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Sally Wang, Jeremy O. Bressman, and Jay S. Reidler are member of the Harvard Law and Health Care Society and students at Harvard Law School.

Recent Case Developments in Health LawFalse Claims Act: The Right Treatment for Off-Label Marketing?

Sally Wang

IntroductionThe False Claims Act (FCA), 31 U.S.C. § 3729, a post-Civil War law inspired by cases of defense contract-ing fraud, was revitalized in 1986.1 Since then it has been used to sue both manufacturers and providers of pharmaceuticals. In some cases, these suits were meant to target off-label marketing of pharmaceuticals. In 2009, the 11th Circuit rendered a decision in Hopper v. Solvay Phar-maceuticals that dramatically limits the ability of private plaintiff whistle-blowers to bring qui tam suits under the FCA for such marketing. In June 2010, the Supreme Court denied certiorari, making the Circuit court decision final. The Solvay decision creates a significant barrier to certain kinds of qui tam suits, requiring the plaintiff to demonstrate the intent to market off-label, including by show-ing specific prescriptions that were written as a result of efforts to do so. The Supreme Court, on the same day, also denied certiorari to an appeal from the 1st Circuit’s ruling in United States ex rel Duxbury v. Ortho Biotech Products, perpetuating serious circuit splits over jurisdictional bars within the statute. In response to rulings like Solvay that narrow the power of False Claims Act, Congress passed the Fraud Enforcement and Recovery Act (FERA) in 2009. The Bill’s sponsor, Senator Charles Grassley (R-Iowa) recently requested 16 drug markers to report on their treatment of whistle-blowers who filed complaints under the FCA by July 20, 2010.2

False Claims Act: An OverviewThe Federal False Claims Act (FCA) 31 U.S.C. §§ 3729-3733, imposes triple damage liability on a party who knowingly submits false records to the federal government in hopes of payment, such as Medicare/Medicaid receipts.3 Originally passed in 1863, FCA was spurred by cases of fraud-ulent goods sold to the Union war effort, including suits qui tam pro domino rege quam pro se ipso in hac parte sequitur, which translates to “who pursues this action on our Lord the King’s behalf as well as his own,” or “qui tam” for short.4 The qui tam cause of action allows a private plain-tiff, who knows of a fraud against the government, to initiate a lawsuit on behalf of the government, in return for a share of the proceedings if suc-cessful.5 In the context of off-labeling marketing, whistleblowers help the United States government seek recov-ery for claims paid by government health programs resulting from these unapproved marketing practices. In turn, the private plaintiffs, known as “relators,” are entitled to 15% to 30% of the government’s recovery, plus legal fees and other related costs.6 Companies can be, and have been, sued both by the government and by qui tam whistleblowers.7

The FCA creates a tension between the ability of the law to generate “pri-vate Attorneys Generals” to assist the government in preventing fraud with their insider knowledge and the creation of suits regarded as oppor-tunistic, trying to reap rewards over false accusations or without provid-ing information that are helpful for

About This Column

The American Journal of Law & Medicine has been tracking and contributing to the development of health law since its inception at Boston University School of Law in 1975. The Journal publishes articles authored by professors, attor-neys, physicians, and other health care professionals on subjects ranging from health law and policy to the legal, ethi-cal, and economic aspects of medical practice, research, and education.

The Harvard Law & Health Care Society is a student-operated health law organization at Harvard University Law School. In addition to contribut-ing to this column, the Harvard Law & Health Care Society also hosts speakers from private practice and academia, presents career panels, and promotes interdisciplinary dialogue with other Harvard University gradu-ate schools.

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the prosecution.8 As a matter of fact, Congress has amended the act sev-eral times to “walk a fine line between encouraging whistle-blowing and

discouraging opportunistic behavior,” which resulted in a series of subject matter jurisdictional bars that rela-tors must satisfy in order to bring qui tam cases in federal court.9

The FCA has been used as one of the primary weapons in enforcing drug marketing regulations, espe-cially in recent years, as evident by the large DOJ settlements.10 Since the federal government does not regulate the practice of medicine and leaves the use of drugs to the judgment of physicians (state law regulates the practice of medicine through medical licensure and malpractice tort law), the federal government specifically contemplates off-label use of FDA-approved drugs and compensates physicians for off-label prescriptions. Therefore, it is legal for a company to submit claims to federal healthcare programs that have not been FDA-approved. However, it is illegal for a pharmaceutical company to engage in organized marketing of off-label claims that persuade physicians to write prescriptions for off-label uses.11 Government programs gener-ally will cover drugs only if their use is “reasonable and necessary” in a “safe and effective” manner, as determined by FDA approval or citation in medi-cal compendia. The submission of a claim otherwise is a false claim, and if it is due to off-label marketing, the

pharmaceutical company is consid-ered to have provided causation, by kicking off the chain of events that led to the submission of the false

claims to the government. The FCA is more commonly used, however, by whistleblowers with insider informa-tion, who are often employed by the pharmaceutical industry, directly against hospitals and doctors, engag-ing in more prosaic billing schemes for services not rendered, or drugs not actually dispensed.

Recent Developments: Battle of Courts and BranchesThe Supreme Court denial of cer-tiorari in Hopper v. Solvay Pharma-ceuticals means that the barrier that whistleblowers must overcome to bring suit under FCA for off-labeling marketing is higher in the Eleventh Circuit than elsewhere. The refusal of the Supreme Court to provide uni-formity in this area of law is unset-tling, considering that the issue has resulted in circuit splits and repeated Congressional actions.

In Solvay, the U.S. Court of Appeals for the Eleventh Circuit ruled that the complaint of the rela-tor is deficient under the heightened pleading standard of Federal Rules of Civil Procedure 9(b) that party must “state with particularity the circumstances constituting fraud or mistake.”12 In the context of the FCA, this means the relator must be able to make specific factual allegations that identify the physicians, pharma-

cists, or health programs that were involved. The Court also made a less relator-friendly interpretation of the Act, adopting an interpretation of the FCA that leads to a more strin-gent pleading standard on both parts of the FCA, making it more difficult for private plaintiffs to successfully bring suit. In 31 U.S.C.S.§ 3729(a)(1), there is a “presentment clause” that imposes liability on any person who “knowingly presents, or causes to be presented, to an officer or employee of the United States Government…a false or fraudulent claim for payment or approval.”13 The 11th Circuit, on public policy grounds, required indi-cation of an actual false claim with specific factual allegations to satisfy the heightened pleading standard of Rule 9(b).14 While §3729(a)(2) does not have a presentment requirement, the court, nevertheless, held that relators must show that the govern-ment paid a false claim to prove a vio-lation of FCA. The rationale is that it is congressional intent to impose lia-bility only when the false statements actually cause the government to pay amounts it does not owe.15

Because relators must not only know of the scheme to engage in off-label marketing, but must have personal knowledge of payments, or show that false claims were paid, their ability to successfully make a claim in complex off-label marketing schemes is limited:16

We will assume arguendo that when a physician writes an off-label prescription with knowledge or intent that the cost of filling that prescription will be borne by the federal government, and when a claim is ultimately sub-mitted to the federal government to pay for that prescription, 31 U.S.C. § 3729(a)(1) may have been violated….Nonetheless, the rela-tors’ Complaint does not identify a single physician who wrote a prescription with such knowledge, does not identify a single pharma-

In response to rulings like Solvay that narrow the power of False Claims Act, Congress passed the Fraud Enforcement and Recovery Act (FERA) in 2009. The Bill’s sponsor, Senator Charles Grassley (R-Iowa) recently requested 16 drug markers to report on their treatment of whistleblowers who filed complaints under the FCA by July 20, 2010.

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cist who filled such a prescription, and does not identify a single state healthcare program that submitted a claim for reimbursement to the federal government. The relators contend that their Complaint “con-tains factual allegations which reli-ably indicate that false claims were submitted to the Government.” We disagree. The Complaint piles inference upon inference to sug-gest that Solvay’s marketing cam-paign influenced some unknown third parties to file false claims. We cannot conclude that the Com-plaint satisfies the particularity requirements of Rule 9(b)…

This decision is a severe blow to the use of the FCA by private relators in enforcement of off-label marketing rules, because now they must have specific evidence — not merely an attempt to engage in off-label mar-keting, but an account of who wrote such prescriptions. Since most per-sonal medical data is protected by HIPAA, relator claims under the FCA will likely be unsuccessful absent monumentally obvious behavior or continued efforts to defraud the government through inducement of off-label prescription writing despite concerted investigation

Further adding to the uncertainty is United States ex rel Duxbury v. Ortho Biotech Products, decided in the First Circuit in August 2009, for which the Supreme Court also denied certiorari, on the same day as Solvay. On the issue of whether to impose a priori restrictions on the information that relators must have before submitting a case, the Ortho holding is favorable to the relators, interpreting the “orig-inal source” standard of § 3730(e)(4)(B) to only require the relators to voluntarily provide the information to the government prior to filing of qui tam suit, as oppose to before pub-lic disclosure of the potential fraud.17 However, the First Circuit’s discus-sion of circuit splits indicates a con-fusion of the law and a lack of unifor-

mity between different jurisdictions that would be helped by a Supreme Court’s hearing of the case. In con-trast to the more permissive First and Fourth Circuit, the relators face a much higher bar in making their case under FCA in the jurisdictions with more restrictive rules, such as the Ninth, Sixth, and D.C. circuits. The lack of a national standard for the use of FCA to regulate pharmaceutical promotion, a national activity, may result in inefficiency of enforcement and forum shopping, weakening the law’s effectiveness and reducing its fairness.

To partially counter these recent court rulings that narrow the power of the False Claims Act, Congress passed the Fraud Enforcement and Recovery Act (FERA) in 2009. The FERA expanded the substan-tive liability sections of the FCA and increased the Government’s ability to investigate and engage in discovery of potential false claims before bring a lawsuit.18 The amendments softened the impact of Solvay on relator’s abil-ity to file suit by striking the “present-ment clause” of § 3729(a)(1); the new provision imposes liability on anyone who “knowingly presents, or causes to be presented a false claim,” with-out requiring that the claim be pre-sented to an officer or employee of the U.S. government.19 The new law also extends anti-retaliation protec-tion to whistleblowers,20 providing them with a safe harbor and prevent-ing industry-wide employment-lock-out, which occurred with relative fre-quency to previous whistleblowers.21

FECA’s sponsor, Senator Charles Grassley (R-Iowa), recently requested 16 drug markers to report on their treatment of whistleblowers who filed complaints under the FCA by July 20, 2010.22 The request posed eight ques-tions, including how companies notify employees of the FCA and FERA, how they treat whistleblowers, and what changes were made in response to FERA on extending anti-retalia-tion protections to whistleblowers.23

Among the 16 pharmaceutical com-panies are several against which FCA suits have resulted in large settle-ments in recent years: Pfizer settled by agreeing to pay $2.3 billion over improper drug marketing, Lilly paid more than $1.6 billion for off-label promotion of Zyprexa, and AstraZen-eca paid $520 million over improper marketing of Seroquel.24 While leg-islative action has balanced and par-tially corrected the narrow interpre-tation of the FCA by several circuit courts, including the 11th Circuit in Solvay, the recent amendments did not resolve the confusion of the law and lack of uniformity that is perva-sive in jurisprudence on the FCA. A Supreme Court ruling is necessary to clarify and give guidance on the proper interpretation of the FCA and its amendments, as used to regulate off-label pharmaceutical promotion.

Recent developments of the law, splits between circuits, and the battle between the judiciary and legislature makes one wonder there is some-thing intrinsic to FCA that is causing the confusion. The FCA was enacted in 1863 with the “principal goal of stopping the massive frauds perpe-trated by large [private] contractors during the Civil War.” 25 Although it has evolved over the past century-and-a-half, it is questionable whether the FCA is suited for addressing the problems of off-label marketing. How is the FCA used within the health care sphere?

Analysis: Is FCA the Right Treatment? The purpose of the FCA’s qui tam cause of action has been to allow insid-ers with specific information to come forward and pursue claims. This is in line with the legislative history of the FCA and its expansions which tried to find “the golden mean between adequate incentives for whistle-blow-ing insiders with genuinely valuable information and discouragement of opportunistic plaintiffs who have no significant information to contribute

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of their own.”26 While the FCA has been very effective in attaining judg-ments for health care fraud — $14.3 billion since 1986-2008 when the FCA was revived and expanded — qui tam suits on off-label pharmaceuti-cal promotion comprise only a very small proportion of this. To put these totals in perspective, the Department of Justice estimates that enforcement by Medicare Fraud Strike Force, a multi-agency team of federal, state, and local investigators,27 in the Miami area alone reduced medical billing by over $2 billion dollars. The problem of false billing by physicians and hospitals dwarfs all medical off-label marketing suits, which totaled

$3 billion in the same period for the entire U.S.28

Prominent qui tam suits are more typically like the case against John-son & Johnson settled on January 15, 201029:

The United States alleges that, in order to induce Omnicare and its pharmacists to recommend J&J drugs, the company paid kick-backs to Omnicare in numerous ways. First, the complaint alleges that J&J entered into agreements with Omnicare by which Omni-care was entitled to increasing levels of rebates from Johnson & Johnson so long as Omnicare

implemented specific programs to increase the prescriptions of J&J drugs. Second, the complaint alleges that J&J paid Omnicare millions of dollars for “data,” much of which Omnicare never pro-vided. According to the complaint, the true purpose of these pay-ments was to induce Omnicare to recommend J&J drugs. Third, the complaint alleges that J&J made various other substantial kickback payments to Omnicare, calling the payments “grants” and “educa-tional funding,” even though their true purpose was to induce Omni-care to recommend J&J drugs.

Year Actions Recoveries

NQT Qui Tam NQT Qui Tam DOJ Relator Share Total of All

1987 12 3 11,361,826 0 0 11,361,826

1988 8 5 2,182,675 355,000 88,750 2,537,675

1989 20 16 350,460 5,099,661 50,000 5,450,121

1990 27 11 10,327,500 903,158 119,474 11,230,658

1991 22 12 8,670,735 5,420,000 861,401 14,090,735

1992 29 15 9,821,640 2,192,478 446,648 12,014,118

1993 22 38 12,523,165 151,760,404 22,946,101 164,283,569

1994 43 76 381,470,015 6,520,815 1,185,597 387,990,830

1995 27 87 96,290,779 85,681,789 14,803,782 181,972,568

1996 20 179 63,059,873 51,576,698 9,374,568 114,636,571

1997 49 274 351,440,027 579,079,581 58,872,855 930,519,608

1998 35 275 40,107,920 258,638,736 47,822,301 298,746,656

1999 28 315 38,000,792 408,128,379 45,492,385 446,129,171

2000 36 211 208,899,015 725,011,203 115,759,246 933,910,218

2001 35 177 435,849,179 900,260,345 147,318,543 1,336,109,524

2002 24 194 74,567,427 961,248,757 154,289,403 1,035,816,184

2003 26 219 536,834,879 1,312,296,030 284,670,601 1,849,130,909

2004 28 275 34,816,447 475,370,142 97,434,278 510,186,589

2005 34 271 204,821,548 912,927,980 122,673,758 1,117,749,528

2006 18 223 1,050,520,714 1,241,774,802 166,735,688 2,292,295,516

2007 24 202 465,052,993 1,065,800,181 155,129,755 1,530,853,174

2008 60 228 150,808,253 966,568,225 183,528,337 1,117,376,478

2009 627 3,306 4,187,777,862 10,116,614,364 1,629,603,471 14,304,392,226

Table 1

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This Johnson & Johnson case is the kind of case which a relator can bring, even if the government later joins the suit and collects the lion’s share of the damages. It involves quid pro quo pay-ments to influence prescribing deci-sions, regardless of FDA label. The case turned around specific payments and rebates, payments for data which was never provided, and false pay-ments labeled grants and educational funding, in contrast to the complexity of Solvay and Ortho, which required access both to the marketing activities

of pharmaceutical companies and the prescribing habits of physicians. The relators need to prove intent, action, and effect, which is virtually impossi-ble for any single insider who is not at the executive level. As a result, while in an ordinary year tens of millions of dollars is paid to relators under FCA claims,30 almost none of this is for off-label marketing not involv-ing kickbacks; instead the bulk is for fraudulent claims filed by doctors.

The numbers show that the FCA is effective primarily in dealing with criminal wrong-doing involving false claims filed and kickbacks. The fol-lowing table was compiled by the law firm of Fried Frank from Depart-ment of Justice (DOJ) Civil Divi-sion records, and shows a breakout of recoveries from health care fraud enforcement action between qui tam and non-qui tam suits.

The table dramatically overstates the share of qui tam recoveries, since non-qui tam judgments do not include the recovery to the Social Security or

Medicare trust funds, and many non-qui tam suits are settled at the district level by the Federal Attorney’s office, not the department of Civil Enforce-ment. Compared to the figures for non-qui tam judgments, the total for relators in off-label marketing as a share of the above numbers comes to less than $100 million, the bulk from a few high profile cases.

FCA claims generally have to be pursued by the Department of Justice and are neither swift nor certain for drug marketing claims. While there

is generally a two-year lead time between suit and judgment, qui tam cases can involve off-labeling mar-keting that happened a decade ago, such as the recent DOJ settlement with Novartis over the marketing of a cystic fibrosis drug that began in 2001.1 While there have been cases of corporate officers prosecuted for knowingly pursuing fraudulent bill-ing activities, these are not associated with any of the large judgments men-tioned earlier. This time-lag between activity and judgment opens the door to a cost-benefit analysis on the part of individuals employed in the indus-try, including executives and manag-ers, in favor of engaging in off-label marketing: they might not be caught, and by the time the financial penalty occurs, even if it is a net negative for the corporation they work for, they might well have sold their own per-sonal stake in the company, or moved on professionally. The FDA does not have the resources to mount long civil prosecutions by itself, as they take

years, and therefore lacks the indi-vidual deterrent effect in the case of marketing.

While the large settlements against big pharmaceutical companies make the headlines and the DOJ has stepped up its enforcement efforts through qui tam actions, it would not be an overstatement to say off-label-ing marketing is minor in the amount of recovery compared to classic health care fraud. The design of the FCA sets a high bar for the private plaintiffs, requesting information that is not often available to most employees. Therefore, the courts and Congress has been struggling over the right law in the last year-and-half, issuing con-flicting opinions and making amend-ments that are inconsistent with cur-rent law.2 Unfortunately, the schism between the circuits and the battle between the branches of govern-ment is likely to further reduce the effectiveness of the FCA. However, congressional support for “whistle blowers,” both in the form of qui tam actions and as a reward for informa-tion in a government case remains high as evidenced by the recent Dodd-Frank Wall Street Reform and Consumer Protection Act, which has ordered the Securities and Exchange Commission to promulgate rules expanding whistleblower rewards beyond insider trading, and to a all related securities legislation, includ-ing the Foreign Corrupt Practices Act FCPA.3 This continuing support from Congress opens the possibility for either complete legislative remedy to the decision in Solvay, or a move to the “bounty” route analogous to Dodd-Frank, where whistleblowers will not file suit themselves, but stand to share in the results of a successful “related action.”

AcknowledgementsThis paper was made possible thanks to the sponsorship of the Petrie-Flom Center for Health Law Policy, Bioethics, and Bio-technology at Harvard Law School. I am tremendously grateful for the guidance and

This continuing support from Congress opens the possibility for either complete legislative remedy to the decision in Solvay, or a move to the “bounty” route analogous to Dodd-Frank, where whistleblowers will not file suit themselves, but stand to share in the results of a successful “related action.”

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support of Professor Benjamin Roin and Professor Peter Barton Hutt. Special thanks to the comments and sug-gestions of Professor Theodore Ruger; Kris-tin Davis, Peter Beckerman, Jarilyn Dupont, and Nancy Ostrove of the Food and Drug Adminstration; Lee Baker; Melissa F. Was-serman, and the faculty and fellows of the Petrie-Flom Center.

References1. United States ex rel. Duxbury v. Ortho

Biotech Prods., L.P., 579 F.3d 13, 26 (1st Cir. 2009); S. R. Slade, “Off-Label Promotions Pursued Under The False Claims Act,” September 2007, available at <http://www.false-claims-act-health-care-fraud-whistleblower-attorney.com/articles/off-label-promotions.php> (last visited August 6, 2010).

2. D. Voreacos, “Grassley Asked Pfizer, Drugmakers How They Treat Whistle-blowers,” Bloomberg Businessweek, July 1, 2010.

3. See Slade, supra note 1.4. United States ex rel. Duxbury v. Ortho

Biotech Prods., L.P., 579 F.3d 13, 16 (1st Cir. 2009).

5. R. Vogel, “2009 Amendments to False Claims Act,” October 2009, available at <http://www.false-claims-act-health-care-fraud-whistleblower-attorney.com/articles/2009_Amendments_FCA.php#.> (last visited August 6, 2010).

6. Hopper v. Solvay Pharms., Inc., 588 F.3d 1318, 1324 (11th Cir. 2009).

7. Id., at 1322.8. United States ex rel. Duxbury v. Ortho

Biotech Prods., L.P., 579 F.3d 13, 16 (1st Cir. 2009).

9. Id. 10. P. B. Hutt, R. A Merrill, and L. A Gross-

man, Food and Drug Law (City of pub-lication: Foundation Press, 2007): at 555.

11. Id., at 548, 554-555.12. Hopper v. Solvay Pharms., Inc., 588

F.3d 1318, 1324 (11th Cir. 2009).13. 31 U.S.C.S. §3729(a)(1).14. Hopper v. Solvay Pharms., Inc., 588

F.3d 1318, 1325 (11th Cir. 2009). 15. Id., at 1328.16. Id., at 1326.17. United States ex rel. Duxbury v. Ortho

Biotech Prods., L.P., 579 F.3d 13, 26 (1st Cir. 2009).

18. See Vogel, supra note 5.19. Id.20. See Voreacos, supra note 2.21. Id.22. Id.23. Id.24. Id.25. Vt. Agency of Natural Res. v. United

States ex rel. Stevens, 529 U.S. 765, 781 (U.S. 2000).

26. United States ex rel. Springfield Ter-minal Ry. v. Quinn, 14 F.3d 645, 649 (D.C. Cir. 1994).

27. Department of Justice, Medicare Fraud Strike Force Charges 94 Doctors, Health

Care Company Owners, Executives, and Others for More Than $251 Million in Alleged False Billing, Press Release, July 16, 2010, available at <http://www.fbi.gov/pressrel/pressrel10/medi-carefraud_071610.htm> (last visited August 6, 2010).

28. Department of Justice, Assistant Attor-ney General Tony West Testifies Before the Senate Judiciary Committee Enti-tled “Effective Strategies for Prevent-ing Health Care Fraud, Press Release, October 28, 2010, available at <http://www.justice.gov/dag/testimony/2009/dag-testimony-091028.html> (last vis-ited August 6, 2010).

29. Department of Justice, U.S. Files Suit against Johnson & Johnson for Paying Kickbacks to Nation’s Largest Nursing Home Pharmacy, Press Release, Janu-ary 15, 2010, available at <http://www.justice.gov/opa/pr/2010/January/10-civ-042.html> (last visited August 6, 2010).

30. Note in 1996 the number of health qui tam suits doubled from 87 to 179, and two years later the qui tam awards jumped from $9 million to $58 million, and have varied between a low of $45 million and a high of $285 million in 2003.

“Willful Modulation of Brain Activity in Disor-ders of Consciousness”: Legal and Ethical Ramifications

Jeremy O. Bressman and Jay S. Reidler

I. IntroductionEnd-of-life care has long been the subject of intense ethical and legal deliberation, and a recent studyay introduce a new level of complexity to the discussion. The study, published in the New England Journal of Medi-cine, found that a fraction of patients in vegetative or minimally conscious states exhibit brain activity that reveals signs of cognition or aware-ness.1 Using functional magnetic resonance imaging (fMRI), research-ers monitored brain activity of 54 unresponsive or minimally respon-sive patients as they were instructed

to imagine one of two possible sce-narios that engage different areas of the brain (i.e., hitting a tennis ball or navigating a familiar location). They identified five patients who could willfully modulate their brain activ-ity upon request. One patient even succeeded in using this technique to communicate correct answers to “yes or no” questions, but remained com-pletely incapable of communicating at the bedside.

These findings challenge our clini-cal understandings of disorders of consciousness, and raise profound legal and ethical questions regarding the treatment of patients in persistent vegetative or minimally conscious states. As noted by the authors of the study, this technology could poten-tially be used to communicate with such patients about the levels of pain they are experiencing so that physi-cians can adjust analgesia accord-ingly. But, if it is developed further, could we rely on this technology to have such patients relay autonomous decisions about questions such as whether they would like to prolong life-sustaining treatments?

This note will provide a back-ground to the medical issues at play in this study, followed by an in-depth consideration of the legal standards for both consent and competency. The article will conclude by consider-ing the various ethical issues raised by this study and provide some avenues to explore in the future.

II. BackgroundAs a result of improvements in care for patients with severe brain injury there has been a rise in the number of patients who survive with severe dis-orders of consciousness such as coma, vegetative state (VS), and minimally conscious state (MCS). In order to more fully appreciate the legal basis for such patients to make autonomous decisions, it is crucial that we consider their respective capacities. Whereas comatose patients cannot be awak-ened by painful stimuli, VS patients

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can be awakened and exhibit occa-sional non-purposeful movement, but lack any reproducible behavioral responses to stimuli. Patients meet-ing VS clinical criteria are presumed to be completely unaware of them-selves and their environment, and after one month are considered to be in persistent vegetative states (PVS), rarely recovering after twelve months in this condition.2 In contrast, MCS

patients show inconsistent but repro-ducible signs of consciousness, such as the capacity to follow commands, but cannot effectively communicate and have been presumed to have partial awareness.3 It is important to distinguish these disorders of con-sciousness from locked-in syndrome, in which a patient is fully awake and aware, but cannot move or commu-nicate due to complete paralysis of all muscles (except the eyes and eye lids).4

Researchers in the above-men-tioned study demonstrated that there exists a subset of PVS and MCS patients who can willfully modulate their brain activity upon request. While such patients exhibit no abil-ity to communicate at the bedside, their correct responses suggest that they possess higher levels of cogni-tion and awareness than previously thought and that fMRI may be a new means by which clinicians can com-municate with them. Presumably, this subset of patients have suffered brain damage that, similar to locked-in syndrome, left at least some men-

tal faculties intact and incapacitated the patient to the extent that they are physically incapable of communicat-ing. While this study suggests that advanced imaging technologies may eventually enable these patients to express their wishes regarding their medical care, it raises fundamental questions regarding the legal cri-teria for competency and informed consent.

III. Legal Consent and the Competency StandardAmong the most important concerns that this study may address are the definitions of vegetative and mini-mally conscious states and, conse-quently, notions of legal consent.5 Persistent questions about the “right to die” in United States law have engaged scholars since In re Quin-lan,6 the first major attempt to deal with the question on the judicial level. More recently, the controversy sur-rounding the case of Terry Schiavo, capped by a number of court cases and an executive attempt to block her death,7 cast these legal and ethi-cal quandaries back into the spotlight and re-engaged the American public in conversation around these issues.

In re Quinlan is significant in its approach to patient consent. Karen Quinlan had been in a persistent veg-etative state for some time when her father requested the court to allow him to remove his daughter’s ventila-tor. As an initial matter, the New Jer-sey Supreme Court was confronted with the issue of whether to recog-

nize a patient’s right to refuse medi-cal care at all. Having balanced the individual’s right to privacy and the prognosis for the patient’s recovery against the state’s interest in keep-ing Quinlan alive, and having come out in favor of Quinlan’s right to dis-continue treatment, the court was then confronted with the secondary issue of who should have the ability to make those decisions. The court ultimately ruled in favor of granting Quinlan’s father the right to decide in accordance with what he perceived to be his daughter’s interests.8 That decision, however, was only precipi-tated by the fact that Quinlan herself, due to her persistent vegetative state, was not able to make that choice. Most jurisdictions have followed the New Jersey approach to this issue, granting legal guardians the right to choose on behalf of another in a veg-etative state;9 statutes have also been enacted that seek to address such situations.10

Of course, the issue of patient choice can be addressed through an advanced written directive (aka a “living will”) that instructs doctors on how to treat an incapacitated patient. In those cases where no directive has been issued, however, some other proxy for the decision must suffice. Generally, the power to make this decision has been granted to the family (as in In re Quinlan), a doc-tor, or a judge.11 The question posed by this study hits at the heart of that practice: Can doctors seek the advice of those PVS or MCS patients who have responded to fMRI treatment in obtaining consent for prolonging or ending medical treatment? And what would be the case if the patient’s directive clashed with decision made by one of the various proxies men-tioned above?

Answering these questions depends, to a certain degree, on the legal definition of “competence.” Many medical scholars have offered broad outlines of tests for legal competence. One writer has suggested that “[l]

Among the most important concerns that this study may address are the definitions of vegetative and minimally conscious states and, consequently, notions of legal consent. Persistent questions about the “right to die” in United States law have engaged scholars since In re Quinlan, the first major attempt to deal with the question on the judicial level.

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egal competence is specific to the task at hand. It requires the mental capac-ities to reason and deliberate, hold appropriate values and goals, appre-ciate one’s circumstances, understand information one is given and commu-nicate a choice.”12 A broader, perhaps looser standard has also been pro-posed, whereby “competence to con-sent to or refuse treatment involves (1) the capacity to understand and reason about choices; (2) the capacity to communicate one’s choice; and (3) the possession of a stable set of values and goals upon which to base one’s choice.”13 Some courts have suggested that the level of capacity to reason should be directly tied to the serious-ness of the decision, i.e., a “sliding scale” approach in which the more serious the case, the higher the level of competency required.14

To the extent that these defini-tions are standards that require the balancing of multiple factors, they provide little guidance in determin-ing whether an fMRI-responsive PVS patient may consent to or refuse medical treatment. Given the drastic consequences involved in these deci-sions, courts that adopt a stricter for-mulation for legal consent would be less likely to find patients capable of consenting. Even more relaxed defi-nitions of consent would likely still require the patient to exhibit some form of reasoning in making these decisions; it is difficult to say that even the most responsive patient in these tests has engaged in a process of reasoning whereby she would “have a stable set of values and goals upon which to base her choice” and the capacity to understand the impact of her decisions.

However, if this technology becomes effective as a mode of com-munication with a PVS, MCS, or locked-in syndrome patient, courts may be wary of taking these decisions out of the hands of the patient. Given that the law has increasingly come to recognize an individual’s right to choose death, placing that choice in

the hands of another decision maker (even if that person happens to be a relative or close friend) when the patient herself can be asked may trouble a sensitive bench. Advocates may add to this mix other quasi-con-stitutional arguments based in the rights of the individual, such as the right to privacy or the right to bodily integrity,15 which may add impetus to assigning the decision to the patient. Whether these questions will actually be litigated is anyone’s guess, since the patient herself will be unable to raise these claims. Still, the legal ramifica-tions of these decisions are immense, and it is quite possible that courts will have to deal with them in the future.

While such questions may take years to formulate, one recently pub-lished case report from the Nether-lands may foreshadow future legal developments.16 The case involves a 56-year-old lawyer who suffered from a massive brain hemorrhage that put him into a coma from which he had little chance of recovery. His wife characterized him as a propo-nent of euthanasia (which is legal in the Netherlands), but was denied this course of action because such a procedure is only legal following the patient’s direct request. Shortly thereafter, the patient opened his eyes upon request and was recognized as having locked-in syndrome, fully conscious but with paralysis of all his voluntary muscles except his eyes. He was trained to respond to “yes or no” questions by blinking his eyes, and through such means he affirmed his desire to receive euthanasia. After 21 days of careful review and repeated questioning, physicians administered euthanasia.

While the Netherland case does not involve PVS or MCS patients whose cognitive faculties are presumably substantially more impaired, it serves as a precedent for the use of atypical means of communication to enable patients to express autonomous deci-sions about their medical care. It employed eye blinking and a “yes or

no” model of questioning to affirm the patient’s wishes. In the case of PVS or MCS patients, would deliberate mod-ulation of brain activity in response to comparable questions similarly suffice? This would likely depend on whether we determine it to be pos-sible and appropriate to assess the competence of these patients through such means as well.17

IV. Limitations and ConclusionsThe above analysis, with its potential implications, is, of course, quite ten-tative. The study outlined above has neither been reproduced nor been subject to intense academic scrutiny (though no one has outright rejected its conclusions). The questions the researchers asked were fairly minimal in scope — the test only consisted of imagining one of two scenarios, and in one patient, a series of six “yes or no” questions. Moreover, since the ques-tions posed only required this patient to provide simple “yes or no” answers, it is difficult to determine whether the study actually reveals a patient’s abil-ity to reason through problems of any sort, let alone questions that under-score such significant physical and philosophical issues. Finally, some have suggested that seemingly inten-tional brain modulation may reflect automatic and unconscious processes rather than an aware “self,” though the authors argue that sustained and consistent responses reflect genuine communication.18

The study, however, brings to light a number of important concerns in the intersection of law and medical eth-ics. Assuming the law grants a broad right to bodily privacy and to medical choice, how is the law to react when the patient can only exercise her right through the use of experimental technology? What happens when the medical arena brings to light previ-ously unidentified factors that can be brought to bear on these determina-tions? Who is best fit to determine these issues, and how should those determinations be allocated?

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The study also complicates the decisions that are currently being made by family members of PVS or MCS patients regarding continuation of treatment. Will the fact that some PVS or MCS patients may be more aware then previously recognized inspire more hope for recovery in family members and push them away from withdrawing treatment? Or will the knowledge that a loved one may be somewhat aware of and suffering through such horrible circumstances push them to opposite conclusions?19 Whether or not future studies in this area help shed light on these ques-tions, this study has brought to the surface the multitude of value assess-ments that must be made every day in determining the correct course of action.

References1. M. M. Monti, A. Vanhaudenhuyse, M. R.

Coleman, M. Boly, J. D. Pickard, and L. Tshibanda et al., “Willful Modulation of Brain Activity in Disorders of Conscious-ness,” New England Journal of Medicine 362 (2010): 579-589.

2. The Multi-Society Task Force on PVS, “Medical Aspects of the Persistent Veg-etative State: Part 1,” New England Jour-nal of Medicine 330 (1994): 1499-1508 (issue number?); The Multi-Society Task Force on PVS, “Medical Aspects of the Persistent Vegetative State: Part 2,” New England Journal of Medicine 330 (1994): 1572-1579.

3. J. T. Giacino, S. Ashwal, N. Childs, R. Cranford, B. Jennett, and D. I. Katz et al., “The Minimally Conscious State: Defini-tion and Diagnostic Criteria,” Neurology 58 (2002): 349-53.

4. See Multi-Society Task Force on PVS, supra note 2.

5. “Legal consent,” as used in this note, con-notes a patient’s ability to communicate assent (or disapproval) to medical treat-ment to a health-care provider. More particular definitions of “consent” will be discussed infra in further detail.

6. In re Quinlan, 355 A.2d 647 (N.J. 1976). See also K. Kirschner, “Calling It Quits: When Patients or Proxies Request to Withdraw or Withhold Life-Sustaining Treatment after Spinal Cord Injury,” Top-ics in Spinal Cord Injury Rehabilitation 13 (2008): 30-44, at 31-34.

7. See Schindler v. Schiavo, 780 So.2d 176, 180 (Fla. Dist. Ct. App. 2001); Bush v. Schiavo, 885 So.2d 321, 324 (Fla. 2004).

8. Quinlan, 355 A.2d at 664. The approach taken by the NJ court has been termed the “substituted judgment test,” to be dis-tinguished from the “limited objective” and “pure objective” tests to determine the incompetent patient’s choice. See S. Weiner, “Privacy, Family, and Medi-cal Decision Making for Persistent Veg-etative Patients,” Cardozo Law Review 11 (1990): 713-734, at 725-729.

9. See, e.g., John F. Kennedy Memorial Hos-pital v. Bludworth, 452 So.2d 921 (Fla. 1984); In re Coyler, 660 P.2d 738 (Wash. 1983); Superintendent of Belchertown State School v. Saikewicz, 370 N.E.2d 417 (Mass. 1977).

10. See, e.g., Patient Self-Determination Act, 42 U.S.C. § 1395 (1994); Arkansas Rights of the Terminally Ill or Perma-nentely Unconscious Act, 1987 Ark. Stat. Ann. 20-17-201 to -218 (Supp. 1989). Readers who are interested in a nar-rative account of a guardian’s struggle with this decision should see generally R. Galli, Rescuing Jeffrey (City of publi-cation?: Name of publisher?, 2000).

11. See Weiner, supra note 8, at 720-724.12. A. Buchanan, “Mental Capacity, Legal

Competence and Consent to Treat-ment,” Journal of the Royal Society of Medicine 97, no. 9 (2004): 415-420; see also P. Appelbaum and T. Grisso, “Assessing Patients’ Capacities to Con-sent to Treatment,” New England Jour-nal of Medicine 319 (1988): 1635-1638.

13. G. Steffen and C. Franklin, “Case Stud-ies: Who Speaks for the Patient with

the Locked-In Syndrome?” Hastings Center Report 15, no. 6 (1985): 13-15.

14. See, e.g., Re T [1992], All ER 649 (arguing that life-threatening circum-stances justified a doctor’s decision to give a blood transfusion to a Jehovah’s Witness who could otherwise not give or refuse consent). This was also the approach endorsed by the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.

15. Justice Cardozo was one of the first to express this right to bodily integrity, writing in Schloendorff v. Society of New York Hospital: “Every human being of adult years and sound mind has a right to determine what should be done with his own body. . .” Schloendorff v. Society of New York Hospital, 105 N.E. 92, 93 (N.Y. 1914).

16. E. J. Kompanje, I. D. de Beaufort, and J. Bakker, “Euthanasia in Intensive Care: A 56-Year-Old Man with a Pontine Hemorrhage Resulting in a Locked-In Syndrome,” Critical Care Medicine 35, no. 10 (2007): 2428-2430.

17. Some locked-in patients have been trained to communicate in sentences by blinking in response to a succession of letters. While it would take far more time and resources, one can imagine potentially employing similar meth-ods in conjunction with fMRI to allow PVS and MCS patients the possibility of expressing words.

18. A. H. Ropper, “Cogito ergo sum by MRI,” New England Journal of Medicine 362 (2010): 648-649.

19. A consideration that may unfortunately play a factor in these decisions is the high cost of prolonged loss of conscious-ness treatment. One review notes that the “projected average per person life-time costs of care alone for severe trau-matic brain injury range from $600,000 to $1,875,000. A single case described by Paris reported in-hospital lifetime costs of $6,104,590.” See Giacino et al., supra note 3, at 349-353.