Petty v. Secretary of Health and Human Services

Opinion

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Not to be Published.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

DECISION 1

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1 Because this unpublished decision contains a reasoned explanation for the special master’s action in this case, the special master intends to post this unpublished decision on the United States Court of Federal Claims’ website, in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 note (2012) (Federal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.

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 H2 receptor antagonist; it inhibits gastric acid secretion and is used in the prophylaxis and treatment of peptic ulcer, the relief of symptoms associated with hyperacidity, and the treatment of gastroesophageal reflux disease . . . .” Id. at 678.

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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.

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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 positive 4 and he had hematochezia 5 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 Nexium 6 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.

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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 nontender . He had two hemoccult 7 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.

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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 Fluticasone 8 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.

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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 cyproheptadine 9 (also known as Zofran) if vomiting were noted early, and ondansetron 10 (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 RAST 11 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 (H1 receptor antagonist) with sedative, 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.

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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 pilaris 12 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.

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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.