Recent Developments in Health Law

Conant v. Walters, 309 F.3d 629 (9th Cir. 2002), cert, denied, 124 S. Ct. 387 (2003) (No. 03–40).

Id. at 636.

Id.

See id., citing Conant v. McCaffrey, No. C 97–00139 WHA, 2000 WL 1281174, at 16 (N.D. Cal.).

See 21 U.S.C. § 801 (2000).

Conant, 2000 WL 1281174, at 1, quoting 21 U.S.C. § 812(b)(1) (2000).

Id.

Id. at 2.

Id., citing 21 U.S.C. 824(a)(4) (2000).

See 21 U.S.C. § 823(f).

Cal. Health & Safety Code § 11362.5(b)(1)(A) (1996).

Cal. Health & Safety Code § 11362.5(c) (1996).

Conant, 2000 WL 1281174, at 2, quoting Joint Stmt. Undisputed Facts § 4.

Id. at 5, citing Joint Stmt. Undisputed Facts § 6.

Conant v. McCaffrey, 172 F.R.D. 681, 691 (N.D. Cal. 1997).

See Conant, 2000 WL 1281174, at 6.

Id.

See id.

Id. at 3, quoting Joint Stmt. Undisputed Facts § 7.

See Conant, 172 F.R.D. at 681.

Id. at 685.

Conant, 2000 WL 1281174, at 1.

Id. at 14.

Id.

Id.

Id.

Id. at 15.

Id. at 16.

Id.

Conant, 309 F.3d at 634.

Id. at 632, citing 21 U.S.C. § 841(a) (2000).

Id. at 636.

See id., petition for cert. filed, 2003 WL 22428466 (U.S. June 7, 2003) (No. 03–40).

See id., cert. denied, 124 S. Ct. 387 (U.S. Oct. 14, 2003) (No. 03–40).

Egelko B. , “Court Victory for Medical Pot Law / Justices Let State's Doctors Discuss Patients' Options,” San Francisco Chronicle, October 15, 2003, at Al (2003 WL 3765584).

Lane C. , “U.S. Appeal of Marijuana Case Rejected”, Washington Post, October 15, 2003, at Al (2003 WL 62222963).

Frieden J. , “Medical Marijuana Ruling Hailed by Some Doctors: Seen as Free Speech Issue,” Internal Medicine News 36, no. 23, (2003): At 6 (2003 WL 14661974).

Egelko , supra note 35.

Frieden , supra note 37.

Id.

Egelko , supra note. 35.

Barbars Feder Ostrov , “Top Court Hands Victory to Backers of Medicinal Pot,” San Jose Mercury News, October 15, 2003, at 1 (2003 WL 65934454).

Id.

Frieden , supra note 37.

Id.

“CIGNA HealthCare Agreement With Physicians Wins Approval in U.S. Federal Court,” PR Newswire, February 2, 2004

In re Managed Care Litig., No. MDL-1334, 2003 U.S. Dist. LEXIS 22066 (S.D. Fla. Dec. 8, 2003).

Singer G. , “Judge to OK Cigna Settlement; He Expresses Concern Over Level of Lawyers' Fees in $1.3B Case,” South Florida Sun-Sentinel, December 19, 2003, at 1D

Walker T. , “Doctors mostly support CIGNA settlement,” Managed Healthcare Executive, October 1, 2003.

Rosen E. L. , “Florida HMO Case Moves Forward: Aetna and Cigna Settle Class Actions; A Judge Pushes Others,” The National Law Journal, November 10, 2003.

CIGNA Physician Settlement: Questions and Answers, at <http://www.cignaphysiciansettlement.com/qa.htm> (last visited January 19, 2004).

Id.

In re Managed Care Litig., 2003 U.S. Dist. LEXIS 22066, at 4.

In re Humana Inc. Managed Care Litig. v. Cigna Corp., 2000 U.S. Dist. LEXIS 15927, at 10 (Judicial Panel on Multidistrict Litigation, Ort. 23, 2000).

In re Managed Care Litig., 209 F.R.D. 678, 681 (S.D. Fla. Sept. 26, 2002).

Settlement Agreement with CIGNA Defendants Applicable to Physicians at 3, In Re Managed Care Litigation (No. MDL-1334), available at <http://www.hmocrisis.com/courtdocuments.html> (last visited February 21, 2004) [hereinafter Cigna Settlement].

“CIGNA Conference Call to Discuss Agreement with Physicians,” FD Wire, November 27, 2002.

Cigna Settlement, supra note 9 at 4.

“Cigna: Settles Class-action Case Over Reimbursement Practices,” American Health Line, December 2, 2002.

In re Managed Care Litig., 236 F. Supp. 2d 1336, 1342 (S.D. Fla. 2002).

Cigna Settlement, supra note 9, at 4.

Id.

Id. at 5.

Id. at 10

Fuhrmans V. ,“Cigna Settles Suit by Doctors Over Bills in $540 Million Pact,” Wall Street Journal, September 4, 2003 at D3.

Cigna Settlement, supra note 9 at 31.

Id. at 33.

Id. at 38.

Id. at 58.

Id. at 60.

Id.

Id. at 74.

Id.

Id. at 43.

Id. at 49.

Id. at 63.

Id. at 41.

Id. at 86.

Id. at 88.

CIGNA Physician Settlement: Questions and Answers, supra note 5.

Cigna Settlement, supra note 9, at 86, 88.

Id. at 130.

Id. at 131.

Shields J. , “Action Against HMOs at Risk of Fizzling Out; With Patients Out of the Picture, Doctors in the Mammoth Lawsuit Are On Their Own,” Fort Lauderdale Sun-Sentinel, January 12, 2003.

“Cigna Settles Class-Action Suit With Physicians For $400M+,” Best's Review, October 1, 2003.

Lowes R. , “The HMO Lawsuit: Is the End in Sight? This Class-Action Lawsuit Could Force Insurers to Stop Shortchanging Physicians,” Medical Economics, June 6, 2003.

Singer, supra note 2.

Id.

Walker T. , “CIGNA Settles Lawsuit; Promises Enhancements: Better Communication Ahead, but Medical Societies Hoped for More Monumental Changes,” Managed Healthcare Executive, January 1, 2003.

Page L. , “Breakaway Tactic: Settlement Talks with Cigna Pull Class Action Plaintiffs Apart,” Modern Physician, December 1, 2002.

“Cigna: Settlement Was Logical Next Step,” Best's Review, September 5, 2003.

“Cigna Settles Class-Action Suit With Physicians For $400M+,” supra note 37

Singer , supra note 2.

Dorschner J. , “Judges' Panel Will Decide Where HMO Suit Should Be Decided,” Miami Herald, December 30, 2002.

“Cigna Reports Third Quarter 2003 Results,” PR Newswire, October 31, 2003.

Cigna Settlement, supra note 9, at 130

Freudenheim M. , “Cigna's Cost in Settlement is Disputed by Plaintiffs,” New York Times, November 28, 2002, at C1.

Rosen , supra note 3.

Settlement Agreement dated as of May 21, 2003 by and among Aetna Inc., the Representative Plaintiffs, The Signatory Medical Societies and Class Counsel at 57, In Re Managed Care Litigation (No. MDL-1334), available at <http://www.hmocrisis.com/courtdocuments.html>

Cigna Settlement, supra note 9, at 82

Page, supra note 42.

Lowes , supra note 38.

Rosen , supra note 3.

Shields , supra note 36.

Valley Drug Co. v. Geneva Pharm., Inc., Abbott Lab., 2003 WL 22120130, 15–16 (11th Cir.).

Id. at 1.

15 U.S.C.A. § 1 (2002).

Valley Drug Co., 2003 WL 22120130, at7.

In re Cardizem CD Antitrust Litigation, 332 F.3d 896, 906 (6th Cir. 2003).

Eastern R.R. Presidents Conference v. Noerr Motor Freight, Inc., 365 U.S. 127 (1961).

Resek J.F. , “Biovail v. Hoechst Aktiengesellschaf, Inc: An Analysis under the Sherman Act and the Noerr – Pennington doctrine,” Fordham Intellectual Property, Media, and Entertainment Journal 10 (Winter 2000): 571–94, at 586.

Gardner B.A. , ed., Black's Law Dictionary, 2nd Pocket Edition, (St. Paul, MN: West Group, 2001): At 476.

In re Terazosin Hydrochloride Antitrust Litigation, l64 F.Supp.2d 1340, 1353 (S.D. Fla. 2000).

See Resek , supra note 4, at 574.

Valley Drug Co., 2003 WL 22120130, at 2.

Id.

In re Cardizem, 332 F.3d at 901.

Valley Drug Co., 2003 WL22120130, at 3.

Id.

Id.

Id.

Id. at 4.

In re Cardizem, 332 F.3d at 901.

However, at the time that the agreements were struck, the FDA had a “successful defense” requirement for generic companies. This required that the generic company successfully defend its ANDA paragraph IV certification before it began exclusively marketing the drug. In re Ciprofloxacin Hydrochloride Antitrust Litigation, 261 F.Supp.2d 188, 239 (E.D.N.Y. 2003).

Valley Drug Co., 2003 WL22120130, at 4.

Id.

Id.

Id. at 5.

Id.

Id.

Id.

In re Terazosin, 164 F. Supp.2d at 1343.

Id.

Id. at 1348–9.

Id. at 1350.

Id.

Id. at 1351.

Id.

Id.

Id. at 1353.

Valley Drug Co., 2003 WL 22120130, at 1.

Id. at 8.

Id.

Id.

Id.

Id.

Id. at 12.

Id.

Id.

Id. at 13.

Id.

“Emmanuel Seeks to Reduce Prescription Drug Costs Through Market Reforms, Co-Sponsors Bills to Foster Competition and Lower Prices,” June 20, 2003, available at <http://www.house.gov/apps/list/press/il05_emanuel/RxDrugBills.html>.

In re Ciprofloxacin, 261 F.Supp.2d at 256–58.

Id.

In re Cardizem, 332 F.3d at 900.

Id.

Troy D. , “Promoting Availability of Lower Cost Drugs,” Congressional Testimony by Federal Document Clearing House, August 1, 2003.

Id.

Anderson D. , “New Generic Drug Rules,” The National Law Journal 25 (September 1, 2003), at 24.

McGinley L. , “Generic-Drug Bill Picks Up Backing of 2 Key Senators,” Wall street Journal, June 5, 2003, at A6.

“Generic Drug Access Speeds Up / Senate Voted 94–1 for Changes to Medicare Prescription Bill,” Houston Chronicle, June 20, 2003.

Wise M. Zhu J. , “Maximizing Effective Patent Life of Innovator Drugs: Extensions Under the Hatch-Waxman Act Are Helpful, But Are They Long Enough?” The National Law Journal 25 (July 7, 2003), at 15.

Id.

U.S. Dept. of Health and Human Services, “FDA Announces Plans to Prohibit Sales of Dietary Supplements Containing Ephedra,” December 30, 2003.

U.S. Department of Health and Human Services, “FDA Proposes Safety Measures for Ephedrine Dietary Supplements,” June 2, 1997.

21 U.S.C. § 342(f)(1)(a).

See “Questions and Answers About FDA's Actions on Ephedra,” at <http://www.fda.gov/oc/initiatives/ephedra/december2003/qa.html> (last visited January 24, 2004).

“Government Announces Ban on Ephedra,” at <http://www.cnn.com/2003/HEALTH/12/30/ephedra> (last visited January 25, 2004).

“FDA Announces Plans to Prohibit Sales of Dietary Supplements Containing Ephedra,” supra note 1.

U.S. Food and Drug Administration, “Evidence on the Safety and Effectiveness of Ephedra: Implications for Regulation,” available at <http://www.fda.gov/bbs/topics/NEWS/ephedra/whitepaper.html> (last visited February 20, 2004).

U.S. Department of Health and Human Services “FDA Statement On Street Drugs Containing Botanical Ephedrine,” April 10, 1996.

“Government Announces Ban on Ephedra,” supra note 5.

Kaufman M. , “U.S. to Stop Ephedra Sales: Diet Aid Called Unsafe,” Washington Post, December 31, 2003, at A01.

“FDA Proposes Safety Measures for Ephedrine Dietary Supplements,” supra note 2.

“Evidence on the Safety and Effectiveness of Ephedra: Implications for Regulation,” supra note 7.

“FDA Statement on Street Drugs Containing Botanical Ephedrine,” supra note 8.

“Evidence on the Safety and Effectiveness of Ephedra: Implications for Regulation,” supra note 7.

“Evidence on the Safety and Effectiveness of Ephedra: Implications for Regulation,” supra note 7.

5 U.S.C. §§ 801–808.

“Questions and Answers about FDA's Actions on Ephedra,” supra note 4.

U.S. Food and Drug Administration, “FDA Warns Against Drug Promotion of ‘Herbal Fen-Phen,” November 6, 1997.

Bechler v. Cytodyne Technologies, Plaintiffs Complaint at 1, available at <http://news.findlaw.com/hdocs/docs/ephedra/bechlercyto7l603cmp.pdf> (last visited February 20, 2004.

“FDA Warns Against Drug Promotion of ‘Herbal Fen-Phen,” supra note 18.

FDA Proposes Safety Measures for Ephedrine Dietary Supplements,” supra note 2.

“Government Announces Ban on Ephedra”, supra note 5, quoting Annals of Internal Medicine.

“Questions and Answers About FDA's Actions on Ephedra,” supra note 4.

Id.

Id.