VICP Registry Case Source Bundle Canonical URL: https://vicp-registry.org/case/USCOURTS-cofc-1_18-vv-00120 Package ID: USCOURTS-cofc-1_18-vv-00120 Petitioner: K.G. Filed: 2018-01-24 Decided: 2023-01-17 Vaccine: influenza Vaccination date: 2011-10-12 Condition: Guillain-Barré syndrome (GBS) and/or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Outcome: compensated Award amount USD: 117499 AI-assisted case summary: K.G., a 48-year-old woman, received an influenza vaccine on October 12, 2011. She later filed a petition alleging that this vaccine caused her to develop Guillain-Barré syndrome (GBS) and/or Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). The initial decision in this case, filed on November 5, 2018, dismissed the petition as untimely. The court found that K.G.'s claim accrued no later than February 2012, and the three-year statute of limitations would have expired in February 2015. While K.G. argued for equitable tolling due to mental incapacity from November 2012 to May 2016, the court determined that tolling should have ceased in March 2014 when her sister was appointed as her legal guardian, who had the authority to file a claim on her behalf. The court also noted that even if the claim were considered under the recent Table amendment for GBS, it failed because the medical evidence overwhelmingly supported a CIDP diagnosis, which is an exclusionary criterion for GBS under the Table, and the onset of symptoms was outside the Table's timeframe. K.G. appealed this dismissal. On March 6, 2019, the Court of Federal Claims affirmed the Special Master's decision, holding that equitable tolling does not continue once a legal guardian is appointed, as the guardian has the statutory authority to file a claim. The court emphasized that the Vaccine Act provides for legal representatives to act on behalf of disabled individuals and does not contain a savings clause that would extend tolling beyond the guardian's appointment. Ultimately, the court found that the petition was filed well after the statute of limitations expired, even with the period of mental incapacity without a guardian considered. However, a subsequent decision on January 17, 2023, shows that the parties reached a stipulation to settle the case. Respondent denied causation but agreed to compensation. The stipulation awarded K.G. a lump sum of $102,941.76, plus $14,558.24 to satisfy a State of Iowa Medicaid lien, for a total award of $117,499. This settlement resolved all claims related to the alleged vaccine injury. Theory of causation field: Table Public staged source text: ================================================================================ DOCUMENT 1: USCOURTS-cofc-1_18-vv-00120-1 Date issued/filed: 2018-11-05 Pages: 17 Docket text: PUBLIC DECISION (Originally filed: 8/17/2018) Regarding 42 DECISION of Special Master (Signed by Special Master Brian H. Corcoran). (cr) Service on parties made. -------------------------------------------------------------------------------- Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 1 of 17 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 18-120V (to be published) * * * * * * * * * * * * * * * * * * * * * * * * * K.G., * Special Master Corcoran * * Petitioner, * Filed: August 17, 2018 * v. * * Influenza Vaccine; Guillain-Barré SECRETARY OF HEALTH * Syndrome; Chronic Inflammatory AND HUMAN SERVICES, * Demyelinating Polyneuropathy; * Table Claim; Limitations Period; Respondent. * Equitable Tolling; Mental Incapacity * * * * * * * * * * * * * * * * * * * * * * * * * * Thomas Reavely, Whitfield & Eddy, P.L.C., Des Moines, IA, for Petitioner. Voris Johnson, U.S. Dep’t of Justice, Washington, DC, for Respondent. DECISION DISMISSING CASE AS UNTIMELY1 On January 24, 2018, K.G. filed a petition seeking compensation under the National Vaccine Injury Compensation Program.2 The petition alleges that an influenza (“flu”) vaccine K.G. received on October 12, 2011, caused her to experience Guillain-Barré syndrome (“GBS”) and/or Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”). See Petition (“Pet.”) (ECF No. 1) at 9-10. 1 This Decision will be posted on the Court of Federal Claims’ website in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). This means the ruling will be available to anyone with access to the internet. As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the Decision’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the Decision in its present form will be available. Id. 2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (“Vaccine Act” or “the Act”). Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix). Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 2 of 17 K.G. seeks an entitlement award based upon an injury she alleges was caused by a vaccine administered seven years ago – raising the question of whether the claim is time-barred under the Program’s three-year limitations period for bringing claims. Section 16(a)(2). The Petition forthrightly acknowledges the above, but argues that K.G. was mentally incapacitated for almost four years (from 2012 until 2016), thereby establishing grounds for equitable tolling of the limitations statute. I directed the parties to brief the merits of Petitioner’s equitable tolling argument. See Order, dated March 20, 2018 (ECF No. 9). Petitioner filed a brief in support of her position on June 14, 2018 (ECF No. 36) (“Brief”), Respondent opposed that position and requested dismissal on July 12, 2018 (ECF No. 37) (“Opp.”), and then Petitioner filed a reply, dated July 19, 2018 (ECF No. 38) (“Reply”). Having reviewed the parties’ submissions, I hereby determine that Petitioner’s claim is untimely, and also that she has not established a basis for equitable tolling of the limitations period. As discussed in greater detail below, although there exists persuasive case law that supports tolling of the Vaccine Act’s limitations statute due to mental incapacity (especially when that incapacity is associated with the claimed injury), it is far from a settled matter in the Program. More importantly, even assuming tolling were available under such circumstances, K.G. had a legal representative/guardian looking after her interests for a large portion of the time in which she was allegedly mentally incapacitated - suggesting that any tolling would have ended upon that person’s appointment in 2014. Petitioner therefore is not excused from her failure to act diligently in exercising her rights, and the claim warrants dismissal. Factual Background Vaccination and Initial Evidence of Reaction/Neurologic Symptoms Petitioner was born on October 21, 1962, and thus was 48 years old when she received the flu vaccine at issue. Ex. 8. The vaccine was administered to her at Mercy Medical Clinic in Johnston, Iowa on October 12, 2011, during pre-op treatment for a bilateral knee replacement surgery scheduled for November 21, 2011. Ex. 1 at 3; Ex. 3 at 497, 504, 512, 526, and 537; Ex. 6 ¶ 3. Petitioner had experienced “multiple” knee surgery procedures since 1979. Ex. 16 at 1. Prior to surgery, K.G.’s treaters observed that she exhibited an elevated heart rate between 92- 108 beats per minute. Ex. 19 at 456; Ex. 2 at 226; Ex. 15 at 55. Later on in the day of her November surgery, Petitioner reported that her right leg and right toes were tingling, and she repeated such concerns on the day after. Ex. 3 at 512, 533, 620; Ex. 16 at 9. Records from the post-operative period in the second half of November suggest that K.G. was experiencing pain associated with her recent procedure, but do not suggest at all any of the kinds of neuropathic symptoms typically associated with GBS (i.e., numbness, parasthesias, leg weakness). Ex. 16 at 9-13. Indeed, a December 1, 2011 record reported that, two weeks from 2 Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 3 of 17 surgery (and now seven weeks from vaccination) Petitioner was “doing well,” and memorialize no complaints of anything approximating a neuropathic symptom. Id. at 14. K.G. continued to experience an elevated heart rate for the next several weeks. Ex. 2 at 236; Ex. 19 at 456. By December 6, 2011, she became concerned enough about the problem to contact her primary care provider, Dr. Amy Mitchell. Ex. 2 at 234. However, this record (like those from the second half of November) also makes no reference to peripheral neuropathic symptoms, and in fact states that Dr. Mitchell learned, after speaking by phone with K.G., that “[p]ain is well controlled and she has no other symptoms.” Id (emphasis added). Dr. Mitchell saw Petitioner on December 8, 2011, and after examination diagnosed her with tachycardia, referring her to a cardiology specialist for further treatment, although these follow-up evaluations did not propose an explanation for her condition – and these records do not reference peripheral neurologic symptoms of any kind. Id. at 227, 236; Ex. 3 at 364, 484; Ex. 15 at 3, 51, 53. In the meantime, K.G. experienced an alleged worsening of the nascent neurologic symptoms she claims to have reported around the time of her November surgery. Thus, on January 12, 2012, she reported to Dr. Mark Matthes, an orthopaedic surgeon at Iowa Ortho in Des Moines, Iowa, for a post-operative follow-up. Ex. 16 at 15. She now reported “decreased sensation” in her lower extremities. Id at 16. However, records from this visit mainly record an examination aimed at assessing Petitioner’s recovery from knee surgery, and contain no suggestion of concerns (by Petitioner or Dr. Matthes) that any problems she faced were unrelated to that surgery. Id. at 15-16. By early February, Petitioner returned to Iowa Ortho complaining of instability and pain in her left knee. Ex. 16 at 18. At a follow-up visit on February 23, 2012, she reported the same plus difficulty walking, which she claimed was “kind of a spontaneous event” that had only begun in January. Id. at 37. On exam, Petitioner exhibited “no gross sensory deficit,” and reasonable extension of the left knee, accompanied with some strength deficit. Id. The treater who saw K.G. allowed for the possible need for an EMG to “rule out something like a neuropathy or some other sort of nerve injury,” and planned to follow up with her after it was conducted in the next several weeks. There is a subsequent ten-week gap in the records before the testing proposed in February was conducted on May 7, 2012. See Ex. 16 at 38. A nerve conduction study of her left tibial nerves resulted in an abnormal finding, with “prolonged distal latency.” Id. at 39. In mid-May, K.G. returned to Iowa Ortho, and now described “hypersensitivity and lack of sensation on the bottom of both feet as well as from the knees down,” along with tingling, [and] sharp burning sensation down both legs into [her] feet.” Id. at 24. She reported that same month to her primary care treater that she was also experiencing “abnormal sensation in the fingertips bilateral hand affecting all fingers.” Ex. 2 at 197. 3 Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 4 of 17 Doctors initially diagnosed her with “tarsal tunnel [syndrome] on the right [leg]” (Ex. 16 at 24), but referred her to neurology specialists for further evaluation. Ex. 16 at 26; Ex. 2 at 198. That evaluation, performed on June 15, 2012, noted “progressive paresthesias involving all four extremities,” “sensory changes” and “depressed” reflexes and indicated that these findings “may go with peripheral nerve disease such as diffuse peripheral neuropathy.” Ex. 7F at 3232. Based upon the above, Petitioner’s treating neurologists disputed the accuracy of the earlier tarsal tunnel syndrome diagnosis, and prescribed Gabapentin to treat Petitioner’s burning and tingling sensations. Id. However, other than observing some lower extremity reflex abnormalities, the records from this neurologic evaluation do not suggest she was suffering from GBS, observing (a) an absence of “progressive parasthesias involving all four extremities,” (b) “no objective motor findings,” (c) and “no involvement of her upper extremities at this time.” Id. Throughout the summer of 2012, K.G. continued to experience similar symptoms, which she felt were worsening in intensity. Ex. 2 at 166; Ex. 20 at 5. On September 11, 2012, she went to the emergency room at Mercy Medical Center (“Mercy”) in Des Moines, Iowa, and was hospitalized for her neurological symptoms at the recommendation of her primary care physician. Ex. 7I at 3847, Ex. 7F at 3168. By the fall, Petitioner’s speech had also become affected, and she was diagnosed in October 2012 with ataxic dysarthria.3 Ex. 13A at 267. She also began to experience increasing bladder control issues. Ex. 2 at 124. After falling at home in November 2012, K.G. was transported by ambulance to Mercy. Ex. 2 at 113; Ex. 7D at 1531. She subsequently went into respiratory distress and was later admitted to Mercy on December 13, 2012, where she remained until mid-January 2013. Ex. 2 at 113; Ex. 21 ¶ 10; Ex. 7B at 457-59. At admission, Petitioner’s initial diagnosis was “immune- mediated sensorimotor polyneuropathy,” but the diagnosis was expanded to include CIDP at discharge. Id. at 457. Subsequent records from the winter of 2013 confirm the CIDP diagnosis. See., e.g., Ex. 18 at 60-63 (February 11, 2013 visit). The discharge records make no mention of GBS. Petitioner, however, has pointed to other documents (primarily from records generated after post-hospitalization visits to her primary care physician, Dr. Mitchell) where a purported GBS diagnosis is referenced. See, e.g., Ex. 2 at 97 (January 28, 2013 visit), and 65 (April 13, 2013 visit).4 However, these records 3 Ataxic dysarthria is “dysarthria seen in patients with cerebellar lesions, characterized by slowness of speech, slurring, a monotonous tone, and scanning.” Dorland’s Illustrated Medical Dictionary (32nd Ed. 2012) (“Dorland’s”) at 575. Dysarthria is “a speech disorder consisting of imperfect articulation due to the loss of muscular control after damage to the central or peripheral nervous system.” Id. 4 Petitioner also points to a “vaccine assessment” form filled out at Mercy during her December 2012 hospitalization in which a box is checked in the “contraindications” section that reads “history of [GBS] within 6 weeks after a previous influenza vaccination,” and the word “plasma” is written in next to it. Ex. 7B at 509. It appears based on this form that Petitioner was not at this time given the flu vaccine – but I do not conclude from this form that its existence reflects a reasoned, supportable treater opinion that, just because the box on the form was checked, in fact 4 Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 5 of 17 contain no independent assessment of Petitioner’s CIDP diagnosis or challenge to its validity, and do not relate any of her symptoms to the flu vaccine; indeed, some records from visits to Dr. Mitchell confirm the CIDP diagnosis. Id. at 105 (January 16, 2013 record noting that Petitioner had been “[h]ospitalized for 9 weeks and diagnosed with CIDP”). She continued to receive treatment for her neurologic symptoms into 2013 and beyond. Mental Health Issues and Appointment of Guardian Petitioner has alleged in this case that during the same time period in 2011-2012 that she was beginning to experience neuropathic symptoms allegedly associated with her receipt of the flu vaccine, she was contending with family problems that in turn took a toll on her mental health. Ex. 2 at 180, 189, 205; Ex. 7I at 3855. By the fall of 2012, she was beginning to report feeling depressed, and linked her state of mind to her declining physical health. Ex. 7F at 3168. She also began to develop substance abuse problems, taking an excessive amount of prescription medications. Ex. 2 at 118, 132, 169; Ex. 7F at 3169. After her discharge from the hospital in January 2013, K.G.’s mental health deteriorated further, exacerbated by financial problems, and she continued to struggle with substance abuse. Ex. 11 at 231; Ex. 2 at 31, 62, 67; Ex. 21 ¶ 12; Ex. 23 ¶ 11. Eventually, her condition became so severe that she received in-patient treatment in May 2013 after being found unresponsive at home by a family member. Ex. 21 ¶ 16; Ex. 11 at 7; Ex. 21 ¶ 17. K.G. received medical treatment and was diagnosed with altered mental status. Ex. 11 at 4. Unfortunately, K.G.’s mental problems thereafter became progressively worse, and she experienced more frequent occasions in which she could not display rational conduct or understanding of her immediate circumstances. Accordingly, in June 2013, she was admitted to Grinnell Health Care Center for in-patient care and rehabilitation services. Ex. 11 at 2-3; Ex. 3 at 833; Ex. 13A at 1. A month later, in July 2013, her sister obtained power of attorney on her behalf. Ex. 3 at 781-83. K.G. remained at the Grinnell Health Care Center until 2016. While an in-patient, treaters were able to observe and evaluate her behaviors. Eventually she obtained psychologic counseling from Dr. Daniel Ephraim Pott-Pepperman at Applied Behavioral Health Consultants. Ex. 13A at 499-500. In October 2013, after a thorough psychological examination, Dr. Pott-Pepperman diagnosed Petitioner with “Korsakoff’s Amnesia,” a syndrome characterized by neurocognitive impairment. Ex. 10 at 9-10.5 a treater was opining that K.G. experienced GBS no later than the end of November 2011 – in the prior year. 5 Korsakoff’s Syndrome is “a syndrome of anterograde and retrograde amnesia with confabulation associated with alcoholic or nonalcoholic polyneuritis.” The term is “currently used synonymously with the term amnestic syndrome.” Dorland’s at 1836. 5 Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 6 of 17 In the ensuing period in which she was treated, Petitioner’s family made the decision to place her under a guardianship and conservatorship. Ex. 4 at 1; Ex. 21 ¶ 23; Ex. 22 ¶ 10; Ex. 23 ¶ 12. They initiated the process for appointment of a guardian in Iowa state court in March 2014, and obtained the appointment later that same month, designating Petitioner’s sister as guardian. Ex. 4 at 1, 16. Petitioner’s sister’s powers as guardian and conservator included control over K.G.’s financial and medical interests. Id. at 17. Improvement and Termination of Guardianship By the spring and summer of 2016, Petitioner’s mental state showed encouraging signs of improvement. Ex. 13D at 1640; Ex. 4 at 141. After it was determined that K.G. could again function independently, the guardianship was terminated by the end of August 2016. Ex. 4 at 194. By late November 2016, Petitioner was again living with her husband in Grinnell, Iowa. Ex. 14 at 159. Procedural History As noted, this case was filed (along with a substantial number of medical records) in January 2018 – almost 18 months from the date K.G.’s in-patient mental health treatment ended, along with termination of her sister’s guardian status. I held a status conference on March 20, 2018, during which I raised questions regarding the Petition’s timeliness. Order, dated March 20, 2018 (ECF No. 9), at 1. Petitioner acknowledged that the claim’s timeliness was an issue, but asserted that the limitations period should be subject to equitable tolling to take into account Petitioner’s mental incapacity for a period of time from 2012-2016. Id. In response, I noted that the degree of tolling Petitioner asserted vastly exceeded what had previously been allowed in other Vaccine Program cases, but I informed Petitioner that I would provide her with an opportunity to make her case. Id. at 2. The parties subsequently filed the aforementioned briefs, concluding the process in mid-July of this year. Petitioner contends that she was mentally incapacitated such that she could not protect her own legal interests from November 9, 2012 (the date when she first was taken to the hospital after falling at home), to May 10, 2016 (when she underwent a mental examination and showed positive results) - a period of 1,278 days, or approximately three and one-half years. Brief at 36. Based upon this assertion, Petitioner adds 1,095 days (representing the Vaccine Act’s three-year statute of limitations) for a total period of 2,373 days after the date of her vaccination in which Petitioner argues she had to file her claim before it would be untimely. Id. at 39-40. Because the Petition was filed on January 24, 2018 -- 2,265 days after the date of her vaccination -- Petitioner argues that her claim is timely. Id. at 40. Respondent advances three counter-arguments regarding the untimeliness of K.G.’s claim. First, Respondent contends that equitable tolling on the basis of mental incapacity should 6 Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 7 of 17 not be available to Vaccine Program petitioners at all - or, at a minimum, should be unavailable during a period in which the petitioner was represented by an appointed legal guardian able to pursue a petitioner’s legal interests. Opp. at 6. In so arguing, Respondent emphasizes that the Federal Circuit’s Barrett decision (relied upon in J.H. and Gray) was heavily dependent on veterans benefits laws and the policy goals behind them, which are not congruent with the Vaccine Act. Id. at 7. Second, Respondent maintains that Petitioner’s proposed period of incapacity is too long, and that application of a more reasonable tolling period would still result in the Petition being untimely. Id. at 9. Finally, Respondent argues that tolling would be improper because the late filing was not the “direct result” of Petitioner’s mental incapacity. Id. at 15. In her Reply, Petitioner contends that prohibiting equitable tolling in Vaccine Program cases would be inconsistent with past precedent as well as the goals of the Program itself. Reply at 3. Second, Petitioner argues that tolling is available even when a claimant has a legal representative, therefore mooting from consideration the fact that K.G. had such a representative during a large portion of her mental incapacitation. Id. at 8. Third, Petitioner maintains that refusing to apply equitable tolling in this case would be inconsistent with how other federal courts have applied the equitable tolling doctrine. Id. at 12. Finally, Petitioner contends that she has demonstrated that her late filing was the direct result of her mental incapacity. Id. at 16. Relevant Legal Standards The statute of limitations prescribed by the Vaccine Act is three years, or thirty-six months. Section 16(a)(2). The statute begins to run from the manifestation of the first objectively cognizable symptom, whether or not that symptom is sufficient for diagnosis (or even recognized by a claimant as significant). Id; Carson v. Sec’y of Health & Human Servs., 727 F.3d 1365, 1369 (Fed. Cir. 2013). Special masters have appropriately dismissed cases that were filed outside the limitations period, even by a single day or two. See, e.g., Spohn v. Sec'y of Health & Human Servs., No. 95-0460V, 1996 WL 532610 (Fed. Cl. Spec. Mstr. Sept. 5, 1996) (dismissing case filed one day beyond thirty-six-month limitations period), mot. for review denied, slip. op. (Fed. Cl. Jan. 10, 1997), aff’d, 132 F.3d 52 (Fed. Cir. 1997). The U.S. Supreme Court has observed that equitable tolling of a limitations period should be permitted “sparingly.” Irwin v. Dep’t of Veterans Affairs, 498 U.S. 89, 96, (1990). To obtain it, a litigant must establish ‘‘(1) that he has been pursuing his rights diligently, and (2) that some extraordinary circumstance stood in his way’’ to filing the claim. Pace v. DiGuglielmo, 544 U.S. 408, 418 (2005). The appropriateness of permitting equitable tolling is, however, to be determined on a case-by-case basis without rigid application of such overarching guidelines. 7 Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 8 of 17 Holland v. Florida, 560 U.S. 631, 649–50 (2010); accord Arctic Slope Native Ass’n v. Sebelius, 699 F.3d 1289, 1295 (Fed. Cir. 2012). The Federal Circuit has held that the doctrine of equitable tolling can apply to Vaccine Act claims in limited circumstances. See Cloer v. Sec’y of Health & Human Servs., 654 F.3d 1322, 1340-41 (Fed. Cir. 2011). To date, these circumstances have been enumerated to include fraud and duress -- but not, for example, lack of awareness on a petitioner’s part that she might have an actionable claim. Cloer, 654 F.3d at 1344-45 (it is well-settled in the Program that tolling of the Vaccine Act’s statute of limitations period is not triggered “due to unawareness of a causal link between an injury and administration of a vaccine”). The Federal Circuit has not yet stated whether a claimant’s mental incapacity should constitute another basis for tolling. Nevertheless, on a handful of occasions special masters have been asked to toll the limitations period for this reason. One of the first such instances occurred in J.H. v. Sec’y of Health & Human Servs., 123 Fed. Cl. 206 (2015), on remand, No. 09-453V, 2015 WL 9685916 (Fed. Cl. Spec. Mstr. Dec. 21, 2015). In that case, a petitioner alleged that he was injured by vaccines received in March and April 2006, with symptoms beginning in early June of that same year. J.H., 123 Fed. Cl. at 208. But the claim was filed in July 2009 – rendering it literally untimely (albeit by approximately one month) under the Act’s limitations statute, and leading the special master presiding over the case to dismiss it. Id. at 215. Petitioner thereupon filed a motion for review, arguing that in the period between onset and filing of the claim, he had suffered from serious mental health problems that constituted reasonable grounds for equitable tolling of the statute. J.H., 123 Fed. Cl. at 216. The Court, reviewing the medical record, found that the special master had not fully evaluated that record (which documented in detail the petitioner’s mental health problems), and remanded the case so that the availability of equitable tolling could be determined. Id. at 219. Despite the implication of the holding, the J.H. Court acknowledged there was limited controlling authority addressing whether mental illness was a sufficient justification for equitable tolling, given that the sole Federal Circuit precedent relevant to the issue – Barrett v. Principi, 363 F.3d 1316, 1318-20 (Fed. Cir. 2004) – involved veteran’s benefits statutes rather than the Vaccine Act.6 Id. at 216. 6 Barrett specifically stated that a veteran claimant could obtain equitable tolling for mental illness by demonstrating that his “failure to file was the direct result of a mental illness that rendered him incapable of ‘rational thought or deliberate decision making,’ or ‘incapable of handling [his] own affairs or unable to function [in] society.’ A medical diagnosis alone or vague assertions of mental problems will not suffice.” Barrett, 363 F.3d at 1321 (citations omitted). The Federal Circuit in Barrett also emphasized that permitting tolling for mental incapacity was consistent with the policy goals of the veterans benefit system, which provides an entitlement to those citizens who have given military service to their country, and that “it would be both ironic and inhumane to rigidly implement [the relevant limitations period] because the condition preventing a veteran from timely filing is often the same illness for which compensation is sought.” Barrett, 363 F.3d at 1321. 8 Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 9 of 17 Indeed, the Court specifically noted that “the issue of whether the Barrett standard should be applied in Vaccine Act cases is not before the court,” because the parties had not contested it in the motion for review. Id. at 216 n.8. On remand, the special master reevaluated the evidence, and in doing so found that tolling was appropriate during the intervening period in which the petitioner was “not capable of managing his affairs” due to mental illness. J.H., 2015 WL 9685916, at *24. However, the special master noted that the lack of Federal Circuit guidance on the subject meant that the conclusions reached therein might warrant revisiting in the future. Id. In addition (and of relevance herein), the special master discussed at some length whether the petitioner’s mental illness meant he should obtain a legal representative going forward – given that the Vaccine Rules expressly permit claimants to have guardians or other duly-authorized individuals pursue claims on an injured individual’s behalf. Id. at *21-23. A subsequent special master’s decision, Gray v. Sec’y of Health & Human Servs., No. 15-146V, 2016 WL 787166 (Fed. Cl. Spec. Mstr. Feb. 4, 2016), is consistent with J.H. There, a petitioner alleged that a flu vaccine she received in October 2011 caused neurologic symptoms that began that November. Gray, 2016 WL 787166, at *1. She filed her claim on February 18, 2015 – three months after the limitations period would have run from alleged onset in November 2011 – but argued that the period should be tolled for a five-month period7 to account for a timeframe in which she was allegedly mentally incapacitated. The special master embraced the reasoning of J.H. and found that the petitioner should have the opportunity to prove that her incapacity met the standard set in Barrett. 2016 WL 787166, at *6-7. After the marshalling of the evidence on that point, the special master found that tolling was appropriate, and therefore that the claim was timely. Gray v. Sec’y of Health & Human Servs., No, 15-146V, 2016 WL 6818884 (Fed. Cl. Spec. Mstr. Oct. 17, 2016). Even more recently, the Court of Federal Claims weighed in again on the availability of equitable tolling for mental incapacity – but reached a result somewhat contrary to J.H. and Gray. Clubb v. Sec’y of Health & Human Servs., 136 Fed. Cl. 255 (2018). In Clubb, a petitioner appealed a special master’s finding that his case - filed in August 2015, and based upon a July 2012 vaccination – was untimely by one day only, arguing that physical and mental impairments relevant to his alleged vaccine-caused injury had incapacitated him, and that therefore the statute should be equitably tolled. Clubb, 136 Fed. Cl. at 263. The special master had observed that the impairment in question, while actual, was not demonstrated to have prevented him from pursuing his legal rights.136 Fed. Cl. at 265. 7 Both Gray and J.H. employed a “stop-clock” approach in calculating the overall limitations period, referencing Federal Circuit law in support. Gray v. Sec’y of Health & Human Servs., No. 15-146V, 2016 WL 787166, at *6 (Fed. Cl. Spec. Mstr. Feb. 4, 2016), citing Checo v. Shinseki, 748 F.3d 1373, 1379 (Fed. Cir. 2014). Under this approach, “the statute is tolled for the period of severe mental disability and begins to run again when the petitioner is capable of asserting a claim.” Gray, 2016 WL 787166, at *6. 9 Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 10 of 17 The Court affirmed dismissal, largely based on its determination that the special master had appropriately found that (assuming tolling was available) the petitioner’s impairment was insufficient to justify tolling. Clubb, 136 Fed. Cl. at 264-66. However, the Court also noted that the policy arguments against allowing equitable tolling in the Vaccine Program for mental or physical incapacity were compelling. Id. at 263-64. The Court thus credited as persuasive Respondent’s arguments that (a) there was no Federal Circuit authority supporting the contention that equitable tolling for mental or physical impairment was appropriate in the context of the Vaccine Act, (b) the Vaccine Act expressly permitted claims to be brought on behalf of injured parties by authorized representatives, and (c) the Act also allowed compensation for injuries that could directly produce cognitive impairment, such as encephalopathy, but did not exclude such claims from the three-year limitations period – all suggesting that the Act envisioned circumstances in which a claimant would need to act to assert a legal cause of action despite mental incapacity. Id. As a result, the Court expressed “misgivings” about the appropriateness of allowing this kind of equitable tolling in Vaccine Program cases. Id. at 264. ANALYSIS I. Tolling the Limitations Period for Petitioner’s Mental Incapacity Would not Render the Claim Timely Filed Based upon the filed medical records, Petitioner has established that she was mentally incapacitated for a lengthy period of time after her vaccination. However, whether equitable tolling on the grounds of mental incapacity should be available to Program claimants remains an unsettled question. Decisions like J.H. and Gray provide reasoned grounds for allowing tolling in the case of mental incapacity. In addition, the flexible, case-by-case manner in which requests for equitable tolling are to be evaluated supports permitting claimants to attempt to substantiate their tolling arguments with evidence, rather than dismissing such attempts categorically. At the same time, the Court’s recent decision in Clubb makes valid points as to why the Vaccine Act might not countenance this kind of tolling. See Opp. at 6-8. And, most fundamentally, there is no Federal Circuit precedent instructing how to apply equitable tolling under these circumstances. Despite the above, I need not add my two cents to this debate – for the untimeliness of Petitioner’s claim is manifest even if I assume that equitable tolling is available for mental incapacity. To evaluate application of tolling to this case, I must determine (a) the nature of Petitioner’s injury, (b) when Petitioner’s claim accrued, (c) whether there was a period of time in which the statute ran before it was subsequently tolled due to mental incapacity, and finally, (d) if the date the case was ultimately filed still fell within the three-year period even after taking into account tolling. 10 Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 11 of 17 As noted above, Vaccine Act claims accrue at the first manifestation of symptoms, regardless of whether those symptoms are understood (by a petitioner or even treaters) to evidence the complained-of injury. Here, Petitioner alleges she experienced some form of peripheral neuropathy after her October 2011 vaccination, and although she has termed it GBS in her Petition, I find that the medical record evidence only supports a diagnosis of CIDP. First, the CIDP diagnosis was actually made by treaters. Ex. 7B at 457-59. GBS, by contrast, is only referenced in passing, subsequent to Petitioner’s late 2012 hospitalization, and those references lack any analytical support and do not reflect reasoned treater views. Ex. 2 at 65, 97. Second, the Petitioner’s symptoms are inconsistent with GBS, which is well understood to be acute and monophasic, reaching nadir in four to six weeks in most instances. Blackburn v. Sec’y of Health & Human Servs., No. 10-410V, 2015 WL 425935, at *23 (Fed. Cl. Spec. Mstr. Jan. 9, 2015). CIDP, by contrast (which is not simply a GBS variant, despite its parallel character as a peripheral neuropathy), can wax and wane over a far longer period of time. Blackburn, 2015 WL 425935, at 31. Petitioner’s medical history reflects a lengthy, halting course progressing from the date of her flu vaccine in October 2011 until her CIDP diagnosis in late 2012, and such evidence persuasively establishes CIDP as the only cognizable neuropathic injury.8 I further conclude that the record suggests onset of K.G.’s CIDP occurred no later than February 2012. Although Petitioner reported experiencing “decreased sensation” in her lower extremities in January 2012 (Ex. 16 at 16), these feelings are most credibly linked to Petitioner’s fall 2011 surgery, and the records at this time do not establish a neuropathic injury. By February, however, Petitioner’s complaints of leg numbness were seen by treaters as the basis for an EMG or nerve conduction study, the kind of tests deemed highly probative of peripheral neuropathic injury. See Simanski v. Sec’y of Health & Human Servs., No. 03-103V, 2013 WL 7017568 (Fed. Cl. Spec. Mstr. Aug. 20, 2013). Such an onset is also consistent with CIDP, which can present erratically, but which (in the views of prior experts testifying in the Program) will typically first present within two or three months post-vaccination. See, e.g., Strong v. Sec’y of Health & Human Servs., 15-1108V, 2018 WL 1125666, at *7, 21 (Fed. Cl. Spec. Mstr. Jan. 12, 2018) (noting that two months would be an appropriate onset timeframe for CIDP post-vaccination, whereas 4-5 months would be too long). Thus, all things being equal, this case should have been filed by mid-February 2015 – not almost three years after that date, in 2018. 8 I also note that, for purposes of my present analysis, it benefits Petitioner to treat her injury as CIDP. Given its more acute nature, GBS would be expected to manifest in no more than six to eight weeks from vaccination at longest – meaning the start of the limitations period in this case would have to have begun no later than November or December 2011, increasing the amount of time that the statute would have run before K.G.’s incapacitation. Assuming the injury to be CIDP is not only more consistent with the record, but also allows me to find onset to have begun slightly later. 11 Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 12 of 17 I next must determine when the limitations statute stopped running due to K.G.’s mental incapacity, applying the “stop-clock” approach for calculating the overall limitations period. Checo v. Shinseki, 748 F.3d 1373, 1379 (Fed. Cir. 2014); Gray, 2016 WL 787166, at *6. Petitioner contends that the proper date for the start of tolling was November 9, 2012. Mot. at 36. The record reflects that on that date, Petitioner was found by her sister and her sister’s husband after a fall, and that because two family members were unable to help her, an ambulance was called which took Petitioner to the hospital. Six days later, Petitioner went into respiratory distress (later diagnosed as Acute Respiratory Distress Syndrome), requiring use of a ventilator and feeding tube. Ex. 7D at 1540, 1846. During this time, Petitioner notes that she was placed in wrist restraints due in part to her cognitive impairment. Id. at 1623. Petitioner was ultimately discharged on January 11, 2013, approximately two months later. Despite the above, evidence subsequent to November 2012 suggests that Petitioner’s overall mental status had not yet so declined that she could be said to be fully incapacitated. Although the record clearly establishes that Petitioner’s mental health may have been a concern around the time of her late 2012 hospital stay, her treaters were then more concerned with her ongoing physical symptoms than her mental symptoms. In addition, K.G. improved to a point where she was allowed to return home. And a February 11, 2013 follow-up appointment for neuropathy and numbness noted Petitioner’s mental state as “alert,” and that her “judgment and insight were intact and appropriate,” and she had an “appropriate fund of knowledge.” Ex. 18 at 61-62. I therefore do not conclude that November 9, 2012, is an appropriate date to begin tolling. Instead, the record best establishes that K.G. did not become sufficiently mentally impaired so as to stop the running of the limitations period before May 26, 2013 – when she was found collapsed at home a second time. Only after this incident was she hospitalized as an in-patient for her mental problems, and subsequently diagnosed that fall by Dr. Pott-Pepperman with a form of amnesia. Her substance abuse and other conduct before this time does not establish sufficient mental impairment, despite its alarming nature. Based on this determination, the limitations period on Petitioner’s claim ran for approximately 15 months before stopping, or from February 2012 to May 2013 – leaving 21 months left before the claim would be time-barred.9 Finally, I must determine the date the limitations countdown started again. Petitioner proposes May 2016 as that start-up time, based on her documented mental health improvement. But the record more persuasively establishes that the “clock” started again in March 2014, when Petitioner’s sister was appointed as her legal guardian. 9 Acceptance of Petitioner’s proposed tolling start date would not render her claim timely. With an onset of symptoms in February 2012, Petitioner’s time to file would have elapsed only nine months before tolling under Petitioner’s theory. But, given my determination (discussed below) that tolling ceased in March 2014, K.G. would only have an additional 27 months to file – or by June 2016 – meaning that the claim would still be untimely. 12 Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 13 of 17 The record establishes that the appointment of K.G.’s sister as guardian in this case empowered her to act on Petitioner’s behalf. Specifically, as noted in Petitioner’s submissions, the guardianship/conservatorship appointment gave K.G.’s sister authority to make decisions with respect to Petitioner’s physical wellbeing and otherwise. Ex. 4 at 17. Concerning conservatorship powers, the “Notice of Your Rights” document (required by statute to be provided to the protected person, and mailed along with the petition for appointment of guardian and conservator), states that “[i]f a conservator is appointed, the conservator may, without court approval, . . . sue and defend any claim by or against you . . . .” Id. at 3 (emphasis added). This language mirrors that of Iowa Code § 633.646, which provides, in pertinent part, that “[t]he conservator shall have the full power, without prior order of the court, with relation to the estate of the ward: 1. To collect, receive, receipt for any principal or income, and to enforce, defend against or prosecute any claim by or against the ward of the conservator; to sue on and defend claims in favor of, or against, the ward or the conservator” (emphasis added). Indeed – it may be particularly appropriate that an individual who was mentally impaired after vaccine administration have such a representative litigating the claim for her. See J.H., 2015 WL 9685916, at *5-6. Petitioner’s guardian was thus a person with the capacity to bring her vaccine injury claim, even if Petitioner’s individualized mental incapacity continued after the appointment.10 Petitioner’s arguments that the appointment of a guardian has no bearing on the availability of equitable tolling are misplaced. She cites J.H. as so holding – but the facts of that case are disparate to the present circumstances. There, Respondent argued that the adult petitioner could have had a parent appointed as guardian during his incapacity, leading the special master to discuss the distinction between an existing representative’s right to file suit for another, versus the obligation of a potential, qualified person to become a legal guardian or representative for another who lacked such a guardian. J.H., 2015 WL 9685916, at *6. The special master emphasized the importance of protecting the rights of such an unrepresented individual under the Vaccine Act, rather than imposing a duty on an otherwise-qualified individual to become a legal representative. Id. at *7.11 Here, by contrast, it cannot be disputed 10 Indeed, in discussing why equitable tolling for mental incapacity should be allowed in Program cases, the special master in Gray emphasized that authority existed elsewhere highlighting the importance of a representative’s appointment in measuring the limitations period. Gray, 2016 WL 787166, at *5, citing Clifford v. United States, 738 F.2d 977 (8th Cir. 1984) (individual’s medical malpractice claim under Federal Tort Claims Act for wrongful coma did not accrue until time of representative’s appointment, since that was time person with requisite knowledge of injury had legal duty to act for the injured party; coma prevented injured party from being aware of claim entirely). 11 Other courts have suggested that appointment of a guardian is actually evidence that a person was mentally incapacitated. See, e.g., Speiser v. Dep’t of Health & Human Servs., 670 F. Supp. 380, 385 (D. D.C. 1986) (claimant seeking to establish mental incapacity basis for tolling of statute of limitations could do so by establishing that she “took measures to let someone else handle her affairs as might be done for someone who is non compos mentis”). But this does not mean that any tolling of a limitations statute continues unabated even after the guardian’s or representative’s appointment – and Petitioner in this case has offered no persuasive authority so holding. 13 Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 14 of 17 that K.G. did have a legal representative for a substantial period, and that this individual had full authority to bring a legal claim on her behalf. Accordingly, I find that the limitations period governing Petitioner’s claim restarted in March 2014. Since the 36-month period had only elapsed 15 months by this date, there remained only 21 months – or until December 2015 – to file the case. Because it was not filed until January 2018, it is untimely by over two years. I also do not find that the broader equitable considerations at play in evaluating a request to toll a limitations period favor Petitioner’s tolling request. In particular, I find that Petitioner and/or her legal representative did not act diligently in exercising her legal rights. Although some cases like J.H. suggest that diligence is not relevant to the specific period of a claimant’s mental incapacity, a claimant’s diligence can be evaluated during the period in which the petitioner or her authorized representative had capacity to bring a Vaccine Act claim – as well as when the petitioner was not so incapacitated. Here, and based upon my onset finding of February 2012, Petitioner had the capacity to bring her claim for more than a year before she lost the mental facilities to act in May 2013. Then, her representative held a guardianship position for over two years without taking action, even though the record establishes that Petitioner’s alleged vaccine-caused symptoms already existed. Given that these symptoms existed for nearly two years before the representative’s appointment in March 2014, it is reasonable under such circumstances to hold that legal representative – who had sufficient authority to act on Petitioner’s behalf in numerous regards - responsible for bringing such a claim in a more timely manner. This – along with the fact that this claim remained unfiled for an additional year and a half more even after Petitioner regained mental competency – does not constitute diligence thwarted by circumstances beyond one’s control.12 The lack of diligence is only underscored when the injury in question is taken into account. Claims that the flu vaccine caused GBS, CIDP, or some other form of peripheral neuropathy are legion in the Vaccine Program, and flu-GBS cases have been deemed to have sufficient medical legitimacy to cause amendment of the Table to add them as a specified injury that can be established without a showing of causation. 42 C.F.R. § 100.3(a); 82 FR 6294-01, 12 Whether Petitioner’s alleged vaccine-caused CIDP is related to her mental incapacity presents a closer call. The medical records do not establish that her neuropathic injuries produced directly a brain or central nervous system injury that could be medically associated with the same process that might in theory produce the kind of demyelination resulting in GBS or CIDP. However, Petitioner has maintained that her decline in physical health post-vaccination contributed to her depression and substance abuse, and it is reasonable to conclude from this that the vaccine injury alleged did play a role in her subsequent mental incapacity. Regardless, I need not resolve this question, given the overall untimeliness of the claim’s filing despite the existence of a legal representative with the capacity to have filed the claim for Petitioner. 14 Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 15 of 17 2017 WL 202456 (Jan. 19, 2017). It should not take a party over six years to allege such a claim unless exceedingly rare circumstances are established. While Petitioner’s personal suffering is self-evident and tragic, it has not been demonstrated herein to constitute the kind of unique situation in which equity would demand tolling. II. The Lookback Provisions of the Table Revision Adding GBS as a Table Injury Do Not Save Petitioner’s Claim Although I have determined that Petitioner’s claim is untimely regardless of equitable tolling, I note that Petitioner’s claim is formally styled as a Table claim alleging GBS as the injury. Petition at ¶ 76. In an abundance of caution, I will therefore also evaluate whether the recent revisions to the Vaccine Act to add GBS as a Table Injury provide an alternative basis for finding the claim timely. Effective March 21, 2017, the Vaccine Table was amended to include GBS as a specified injury for individuals receiving the flu vaccine. 82 FR 6294-01, 2017 WL 202456 (Jan. 19, 2017). The enacting regulations specified that this new Table claim was subject to the Act’s existing three-year limitations period, but included a lookback provision, providing that any individual who alleged to have experienced injury occurring not more than eight years before the effective date of revision (March 21, 2017) could file suit based on the new Table claim within two years of the effective date. 42 U.S.C. § 300aa-16(b). Petitioner’s claim was filed on January 24, 2018 – clearly within two years of the addition of the flu-GBS claim to the Table. Moreover, she alleges GBS as her injury, with onset in November 2011 – a date within eight years of the Table amendment’s effective date. Thus, Petitioner’s claim could be timely based on this lookback provision despite her inability to establish grounds for equitable tolling. There is, however, a significant bar to Petitioner making use of this lookback provision to save her claim. The evidence submitted in this case, which is already voluminous, overwhelmingly does not support the conclusion that she suffered from GBS, but rather CIPD, an exclusionary criteria under the Table’s Qualifications and Aids to Interpretation (“QAI”). 42 C.F.R. § 100.3(c)(15)(iv) (stating, in pertinent part, that “[e]xclusionary criteria for the diagnosis of all subtypes of GBS include the ultimate diagnosis of any of the following conditions: chronic immune demyelinating polyradiculopathy (CIDP) . . .”). As noted above, although GBS is referenced in offhand fashion in some medical records, Petitioner ultimately received a formal diagnosis of CIDP. Ex. 7B at 457-59; Ex. 18 at 60-63. Moreover, and independent of diagnosis, Petitioner’s course of injury is wholly inconsistent with GBS, which is known to be acute and monophasic, rapidly reaching nadir after 15 Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 16 of 17 initial insult (whether caused by infection or vaccination less commonly). See Reichert v. Sec’y of Health & Human Servs., No. 16-697V, slip op. at 21 (Fed. Cl. Spec. Mstr. Aug. 2, 2018). K.G. received the flu vaccine in October 2011; experienced some possibly neurologic symptoms a few weeks later that were more likely associated with her November 2011 knee replacement surgery; and then did not truly experience the symptoms classically associated with a peripheral neuropathy until February 2012 (at earliest) – approximately four months after vaccination on October 12, 2011, and thus well outside what special masters have found to be a reasonable timeframe for GBS onset. See, e.g., Barone v. Sec’y of Health & Human Servs., No. 11-707V, 2014 WL 6834557, at *13 (Fed. Cl. Spec. Mstr. Nov. 12, 2014) (eight weeks is the longest reasonable timeframe for a flu vaccine/GBS injury). Arguably, the timeframe is even longer, since she was not diagnosed with any kind of possible neuropathic injury before May 2012 (Ex. 16 at 24-26), and only sought emergency treatment in the fall of 2012 – now a year post- vaccination. Brief at 7. This course most persuasively describes the waxing/waning nature of CIDP – not GBS – and therefore the existing record does not at all support the conclusion that a claim based on GBS as the injury could possibly succeed.13 For similar reasons, Petitioner’s claim also fails a second flu-GBS Table requirement involving symptom onset. A Table claim of flu vaccine-caused GBS must establish the first symptom or manifestation of onset occurred 3-42 days after vaccination. 42 C.F.R. § 100.3. This means that because Petitioner was vaccinated on October 12, 2011, her GBS must have presented in some form by November 23, 2011. However, the medical records do not permit the finding that more likely than not her neurologic symptoms (assuming for argument that they did reflect GBS) began any earlier than February 2012. Prior to this date, she complained only intermittently of leg pain and tachycardia (a symptom not associated with GBS); after, she noted “decreased sensation” in her legs, and then obtained testing results that clearly documented the neurologic nature of her injury. Onset in February is too long outside the 42-day window to successfully establish a Table injury based on a vaccine received the prior October. CONCLUSION This case is dismissed because it was not filed within the three-year statute of limitations. The Clerk shall enter judgment accordingly. 13 For such reason, and based upon my review of the extensive records filed, I would find that a claim positing GBS as the injury in this case would lack reasonable basis (meaning fees generated in prosecution of the case should not be reimbursed) even if it had been filed in a timely manner. In the face of such evidence, an expert could not reasonably, credibly establish that her injury is not as her treaters ultimately determined. 16 Case 1:18-vv-00120-MCW Document 50 Filed 11/05/18 Page 17 of 17 IT IS SO ORDERED. s/Brian H. Corcoran Brian H. Corcoran Special Master 17 ================================================================================ DOCUMENT 2: USCOURTS-cofc-1_18-vv-00120-2 Date issued/filed: 2019-03-06 Pages: 8 Docket text: **VACATED PURSUANT TO THE C.A.F.C. MANDATE, DATED APRIL 27, 2020. ** JUDGE VACCINE REPORTED OPINION re: 51 Order on Motion for Review, Judge Vaccine Reported Opinion. Signed by Senior Judge Mary Ellen Coster Williams. (mm) Service on parties made. Modified on 5/7/2020 to indicate opinion has been vacated. (dls). -------------------------------------------------------------------------------- Case 1:18-vv-00120-MCW Document 53 Filed 03/06/19 Page 1 of 8 In the United States Court of Federal Claims No. 18-120V (Filed: March 6, 2019)1 * * * * * * * * * * * * * * * * * * * * * * * * * K.G., * National Childhood Vaccination Petitioner, * Injury Act of 1986, 42 U.S.C. * §§ 300aa-1 et seq.; Statute of v. * Limitations; Equitable Tolling; * Mental Incapacity; Savings SECRETARY OF HEALTH AND * Clause; Appointment of Legal HUMAN SERVICES, * Guardian. Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * Zachary James Hermsen, Whitfield & Eddy Law, 699 Walnut Street, Suite 2000, Des Moines, IA 50309, for Petitioner. Joseph H. Hunt, C. Salvatore D’Alessio, Catharine E. Reeves, Heather L. Pearlman, and Voris Edward Johnson, U. S. Department of Justice, Torts Branch, Civil Division, P.O. Box 146, Benjamin Franklin Station, Washington, DC 20044-0146, for Respondent. _________________________________________________________ OPINION AND ORDER _________________________________________________________ WILLIAMS, Senior Judge. This Vaccine Act case presents a novel issue of statutory interpretation: whether the statute of limitations may be tolled during the timeframe when a petitioner who lacks mental capacity, has a legal guardian. The Special Master determined that there was no basis to toll the statute of limitations, finding that while Petitioner herself may have been unable to file suit, Petitioner’s guardian had the capacity to sue on her behalf. This Court sustains the Special Master’s decision. 1 Pursuant to Vaccine Rule 18 of the Rules of the United States Court of Federal Claims, the Court issued its Opinion under seal to provide the parties an opportunity to submit redactions. The parties did not propose any redactions. Accordingly, the Court publishes this Opinion. Case 1:18-vv-00120-MCW Document 53 Filed 03/06/19 Page 2 of 8 Background2 On October 12, 2011, Petitioner, a 48-year old woman, received the flu vaccine in preparation for a knee replacement at Mercy Medical Clinic in Johnston, Iowa. After the surgery on November 21, 2011, Petitioner reported tingling sensations in her toes as well as pain, which her medical providers attributed to the recent procedure. Dec. *3-4. In December 2011, Petitioner’s primary physician observed no other symptoms, but in the months following, Petitioner reported “decreased sensations” in her lower extremities, instability in her left knee and difficulty walking. Dec. *5. In February 2012, Petitioner’s physician ordered an electromyography test (EMG) to “rule out something like a neuropathy or some other sort of nerve injury . . . .” Dec. *6. The EMG was performed on May 7, 2012, and produced abnormal findings of “prolonged distal latency” in her left tibial nerves. Id. (citing Ex. 16, at 39). In mid-May, after reporting hypersensitivity and lack of sensation at the bottom of both feet, burning sensations in her legs, and abnormal sensations in her fingers, Petitioner was referred to a neurology specialist, whose findings suggested a possible “peripheral nerve disease.” Dec. *6-7 (citing Ex. 7F, at 3232). Over the summer of 2012, these symptoms worsened, and others appeared – slurred speech and depression as well as impaired judgment due to “the enormous amounts of alcohol and prescription medications she was consuming.” Pet’r’s Mot. 5; Ex. 2, at 118, 132, 169. On November 9, 2012, Petitioner fell in her home and was transported to the hospital. Ex. 2, at 113. Records of her commitment indicate that Petitioner was unable to speak and was hallucinating, which required her providers to use wrist restraints, a ventilator, and a feeding tube. At discharge on January 11, 2013, Petitioner’s diagnosis included Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”). Upon returning home, Petitioner continued to struggle with substance abuse, and while Petitioner’s mental health generally deteriorated over the next four months, the record of a February 11, 2013 follow-up appointment with her neurologist noted that Petitioner was alert and that her “[j]udgment and insight were intact and appropriate.” Ex. 18, at 61-62. On May 26, 2013, Petitioner was again hospitalized after being found unconscious on the floor of her home. On June 21, 2013, she was transferred to an in-patient facility, where she remained against her will and “under constant medical supervision for the next three and a half years, during which time she continued exhibiting significant mental incapacity.” Pet’r’s Mot. 8. In the Fall of 2013, Petitioner was diagnosed with Korsakoff’s Amnesia, “a syndrome of anterograde and retrograde amnesia with confabulation associated with alcoholic or nonalcoholic polyneuritis.” Dec. *11 & n.5. On July 17, 2013, shortly after Petitioner moved into the in-patient facility, Petitioner’s sister was granted a power of attorney over Petitioner’s health care decisions by an Iowa state court. Ex. 3, at 780-83. On March 24, 2014, with the entire family’s agreement, Petitioner’s sister was appointed her guardian and conservator by the Iowa District Court for Poweshiek County. 2 These facts are derived from the Special Master’s decision dismissing Petitioner’s case, K.G. v. Sec’y of Health & Human Servs., No. 18-120V, 2018 U.S. Claims LEXIS 1523 (Fed. Cl. Aug. 17, 2018) (“Dec.”), as well as the Appendix to Petitioner’s Motion for Review. 2 Case 1:18-vv-00120-MCW Document 53 Filed 03/06/19 Page 3 of 8 Dec. *11; Ex. 4, at 16-17; Ex. 21 ¶ 23; Ex. 22 ¶ 10; Ex. 23 ¶ 12. According to the “Notice of Your Rights” given to Petitioner when her sister became her guardian and conservator, these designations gave Petitioner’s sister the authority to make decisions with respect to Petitioner’s physical wellbeing and otherwise and “to sue and defend any claim by or against [Petitioner] . . . .” Ex. 4, at 17, 3. The order granting guardianship and conservatorship to Petitioner’s sister stated that there was “clear and convincing evidence and good cause for the appointment of a guardian and conservator of the proposed ward, all without limitations.” Ex. 4, at 16. During assessments at the in-patient facility, Petitioner consistently blamed her sister “for all her problems and sadness,” for making “[her] room [her] prison,” and for telling her sons that “she [had] brain problems from drinking so much.” Ex. 13D, at 1398; Ex. 17, at 4, 10, 21. Petitioner’s sister testified in her declaration that her appointment as guardian caused a strain on their relationship that ultimately caused her to stop “acting as [Petitioner’s] guardian and conservator [because it] became too much . . . to personally handle.” Ex. 21 ¶ 24. Nevertheless, Petitioner’s sister continued to act as her guardian and conservator. See also, Ex. 4, at 134-36; 139-42. In an assessment on May 10, 2016, Petitioner “finally showed medical evidence of cognitive improvement.” Pet’r’s Mot. 11. On August 29, 2016, the Iowa District Court terminated Petitioner’s sister’s guardianship and conservatorship, and by November 2016, Petitioner had returned home. Procedural History On January 24, 2018, Petitioner, who no longer had a guardian, filed a claim for compensation under the National Vaccine Injury Compensation Program, alleging that she developed Guillain-Barre Syndrome (“GBS”) and/or Chronic Inflammatory Demyelinating Polyneuropathy (“CIDP”) as a result of the influenza vaccine she received on October 12, 2011. Petitioner admitted that her claim, filed more than six years after onset of her symptoms, was untimely under the Vaccine Act’s three-year statute of limitations. However, Petitioner argued that because she was mentally incapacitated from November 9, 2012, to May 10, 2016, the statute of limitations should have been equitably tolled for that time period – some three and one-half years. The Special Master determined that the statute of limitations began to run “no later than February 2012,” when Petitioner first experienced leg numbness, a symptom consistent with CIDP, a slowly progressive autoimmune disease. Dec. *23 (“Thus, all things being equal, this case should have been filed by mid-February 2015 . . . .”); see Dorland’s at 1491. The Special Master further determined that Petitioner was “sufficiently mentally impaired so as to stop the running of the limitations period” on May 26, 2013, when Petitioner was hospitalized after being found unresponsive at home. Dec. *24-25. The Special Master rejected Petitioner’s argument that she became mentally incapacitated on November 9, 2012, finding that, while Petitioner’s mental health was a concern by that date, her release from the hospital and positive mental health assessment at the February 2013 follow-up appointment demonstrated that her mental health had not yet declined to the point where she was fully incapacitated. Id. The Special Master then determined that the limitations period resumed on March 24, 2014, when an Iowa state court appointed Petitioner’s sister as her legal guardian and conservator, because these appointments gave Petitioner’s sister the authority “‘to sue and defend any claim by or against [Petitioner] . . . .’” Dec. *26 (quoting Ex. 4, at 3). The Special Master cited the “Notice 3 Case 1:18-vv-00120-MCW Document 53 Filed 03/06/19 Page 4 of 8 of Your Rights” Petitioner received and relied upon language in that Notice that mirrored Iowa Code § 633.646, the statute setting forth the powers of a conservator. This Iowa Code provision stated that “[the] conservator shall have the full power, without prior order of the court, with relation to the estate of the ward . . . to sue on and defend claims in favor of, or against, the ward or the conservator.” Iowa Code § 633.646 (2018). The Special Master determined that, despite Petitioner’s continued mental incapacity, tolling was no longer appropriate once her guardian was appointed, because she “did have a legal representative for a substantial period,” who “had full authority to bring a legal claim on her behalf.” Dec. *28. The Special Master concluded that the petition filed on January 24, 2018, was untimely, as the three-year statute of limitations expired in December 2015, even tolling for the period from May 26, 2013 until March 24, 2014, when Petitioner was mentally incapacitated without a guardian. Id.3 In her Motion for Review, Petitioner argues that the statute of limitations should be tolled for the entire period that she was mentally incapacitated - - even when she had a guardian - - and that the Special Master erred by restarting the limitations clock when Petitioner’s sister became her court-appointed legal guardian. Petitioner submits that, even if tolling generally ends once a guardian is appointed, tolling should nevertheless continue in this case, because Petitioner’s guardian could not effectively communicate with Petitioner or “identify the need to file a Vaccine Act claim . . . .” Pet’r’s Mot. 20. Petitioner cites Petitioner’s “severe psychological decline, including impaired memory, impaired logical reasoning abilities, communication difficulties, and a paranoid distrust toward her guardian.” Id. Discussion In Vaccine Act cases, the Court of Federal Claims may: (1) uphold the findings of fact and conclusions of law and sustain the special master’s decision; (2) set aside any of the findings of fact or conclusions of law “found to be arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law and issue its own findings of fact and conclusions of law” or (3) “remand the petition to the special master for further action in accordance with the court’s direction.” 42 U.S.C. § 300aa-12(e)(2)(A)-(C) (2012); Althen v. Sec’y of Health & Human Servs., 418 F.3d 1274, 1277 (Fed. Cir. 2005); Saunders v. Sec’y of Dep’t of Health & Human Servs., 25 F.3d 1031, 1033 (Fed. Cir. 1994). Section 11(b)(1)(A) of the Vaccine Act provides that: any person who has sustained a vaccine-related injury, the legal representative of such person if such person is a minor or is disabled, or the legal representative of any person who died as the result of the administration of a vaccine set forth in the Vaccine Injury Table may. . . file a petition for compensation under the Program. 42 U.S.C. § 300aa-11(b)(1)(A). The Vaccine Act defines “legal representative” as “a parent or an individual who qualifies as a legal guardian under State law.” Id. § 300aa-33(2). 3 There is no dispute that Petitioner was no longer mentally incapacitated on May 10, 2016, the date of her first medical test demonstrating cognitive improvement. Pet’r’s Mot. 2. 4 Case 1:18-vv-00120-MCW Document 53 Filed 03/06/19 Page 5 of 8 Section 16(a)(2) of the Act establishes the limitations period within which the person “who has sustained a vaccine-related injury” or that person’s legal representative must file a claim, stating: [I]f a vaccine-related injury occurred as a result of the administration of such vaccine, no petition may be filed for compensation under the Program for such injury after the expiration of 36 months after the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of such injury. Id. § 300aa-16(a)(2). This statute of limitations is subject to equitable tolling. Cloer v. Sec’y of Health & Human Servs., 654 F.3d 1322, 1343-44 (Fed. Cir. 2011) (en banc). As the United States Court of Appeals for the Federal Circuit recognized in Cloer, the Vaccine Act’s limitations period may be tolled where “extraordinary circumstance[s],” such as fraud or duress, block a claimant from filing on time. Id. at 1344-45 (quoting Pace v. DiGuglielmo, 544 U.S. 408, 418 (2005)). In his decision dismissing the petition as untimely, the Special Master did not reach the issue of whether Petitioner’s claimed mental incapacity constituted the type of extraordinary circumstance under Cloer that would warrant equitable tolling of the Vaccine Act’s statute of limitations. The Special Master, instead, determined that assuming arguendo that tolling was available due to Petitioner’s mental incapacity, the petition was still time-barred because once Petitioner’s guardian was appointed, Petitioner had a legal representative who “had full authority to bring a legal claim on her behalf.” Dec. *28. Petitioner argues that the Special Master erred by not continuing the tolling period for the duration of her mental incapacity after the appointment of her legal guardian. This Court disagrees. Assuming, as the Special Master did, that Petitioner had a mental illness that constituted an extraordinary circumstance that prevented her from pursuing her claim herself, the appointment of Petitioner’s sister as her legal guardian removed that obstacle.4 The Vaccine Act expressly grants the statutory right to bring a claim to the legal representative of a disabled person who allegedly has sustained a vaccine-related injury. 42 U.S.C. § 300aa-11(b)(1)(A). The Act defines a “legal representative” as “a parent or an individual who qualifies as a legal guardian under State law.” Id. § 300aa-33(2). Here, Petitioner’s sister was duly appointed as Petitioner’s legal guardian by the Iowa District Court for Poweshiek County and was granted the power to sue and defend actions. Ex. 4, at 16-17; Iowa Code § 633.646. As such, Petitioner’s sister qualified as her legal representative under the Vaccine Act. Under the Act’s statute of limitations, a disabled person’s legal representative must file a petition before “the expiration of 36 months after the date of the occurrence of the first symptom or manifestation of onset or of the significant aggravation of such injury.” 42 U.S.C. § 300aa- 16(a)(2). Once Petitioner’s sister became her legal guardian, she possessed a statutory right to file 4 The Special Master assumed arguendo that Petitioner had demonstrated the requisite mental incapacity to trigger tolling. Such mental incapacity would have rendered Petitioner “disabled” within the meaning of the Vaccine Act. 5 Case 1:18-vv-00120-MCW Document 53 Filed 03/06/19 Page 6 of 8 suit on Petitioner’s behalf, and there was no longer any impediment preventing Petitioner from suing or any “extraordinary circumstance” warranting equitable tolling. As such, the Special Master correctly determined to end the tolling period once Petitioner’s sister became her legal guardian on March 24, 2014. Petitioner urges this Court to follow what she characterizes as the “overwhelming majority of jurisdictions” that have decided that tolling based on mental incapacity should continue even after the appointment of a legal guardian. Pet’r’s Mot. 16-17. The cases Petitioner cites are distinguishable however, as the statutes of limitations in those cases contain savings clauses. By its terms, a savings clause tolls or suspends the statute of limitations for certain classes of incompetent individuals - - typically minors and mentally incapacitated persons - - until the incompetency is removed. See, e.g., Whalen v. Certain-Teed Prods. Corp., 134 S.E.2d 528, 529- 30 (Ga. Ct. App. 1963) (where the savings clause, Ga. Code Ann. § 3-801, provided that “[i]nfants, idiots, or insane persons, or persons imprisoned, who are such when the cause of action shall have accrued, shall be entitled to the same time, after the disability shall have been removed, to bring an action, as is prescribed for other persons”); Tzolov v. Int’l Jet Leasing, Inc., 283 Cal. Rptr. 314, 316-17 (Cal. Dist. Ct. App. 1991) (where the savings clause, Cal. Civ. Proc. § 352, provided that for persons lacking legal capacity at the time of accrual of the claim, “the time of the disability is not part of the time limited for the commencement of the action”); Talley by Talley v. Portland Residence, Inc., 582 N.W.2d 590, 591 (Minn. Ct. App. 1998) (where the statute of limitations, Minn. Stat. § 541.15(a), provided that insanity “existing at the time when a cause of action accrued or arising anytime during the period of limitation, shall suspend the running of the period of limitation until the same is removed; provided that such period . . . , shall not be extended for more than five years, nor in any case for more than one year after the disability ceases”). Or a savings clause may provide a different limitations period for a person with a legal disability, which is triggered after the disability is removed. See, e.g., Freeman v. Alex Brown & Sons, Inc., 73 F.3d 279, 281 (10th Cir. 1996) (where the savings clause, Okla. Stat. tit. 12, § 96, provided that if “a person entitled to bring an action . . . be, at the time the cause of action accrued, under any legal disability, every such person shall be entitled to bring such action within one (1) year after such disability shall be removed”). In the cases cited by Petitioner, the courts relied on the express text of the savings clauses in holding that the appointment of a legal guardian did not end tolling but that a different statutorily prescribed circumstance did - - the removal of the incapacity. Those courts did not rely upon traditional notions of equity that would be implicated in tolling the Vaccine Act’s limitations period here, but instead relied on principles of law - - the express language of the savings clauses themselves - - in suspending the running of the statute of limitations until the claimants regained mental capacity.5 5 Two of the cases Petitioner cites, recognizing that the savings clause only covered persons who were incompetent at the time the cause of action accrued, relied on equitable principles to toll the limitations period for persons who allegedly became incompetent after accrual and were not covered by the savings clause. See, e.g., Pardy v. United States, 548 F. Supp. 682, 683 (S.D. Ill. 1982); Unkert v. Gen. Motors Corp., 694 A.2d 306, 309 (N.J. Super. Ct. App. Div. 1997). 6 Case 1:18-vv-00120-MCW Document 53 Filed 03/06/19 Page 7 of 8 In stark contrast to the statutes Petitioner cites in which savings clauses dictate the operation or suspension of the limitations period, the Vaccine Act’s statute of limitations lacks a savings clause. The Vaccine Act does not provide a statutory mechanism for suspending the limitations period for a disabled person and restarting the limitations period once his disability is removed, or for a minor until he comes of age. Instead, the Act empowers a legal representative to sue on behalf of a disabled person or a minor as of the accrual of the cause of action or once a disability is demonstrated. Equitable tolling is not appropriate in instances where a statutory limitations bar is structured to either encompass or withhold the relief tolling would otherwise effect. In Cloer, the Federal Circuit declined to apply equitable tolling where the petitioner was unaware of the causal link between her injury and the administration of a vaccine until after the limitations period had run. As the Cloer majority found, a Vaccine Act claim accrues, and the limitations period begins, upon the “occurrence of the first symptom or manifestation of onset of a vaccine-related injury” and not upon awareness of the causal link between an injury and administration of a vaccine. Cloer, 654 F.3d at 1338-40. In Cloer, the Court declined to apply equitable tolling recognizing that doing so would have granted “the same relief as a matter of equity that Congress has withheld from all petitioners as a matter of law.” Id. at 1344. Here, in a similar vein, equitable tolling is unavailable as the language of the Vaccine Act itself addresses the circumstance for which tolling is sought; the Act accommodates a disabled person’s inability to file suit within the statutory period by giving the guardian the right to sue on his behalf. Finally, Petitioner argues that even if equitable tolling is generally not available under the Vaccine Act once a guardian is appointed, the doctrine should be applied here because Petitioner’s guardian could not effectively communicate with Petitioner and identify the need to file a Vaccine Act claim. Petitioner cites her “severe psychological decline, including impaired memory, impaired logical reasoning abilities, communication difficulties, and a paranoid distrust toward her guardian.” Pet’r’s Mot. 19. Petitioner continues that to end tolling “‘would ignore the fact that so long as the injured party remains incompetent, he is unable to assist in the preparation and presentation of his case.’” Id. at 17 (quoting Unkert v. Gen. Motors Corp., 694 A.2d 306, 310 (N.J. Super. Ct. App. Div. 1997)). However, the language of the Vaccine Act presumes that the legal representative, unassisted by the injured person, will file the petition and pursue the case for the minor (often an infant), disabled person or deceased person. By granting a legal guardian the statutory right to file a claim on a disabled person’s behalf, the Vaccine Act envisions that the injured party may not be able to assist his or her legal guardian, as the status of injured claimants for whom guardians may sue - - minors, disabled, and deceased individuals - - would as a practical matter foreclose such assistance. 42 U.S.C. § 300aa-11(b)(1)(A). According to the Act’s legislative history, Congress anticipated that “legal representatives will be parties in the filing and processing of most petitions for compensation” because most individuals injured by vaccines are children, who are unable to assist their parent or legal guardian in bringing their own Vaccine Act claim. H.R. Rep. No. 99-908, at 31 (1986); accord Somosot on behalf of R.D.S. v. Sec’y of Health & Human Servs., 118 Fed. Cl. 687, 693-94 (2014) (affirming Special Master’s dismissal of claim filed by parents on behalf of seven-year-old child as time- barred because onset of first symptom occurred six years prior to filing). 7 Case 1:18-vv-00120-MCW Document 53 Filed 03/06/19 Page 8 of 8 In sum, the circumstances of this case and Petitioner’s inability to communicate with her guardian do not constitute grounds to toll the statute of limitations.6 Conclusion The Court denies Petitioner’s Motion for Review and sustains the decision of the Special Master. s/Mary Ellen Coster Williams MARY ELLEN COSTER WILLIAMS Senior Judge 6 The Iowa court found that Petitioner’s sister was fully qualified to serve as Petitioner’s guardian and conservator. Petitioner stated that the deterioration of her relationship with her sister “should not be interpreted as a criticism of [her sister’s] work on [her] behalf.” Pet’r’s Suppl. Resp. Br. 12 n.3. Further, Petitioner represented that “[m]edical records and affidavits filed in this case largely depict [Petitioner’s sister] as a concerned and dedicated sister who struggled with [Petitioner’s] mental deterioration, just as [Petitioner’s] husband and children did.” Id. 8 ================================================================================ DOCUMENT 3: USCOURTS-cofc-1_18-vv-00120-4 Date issued/filed: 2023-01-17 Pages: 8 Docket text: PUBLIC DECISION (Originally filed: 12/21/2022) regarding 120 DECISION Stipulation/Proffer. Signed by Chief Special Master Brian H. Corcoran. (saj) Service on parties made. -------------------------------------------------------------------------------- Case 1:18-vv-00120-MCW Document 123 Filed 01/17/23 Page 1 of 8 In the United States Court of Federal Claims OFFICE OF SPECIAL MASTERS No. 18-120V * * * * * * * * * * * * * * * * * * * * * * * * * * Special Master Corcoran K.G., * * Petitioner, * Filed: December 21, 2022 * v. * * SECRETARY OF HEALTH * AND HUMAN SERVICES, * * Respondent. * * * * * * * * * * * * * * * * * * * * * * * * * * * Zachary James Hermsen, Whitfield & Eddy Law, Des Moines, IA, for Petitioner. Voris Edward Johnson, U.S. Dep’t of Justice, Washington, DC, for Respondent. DECISION AWARDING DAMAGES1 On January 24, 2018, K.G. filed a petition seeking compensation under the National Vaccine Injury Compensation Program (“Vaccine Program”).2 Petitioner alleged that she suffered from Guillain-Barré syndrome (“GBS”) as a result of her October 12, 2011, receipt of the influenza (“flu”) vaccine. (She later contended she had experienced a chronic GBS variant due to vaccination). 1 Because this decision contains a reasoned explanation for my actions in this case, I will post it on the United States Court of Federal Claims website, in accordance with the E-Government Act of 2002, 44 U.S.C. § 3501 (2012). As provided by 42 U.S.C. § 300aa-12(d)(4)(B), however, the parties may object to the decision’s inclusion of certain kinds of confidential information. Specifically, under Vaccine Rule 18(b), each party has fourteen days within which to request redaction “of any information furnished by that party: (1) that is a trade secret or commercial or financial in substance and is privileged or confidential; or (2) that includes medical files or similar files, the disclosure of which would constitute a clearly unwarranted invasion of privacy.” Vaccine Rule 18(b). Otherwise, the whole decision will be available to the public. Id. 2 The Vaccine Program comprises Part 2 of the National Childhood Vaccine Injury Act of 1986, Pub. L. No. 99-660, 100 Stat. 3758, codified as amended at 42 U.S.C. §§ 300aa-10 through 34 (2012) (“Vaccine Act” or “the Act”). Individual section references hereafter will be to § 300aa of the Act (but will omit that statutory prefix). Case 1:18-vv-00120-MCW Document 123 Filed 01/17/23 Page 2 of 8 Respondent denies that the flu vaccine caused Petitioner to suffer from GBS or any other injury or condition. Nonetheless both parties, while maintaining their above-stated positions, agreed in a stipulation (filed on December 14, 2022) that the issues before them could be settled, and that a decision should be entered awarding Petitioner compensation. I have reviewed the file, and based upon that review, I conclude that the parties’ stipulation (as attached hereto) is reasonable. I therefore adopt it as my decision in awarding damages on the terms set forth therein. The stipulation awards: • A lump sum of $102,941.76, in the form of a check payable jointly to Petitioner and the Whitfield & Eddy Trust Account; and • A lump sum of $14,558.24 to satisfy a State of Iowa Medicaid lien, in the form of a check made payable jointly to Petitioner and: Iowa Medicaid PO Box 36446 Des Moines, IA 50315 Ref.: K. Gipple, IME Case No. 129597 Stipulation ¶ 8. These amounts represent compensation for all damages that would be available under Section 15(a) of the Act. I approve a Vaccine Program award in the requested amounts set forth above to be made to Petitioner. In the absence of a motion for review filed pursuant to RCFC Appendix B, the Clerk of the Court is directed to enter judgment herewith in accordance with this Decision.3 IT IS SO ORDERED. /s/ Brian H. Corcoran Brian H. Corcoran Chief Special Master 3 Pursuant to Vaccine Rule 11(a), the parties may expedite entry of judgment by each filing (either jointly or separately) a notice renouncing their right to seek review. 2 Case 1:18-vv-00120-MCW Document 123 Filed 01/17/23 Page 3 of 8 IN THE UNITED STATES COURT OF FEDERAL CLAIMS OFFICE OF SPECIAL MASTERS _________________________________________ ) K.G., ) ) Petitioner, ) ) No. 18-120V (ECF) v. ) Chief Special Master Corcoran ) SECRETARY OF HEALTH ) AND HUMAN SERVICES, ) ) Respondent. ) _________________________________________) STIPULATION The parties hereby stipulate to the following matters: 1. K.G. (“petitioner”) filed a petition for vaccine compensation under the National Vaccine Injury Compensation Program, 42 U.S.C. §§ 300aa-10 to -34 (the “Vaccine Program”). The petition seeks compensation for injuries allegedly sustained following petitioner’s receipt of an influenza (“flu”) vaccine, which vaccine is contained in the Vaccine Injury Table (the “Table”), 42 C.F.R. §100.3(a). 2. Petitioner received a flu vaccine on October 12, 2011. 3. The vaccine was administered within the United States. 4. Petitioner alleges that she suffered the injury Guillain-Barré syndrome (“GBS”) within the time period set forth in the Table. Petitioner further alleges that she experienced the residual effects of her GBS for more than six months. 5. Petitioner represents that there has been no prior award or settlement of a civil action for damages as a result of her condition. 6. Respondent denies that the flu vaccine caused petitioner’s alleged GBS or any Case 1:18-vv-00120-MCW Document 123 Filed 01/17/23 Page 4 of 8 other injury, or her current condition. 7. Maintaining their above-stated positions, the parties nevertheless now agree that the issues between them shall be settled and that a decision should be entered awarding the compensation described in paragraph 8 of this Stipulation. 8. As soon as practicable after an entry of judgment reflecting a decision consistent with the terms of this Stipulation, and after petitioner has filed an election to receive compensation pursuant to 42 U.S.C. § 300aa-21(a)(1), the Secretary of Health and Human Services will issue the following vaccine compensation payment: a. A lump sum of $102,941.76, in the form of a check payable jointly to petitioner, K.G., and the Whitfield & Eddy Trust Account; and b. A lump sum of $14,558.241 to satisfy a State of Iowa Medicaid lien, in the form of a check made payable jointly to petitioner and: Iowa Medicaid PO Box 36446 Des Moines, IA 50315 Ref.: K. Gipple, IME Case No. 129597 Petitioner agrees to endorse this check over to Iowa Medicaid. These amounts represent compensation for all damages that would be available under 42 U.S.C. §300aa-15(a). 9. As soon as practicable after the entry of judgment on entitlement in this case, and after petitioner has filed both a proper and timely election to receive compensation pursuant to 42 U.S.C. § 300aa-21(a)(1), and an application, the parties will submit to further proceedings 1 This amount represents full satisfaction of any right of subrogation, assignment, claim, lien, or cause of action the State of Iowa may have against any individual as a result of any Medicaid payments Iowa Medicaid has made to or on behalf of K.G. as a result of her alleged vaccine- related injury suffered in or around January 2012, under Title XIX of the Social Security Act, see 42 U.S.C. § 300aa-15(g), (h). 2 Case 1:18-vv-00120-MCW Document 123 Filed 01/17/23 Page 5 of 8 before the special master to award reasonable attorneys’ fees and costs incurred in proceeding upon this petition. 10. Petitioner and her attorney represent that compensation to be provided pursuant to this Stipulation is not for any items or services for which the Program is not primarily liable under 42 U.S.C. § 300aa-15(g), to the extent that payment has been made or can reasonably be expected to be made under any State compensation programs, insurance policies, Federal or State health benefits programs (other than Title XIX of the Social Security Act, 42 U.S.C. § 1396 et seq.), or by entities that provide health services on a pre-paid basis. 11. Payment made pursuant to paragraph 8 and any amounts awarded pursuant to paragraph 9 of this Stipulation will be made in accordance with 42 U.S.C. § 300aa-15(i), subject to the availability of sufficient statutory funds. 12. The parties and their attorneys further agree and stipulate that, except for any award for attorneys’ fees and litigation costs, and past unreimbursed expenses, the money provided pursuant to this Stipulation will be used solely for the benefit of petitioner, as contemplated by a strict construction of 42 U.S.C. § 300aa-15(a) and (d), and subject to the conditions of 42 U.S.C. § 300aa-15(g) and (h). 13. In return for the payments described in paragraphs 8 and 9, petitioner, in her individual capacity, and on behalf of her heirs, executors, administrators, successors or assigns, does forever irrevocably and unconditionally release, acquit and discharge the Secretary of Health and Human Services and the United States of America from any and all actions or causes of action (including agreements, judgments, claims, damages, loss of services, expenses and all demands of whatever kind or nature) that have been brought, could have been brought, or could be timely brought in the Court of Federal Claims, under the National Vaccine Injury 3 Case 1:18-vv-00120-MCW Document 123 Filed 01/17/23 Page 6 of 8 Compensation Program, 42 U.S.C. § 300aa-10 et seq., on account of, or in any way growing out of, any and all known or unknown, suspected or unsuspected personal injuries to, or death of, petitioner resulting from, or alleged to have resulted from, the flu vaccine administered on October 12, 2011, as alleged by petitioner in a petition for vaccine compensation filed on or about January 24, 2018, in the United States Court of Federal Claims as petition No. 18-120V. 14. If petitioner should die prior to entry of judgment, this agreement shall be voidable upon proper notice to the Court on behalf of either or both of the parties. 15. If the special master fails to issue a decision in complete conformity with the terms of this Stipulation, or if the Court of Federal Claims fails to enter judgment in conformity with a decision that is in complete conformity with the terms of this Stipulation, then the parties’ settlement and this Stipulation shall be voidable at the sole discretion of either party. 16. This Stipulation expresses a full and complete negotiated settlement of liability and damages claimed under the National Vaccine Injury Act of 1986, as amended, except as otherwise noted in paragraph 9 above. There is absolutely no agreement on the part of the parties hereto to make any payment or to do any act or thing other than is herein expressly stated and clearly agreed to. The parties further agree and understand that the award described in this Stipulation may reflect a compromise of the parties’ respective positions as to liability and/or amount of damages, and further, that a change in the nature of the injury or condition or in the items of compensation sought, is not grounds to modify or revise this agreement. 17. This Stipulation shall not be construed as an admission by the United States of America or the Secretary of Health and Human Services that petitioner’s alleged GBS and residual effects, or any other injury, were caused by the flu vaccine. 4 Case 1:18-vv-00120-MCW Document 123 Filed 01/17/23 Page 7 of 8 18. All rights and obligations of petitioner hereunder shall apply equally to petitioner’s heirs, successors and/or assigns. END OF STIPULATION / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / / 5 Case 1:18-vv-00120-MCW Document 123 Filed 01/17/23 Page 8 of 8