Hostname: page-component-78c5997874-94fs2 Total loading time: 0 Render date: 2024-11-09T14:05:24.634Z Has data issue: false hasContentIssue false

Recent Case Developments in Health Law: Pharmaceutical Price-Fixing and Consumer Protection: Blue Cross & Blue Shield v. AstraZeneca Pharmaceuticals LP

Published online by Cambridge University Press:  01 January 2021

Extract

In September 2009, the First Circuit Court of Appeals decided Blue Cross & Blue Shield v. AstraZeneca Pharmaceuticals LP, part of the class action suit known as In re Pharmaceutical Industry Average Wholesale Price Litigation. The First Circuit upheld a Massachusetts District Court finding that AstraZeneca violated Massachusetts’ consumer protection laws by manipulating the “average wholesale price” of its physician-administered injectable cancer drug Zoladex, leading to overpayment by the government, third-party payers, and consumers. This case, which highlights the persistent tension between pharmaceutical pricing flexibility and consumer protection, has important implications for similar pending class actions.

Between 1991 and 2003, Medicare, as well as many private insurance companies, pegged reimbursement for certain pharmaceutical products to a national “average wholesale price” (AWP) for each drug. Although the amended 1991 Medicare Part B regulations3 that introduced the term “average wholesale price” failed to define it explicitly, there is some indication in the legislative history that AWP was intended to refer to the prices that physicians and pharmacists actually pay to the drug manufacturers.

Type
JLME Column
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

Blue Cross & Blue Shield v. AstraZeneca Pharms. LP, 582 F.3d 156 (1st Cir. 2009).Google Scholar
In re Pharm. Indus. Average Wholesale Price Litig., 491 F. Supp. 2d 20 (D. Mass. 2007).Google Scholar
“Medicare Program; Fee Schedule for Physicians' Services,” Federal Register 56 (November 25, 1991): 59,502.Google Scholar
Blue Cross & Blue Shield v. AstraZeneca Pharms. LP, 582 F.3d 156, 161–62 (1st Cir. 2009).Google Scholar
Id., at 184.Google Scholar
Id., at 160.Google Scholar
Id., at 162.Google Scholar
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).+(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).>Google Scholar
Id., at 168–69.Google Scholar
Id., at 167–68.Google Scholar
Id., at 169–72.Google Scholar
Id., at 178–80.Google Scholar
Id., at 181–84.Google Scholar
Id., at 186–88.Google Scholar
Id., at 188.Google Scholar
Id., at 191.Google Scholar
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).Google Scholar
18 U.S.C §1962 (1970).Google Scholar
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).Google Scholar
AstraZeneca LP v. State, 2009 Ala. LEXIS 244 (Ala. 2009).Google Scholar
Id., at 1, 46.Google Scholar
Id., at 1, 29.Google Scholar
Id., at 1, 29–46.Google Scholar
Blue Cross & Blue Shield v. AstraZeneca Pharms. LP, 582 F.3d 156, 167 (1st Cir. 2009).Google Scholar
42 U.S.C. §1395w-3a (2003); 42 U.S.C. §1395w-3b (2003).Google Scholar
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).Google Scholar
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.Google Scholar

References

Department of Defense Anthrax Vaccine Immunization Program, available at <http://www.anthrax.osd.mil> (last visited February 5, 2010).+(last+visited+February+5,+2010).>Google Scholar
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): 325343, at 329332.CrossRefGoogle Scholar
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).Google Scholar
Rempfer v. Sharfstein, 583 F.3d 860 (D.C. Cir. 2009).Google Scholar
Id., at 867.Google Scholar
Centers for Disease Control and Prevention, available at <http://www.bt.cdc.gov/agent/agentlist-category.asp> (last visited February 5, 2010).+(last+visited+February+5,+2010).>Google Scholar
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].CrossRefGoogle Scholar
Id., at 41–42.Google Scholar
Id., at 183–186.Google Scholar
Id., at 48–49.Google Scholar
Id., at 33–34.Google Scholar
See Miller, , supra note 4, at 334.Google Scholar
See, e.g., United States v. Chadwell, 36 C. M.R. 741 (1965).Google Scholar
Food and Drug Administration, “2005 Final Order,” Federal Register 70 (2005): 75,180 [hereinafter “FDA Final Order”].Google Scholar
See, e.g., Katz, R. D., “Friendly Fire: The Mandatory Military Vaccination Program,” Duke Law Journal 50 (2001): 18351865, 1852.CrossRefGoogle Scholar
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”).Google Scholar
U.S.C. §1107(f)(1) (2006); see also Miller, , supra note 4, at 342.Google Scholar
See Noah, L., “Informed Consent and the Elusive Dichotomy between Standard and Experimental Therapy,” American Journal of Law and Medicine 28, no. 4 (2002): 361408, at 388391.CrossRefGoogle Scholar
297 F.Supp.2d 119, 133 (D.D.C. 2003).CrossRefGoogle Scholar
Id., at 135.Google Scholar
Doe v. Rumsfeld, 297 F.Supp.2d 200 (D.D.C. 2004).Google Scholar
See Rempfer, supra note 6, citing Doe v. Rumsfeld, 341 F. Supp. 2d 1, 16 (D.D.C. 2004).Google Scholar
See FDA Final Order, supra note 16.Google Scholar
Rempfer v. Von Eschenbach, 535 F. Supp.2d 99, 112 (D.D.C. 2008).Google Scholar
Administrative Procedure Act, 5 U.S.C. §706(2)(A) (2006).Google Scholar
Brachman, P. S. et al., “Field Evaluation of a Human Anthrax Vaccine,” American Journal of Public Health 52 (1962): 632645.CrossRefGoogle Scholar
See IOM Report, supra note 9, at 77.Google Scholar
See Rempfer, supra note 6.Google Scholar
Motor Vehicle Mfrs. Ass'n of U.S., Inc. v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983).Google Scholar
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): 939979, 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).Google Scholar
Id., at 952.Google Scholar
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).Google Scholar
Weinberger v. Bentex Pharm., Inc., 412 U.S. 645, 653–54 (1973).Google Scholar
See FDA Final Order, supra note 16, at 75,187.Google Scholar
Id., at 75,184.Google Scholar
See IOM Report, supra note 9, at 22.Google Scholar
See Rempfer, supra note 6, at 866–867.Google Scholar
Id., at 868.Google Scholar
See e.g., Annas, G. J., “Blinded by Bioterrorism: Public Health and Liberty in the 21st Century,” Health Matrix 13, no. 1 (2003): 3370, 45.Google Scholar
Government Accountability Office, GAO-02-445: Anthrax Vaccine (GAO's Survey of Guard and Reserve Pilots and Aircrew) (2002), at 10.Google Scholar
Id., at 17.Google Scholar
See IOM Report, supra note 9, at 199.Google Scholar
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).+(last+visited+February+5,+2010).>Google Scholar
See IOM Report, supra note 9, at 61; FDA Final Order, supra note 16, at 75, 192.Google Scholar
21 C.F.R. §314.600 (2009).Google Scholar
“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).+(last+visited+February+5,+2010).>Google Scholar
See IOM Report, supra note 16, at 61–69.Google Scholar
Id., at 61–62.Google Scholar
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): 37116, 39.Google Scholar
Public Law 108276.Google Scholar
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).CrossRefGoogle Scholar
See O'Reilly, , supra note 32, at 973.Google Scholar
Id., at 974.Google Scholar
Id., at 956.Google Scholar

References

Indep. Living Ctr. of S. Cal., Inc. v. Maxwell-Jolly, 572 F.3d 644 (9th Cir.2009).Google Scholar
Cal Welf & Inst. Code §§ 14105.19, 14166.245 (2009)Google Scholar
Cal Welf & Inst. Code §§ 14105.19, 14166.245 (2009).Google Scholar
Indep. Living Ctr. Of S. Cal., Inc., 572 F.3d at 649.Google Scholar
Cal Welf & Inst. Code § 14166.245 (2009).Google Scholar
Cal Welf & Inst. Code § 14166.245 (2009).Google Scholar
Indep. Living Ctr. of S. Cal., Inc., 572 F.3d at 649.Google Scholar
Id. at 649.Google Scholar
42 U.S.C. § 1396a(a)(30)(A) (2006).Google Scholar
Indep. Living Ctr. of S. Cal., Inc., 572 F.3d at 649.Google Scholar
Id., at 649.Google Scholar
Sanchez v. Johnson, 416 F.3d 1051, 1060 (9th Cir. 2005).Google Scholar
Ninth Circuit Rules Against Cut In Medi-Cal Reimbursement Rates, 15 Health Plan & Prov. Rep. (BNA) 824 (July 15, 2009).Google Scholar
Indep. Living Ctr. of S. Cal., Inc., 572 F. 3d at 649.Google Scholar
Indep. Living Ctr. v. Shewry, 543 F.3d 1050 (9th Cir. 2008).Google Scholar
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).Google Scholar
Cal Welf & Inst. Code §§ 14166.245 (2009) (applied the rate reductions to managed care plans and non-contract acute care hospitals).Google Scholar
Indep. Living Ctr. of S. Cal., Inc., 572 F. 3d at 650.Google Scholar
Id., at 650.Google Scholar
Indep. Living Ctr. of S. Cal., Inc., No. 08-56422Google Scholar
Indep. Living Ctr. of S. Cal., Inc., No. 08-56554Google Scholar
Orthopaedic Hosp. v. Belshe, 103 F.3d 1491 (9th Cir. 1997).Google Scholar
Orthopaedic Hosp., 103 F.3d at 1492.Google Scholar
Orthopaedic Hosp., 103 F.3d at 1500.Google Scholar
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).Google Scholar
Gonzaga Univ. v. Doe, 536 U.S. 273 (2002).Google Scholar
See Sanchez, , 416 F.3d at 1060; Clayworth v. Bonta, 140 Fed. Appx. 677(9th Cir. Cal. 2005).Google Scholar
Gonzaga Univ., 536 U.S. at 290.Google Scholar
Indep. Living Ctr. of S. Cal., Inc., 572 F. 3d at 652.Google Scholar
Orthopaedic Hosp., 103 F.3d at 1496.Google Scholar