Annette Molina v. HHS - Influenza, right shoulder injury (2024)

Filed 2020-07-13Decided 2024-09-17Vaccine Influenza
dismissed

Case summary [AI summaries can sometimes make mistakes]

Annette Molina, a 28-year-old adult, filed a petition on July 13, 2020, alleging that she suffered a right shoulder injury resulting from an influenza vaccination administered on October 4, 2018. The respondent is the Secretary of Health and Human Services.

Initially, the case was considered for a Table Injury, specifically Shoulder Injury Related to Vaccine Administration (SIRVA), which is compensable if it occurs within 48 hours of vaccination. However, the Chief Special Master dismissed the Table SIRVA claim, finding that the petitioner's condition was diagnosed as calcific tendinitis, which, when it can explain the symptoms, is not a Table SIRVA.

The case then proceeded as an off-Table claim, requiring Ms. Molina to prove causation-in-fact between the vaccination and her injury under the Althen test.

Ms. Molina received the influenza vaccination in her right deltoid.

She reported immediate onset of shoulder pain post-vaccination. Approximately four months later, she presented with complaints of right arm pain that had increased since December, stating she could not raise her arm beyond 90 degrees of flexion and that the pain radiated.

However, physical examination at that time showed no tenderness and full range of motion. On March 19, 2019, she presented to a primary care provider with tenderness over the deltoid and acromioclavicular joint, pain with elevation above 90 degrees, and limited active range of motion.

X-rays revealed calcification adjacent to the greater tuberosity, leading to a diagnosis of calcific tendinitis. She was referred for physical therapy and saw a physiatrist on August 26, 2019, who diagnosed calcific tendinitis and noted reduced flexion and abduction, positive empty can and Hawkins tests, but also stated the pain was likely referred from the calcific tendinitis and it was difficult to say if it occurred from an inappropriate injection.

Over a year later, on September 28, 2020, an orthopedist maintained the diagnosis of calcific tendinitis, though noting the chronicity was atypical, and findings suggested mild supraspinatus tendinitis. Treatment included a therapeutic injection, and a possible subacromial decompression was considered.

Petitioner presented an expert report from Naveed Natanzi, D.O., who opined that Ms. Molina's clinical history was consistent with a SIRVA-like injury, citing no prior shoulder pain, onset within 48 hours of vaccination, and documented reduced range of motion.

Dr. Natanzi suggested that post-vaccination inflammation could activate calcific tendinitis, citing a case report.

Respondent presented an expert report from Geoffrey Abrams, M.D., an orthopedic surgeon, who opined that Ms. Molina's shoulder pain was most likely explained by her confirmed calcific tendinitis, not SIRVA.

Dr. Abrams argued that calcific tendinitis is a common cause of shoulder pain with an acute phase that can cause pain and restriction, representing a distinct etiology from SIRVA.

He also noted that Ms. Molina's exam findings were inconsistent with expected SIRVA in terms of limited range of motion, as she had documented full range of motion in early encounters.

Special Master Daniel T. Horner adopted the Chief Special Master's findings regarding the dismissal of the Table SIRVA claim.

Regarding the off-Table claim, the Special Master found that while vaccines can cause some shoulder pathologies, Ms. Molina failed to prove that the vaccination specifically caused her asymptomatic calcific tendinitis to become symptomatic.

The Special Master noted that calcific tendinitis, as diagnosed by treating physicians, could independently explain her symptoms, including acute onset. The court found Dr.

Natanzi's theory that vaccination could activate calcific tendinitis to be inadequately supported, relying heavily on a single case report that was discounted. The Special Master concluded that calcific tendinitis can have an acute onset and is an inflammatory condition in its resorptive phase, which can explain the symptoms without requiring a separate inflammatory trigger from vaccination.

Therefore, Ms. Molina did not meet her burden of proof under the Althen test for causation-in-fact.

The petition was dismissed.

Theory of causation

Petitioner Annette Molina, age 28, received an influenza vaccination on October 4, 2018, and alleged a right shoulder injury. The case proceeded as an off-Table claim after a Table SIRVA claim was dismissed due to a diagnosis of calcific tendinitis. Petitioner's expert, Naveed Natanzi, D.O., opined that post-vaccination inflammation activated pre-existing asymptomatic calcific tendinitis, citing a case report. Respondent's expert, Geoffrey Abrams, M.D., opined that calcific tendinitis, a common cause of shoulder pain with an acute phase, was the sole cause of petitioner's symptoms and distinct from SIRVA. Special Master Daniel T. Horner found that petitioner failed to prove by a preponderance of the evidence that the vaccination caused her calcific tendinitis to become symptomatic. The Special Master determined that calcific tendinitis can explain the acute onset of shoulder pain independently and that the theory of vaccine-induced activation of calcific tendinitis was inadequately supported, relying on a single case report. The petition was dismissed. Attorneys for petitioner were David John Carney and Green & Schafle, LLC. Attorney for respondent was Ryan Daniel Pyles. Decision date: September 17, 2024.

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