dorland’s). “[C]hronic diarrhea is the most common presenting complaint[,] and abdominal pain and weight loss are present in over 60% of [Crohn’s disease] patients at diagnosis.” Textbook of Gastroenterology 1402 (T. Yamada ed., 5th ed. 2009). In addition, “[I]ntercurrent infections . . . may impact on symptoms or inflammatory features.” Id. at 1404. On October 31, 2014, the undersigned issued a lengthy Order, describing the contents of the medical records as well as the issues in the case. The undersigned discussed the October 31, 2014 Order with counsel on November 5, 2014, during the first telephonic status conference. On December 11, 2014, respondent filed her Rule 4(c) Report, stating that compensation is not appropriate in this case because J.O.’s Crohn’s disease began before his hepatitis A and Menactra vaccinations, and petitioners had not filed a medical expert report supporting the allegation that his vaccinations significantly aggravated his pre-existing Crohn’s disease. On December 17, 2014, the undersigned held another telephonic status conference with counsel. Petitioners’ counsel stated he was looking for a medical expert, and he had shared both the undersigned’s October 31, 2014 Order and respondent’s Rule 4(c) Report with petitioners. On February 19, 2015, the undersigned held another telephonic status conference with counsel. Petitioners’ counsel orally moved to dismiss this case. The undersigned GRANTS petitioners’ motion and DISMISSES this case for failure to prove that hepatitis A and Menactra vaccinations caused or, in the alternative, significantly aggravated J.O.’s Crohn’s disease. FACTS J.O. was born on November 9, 1999. On February 22, 2013, J.O. visited his personal care physician (“PCP”), Dr. Anthony Marinello, at Capital Care Family Practice. Med. recs. Ex. 4, at 22–23. Dr. Marinello noted his concern about whether J.O. had food allergies to milk and gluten, based on J.O.’s previous 2 Case 1:14-vv-00932-UNJ Document 15 Filed 03/13/15 Page 3 of 5 complaints that he had adverse experiences when he drank milk and/or ate anything with gluten, such as wheat. Id. at 22. J.O.’s complaint to Dr. Marinello preceded his receipt of hepatitis A vaccine and Menactra on February 22, 2013. Id. This visit to Dr. Marinello occurred two days before J.O. visited his grandfather on February 24, 2013, for his grandfather’s birthday. At the grandfather’s birthday celebration, J.O.’s mother had an upset stomach, vomiting, and diarrhea. Ex. 6, at 2. Within a few days, J.O. had the gastroenteritis his mother had. Id. Eleven days after his grandfather’s birthday, on March 7, 2013, and approximately one week after J.O. caught his mother’s gastroenteritis, J.O. saw an allergist, Dr. Ari Kounavis, and gave a history that he had had diarrhea associated with meals for the prior three months. Med. recs. Ex. 2, at 4. The diarrhea occurred one hour after breakfast, after school, and after dinner. Id. J.O. had dairy with each meal. Id. The diarrhea looked like watery loose stools without blood in them. Id. One week earlier (which would be around February 28), he had dark red blood in his stool. Id. One month previously, he also had been vomiting for two days associated with gastroenteritis. Id. J.O. had been drinking more cow’s milk and eating pasta and wheat over the past six months in order to increase his weight for sports, but he had been losing weight instead of gaining it. Id. Skin testing for allergy to cow’s milk and wheat was negative. Id. at 6. (From this record, we see that J.O. was experiencing weight loss over the prior six months even though he was eating more, that he had been experiencing diarrhea associated with meals for the prior three months, and that he had been sensitive to milk and wheat although he tested negatively for an allergy to both substances. His weight loss in the context of increased caloric intake, abdominal upset, and diarrhea occurred before his hepatitis A and meningitis vaccinations.) On March 28, 2013, three weeks after J.O. saw the allergist Dr. Kounavis, J.O. saw Dr. Nikki Allmendinger, a pediatric gastroenterologist, at Albany Medical Center. Med. recs. Ex. 1A, at 18. J.O. gave a similar history to Dr. Allmendinger that he had given to Dr. Kounavis, but with additional information. Id. (Dr. Kounavis and Dr. Allmendinger work at different medical facilities, and there is nothing in the records to suggest that Dr. Allmendinger had access to Dr. Kounavis’s records and copied J.O.’s history from them. Thus, two independent histories from J.O. establish his Crohn’s symptomatology preceded his vaccinations, in addition to his history to Dr. Marinello of digestive problems preceding vaccination.) J.O. told Dr. Allmendinger that for at least the last three months, he had been having daily diarrhea of a small amount, and he only had a formed stool once a week or so. Id. There was no blood in the stool. Id. At the beginning of all this, J.O. and other family members were sick with vomiting and diarrhea, but J.O.’s diarrhea continued. Id. When his parents removed dairy from his diet, he had some improvement, although he still had issues. Id. He returned to milk again four days before the appointment and seemed to be a little worse. Id. He complained of abdominal pain once a week that was relieved with stooling. Id. Spicy foods made him feel worse. Id. Dr. Allmendinger commented that J.O. did not seem to have a very well balanced 3 Case 1:14-vv-00932-UNJ Document 15 Filed 03/13/15 Page 4 of 5 diet. Id. J.O. ate a lot of carbohydrates and meats, but not a lot of fruits and vegetables. Id. J.O. had been attempting to gain weight by ingesting more calories, but he had not been gaining weight. Id. J.O. was in the 37th percentile for weight, but in the 56th percentile for height. Id. at 19. He had iron deficiency anemia, elevated sedimentation rate, diarrhea, and poor weight gain. Id. On April 8, 2013, Dr. Allmendinger performed a colonoscopy on J.O. and diagnosed him with disorder of the intestine, ulceration of the intestine, diarrhea, and blood in his stool. Med. recs. Ex. 1B, at 1. On April 16, 2013, Dr. Allmendinger diagnosed J.O. with Crohn’s disease. Med. recs. Ex. 1A, at 16. On April 19, 2013, Dr. Marinello referred J.O. to an ear-nose-throat (“ENT”) specialist because he had an inflamed epiglottis. Med. recs. Ex. 4, at 2. On April 29, 2013, J.O. saw Dr. Michael De Vito, an ENT, who diagnosed J.O. with allergic rhinitis. Id. at 21. J.O. suffered from allergies throughout the year. Id. On November 11, 2013, J.O.’s mother requested Dr. Allmendinger write a letter, as she felt there might be a connection between J.O.’s Crohn’s disease and the MMRV vaccine that J.O. received on February 22, 2013, because his symptoms developed about a week after it. Med. recs. Ex. 1A, at 11. J.O. did not receive MMR and varicella vaccines on February 22, 2013. He received hepatitis A vaccine and Menactra on that date. Med. recs. Ex. 4, at 4. MMR and varicella vaccines are attenuated live viral vaccines. MMRV vaccine, Wikipedia, http://www.wikipedia.org/wiki/MMRV_vaccine (last visited Feb. 20, 2015). Hepatitis A vaccine is a killed virus vaccine. Hepatitis A Vaccine and Prevention, eMedicineHealth, http://www.emedicinehealth.com/hepatitis_a/page11_em.htm (last updated Dec. 15, 2014). Menactra is a meningococcal conjugated vaccine. Dorland’s at 1131. Its purpose is to prevent the bacterial disease meningitis, and there is no virus in it. Meningococcal Vaccine, WebMD, http://www.webmd.com/children/vaccines/meningococcal-vaccine (last visited Feb. 20, 2015). DISCUSSION To satisfy their burden of proving causation in fact, petitioners must prove by preponderant evidence: “(1) a medical theory causally connecting the vaccination and the injury; (2) a logical sequence of cause and effect showing that the vaccination was the reason for the injury; and (3) a showing of a proximate temporal relationship between vaccination and injury.” Althen v. Sec’y of HHS, 418 F.3d 1274, 1278 (Fed. Cir. 2005). In Althen, the Federal Circuit quoted its opinion in Grant v. Secretary of Health and Human Services, 956 F.2d 1144, 1148 (Fed. Cir. 1992): 4 Case 1:14-vv-00932-UNJ Document 15 Filed 03/13/15 Page 5 of 5 A persuasive medical theory is demonstrated by “proof of a logical sequence of cause and effect showing that the vaccination was the reason for the injury[,]” the logical sequence being supported by a “reputable medical or scientific explanation[,]” i.e., “evidence in the form of scientific studies or expert medical testimony[.]” 418 F.3d at 1278. Without more, “evidence showing an absence of other causes does not meet petitioners’ affirmative duty to show actual or legal causation.” Grant, 956 F.2d at 1149. Mere temporal association is not sufficient to prove causation in fact. Id. at 1148. Petitioners must show not only that but for hepatitis A and Menactra vaccinations, J.O. would not have Crohn’s disease or significant aggravation of his Crohn’s disease, but also that the vaccines were a substantial factor in causing or significantly aggravating his Crohn’s disease. Shyface v. Sec’y of HHS 165 F.3d 1344, 1352 (Fed. Cir. 1999). The Vaccine Act does not permit the undersigned to rule for petitioners based on their claims alone, “unsubstantiated by medical records or by medical opinion.” 42 U.S.C. § 300aa- 13(a)(1). In this case, J.O.’s medical records do not substantiate petitioners’ claims. Moreover, petitioners have not filed an expert medical opinion substantiating their claims. The undersigned GRANTS petitioners’ motion to dismiss and DISMISSES this case for petitioners’ failure to prove by a preponderance of the evidence the matters required in the petition. 42 U.S.C. § 300aa-13(a)(1). CONCLUSION This petition is DISMISSED. In the absence of a motion for review filed pursuant to RCFC, Appendix B, the clerk of the court is directed to enter judgment herewith.2 IT IS SO ORDERED. February 20, 2015 s/Laura D. Millman DATE Laura D. Millman Special Master 2 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party, either separately or jointly, filing a notice renouncing the right to seek review. 5 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_14-vv-00932-1 Date issued/filed: 2015-05-13 Pages: 2 Docket text: PUBLIC DECISION (Originally filed: 04/14/2015) regarding 21 DECISION Fees Stipulation/Proffer Signed by Special Master Laura D Millman. (tlj) Copy to parties. -------------------------------------------------------------------------------- Case 1:14-vv-00932-UNJ Document 25 Filed 05/13/15 Page 1 of 2 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 14-932V Filed: April 14, 2015 Not for Publication ************************************* J.O., a Minor, by his Parents, * DEBI OLIVEIRA and TONY OLIVEIRA, * * Petitioners, * Attorneys’ fees and costs decision based on * stipulation of fact v. * * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * ************************************* William E. Cochran, Jr., Memphis, TN, for petitioners. Lisa A. Watts, Washington, DC, for respondent. MILLMAN, Special Master DECISION AWARDING ATTORNEYS’ FEES AND COSTS1 On April 14, 2015, the parties filed a stipulation of fact in which they agreed on an appropriate amount for attorneys’ fees and costs in this case. In accordance with the General Order #9 requirement, petitioners assert that they did not incur any costs in pursuit of their petition. Petitioners submitted their request for attorneys’ fees and costs to respondent. Petitioners request $15,201.40 in attorneys’ fees and costs, consisting of $12,454.50 in attorneys’ fees and 1 Because this unpublished decision contains a reasoned explanation for the special master’s action in this case, the special master intends to post this unpublished decision on the United States Court of Federal Claims’s website, in accordance with the E-Government Act of 2002, Pub. L. No. 107-347, 116 Stat. 2899, 2913 (Dec. 17, 2002). Vaccine Rule 18(b) states that all decisions of the special masters will be made available to the public unless they contain trade secrets or commercial or financial information that is privileged and confidential, or medical or similar information whose disclosure would constitute a clearly unwarranted invasion of privacy. When such a decision is filed, petitioner has 14 days to identify and move to redact such information prior to the document=s disclosure. If the special master, upon review, agrees that the identified material fits within the banned categories listed above, the special master shall redact such material from public access. Case 1:14-vv-00932-UNJ Document 25 Filed 05/13/15 Page 2 of 2 $2,746.90 in attorneys’ costs. Respondent does not object to this amount. The undersigned finds this amount to be reasonable. Accordingly, the Court awards $15,201.40, representing reimbursement for attorneys’ fees and costs. The award shall be in the form of a check payable jointly to petitioners and Black McLaren Jones Ryland & Griffee, P.C. in the amount of $15,201.40. In the absence of a motion for review filed pursuant to RCFC Appendix B, the clerk of the court is directed to enter judgment herewith.2 IT IS SO ORDERED. Dated: April 14, 2015 s/ Laura D. Millman Laura D. Millman Special Master 2 Pursuant to Vaccine Rule 11(a), entry of judgment can be expedited by each party, either separately or jointly, filing a notice renouncing the right to seek review. 2