Kimberly Pendleton v. HHS - Tdap, Shoulder Injury Related to Vaccine Administration (SIRVA) (2024)

Filed 2022-01-11Decided 2024-12-10Vaccine Tdap
dismissed

Case summary [AI summaries can sometimes make mistakes]

Petitioner Kimberly Pendleton filed a petition on January 11, 2022, alleging that the Tdap vaccine she received on July 31, 2019, at age 49, caused her to suffer from an on-Table Shoulder Injury Related to Vaccine Administration (SIRVA) or, alternatively, an off-Table shoulder injury caused-in-fact by the vaccine. Ms.

Pendleton's initial symptoms began approximately 24 hours after vaccination, with right arm pain radiating to her neck and scapula. Medical records from September 3, 2019, noted pain from the cervical spine to the upper right arm with limited range of motion, and an assessment of brachial neuritis.

By September 17, 2019, her symptoms included right arm pain extending down to her scapula and right arm, with weakness, and an assessment of cervical radiculopathy with possible brachial plexus injury. Physical therapy evaluations described pain radiating from the base of the neck into the right upper extremity and down to the fingers, characterized as shooting, burning, tingling, and throbbing, with significant muscle guarding in the right shoulder and limited range of motion.

An EMG study on October 2, 2019, showed evidence of right median neuropathy of the wrist of mild to moderate severity, with similar findings on the left. Ms.

Pendleton was discharged from physical therapy on January 20, 2020. Later medical records noted recurrent right arm pain/numbness/tingling, and ongoing lower back pain.

Petitioner filed an expert report from Dr. Asif M.

Ilyas, an orthopedic surgeon, who opined that Ms. Pendleton had "Right shoulder impingement/bursitis, caused by 'shoulder injury related to vaccine administration'" and that her symptoms were consistent with shoulder impingement/bursitis related to vaccination.

Respondent filed an expert report from Dr. Paul J.

Cagle, an orthopedic surgeon, who opined that Ms. Pendleton's case was not a demonstration of SIRVA, citing the onset of pain more than a month after vaccination, pain referenced as having a neurologic origin, lack of definitive evidence of true loss of shoulder range of motion, and symptoms frequently attributed to radiculopathy and/or neck/cervical pathology.

Dr. Cagle also stated there was no objective evidence of impingement syndrome and no evidence of a shoulder injury, sustained loss of shoulder motion, or structural shoulder injury.

The Special Master found that Ms. Pendleton failed to establish her off-Table claim because she did not present a medical theory explaining how the Tdap vaccine could cause impingement syndrome, thus failing the first Althen prong.

For her on-Table SIRVA claim, the Special Master found that the medical records consistently indicated the injury was not confined to the shoulder, citing pain radiating to the neck, scapula, and arm, and thus she failed to meet the third SIRVA criterion. Consequently, the case was dismissed for lack of persuasive evidence.

Petitioner was represented by Ying Zhou, and Respondent by Emily Hanson. The decision was issued by Special Master Christian J.

Moran on December 10, 2024.

Theory of causation

Petitioner Kimberly Pendleton alleged that a Tdap vaccine administered on July 31, 2019, caused an on-Table Shoulder Injury Related to Vaccine Administration (SIRVA) or an off-Table shoulder injury. Petitioner's expert, Dr. Asif M. Ilyas, opined that Ms. Pendleton suffered from right shoulder impingement/bursitis caused by the vaccine administration and that her symptoms were consistent with this diagnosis. Respondent's expert, Dr. Paul J. Cagle, disagreed, stating that the medical records did not support a SIRVA diagnosis due to the delayed onset of pain, the involvement of neck and neurological symptoms, and the lack of objective shoulder injury evidence. For the off-Table claim, the Special Master found that Ms. Pendleton failed to establish the first Althen prong because Dr. Ilyas did not provide a medical theory explaining how the Tdap vaccine could cause impingement syndrome. For the on-Table SIRVA claim, the Special Master found that Ms. Pendleton failed the third criterion because medical records indicated her pain extended beyond the shoulder to the neck, scapula, and arm. The case was dismissed for lack of persuasive evidence. Petitioner was represented by Ying Zhou, and Respondent by Emily Hanson. Special Master Christian J. Moran issued the decision on December 10, 2024.

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