Sheela Blackburn v. HHS - HPV, Guillain-Barré syndrome (GBS) variant, later diagnosed as Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) (2015)

Sheela Blackburn, who filed the petition under her former name Sheela Roten (the caption was updated on March 1, 2013), filed a petition on June 30, 2010, alleging that an HPV (Gardasil) vaccine she received on July 23, 2009 caused her to develop a variant of Guillain-Barré syndrome or Chronic Inflammatory Demyelinating Polyneuropathy. Ms.

Blackburn had a substantial pre-vaccination medical history involving symptoms similar to those she alleged resulted from the vaccination. Beginning in October 2008, approximately nine months before her vaccination, she presented to a chiropractor complaining of left hip and shoulder pain, constant numbness in her feet, and frequent numbness in her hands.

In November 2008, she presented to the Exodus Health Care Clinic with numbness in her feet over the prior four months (placing onset at approximately July 2008) and numbness and tingling in her hands. Neurologist Dr.

Zimmerman evaluated her in December 2008, noting mild sensory loss and left-side hyperalgesia; MRIs of her brain and cervical spine were essentially normal. In January 2009, Dr.

Zimmerman again noted right shoulder pain, bilateral leg numbness, and foot numbness. At the vaccination visit in July 2009, the contemporaneous records noted that petitioner had experienced tingling in her legs and feet in the past couple of weeks, and listed unspecified polyarthritis and neuralgia/neuritis as part of her prior medical history.

Following the vaccination, Ms. Blackburn reported worsening tingling and leg weakness on August 7, 2009, and presented with complete numbness from the knees down bilaterally and areflexia on August 11, 2009.

An entitlement hearing was held on March 25-26, 2014. Special Master Corcoran denied entitlement on January 9, 2015.

The case presented two intertwined questions: whether Ms. Blackburn suffered from GBS, and whether her illness began before she received the vaccine.

The special master found that petitioner had not established by preponderant evidence that she suffered from GBS. Even if she had suffered from GBS or CIDP, her illness predated the vaccination by many months, dating to at least July or October 2008.

And even setting aside the temporal relationship issue, there was no medically acceptable temporal relationship between the July 2009 vaccination and the acute onset of her condition, given that the longest recognized medically acceptable onset period for acute GBS is two months, and that CIDP's characteristically longer course is inconsistent with becoming acute within one month of vaccination. All three Althen prongs remained unsatisfied.

On August 3, 2015, the parties filed a stipulation for attorneys' fees and costs. Special Master Corcoran awarded $131,474.68, payable jointly to Ms.

Blackburn and her counsel, Isaiah Kalinowski.