VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_17-vv-00203 Package ID: USCOURTS-cofc-1_17-vv-00203 Petitioner: L.P. Filed: 2017-02-10 Decided: 2017-11-21 Vaccine: DTaP and rotavirus Vaccination date: 2014-02-11 Condition: gastrointestinal injuries / unsupported significant-aggravation claim Outcome: dismissed Award amount USD: AI-assisted case summary: On February 10, 2017, Mary Petty, as parent and natural guardian of her infant son L.P., filed a petition under the National Childhood Vaccine Injury Act. The petition alleged that the diphtheria-tetanus-acellular pertussis (DTaP) and rotavirus vaccines administered on February 11, 2014, when L.P. was two months old, caused gastrointestinal injuries and subsequent complications. Petitioner was represented by Amy A. Senerth. Respondent was represented by Ilene C. Albala. Pre-vaccination medical records indicated that L.P. had experienced gastrointestinal issues. On December 26, 2013, his mother reported green stools, fussiness, and gas after feedings. By January 10, 2014, L.P. was excessively fussy, uncomfortable after feedings, cried for feedings, spat up, had wet burps, and arched during feedings. He was diagnosed with gastroesophageal reflux disease (GERD). On January 29, 2014, L.P. was still uncomfortable, spitting up, gassy, and had a speck of blood in his diaper. He was treated with Zantac and Pepcid, and his mother adjusted her diet. Dr. Tracy Lim diagnosed GERD and suggested dietary changes for the breastfeeding mother. On February 11, 2014, L.P. was doing better, not spitting up or being fussy, and received the DTaP and rotavirus vaccines. The following evening, L.P. was taken to the Cleveland Clinic emergency department for vomiting, choking, lethargy, decreased appetite, and green liquid stool. An examination revealed L.P. was active and alert with no abdominal distention, tenderness, or guarding, and a pyloric ultrasound was normal. Dr. Brian P. Wood diagnosed nausea and/or vomiting. By February 13, vomiting had stopped, though fussiness and loose stools continued. Dr. Lim diagnosed fussiness, diarrhea, and GERD, suggesting L.P. might have had a viral illness. Later medical records showed varied symptom duration and significance. A March 13, 2014 note stated vomiting and diarrhea lasted one day, and green diarrhea lasted two weeks. At an April 16, 2014 visit, L.P.'s elimination and sleep were normal, though stool testing showed blood. Gastroenterologist Dr. Rita Steffen discussed reflux, cow's milk protein allergy, and the natural history of infant reflux, noting negative abdominal imaging. In November 2015, an allergist recorded a history that L.P. had diarrhea for six months after his two-month immunizations, but other records indicated he had not experienced continued diarrhea, failure to thrive, or severe infections after the alleged vaccine reaction. Various other specialists, including Dr. Rajeev Kishore, Dr. Sara M. Bohac, CNP Lydia Glaude, Dr. Mona G. Rifka, Dr. Jaclyn Bjelac, Dr. Thomas E. Phelps, and Dr. Lori Mahajan, evaluated L.P. for various gastrointestinal, allergic, and respiratory issues over the following years. On November 20, 2017, petitioner filed a Motion for a Decision Dismissing her Petition, stating she would be unable to prove entitlement to compensation and that proceeding further would be unreasonable. Special Master Laura D. Millman granted the motion and dismissed the petition on November 21, 2017, finding that the medical records did not support the allegations and that petitioner had not filed a medical expert opinion. Special Master Millman noted that the records did not show a vaccine injury lasting more than six months and that, given L.P.'s pre-existing GERD and feeding issues, petitioner would need to allege significant aggravation and show substantial deterioration. Petitioner subsequently sought attorneys' fees and costs. Special Master Millman denied the request, finding no reasonable basis for the claim. Senior Judge Victor J. Wolski reviewed this denial. On October 23, 2020, Judge Wolski issued an opinion sustaining the Special Master's denial. The court held that the medical records did not support the claim that L.P.'s immediate vomiting and diarrhea lasted six months, that later gastrointestinal complaints had to be evaluated against pre-existing GERD and feeding issues, and that a looming statute-of-limitations deadline did not create a reasonable basis for an otherwise unsupported claim. No compensation or fees were awarded. Theory of causation field: Petitioner Mary Petty, on behalf of her infant son L.P., alleged that DTaP and rotavirus vaccines administered on February 11, 2014, at two months of age, caused gastrointestinal injuries and subsequent complications. The petition was dismissed by Special Master Laura D. Millman on November 21, 2017, upon petitioner's motion, due to insufficient proof and lack of a medical expert opinion. Pre-vaccination records showed L.P. had GERD, green stools, fussiness, and gas. Post-vaccination, L.P. experienced vomiting and diarrhea, which the Special Master found did not last more than six months. Later gastrointestinal issues were evaluated against pre-existing conditions. Petitioner's subsequent request for attorneys' fees and costs was denied by the Special Master and affirmed by Senior Judge Victor J. Wolski on October 23, 2020, who found no reasonable basis for the claim, noting that a looming statute of limitations deadline did not establish such a basis. Attorneys for petitioner were Amy A. Senerth and Muller Brazil, LLP. Respondent was represented by Ilene C. Albala and later Voris E. Johnson, Jr., et al. No compensation or fees were awarded. Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_17-vv-00203-0 Date issued/filed: 2017-12-18 Pages: 9 Docket text: PUBLIC DECISION (Originally filed: 11/21/2017) regarding 18 DECISION of Special Master Signed by Special Master Laura D Millman. (tlf) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-00203-VJW Document 20 Filed 12/18/17 Page 1 of 9 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 17-203V Filed: November 21, 2017 Not to be Published. ************************************* L.P., by and through his parent and * natural guardian, MARY PETTY, * * Petitioner, * * DTaP and Rotavirus vaccines; v. * GI injuries; no proof of causation; * petitioner moves to dismiss SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * ************************************* Amy A. Senerth, Dresher, PA, for petitioner. Ilene C. Albala, Washington, DC, for respondent. MILLMAN, Special Master DECISION1 On February 10, 2017, petitioner filed a petition under the National Childhood Vaccine Injury Act, 42 U.S.C. § 300aa-10-34 (2012), alleging that diphtheria, tetanus, and acellular pertussis (“DTaP”) and Rotavirus vaccines administered on February 11, 2014 to her son L.P. when he was two months old caused him gastrointestinal injuries and subsequent complications. Pet. Preamble and ¶¶ 4-20. On November 20, 2017, petitioner filed a Motion for a Decision Dismissing her Petition. She states that “she will be unable to prove that she is entitled to compensation in the Vaccine 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’ website, in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 note (2012) (Federal Management and Promotion of Electronic Government Services). 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 1:17-vv-00203-VJW Document 20 Filed 12/18/17 Page 2 of 9 Program” and that “to proceed further would be unreasonable and would waste the resources” of the court, respondent, and the Vaccine Program. Pet’r’s Mot. at 1. The undersigned GRANTS petitioner’s Motion for a Decision Dismissing her Petition and DISMISSES this case. FACTS Medical Records Prevaccination Records On December 26, 2013, L.P. saw Dr. Mary Anne Murphy, a pediatrician. Med. recs. Ex. 2, at 7. Petitioner told Dr. Murphy that L.P.’s stools were green, and he seemed fussy and gassy after a feeding. Id. On January 10, 2014, L.P. saw Dr. Murphy again. Id. at 17. Petitioner told Dr. Murphy that L.P. was excessively fussy. Dr. Murphy had seen L.P. the day before when petitioner told Dr. Murphy about L.P.’s stooling and gassiness. Id. at 11. Over the past few weeks, L.P. had been very fussy. Especially after feedings, he seemed very uncomfortable. Id. He cried for feedings, would spit up after feedings, had wet burps, and arched during feedings. Id. at 17. Dr. Murphy diagnosed L.P. with gastroesophageal reflux (“GERD”). Id. at 18. On January 29, 2014, L.P. saw Dr. Tracy Lim, a pediatrician. Id. at 21. Petitioner brought L.P. to see the doctor for her to evaluate his stomach issues. Around four weeks of age, L.P. was arching his back during feedings and seemed uncomfortable. He spat up frequently both immediately after and an hour after feeding. He was much fussier than he used to be. L.P. was started on Zantac,2 but after a week, it did not seem to help. Petitioner took L.P to an urgent care facility which changed his treatment to Pepcid,3 but L.P. seemed wheezy after that. Petitioner took him to the emergency room, which switched him back to Zantac. He seemed a little less fussy afterward, but was gassy. Petitioner gave L.P. Mylicon gas drops, but they did not help. She also used gripe water, which helped a little. On January 27 and 28, 2014, L.P. had a speck of blood in his diaper. Id. Dr. Lim’s diagnosis was GERD. Id. at 22. Dr. Kim suggested switching L.P. back to Pepcid and eliminating milk products and cruciferous vegetables from petitioner’s diet since she was breastfeeding L.P. Id. 2 Zantac is a “trademark for preparations of ranitidine hydrochloride.” Dorland’s Illustrated Medical Dictionary 2091 (32nd ed. 2012) (hereinafter, “Dorland’s.”). Ranitidine hydrochloride is “used to inhibit gastric acid secretion in the prophylaxis and treatment of gastric and duodenal ulcer, gastroesophageal reflux disease, and conditions that cause gastric hypersecretion . . . .” Id. at 1592. 3 Pepcid is a “trademark for preparations of famotidine.” Dorland’s at 1408. Famotidine is “a histamine H receptor antagonist; it inhibits gastric acid secretion and is used in the prophylaxis and treatment of 2 peptic ulcer, the relief of symptoms associated with hyperacidity, and the treatment of gastroesophageal reflux disease . . . .” Id. at 678. 2 Case 1:17-vv-00203-VJW Document 20 Filed 12/18/17 Page 3 of 9 On February 11, 2014, L.P. saw Dr. Lim, who tested L.P.’s stool for blood. Id. at 26, 28. L.P. had been on Alimentum and petitioner had eliminated milk products from her diet. Id. at 26. L.P. was doing much better and was not spitting up or being fussy. He was on Pepcid. Petitioner had tried a Similac supplement, but L.P. had blood in his stool. She did not notice any more blood since eliminating milk products from her diet. Id. Petitioner was still breastfeeding L.P., with occasional Nutramigen supplements if she had to go out. Id. at 27. L.P. received DTaP and Rotavirus vaccines. Id. Postvaccination Records On February 12, 2014, L.P. went to the Emergency Department of Cleveland Clinic and saw Dr. Brian P. Wood. Id. at 66. L.P.’s parents said that L.P. was vomiting and choking starting at 8:15 p.m. He was lethargic and had a decreased appetite since he received Rotavirus vaccine. Per L.P.’s father, L.P. had two to three large projectile white vomits that evening and medium liquid green stool in his diaper. Id. L.P. had a history of GERD. Id. On a physical examination at 10:27 p.m., L.P. was active and alert. Id. at 67. His temperature was 99.5 degrees rectally. His stomach had no distension, tenderness, or guarding. An ultrasound was done of the pyloric channel. The results were normal. L.P. did not have hypertrophic pyloric stenosis or narrowing. Id. Dr. Wood’s diagnosis was nausea and/or vomiting. Id. On February 21, 2014, L.P. saw Dr. Lim. Id. at 34. Petitioner said that after L.P. received Rotavirus and DTaP vaccines, he slept most of the day. He was a little fussy and had some loose stools. On February 12, 2014, he was very fussy and started to vomit. Petitioner took him to the ER and he vomited multiple times. He had a normal pyloric examination in the ER. On February 13, 2014, which was the next day, L.P. stopped vomiting, but continued to be fussy and have loose stools. He had a history of GERD and an allergy to milk. He was taking famotidine (Pepcid) daily. Id. Dr. Lim thought L.P. might have had a viral illness and increased his dosage of Pepcid. Id. at 35. Dr. Lim diagnosed L.P. with fussiness, diarrhea, and GERD. Id. Nursing notes state L.P. was content, relaxed, and lying quietly. Id. at 37. Petitioner filed as part of the medical records a typed note dated March 13, 2014. Med. recs. Ex. 3, at 9. She states that she took L.P. to an herbalist and gave him digestive bitters tonic (called Nature’s Sunshine), licorice root, colic calm homeopathic, and Pepcid. It was hard to tell if these things were helping. Some days, L.P. was fussy and gassy and pulled his knees to his chest. Since he became three months of age, his diapers were not as “mucousy.” Id. She also states that L.P. got the DTaP and Rotavirus vaccines on February 11, 2014 and, the next day, he was in the ER with vomiting and diarrhea that lasted for a day. He was soaking his clothes with vomit. But the next day he was not vomiting any more. He had green diarrhea for two weeks after that and slept for two days straight. Id. On April 16, 2014, L.P. returned to Dr. Lim. Med. rec. Ex. 2, at 39. Petitioner wondered if L.P. were teething. L.P. was still breastfeeding, but no longer tolerating Nutramigen supplements. Id. L.P. did not have any tooth eruption. Id. at 40. He was normal in elimination and petitioner had no concerns. He was normal in sleeping and petitioner had no concerns. L.P. 3 Case 1:17-vv-00203-VJW Document 20 Filed 12/18/17 Page 4 of 9 cooed, laughed, tracked objects to 180 degrees, responded to sounds, reached for objects, had a good grasp, played with his hands, had good head support, lifted on his arms, rolled from front to back and from back to front, played with his feet, and lifted his head when in a prone position. L.P. was alert, active, and in no apparent distress. Id. Dr. Lim noted that L.P.’s stools were guaiac positive4 and he had hematochezia5 on testing. Id. at 41, 44, 46. The doctor would check his stool at the next visit and, if it were still positive, refer L.P. to a gastroenterologist. Id. at 41. On April 23, 2014, L.P. and petitioner went to the Cleveland Clinic Pediatric Nutrition section for diet education and petitioner spoke with Tara Harwood. Id. at 50. L.P. had a history of fussiness. Petitioner was giving vitamin D to L.P., but stopped because he did not tolerate it. Petitioner eliminated soy as well as cow’s milk from her diet. Id. On the same day, L.P. saw gastroenterologist Dr. Rita Steffen for a consultation. Id. at 52. Petitioner told Dr. Steffen that on April 22, 2014, she had taken L.P. to Rainbow Babies and Children’s Emergency Room because of his screaming. He had an x-ray and an ultrasound of his abdomen. At about six weeks of age (i.e., prevaccination), L.P. was prescribed Zantac because he was coughing, gagging, and had symptoms of reflux. Zantac made no difference and petitioner discontinued eating dairy and soy. At seven weeks, Dr. Lim did a stool test which was negative for occult blood. L.P. received vaccines against DPaT and Rotavirus at two months of age and petitioner felt he had more symptoms after that. He had “a lot of vomiting, soaked his clothes with emesis and then diarrhea.” Id. L.P. had 10-12 stools a day. Petitioner felt L.P. was sensitive to many things in her diet and he had yellow globs of mucus in his stool. Some stools were green and watery and soaked into his diaper. Id. Petitioner felt L.P. was sensitive to corn syrup, soy, and gluten. Petitioner eliminated them from her diet because she was still breastfeeding. She lost about 90 pounds from not only giving birth but also changing her diet. She gave L.P. rice cereal on April 22, 2014 and he produced a greenish soft stool that day with no blood in it. Petitioner was very concerned because there was a dot of blood in his stool one time. She worried it would cause long-term damage to his intestines if the doctor missed something that might be damaging his intestines. L.P. spent time sleeping on an inclined angle. When L.P. woke up, he screamed as if in pain. Petitioner stopped his Pepcid because she thought it was not making a difference. Id. at 52-53. L.P. did not have any rash or eczema. Id. at 53. His stool frequency used to be six to seven per day and then changed within the last few weeks to having one stool every day or every other day. He also had a stuffy nose intermittently and petitioner wondered if reflux might be behind that. Petitioner said that L.P. had deep suctioning after delivery and she was concerned that the suctioning may have disturbed or made a problem in his throat or pharynx. He was partly tongue-tied and had laser surgery on his lip. Petitioner herself has hypertension and reflux. Petitioner was giving L.P. a probiotic daily. Id. She said she was on Nexium6 in college and it “messed up” her gastrointestinal tract and she had to be on probiotics. Id. 4 Guiaic is a wood resin used as a reagent in testing for occult blood. Dorland’s at 809. 5 Hematochezia is the “presence of blood in feces.” Dorland’s at 831. 6 Nexium is a “trademark for a preparation of esomeprazole magnesium.” Dorland’s at 1275. Esomeprazole magnesium is “proton pump inhibitor used as a gastric acid secretion inhibitor in the treatment of symptomatic gastroesophageal reflux disease . . . .” Id. at 647. 4 Case 1:17-vv-00203-VJW Document 20 Filed 12/18/17 Page 5 of 9 Dr. Steffen’s impression was that L.P. was a four-month-old baby boy with some symptoms of reflux. Dr. Steffen spoke to petitioner about the natural history of reflux, including that it can actually be worse between the ages of four and six months. Petitioner replied that her internet reading about GERD said it should be cleared up by four months. Petitioner was concerned that if she saw a dot of blood that L.P. may have long-term damage to his intestines. Dr. Steffen spent time reassuring her and answering questions. Id. Dr. Steffen discussed the natural history of reflux, cow’s milk, protein allergy, and how to deal with them. Id. at 53-54. At Rainbow Babies, a kidneys, ureters, and bladder (“KUB”) x-ray was done to rule out obstruction. An ultrasound of L.P.’s abdomen was done to rule out telescoping or intussusception. All results were negative. On examination, L.P.’s abdomen was soft and non- tender. He had two hemoccult7 tests done with one result on April 16, 2014 positive and one result negative. Id. On November 2, 2015, L.P. saw Dr. Rajeev Kishore at Akron Children’s Hospital for a second opinion. Med. recs. Ex. 3, at 1. An allergist at University Hospitals diagnosed L.P. with a milk allergy and allergy to ragweed. His initial test was done at five months of age and repeated at 11 months of age. L.P. was a refluxing and colicky baby. He had a rash on his cheeks and the dorsal aspects of his knees. He had a slight rash on his ears. He had a mild speech delay. At the age of two months, he was vaccinated and had diarrhea lasting six months. Id. L.P.’s skin tests to milk, soy, wheat, corn, and peanuts were all negative. Id. at 3. Dr. Kishore suggested adding wheat, corn, and soy to L.P.’s diet, but waiting to add peanut and milk. He diagnosed L.P. with mild eczema and food intolerance. Id. On February 2, 2016, L.P. saw Dr. Sara M. Bohac, a pediatrician, for an upper respiratory infection. Med. recs. Ex. 2, at 72. Petitioner said L.P. had a change in appetite, congestion, coryza, cough, irritability, and malaise. The onset was two days previously. However, he had had an upper respiratory infection intermittently since November 2015. Sometimes, he had shortness of breath. Physical examination was negative for sore throat, ear drainage, emesis, diarrhea, or headache. He was alert and active in no apparent distress. Id. On March 25, 2016, L.P. went to Express Care to see CNP Lydia Glaude for an evaluation of his right ear. Id. at 88. He had a cough and runny nose and was fussy. Petitioner was still breastfeeding and discovered she had thrush which was treated with gentian violet. L.P. was treated with the same. Petitioner told CNP Glaude that the last time L.P. was treated for an ear infection, he developed severe diarrhea and had a very difficult time accepting medicine. Id. On March 31, 2016, L.P. saw Dr. Mona G. Rifka, a pediatrician, to follow up on his pneumonia for which he was seen earlier that week. Id. at 100. He just completed a course of Zithromax and was doing better. Petitioner said L.P. had always had an issue with emesis while eating and might have an exaggerated gag reflex but petitioner was not sure. They saw an ENT but there were no findings. When L.P. was an infant, they saw a gastroenterologist because of 7 Hemoccult is “trademark for a modification of the guiaic test for occult blood, in which guaiac-impregnated filter paper is used; the test is positive if the specimen turns blue.” Dorland’s at 838. 5 Case 1:17-vv-00203-VJW Document 20 Filed 12/18/17 Page 6 of 9 L.P.’s fussiness and “possible silent reflux.” Id. L.P. seemed to choke on food and throw up. An OT saw him also and found nothing wrong. Id. On April 28, 2016, L.P. saw Dr. Jaclyn Bjelac, an Allergy and Immunology Fellow, for evaluation of a food allergy. Id. at 108. Petitioner told Dr. Bjelac that L.P. had a diarrheal illness lasting two weeks after his two-month vaccinations. She said that following this, L.P. seemed very intolerant to “all” foods, with severe reflux and colic, requiring her to start a paleo diet while breastfeeding with some improvement. Dr. Hostoffer tested L.P. at six months and L.P. was positive for milk, but negative to peanut, soy, corn, and multiple other foods. Repeat skin testing at one year showed continued sensitivity to milk plus ragweed. At 23 months, L.P. underwent additional testing at Akron Children’s Hospital with Dr. Rajeev Kishore. Id. Test results were negative to milk, soy, wheat, corn, and peanut. L.P. had been tolerating all these foods except for whole milk, which he refused. Petitioner stated, however, that L.P.’s eczema recently worsened in the context of more frequent upper respiratory symptoms and she decided to eliminate gluten, dairy, and soy from L.P.’s diet. Petitioner was most concerned that these foods worsened his eczema, particularly on his face and ears, as well as his perennial rhinorrhea and intermittent cough since January 2016. L.P. used Claritin as needed which appeared to relieve some of these symptoms. L.P. currently took a bath or had a shower one to two times a week, followed by eczema relief lotion over his full body and once on his face when he did not take a bath or shower. Petitioner applied hydrocortisone 1% cream once or twice weekly at L.P.’s bedtime. Petitioner wanted to know more about L.P.’s eczema and why he was getting infections. Id. L.P. had not had any continued diarrhea, failure to thrive, or severe infections since he had severe diarrhea at age two months after his alleged reaction to vaccines. Id. L.P. did not have a history of asthma, drug allergy, venom allergy, or other allergic complaints. Id. On a physical examination, L.P. had yellow nasal drainage. Id. at 110. He had erythematous eczematous plaques over his cheeks bilaterally and the folds of his ears. Dr. Bjelac’s assessment was that L.P.’s inhalant skin testing was negative. She told petitioner that there was no concern for immunodeficiency despite L.P.’s reaction to Rotavirus vaccine at two months because he had no other concerning history since then of having a congenital combined immunodeficiency disorder (“SCID”)-type immunodeficiency that would have increased his risk for a rotavirus reaction. Id. Dr. Bjelac reviewed dry skin care at length with petitioner and suggested use of Fluticasone8 topical ointment to affected areas. Id. On May 4, 2016, L.P. saw Dr. Thomas E. Phelps, a pediatrician, who noted L.P. was a two-year-old with a long history of sensitivity to diet and diarrhea. Id. at 117. L.P. had loose stools over weeks and intolerance in the early months of life to maternal foods. He gained weight all right and had three to four loose bowel movements a day. On a physical examination, he had congestion. He was in no distress. Id. Dr. Phelps diagnosed L.P. with diarrhea, food allergy, and other allergic rhinitis. Id. at 118. 8 Fluticasone propionate is “a synthetic corticosteroid used topically as an anti-inflammatory and antipruritic in treatment of corticosteroid-responsive dermatoses . . . .” Dorland’s at 722. 6 Case 1:17-vv-00203-VJW Document 20 Filed 12/18/17 Page 7 of 9 On June 4, 2011, L.P. saw Dr. Phelps with a history of vomiting which had been a cyclic pattern. Id. at 131. He was seen in the emergency department with no obvious diagnosis and was there to follow up. He was better that day. Id. Dr. Phelps diagnosed L.P. with cyclical vomiting associated with migraine and prescribed cyproheptadine9 (also known as Zofran) if vomiting were noted early, and ondansetron10 (also known as Periactin) as prevention over a month. Id. On June 21, 2016, L.P. saw Dr. Lori Mahajan, a pediatric gastroenterologist, at Cleveland Clinic. Id. at 146. Petitioner sought Dr. Mahajan’s evaluation and management of L.P.’s intermittent emesis. Petitioner said L.P. developed reflux within the first several months of life. He was put on Zantac for several weeks and then switched to Pepcid. He was taken off acid suppression therapy by the age of six months. Petitioner said that both an upper gastroenterology series and a modified barium swallow were done at University Hospitals when L.P. was between six to eight months, and the results were normal. During L.P.’s infancy, petitioner tried various formulas including amino acid-based formulas. L.P. was now two years old and his mother continued to breastfeed him. She remained on a paleo diet (free of milk, soy, and grain). When he was about eight months of age, she started L.P. on solids. Petitioner said L.P. had a prior RAST11 test that was positive for milk protein. However, the RAST test was recently repeated and was negative. L.P. continued to breastfeed at night and used a pacifier throughout the appointment with Dr. Mahajan. He drank water throughout the day and was on a calcium supplement. He was a selective eater. Petitioner maintained him on an essentially gluten-free diet. He ate bread without difficulty and occasionally bananas. Id. Petitioner said L.P. was overall doing fairly well until they moved into a new home in January 2016. Id. After the move, L.P. had several episodes of recurrent nocturnal emesis (three episodes in January, two in February, and one in three subsequent months). He reportedly seemed somewhat more lethargic in the hours after these episodes, but was completely normal between these episodes. Emesis typically occurred between 2:00 and 6:00 a.m. It was not associated with any particular foods, activities, or psychosocial stressors. Petitioner did not think it was correlated with any infection or illness. Id. L.P.’s primary care physician suspected that L.P. might have cyclic vomiting syndrome. Id. at 146-47. L.P. was started on cyproheptadine three weeks earlier. Id. at 147. When petitioner gave L.P. the first dose, he was excessively sedated. Since then, she gave him a significantly reduced dose. L.P.’s stools are variable. He often has loose stools multiple times a day. He does not have any blood in his stool. L.P. had done well developmentally, and had a mild speech delay, but no motor delays. He had viral pneumonia in March 2016, but no aspiration pneumonia. He had recurrent episodes of otitis 9 Cyproheptadine hydrochloride is “an antihistamine (H receptor antagonist) with sedative, 1 anticholinergic, serotonin-blocking, and calcium channel-blocking effects; used in the treatment of allergic rhinitis, allergic conjunctivitis, and cutaneous and systemic manifestations of allergic reactions, and the prophylaxis of migraine . . . .” Dorland’s at 457. 10 Ondansetron hydrochloride is “an antiemetic used for prevention of nausea and vomiting . . . .” Dorland’s at 1321. 11 RAST is an acronym for “radioallergosorbent test.” Dorland’s at 1593. 7 Case 1:17-vv-00203-VJW Document 20 Filed 12/18/17 Page 8 of 9 media, upper respiratory tract infections, and cough since January. Petitioner said she was a nanny for several children who have recurrent illnesses and attributed L.P.’s persistent symptoms to this. L.P. had an erythematous facial rash over both cheeks that was diagnosed as eczema. No therapies had helped. Petitioner did not think the rash correlated to any particular food ingestion, but questioned if L.P. could have a food allergy. Id. Dr. Mahajan noted that L.P.’s paternal grandmother had many gastrointestinal issues. Id. at 152. She agreed with L.P.’s primary care physician that L.P’s intermittent episodes of emesis followed by fatigue could represent a chronic vomiting syndrome. If the episodes became more frequent or were associated with neurologic symptoms, she recommended petitioner consult with a pediatric neurologist. Meanwhile, she recommended L.P. continue with cyproheptadine and that petitioner increase L.P.’s dosage. Dr. Mahajan also said that L.P.’s current stooling pattern might represent toddler’s diarrhea and recommended she limit L.P.’s fluid to 40-45 ounces a day. She also advised petitioner to eliminate L.P.’s use of a pacifier as it increased air in L.P.’s gastrointestinal tract and might make him feel full or interfere with dentition and speech. Dr. Mahajan also recommended that petitioner give L.P. fluid only in a sippy cup when traveling to prevent him from drinking too much. Dr. Mahajan said L.P.’s facial rash was most consistent with keratosis pilaris12 rubra. Id. DISCUSSION To satisfy her burden of proving causation in fact, petitioner 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): A persuasive medical theory is demonstrated by “proof of a logical sequence of cause of 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 petitioner’s 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. Petitioner must show not only that but for DTaP and Rotavirus vaccines, L.P. would not have had gastrointestinal conditions and subsequent complications, but also that DTaP and 12 Keratosis pilaris is “a common, benign condition in which hyperkeratosis occurs around hair follicles ....” Dorland’s at 982. 8 Case 1:17-vv-00203-VJW Document 20 Filed 12/18/17 Page 9 of 9 Rotavirus vaccines were substantial factors in causing L.P.’s gastrointestinal conditions and subsequent complications. Shyface v. Sec’y of HHS, 165 F.3d 1344, 1352 (Fed. Cir. 1999). The Vaccine Act, 42 U.S.C. § 300aa-13(a)(1), prohibits the undersigned from ruling for petitioner based solely on her allegations unsubstantiated by medical records or medical opinion. The medical records do not support petitioner’s allegations. She has not filed a medical expert opinion in support of her allegations. Petitioner moves for a dismissal of her petition. The undersigned GRANTS petitioner’s motion and DISMISSES this petition. CONCLUSION The petition is DISMISSED. In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of Court is directed to enter judgment herewith.13 IT IS SO ORDERED. Dated: November 21, 2017 /s/ Laura D. Millman Laura D. Millman Special Master 13 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. 9 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_17-vv-00203-2 Date issued/filed: 2020-10-23 Pages: 11 Docket text: JUDGE VACCINE REPORTED OPINION re: 34 Order on Motion for Review, Judge Vaccine Order/Opinion Signed by Senior Judge Victor J. Wolski. (jad) Service on parties made. -------------------------------------------------------------------------------- Case 1:17-vv-00203-VJW Document 36 Filed 10/23/20 Page 1 of 11 In the United States Court of Federal Claims No. 17-203V (Filed under seal October 8, 2020) (Reissued October 23, 2020)† * * * * * * * * * * * * * * * * * * * * * * * * * L.P., by and through his parent * Vaccine Act; voluntary dismissal; and natural guardian, MARY * attorneys’ fees and costs, 42 U.S.C. PETTY, * § 300aa-15(e)(1); reasonable basis * standard; preexisting condition; Petitioner, * failure to plead significant * aggravation; looming statute of v. * limitations deadline; Simmons v. * Secretary decision. SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * Amy A. Senerth, Muller Brazil, LLP, Dresher, Pa., for the petitioner. Voris E. Johnson, Jr., Senior Trial Attorney, Torts Branch, Civil Division, Department of Justice, with whom were Chad A. Readler, Acting Assistant Attorney General, C. Salvatore D’Alessio, Acting Director, and Catharine E. Reeves, Deputy Director, all of Washington, D.C., for the respondent. MEMORANDUM OPINION AND ORDER WOLSKI, Senior Judge. Petitioner Mary Petty has moved for review, pursuant to 42 U.S.C. § 300aa- 12(e), of a special master’s decision denying an award of attorneys’ fees and costs. The request for fees and costs was filed after petitioner had acknowledged an inability to prove an entitlement to compensation and moved for the dismissal of † Pursuant to Vaccine Rule 18(b) of the Rules of the United States Court of Federal Claims, the parties were given fourteen calendar days in which to object to the public disclosure of information contained in this opinion prior to its publication. No objection has been filed. Accordingly, the opinion is reissued for publication with some minor typographical and grammatical corrections. Case 1:17-vv-00203-VJW Document 36 Filed 10/23/20 Page 2 of 11 her petition. After a review of the record, the Special Master concluded that no reasonable basis existed for filing the claim against the Secretary of Health and Human Services (Secretary). L.P. v. Sec’y of Health & Human Servs., No. 17-203V, 2018 WL 1044952, at *3 (Fed. Cl. Spec. Mstr. Jan. 30, 2018) [hereinafter Fees Decision]. Thus, the Special Master declined to award petitioner’s counsel fees and costs per 42 U.S.C. § 300aa-15(e)(1). For the reasons that follow, petitioner’s motion for review is DENIED and the Special Master’s decision is SUSTAINED. I. BACKGROUND Petitioner filed the petition on behalf of her infant son, L.P., on February 10, 2017. See Pet., ECF No. 1. The petition sought compensation “for gastrointestinal injuries, and subsequent complications” which L.P. suffered, allegedly as a result of receiving two vaccinations on February 11, 2014, when he was two months old---the diphtheria, tetanus, and acellular pertussis (DTaP) and rotavirus vaccinations. Id. at 1 & ¶¶ 2, 8. The petition described L.P.’s health problems and medical visits through June 21, 2016, see id. ¶¶ 4–19, and was accompanied by 229 pages of medical records from the Cleveland Clinic and Akron Children’s Hospital, Pet. Exs. 1–3, ECF Nos. 1-4 through 1-6. On the same day that the petition was filed, Ms. Petty also filed a statement indicating that she believed “all relevant medical records had been filed.” Statement of Completion, ECF No. 4. On May 5, 2017, three days before the scheduled initial status conference, the special master assigned to the case filed an order informing the parties of her assessment of the medical records submitted by petitioner. Order (May 5, 2017), ECF No. 8 [hereinafter Records Order]. The Special Master stated she “fails to see that if L.P. had any vaccine injury, it lasted more than six months” and added that “since L.P. had gastroesophageal reflux disease, green stools, fussiness, and gas before he received his vaccination, petitioner would need to amend her petition to allege significant aggravation.” Id. at 1. Referencing the definition of significant aggravation from the Vaccine Act, 42 U.S.C. § 300aa-33(4), she noted that she “does not see a substantial deterioration of health in these records.” Id. The Special Master then accurately discussed the state of L.P.’s health as reflected in the filed records, the significant portions of which are summarized below. The medical records indicated that L.P. had suffered from gastrointestinal problems since shortly after his birth. On December 26, 2013, when he was a few weeks old, L.P. visited his pediatrician and petitioner reported his fussiness, gassiness following feedings, and green stools. Id. at 1–2; see Pet. Ex. 2 at 7. On January 10, 2014, L.P.’s doctor diagnosed him with “gastroesophageal reflux [disease] (‘GERD’).” Records Order at 2; Pet. Ex. 2 at 17–18. A few weeks later, on January 29, 2014, petitioner brought L.P. to see another pediatrician because of continuing stomach issues that had previously necessitated visits to an urgent care - 2 - Case 1:17-vv-00203-VJW Document 36 Filed 10/23/20 Page 3 of 11 facility and an emergency room. Records Order at 2; see Pet. Ex. 2 at 21. Petitioner reported that L.P. remained gassy and spits up after feedings, and that she noticed blood in his diaper the two previous days, and the doctor confirmed the diagnosis of GERD. Id.; Pet. Ex. 2 at 21–22. On February 11, 2014, L.P. returned to the second pediatrician’s office for his two-month check-up, and Ms. Petty reported that he had recently ceased spitting up and being fussy. Pet. Ex. 2 at 26; Records Order at 2. The doctor tested L.P.’s stool for blood and found none, Pet. Ex. 2 at 26, 28, and administered L.P.’s DTaP and rotavirus vaccinations, id. at 27; Records Order at 2. The next day, L.P. was brought to the Emergency Department of the Cleveland Clinic because he was vomiting and choking, and he had a liquid green stool. Records Order at 2–3; Pet. Ex. 2 at 66. After an examination and an ultrasound of his pyloric channel which showed it to be normal, he was diagnosed with “nausea and/or vomiting.” Records Order at 3; Pet. Ex. 2 at 67–68. On February 21, 2014, L.P. returned to his pediatrician, and petitioner reported that he suffered from fussiness and loose stools, but that his post-vaccination vomiting lasted just one day. Records Order at 3; Pet. Ex. 2 at 34. Id. He continued to be diagnosed as having GERD. Pet. Ex. 2 at 36; Records Order at 3. Petitioner subsequently reported to physicians treating L.P. that his diarrhea persisted for two weeks after he was vaccinated. Pet. Ex. 2 at 108; Pet. Ex. 3 at 9; Records Order at 3, 5. Petitioner’s son continued to have gastrointestinal problems. At an April 16, 2014 appointment with a pediatrician, although his elimination was normal at that time, blood was detected in his stools. Records Order at 3; Pet. Ex. 2 at 40–41. The following week he had a consultation with a gastroenterologist, to whom petitioner recounted L.P.’s history of reflux and soft stools. Records Order at 3–4; Pet. Ex. 2 at 52–53. The gastroenterologist recognized that L.P. exhibited reflux symptoms and told petitioner that infant gastrointestinal reflux can get worse between four and six months of age. Records Order at 4; Pet. Ex. 2 at 53. In November of 2015, L.P. was brought to see an allergist for a second allergist’s opinion and was diagnosed as having mild eczema and food intolerance. Records Order at 5; Pet. Ex. 3 at 1–3. In recounting L.P.’s medical history, petitioner reported that he had suffered from diarrhea lasting six months following his vaccinations. Records Order at 5; Pet. Ex. 3 at 1. Three months later, L.P. was examined by a pediatrician because of an upper respiratory infection, and petitioner reported that her son had exhibited a change in appetite. Records Order at 5; Pet. Ex. 2 at 72. The doctor noted that L.P. did not have diarrhea or emesis. Records Order at 5; Pet. Ex. 2 at 72. On March 31, 2016, at a follow-up doctor’s visit concerning L.P.’s pneumonia, petitioner reported that L.P. “always had an issue with emesis while eating,” and noted the possibility of “an exaggerated gag reflex.” Pet. Ex. 2 at 100; Records - 3 - Case 1:17-vv-00203-VJW Document 36 Filed 10/23/20 Page 4 of 11 Order at 5. He had no diarrhea at that time. Pet. Ex. 2 at 100. At an April 26, 2016 doctor’s visit, petitioner reported that L.P. “had a reaction to vaccines with severe diarrhea at 2 months old with no continued diarrhea, [failure to thrive], or severe infections since then.” Pet. Ex. 2 at 108; Records Order at 6. The following week L.P. was brought by petitioner to see a pediatrician. Petitioner reported that L.P. had diarrhea for the previous week and a half. Pet. Ex. 2 at 118. He was diagnosed as having diarrhea, a food allergy, and other “allergic rhinitis.” Records Order at 6; Pet. Ex. 2 at 118. One month later, on June 4, 2016, following a visit to the Emergency Department of the Cleveland Clinic, L.P. was brought back to the pediatrician’s office and was diagnosed with cyclical vomiting associated with migraine. Pet. Ex. 2 at 131–32; Records Order at 6. Two and a half weeks later, petitioner brought L.P. to see a pediatric gastroenterologist, and reported that L.P. “was overall doing fairly well until” January of that year, when he began having nighttime episodes of emesis---three times in January, twice in February, and once in three subsequent months. Pet. Ex. 2 at 146; Records Order at 7. Petitioner also reported that L.P. often had loose stools multiple times daily. Records Order at 7; Pet. Ex. 2 at 147. The doctor agreed with the earlier diagnosis of cyclical vomiting and explained that L.P. might have toddler’s diarrhea. Records Order at 7; Pet. Ex. 2 at 153. The Special Master discussed her assessment of the medical records at the initial status conference held on May 8, 2017. See Order (May 8, 2017), ECF No. 9. Petitioner was to file a status report the following month, indicating if she wanted to proceed with the case, and was to check to see if the medical records needed to be updated or supplemented. Id. For three successive months, petitioner requested an extra month in which to obtain and review medical records, see Status Reports, ECF Nos. 10, 11, 13, and then concluded that the additional medical records would not support L.P.’s claim, Mot. for Enlargement, ECF No. 14. Petitioner then moved for a decision dismissing the case. Pet’r’s Mot. for Decision, ECF No. 17. She stated that “[a]n investigation of the facts and science supporting have demonstrated to Petitioner she will be unable to prove that she is entitled to compensation in the Vaccine Program,” and acknowledged that “[i]n these circumstances, to proceed further would be unreasonable.” Id. at 1. The following day, the Special Master issued a decision dismissing the case, containing a factual discussion that was repeated nearly verbatim from the Records Order. See L.P. v. Sec’y of Health & Human Servs., No. 17-203V, 2017 WL 6419982, at *1–6 (Fed. Cl. Spec. Mstr. Nov. 21, 2017) [hereinafter Dismissal Decision].1 1 The only apparent differences were the addition of footnote 7 and some grammatical changes. - 4 - Case 1:17-vv-00203-VJW Document 36 Filed 10/23/20 Page 5 of 11 Petitioner then moved for attorneys’ fees and costs, initially requesting $9,110 in attorney and paralegal fees and the $400 filing fee. Pet’r’s Appl. for Att’ys’ Fees, ECF No. 19, at 2. The Secretary opposed the request, arguing that “petitioner has failed to establish a reasonable basis for her claim,” and that the “claim never possessed a reasonable basis.” Resp’t’s Opp’n to Pet’r’s Mot. for Att’ys’ Fees and Costs, ECF No. 21, at 2, 4. Petitioner filed a reply, maintaining that medical records showing a post-vaccination injury and the consideration of a looming statute of limitations amounted to a reasonable basis for the claim, and adding to the requested amount the $1,552.50 in attorneys’ fees incurred in preparing the reply paper. Pet’r’s Reply to Resp’t’s Resp., ECF No. 23, at 4–8. The Secretary then filed a short sur-reply, primarily focusing on the applicability of the Federal Circuit’s decision in Simmons v. Sec’y of Health & Human Servs., 875 F.3d 632 (Fed. Cir. 2017). See Resp’t’s Sur-reply, ECF No. 25, at 1–2. The Special Master agreed with the Secretary and denied fees and costs. Fees Decision at *3. She noted that the Simmons decision “holds that a looming statute of limitations deadline has no bearing on whether there is an objective reasonable basis for the claim” filed in a petition. Id. (citing Simmons, 875 F.3d at 636). Instead, the “analysis must focus on whether there is evidentiary support for the claim set forth in the petition.” Id. Finding in the medical records that “L.P. had gastroesophageal reflux disease, green stools, fussiness, and gas before he received his vaccinations,” and that there was no support for a significant aggravation claim, the Special Master concluded that the claim in the petition lacked a reasonable basis. Id. Petitioner then filed a motion for review of that decision, objecting to the Special Master’s assessment of the medical records, her application of the reasonable basis standard, and her failure to take account of the looming statute of limitations deadline at the time the petition was filed. Pet’r’s Mot. for Review, ECF No. 28, at 4–6, 11–14 (Pet’r’s Mot.).2 The Secretary responded, defending the Special Master’s decision. Resp’t’s Mem. in Resp. to Pet’r’s Mot. for Review (Response Br.), ECF No. 30, at 8–17. The Court has given careful consideration to the arguments in those papers, and closely reviewed the Special Master’s decision and the medical records. 2 Because petitioner combined her motion for review and her memorandum in support of the motion in one filing, with no internal pagination, see ECF No. 28 at 1, 6, the Court has adopted the convention of citing pages from either as being from the motion, and using the ECF pagination for filing ECF No. 28. - 5 - Case 1:17-vv-00203-VJW Document 36 Filed 10/23/20 Page 6 of 11 II. DISCUSSION A. Legal Standards Under the National Vaccine Injury Compensation Program, a petitioner whose claim fails on the merits may nevertheless seek “reasonable attorneys’ fees and other costs.” 42 U.S.C. § 300aa-15(e)(1) (2018). But the statute contains an important qualification. Fees and costs to an uncompensated petitioner may be awarded only “if the special master or court determines that the petition was brought in good faith and there was a reasonable basis for the claim for which the petition was brought.” Id. Whether this petition was filed in good faith is not at issue. See Fees Decision at *3 (“There is no evidence that this petition was brought in bad faith.”). Instead, the central question in this appeal is whether a “reasonable basis” for filing this Vaccine Act claim existed. See Pet’r’s Mot. at 10. The Federal Circuit has held that decisions regarding awards of attorneys’ fees are to be reviewed under the abuse-of-discretion standard. Hall v. Sec’y of Health & Human Servs., 640 F.3d 1351, 1356 (Fed. Cir. 2011) (citing Pierce v. Underwood, 487 U.S. 552, 558 (1988); Saxton ex rel. Saxton v. Sec’y of Health & Human Servs., 3 F.3d 1517, 1520 (Fed. Cir. 1993)). In cases where compensation is denied, the Vaccine Act “clearly gives” special masters “discretion over whether to make such an award.” Saxton, 3 F.3d at 1520 (citing Perreira v. Sec’y of Dep’t of Health & Human Servs., 27 Fed. Cl. 29, 31 (1992), aff’d, 33 F.3d 1375 (Fed. Cir. 1994)). A special master’s “application of the law is reviewed de novo.” Rodriguez v. Sec’y of Health & Human Servs., 632 F.3d 1381, 1384 (Fed. Cir. 2011). Absent a misapplication of law, “only if [a tribunal] erred in interpreting the law or exercised its judgment on clearly erroneous findings of material fact, or its decision represents an irrational judgment in weighing the relevant factors can its decision be overturned.” Chiu v. United States, 948 F.2d 711, 713 (Fed. Cir. 1991); see also Hendler v. United States, 952 F.2d 1364, 1380 (Fed. Cir. 1991) (“An abuse of discretion may be found when (1) the court’s decision is clearly unreasonable, arbitrary, or fanciful; (2) the decision is based on an erroneous conclusion of the law; (3) the court’s findings are clearly erroneous; or (4) the record contains no evidence upon which the court rationally could have based its decision.”). Generally, “reversible error is ‘extremely difficult to demonstrate’ if the special master ‘has considered the relevant evidence of record, drawn plausible inferences and articulated a rational basis for the decision.’” Lampe v. Sec’y of Health & Human Servs., 219 F.3d 1357, 1360 (Fed. Cir. 2000) (quoting Hines ex rel. Sevier v. Sec’y of Health & Human Servs., 940 F.2d 1518, 1528 (Fed. Cir. 1991)). - 6 - Case 1:17-vv-00203-VJW Document 36 Filed 10/23/20 Page 7 of 11 B. Analysis In this case, in which petitioner alleged that her infant son suffered gastrointestinal injuries due to two vaccinations, Pet. at 1, the Special Master correctly noted that the medical records showed gastrointestinal problems prior to the vaccinations---gassiness, green stools, spitting up after feedings, blood in his diaper, and a diagnosis of gastroesophageal reflux disease. Dismissal Decision at *1; see Pet. Ex. 2 at 7, 17–18, 21–22. After petitioner was informed by the Special Master that the records showed neither a vaccine injury lasting six months nor a significant aggravation of L.P.’s preexisting gastrointestinal problems, Records Order at 1, Ms. Petty asked that her case be dismissed, because “she will be unable to prove that she is entitled to compensation” and thus “to proceed further would be unreasonable.” Pet’r’s Mot. for Decision at 1. She nevertheless maintains that she had a reasonable basis for filing the claim. Petitioner contends that the Special Master’s decision must be overruled because L.P.’s medical records contained information showing gastrointestinal injuries to L.P. manifesting the day following the DTaP and rotavirus vaccinations and lasting more than six months. Pet’r’s Mot. at 11–13. She argues that the Special Master improperly employed the more stringent entitlement standard to determine the reasonableness of the claim. Id. at 13. Finally, petitioner notes that she contacted counsel about one month before the statute of limitations was due to expire, and counsel thus had a limited opportunity to review the records and determine if a claim could be proven. Id. at 14. Petitioner maintains that the timing of counsel’s review supports the reasonableness of the filing of her claim. For the reasons discussed below, the Court concludes that the Special Master did not abuse her discretion in determining that an award of fees and costs was inappropriate. First, the record contains evidence consistent with the Special Master’s determination that no reasonable basis existed for bringing the claim---a determination which rests on plausible inferences and is explained in a rational manner. See Lampe, 219 F.3d at 1360. Moreover, the Special Master did not employ the wrong standard in making this determination. And finally, the Special Master was correct in concluding that a looming statute-of-limitations deadline has no impact on the question of whether a reasonable basis existed for bringing the claim. 1. The Special Master Did Not Err in Concluding That No Reasonable Basis Existed for Bringing the Claim. In objecting to the Special Master’s denial of attorneys’ fees and costs, petitioner stresses L.P.’s condition the day after the vaccination. See Pet’r’s Mot. at 4, 11. She notes that “L.P. had been vomiting and choking, appeared lethargic and had a decreased appetite,” and that his “father reported that [L.P.] had two to three - 7 - Case 1:17-vv-00203-VJW Document 36 Filed 10/23/20 Page 8 of 11 large projectile white vomits and medium liquid green stool.” Id. at 12; see also Pet. Ex. 2 at 66. The diagnosis for L.P. was nausea and vomiting. Pet. Ex. 2 at 68. But even if this illness was caused by the vaccinations, a petition must demonstrate the suffering of “residual effects or complications of such illness, disability, injury, or condition for more than 6 months.” 42 U.S.C. § 300aa-11(c)(1)(D)(i) (2018). The medical records show, however, that the vomiting lasted one day, Pet. Ex. 2 at 34, and the “severe diarrhea” lasted for two weeks, id. at 108; see also Pet. Ex. 3 at 9. In an attempt to show an injury lasting more than six months, Petitioner highlights a November 2, 2015 medical record, which contains her report to the doctor that L.P. “received his 2 month immunizations and developed diarrhea that lasted for 6 months.” Pet. Ex. 3 at 1; see Pet’r’s Mot. at 7, 12. This medical history report is not only contradicted by the other two reports stating L.P.’s diarrhea lasted two weeks, see Pet. Ex. 2 at 108; Ex. 3 at 9, but also by a medical record of a visit just two months after the vaccinations showing L.P.’s elimination was “normal,” with “no concerns” by that time. Pet. Ex. 2 at 40. The Special Master reasonably concluded from these records that the injuries alleged to have been the immediate adverse reaction from the vaccinations did not last six months. Petitioner suggests, however, that the medical records showing L.P.’s “intermittent emesis” and “loose stools” over the two-plus years following the vaccinations also support her vaccine injury claim. Pet’r’s Mot. at 2. And she notes that L.P. was suffering from no gastrointestinal issues on the day he was vaccinated. Id. at 12–13; see Pet. Ex. 2 at 26–28. But by the time L.P. received his vaccinations, he already had a well-established medical history of gastrointestinal problems. At L.P.’s check-up when he was two weeks old, petitioner was concerned about green stools, gassiness, and excessive fussiness. Pet. Ex. 2 at 7. At four weeks old, L.P. remained fussy and would spit up after feeding. Id. at 17. And at seven weeks old, L.P. would spit up frequently after feedings, suffered from gas and had blood in his stool. Id. at 21. Thus, L.P. was diagnosed with gastroesophageal reflux disease prior to his vaccinations. Id. at 22. With the medical records showing that L.P. suffered from gastrointestinal issues prior to the day he was vaccinated, and petitioner alleging that L.P.’s subsequent, intermittent gastrointestinal issues were caused by the vaccinations, see Pet. ¶¶ 11–20, the Special Master reasonably informed petitioner both that significant aggravation would need to be alleged in light of L.P.’s preexisting condition, and that the medical records accompanying the petition did not show a substantial deterioration of L.P.’s health, Records Order at 1. As petitioner herself concedes, “[b]ecause no further records were found to support a substantial deterioration of health, [she] moved for a dismissal.” Pet’r’s Mot. at 3. In denying the fees request, the Special Master rationally explained that “counsel should have realized through their review . . . that L.P.’s medical records do not support a - 8 - Case 1:17-vv-00203-VJW Document 36 Filed 10/23/20 Page 9 of 11 vaccine-related injury as alleged and [that] petitioner did not have a reasonable basis to bring her claim.” Fees Decision at *3. Whether a “reasonable basis” for a Vaccine Act claim exists “is an objective consideration determined by the totality of the circumstances.” McKellar v. Sec’y of Health & Human Servs., 101 Fed. Cl. 297, 303 (2011). Special masters will consider the factual basis and medical support underlying the claim to decide if it is reasonable. Chuisano v. United States, 116 Fed. Cl. 276, 288 (2014). It is incumbent on the petitioner to “affirmatively establish a reasonable basis to recover attorneys’ fees and costs.” Id. at 287. While the “burden is something less than the preponderant evidence ultimately required to prevail on one’s vaccine-injury claim,” petitioners must furnish some support for their contentions. Simmons v. Sec’y of Health & Human Servs., 128 Fed. Cl. 579, 583 (2016) (citations omitted), aff’d, 875 F.3d 632 (Fed. Cir. 2017). As was described above, the Special Master rationally concluded that L.P.’s alleged reaction to the vaccinations, in the form of vomiting and severe diarrhea, did not last six months. And given L.P.’s preexisting gastrointestinal issues, the Special Master rationally found that petitioner would have to plead that L.P.’s condition was significantly aggravated by the vaccinations for the subsequent gastrointestinal injuries to be the basis for a claim. Under these circumstances, the Special Master acted well within her discretion in concluding that no reasonable basis existed for alleging a vaccine injury claim and thus denying the requested award of attorneys’ fees. Petitioner has identified no medical record connecting the vaccinations to L.P.’s illnesses or condition more than six months after receiving the vaccinations, let alone any medical record suggesting that a substantial deterioration of his health resulted from the vaccinations. Cf. Chuisano, 116 Fed. Cl. at 290 (finding that no reasonable basis existed in a case where, inter alia, the decedent had preexisting medical conditions prior to the vaccination, the medical records attributed her death to those preexisting conditions, and treating providers were unwilling to attribute her injuries to her vaccination). Instead, based on these records, petitioner acknowledged that “to proceed further would be unreasonable and would waste the resources of this Court, the Respondent, and the Vaccine Program.” Pet’r’s Mot. for Decision at 1. This is not a case in which the information initially available to a petitioner supported a vaccine claim, but subsequent information showed the claim not to be viable. Cf. Perreira v. Sec’y of Dep’t of Health & Human Servs., 33 F.3d 1375, 1377 (Fed. Cir. 1994) (finding that reasonable basis for claim ended upon review of expert opinion). If it was unreasonable to proceed further upon the basis of the medical records submitted with the petition, it was unreasonable to bring the claim in the first place. - 9 - Case 1:17-vv-00203-VJW Document 36 Filed 10/23/20 Page 10 of 11 Moreover, petitioner is incorrect in her contention that the Special Master’s decision was based on the standard for proving entitlement rather than the reasonable basis standard. See Pet’r’s Mot. at 13. The Special Master explained that she must look “more to the feasibility of the claim” and “not at the likelihood of success,” and that factors such as “factual basis” and “medical support” needed to be considered. Fees Decision at *2 (citations omitted); see also Chuisano, 116 Fed. Cl. at 288) (citations omitted) (identifying factual basis and medical support as among the factors to be considered). After describing L.P.’s pre-vaccination condition, the Special Master noted that “[n]o post-vaccination record substantiates L.P. having a substantial deterioration of health.” Fees Decision at *3. Under the circumstances, this would have been a sufficient basis for her exercise of the discretion which “the statute clearly gives” special masters when a petition is not successful, Saxton, F.3d at 1520. She further noted the absence of a causation theory or a medical expert report, see Fees Decision at *3, not to require that reasonableness be based on the entitlement standard, but to acknowledge additional means by which the reasonableness of a claim may be established, see Carter v. Sec’y of Health & Human Servs., 132 Fed. Cl. 372, 380 (2017) (recognizing that expert opinions may be used to demonstrate reasonable basis of a claim). The Special Master properly considered whether there was a reasonable basis for a vaccine injury claim based on such elements as allegations of an injury or significant aggravation lasting more than six months and linked to a vaccination. See 42 U.S.C. § 300aa-11(c)(1); Santacroce ex rel. J.R. v. Sec’y of Health & Human Servs., No. 15-555V, 2018 WL 405121, at *7 (Fed. Cl. Jan. 5, 2018). Based on this record, it was far from irrational or implausible for the Special Master to find that petitioner did not have a reasonable basis for bring her claim. The Special Master clearly considered all of the relevant medical records, drew plausible inferences and articulated a rational basis for denying the attorneys’ fees request. See Lampe, 219 F.3d at 1360. 2. A Looming Statute of Limitations Deadline Has No Bearing on the Reasonableness of Filing a Vaccine Claim. Petitioner also contends that the Special Master erroneously failed to account for the fact that the statute of limitations was about to expire when petitioner’s counsel reviewed the medical records and filed the petition. Pet’r’s Mot. at 14. This argument, however, is squarely foreclosed by Federal Circuit precedent. In Simmons v. Secretary of Health and Human Services, 875 F.3d 632, 634 (Fed. Cir. 2017), the Federal Circuit faced the question of whether counsel’s inability to review a record due to a looming statute of limitations deadline should be considered in the reasonable basis analysis. Writing for the court, Chief Judge Prost began by noting that whether the reasonable basis requirement is met “is an objective inquiry unrelated to counsel’s conduct.” Id. at 636. The focus, therefore, is - 10 - Case 1:17-vv-00203-VJW Document 36 Filed 10/23/20 Page 11 of 11 on the claim itself---and whether a reasonable basis existed for bringing it. Id. Thus, the court held that “a looming statute of limitations deadline . . . has no bearing on whether there is a reasonable factual basis ‘for the claim’ raised in the petition.” Id. (quoting 42 U.S.C. § 300aa-15(e)(1)). As such, “counsel may not use [an] impending statute of limitations deadline to establish a reasonable basis” for filing a claim lacking in factual support. Id. The amount of time left before a statute of limitations will run out is simply irrelevant to the reasonable basis determinations. See Amankwaa v. Sec’y of Health & Human Servs., 138 Fed. Cl. 282, 289 (2018) (holding that “the Federal Circuit forbade, altogether, the consideration of statutory limitations deadlines . . . in determining whether there was a reasonable basis for a claim”). Petitioner thus cannot use the looming statute of limitations deadline to support her argument that there was a reasonable basis for the filing of her claim. The Special Master was therefore correct in rejecting the statute of limitations argument, see Fees Decision at *3, and instead looking only to the medical records and allegations in deciding if the claim had an objectively reasonable basis. III. CONCLUSION For the foregoing reasons, the Special Master’s denial of attorneys’ fees and costs was not arbitrary, irrational, an abuse of discretion or otherwise unlawful. Petitioner’s motion for review is hereby DENIED and the Special Master’s decision is SUSTAINED. The Clerk shall enter judgment accordingly. No fees or costs are awarded. IT IS SO ORDERED. s/ Victor J. Wolski VICTOR J. WOLSKI Senior Judge - 11 -