Mack v. Secretary of Health and Human Services
15-149
| Fed. Cl. | Oct 3, 2016Background
- Petitioner Francine Mack filed a Vaccine Act claim alleging bilateral shoulder injuries (including bursitis / SIRVA-like symptoms) after influenza vaccinations on Feb 20, 2012; Oct 4, 2012; and Dec 5, 2013. Two amended petitions and multiple affidavits were filed.
- Medical records show MRIs of right shoulder (Nov 8, 2013) and left shoulder (Jan 13, 2014) demonstrating tendinosis and mild subacromial/subdeltoid bursitis; EMG/NCV studies were essentially normal. Treating physicians questioned a clear causal link to vaccination.
- Petitioner provided limited pre‑vaccination records and inconsistent statements about which vaccine caused which symptoms and about onset timing; she asserted lack of records was due to self‑treatment and limited insurance.
- Respondent moved to dismiss for insufficient proof; petitioner moved for ruling on the record. The case was adjudicated on the written record without a hearing.
- The special master found petitioner proved receipt of the three vaccines but failed to satisfy Althen’s three prongs (medical theory, logical sequence / causation, and appropriate temporal relationship) for any claimed vaccine‑caused injury, and also failed the six‑month residual‑effect requirement for the December 2013 shot. Case dismissed for insufficient proof.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether petitioner proved a medical theory linking each flu vaccine to her shoulder injuries | Mack contended the vaccines caused her shoulder pain/bursitis (SIRVA‑type claim) | HHS argued petitioner offered no expert medical theory or reliable medical opinion supporting causation | Held: Petitioner failed Althen prong 1; no medical theory or expert opinion was submitted |
| Whether petitioner proved a logical sequence showing vaccine caused the injury (causation in fact) | Mack relied on treatment records and affidavits asserting onset after vaccination | HHS pointed to treating records attributing symptoms to other causes (degenerative spine changes) and to physicians’ skepticism | Held: Petitioner failed Althen prong 2; no treating or expert opinion supports vaccine causation |
| Whether onset timing was within a medically acceptable timeframe for causation | Mack gave inconsistent onset dates but asserted immediate/near‑immediate onset (esp. for Dec 5, 2013 shot) | HHS emphasized inconsistencies and medical records showing earlier or substantially delayed onset for two vaccines | Held: For Feb 20 and Oct 4, 2012 vaccines petitioner failed Althen prong 3 (onsets too remote and unsupported); for Dec 5, 2013 temporal proximity was satisfied |
| Whether petitioner met the statutory six‑month residual‑effects requirement for compensation | Mack asserted chronic symptoms continued beyond six months | HHS noted absence of medical records documenting >6 months of residual effects after Dec 5, 2013 | Held: Petitioner failed the six‑month residual effect requirement for the Dec 5, 2013 claim (and lacked other Althen proof), so entitlement denied |
Key Cases Cited
- Grant v. Secretary of Health & Human Servs., 956 F.2d 1144 (Fed. Cir.) (establishes causation presumption for Table injuries and need for medical theory for off‑Table claims)
- Althen v. Secretary of Health & Human Servs., 418 F.3d 1274 (Fed. Cir.) (Three‑prong test for proving causation in fact: medical theory, logical sequence, and temporal relationship)
- Shyface v. Secretary of Health & Human Servs., 165 F.3d 1344 (Fed. Cir.) (vaccine must be a but‑for and substantial factor; need for medical theory and logical sequence)
- Pafford v. Secretary of Health & Human Servs., 451 F.3d 1352 (Fed. Cir.) (discusses need for reputable medical theory and consideration of treating physician opinions)
- Moberly v. Secretary of Health & Human Servs., 592 F.3d 1315 (Fed. Cir.) (reliability requirement for expert medical theory)
- Broekelschen v. Secretary of Health & Human Servs., 618 F.3d 1339 (Fed. Cir.) (burden of proof for Althen prongs is preponderance)
- Capizzano v. Secretary of Health & Human Servs., 440 F.3d 1317 (Fed. Cir.) (special master must consider treating physician opinions when assessing causation)