By Dan Zhang
In Flynn v. Holder (2011), the U.S. Court of Appeals for the Ninth Circuit ruled that a common method of bone marrow donation – “peripheral blood stem cell apheresis” – did not fall under the ban on compensated organ donation under the National Organ Transplant Act (NOTA) of 1984. [1]
The plaintiffs consisted of relatives of sick persons in need of bone marrow transplantation, a medical expert on bone marrow transplantation, and a non-profit seeking to launch a program offering paid incentives for bone marrow donors. Their case against the government was brought to the U.S. Court of Appeals for the Ninth Circuit after being dismissed by the District Court for failure to state a claim upon which relief could be granted. [2]
Section 301 of NOTA places a ban on compensating organ donors, defining human organs as: “the human kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin, and any other human organ specified by the Secretary of Health and Human Services by regulation.” [3] The regulation further adds: “[the] intestine, including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract.” [4]
In Flynn v. Holder (2011), the U.S. Court of Appeals for the Ninth Circuit ruled that a common method of bone marrow donation – “peripheral blood stem cell apheresis” – did not fall under the ban on compensated organ donation under the National Organ Transplant Act (NOTA) of 1984. [1]
The plaintiffs consisted of relatives of sick persons in need of bone marrow transplantation, a medical expert on bone marrow transplantation, and a non-profit seeking to launch a program offering paid incentives for bone marrow donors. Their case against the government was brought to the U.S. Court of Appeals for the Ninth Circuit after being dismissed by the District Court for failure to state a claim upon which relief could be granted. [2]
Section 301 of NOTA places a ban on compensating organ donors, defining human organs as: “the human kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin, and any other human organ specified by the Secretary of Health and Human Services by regulation.” [3] The regulation further adds: “[the] intestine, including the esophagus, stomach, small and/or large intestine, or any portion of the gastrointestinal tract.” [4]
The plaintiffs in Flynn point out that blood is missing from this list. They argue then that there is no rational basis for permitting compensation for blood donations while prohibiting compensation for bone marrow donations, since the prohibited procedure (peripheral blood stem cell apheresis) merely extracts regenerative cells (blood stem cells) in the same way that the permitted procedure does. Given this distinction and its alleged lack of rational basis, the plaintiffs argue that the ban violates the Equal Protection Clause.
Ultimately, the court concluded that the distinction did indeed have a rational basis, due to two sets concerns: (1) policy concerns and (2) philosophical concerns.
The policy concerns cited include worries of coercion. For example, if donors could be compensated, then rich patients or the medical industry might coerce poor people to sell their organs in spite of health risks or pain for the donor. Furthermore, the court argued that extremely sick and needy patients might be vulnerable to coercive “your money or your life” offers from donors [5]. Aside from coercion, allowing compensated donation might degrade the quality of the organ supply by creating an incentive for potential donors to lie about their medical histories in order to better market their organs.
Philosophical concerns, on the other hand, stem from an “instinctive revulsion at denial of bodily integrity,” which refers to the objectification of the human body for commercial sale. [6] That is to say, compensated organ donation violates an intuitive need to preserve one’s identity and humanity.
The court concluded that these concerns do in fact demonstrate a rational basis. Judge Kleinfeld, writing for the majority, asserted that the policy and philosophical concerns were for Congress to make. [7] As long as Congress had reasons for passing legislation, then the law passes rational basis review. Furthermore, Kleinfeld noted that the basis need not be persuasive, only rational. [8] Thus, the distinction was indeed made with rational basis and therefore the NOTA prohibition on compensated bone marrow donations does not violate the Equal Protection Clause.
However, an important consideration in this case is the particular method of bone marrow donation in question – “peripheral blood stem cell apheresis.” Developed in the past twenty years, this method involves inserting a needle into a donor’s vein, withdrawing blood and using an apheresis, or “separation,” machine to extract blood stem cells. Only these cells are needed for bone marrow transplantation; the actual marrow is not harvested. Once the blood stem cells are extracted, the remainder is returned to the donor’s vein and the extracted blood stem cells are then available for use in bone marrow transplantation. The procedure is very similar to blood platelet or plasma collection procedures by apheresis. Overall, the procedure requires no sedatives or anesthesia, and complications for the donor are very rare.
When NOTA was originally passed in 1984, a process called aspiration was the dominant method of bone marrow transplantation. This involved inserting a long, thick needle into a donor’s hipbones to extract soft, fatty bone marrow. Aspiration required anesthesia and hospitalization, and donors often faced considerable risk of complications.
Peripheral blood stem cell apheresis, on the other hand, was discovered years after NOTA’s passage. The court therefore observed that Congress could not have intended to address peripheral blood stem cell apheresis when passing NOTA since the method did not exist at the time. The statute contains no prohibition on peripheral blood stem cell apheresis, and thus, the court found it was not compelled to answer the question of constitutionality. Instead, the court “must construe the words of the statute to see what they imply about the extraction of hematopoietic stem cells by this method.” [9]
The government argued that bone marrow is a statutory organ, and that the statute prohibits compensation for the donation of statutory organs and also any “subpart[s] thereof”; therefore, the blood stem cells are to be viewed as “subparts” of the bone marrow and peripheral blood stem cell apheresis falls under the NOTA ban. [10] However, the court rejected this argument because it (1) “proves too much” and (2) contradicts ordinary usage. [11]
The court found that the government’s argument actually proves that blood stem cells are not statutory “subparts” of bone marrow. Like blood stem cells, red and white blood cells are produced by bone marrow and flow freely in the blood.
In addition, the court found that the government’s argument contradicted ordinary usage of the word “bone marrow.” The government’s argument seemed to imply that any X that is produced by or contained in organ Y is a “subpart” of Y. Furthermore, any “subpart” X of Y is subject to prohibition under statute as long as Y is mentioned in the statute. According to this reasoning, blood, which is produced by bone marrow, can be considered a subpart of bone marrow and would be subject to prohibition under statute.
However, this would be a contradiction of the ordinary usage of the words “bone marrow” and “blood.” According to the court, “bone marrow” is commonly understood as “soft, fatty stuff that the needle extracts [in aspiration].” However, peripheral blood stem cell apheresis withdraws blood; therefore, the process does not involve the transplantation of “bone marrow” as per its common usage. Judge Kleinfeld noted, “[t]here is no reason to think that Congress intended ‘bone marrow’ to mean something so different from ordinary usage.” [12]
Given these arguments, the court ruled that peripheral blood stem cell apheresis did not involve a transfer of a “human organ” or “subpart thereof”; thus, compensation for this method bone marrow donation was not prohibited under NOTA.
In May 2012, the court denied the government’s petition for a rehearing. [13] However, in November 2013, the Department of Health and Human Services proposed a new regulation which would redefine bone marrow as an “organ,” thereby nullifying the Flynn decision. [14] The proposal never made it past the open comment period.
Flynn v. Holder can be considered an important win for those looking to address a shortage in the bone marrow supply, one of the nation’s more difficult health problems. Unlike blood, which exists only in four types, bone marrow exists in millions of types. As a result, finding a match between a recipient and a donor is extremely challenging. Furthermore, as a patient’s genetic or ethnic heritage becomes more diverse, the odds of finding a match become even lower. For example, the probability that two randomly selected white Americans are of matching type is less than one in 10,000; on the other hand, the probability that two randomly selected African Americans are of matching types is less than one in 100,000. [15]
Supporters of a bone marrow market assert that allowing compensation for bone marrow donation could be a potential solution to the shortage problem. Currently, the National Bone Marrow Registry assists registered potential donors and recipients in finding matches. However, matches are still difficult to find, and, even if a good match can be found, it is often difficult to track down the registered donor and to ensure he or she follows through with the donation. Supporters of a bone marrow market believe that a financial incentive will cause more donors to sign up, stay in contact, and follow through if called upon to donate.
One the other hand, Flynn v. Holder can also be seen as an overall loss for organ markets. Advocates for organ markets allege that financial incentives will solve organ and donor shortages. Advocates often cite Iran as a successful case, where legal kidney markets have had some success in reducing kidney shortages. [16] However, the court did not address the constitutionality of a prohibition on compensated organ donations. The ruling merely concluded that a particular method of bone marrow donation – peripheral blood stem cell apheresis – did not qualify as organ transplantation as defined by NOTA. Therefore, the future for organ markets in the US remains uncertain.
[1] Flynn v. Holder, No. 10-55643 D.C. No. 2:09-cv-07772-VBF-AJW. <http://cdn.ca9.uscourts.gov/datastore/opinions/2011/12/01/10-55643.pdf>
[2] National Organ Transplant Act of 1984. Pub. L. 98-507. 98 Stat. 2339. NIH. Web. 2 April 2014. <http://history.nih.gov/research/downloads/PL98-507.pdf>
[3] Ibid.
[4] Ibid.
[5] Flynn v. Holder, No. 10-55643 D.C. No. 2:09-cv-07772-VBF-AJW. <http://cdn.ca9.uscourts.gov/datastore/opinions/2011/12/01/10-55643.pdf>
[6] Ibid.
[7] Ibid.
[8] Ibid.
[9] Ibid.
[10] National Organ Transplant Act of 1984. Pub. L. 98-507. 98 Stat. 2339. NIH. Web. 2 April 2014. <http://history.nih.gov/research/downloads/PL98-507.pdf>
[11] Ibid.
[12] Ibid.
[13] Cain, Robyn Hagan. “Onward to SCOTUS? Ninth Circuit Says No to Bone Marrow Re-Hearing – Court News – U.S. Ninth Circuit.” FindLaw. Thomson Reuters, 30 Mar. 2012. Web. 1 Apr. 2014. <http://blogs.findlaw.com/ninth_circuit/2012/03/onward-to-scotus-ninth-circuit-says-no-to-bone-marrow-re-hearing.html>
[14] Sibilla, Nick. “Federal Regulation Could Refine The Word ‘Organ,’ Jeopardize Bone Marrow Donations.” Forbes.com. Forbes, Inc., 25 Nov. 2013. Web. 1 Apr. 2014. <http://www.forbes.com/sites/instituteforjustice/2013/11/25/federal-regulation-could-re-define-the-word-organ-jeopardize-bone-marrow-donations/>
[15] Bergstrom, Theodore C., Rodney J. Garratt, and Damien Sheehan-Connor. 2009. “One Chance in a Million: Altruism and the Bone Marrow Registry.” American Economics Review, 99(4): 1309-34.
[16] Hippen, Benjamin E. “Organ Sales and Moral Travails: Lessons from the Living Kidney Donor Program in Iran | Cato Institute.” Cato Institute. n.p., 20 Mar. 2008. Web. 1 Apr. 2004. <http://www.cato.org/publications/policy-analysis/organ-sales-moral-travails-lessons-living-kidney-vendor-program-iran>
Photo Credit: Flickr user Thirteen of Clubs
Ultimately, the court concluded that the distinction did indeed have a rational basis, due to two sets concerns: (1) policy concerns and (2) philosophical concerns.
The policy concerns cited include worries of coercion. For example, if donors could be compensated, then rich patients or the medical industry might coerce poor people to sell their organs in spite of health risks or pain for the donor. Furthermore, the court argued that extremely sick and needy patients might be vulnerable to coercive “your money or your life” offers from donors [5]. Aside from coercion, allowing compensated donation might degrade the quality of the organ supply by creating an incentive for potential donors to lie about their medical histories in order to better market their organs.
Philosophical concerns, on the other hand, stem from an “instinctive revulsion at denial of bodily integrity,” which refers to the objectification of the human body for commercial sale. [6] That is to say, compensated organ donation violates an intuitive need to preserve one’s identity and humanity.
The court concluded that these concerns do in fact demonstrate a rational basis. Judge Kleinfeld, writing for the majority, asserted that the policy and philosophical concerns were for Congress to make. [7] As long as Congress had reasons for passing legislation, then the law passes rational basis review. Furthermore, Kleinfeld noted that the basis need not be persuasive, only rational. [8] Thus, the distinction was indeed made with rational basis and therefore the NOTA prohibition on compensated bone marrow donations does not violate the Equal Protection Clause.
However, an important consideration in this case is the particular method of bone marrow donation in question – “peripheral blood stem cell apheresis.” Developed in the past twenty years, this method involves inserting a needle into a donor’s vein, withdrawing blood and using an apheresis, or “separation,” machine to extract blood stem cells. Only these cells are needed for bone marrow transplantation; the actual marrow is not harvested. Once the blood stem cells are extracted, the remainder is returned to the donor’s vein and the extracted blood stem cells are then available for use in bone marrow transplantation. The procedure is very similar to blood platelet or plasma collection procedures by apheresis. Overall, the procedure requires no sedatives or anesthesia, and complications for the donor are very rare.
When NOTA was originally passed in 1984, a process called aspiration was the dominant method of bone marrow transplantation. This involved inserting a long, thick needle into a donor’s hipbones to extract soft, fatty bone marrow. Aspiration required anesthesia and hospitalization, and donors often faced considerable risk of complications.
Peripheral blood stem cell apheresis, on the other hand, was discovered years after NOTA’s passage. The court therefore observed that Congress could not have intended to address peripheral blood stem cell apheresis when passing NOTA since the method did not exist at the time. The statute contains no prohibition on peripheral blood stem cell apheresis, and thus, the court found it was not compelled to answer the question of constitutionality. Instead, the court “must construe the words of the statute to see what they imply about the extraction of hematopoietic stem cells by this method.” [9]
The government argued that bone marrow is a statutory organ, and that the statute prohibits compensation for the donation of statutory organs and also any “subpart[s] thereof”; therefore, the blood stem cells are to be viewed as “subparts” of the bone marrow and peripheral blood stem cell apheresis falls under the NOTA ban. [10] However, the court rejected this argument because it (1) “proves too much” and (2) contradicts ordinary usage. [11]
The court found that the government’s argument actually proves that blood stem cells are not statutory “subparts” of bone marrow. Like blood stem cells, red and white blood cells are produced by bone marrow and flow freely in the blood.
In addition, the court found that the government’s argument contradicted ordinary usage of the word “bone marrow.” The government’s argument seemed to imply that any X that is produced by or contained in organ Y is a “subpart” of Y. Furthermore, any “subpart” X of Y is subject to prohibition under statute as long as Y is mentioned in the statute. According to this reasoning, blood, which is produced by bone marrow, can be considered a subpart of bone marrow and would be subject to prohibition under statute.
However, this would be a contradiction of the ordinary usage of the words “bone marrow” and “blood.” According to the court, “bone marrow” is commonly understood as “soft, fatty stuff that the needle extracts [in aspiration].” However, peripheral blood stem cell apheresis withdraws blood; therefore, the process does not involve the transplantation of “bone marrow” as per its common usage. Judge Kleinfeld noted, “[t]here is no reason to think that Congress intended ‘bone marrow’ to mean something so different from ordinary usage.” [12]
Given these arguments, the court ruled that peripheral blood stem cell apheresis did not involve a transfer of a “human organ” or “subpart thereof”; thus, compensation for this method bone marrow donation was not prohibited under NOTA.
In May 2012, the court denied the government’s petition for a rehearing. [13] However, in November 2013, the Department of Health and Human Services proposed a new regulation which would redefine bone marrow as an “organ,” thereby nullifying the Flynn decision. [14] The proposal never made it past the open comment period.
Flynn v. Holder can be considered an important win for those looking to address a shortage in the bone marrow supply, one of the nation’s more difficult health problems. Unlike blood, which exists only in four types, bone marrow exists in millions of types. As a result, finding a match between a recipient and a donor is extremely challenging. Furthermore, as a patient’s genetic or ethnic heritage becomes more diverse, the odds of finding a match become even lower. For example, the probability that two randomly selected white Americans are of matching type is less than one in 10,000; on the other hand, the probability that two randomly selected African Americans are of matching types is less than one in 100,000. [15]
Supporters of a bone marrow market assert that allowing compensation for bone marrow donation could be a potential solution to the shortage problem. Currently, the National Bone Marrow Registry assists registered potential donors and recipients in finding matches. However, matches are still difficult to find, and, even if a good match can be found, it is often difficult to track down the registered donor and to ensure he or she follows through with the donation. Supporters of a bone marrow market believe that a financial incentive will cause more donors to sign up, stay in contact, and follow through if called upon to donate.
One the other hand, Flynn v. Holder can also be seen as an overall loss for organ markets. Advocates for organ markets allege that financial incentives will solve organ and donor shortages. Advocates often cite Iran as a successful case, where legal kidney markets have had some success in reducing kidney shortages. [16] However, the court did not address the constitutionality of a prohibition on compensated organ donations. The ruling merely concluded that a particular method of bone marrow donation – peripheral blood stem cell apheresis – did not qualify as organ transplantation as defined by NOTA. Therefore, the future for organ markets in the US remains uncertain.
[1] Flynn v. Holder, No. 10-55643 D.C. No. 2:09-cv-07772-VBF-AJW. <http://cdn.ca9.uscourts.gov/datastore/opinions/2011/12/01/10-55643.pdf>
[2] National Organ Transplant Act of 1984. Pub. L. 98-507. 98 Stat. 2339. NIH. Web. 2 April 2014. <http://history.nih.gov/research/downloads/PL98-507.pdf>
[3] Ibid.
[4] Ibid.
[5] Flynn v. Holder, No. 10-55643 D.C. No. 2:09-cv-07772-VBF-AJW. <http://cdn.ca9.uscourts.gov/datastore/opinions/2011/12/01/10-55643.pdf>
[6] Ibid.
[7] Ibid.
[8] Ibid.
[9] Ibid.
[10] National Organ Transplant Act of 1984. Pub. L. 98-507. 98 Stat. 2339. NIH. Web. 2 April 2014. <http://history.nih.gov/research/downloads/PL98-507.pdf>
[11] Ibid.
[12] Ibid.
[13] Cain, Robyn Hagan. “Onward to SCOTUS? Ninth Circuit Says No to Bone Marrow Re-Hearing – Court News – U.S. Ninth Circuit.” FindLaw. Thomson Reuters, 30 Mar. 2012. Web. 1 Apr. 2014. <http://blogs.findlaw.com/ninth_circuit/2012/03/onward-to-scotus-ninth-circuit-says-no-to-bone-marrow-re-hearing.html>
[14] Sibilla, Nick. “Federal Regulation Could Refine The Word ‘Organ,’ Jeopardize Bone Marrow Donations.” Forbes.com. Forbes, Inc., 25 Nov. 2013. Web. 1 Apr. 2014. <http://www.forbes.com/sites/instituteforjustice/2013/11/25/federal-regulation-could-re-define-the-word-organ-jeopardize-bone-marrow-donations/>
[15] Bergstrom, Theodore C., Rodney J. Garratt, and Damien Sheehan-Connor. 2009. “One Chance in a Million: Altruism and the Bone Marrow Registry.” American Economics Review, 99(4): 1309-34.
[16] Hippen, Benjamin E. “Organ Sales and Moral Travails: Lessons from the Living Kidney Donor Program in Iran | Cato Institute.” Cato Institute. n.p., 20 Mar. 2008. Web. 1 Apr. 2004. <http://www.cato.org/publications/policy-analysis/organ-sales-moral-travails-lessons-living-kidney-vendor-program-iran>
Photo Credit: Flickr user Thirteen of Clubs
