FadenR. R.BeauchampT. L. with KingN. M. P., A History and Theory of Informed Consent (New York: Oxford University Press, 1986);.
2.
ColemanC. H., “Duties to Subjects in Clinical Research,”Vanderbilt Law Review58, no. 3 (2005): 387–426.
3.
Id. (Faden and Beauchamp with King,).
4.
According to a press release issued by the Alternative Dispute Resolution Center, the NFL agreed to pay 50 percent of the amount over 3 years, and the remainder over the next 17 years. See NFL Retired Players Resolve Concussion Litigation; Court-Appointed Mediator Hails “Historic” Agreement, available at <http://static.nfl.com/static/content/public/photo/2013/08/29/0ap2000000235504.pdf>(last visited July 14, 2014). The greatest portion of the total ($675 million) is to be allotted to an “Injury Compensation Fund,” “to pay monetary awards to retired players who present medical evidence of severe cognitive impairment, dementia, Alzheimer's, ALS, or to their families.” Id., at 4. The amount of the settlement has been assailed. Despite the fact that $765 million is an exceptionally large sum, in context it barely signifies. Former player Brent Boyd had this reaction: “The breakdown is $1.2 million over 20 years per team. What is that, a third of the average salary? There is no penalty there. It's pocket change.” WilnerB., “NFL Concussion Settlement Draws Mixed Reactions from Former Players,” Huffington Post, August 30, 2013, available at <http://www.huffingtonpost.com/2013/08/30/nfl-concussion-settlement-former-players_n_3845954.html>(last visited July 14, 2014).
5.
In January 2014, Judge Anita B. Brody of the United States District Court for the Eastern District of Pennsylvania rejected the proposed settlement. According to the New York Times, Judge Brody expressed “concerns about the fairness, reasonableness and adequacy of the settlement.” BelsonK., “Judge Rejects NFL Settlement, for Now,”New York Times, January 15, 2014, available at <http://www.nytimes.com/2014/01/15/sports/football/judge-questions-whether-sum-of-nfl-settlement-is-enough.html>(last visited July 14, 2014). On April 16, 2014 Judge Brody in a one-sentence ruling once again rejected the settlement. This appears to be a procedural ruling only; according to plaintiffs' counsel, the status of the litigation remains unchanged. S. Farmer, “Federal Judge Holds Off Decision on NFL Concussion Settlement,” Los Angeles Times, April 16, 2014, available at <http://touch.latimes.com/$-section/-1/article/p2p-79934611/>(last visited July 14, 2014). On June 25, 2014 the NFL and counsel for the retired player litigants, pursuant to Judge Brody's concerns, announced a new agreement that un-capped the settlement amount, pending the Court's approval. NFL Communications, “Update on NFL Concussions Litigation,” available at <http://nflcommunications.com/2014/06/25/update-on-nfl-concussion-litigation/>(last visited July 20, 2014).
6.
As expressed in the subsection of the ADRC's press release titled Principal Terms of the NFL Litigation Settlement: “The settlement does not represent, and cannot be considered, an admission by the NFL of liability, or an admission that plaintiffs' injuries were caused by football. Nor is it an acknowledgement by the plaintiffs of any deficiency in their case. Instead, it represents a decision by both sides to compromise their claims and defenses, and to devote their resources to benefit retired players and their families, rather than litigate these cases.” Id., at 3.
7.
In a commentary following the announcement of the settlement, clinical psychologist Lloyd Glauberman posits that the agreement is tantamount to a “get out of jail free liability disclaimer.” He further argues that “[if] the case had gone to discovery, Dr. Pellman's incompetence would have sunk the [NFL's] ship.” (Dr. Elliott Pellman chaired the first NFL MTBI committee, and claimed insufficient evidence to connect concussion with degenerative brain disease. See text accompanying note 16 infra, and note 31 infra.) <http://www.huffingtonpost.com/lloyd-glauberman-phd/the-nfl-now-thinksits-bu_b_3857687.html>(last visited July 14, 2014). Player reaction has been mixed regarding the lack of transparency the agreement allows the NFL to maintain, about what it knew about long-term health consequences of concussions. Former player Kevin Mawae has called the settlement “$700 million worth of hush money.” See Wilner, supra note 3.
KingN. M. P.RobesonR., “Athlete or Guinea Pig? Sports and Enhancement Research,”Studies in Law, Ethics and Technology1, no. 1 (2007): 1–17, at 7.
14.
This pattern of evidentiary skepticism and rhetorical manipulation in the context of information asymmetry is common. See, e.g., BrandtA. M., The Cigarette Century (New York: Basic Books, 2007). The NFL's approach to concussion evidence has been compared to that of tobacco manufacturers regarding smoking and lung cancer. See, e.g., D. S. Goldberg, “Concussions Professional Sports, and Conflicts of Interest: Why the National Football League's Current Policies Are Bad for Its (Players') Health,” Healthcare Ethics Committee Forum20, no. 4 (2008): 337–355. And caution about concussion evidence is hardly unique to American football; the same downplaying of evidence, assertion of differences between sports, and manipulation of language is readily seen in contemporary discussion of concussion risks in soccer and rugby, to name just two sports with cultural roles and amateur-to-professional trajectories in the Europe and the U.K. that closely resemble that of football in the U.S.
15.
GuskiewiczK. M.MarshallS. W.BailesJ.McCreaM.HardingH. P.Jr.MatthewsA.MihalikJ. R.CantuR. C., “Recurrent Concussion and Risk of Depression in Retired Professional Football Players,”Medicine Science Sports Exercise39, no. 6 (2007): 903–909.
16.
OrentlicherD.DavidW. S., “Concussions in Football: Failures to Respond by the NFL and the Medical Profession,”Florida International University Law Review8, no. 1 (2013): 17–30.
17.
A 1928 article in a major medical journal on concussion, brain hemorrhage, and “post-traumatic encephalitis” in professional boxers describes a syndrome that was well-known to sports fans at the time, but disputed by neurologists, sports journalists, and boxing promoters, who challenged the thesis of brain injury as lacking definitive proof despite a growing body of evidence. MaitlandH. S., “Punch Drunk,”JAMA91, no. 15 (1928): 1103–1107.
18.
See, e.g., TestoniD.HornikC. P.SmithP. B.BenjaminD. K.Jr.McKinneyR. E.Jr., “Sports Medicine and Ethics,”American Journal of Bioethics13, no. 10 (2013): 4–12.
19.
See supra note 6.
20.
See, e.g., KingN. M. P.HendersonG. E.ChurchillL. R.DavisA. M.HullS. C.NelsonD. K.Parham-VetterP. C.RothschildB. B.EasterM. M.WilfondB. S., “Consent Forms and the Therapeutic Misconception: The Example of Gene Transfer Research,”IRB: Ethics & Human Research27, no. 1 (2005): 1–8;.
21.
HendersonG. E.DavisA. M.KingN. M. P.EasterM. M.ZimmerC. R.RothschildB. B.WilfondB. S.NelsonD. K.ChurchillL. R., “Uncertain Benefit: Investigators' Views and Communications in Early Phase Gene Transfer Trials,”Molecular Therapy10, no. 3 (2004): 225–231;.
22.
KoyfmanS. A.McCabeM. S.EmanuelE. J.GradyC., “A Consent Form Template for Phase I Oncology Trials,”IRB: Ethics & Human Research31, no. 4 (2009): 1–8.
23.
One of the more noteworthy examples of the corrosive effect of the NFL's loyalty ethos can be found in the case of defensive back Myron Rolle. An All-American at Florida State University, Rolle was regarded as a certain first-rounder in the 2009 draft. He had graduated a year early, but he had a year of NCAA eligibility remaining. But instead of playing college football another year, he applied for and was awarded a Rhodes Scholarship. He entered the draft after a year spent at Oxford earning a master's degree in medical anthropology. In pre-draft interviews he was continually asked, “Why did you desert your teammates?” He retired from the NFL prior to the beginning of the 2013–14 season. J. Cole, “Rolle's Commitment Called into Question,” available at <http://sports.yahoo.com/news/rolles-commitment-called-034100810-nfl.html?soc_src=copy>(last visited July 19, 2014). Myron Rolle is now a medical student at the Florida State University College of Medicine. See the article at <http://www.sbnation.com/longform/2014/2/12/5401774/myron-rolle-profile-florida-state-football-nfl-rhodes-scholar>(last visited July 19, 2014).
“Why Have a Doctor If Everyone's Going to Be Allowed to Diagnose Themselves?” John Feinstein, CBS Sports Minute, CBS Radio, Broadcast date: January 10, 2013, 2:59 p.m.
As reported by Frontline, in 1994 Commissioner Tagliabue said, “On concussions, I think is one of these pack journalism issues, frankly… There is no increase in concussions, the number is relatively small… The problem is a journalist issue.” PBS, “Timeline: The NFL's Concussion Crisis,” available at <http://www.pbs.org/wgbh/pages/frontline/sports/league-of-denial/timeline-the-nfls-concussion-crisis/>(last visited July 29, 2014).
34.
Id.
35.
See supra note 13, at 21–22.
36.
See Frontline timeline, supra note 27.
37.
When asked about the issue of concussions in 1994, Pellman tells Newsday: “We discuss it on the list of things every time we have a league meeting … We think the issue of knees, of drugs and steroids and drinking is a far greater problem, according to the number of incidents.” Pellman also tells Sports Illustrated that “concussions are part of the profession, an occupational risk.” Id.
38.
Id., at September 2009.
39.
The suicides of a number of former NFL stars are especially significant in this regard. The 2006 death of former Philadelphia Eagles safety Andre Waters has been called a turning point in public perception about the relationship between concussions and football, and in perceptions about the integrity of the NFL.Philly.com website, “Rich Hofmann: Death of Ex-Eagle Andre Waters Sparked Concussion Awareness,” available at <http://www.philly.com/dailynews/sports/top_sports/20100211_Rich_Hofmann__Death_of_ex-Eagle_Andre_Waters_sparked_concussion_awareness.html>(last visited July 29, 2014). This was due in no small part to the efforts of Christopher Nowinski, a former Harvard football player and co-founder of the Sports Legacy Institute, available at <http://www.sportslegacy.org/>(last visited July 29, 2014, who obtained permission from Waters' family to have his brain studied for evidence of CTE. Waters' brain was determined to show the deterioration of “an Alzheimer's patient in his 80s.” Later suicides by other players clearly indicated that they believed in a connection between concussions and brain disease, with players taking their own lives in ways that would allow researchers to study their brains for CTE. Former Chicago Bear Dave Duerson is one such player, whose suspicions about CTE were confirmed. A. Scwarz, “Duerson's Brain Trauma Diagnosed,” New York Times, available at <http://www.nytimes.com/2011/05/03/sports/football/03duerson.html>(last visited July 29, 2014).
40.
GoldbergD. S., “Mild Traumatic Brain Injury, the National Football League, and the Manufacture of Doubt,”Journal of Legal Medicine34 (2013): 157–191.
41.
See Frontline timeline, supra note 27, at October 2009.
According to NFL.com, the memo distributed by Commissioner Goodell to all 32 teams contains such provisions as disallowing a return to play or practice if the player demonstrates “an inability to remember assignments or plays, a gap in memory and persistent dizziness and headaches. The old standard, established in 2007, said a player shouldn't be allowed to return to the same game if he lost consciousness.” Associated Press, “Goodell Issues Memo Changing Return-to-Play Rules for Concussions,” available at <http://www.nfl.com/news/story/09000d5d814a9ecd/article/goodell-issues-memo-changing-returntoplay-rules-for-concussions>(last visited July 15, 2014). As low a threshold as the new standard might seem, its stark contrast with the 2007 standard confers legitimacy upon the complaints regarding the NFL's historical disregard for its players.
44.
Id.
45.
Id.
46.
See KingRobeson, supra note 10.
47.
As we have argued throughout, the effects of team-level pressures on decision making by individual players (and/or their parents) can readily rise to the level of undue influence. In a team culture characterized by ongoing innovation and research, this degree of institutional pressure is especially pernicious. See King and Robeson, supra notes 10 and 25.
48.
Examples abound. A number of highly publicized abuses in research, notably including the Tuskegee syphilis study (see JonesJ. H., Bad Blood: The Tuskegee Syphilis Experiment (New York: The Free Press, 1992), led to the enactment of the 1974 National Research Act (Public Law 93–348), which created the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. In 1978, the Commission published “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” also known as the Belmont Report, available at <http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html>(last visited July 15, 2014). The Belmont Report provides the ethical foundation for federal human subjects research regulations, which were initially promulgated in 1979 and finally consolidated as the Common Rule in 1991. See <http://www.hhs.gov/ohrp/humansubjects/index.html>(last visited July 15, 2014). The pattern has been similar in the context of medical treatment, in particular with regard to end-of-life decision-making. See, e.g., In re Quinlan, 70 N.J. 10, 355 A.2d 647 (NJ 1976), which led to the development of ethics committees in hospitals nationwide.
A very similar balance between safety and medical progress is fundamental to clinical research. See, e.g., EmanuelE.WendlerD.GradyC., “What Makes Clinical Research Ethical?”JAMA283, no. 20 (2000): 2701–2711.
This trend is most recently and thoroughly exemplified in a new report, Committee on Sports-Related Concussions in Youth, Institute of Medicine, National Research Council, Sports-Related Concussions in Youth: Improving the Science, Changing the Culture (Washington, D.C.: National Academies Press, 2013). The IOM Committee's conclusions and recommendations appear at 12 and 243–247. All of the Committee's recommendations reference a lack of reliable evidence and highlight the desirability of extensive further research: Coordinated national surveillance of and data collection about concussion incidence in youth ages 5–21;.
58.
research into and development of evidence-based concussion management guidelines; large-scale controlled longitudinal studies, including development of a national brain tissue and biological sample repository, to assess the consequences of concussion; rigorous evaluation of the effectiveness of risk-reducing changes in play and practice; research into biomechanical determinants of injury risk, including safety equipment and impact-monitoring systems; and mounting and evaluating of large-scale evidence-based educational interventions to change the culture surrounding concussions.
Goldberg, supra note 11, at 346. See also the National Academy of Sciences press release announcing the publication of the findings from the Sports-Related Concussion in Youth study highlighting the finding that “there is not enough evidence to support the claim that helmets reduce concussion risk.” See Extensive Study on Concussions in Youth Sports Finds ‘Culture of Resistance’ for Self-Reporting Injury; Not Enough Evidence to Support Claim That Helmets Reduce Concussion Risk, Press Release, available at <http://www8.nationalacademies.org/onpinews/newsitem.aspx?RecordID=18377&utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+nationalacademies%2Fna+%28News+from+the+National+Academies%29>(last visited July 15, 2014). It is also acknowledged that the data gathered in concussion studies via helmets fitted with sensors that measure force of impact – the High Impact Telemetry System (HITS) – have utility outside of football.
See Committee on Sports-Related Concussions in Youth, supra note 49.
63.
Id., at 6.
64.
It should be obvious that all such potential criteria have uncertain connections to injury prevention data, at least at present. The question should not be whether empirical data alone are sufficient to change policy, nor should it be whether players and parents can be trusted to say no to youth football. A deeper inquiry is called for to arrive at institutional reforms that can be both meaningful and successful.
65.
RivaraF. P.GrahamR.Viewpoint, “Sports-Related Concussions in Youth: Report From the Institute of Medicine and National Research Council,”JAMA311, no. 3 (2013): 239–240.
