Hostname: page-component-586b7cd67f-gb8f7 Total loading time: 0 Render date: 2024-11-25T17:13:09.852Z Has data issue: false hasContentIssue false
  • English
  • Français

Recent Case Developments in Health Law

Published online by Cambridge University Press:  01 January 2021

Sally Wang
Get access Rights & Permissions [Opens in a new window]

Extract

The False Claims Act (FCA), 31 U.S.C. § 3729, a post-Civil War law inspired by cases of defense contracting fraud, was revitalized in 1986. Since then it has been used to sue both manufacturers and providers of pharmaceuticals. In some cases, these suits were meant to target offlabel marketing of pharmaceuticals. In 2009, the 11th Circuit rendered a decision in Hopper v. Solvay Pharmaceuticals 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 showing specific prescriptions that were written as a result of efforts to do so.

Type
JLME Column
Information
Journal of Law, Medicine & Ethics , Volume 38 , Issue 3 , Fall 2010 , pp. 708 - 716
Copyright
Copyright © American Society of Law, Medicine and Ethics 2010

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

References

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).+(last+visited+August+6,+2010).>Google Scholar
Voreacos, D., “Grassley Asked Pfizer, Drugmakers How They Treat Whistleblowers,” Bloomberg Businessweek, July 1, 2010.Google Scholar
See Slade, , supra, note 1.Google Scholar
United States ex rel. Duxbury v. Ortho Biotech Prods., L.P., 579 F.3d 13, 16 (1st Cir. 2009).Google Scholar
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).+(last+visited+August+6,+2010).>Google Scholar
Hopper v. Solvay Pharms., Inc., 588 F.3d 1318, 1324 (11th Cir. 2009).Google Scholar
Id., at 1322.Google Scholar
United States ex rel. Duxbury v. Ortho Biotech Prods., L.P., 579 F.3d 13, 16 (1st Cir. 2009).Google Scholar
Id.Google Scholar
Hutt, P. B., Merrill, R. A., and Grossman, L. A., Food, and Drug Law (City of publication: Foundation Press, 2007): At 555.Google Scholar
Id., at 548, 554–555.Google Scholar
Hopper v. Solvay Pharms., Inc., 588 F.3d 1318, 1324 (11th Cir. 2009).Google Scholar
31 U.S.C.S. §3729(a)(1).Google Scholar
Hopper v. Solvay Pharms., Inc., 588 F.3d 1318, 1325 (11th Cir. 2009).Google Scholar
Id., at 1328.Google Scholar
Id., at 1326.Google Scholar
United States ex rel. Duxbury v. Ortho Biotech Prods., L.P., 579 F.3d 13, 26 (1st Cir. 2009).Google Scholar
See Vogel, , supra note 5.Google Scholar
Id.Google Scholar
See Voreacos, , supra note 2.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Id.Google Scholar
Vt. Agency of Natural Res. v. United States ex rel. Stevens, 529 U.S. 765, 781 (U.S. 2000).Google Scholar
United States ex rel. Springfield Terminal Ry. v. Quinn, 14 F.3d 645, 649 (D.C. Cir. 1994).Google Scholar
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).+(last+visited+August+6,+2010).>Google Scholar
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).+(last+visited+August+6,+2010).>Google Scholar
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).+(last+visited+August+6,+2010).>Google Scholar
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.Google Scholar

References

Monti, M. M., Vanhaudenhuyse, A., Coleman, M. R., Boly, M., Pickard, J. D., and Tshibanda, L. et al., “Willful Modulation of Brain Activity in Disorders of Consciousness,” New England Journal of Medicine 362 (2010): 579–589.CrossRefGoogle Scholar
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.CrossRefGoogle Scholar
Giacino, J. T., Ashwal, S., Childs, N., Cranford, R., Jennett, B., and Katz, D. I. et al., “The Minimally Conscious State: Definition and Diagnostic Criteria,” Neurology 58 (2002): 349–53.CrossRefGoogle Scholar
See Multi-Society Task Force on PVS, supra note 2.Google Scholar
“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.Google Scholar
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.CrossRefGoogle Scholar
See Schindler v. Schiavo, 780 So.2d 176, 180 (Fla. Dist. Ct. App. 2001); Bush v. Schiavo, 885 So.2d 321, 324 (Fla. 2004).Google Scholar
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.Google Scholar
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).Google Scholar
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).Google Scholar
See Weiner, , supra note 8, at 720–724.Google Scholar
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. and Grisso, T., “Assessing Patients' Capacities to Consent to Treatment,” New England Journal of Medicine 319 (1988): 1635–1638.CrossRefGoogle Scholar
Steffen, G. and Franklin, C., “Case Studies: Who Speaks for the Patient with the Locked-In Syndrome?” Hastings Center Report 15, no. 6 (1985): 13–15.CrossRefGoogle Scholar
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.Google Scholar
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).Google Scholar
Kompanje, E. J., de Beaufort, I. D., and 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.CrossRefGoogle Scholar
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.Google Scholar
Ropper, A. H., “Cogito ergo sum by MRI,” New England Journal of Medicine 362 (2010): 648–649.CrossRefGoogle Scholar
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, et al., supra note 3, at 349–353.Google Scholar