Crutchfield v. Secretary of Health & Human Services

125 Fed. Cl. 251, 2014 U.S. Claims LEXIS 1558, 2014 WL 11160516
CourtUnited States Court of Federal Claims
DecidedSeptember 8, 2014
DocketNo. 09-39 V
StatusPublished
Cited by38 cases

This text of 125 Fed. Cl. 251 (Crutchfield v. Secretary of Health & Human Services) is published on Counsel Stack Legal Research, covering United States Court of Federal Claims primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Crutchfield v. Secretary of Health & Human Services, 125 Fed. Cl. 251, 2014 U.S. Claims LEXIS 1558, 2014 WL 11160516 (uscfc 2014).

Opinion

National Childhood Vaccine Injury Act of 1986, 42 U.S.C. § 300aa-10 et seg. (2012); MMR vaccine; Diabetes Type 1.

MEMORANDUM OPINION AND FINAL ORDER

BRADEN, Judge.

Amy Crutchfield (“Petitioner”) claims entitlement to compensation under the National Childhood Vaccine Injury Act of 1986, codified as amended at 42 U.S.C. § 300aa-10 et seq. (2012) (the “Vaccine Act”), because she developed Type 1 diabetes mellitus (“Type 1 diabetes”) following a measles-mumps-rubella (“MMR”) vaccination.

On April 7, 2014, Special Master George L. Hastings, Jr. (the “special master”) denied Petitioner’s claim for compensation, finding that she failed to satisfy the three elements set forth by the United States Court of Appeals for the Federal Circuit in Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274 (Fed.Cir.2005). See Crutchfield v. Sec’y of Health & Human Servs., No. 09-39, 2014 WL 1665227, at *21-22 (Fed.Cl. Apr. 7, 2014).

On April 29, 2014, Petitioner filed a Motion for Review of the special master’s Decision.

I. RELEVANT FACTS.1

A. Petitioner’s Medical Records.

Petitioner was bom on October 17,1970 in Manhasset, New York. Pet. 1/16/09 Ex. 7 at [253]*253118. On October 18,1971, she received the live measles vaccine. Pet. 1/16/09 Ex. 7 at 119. On April 21, 1972, she received the muihps vaccine. Pet. 1/16/09 Ex. 7 at 119. On January 31,1972, she received the rubella live virus vaccine. Pet. 1/16/09 Ex. 7 at 119. On May 24, 1978, she received the measles vaccine booster. Pet. 1/16/09 Ex. 7 at 119.

As an adult, Petitioner’s blood glucose periodically was tested as part of her routine health care. Pet.. 1/16/09 Ex. 6 at 93-116. On February 8, 2002, her blood glucose levels were found to be normal, and slightly low on August 14, 2003, at 63 mg/dL compared to a reference range of 70-106 mg/dL. Pet. 1/16/09 Ex. 6 at 102, 113. On May 16, 2005, before she began experiencing the health problems at issue in this case, a blood glucose test was taken and the results were normal. Pet. 1/16/09 Ex. 6 at 98.

On October 19, 2006, Dr. Orli Etingin, an internist, reported that Petitioner was trying to conceive. Pet. 1/16/09 Ex. 6 at 93. On December 15, 2005, Petitioner visited her gynecologist, Dr. Julie Beyers, for a “routine exam” with the “chief ... reason for visit” that she was “attempting eonception[.]” This exam included a laboratory blood test; the results indicated that Petitioner was not immune to measles, had an “equivocal” immune response to mumps, but was immune to rubella. Pet. 1/16/09 Ex. 2 at 6, 9. A follow up test on January 6, 2006, had the same results. Pet. 1/16/09 Ex. 2 at 11.

Petitioner did not experience any serious health problems before 2006. Pet. 1/16/09 Ex. 6 at 93-116. On'or around January 26, 2006, Petitioner received a MMR vaccination.2

During April and May 2006, Petitioner experienced recurrent vaginal yeast infections and, on April 4, 2006, Dr. Beyers prescribed treatment with Diflucan. Pet. 1/16/09 Ex. 2 at 10,13,16. Laboratory tests performed on May 5, 2006 showed no urogenital infection. Pet. 1/16/09 Ex. 2 at 18. On May 30, 2006, Dr. Beyers began treating Petitioner with Clomid to promote fertility. Pet. 1/16/09 Ex. 2 at 18. On June 19, 2006, Petitioner visited Dr. Etingin and reported that over the past three to four months, she experienced hair loss, increased thirst, and unintentional weight loss, despite a decrease in exercise. Pet. 1/16/09 Ex. 6 at 90. During this visit, Petitioner requested that blood tests be performed, because she suspected Type’ 1 diabetes. Pet, ¶¶ 8, 9. The results confirmed that Petitioner was suffering from diabetes. Pet. 1/16/09 Ex. 5 at 29, 71-74.

On June 23, 2006, Dr. Levy, an endocrinologist, saw Petitioner, whose family history included rheumatoid arthritis in her mother and aunt and celiac disease in a maternal cousin, but no history of diabetes mellitus. Pet. 1/16/09 Ex. 5 at 33.3 Nevertheless, Dr. Levy diagnosed Petitioner with Type 1 diabetes. Pet. 1/16/09 Ex. 5 at 34; Pet. 1/16/09 Ex. 6 at 79. Thereafter, Petitioner began a program of insulin treatment and, on July 5, 2006, Dr. Levy reported that Petitioner’s blood glucose levels improved. Pet. 1/16/09 Ex. 5 at 31, 35. In February 2007, Dr. Levy prescribed an insulin pump for Petitioner. Pet. 1/16/09 Ex. 5 at 24.

On January 31, 2011, blood tests were requested by the Government’s expert, Dr. Noel Melaren, and the results confirmed that [254]*254Petitioner had Type 1 diabetes. Pet. 2/9/11 Exs. 101,102.

B. Type 1 Diabetes Mellitus.

Type 1 diabetes is an autoimmune disease, where the patient’s immune system attacks and destroys islet cells (also referred to as “beta cells”) in the patient’s pancreas. Pet. 1/16/09 Ex. 1 at 4; Gov’t 5/8/09 Ex. A at 3; Crutchfield, 2014 WL 1665227, at *8. The resulting damage to the pancreas requires the patient to take insulin to survive. Pet. Ex. 1/16/09 Ex. 1 at 4; Crutchfield, 2014 WL 1665227, at *8.

First identified in children, more recently Type 1 diabetes also has been found in adults, which is sometimes referred to as “latent autoimmune diabetes in adulthood,” or “LADA.” Gov’t 5/8/09 Ex. A at 3; Crutchfield, 2014 WL 1665227, at *8. Although causation of this condition is not well understood, experts agree that genetic susceptibility to autoimmune disease and environmental factors may play a role. Gov’t 5/8/09 Ex. A at 6-7; PI. 1/16/09 Ex. 1 at 4; Crutchfield, 2014 WL 1665227, at *9.

C. Petitioner’s Expert Testimony.

1. Yehuda Shoenfeld, M.D.4

In 1972, Dr. Yehuda Shoenfeld received his medical degree from the Hebrew University’s Hadassa Medical School in Israel. He is a Professor of Medicine at the Tel-Aviv University Medical School, Sackler Faculty of Medicine, and served as the head of the Department of Medicine at the Sheba Medical Center of Tel-Aviv University, the largest hospital in Israel. He also has served as the head of the Hybridoma Unit and Research Laboratory for Autoimmune Diseases of the Soroku Medical Center of Ben-Gurion University of the Negev, and, in that capacity, founded the Center for Autoimmune Diseases, where he serves as Director. Dr. Shoenfeld has authored or co-authored over 1,200 articles, 43 books, and 130 chapters in medical texts, many of them focusing on autoimmune diseases. He is the Editor-in-Chief of Autoimmunity Reviews, Co-Editor of the Journal of Autoimmunity, and has served on the Editorial Boards of numerous other medical journals. As head of the Department of Medicine at the Sheba Medieal Center, he has treated many types of patients, approximately 15 to 20 percent of whom are diabetic.

Dr. Shoenfeld noted that Type 1 diabetes is an autoimmune condition and that Petitioner’s family history of autoimmune conditions made her more susceptible. 3/30/11 TR 22, 59, 66 (Shoenfeld).

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125 Fed. Cl. 251, 2014 U.S. Claims LEXIS 1558, 2014 WL 11160516, Counsel Stack Legal Research, https://law.counselstack.com/opinion/crutchfield-v-secretary-of-health-human-services-uscfc-2014.