Donald D. Meyer v. HHS - Pneumococcal, Guillain-Barré Syndrome (“GBS”) (2024)
Case summary [AI summaries can sometimes make mistakes]
On April 3, 2018, Bette M. Anderson, as personal representative of the estate of Donald D.
Meyer, filed a petition for compensation under the National Vaccine Injury Compensation Program. The petition alleged that a pneumococcal conjugate (Prevnar 13) vaccine administered on July 26, 2017, caused Mr.
Meyer to develop Guillain-Barré Syndrome (GBS) and subsequently die on August 26, 2017. Respondent argued against compensation.
The Special Master found that Petitioner proved by a preponderance of the evidence that the Prevnar 13 vaccine caused Mr. Meyer's GBS and subsequent death, satisfying all three prongs of the Althen test for off-Table claims.
Petitioner is entitled to compensation, with damages to be determined in a separate order. Mr.
Meyer, age 62, had a medical history significant for cardiomegaly, carotid artery blockage, tonsillar cancer, depression, lumbar disc disease, and hypothyroidism. He received the Prevnar 13 vaccine during an annual physical examination on July 26, 2017, with no other concerns noted besides elbow pain.
Symptom onset, including abdominal pain, sweating, and later generalized joint pain, began around August 5, 2017. He was seen by multiple healthcare providers, including emergency room visits and his primary care physician, with initial assessments suggesting a viral syndrome or rheumatological illness.
By August 6, 2017, Mr. Meyer developed new symptoms including double vision, lack of coordination, tingling in his hands and feet, and difficulty handling objects.
He choked on food and was intubated, requiring transfer to the ICU. He was diagnosed with an axonal variant of GBS with oculomotor manifestations, later confirmed by lumbar puncture and EMG.
Testing for infections, including Campylobacter, was negative. Treating neurologist Dr.
Ivan Brodsky noted the pneumococcal vaccine one week prior to onset and stated in a letter dated August 11, 2017, that within reasonable medical certainty, Mr. Meyer's GBS was causally related to the preceding pneumococcal vaccination.
Mr. Meyer's condition deteriorated, and despite treatments including IVIG and plasmapheresis, he remained ventilator-dependent.
He was discharged to inpatient rehabilitation on August 18, 2017, but returned to the hospital on August 23, 2017, due to unresponsiveness. Life support was discontinued, and Mr.
Meyer passed away on August 26, 2017. His death certificate listed GBS as the immediate cause of death.
Petitioner presented expert testimony from Dr. M.
Eric Gershwin and Dr. Lawrence Steinman.
Dr. Gershwin opined that GBS was more likely than not caused by molecular mimicry following vaccination.
Dr. Steinman opined that Prevnar 13 can cause GBS via molecular mimicry, proposing two mechanisms: homology between vaccine components (phosphoglycerol in serotypes 18C and 23F) and phospholipids in myelin/axons, and homology between the CRM197 protein carrier and Contactin-1.
Dr. Steinman also cited medical literature supporting the link between pneumococcal vaccines and GBS, and the temporal relationship.
Dr. Praful Kelkar, who provided treatment to Mr.
Meyer, opined that the Prevnar 13 vaccine served as a trigger for Mr. Meyer's severe axonal GBS, noting the absence of any antecedent infection or alternative cause.
Respondent presented expert testimony from Dr. Peter D.
Donofrio and Dr. J.
Lindsay Whitton. Dr.
Donofrio opined that the Prevnar 13 vaccine did not lead to Mr. Meyer's GBS, questioning the supportive literature and noting Mr.
Meyer's atypical presentation. Dr.
Whitton opined that Prevnar 13 has an excellent safety record with no evidence of causal association with GBS, and that S. pneumoniae is not generally implicated as a cause of GBS. The Special Master found Petitioner proved by a preponderance of the evidence that the Prevnar 13 vaccine caused Mr.
Meyer's GBS and subsequent death, satisfying all three prongs of the Althen test. The case was filed on April 3, 2018, and the decision on entitlement was issued on February 12, 2024.
Petitioner's counsel was Kathleen Margaret Loucks. Respondent's counsel was Emilie Williams.
Special Master Nora Beth Dorsey presided.
Theory of causation
Petitioner Donald D. Meyer, age 62, received a Prevnar 13 vaccine on July 26, 2017. Approximately 10 days later, on August 5, 2017, he developed symptoms consistent with Guillain-Barré Syndrome (GBS), which progressed rapidly, leading to quadriplegia, respiratory failure, and death on August 26, 2017. Petitioner alleged the Prevnar 13 vaccine caused the GBS and death. Petitioner's experts, Dr. M. Eric Gershwin and Dr. Lawrence Steinman, proposed a theory of molecular mimicry, suggesting that components of the Prevnar 13 vaccine (specifically phosphoglycerol in serotypes 18C and 23F, or the CRM197 protein carrier) share antigenic similarities with components of human myelin and nerve proteins (phospholipids or Contactin-1), triggering an autoimmune response that attacks the peripheral nerves. Dr. Steinman identified specific amino acid sequences and homology through BLAST searches. Dr. Praful Kelkar, a treating physician, also opined that the vaccine likely triggered the GBS, noting the absence of alternative causes. Respondent's experts, Dr. Peter D. Donofrio and Dr. J. Lindsay Whitton, contested the causal link, arguing a lack of sufficient scientific literature supporting a vaccine-GBS connection for Prevnar 13 and questioning the molecular mimicry theories. Dr. Donofrio noted an atypical presentation and suggested a possible viral illness, while Dr. Whitton asserted Prevnar 13 has an excellent safety record and S. pneumoniae is not generally implicated in GBS. The Special Master found Petitioner proved by a preponderance of the evidence that the Prevnar 13 vaccine caused Mr. Meyer's GBS and death, satisfying the three Althen prongs: a sound medical theory (molecular mimicry), a logical sequence of cause and effect (no alternative cause found, treating physician's opinion), and a proximate temporal relationship (10-day onset consistent with theory and literature). Petitioner was found entitled to compensation. Attorneys for Petitioner: Kathleen Margaret Loucks. Attorneys for Respondent: Emilie Williams. Special Master: Nora Beth Dorsey. Decision Date: February 12, 2024.
Source PDFs
USCOURTS-cofc-1_18-vv-00484