Recent Case Developments in Health Law

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

Voreacos D. , “Grassley Asked Pfizer, Drugmakers How They Treat Whistleblowers,” Bloomberg Businessweek, July 1, 2010.

See Slade , supra, note 1.

United States ex rel. Duxbury v. Ortho Biotech Prods., L.P., 579 F.3d 13, 16 (1st Cir. 2009).

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

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

Id., at 1322.

United States ex rel. Duxbury v. Ortho Biotech Prods., L.P., 579 F.3d 13, 16 (1st Cir. 2009).

Id.

Hutt P. B. Merrill R. A. Grossman L. A. , Food, and Drug Law (City of publication: Foundation Press, 2007): At 555.

Id., at 548, 554–555.

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

31 U.S.C.S. §3729(a)(1).

Hopper v. Solvay Pharms., Inc., 588 F.3d 1318, 1325 (11th Cir. 2009).

Id., at 1328.

Id., at 1326.

United States ex rel. Duxbury v. Ortho Biotech Prods., L.P., 579 F.3d 13, 26 (1st Cir. 2009).

See Vogel , supra note 5.

Id.

See Voreacos , supra note 2.

Id.

Id.

Id.

Id.

Vt. Agency of Natural Res. v. United States ex rel. Stevens, 529 U.S. 765, 781 (U.S. 2000).

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

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/medicarefraud_07l6l0.htm> (last visited August 6, 2010).

Department of Justice, Assistant Attorney General Tony West Testifies Before the Senate Judiciary Committee Entitled. “Effective Strategies for Preventing Health Care Fraud, Press Release, October 28, 2010, available at <http://www.justice.gov/dag/testimony/2OO9/dag-testimony-091028.html> (last visited August 6, 2010).

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

Note in 1996 the number of health qui tarn 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.

Monti M. M. Vanhaudenhuyse A. Coleman M. R. Boly M. Pickard J. D. Tshibanda L. , “Willful Modulation of Brain Activity in Disorders of Consciousness,” New England Journal of Medicine 362 (2010): 579–589.

The Multi-Society Task Force on PVS, “Medical Aspects of the Persistent Vegetative State: Part 1,” New England Journal 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.

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

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

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

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

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

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

See, e.g., John F. Kennedy Memorial Hospital 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).

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

See Weiner , supra note 8, at 720–724.

Buchanan A. , “Mental Capacity, Legal Competence and Consent to Treatment,” Journal of the Royal Society of Medicine 97, no. 9 (2004): 415–420; see also Appelbaum P. Grisso T. , “Assessing Patients' Capacities to Consent to Treatment,” New England Journal of Medicine 319 (1988): 1635–1638.

Steffen G. Franklin C. , “Case Studies: Who Speaks for the Patient with the Locked-In Syndrome?” Hastings Center Report 15, no. 6 (1985): 13–15.

See, e.g., Re T [1992], All ER 649 (arguing that life-threatening circumstances 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.

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).

Kompanje E. J. de Beaufort I. D. Bakker J. , “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.

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 methods in conjunction with fMRI to allow PVS and MCS patients the possibility of expressing words.

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

A consideration that may unfortunately play a factor in these decisions is the high cost of prolonged loss of consciousness treatment. One review notes that the “projected average per person lifetime costs of care alone for severe traumatic 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 , supra note 3, at 349–353.