Friedman v. Fed. Aviation Admin.
Opinion
*1094
For the second time, Eric Friedman, a type-one diabetic and aspiring commercial pilot, challenges the Federal Aviation Administration's refusal to grant him a medical certificate required for commercial flight. Because Friedman uses insulin to manage his blood sugar, the FAA required him to submit data from a relatively new method of blood-glucose testing known as continuous glucose monitoring (CGM), which Friedman declined to provide. In a prior decision, our court held that the FAA "ha[d] not borne its burden of justification" for requiring CGM data.
Friedman v. FAA
(
Friedman I
),
I.
The opinion in
Friedman I
describes the background of this case.
Friedman I
,
Congress has directed the FAA to promulgate regulations that "promote safe flight of civil aircraft,"
Under FAA regulations, some medical conditions, including diabetes treated with insulin, are presumptively disqualifying for any class of medical certificate.
*1095
Special Issuance of Third-Class Airman Medical Certificates to Insulin-Treated Diabetic Airman Applicants,
Notwithstanding this presumptive disqualification, FAA regulations provide that, "[a]t the discretion of the Federal Air Surgeon," the agency may grant a "Special Issuance" medical certificate to any applicant who shows an ability to safely perform all authorized duties "to the satisfaction of the ... Air Surgeon."
Although the Air Surgeon has never granted a special-issuance first- or second-class medical certificate to an insulin-treated diabetic, the FAA announced in 2013 that it "hope[d] that in the future [it] may be able to ... safely certificate ... a subset of [insulin-treated diabetics]" at the first- and second-class level, and asked the American Diabetes Association (ADA) to form an expert panel "to investigate the possibility of identifying" such diabetics. Letter from Michael P. Huerta, Administrator, FAA, to Robert Ratner, Chief Scientific & Medical Officer, ADA (July 15, 2013), Joint Appendix (J.A) 416. In its report, the panel recommended a protocol for identifying low-risk insulin-treated diabetics and concluded that for such pilots "there is no incremental risk of permitting [them] to fly." ADA, Expert Panel Recommendations for Pilots with Insulin-Treated Diabetes 6 (2015), J.A. 368.
The FAA declined to adopt the recommended protocol, explaining that it found the panel's recommendations lacking in "evidentiary support" and neither "operationally feasible" nor sensitive to commercial pilots' "real-world challenges." Letter from James R. Fraser, Federal Air Surgeon, FAA, to Robert Ratner, Chief Scientific & Medical Officer, ADA (Apr. 9, 2015), J.A. 447. The FAA also believed that the panel's protocol was too lax, as it would have allowed certification of pilots with blood-glucose levels "outside the normal glycemic range at least 20 percent of the time."
In April 2015, Petitioner, Eric Friedman, an insulin-treated diabetic who currently holds a special-issuance third-class medical certificate, applied to upgrade his certificate to first class. After receiving Friedman's application, the FAA requested blood-glucose testing results either from finger-stick testing, which involves pricking a finger and using a glucometer to test extracted blood, or "if applicable," from CGM, a newer and less commonly used method of blood-glucose testing that measures glucose levels continuously using a subcutaneously inserted sensor and a small, wearable device. Letter from James R. De Voll, Medical Appeals Manager, FAA, to Eric Friedman (Apr. 30, 2015), J.A. 73.
In response, Friedman provided only finger-stick data, explaining that he does not use CGM. Over the next several months, the FAA again suggested-and later demanded-that Friedman provide CGM data for a minimum of 90 days, eventually warning that failure to do so would result in denial of his application. Friedman reiterated that he does not use a CGM device "because neither of [his] treating physicians ... has found ... [the *1096 device] is clinically indicated or medically necessary." Letter from Eric Friedman to James R. De Voll, Medical Appeals Manager, FAA (Nov. 6, 2015), J.A. 42. Friedman also pointed out that the ADA expert panel had recommended against CGM's use due to its tendency to "record transient postprandial spikes in glucose levels," which are "of no clinical significance." ADA, Expert Panel Recommendations for Pilots with Insulin-Treated Diabetes 7 n.ii, J.A. 369. The panel itself wrote in support of Friedman's application, stating that although CGM is "useful in identifying trends" in blood-glucose levels, it is less accurate than fingerstick monitoring and thus neither necessary nor appropriate for medical certification decisions. Letter from Daniel Lorber, on behalf of ADA Expert Panel, to James Fraser, Federal Air Surgeon, FAA (Nov. 6, 2015), J.A. 65-66. Unconvinced, the FAA informed Friedman that it was "unable to proceed with" his application "until [it] receive[d] the information previously requested." Letter from James R. De Voll, Medical Appeals Manager, FAA, to Eric Friedman (Dec. 1, 2015), J.A. 53.
Friedman then filed a petition for review in this court, in which he claimed that the FAA's denial violated the Administrative Procedure Act (APA),
Two months later, on January 27, 2017, the FAA sent Friedman a letter "in response to the D.C. Circuit's decision." Letter from Michael A. Berry, Federal Air Surgeon, FAA, to Eric Friedman (Jan. 27, 2017), J.A. 439 ("January 27 Letter"). The FAA began by explaining that although it "ha[s] not allowed special issuance first- or second-class medical certification for [insulin-treated diabetics]," its "goal" was to change that, and "[t]o that end," it was "working to develop an evidence-based framework."
Current studies of the safety and efficacy of CGM devices ... show ... that ... hypoglycemia remains common and frequently goes unrecognized by traditional finger-stick testing. Thus, self-monitoring using finger-stick testing alone is not an adequate mitigation strategy for operations requiring a first- or second-class medical certificate.
Because it is impossible to know the true extent of glycemic variability through self-monitoring with traditional "finger-stick" tests, we have determined that a fixed period (90 days) of CGM is *1097 necessary in order to consider your eligibility for an Authorization for special issuance of a first-class medical certificate. The CGM data that we have requested will be reviewed for evidence of glycemic control and stability, as well as to evaluate the potential use of CGM as risk mitigation during operations requiring a first- or second-class medical certificate.
In this petition for review, Friedman argues that the FAA "still fails to articulate a defensible rationale for denying [his] application." Pet'r's Br. 2. Again arguing that the FAA has violated both the APA and the Pilot's Bill of Rights, Friedman urges us to "remand for the FAA to (finally) grant [him] a first-class medical certificate." Id. at 3. The ADA has filed an amicus brief in support of Friedman.
II.
At the outset, we emphasize the narrowness of the issue before us. Because the FAA sent its January 27 letter in response to this court's remand, the only question we must answer is whether it has "fill[ed] the analytical gap identified in [our] opinion."
Heartland Regional Medical Center v. Leavitt
,
Friedman insists that the explanation the FAA provided in its January 27 letter is "no better" than that considered in
Friedman I
. Pet'r's Br. 28. This is inaccurate. In
Friedman I
, the FAA had simply demanded, without explanation, that Friedman submit CGM data. Not until its brief before this court did the FAA provide a reason, namely that the ADA panel had acknowledged CGM's value. But as we pointed out, the FAA "overstate[d] the usefulness of this concession," given the panel's conclusion that CGM was inappropriate for this purpose.
Friedman I
,
By contrast, in its January 27 letter, the FAA provided its own, unequivocal medical explanation for requiring CGM data: that such data is needed to detect hypoglycemic episodes that could well be missed by traditional finger-stick monitoring. "Current studies of the safety and efficacy of CGM
*1098
devices," the FAA explained, show that "hypoglycemia remains common and frequently goes unrecognized by traditional finger-stick testing." January 27 Letter, J.A. 439-40. As a result, "self-monitoring using finger-stick testing alone is not an adequate mitigation strategy for operations requiring a first- or second-class medical certificate."
This explanation, moreover, finds support in the administrative record. In contrast to
Friedman I
, where there was a "complete absence of a relevant administrative record to review,"
Friedman I
,
Friedman argues that CGM is an "inappropriate" source of data because it records clinically insignificant spikes in blood glucose and tends to lag behind and differ from finger-stick values. Pet'r's Br. 22; see also id. at 9-10. He fails, however, to explain how these limitations, acknowledged by the FAA, undermine the agency's intended use of CGM data: to "augment" the finger-stick data that Friedman has already provided "to confirm his assertion that he can recognize and appropriately respond to hypoglycemic episodes." Resp't's Br. 31-32; see also January 27 Letter, J.A. 440 ("[S]elf-monitoring using finger-stick testing alone is not an adequate mitigation strategy." (emphasis added) ).
Next, pointing out that "none [of the studies] addresses the medical evaluation of pilots with [insulin-treated diabetes]," Pet'r's Br. 22, Friedman maintains that the only word on the subject is that of the expert panel, which, he insists, was surely aware of the studies the FAA cites, yet concluded that "CGM data is unnecessary," id. The FAA, however, was not bound by the expert panel's assessment: "When specialists express conflicting views, an agency must have discretion to rely on the reasonable opinions of its own qualified experts."
*1099
Marsh v. Oregon Natural Resources Council
,
Finally, Friedman claims that there is no reason to believe that the FAA relied on the studies it cites, as it "did not identify
any
medical studies in its terse January 2017 Letter." Pet'r's Reply Br. 14. From our perspective, it certainly would have been helpful for the FAA to have elaborated on its generic reference to "current studies." But aided by the FAA's brief, which cites and explains the relevant studies, we can "discern" the basis for its decision.
BellSouth Corp. v. FCC,
We can easily dispose of Friedman's claims under the Pilot's Bill of Rights. That statute provides, in part, that the "[g]oals of the [FAA]'s medical certification process are ... to give medical standards greater meaning by ensuring the information requested aligns with present-day medical judgment and practices" and "to ensure that ... the application of such medical standards provides an appropriate and fair evaluation of an individual's qualifications." Pilot's Bill of Rights, Pub. L. No. 112-153, § 4(b),
III.
For the foregoing reasons, we deny the petition for review. In doing so, we have taken the FAA at its word: that it is "working to develop an evidence-based framework" to allow special issuance of first- and second-class medical certificates to certain insulin-treated diabetics, January 27 Letter, J.A. 439, and that "should Mr. Friedman's CGM data corroborate his *1100 assertion" that he "does not pose a risk while he is in the cockpit," he will receive a certificate, Oral Argument 31:55-33:15, 38:32-40.
So ordered.
Reference
- Full Case Name
- Eric FRIEDMAN, Petitioner v. FEDERAL AVIATION ADMINISTRATION, Respondent
- Cited By
- 3 cases
- Status
- Published