Kraus v. Secretary of Health and Human Services
17-2001
| Fed. Cl. | Oct 8, 2021Background:
- Petitioner Leslie Kraus received an intramuscular influenza vaccination in her right deltoid on September 26, 2016 and later alleged a SIRVA (shoulder injury related to vaccine administration).
- She reported shoulder pain beginning within a day or two after vaccination, but did not seek shoulder-focused medical care until December 20, 2016; earlier October 17, 2016 visit to a podiatrist did not mention shoulder pain.
- Imaging and specialty care: February 2017 MRI showed a tiny infraspinatus insertional tear; treated with steroid injections, physical therapy, and ongoing orthopedics follow-up documenting persistent right shoulder pain and limited ROM beyond six months.
- Respondent argued the records are unclear about onset within the 48-hour Table window and thus Petitioner failed to meet the Table SIRVA onset requirement.
- The Chief Special Master reviewed the whole record (including affidavits and contemporaneous notes), concluded onset was more likely than not within 48 hours, found all QAI/Table SIRVA criteria and statutory requirements met, and awarded entitlement; a separate damages order was to follow.
Issues:
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether onset of shoulder pain occurred within 48 hours of vaccination (Table SIRVA onset) | Kraus: contemporaneous records and witness affidavits show pain began within 1–2 days of the shot | Secretary: records are vague/contradictory (e.g., "two days after"), delay in reporting undermines proof of 48‑hour onset | Held for Kraus: preponderant evidence establishes onset within 48 hours |
| Whether a prior shoulder condition disqualifies Table SIRVA (QAI (i)) | Kraus: no medically relevant shoulder problem in the years before vaccination | Secretary: medical note references a fall 15 years earlier | Held for Kraus: no recent/ongoing prior shoulder condition; QAI (i) satisfied |
| Whether pain and reduced ROM were limited to the vaccinated shoulder (QAI (iii)) | Kraus: diagnoses and treatment limited to right shoulder | Secretary: not contested | Held for Kraus: criterion satisfied |
| Whether another condition explains symptoms and statutory requirements (QAI (iv); duration/vaccine receipt) | Kraus: no other explanatory condition; residual effects >6 months; vaccine administered in U.S. | Secretary: did not contest these additional elements | Held for Kraus: no other condition explains symptoms; residual effects and other statutory elements met; entitlement granted |
Key Cases Cited
- Burns v. Sec'y of Health & Human Servs., 3 F.3d 415 (Fed. Cir. 1993) (special master may weigh medical records and testimony)
- Cucuras v. Sec'y of Health & Human Servs., 993 F.2d 1525 (Fed. Cir. 1993) (contemporaneous medical records are presumed accurate)
- Shyface v. Sec'y of Health & Human Servs., 165 F.3d 1344 (Fed. Cir. 1999) (vaccine must be a but‑for cause and a substantial factor for off‑Table claims)
- Grant v. Sec'y of Health & Human Servs., 956 F.2d 1144 (Fed. Cir. 1992) (need a medical theory connecting vaccination and injury)
- Althen v. Sec'y of Health & Human Servs., 418 F.3d 1274 (Fed. Cir. 2005) (three‑prong test for causation in fact)