Recent Case Developments in Health Law

Blue Cross & Blue Shield v. AstraZeneca Pharms. LP, 582 F.3d 156 (1st Cir. 2009).

In re Pharm. Indus. Average Wholesale Price Litig., 491 F. Supp. 2d 20 (D. Mass. 2007).

“Medicare Program; Fee Schedule for Physicians' Services,” Federal Register 56 (November 25, 1991): 59,502.

Blue Cross & Blue Shield v. AstraZeneca Pharms. LP, 582 F.3d 156, 161–62 (1st Cir. 2009).

Id., at 184.

Id., at 160.

Id., at 162.

Track 2 Settlement Website, available at <http://awptrack2settlement.com/index.htm> (last visited February 5, 2010); Howe v. Townsend (In re In re Pharm. Indus. Average Wholesale Price Litig.), 2009 U.S. App. LEXIS 25536 (1st Cir. 2009).

Id., at 168–69.

Id., at 167–68.

Id., at 169–72.

Id., at 178–80.

Id., at 181–84.

Id., at 186–88.

Id., at 188.

Id., at 191.

Massachusetts v. Mylan Labs., Inc., 2009 U.S. Dist. LEXIS 2033 2 (D. Mass. 2009); Commonwealth v. TAP Pharm. Prods., 885 A.2d 1127 (Pa. Commw. Ct. 2005); In re McKesson, 2009 U.S. Dist. LEXIS 108703 (D. Cal. 2009); Montana v. Abbott Labs., 266 F. Supp. 2d 250 (D. Mass. 2003); Hawaii v. Abbott Labs., Inc., 469 F. Supp. 2d 842 (D. Haw. 2006); Alaska v. Abbott Labs., 2007 U.S. Dist. LEXIS 38817 (D. Alaska 2007).

18 U.S.C §1962 (1970).

New Eng. Carpenters Health Benefits Fund v. First DataBank, Inc., 602 F. Supp. 2d 277 (D. Mass. 2009). A similar case is In re Lupron(R) Mktg. & Sales Practices Litig., 228 F.R.D. 75 (D. Mass. 2005).

AstraZeneca LP v. State, 2009 Ala. LEXIS 244 (Ala. 2009).

Id., at 1, 46.

Id., at 1, 29.

Id., at 1, 29–46.

Blue Cross & Blue Shield v. AstraZeneca Pharms. LP, 582 F.3d 156, 167 (1st Cir. 2009).

42 U.S.C. §1395w-3a (2003); 42 U.S.C. §1395w-3b (2003).

Wooster A. K. , Annotation, Statute of Limitations in Civil Actions for Damages under the Racketeer Influenced and Corrupt Organizations Act (RICO), 18 U.S.C.A. § 1961–1968,156A.L.R. Fed. 361 (2009).

Zitter J. M. , Annotation, When Statute of Limitations Commences to Run on Action under State Deceptive Trade Practice or Consumer Protection Acts, 18 A.L.R. 4th 1340 (2009). For example, Louisiana and New Jersey's limitation periods on consumer protection claims are one year; Texas is two; Illinois and Wisconsin are three; and Massachusetts, North Carolina, and Tennessee are four.

Department of Defense Anthrax Vaccine Immunization Program, available at <http://www.anthrax.osd.mil> (last visited February 5, 2010).

Id.

Id.

Miller R. K. , “Informed Consent in the Military, Fighting a Losing Battle Against the Anthrax Vaccine,” American Journal of Law and Medicine 28, nos. 2–3 (2002): 325–343, at 329–332.

See, e.g., United States v. Washington, 54 M.J. 936, 942 (A.F. Ct. Crim. App. 2001) (noting that of 150 Air Force disciplinary actions for refusing anthrax vaccination, eight were referred to trial by court-martial).

Rempfer v. Sharfstein, 583 F.3d 860 (D.C. Cir. 2009).

Id., at 867.

Centers for Disease Control and Prevention, available at <http://www.bt.cdc.gov/agent/agentlist-category.asp> (last visited February 5, 2010).

Joellenbeck L. M. Zwanziger L. L. Durch J. S. , and Strom B. L. , eds., The Anthrax Vaccine: Is It Safe? Does It Work? (Washington, D.C.: National Academies Press, 2002): at 41 [hereinafter IOM Report].

Id., at 41–42.

Id., at 183–186.

Id., at 48–49.

Id., at 33–34.

See Miller , supra note 4, at 334.

See, e.g., United States v. Chadwell, 36 C. M.R. 741 (1965).

Food and Drug Administration, “2005 Final Order,” Federal Register 70 (2005): 75,180 [hereinafter “FDA Final Order”].

See, e.g., Katz R. D. , “Friendly Fire: The Mandatory Military Vaccination Program,” Duke Law Journal 50 (2001): 1835–1865, 1852.

Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10, The Medical Case at 181 (U.S. Government Printing Office: 1949) (“The voluntary consent of the human subject is absolutely essential”).

U.S.C. §1107(f)(1) (2006); see also Miller , supra note 4, at 342.

See Noah L. , “Informed Consent and the Elusive Dichotomy between Standard and Experimental Therapy,” American Journal of Law and Medicine 28, no. 4 (2002): 361–408, at 388–391.

297 F.Supp.2d 119, 133 (D.D.C. 2003).

Id., at 135.

Doe v. Rumsfeld, 297 F.Supp.2d 200 (D.D.C. 2004).

See Rempfer, supra note 6, citing Doe v. Rumsfeld, 341 F. Supp. 2d 1, 16 (D.D.C. 2004).

See FDA Final Order, supra note 16.

Rempfer v. Von Eschenbach, 535 F. Supp.2d 99, 112 (D.D.C. 2008).

Administrative Procedure Act, 5 U.S.C. §706(2)(A) (2006).

Brachman P. S. , “Field Evaluation of a Human Anthrax Vaccine,” American Journal of Public Health 52 (1962): 632–645.

See IOM Report, supra note 9, at 77.

See Rempfer, supra note 6.

Motor Vehicle Mfrs. Ass'n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983).

O'Reilly J. T. , “Losing Deference in the FDA's Second Century: Judicial Review, Politics, and a Diminished Legacy of Expertise,” Cornell Law Review 93, no. 5 (2008): 939–979, at 952; see Almay, Inc. v. Califano 569 F. 2d 674, 682–83 (ruling that the FDA's definition of “hypoallergenic” was arbitrary and capricious for lack of supporting evidence).

Id., at 952.

See Rempfer, supra note 6, at 12, citing A.L. Pharma v. Shalala, 62 F. 3d 1484, 1490 (D.C. Cir. 1995); see also Bristol-Myers Squibb v. Shalala, 923 F. Supp. 212, 216 (D.D.C. 1996).

Weinberger v. Bentex Pharm., Inc., 412 U.S. 645, 653–54 (1973).

See FDA Final Order, supra note 16, at 75,187.

Id.

Id., at 75,184.

See IOM Report, supra note 9, at 22.

See Rempfer, supra note 6, at 866–867.

Id.

Id.

Id., at 868.

See e.g., Annas G. J. , “Blinded by Bioterrorism: Public Health and Liberty in the 21st Century,” Health Matrix 13, no. 1 (2003): 33–70, 45.

Government Accountability Office, GAO-02-445: Anthrax Vaccine (GAO's Survey of Guard and Reserve Pilots and Aircrew) (2002), at 10.

Id., at 17.

See IOM Report, supra note 9, at 199.

Department of Health and Human Services, “HHS Modifies Approach to Supporting Second Generation Anthrax Vaccine,” available at <http://www.hhs.gov/disasters/rpaapproach.html> (last visited February 5, 2010).

See IOM Report, supra note 9, at 61; FDA Final Order, supra note 16, at 75, 192.

21 C.F.R. §314.600 (2009).

“Approval of New Drugs When Human Efficacy Studies Are Not Ethical or Feasible,” Federal Register 67 (May 31, 2002): 37992, available at <http://www.fda.gov/OHRMS/DOCKETS/98fr/053102a.htm> (last visited February 5, 2010).

See IOM Report, supra note 16, at 61–69.

Id., at 61–62.

Javitt G. H. , “Drugs and Vaccines for the Common Defense: Refining FDA Regulation to Promote the Availability of Products to Counter Biological Attacks,” Journal of Contemporary Health Law and Policy 19, no. 1 (2003): 37–116, 39.

Public Law 108–276.

Nightingale S. L. Prasher J. M. , and Simonson S. , “Emergency Use Authorization (EUA) to Enable Use of Needed Products in Civilian and Military Emergencies, United States,” Emerging Infectious Diseases, 2007, available at <http://www.cdc.gov/EID/content/13/7/1046.htm> (last visited February 5, 2010).

Id.

See O'Reilly , supra note 32, at 973.

Id., at 974.

Id., at 956.

Indep. Living Ctr. of S. Cal., Inc. v. Maxwell-Jolly, 572 F.3d 644 (9th Cir.2009).

Id.

Cal Welf & Inst. Code §§ 14105.19, 14166.245 (2009)

Cal Welf & Inst. Code §§ 14105.19, 14166.245 (2009).

Indep. Living Ctr. Of S. Cal., Inc., 572 F.3d at 649.

Cal Welf & Inst. Code § 14166.245 (2009).

Cal Welf & Inst. Code § 14166.245 (2009).

Indep. Living Ctr. of S. Cal., Inc., 572 F.3d at 649.

Id. at 649.

42 U.S.C. § 1396a(a)(30)(A) (2006).

Indep. Living Ctr. of S. Cal., Inc., 572 F.3d at 649.

Id., at 649.

Sanchez v. Johnson, 416 F.3d 1051, 1060 (9th Cir. 2005).

Ninth Circuit Rules Against Cut In Medi-Cal Reimbursement Rates, 15 Health Plan & Prov. Rep. (BNA) 824 (July 15, 2009).

Indep. Living Ctr. of S. Cal., Inc., 572 F. 3d at 649.

Indep. Living Ctr. v. Shewry, 543 F.3d 1050 (9th Cir. 2008).

Cal Welf & Inst. Code §§ 14105.19(b) (1) (2009) (applied the ten percent rate cut tofee-for-servicephysicians, dentists, pharmacies, adult health care centers, clinics, health systems, and other providers).

Cal Welf & Inst. Code §§ 14166.245 (2009) (applied the rate reductions to managed care plans and non-contract acute care hospitals).

Indep. Living Ctr. of S. Cal., Inc., 572 F. 3d at 650.

Id., at 650.

Indep. Living Ctr. of S. Cal., Inc., No. 08-56422

Indep. Living Ctr. of S. Cal., Inc., No. 08-56554

Orthopaedic Hosp. v. Belshe, 103 F.3d 1491 (9th Cir. 1997).

Orthopaedic Hosp., 103 F.3d at 1492.

Orthopaedic Hosp., 103 F.3d at 1500.

See e.g., Methodist Hosp., Inc. v. Sullivan, 91 F.3d 1026, 1029 (7th Cir. 1996) (holding providers of medical care have a private right of action under § 1983 to enforce § 1396a(a)(30)(A)); Ark.Med. Soc'y, Inc. v. Reynolds, 6 F.3d 519 (8th Cir. 1993) (holding both providers and recipients have a private right to enforce § 1396a(a)(30) (A)); Clayworth v. Bonta, 295 F. Supp. 2d 1110, 1116 (E.D. Cal. 2003) (holding MediCal recipients have an enforceable claim under § 1983, but providers do not).

Gonzaga Univ. v. Doe, 536 U.S. 273 (2002).

See Sanchez , 416 F.3d at 1060; Clayworth v. Bonta, 140 Fed. Appx. 677(9th Cir. Cal. 2005).

Gonzaga Univ., 536 U.S. at 290.

Indep. Living Ctr. of S. Cal., Inc., 572 F. 3d at 652.

Orthopaedic Hosp., 103 F.3d at 1496.