CHRISTIAN J. MORAN, Special Master.
Represented by an attorney at the onset of this case, Michelle Stokes filed a petition under the National Childhood Vaccine Injury Act, 42 U.S.C. §§ 300aa-10 through 34 (2012), on May 21, 2014. Her petition alleged that she suffered from lymphadenopathy and other injuries as a result of her receipt of a human papillomavirus ("HPV") vaccine on June 17, 2011. After Ms. Stokes's attorney withdrew his representation, Ms. Stokes did not prosecute her case and it was dismissed.
Before Ms. Stokes's attorney withdrew, he filed a motion for an award of attorneys' fees and costs on an interim basis. No action was taken on this motion while the case remained pending. Now, because the merit of Ms. Stokes's case has been adjudicated, the motion is ripe. The undersigned has reviewed the record and determined that Ms. Stokes's case does not fulfill a statutory requirement to be eligible for an award of attorneys' fees — reasonable basis. Therefore, the motion for an award of attorneys' fees and costs is DENIED.
Ms. Stokes received the first dose of the HPV vaccine on April 15, 2011. On June 17, 2011, she received a second dose. Exhibit 11 at 15-16. Ms. Stokes returned to her primary care physician, Joy Brasfield, on August 4, 2011, with complaints of"continued swelling" on the left side of her neck, which was diagnosed as "swollen adenoid/leukocytosis." Exhibit 11 at 14. Dr. Brasfield's note does not state the duration of this swelling. Dr. Brasfield referred her to an ear, nose, and throat physician for further evaluation.
Based on that referral, Ms. Stokes saw ENT doctor Glenn Williams for her "swollen lymph node" on August 17, 2011. Dr. Williams's notes state that the swelling had been present for six weeks.
The CT scan revealed additional masses, leading to a conclusion that Ms. Stokes was suffering from "bilateral cervical lymphadenopathy." The interpreting doctor stated that "bilateral cervical lymphadenopathy is a nonspecific finding, but in a patient of this age, is most likely infectious in nature." Exhibit 17d at 223.
Over the next few years, Ms. Stokes was consistently diagnosed as suffering from lymphadenopathy. Upon discharge from a hospital, Ms. Stokes was given a handout providing basic information about lymphadenopathy. This sheet indicated:
Exhibit 17d at 210.
After Dr. Williams reviewed the results from the CT scan, he aspirated a lymph node during the next appointment with Ms. Stokes. Exhibit 5 at 21. The result showed "several small lymphocytes with few macrophages and occasional benign epithelial cells. Favor reactive process/lymph node."
A biopsy was conducted on October 13, 2011. The result showed "No immunophenotypic evidence of involvement by a neoplastic lymphoid proliferation." Exhibit 5 at 47. Dr. Williams planned to obtain another biopsy and also ordered a series of laboratory tests.
The laboratory tests showed that Ms. Stokes had a low hemoglobin and low hematocrit. Exhibit 5 at 45. (Later, Ms. Stokes was treated for anemia.
On January 4, 2012, Dr. Williams again saw Ms. Stokes. He referred her to a specialist in infectious diseases. Exhibit 5 at 11.
It appears that the infectious disease specialist who saw Ms. Stokes was William Mason.
At the first appointment with Ms. Stokes, Dr. Mason recorded that she "is a very pleasant 18 year old lady with no real contributory [past medical history] who presents to clinic for further evaluation and management of a 6 month history of lymphadenopathy." Exhibit 13 at 13-14. According to the history Ms. Stokes provided, "the onset was in August 2011 [when] she noticed left sided neck pain." Dr. Mason also recorded that Ms. Stokes received an HPV "vaccination in March/April 2011 with post vaccination abdominal pain 1-3 days post vaccination."
Dr. Mason obtained a comprehensive history from Ms. Stokes and examined her. His assessment was that "Ms. Stokes appears to have a prolonged case of cervical lymphadenitis/lymphadenopathy without a clear diagnosis and lack of improvement despite several courses of various antibiotics. The biopsy specimens thus far have not yielded a diagnosis." Exhibit 13 at 15-16. For purposes of this case, it is important to note that Dr. Mason stated: "I am not suspicious that the vaccination preceding this has caused this complication, but I will speak with the company to see if any post marketing experience has been seen with regard to her specific complaints."
CT scans continued to show that Ms. Stokes had swollen lymph glands.
On August 24, 2012, a doctor affiliated with Dr. Williams's group removed Ms. Stokes's tonsils and adenoids. Exhibit 5 at 25. The interpreting pathologist indicated that the diagnosis was "extranodal Rosai-Dorfman disease."
Throughout the fall 2012, Ms. Stokes continued to see various doctors for her swollen lymph nodes.
On December 10, 2012, Dr. Mason saw her again. He reported that "Ms. Stokes continues to have ongoing LAD with no specific cause other than possible histoplasmosis. She has been on treatment for this and she is not immunosuppressed in any way as far as we can tell." Exhibit 13 at 7. In addition to ordering more tests, Dr. Mason concluded: "we may need to consider referral to another specialized facility for a second opinion. This is a very complicated case with complicated medical decision-making to say the very least."
Dr. Mason referred Ms. Stokes to Charles Arkin, a rheumatologist. The history that Dr. Arkin obtained states that "a year ago," Ms. Stokes "received her second HPV vaccination and soon after that she began to notice feeling sick. She subsequently developed swollen and enlarged lymph nodes in the neck area." Exhibit 12 at 37 (Jan. 24, 2013). Dr. Arkin's history is more or less consistent with the previous recitation of events. Dr. Arkin assessed her as having lymphadenopathy, arthralgia, and pericardial effusion. He commented that he wanted to evaluate her for the "possibility of IgG [4] syndrome."
On February 8, 2013, Dr. Arkin saw Ms. Stokes in follow up. He ordered a series of labs, including an ANA panel. Exhibit 12 at 32-36. His note also states:
Exhibit 12 at 36.
When Dr. Arkin received the results of laboratory studies is not entirely clear, but his records include a note dated February 19, 2013 saying Ms. Stokes's IgG 4 "level is 282 with normal being up to 86. This would be compatible with the IgG [4] related syndrome diagnosis. I called and talked with Dr. William Mason . . . And he has no objection for her start[ing] . . . prednisone." Exhibit 12 at 30.
In this same February 19, 2013 note, Dr. Arkin states that Ms. Stokes indicated that "she has become aware of an article in the New England Journal of Medicine suggesting that Gardasil has been associated with an abnormal IgG[4] and aluminum toxicity causing disease. Her initial effort to find the article was unsuccessful but she is going to send us a copy of the article."
Dr. Mason corroborates what Dr. Arkin reported. In a note from an appointment on February 18, 2013, Dr. Mason wrote: "I spoke with Dr. Arkin today who has supportive testing indicating that she has an IgG4 related disease/syndrome and is planning a course of steroids for this." Exhibit 13 at 3.
Records from both Dr. Mason and Dr. Arkin showed that Ms. Stokes began taking prednisone. However, Dr. Mason and Dr. Arkin differed about any consequence of taking the steroid. Dr. Mason reported "her lymphadenopathy has improved significantly." Exhibit 13 at 1. Dr. Arkin stated "Enlarged lymph nodes no [sic] have cleared." Exhibit 12 at 25.
On May 13, 2013, Ms. Stokes saw Dr. Arkin, stating that she has swelling in her right mandible and a nodule in her left forearm. Exhibit 12 at 19. Dr. Arkin stated that he "read the report that the patient brought."
The next visit between Dr. Arkin and Ms. Stokes occurred on May 28, 2013. Ms. Stokes stated that "she is just not feeling well." Exhibit 12 at 15. Dr. Arkin's plan was: "Talk to Dr. R. [sic]. He'll obtain a biopsy of the nodule on the forearm for a superior and [I] also talked with Dr. Lieberman about elevation of IgG for [sic, should be 4?] an immunization [Dr. Lieberman] is going to get back with me on that."
A July 3, 2013 report by Dr. Arkin indicates that Dr. Andrews performed a biopsy of a subcutaneous nodule in Ms. Stokes's left forearm. Dr. Arkin's note states that "The path report came back compatible with xanthogranulomatous infiltrate. There was gram-positive plasma cells for both IgG for [sic, should be 4?] an IgG of less than 10 percent of IgG4 positive cells which are usually necessary to make the diagnosis ofigG4 related to his syndrome." Exhibit 12 at 11.
The final visit between Dr. Arkin and Ms. Stokes was on August 13, 2013. Ms. Stokes indicated that she was likely to obtain a new primary care physician because she was "now on Tenncare."
A record from September 3, 2013, indicates that Ms. Stokes recently moved from Memphis to Nashville and was seeking a new primary care physician. Exhibit 14 at 13. Ms. Stokes was requesting a referral for a new rheumatologist. The person who evaluated Ms. Stokes, apparently nurse practitioner Patricia M. Michael, sent a request for a referral to a rheumatologist "for evaluation/treatment of IgG4 deficiency."
The ensuing appointment at Comprehensive Rheumatology Care occurred on September 25, 2013 with Marla Anderson, also a nurse practitioner. Ms. Stokes complained about "polyarthralgias and other complaints. These symptoms started 3 days after HPV vaccination." Exhibit 4 at 1. Ms. Anderson's examination revealed two enlarged lymph nodes. Ms. Anderson ordered a series of lab studies.
About two months later, Ms. Stokes returned to the rheumatology clinic and was seen by a physician assistant, Jennifer Saale. Ms. Saale's history mentions that Dr. Arkin had previously diagnosed Ms. Stokes "with IgG 4 related disease." Ms. Stokes told Ms. Saale that her lymphadenopathy had returned. Exhibit 4 at 7. Ms. Saale recommended decreasing prednisone and starting Plaquenil. Ms. Saale added a test for IgG4 to the labs. She wrote: "IfigG 4 is positive, will consider repeat lymph node biopsy and will be sure pathology uses the correct stain this time."
However, on February 3, 2014, Ms. Saale stated: "ordered IgG 4 with last labs, but it was not done. We will test for IgG 4 level again at a later time." Exhibit 4 at 13.
On February 17, 2014, Ms. Stokes went to Ear, Nose & Throat Specialists of Nashville, where a certified physician's assistant Wendy Beth Sumner Alexander saw her. Ms. Sumner Alexander's history is comprehensive and mentions that Ms. Stokes's "symptoms began after she received her second Gardasil injection and [Ms. Stokes] attributes the problems to this immunization." Exhibit 16 at 1. Ms. Sumner Alexander recommended that Ms. Stokes return in six weeks to see Dr. Williams.
By self-referral, Ms. Stokes saw Bruce Wolf, a doctor at Allergy & Asthma Specialists, P.L.L.C. Ms. Stokes was requesting an "evaluation of possible immune deficiency to account for [a] mysterious illness that has been plaguing her over the last few years." Exhibit 2 at 3. After a history and physical, Dr. Wolf's plan was "to read about IgG4 syndrome and make inquiries to Merck regarding possible reports of adverse reaction to Gardasil as seen in this woman."
In the bottom margin of this typed report, there is a hand written entry saying: "NEJM article says [biopsy] ([unknown symbol] in lgG4) needs to be supportive for IgG4 syndrome [diagnosis]. Her [biopsy] was stained accordingly and found not to be supportive."
On March 25, 2014, Ms. Stokes returned to Dr. Wolf because she was "not feeling any better. . . . The third rheumatologist that she has seen has no ready explanation for her problems or treatment besides nonsteroidals." Dr. Wolf recorded that he had a "long conversation" "discussing her lab results and that her antibody status looks normal." Dr. Wolf also "told her that I do not know anything else that I can offer to help her situation." Exhibit 2 at 1.
Shortly after this appointment with Dr. Wolf, Ms. Stokes contacted her former attorney, Mr. Cochran. By April 28, 2014, Mr. Cochran was reviewing "medical records provided by client, develop[ing] brief chronology, identify[ing] additional information needed and conduct[ing] search for literature linking her injuries to HPV vaccine." Timesheets.
Once Mr. Cochran started drafting the petition, a paralegal at the law firm began requesting medical records. On May 7, 2014, the paralegal prepared 15 letters to various health care providers. Within a week, the law firm received some medical records, including records from Dr. Williams and Dr. Arkin. Other records, including records from Dr. Wolf, followed in the next few days. Timesheets.
Mr. Cochran submitted the petition on May 21, 2014. The timesheets, however, do not indicate that Mr. Cochran had reviewed any of the medical records his paralegal had obtained before Mr. Cochran submitted the petition.
The paralegal continued to obtain additional medical records. Eventually, the law firm planned to file those records and, in this context, Mr. Cochran reviewed all the records received to date on July 30, 2014. On Ms. Stokes's behalf, Mr. Cochran filed her affidavit and medical records on August 1, 2014. Exhibits 1-7, 9-16.
The Secretary filed her report pursuant to Vaccine Rule 4 on October 28, 2014. In his report, the Secretary argued that Ms. Stokes did not establish that she was entitled to compensation as neither a treating doctor nor a retained expert presented this opinion.
On the day that the Secretary filed his report, Mr. Cochran "communicate[d] with [a] potential expert, and forward[ed] case materials to expert for review." Timesheets. Although Mr. Cochran did not identify this expert, it is likely that Mr. Cochran spoke with Dr. Eric Gershwin because Dr. Gershwin has submitted an invoice for his work in this case.
During the status conference to discuss the Rule 4(c) report, the Secretary's concerns regarding onset were discussed. At this time, Mr. Cochran stated that an expert would be retained to opine on the case. Following the status conference, Mr. Cochran and other attorneys worked with an expert to obtain a favorable opinion.
Meanwhile, on November 17, 2014, Ms. Stokes underwent another biopsy of a cervical lymph node. The interpreting pathologist stated that the "Histologic features are classic for Rosai-Dorfman disease." Exhibit 19 at I. Mr. Cochran filed this biopsy report on December 5, 2014.
Mr. Cochran consulted Dr. Gershwin to provide an opinion on vaccine causation on December 5, 2014. Dr. Gershwin's invoice states that he "[reviewed] literature on IgG4 diseases/lymphadenopathy and also on Rosai-Dorfman" disease. Pet'r's Mot., exhibit A at 33. However, Dr. Gershwin did not produce a report.
Without a positive response from Dr. Gershwin, Mr. Cochran filed a motion to extend the deadline for Ms. Stokes to file an expert report. This motion stated that Ms. Stokes was seeking alternate counsel to proceed with her claim. Pet'r's Mot., filed Jan. 7, 2015.
During the status conference held to discuss the motion for an extension of time, Mr. Cochran expressed his intent to withdraw from representing Ms. Stokes and stated that he would not be filing an expert report. The undersigned explained that an expert report would be required if Ms. Stokes continued her case. The undersigned ordered Ms. Stokes's attorney to file his motion to withdraw. Order, filed Jan. 22, 2015.
On April 6, 2015, while still representing Ms. Stokes, Mr. Cochran filed the pending motion for attorneys' fees and costs. The motion for attorneys' fees includes five medical articles. A few days later, Mr. Cochran filed his motion to withdraw, which was granted. Order, filed May 15, 2015.
Over the next several months, Ms. Stokes, on a pro se basis, filed status reports stating that she was seeking alternate counsel and an expert to opine on her case. Ms. Stokes did not obtain alternate counsel or retain an expert, and ultimately stopped responding to orders. This failure to prosecute eventually led to the issuance of two orders to show cause as to why her case should not be dismissed. When Ms. Stokes did not respond to these orders, her case was dismissed.
With respect to the motion for attorneys' fees, the Secretary filed an opposition. The Secretary presented two arguments. Preliminarily, the Secretary argued that an award of attorneys' fees on an interim basis was not appropriate. Resp't's Opp'n, filed April 23, 2015, at 22-25. This objection has now been rendered moot, as the motion is being adjudicated after the merit of Ms. Stokes's case has been resolved.
The Secretary's main argument was that Ms. Stokes's case lacked a reasonable basis, offering four points.
When the Secretary filed this opposition, Mr. Cochran was still counsel of record. He confirmed during a May 14, 2015 status conference that he was not filing a reply to the Secretary's opposition. Order on Mot. to Withdraw, filed May 15, 2015, n.1.
Because the Secretary questioned the reasonable basis for Ms. Stokes's claim that the HPV vaccine caused her lymphadenopathy, the record was left open. With the dismissal of Ms. Stokes's case and Mr. Cochran's representation that he did not intend to file a reply brief, the record has closed. Thus, the motion for attorneys' fees and costs is ready for adjudication.
Under the "American rule," each litigant pays for its participation in litigation.
The Federal Circuit has not interpreted this phrase or provided any guidance as to how petitioners satisfy the reasonable basis standard.
Recent decisions have examined whether any evidence supports "the claim for which the petition was brought." The statute's use of the phrase "reasonable basis for the claim for which the petition was brought" is consistent with other portions of the statute that require the petition to be filed with evidence.
When some (as yet undefined) quantity and quality of evidence supports the claim for which the petition was brought, then the petitioner satisfies the reasonable basis standard. However, when the only evidence supporting the claim that the vaccine caused an injury is a sequence of events in which the vaccination preceded the injury, then the petitioner does not satisfy the reasonable basis standard.
"The burden is on the petitioner to affirmatively demonstrate a reasonable basis."
In determining whether there was a reasonable basis for Ms. Stokes's claim that the HPV vaccine caused her to suffer lymphadenopathy, the preliminary question is the standard by which to evaluate "reasonable basis." The motion for attorneys' fees and costs advances a "totality of the circumstances" test. Pet'r's Mot., filed April 6, 2015, at 8. In contrast, the Secretary maintains that the "statutory language of the Vaccine Act supports [an] evidentiary-based reasonable basis analysis." Resp't's Resp. at 13. Both are considered below.
At the most basic level, the evidence shows that Ms. Stokes received two doses of the HPV vaccine (one on April 15, 2011, and the other on June 17, 2011), and, then, developed swollen lymph nodes. The date of onset for Ms. Stokes's swollen lymph nodes is somewhat vague. In the briefs regarding reasonable basis, the parties assert different dates. Mr. Cochran argues that onset was approximately July 6, 2011. Pet'r's Mot. at 6 (citing exhibit 5 at 17, which is Dr. Williams's note from November 16, 2011). The July 6, 2011 date is 19 days after vaccination.
In contrast, the Secretary argues that the more likely onset was between one and three days after vaccination. Resp't's Resp. at 20. For this proposition, the Secretary cites three medical records (exhibit 2 at 3, exhibit 13 at 14, exhibit 4 at 1) plus Ms. Stokes's own affidavit, which discusses the onset of abdominal pain (exhibit 1 ¶ 3).
Given the issue at hand — whether reasonable basis supports Ms. Stokes's claim that the HPV vaccination caused her lymphadenopathy — delving deeply into this particular onset dispute is not necessary. Although the Secretary has a fair degree of support for arguing that the onset of the swollen lymph nodes occurred within three days of the second dose of the HPV vaccine, the Secretary fails to connect this potential finding of fact to the question of reasonable basis. The relatively short interval could have made an award of compensation problematic. However, the latency between vaccination and the Secretary's understanding of onset is not so brief that the claim would be unreasonable.
Finding the sequence of events in Ms. Stokes's case is just the first step in evaluating whether reasonable basis supported her claim. "Temporal proximity is necessary, but not sufficient."
At the next level of analysis, Ms. Stokes's argument that her claim was supported by reasonable basis begins to falter. In determining whether to award compensation, the Vaccine Act directs special masters to base decisions upon "medical records or opinions." 42 U.S.C. § 300aa-13(a). Likewise, "medical records or opinions" are a foundation for evaluating the reasonable basis for the claim in the petition.
With respect to opinions of specially retained experts, Ms. Stokes did not present any. Although Mr. Cochran consulted Dr. Gershwin, Dr. Gershwin did not provide a report. Thus, Ms. Stokes cannot rely upon a medical opinion as evidence to support a finding of reasonable basis.
With respect to medical records, the evidence weighs against finding reasonable basis. Mr. Cochran has not cited and the undersigned has not independently located a medical record from a treating doctor that indicates that a doctor believed that the HPV vaccine caused Ms. Stokes's lymphadenopathy. It is certainly true that some doctors and some affiliated health care providers, such as nurse practitioners and certified physician's assistants, included the HPV vaccinations in the history that they obtained. However, presenting a sequence of events in which A preceded B is not the same as expressing an opinion that A caused B.
The evidence shows that Ms. Stokes received two doses of the HPV vaccine. The evidence shows that she subsequently developed lymphadenopathy. This sequence of events is temporally consistent with an allegation that the vaccination caused the lymphadenopathy in that the vaccination preceded the onset of the lymphadenopathy. However, by itself, timing is not enough to satisfy the reasonable basis standard. The evidence that is lacking is evidence that could be a basis for finding a causal connection. Thus, the claim in Ms. Stokes's petition lacks a reasonable basis.
Although the Secretary advocated for an "evidentiary-based reasonable basis analysis" (Resp't's Resp. at 13), Mr. Cochran advocates for the "totality of the circumstances." Pet'r's Mot. at 9-10 (citing cases). However, the totality of the circumstances does not change the outcome.
The totality of the circumstances includes an evaluation of the medical records.
Other petitioners and their attorneys have invoked the "totality of the circumstances" when the petitioner consulted an attorney shortly before the expiration of the time set in the statute of limitations. However, as the Secretary pointed out (
A more thorough review of the medical records available to Mr. Cochran before he filed the petition could have led Mr. Cochran to consult an expert much earlier. As it turns out, Mr. Cochran appears to have first contacted an expert on October 28, 2014. In the briefregarding attorneys' fees, Mr. Cochran did not justify this delay in consulting an expert. An expert's review may have been helpful because after Mr. Cochran did consult Dr. Gershwin, Mr. Cochran declined to pursue the case.
Arguably, the totality of circumstances could also include an assessment of the medical articles that Mr. Cochran filed in support of the motion for attorneys' fees. But, without the assistance of an expert or at least an attorney's explicit and specific assertion about the import of an article, comprehending the relevance of any article is difficult.
From the information available to Mr. Cochran before he filed the petition, including medical records from Dr. Arkin and Dr. Wolf, Mr. Cochran knew or should have known, in the words of Dr. Mason, that Ms. Stokes presents "a very complicated case with complicated medical decision-making to say the very least." Exhibit 13 at 7. This apparent complication should have led Mr. Cochran to conduct additional diligence before filing the petition. This diligence could have (and probably would have) revealed that there was not a reasonable basis for the claim that the HPV vaccination caused Ms. Stokes's lymphadenopathy.
Ms. Stokes's claim was not supported by a reasonable basis. The April 6, 2015 motion for attorneys' fees and costs is DENIED.
The Clerk's Office is instructed to send this decision to the last known address for Ms. Stokes. In addition, when this decision becomes available on the court's website (see footnote 1, above), the Clerk's Office shall transmit a courtesy copy of this decision to Ms. Stokes's former counsel by facsimile or email.
At first blush, the "totality of the circumstances" may seem different from the undersigned special master's approach to look at the evidence. However, the issues the former Chief Judge identified as part of the totality of the circumstances are, generally speaking, issues resolved by analyzing evidence. The primary point of departure between the two opinions in
