Recent Developments in Health Law

Rivera v. Yale New Haven Hospital Inc., No. 3:04-CV-1515 (D. Conn. filed Sept. 13, 2004), available through <http://www.nfplitigation.com>.

Moore N. J. and Sturges P. M. , “Charity Care Litigation Sees New Filing As Defense's Theories, Strategies Evolve,” BNA's Health Law Reporter 13 (2004): 1318–19, at 18; Abelson R. and Glater J.D. , “Suits Challenge Hospital Bills of Uninsured,” New York Times, June 17, 2004, at C01.

Ostrom C. , “Hospital Systems Sued Over Charity-Case Fees,” Seattle Times, September 30, 2004, at B-4; Appleby J. , “Barrage of Lawsuits ‘Huge Wake-Up Call’ For Non-Profit Hospitals,” USA Today, July 19, 2004, at B-3.

Rivera , supra note 1, at 22–43; Moore and Sturges , supra note 2.

Id; see Conn. Gen. Stat. § 19a-673 (2003).

Rivera , supra note 1, at 35; see 42 U.S.C. § 1395dd.

Rivera , supra note 1, at 22.

Id. at 25.

Id. at 25.

Moore and Sturges , supra note 2, citing Fields v. Banner Health, No. 04-CV-1297 ( Ariz D. , motion filed Aug. 11, 2004).

Moore and Sturges , supra note 2, quoting Watts v. Advocate Health Care Network, No. 04 C 4062 (N.D. Ill. motion filed Aug. 13, 2004).

Condon G. , “Yale-New Haven Sued in Class Action; Hospital Accused of Unfair Treatment For Uninsured Patients,” Hartford Courant, September 14, 2004, at B-1.

Abelson and Glater , supra note 2.

Condon , supra note 8.

Brady P. , “Patients Allege Bad Practices,” Yale Daily News, September 14, 2004, available through <http://www.yaledailynews.com/article.asp?AID=26195>; Condon , supra note 8.

Brady , supra note 10.

Committee on Ways and Means, Subcommittee on Oversight, Hearing Archives, at <http://waysandmeans.house.gov/hearings.asp?fbrmmode=detail&hearing=157>.

Id.; Appleby J. , supra note 3.

Appleby J. , supra note 3.

Condon G. , supra note 7.

Rivera , supra note 1, at 3.

Lewis B. , “Saint Thomas, Others Win Early Victory in Suit,” The Tennessean, October 21, 2004, at E03.

Davidson D. , Statement on the Multidistrict Litigation Ruling, at <http://www.aha.org/aha/press_roominfo/jsp/releasedisplay.jsp?dcrpath=AHA/Press_Release/data/PR_041020_MDL&domain=AHA>.

Abelson and Glater , supra note 2; Id.

Amato v. UPMC, No. 04-1025 (W.D. Pa. Nov. 23, 2004); Darr v. Sutter Health, No. C 04–02624 WHA (N.D. Cal. Nov. 30, 2004).

Darr , supra note 26, at 5–8.

Amato , supra note 26, at 4–10.

Abelson and Glater , supra note 2

Hopper L. , “Liver Recipient Returns Home,” Houston Chronicle, August 19, 2004, at B-1.

Auge K. , “Kidney Gift is at Heart of Debate,” The Denver Post, October 21, 2004, at A-01.

Bone J. , “Patient Finds Kidney Donor after Advertising for Help on Internet,” The Times (London), October 22, 2004, at 39.

42 U.S.C. § 274.

Hartman T. , “Kidney Donor to be Feed from Jail,” Rocky Mountain News (Denver), November 2, 2004, at 21-A.

Healy M. , “Changing Rules of Organ Donation,” LA Times, November 1, 2004, at F-1.

Unless otherwise noted all statistics are from Organ Procurement & Transplant Network, available at <http://www.optn.org/latestData/rptData.asp>.

“While the number of patients waiting for an organ has increased 14.1 percent annually, the rate of donors has only increased 2.9 percent.” “American Medical Association Testifies Before Congress on Organ Donation Motivation; Encourages Study of Financial Incentives”; press release, American Medical Association, June 3, 2003, at <www.ama-assn.org/ama/pub/article/print/1616-7726.htm>.

United Network for Organ Sharing, at http://www.unos.org/whatWeDo/donationEducation.asp.

Sheehy E. , “Estimating the Number of Potential Organ Donors in the United States,” New Eng. J Med. 349 (2003): 667–674, at 671. See also Office of Inspector Gen., Dept. Health & Hum. Serv., “Variation In Organ Donation Among Transplant Centers” (2003), at <http://oig.hhs.gov/oei/reports/oei-01-02-00210.pdf>.

Steinberg D. , “An ‘Opting In’ Paradigm for Kidney Transplantation.” American Journal of Bioethics 4 (2004): 4–14, at 7.

See Auge , supra note 2, at 1.

Report of the OPTN/UNOS Ethics Committee, June 24–25, 2004, at <http://www.optn.org/members/docs/report_3.doc>.

State Legislatures, no. 9 Vol. 30, October 1, 2004, at 10.

Clark K. , “Organ Donor Tax Breaks,” State Net Capitol Journal, Vol. XII. No. 35, September 6, 2004.

Id. Connecticut, Illinois, Indiana, Massachusetts, Minnesota, New Jersey, New York, Pennsylvania, Rhode Island and South Carolina.

42 U.S.C. § 274, at (b)2(D) and (b)2(B).

42 U.S.C. § 274(e): “It shall be unlawful for any person to knowingly acquire, receive, or otherwise transfer any human organ for valuable consideration…The term ‘valuable consideration’ does not include the reasonable payments associated with the removal, transportation, implantation, processing, preservation, quality control, and storage of a human organ or the expenses of travel, housing, and lost wages incurred by the donor…”

Harrop F. , Editorial, The Providence Journal (Rhode Island) March 3, 2004, at B-05.

UNOS Ethics Committee, supra note 14.

Davis R. , “Online organ match raises ethical concerns,” USA Today, October 26, 2004, at 8-D.

A similar problem arises in the system's allowance of those who can afford it to be listed as an organ recipient in multiple organ transplant centers, thereby increasing their odds of receiving an organ that might otherwise go to someone listed at just one center. Currently more than 6,000 people are listed at more than one center. See Allen S. , “When Love Isn't Enough, Without Connections, Vermont Woman Died Waiting for Lung transplant,” The Boston Globe, September 7, 2004, at H-1.

The wealth disparities may be less of an issue for the DonorMatching.com website than it is for more other advertising campaigns, since the website now offers free memberships for patients that cannot afford the fees. See <http://www.matchingdonors.com/life/index.cfm?page=services>.

Davis , supra note 22.

Davis , supra note 22.

Feinberg J. , Harm to Others. (Oxford: Oxford U Press, 1984); at 36.

E.g., Cohen C. , “The Case for Presumed Consent to Transplant Human Organs After Death,” 24 Transplant Proc. (1992): 2168–2172 (on routine harvesting), and Radcliffe-Richards J. , “The Case for Allowing Kidney Sales,” Lancet 351 (1998): 1950–1952 (on an organ market).

One of the first proposals for such a system is Kaufelt J. , Letter, Wall St. J, May 15, 1986, at 29. A more complete argument is Jarvis R. , “Join the Club: A Modest Proposal to Increase Availability of Donor Organs,” Journal of Medical Ethics 21 (1995): 199–204, at 202.

See Klassen A. and Klassen D. , “Who Are the Donors in Organ Donation? The Family's Perspective in Mandated Choice,” Annals Internal Med. 125 (1996): 70–73.

For analysis of DNR orders and their relation to autonomy, see Rutkow L. , “Note: Dying To Live: The Effect Of The Patient Self-Determination Act On Hospice Care,” N.Y.U. J. Legis. & Pub. Pol'y 7 (2003/2004): 393–435.

See Gimbel R. W. , “Presumed Consent and Other Predictors of Cadaveric Organ Donation in Europe,” Progress in Transplantation 13 (2003): 17–23, at 19.

No states have implemented such a system, and they have not yet received scholarly attention. See however, Robertson C. , open peer commentary, “Framing the Organ System: Altruism or Reciprocity,” American Journal of Bioethics 4 (2004): 46–48.

This is one reason why even those systems that rely upon opt-out provisions still fail to produce sufficient organs. See Office of Inspector General, supra note 10 for an account of the wide variations between harvesting rates at medical centers.

On framing, see Lakoff G. , Metaphors We Live By (Chicago: U. Chicago Press, 2003).

Falsetti A. E. , “Fluoxetine-Induced Suicidal Ideation: An Examination of the Medical Literature, Case Law, and the Legal Liability of Drug Manufacturers,” Food and Drug Law Journal 57 (2002) 273–292, at 273.

Healy D. , “Lines of Evidence on the Risks of Suicide with Selective Serotonin Reuptake Inhibitors,” Psychotherapy and Psychosomatics 72 (2003) 71–79, at 71.

The People of the State of New York v. GlaxoSmithKline, Verified Complaint at 1.

The People of the State of New York v. GlaxoSmithKline, Verified Consent Order & Judgment at 5–6.

Falsetti A. E. , supra note 1 at 275 (citing Teicher M. H. , “Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment,” American Journal of Psychiatry 147 (1990) at 207–10).

Id. at 275 (citing Teicher M. H. , “Emergence of Intense Suicidal Preoccupation During Fluoxetine Treatment,” American Journal of Psychiatry 147 (1990) 207–10, at 207.).

Id. at 276 (citing, inter alia, Brewerton T. D. , “Fluoxetine-Induced Suicidality, Serotonin, and Seasonality,” Biological Psychiatry 30 (1991) at 190–96; Chouinard G. , “Fluoxetine and Preoccupation with Suicide,” American Journal of Psychiatry 148 (1991) at 1258–59; Dasgupta K. , “Additional Cases of Suicidal Ideation Associated with Fluoxetine,” American Journal of Psychiatry 147 (1990) at 1570; Downs J. , “Preoccupation with Suicide in Patients Treated with Fluoxetine,” American Journal of Psychiatry 148 (1991) at 1090–91.

Id. at 276. See, specifically, Rothschild A. J. and Locke C. A. , “Reexposure to Fluoxetine After Serious Suicide Attempts by Three Patients: The Role of Akathisia,” Journal of Clinical Psychiatry 52 (1991), 491–93.

Id. at 277 (citing, inter alia, Berkley R. B. , “Discussion of Fluoxetine and Suicidal Tendencies,” American Journal of Psychiatry 147 (1990), 1572).

Id. at 279 (citing Ahmad S. R. , “USA: Fluoxetine ‘Not Linked to Suicide,’” Lancet 338 (1991), at 875).

Id. at 279 (citing Ahmad S. R. , “USA: Fluoxetine ‘Not Linked to Suicide,’” Lancet 338 (1991), at 876).

Id. at 274.

Healy D. , supra note 2.

Id. at 74.

Id. at 74 and 77.

Id. at 74.

Thompson A. , “Paxil Maker Held Liable in Murder/Suicide,” Lawyers Weekly USA, July 9, 2001, at <http://www.baumhedlundlaw.com/media/ssri/Paxil_murder.htm> (last visited January 25, 2005).

The People of the State of New York v. GlaxoSmithKline, Verified Complaint at 1.

Id. at 3.

Id. at 2.

Id. at 4.

Id. at 4–5.

Id. at 5.

Id. at 5.

Id. at 6. Prior to study 329, GlaxoSmithKline identified seven measures of efficacy which it purported to test. Two of these were identified as “primary” endpoints, while the other five were considered “secondary” endpoints. According to the State of New York's interpretation of study 329, paroxetine was superior to the placebo with regard to three of the five secondary endpoints but neither of the primary endpoints.

Id. at 6–7.

Id. at 8.

Id. at 8.

Id. at 9.

Id. at 9. The memorandum also stated that the information was for pharmaceutical consultants' information only and should not be distributed to physicians. The Attorney General, however, asserted that this was clearly the company's purpose for they would have no other reason to release such a memo.

Id. at 9.

Id. at 10.

Id. at 11–14.

Id. at 11–14.

The People of the State of New York v. GlaxoSmithKline, Verified Notice of Removal; The People of the State of New York v. GlaxoSmithKline, Verified Consent Order & Judgment at 5–6.

Id. at 1

Id. at 5.

Id. at 7.

Id. at 6.

Id. at 8.

In the Matter of GlaxoSmithKline, Verified Assurance of Discontinuance Pursuant to Executive Law Section 63, Subdivision 15 at 5.

Id. at Appendix C.

See Nagle M. E. , “State ‘Fraud’ Suits Over Clinical Trial Results Tread on Free Speech Rights,” Mealey's Litigation Report: Antidepressant Drugs, September 24, 2004; Abramson J. , Overdosed America (New York: HarperCollins, 2004): At 104–105 (Discussing the Controlled Onset Verapamil Investigation of Cardiovascular End Points (CONVINCE) study, a five-year study sponsored by Pharmacia that was stopped two years early because the results up to that point demonstrated that Pharmacia's more expensive blood pressure medication Covera was slightly less effective at preventing the complications of high blood pressure than less expensive drugs; see Psaty B. M. and Rennie D. , “Stopping Medical Research to Save Money: A Broken Pact with Researchers and Patients,” JAMA 289, no. 16 (2003) 2128–2131). Critics might argue that in virtually all trials, the investigators, sponsors and patients are all blinded to the treatment each participant receives, and thus it is impossible for pharmaceutical companies to know in advance whether or not a study is likely to produce negative results. In such double-blind studies, Data and Safety Monitoring Boards (DSMBs) are responsible for monitoring interim results in order to protect patients' welfare. Although employees of the trial's sponsor are not permitted to serve as members of DSMBs, they are allowed to assist the DSMB in its evaluation of clinical data. Moreover, voting members of DSMBs are permitted to have limited financial ties to the sponsor, and non-voting members are allowed even greater financial connections to the company funding the trial. See Principles on Conduct of Clinical Trials and Communication of Clinical Trial Results, at <http://www.phrma.org/publications/publications//2004-06-30.1035.pdf>. With such poor boundaries between DSMBs and sponsors, it seems likely that decisions to prematurely terminate clinical trials are often based at least in part on a study's potential for generating adverse data. Requiring pharmaceutical companies to submit data from all unfinished (as well as completed) trials in order to achieve FDA approval would not adequately deter the premature termination of projects that are likely to produce negative results. Under the current regime, FDA approval is granted on an all-or-nothing basis and thus public disclosure of a study with negative results could hurt market share, even though the results are not sufficiently damning to foreclose FDA approval. Under a system in which the FDA rates drugs in addition to approving them (see infra), however, such a mandate may sufficiently deter the premature termination of studies conducted prior to the product's launch. In order to prevent the inappropriate abortion of post-launch studies, the government would have to either (a) require all companies to publicly disclose the termination of trials, along with the rationale for each decision (see infra), or (b) regularly adjust the “ratings” of previously launched products according to all available data (both completed and unfinished trials).

The pharmaceutical industry, represented by the European Federation of Pharmaceutical Industries and Associations (EFPIA), the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), the Japanese Pharmaceutical Manufacturers Association (JPMA) and the Pharmaceutical Research and Manufacturers of America (PhRMA), has recently committed to disclosing information pertaining to all “non-exploratory,” industry-sponsored clinical trials. See “Joint Position on the Disclosure of Clinical Trial Information via Clinical Trial Registries and Databases,” at <http://www.efpia.org/4_pos/sci_regu/Clinicaltrials2005.pdf> (last visited January 26, 2005); “PhRMA Clinical Trial Registry Proposal” at <http://www.phrma.org/publications/policy/06.01.2005.1111.cfm> (last visited January 26, 2005). Although this policy has the potential to reduce pharmaceutical companies' incentive to prematurely terminate studies that are likely to produce negative data, the extent to which this occurs will depend on several factors such as (a) the number and types of studies that companies classify as “exploratory” and are thus exempted from the disclosure requirements, (2) whether the industry's commitment to disclosing “trial phase” and “trial status” includes an obligation to disclose trial terminations, (3) if pharmaceutical companies have indeed committed to announcing trial terminations, the (a) language used to convey this point, (b) the amount of time that is allowed to lapse between a trial termination and disclosure of this fact, (c) whether companies will be able to circumvent their obligations by slowing the progress of a trial to a virtual standstill instead of aborting the project entirely.

The People of the State of New York v. GlaxoSmithKline, Verified Complaint at 2.

See Meadows M. , “The FDA's Drug Review Process: Ensuring Drugs are Safe and Effective,” FDA Consumer, July 2002, at <http://www.fda.gov/fdac/features/2002/402_drug.html> (last visited January 25, 2005).

Waltz J. A. , “CMS Report Analyzes Factors Affecting the Marketing of Prescription Drugs,” Medscape from WebMD, April 22, 2003, at <http://www.medscape.com/viewarticle/452211_1> (last visited January 25, 2005).

Herzlinger R. E. Lagor W. Perry C. St. Germain S. , “I've Got Rhythm: Selling Cardiac Rhythm Management Devices” Harvard Business School Case Number 9-304-012, August 20, 2004, at 6.

See Waltz J. A. , supra note 50. Although such a discussion is beyond the scope of this paper, it is highly questionable whether the distribution of samples effectuates laudable societal goals. Anecdotal evidence suggests that a high percentage of samples go to individuals who have adequate insurance coverage or can afford the medicine by themselves. Thus, the dissemination of samples does not address any distributional concerns (and may even exacerbate problems of wealth disparity), insofar as all drug users pay for the cost of samples in the form of higher insurance premiums or higher drug costs.

See Dana J. and Loewenstein G. , “A Social Science Perspective on Gifts to Physicians from Industry,” JAMA 290, no. 2 (2003) 252–255 (Concluding that, notwithstanding physicians' belief to the contrary, doctors are heavily influenced by the fringe benefits provided by pharmaceutical companies); Wazana A. , “Physicians and the Pharmaceutical Industry: Is a Gift Ever Just a Gift?” JAMA 283, no. 3 (2000) 373–380; Jhon P. , “Drug Company Dependent?,” Medscape from WebMD, 2003, at <http://www.medscape.com/viewarticle/414513> (last visited January 25, 2005).

Herzlinger R. E. , note 51 supra, at 5 (stating: “Physicians felt they had enough information within the first six months to year of launch…Some physicians felt they could learn more about new drugs themselves than from their sales reps. Frequently, drug reps did little more than drop off samples to the nurses or the supply cabinets.”)

Jhon P. , supra note 53.

Pharmaceutical sales representatives are clearly subject to much higher regulation (both internally and by the FDA) than car salesmen. The point, however, is merely that both parties are expected to carefully select language (and potentially data) that portrays their products in the most favorable light.

See Kramer T. A. M. , “A Plea for Biased Information,” Medscape from WebMD, February 10, 2004, at <http://www.medscape.com/viewarticle/468112_1> (last visited January 25, 2005).

Ratings could be made on a 1 to 100 scale or any other scale that allows for sufficient differentiation. The FDA currently assesses the efficacy and safety of drugs in an attempt to determine if they reach the threshold required for approval. This suggests that the FDA would be the best equipped (compared to other governmental bodies) to engage in the additional evaluation necessary to provide products with relative rankings. Of course, in order to accurately assess cost-effectiveness, personnel with different backgrounds (e.g. economists) would have to be hired. Although a detailed discussion of this point is beyond the scope of this paper, the FDA could establish a standardized process through which it regularly reevaluates pharmaceuticals after their launch. The FDA could be required to reassess all drugs every few years on the basis of post-launch clinical trials, and pharmaceutical companies could be permitted to petition the government for reevaluation when sufficient data becomes available.

Angell M. , The Truth about the Drug Companies (New York: Random House, 2004): at 40 and 122. The exact amounts of money that pharmaceutical companies spend on marketing and R&D are hotly debated. The pharmaceutical industry, speaking through the Pharmaceutical Research and Manufacturers of America (PhRMA), contends that R&D expenditures “far exceed” spending on marketing and promotion (see Pharmaceutical Marketing and Promotion, at <http://www.phrma.org/publications/policy//2004-11-10.1095.pdf>) (last visited January 25, 2005). Resolution of this issue is far beyond the scope of this paper, but it is important to realize, that regardless of which figures are used, pharmaceutical companies' marketing expenditures are large enough that a relatively modest reduction in the percent of revenue spent on promotional activities could have a substantial impact on drug prices.

Herzlinger R. E. , note 51 supra, at 5.

Id. at 5.

Of course, idiosyncrasies amongst the patient population may make it preferable for some patients to forego higher rated pharmaceuticals for lower rated drugs that are better suited to the patients' needs. Pharmaceutical representatives can provide physicians with valuable information by alerting them to such instances. When certain classes of people (as a whole) respond more favorably to a drug than others, the FDA may wish to provide a separate set of ratings for each group. Such disparate ratings may be warranted for SSRIs, since an antidepressant's effect on suicidality appears to depend on the personality of the user (see supra note 2). Therefore, it may be appropriate for the FDA to issue different safety ratings that correlate with users of different personalities. The funding necessary to create the FDA rating system from scratch and retrain pharmaceutical sales representatives will likely raise costs for pharmaceutical companies in the beginning. However, once the rating system is in place and reps have been retrained, it is likely that firms will experience significant savings.

Polan v. State of N.Y. Ins. Dep't, 3 N.Y. 3d 54, 57 (2004).

Id. at 58–59.

Pub. L. No. 104-204, codified at 42 U.S.C. § 201.

Nirtaut D. J. , “Ask a Benefit Manager,” Business Insurance, January 13, 1997, at 31.

Reddy S. , “Mental Health Care: From Grief Rises Timothy's Law,” Newsday, April 5, 2004.

Polan, 3 N.Y.3d at 57.

Polan, 3 N.Y.3d at 57; NY CLS Ins § 4224 (2004).

Polan, 3 N.Y.3d at 57.

Id. at 57–58.

Polan, 768 N.Y.2d at 441 (N.Y. App. Div. 2003).

Id. at 448, 450 (Sullivan, J. dissenting).

Id. at 450 (Sullivan, J. dissenting).

Polan, 3 N.Y.3d at 58.

Id. at 58–59.

Id. at 58.

Id. at 56.

Id. at 58–59, citing McNeil v. Time Ins. Co., 205 F.3d 179 (5th Cir., 2000) and El-Hajj v. Fortis Benefits Ins. Co., 156 F. Supp. 2d 27 (D. Me. 2001).

Id. at 62.

Id. at 62–63.

Id. at 58, 60.

Id. at 59–60.

Id. at 60.

Id. at 60–62.

“American Psychological Association; Lack of Insurance, Cost Cited as Reasons for Not Seeking Mental Health Services,” Disease Risk Factor Week, July 25, 2004, at 12 [hereinafter “American Psychological Association”].

“Court Finds Disability Insurers Can Vary Coverage for Mental and Physical Conditions,” BestWire, July 6, 2004.

Gonzalez G. , “Parity Advocates Aim to Close Loopholes in Mental Health Law; Employers, Insurers Oppose Bill,” Business Insurance, August 9, 2004, at 4.

“Late News,” Business Insurance, September 27, 2004, at 1; Gonzalez supra note 43.

Gonzalez , supra note 43.

Arsenault M. , “First Congressional District Race – Democrat Patrick Kennedy – 5-term incumbent has found his comfort zone at home, in House,” Providence Journal, October 4, 2004, at A-1; Sontag D. , “When Politics Is Personal,” New York Times, September 15, 2002, at 13.

“American Psychological Association,” supra note 40.

Reddy , supra note 5.

“Welfare Plan Update – Sutherland Asbill & Brennan,” Mondaq Ltd., March 19, 2004.

N.Y. Ins. § 4224 (2004).