Case: 23-60167 Document: 134 Page: 1 Date Filed: 06/12/2023
`
`No. 23-60167
`
`IN THE
`United States Court of Appeals
`FOR THE FIFTH CIRCUIT
`
`ILLUMINA, INC. AND GRAIL, INC.,
`
`v.
`FEDERAL TRADE COMMISSION,
`
`Petitioners,
`
`Respondent.
`
`PETITION FOR REVIEW OF
`AN ORDER OF THE FEDERAL TRADE COMMISSION
`
`BRIEF OF AMICI CURIAE
`MILITARY ORDER OF THE PURPLE HEART AND
`THE NATIONAL TRAUMA EDUCATION AND POLICY INSTITUTE
`IN SUPPORT OF PETITIONERS
`
`STEVEN A. ENGEL
`M. SCOTT PROCTOR
`DECHERT LLP
`1900 K Street, NW
`Washington, DC 20006-1110
`Phone: (202) 261-3300
`Fax: (202) 261-3333
`steven.engel@dechert.com
`scott.proctor@dechert.com
`
`MICHAEL H. MCGINLEY
` Attorney of Record
`ANTHONY R. JADICK
`DECHERT LLP
`Cira Centre
`2929 Arch Street
`Philadelphia, PA 19104
`Phone: (215) 994-2000
`Fax: (215) 994-2222
`michael.mcginley@dechert.com
`anthony.jadick@dechert.com
`
`Counsel for Amici Curiae
`
`

`

`Case: 23-60167 Document: 134 Page: 2 Date Filed: 06/12/2023
`
`CERTIFICATE OF INTERESTED PERSONS
`
`Illumina, Inc. v. Federal Trade Commission, No. 23-60167
`
`The undersigned counsel of record certifies that the following listed persons
`
`and entities as described in the fourth sentence of 5th CIR. Rule 28.2.1 have an
`
`interest in the outcome of this case. These representations are made in order that the
`
`judges of this Court may evaluate possible disqualification or recusal.
`
`1.
`
`Illumina, Incorporated, Defendant-Appellant, represented by:
`
`David R. Marriott,
`Sharonmoyee Goswami,
`Christine A. Varney,
`Jesse M. Weiss,
`Michael J. Zaken,
`Antony L. Ryan,
`Benjamin A. Atlas
`CRAVATH, SWAINE & MOORE LLP
`
`2.
`
`GRAIL, Incorporated, now known as GRAIL, L.L.C., Defendant-
`
`Appellant, represented by:
`
`Gregory G. Garre,
`Michael G. Egge,
`Marguerite M. Sullivan,
`Anna M. Rathbun,
`David L. Johnson,
`
`Alfred C. Pfeiffer, Jr.
`LATHAM & WATKINS LLP
`
`3.
`
`Federal Trade Commission, Plaintiff-Appellee, represented by:
`
`Anisha S. Dasgupta,
`Joel Marcus-Kurn,
`Matthew M. Hoffman
`
`
`
`i
`
`

`

`Case: 23-60167 Document: 134 Page: 3 Date Filed: 06/12/2023
`
`FEDERAL TRADE COMMISSION
`
`5. Washington Legal Foundation, Amicus Curiae, represented by:
`
`John M. Masslon II,
`Cory L. Andrews
`WASHINGTON LEGAL FOUNDATION
`
`6. Military Order of the Purple Heart, Amicus Curiae, represented by:
`
`Steven A. Engel
`Michael H. McGinley
`M. Scott Proctor
`Anthony R. Jadick
`DECHERT LLP
`
`The Military Order of the Purple Heart is a congressionally chartered United
`
`States war veterans organization headquartered in the District of Columbia. The
`
`Order has no parent corporation, and no publicly held company has 10% or greater
`
`ownership in the Order.
`
`7.
`
`The National Trauma and Education Policy Institute, Amicus
`
`Curiae, represented by:
`
`Steven A. Engel
`Michael H. McGinley
`M. Scott Proctor
`Anthony R. Jadick
`DECHERT LLP
`
`The National Trauma and Education Policy Institute is a nonprofit, tax-
`
`exempt organization incorporated in Silver Spring, Maryland. The Institute has no
`
`ii
`
`

`

`Case: 23-60167 Document: 134 Page: 4 Date Filed: 06/12/2023
`
`parent corporation, and no publicly held company has 10% or greater ownership in
`
`the Institute.
`
`8.
`
`The Chamber of Commerce of the United States, Amicus Curiae,
`
`represented by:
`
`Tyler S. Badgley
`Jordan L. Von Bokern
`U.S. CHAMBER LITIGATION CENTER
`
`Jeffrey M. Harris
`Frank H. Chang
`CONSOVOY MCCARTHY PLLC
`
`Dated: June 12, 2023
`
`
`
`/s/ Michael H. McGinley
`Michael H. McGinley
`DECHERT LLP
`Cira Centre
`2929 Arch Street
`Philadelphia, PA 19104
`Phone: (215) 994-2000
`Fax: (215) 994-2222
`michael.mcginley@dechert.com
`
`Attorney of record for Amici Curiae
`
`iii
`
`

`

`Case: 23-60167 Document: 134 Page: 5 Date Filed: 06/12/2023
`
`TABLE OF CONTENTS
`
`Page
`CERTIFICATE OF INTERESTED PERSONS ......................................................... i
`STATEMENT OF COMPLIANCE WITH FEDERAL RULE OF
`APPELLATE PROCEDURE 29 .............................................................................. ix
`INTEREST OF AMICI CURIAE ............................................................................... 1
`INTRODUCTION AND SUMMARY OF ARGUMENT ........................................ 3
`ARGUMENT ............................................................................................................. 5
`I.
`The Illumina-Grail Vertical Merger Will Save Veterans’ Lives. ......... 5
`A.
`Veterans Face a Higher Rate of Cancer than Their Civilian
`Counterparts. ............................................................................... 5
`By Enhancing Early Detection, Galleri Promises to Prolong and
`Improve Veterans’ Lives. ............................................................ 7
`The Illumina-Grail Vertical Merger Will Improve the Department of
`Veterans Affairs’ Overall Effectiveness. ............................................ 10
`A.
`Access to the Galleri Test Will Improve the VA’s Ability to
`Care for Veterans. ..................................................................... 11
`Access to the Galleri Test Will Further VA Policy Goals. ....... 15
`B.
`CONCLUSION ........................................................................................................ 18
`CERTIFICATE OF COMPLIANCE ....................................................................... 19
`CERTIFICATE OF SERVICE ................................................................................ 20
`
`B.
`
`II.
`
`iv
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`

`

`Case: 23-60167 Document: 134 Page: 6 Date Filed: 06/12/2023
`
`TABLE OF AUTHORITIES
`
`CASES
`Comcast Cable Commc’ns, LLC v. FCC,
`717 F.3d 982 (D.C. Cir. 2013) (Kavanaugh, J., concurring) ................................ 3
`STATUTES
`36 U.S.C. § 140501 et seq. ......................................................................................... 1
`36 U.S.C. § 140502(b)(4), (5) .................................................................................... 1
`36 U.S.C. § 140503 .................................................................................................... 1
`LEGISLATIVE MATERIALS
`Honoring Our PACT Act of 2022,
` Pub. L. No. 117-168, 136 Stat. 1789 (2022) ..................................................... 15
`Honoring Our PACT Act of 2022 § 103 .................................................................. 15
`Honoring Our PACT Act of 2022 § 604 .................................................................. 15
`Honoring Our PACT Act of 2022 § 704 .................................................................. 15
`Honoring Our PACT Act of 2022 § 902 .................................................................. 15
`OTHER AUTHORITIES
`Ady Oster & Andrew B. Bindman, Emergency Department Visits for Ambulatory
`Care Sensitive Conditions: Insights into Preventable Hospitalizations, 41 MED.
`CARE 198 (Feb. 2003) ......................................................................................... 12
`Amir A. Tabriz A et al., Trends and Characteristics of Potentially Preventable
`Emergency Department Visits Among Patients With Cancer in the US, 6 JAMA
`NETW. OPEN e2250423 (Jan. 2023) .................................................................... 12
`Angela B. Mariotto et al., Medical Care Costs Associated with Cancer
`Survivorship in the United States, 29 CANCER EPIDEMIOL. BIOMARKERS &
`PREV. 1304 (July 2020) ....................................................................................... 11
`
`v
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`

`

`Case: 23-60167 Document: 134 Page: 7 Date Filed: 06/12/2023
`
`Courtney Franchio, Cancer Screenings Save Lives, VA News (Oct. 27, 2021),
`http://bit.ly/3J8C2Px (last accessed June 4, 2023) ............................................... 7
`Dave Philipps, For Suicidal Veterans, a Frayed Lifeline, N.Y. TIMES (July 17,
`2016), https://nyti.ms/3J9k13L ........................................................................... 11
`David Crosby et al., Early Detection of Cancer, 375 SCIENCE 1244 (Mar. 2022),
`available at https://bit.ly/3CkZ41X ...................................................................... 7
`David Mosher, Trends in DoD’s and VA’s Budgets for Military Compensation
`(Mar. 22, 2023, Cong. Budget Office), available at http://bit.ly/3P7Wxzt ....... 13
`Department of Defense, Study on the Incidence of Cancer Diagnosis and Mortality
`among Military Aviators and Aviation Support Personnel (Feb. 8, 2023),
`http://bit.ly/3p2v6fS .......................................................................................... 6, 7
`Department of Veterans Affairs, Spotlight on Cancer Research (Oct. 2021),
`http://bit.ly/3Noy5Zz ........................................................................................... 5
`Department of Veterans Affairs, VA MISSION Act: What is the Latest on
`Community Care? (Apr. 2019), https://bit.ly/43zToNg; .................................... 15
`Department of Veterans Affairs, VA Research on Cancer, http://bit.ly/3X3Ckgn
`(last accessed June 3, 2023) ............................................................................... 16
`Department of Veterans Affairs, Veterans Benefits Administration Reports,
`Appeals Modernization Act Comprehensive Plan and
`Reporting, https://bit.ly/3oVSk7B (last accessed June 3, 2023) ........................ 15
`Department of Veterans Affairs, Veterans’ Diseases Associated with Agent
`Orange, http://bit.ly/43UYKm9 (last accessed June 3, 2023) .............................. 6
`Donald Musa et al., Trust in the Health Care System and the Use of Preventive
`Health Services by Older Black and White Adults, 99 AM. J. PUB. HEALTH 1293
`(July 2009) .......................................................................................................... 16
`Empowerment Behavioral Services, National Trauma Education and Policy
`Institute, https://bit.ly/461ZHv0 (last accessed June 10, 2023) ............................ 2
`Erika L. Sabbath et al., Preventive Care Utilization: Association with Individual-
`and Workgroup-Level Policy and Practice Perceptions, 111 PREV. MED. 235
`(June 2018) .......................................................................................................... 10
`
`vi
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`Case: 23-60167 Document: 134 Page: 8 Date Filed: 06/12/2023
`
`Galleri, Types of Cancer Detected, http://bit.ly/3X5W7M3 (last accessed June 7,
`2023) ..................................................................................................................... 8
`Girish Putcha G. et al., Multicancer Screening: One Size Does Not Fit All, 5 JCO
`PRECIS. ONCOL. 574 (Nov. 2021) ......................................................................... 7
`Grace C. Hillyer et al., Positive Attitudes Toward Clinical Trials Among Military
`Veterans Leaves Unanswered Questions About Poor Trial Accrual, 48 SEMIN.
`ONCOL. 130 (May 2021) ..................................................................................... 14
`Hermann Faller et al., Effects of Psycho-Oncologic Interventions on Emotional
`Distress and Quality of Life in Adult Patients with Cancer: Systematic Review
`and Meta-Analysis, 31 J. CLIN. ONCOL. 782 (Feb. 2013) .................................... 8
`Jerry SH Lee et al., From Discovery to Practice and Survivorship: Building a
`National Real-World Data Learning Healthcare Framework for Military and
`Veteran Cancer Patients, 6 CLIN. PHARMACOL. THER. 52 (Jul. 2019) ......... 11, 16
`John E. Till et al., Asbestos Exposure and Mesothelioma Mortality among Atomic
`Veterans, 98 INT’L J. RADIATION BIOLOGY 1 (Sept. 2018) ................................... 7
`K. Robin Yabroff et al., Economic Burden of Cancer in the U.S.: Estimates,
`Projections, and Future Research, 20 CANCER EPIDEMIOL. BIOMARKERS &
`PREV. 2006, 2008 (Oct. 2011) ............................................................................ 10
`Kangmin Zhu et al., Cancer Incidence in the U.S. Military Population:
`Comparison with Rates from the SEER Program, 18 CANCER EPIDEMIOL.
`BIOMARKERS PREV. 1740 (2009) .......................................................................... 5
`Leslie R. Martin et al., The Challenge of Patient Adherence, 1 THERAPEUTICS AND
`CLINICAL RISK MGMT. 189 (Oct. 2005) ................................................................ 9
`Mesothelioma Veterans Center, Asbestos on Frigates, http://bit.ly/3N22j3g (last
`accessed June 6, 2023) .......................................................................................... 7
`The Military Order of the Purple Heart, About: The Purple Heart,
`http://bit.ly/3NmWxuo (last accessed June 10, 2023) .......................................... 2
`National Academies of Sciences, Engineering, and Medicine, Committee to
`Review the Health Effect in Vietnam Veterans of Exposure to Herbicides, A
`Consensus Study Report, Veterans and Agent Orange: Update 11 (2018)
`(2018), http://bit.ly/3N30dAb ............................................................................. 16
`
`vii
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`Case: 23-60167 Document: 134 Page: 9 Date Filed: 06/12/2023
`
`National Cancer Inst., Clinical Trials Information for Patients and Caregivers,
`http://bit.ly/3PfTvt0 (last accessed June 3, 2023) ............................................... 14
`News Release, Department of Veterans Affairs, Secretary McDonough Statement
`on FY 2023 Budget (Mar. 28, 2022), http://bit.ly/42uNk7y .............................. 12
`News Release, H.R. 6092, 116th Cong., Veterans Prostate Cancer Treatment and
`Research Act (2020), H. Comm. on Veterans’ Affairs, https://bit.ly/3qALF34 .. 5
`Patrick Richard et al., The Financial Burden of Cancer on Families in the United
`States, 18 INT’L J ENVT’L RES. PUBLIC HEALTH 3790 (Apr. 2021) ...................... 9
`U.S. Department of Veterans Affairs, Celebrating America’s Freedoms: The
`Purple Heart, http://bit.ly/3JatlnI ......................................................................... 1
`
`viii
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`Case: 23-60167 Document: 134 Page: 10 Date Filed: 06/12/2023
`
`STATEMENT OF COMPLIANCE WITH
`FEDERAL RULE OF APPELLATE PROCEDURE 29
`All parties have consented to the filing of this brief. No counsel for a party
`
`authored any part of this brief. No party, party’s counsel or any person other than
`
`the amici curiae or their counsel contributed money that was intended to finance the
`
`preparation or submission of this brief.
`
`ix
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`Case: 23-60167 Document: 134 Page: 11 Date Filed: 06/12/2023
`
`INTEREST OF AMICI CURIAE
`In 1782, then-General George Washington ordered the creation of a new
`
`military award. Fashioned in “the figure of a heart in purple cloth, or silk,” it was to
`
`be awarded to those who exhibited “unusual gallantry” in the field or rendered
`
`“extraordinary fidelity and essential service” to their country. U.S. Department of
`
`Veterans Affairs, Celebrating America’s Freedoms: The Purple Heart,
`
`http://bit.ly/3JatlnI (last accessed June 10, 2023) (quoting Washington’s 1782
`
`order). After the Revolutionary War ended, the award fell into disuse for 150 years.
`
`Then, in 1932, President Franklin D. Roosevelt revived it. He ordered that the
`
`military bestow it upon those wounded or killed in combat. Id.
`
`The Military Order of the Purple Heart was formed the same year that
`
`President Roosevelt revived the award. Id. Today, it is congressionally chartered.
`
`See 36 U.S.C. §140501 et seq. By statute, all members of the Order must have
`
`received the decoration, making it the only veteran service organization composed
`
`entirely of combat veterans. Id. §140503. The Order exists to protect the interests
`
`of all combat-wounded veterans by, among other things, “assisting, comforting, and
`
`aiding all needy and distressed members and their dependents” and “giving needed
`
`hospital and service work through its Department of Veterans Affairs certified
`
`service officers.” Id. §140502(b)(4), (5); see also The Military Order of the Purple
`
`1
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`

`

`Case: 23-60167 Document: 134 Page: 12 Date Filed: 06/12/2023
`
`Heart, About: The Purple Heart, http://bit.ly/3NmWxuo (last accessed June 10,
`
`2023).
`
`The Order’s interest in the Illumina-Grail vertical merger stems from the fact
`
`that tens of thousands of veterans, including many who have received the Purple
`
`Heart, are diagnosed with cancer every year. Their diagnoses often come too late
`
`for effective treatment. Grail’s product, Galleri, promises to provide a non-invasive
`
`test for a host of the cancers from which these veterans suffer. And Illumina
`
`produces the inputs that the Galleri test uses. Their merger would speed up the
`
`widespread production, distribution, and use of the Galleri test. Once widely
`
`available, the test will help diagnose cancer in veterans early, saving or improving
`
`their lives. The Order thus has an interest in seeing Galleri sped to market because
`
`it will “assist[], comfort[], and aid[]” many “needy and distressed” veterans. Id.
`
`The National Trauma Education and Policy Institute too has an interest in this
`
`case. Among other things, the Institute seeks to influence and improve how U.S.
`
`communities identify and treat trauma of all types, including the trauma suffered by
`
`veterans afflicted with cancer. See Empowerment Behavioral Services, National
`
`Trauma Education and Policy Institute, https://bit.ly/461ZHv0 (last accessed June
`
`10, 2023). Like the Order, the Institute expects that the Illumina-Grail vertical
`
`merger will speed up the widespread distribution and use of Galleri, which will help
`
`reduce the harm that cancer inflicts on the veteran community.
`
`2
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`

`

`Case: 23-60167 Document: 134 Page: 13 Date Filed: 06/12/2023
`
`INTRODUCTION AND SUMMARY OF ARGUMENT
`The Illumina-Grail merger would significantly improve the lives of this
`
`Nation’s veterans, who disproportionately suffer from cancer and thus would acutely
`
`benefit from the early screening test that this merger would speed to market.
`
`The merger would vertically integrate a producer of blood-based cancer tests
`
`with the company that supplies the inputs for the tests. Unlike horizontal mergers,
`
`which can in certain circumstances risk concentrating market power in few
`
`participants, vertical mergers typically benefit consumers. They “encourage product
`
`innovation, lower costs for businesses, and create efficiencies—and thus reduce
`
`prices and lead to better goods and services for consumers.” Comcast Cable
`
`Commc’ns, LLC v. FCC, 717 F.3d 982, 990 (D.C. Cir. 2013) (Kavanaugh, J.,
`
`concurring). Consumers then enjoy cheaper, better products and services. Id.
`
`The Illumina-Grail vertical merger would yield precisely those beneficial
`
`results. Illumina “is a global leader in next-generation sequencing (‘NGS’).”
`
`Illumina Br. at 5.1 Grail makes a blood test, called Galleri, that uses NGS technology
`
`to “detect more than 50 cancer types in asymptomatic patients from a single blood
`
`draw.” Id. at 6. As Petitioners explain, the merger would spur innovation and reduce
`
`costs by enabling Galleri to be brought to market more efficiently. See, e.g., id. at 7–
`
`1 Amici cites Petitioners’ brief filed on June 5, 2023. As of the time of this filing,
`Petitioners have not filed a subsequent brief.
`3
`
`

`

`Case: 23-60167 Document: 134 Page: 14 Date Filed: 06/12/2023
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`8, 70–71. And that will accelerate Galleri’s widespread availability—which will
`
`save countless lives.
`
`Veterans in particular stand to benefit. Military service calls on those who
`
`serve to hazard many dangers. Some of those dangers are familiar and tangible, such
`
`as those faced in combat. But other dangers are subtle and insidious. Millions of
`
`veterans answered the call to duty by serving in locales or aboard platforms rife with
`
`carcinogens. Today, those veterans face significantly higher cancer risks than their
`
`civilian peers, and they rely on the United States Department of Veterans Affairs
`
`(“VA”) to help them detect and then combat those cancers. But the VA’s resources
`
`are limited, and many cancers are difficult to detect until it is too late. By speeding
`
`Galleri to market, the Illumina-Grail merger promises both to help mitigate cancer
`
`risks through early detection and treatment and to save the VA resources that it could
`
`then use to improve veteran medical care generally.
`
`4
`
`

`

`Case: 23-60167 Document: 134 Page: 15 Date Filed: 06/12/2023
`
`I.
`
`ARGUMENT
`The Illumina-Grail Vertical Merger Will Save Veterans’ Lives.
`A.
`Veterans Face a Higher Rate of Cancer than Their Civilian
`Counterparts.
`Statistics show that cancer strikes veterans harder than their peers. For
`
`example, studies have shown breast cancer rates are 20% to 40% higher among
`
`veterans than among the general population. See Kangmin Zhu et al., Cancer
`
`Incidence in the U.S. Military Population: Comparison with Rates from the SEER
`
`Program, 18 CANCER EPIDEMIOL. BIOMARKERS PREV. 1740 (2009). Veteran
`
`prostate cancer rates have been found to be double those in the general population,
`
`with an estimated 1 in 5 male veterans expected to suffer from prostate cancer in
`
`their lifetime. Id.; see also News Release, H.R. 6092, 116th Cong., Veterans
`
`Prostate Cancer Treatment and Research Act (2020), H. Comm. on Veterans’
`
`Affairs, https://bit.ly/3qALF34. Overall, approximately 50,000 veterans are
`
`diagnosed with cancer every year. Department of Veterans Affairs, Spotlight on
`
`Cancer Research (Oct. 2021), http://bit.ly/3Noy5Zz (hereinafter “VA Spotlight on
`
`Cancer Research”).
`
`Veterans face these heightened cancer risks because they answered the call to
`
`safeguard our liberties wherever and whenever necessary. Often, their duties took
`
`them to inhospitable environments. Infantrymen advancing across burning Middle
`
`Eastern deserts, crewmen strapped to jumpseats of heavy-lift aircraft, and enginemen
`
`5
`
`

`

`Case: 23-60167 Document: 134 Page: 16 Date Filed: 06/12/2023
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`sweating in the bowels of a ship’s main space all endured heat, cold, fatigue, and
`
`extreme discomfort. And, too often, they endured exposure to hazards that
`
`permeated the environments in which they served.
`
`As one example, consider the land force’s exposure to Agent Orange during
`
`the Vietnam conflict. During that conflict, U.S. aircraft drenched the Vietnamese
`
`jungles in the defoliant Agent Orange to deprive enemy soldiers of cover. U.S.
`
`servicemembers inhaled it alongside their enemy. Today, the VA recognizes an
`
`association between exposure to Agent Orange and an increased risk of developing
`
`various types of cancer, including non-Hodgkin lymphoma, soft tissue sarcomas,
`
`and certain respiratory cancers. Department of Veterans Affairs, Veterans’ Diseases
`
`Associated with Agent Orange, http://bit.ly/43UYKm9 (last accessed June 3, 2023).
`
`For another example, consider the air service’s exposure to military
`
`chemicals. A comprehensive yearlong study conducted by the Pentagon examined
`
`900,000 service members who either flew on or worked with military aircraft
`
`between 1992 and 2017. Department of Defense, Study on the Incidence of Cancer
`
`Diagnosis and Mortality among Military Aviators and Aviation Support Personnel
`
`(Feb. 8, 2023), http://bit.ly/3p2v6fS. The findings revealed that aircrew members
`
`experienced an 87% higher rate of melanoma and a 39% higher rate of thyroid
`
`cancer. Further, within this study, men exhibited a 16% higher rate of prostate
`
`cancer, while women showed a 16% higher rate of breast cancer. Overall, the study
`
`6
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`

`

`Case: 23-60167 Document: 134 Page: 17 Date Filed: 06/12/2023
`
`concluded that veterans who served as aircrew members experienced a 24% increase
`
`in cancer diagnoses. Id. at 4, 16.
`
`For a third example, take the sea service’s exposure to asbestos. Navy ships
`
`employed asbestos to mitigate fire risks. See Mesothelioma Veterans Center,
`
`Asbestos on Frigates, http://bit.ly/3N22j3g (last accessed June 6, 2023). Studies link
`
`asbestos to higher cancer death rates among machinist’s mates, boiler technicians,
`
`pipe fitters, and other ratings who worked in spaces containing asbestos. See John
`
`E. Till et al., Asbestos Exposure and Mesothelioma Mortality among Atomic
`
`Veterans, 98 INT’L J. RADIATION BIOLOGY 1 (Sept. 2018).
`
`B.
`
`By Enhancing Early Detection, Galleri Promises to Prolong and
`Improve Veterans’ Lives.
`Needless to say, the “earlier a cancer is diagnosed, the better the outcome” for
`
`the cancer patient. See Courtney Franchio, Cancer Screenings Save Lives, VA News
`
`(Oct. 27, 2021), http://bit.ly/3J8C2Px (last accessed June 4, 2023). More patients
`
`live longer when doctors identify a cancer at an early, localized stage rather than at
`
`a later, regional/metastatic stage. See David Crosby et al., Early Detection of
`
`Cancer, 375 SCIENCE 1244 (Mar. 2022), available at https://bit.ly/3CkZ41X; see
`
`also Girish Putcha G. et al., Multicancer Screening: One Size Does Not Fit All,
`
`5 JCO PRECIS. ONCOL. 574 (Nov. 2021). Unfortunately, for many cancers,
`
`physicians lack the tools to detect those diseases early. Thus, veterans, who
`
`7
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`Case: 23-60167 Document: 134 Page: 18 Date Filed: 06/12/2023
`
`disproportionately suffer from cancer, stand to disproportionately benefit from
`
`advances in cancer detection tools.
`
`As a result, the Galleri test promises to be a game-changer for veterans. As
`
`explained in Illumina’s brief, Galleri would provide a non-invasive means to detect
`
`over 50 types of cancer early on, using a simple blood test. See Illumina Br. at 6.
`
`Those would include the cancers that often strike veterans, including non-Hodgkin
`
`lymphoma, melanoma, prostate cancer, and breast cancer. See Galleri, Types of
`
`Cancer Detected, http://bit.ly/3X5W7M3 (last accessed June 7, 2023). While the
`
`VA cannot reverse the service-related exposures that cause veterans to suffer
`
`disproportionately from cancer, a test like Galleri could revolutionize how the VA
`
`catches and treats it.
`
`Moreover, the very existence of an early detection test like Galleri would
`
`improve the lives of many veterans. In addition to the myriad cancers that arise from
`
`their service, veterans often suffer from mental health issues. If a veteran’s cancer
`
`is caught early, physicians have time to integrate mental health and cancer care into
`
`a holistic care plan. Researchers have shown that doing so elevates patients’
`
`psychological well-being and overall satisfaction with care, potentially improving
`
`their overall prospect of achieving remission and returning to a normal life. See
`
`Hermann Faller et al., Effects of Psycho-Oncologic Interventions on Emotional
`
`8
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`

`

`Case: 23-60167 Document: 134 Page: 19 Date Filed: 06/12/2023
`
`Distress and Quality of Life in Adult Patients with Cancer: Systematic Review and
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`Meta-Analysis, 31 J. CLIN. ONCOL. 782 (Feb. 2013).
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`And the data collected from the early and widespread use of a test like Galleri
`
`could itself have a direct salutary effect on veterans. Psychiatrists and
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`neuroscientists have recognized that it matters what a patient believes about a
`
`diagnosis and accompanying treatment. A patient is less likely to comply with
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`cancer treatment requirements if he or she does not understand the illness’s cause,
`
`the treatment’s effects, or their connection. Leslie R. Martin et al., The Challenge
`
`of Patient Adherence, 1 THERAPEUTICS AND CLINICAL RISK MGMT. 189 (Oct. 2005).
`
`Access to the multi-cancer early detection tests—along with the better association
`
`between exposure and illness gleaned from widespread usage—can provide medical
`
`professionals with data needed to connect an illness to service, teach the veteran
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`about that connection, and encourage the veteran to stick with proven treatments.
`
`Comprehensive early screening would enhance the overall health and well-
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`being of not only veterans, but their families as well. A cancer diagnosis can also
`
`have a devastating impact on the quality of life for those who live and care for the
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`patient. See, e.g., Patrick Richard et al., The Financial Burden of Cancer on Families
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`in the United States, 18 INT’L J ENVT’L RES. PUBLIC HEALTH 3790 (Apr. 2021).
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`Early detection would promote positive treatment outcomes and minimize the
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`financial, physical, and emotional toll on veterans and their loved ones.
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`9
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`Case: 23-60167 Document: 134 Page: 20 Date Filed: 06/12/2023
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`Finally, Galleri tests would facilitate a veteran’s return to work. Cancer levies
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`a heavy toll on the U.S. economy by removing people from the workforce or, if they
`
`stay on the job, reducing their productivity. See K. Robin Yabroff et al., Economic
`
`Burden of Cancer in the U.S.: Estimates, Projections, and Future Research,
`
`20 CANCER EPIDEMIOL. BIOMARKERS & PREV. 2006, 2008 (Oct. 2011). And it levies
`
`a heavy toll on individuals who derived a livelihood and sense of purpose from their
`
`work. Veterans are no exception. With multi-cancer early screening tests like
`
`Galleri, doctors would have a better chance of detecting cancer early, optimizing
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`treatment outcomes, and minimizing the impact on veterans’ ability to work, thus
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`enhancing the overall quality of life for afflicted veterans. See Erika L. Sabbath et
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`al., Preventive Care Utilization: Association with Individual- and Workgroup-Level
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`Policy and Practice Perceptions, 111 PREV. MED. 235 (June 2018).
`
`II.
`
`The Illumina-Grail Vertical Merger Will Improve the Department of
`Veterans Affairs’ Overall Effectiveness.
`The benefits of Illumina-Grail merger will also improve the overall
`
`effectiveness of the VA by speeding the introduction of Galleri. Once in widespread
`
`use, this cancer-testing tool promises to improve the VA’s ability to care for
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`veterans, reduce costs, and further other VA policy goals.
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`10
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`Case: 23-60167 Document: 134 Page: 21 Date Filed: 06/12/2023
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`A.
`
`Access to the Galleri Test Will Improve the VA’s Ability to Care
`for Veterans.
`Early cancer screening would enable the VA to provide more and better care
`
`to veterans. Cancer treatment can be incredibly expensive—especially when
`
`detected at a later stage. The Agency for Healthcare Research and Quality’s Medical
`
`Expenditure Panel Survey estimates that, for 2019, the direct medical costs for
`
`cancer in the United States were $172.1 billion. Agency for Healthcare Research
`
`and Quality. Agency for Healthcare Research and Quality, Medical Expenditure
`
`Panel
`
`Survey
`
`(MEPS) Household Component
`
`(HC),
`
`available
`
`at
`
`http://bit.ly/3qKCzRa. And experts expect those costs to reach more than $240
`
`billion by 2030. Angela B. Mariotto et al., Medical Care Costs Associated with
`
`Cancer Survivorship in the United States, 29 CANCER EPIDEMIOL. BIOMARKERS &
`
`PREV. 1304 (July 2020).
`
`The Veterans Health Administration operates the largest integrated healthcare
`
`system in the United States, serving more than 9 million veterans annually. Jerry
`
`SH Lee et al., From Discovery to Practice and Survivorship: Building a National
`
`Real-World Data Learning Healthcare Framework for Military and Veteran Cancer
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`Patients, 6 CLIN. PHARMACOL. THER. 52 (Jul. 2019). Unsurprisingly, it is often
`
`overstretched. See, e.g., Dave Philipps, For Suicidal Veterans, a Frayed Lifeline,
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`N.Y. TIMES (July 17, 2016), https://nyti.ms/3J9k13L.
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`11
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`Case: 23-60167 Document: 134 Page: 22 Date Filed: 06/12/2023
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`The heavy cost of cancer care does not help. With 50,000 new diagnoses per
`
`year, cancer care absorbs a particularly significant portion VA resources. See also,
`
`e.g., News Release, Department of Veterans Affairs, Secretary McDonough
`
`Statement on FY 2023 Budget (Mar. 28, 2022), http://bit.ly/42uNk7y (noting that
`
`the fiscal year 2023 budget included $167 million in funds just for precision
`
`oncology). A rapid cancer screening test like Galleri would reduce the demand for
`
`intensive late-stage care among veterans, which would alleviate strain on the VA.
`
`VA hospitals and clinics could then provide more efficient and effective care for all
`
`veterans, enhancing the overall healthcare system for all those who have served our
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`country.
`
`Early cancer detection also leads to less emergency care. Emergency care is
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`costly and often less effective than preventive care and early intervention. Increased
`
`access to preventive care services might prevent a significant proportion of
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`emergency department visits by cancer patients. See, e.g., Ady Oster & Andrew B.
`
`Bindman, Emergency Department Visits for Ambulatory Care Sensitive Cond