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AN OFFICIAL PUBLICATION OF THE AMERICAN SOCIETY FOR PHARMACY LAW
Volume 36 Number 2
March/April 2009
The American Society for Pharmacy Law waslaunched in Chicago, Illinois, during August,1974 when a group of pharmacist-lawyers metin the Conrad Hilton Hotel at 720 SouthMichigan Avenue in conjunction with the121st Annual Meeting of the AmericanPharmacists Association (APhA). What wasgoing on in that period to stimulate formationof the organization?
It was a time of myriad changes in thelegal framework for pharmacy practice. APhAwas very active in advocating modification of state-level antisubstitution laws in order to restoreto pharmacists the right to select the brand of medication to be dispensed in certain circumstances.It had adopted two policy positions on that issue during 1969 and 1970 resulting in theFederal trade Commission getting on board to support the changes.
This followed on the heels of enactment of Medicare and Medicaid during 1966, withthe latter program’s opportunity for states to elect to have coverage of prescription medicationsfor enrollees. Eventually all states would offer such coverage under their Medical AssistancePrograms, reducing cost as a barrier for numerous patients and coalescing purchasing powerover medications in state governments.
Private prescription drug insurance programs were also evolving quickly as employersadded them to their fringe benefit plans for employees. As pharmacists reacted to thosedevelopments it brought to the fore issues related to the interplay of the antitrust laws withpharmacy owners’ efforts to respond to the newly redefined marketplace.
Just the year before the Chicago meeting the U.S. Supreme Court had decided thepharmacy ownership case out of North Dakota, North Dakota Board of Pharmacy v. Snyder’sDrug Stores, Inc. 414 U.S. 156 (1973). In the past few months that issue has surfaced again inthe North Dakota legislature where an effort was mounted to overturn the state’s statutorymandate that a majority interest in any pharmacy be owned by pharmacist(s). The legislatureacted this year to leave the mandate unchanged.
The pharmacist-lawyers who convened in Chicago to launch the Society foresaw that thelaw would have an ever increasing impact on the profession of pharmacy and that there was aneed for an unbiased source of legal information for pharmacists. The organization was launchedto meet that need and for thirty-five years has done so admirably.
A more complete discussion of the history of the association is available on the society’swebsite at www.aspl.org/doc/ASPLHistoryFink.PDF.
ASPL is celebrating its35th Anniversary in2009 and I am proudto serve as the Society’sPresident this year. Aswe enter a new yearwith new Officers and
a new Board of Directors, I want to thank JayCampbell for his outstanding work last year asPresident. I have let our now Past-President aswell as our President-Elect Kim Burns and therest of the Board of Directors know that I amcounting heavily on them as things progress thisyear.
For those of you who have been membersfor some time, you’ll remember that I served inthe mid-1990’s as the Executive Director ofASPL. I learned a lot in those years about themechanics of running an organization like thisone, which is highly dependent on the work ofvolunteers to make it work. ASPL has a numberof committees that need volunteers: Educationand Scholarship; Communication and MemberRelations; and Sponsorship and PartnerDevelopment. If you want to be more involvedin ASPL and are looking for a place to start, let meknow. We are always able to find a place for awilling volunteer. For more information on thecommittees, visit our website, www.aspl.org.
ASPL sponsored eight educational programsat the APhA Annual Meeting earlier this monthin San Antonio, Texas. All the programs werewell received and many were among the bestattended sessions at the meeting. We also heldour own ASPL Annual Meeting while in SanAntonio and were able to report to themembership that ASPL is a robust and financiallyhealthy organization. To stay that way, the ASPLBoard of Directors is developing a new strategic
President’sMessage
John CroninASPL President
In the Beginning...Those Were Interesting Times for Pharmacy Law
Joseph L. Fink III, BSPharm, JD - Professor of Pharmacy Law and PolicyUniversity of Kentucky College of Pharmacy - Lexington, KY
continued on page 2
American Society for Pharmacy Law2
Wyeth v. Levine, 555 U.S. ____, No. 06-1249 (March 4, 2009)Warning! Excluding Known Hazards from FDA-Approved Labeling Contraindicated by
State Common Law Tort Suits and the Supreme CourtBy Susan Brichler Trujillo, J.D.
Featured Case
The Supreme Court of the United States dealta surprising blow to both the pharmaceuticalmanufacturing industry and the FDA when itissued its opinion recently in Wyeth v. Levine.
A Vermont jury awarded Diana Levinemore than $6 million in damages tocompensate her for injuries sustained from theadministration of Wyeth Pharmaceuticals’ drug,Phenergan. The factual background of the caseis as follows. Ms. Levine, a musician, soughttreatment twice in one day for a severeheadache. During her second doctor’s visit, aPhysicians Assistant (“P.A.”) administered thedrug Phenergan via the “IV Push” method tohelp alleviate Ms. Levine’s pain. The P.A. chosethis method of administration in spite of thepackage insert’s explicit warning that IV Pushwas not recommended due to the known riskof severe chemical irritation and gangrene. TheP.A. accidentally penetrated Ms. Levine’s arterialvein, causing an immediate, painful chemicalreaction, followed by gangrene, resulting in theamputation of Ms. Levine’s forearm – all risksdisclosed on the drug’s FDA approved label.After settling claims against the P.A. and thehealth center, Ms. Levine sued Wyeth alleging
that its warning was deficient and should haveprohibited the IV Push method ofadministration. The jury found that (1) Wyethwas negligent, (2) the drug’s inadequatewarnings and instructions caused the productto be defective; and (3) the P.A.’s decision toadminister the drug via I.V. Push was not anintervening cause of Ms. Levine’s injuries.
In its Opinion,1 the divided Court voted6-3 to uphold the Jury’s verdict and rejectWyeth’s defense that the FDA’s comprehensiveregulatory scheme preempts state laws andclaims relating to drug labeling. The Courtdisagreed and instead held that, unless it isimpossible to comply with both state andfederal laws at the same time, manufacturersare subject to both state and federal laws.
This impact of this case has already beenfelt in courtrooms across the country. Plaintiffsin similar cases have asked courts to vacatejudgments or grant leave to amend complaintsto plead claims consistent with Levine, and theSupreme Court remanded two cases to theThird Circuit for reconsideration.
This decision is significant to drugmanufacturers, as well as other regulated
1 http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf
businesses, in at least three ways. First, theCourt has clearly established that drugmanufacturers have a duty to keep drugwarning labels current and to disclose allreasonably known risks. Second, the Courtdistinguished between the regulatory schemesfor drugs and devices. And, third, the Courtconfirmed that regulated businesses cannot relyon non-binding regulations or commentariesthat do not have the force of law to preemptstate laws and lawsuits. Drug manufacturersand other regulated businesses should considerhow to develop a clear record of the FDA’sconsideration of their product and the contentof the warning as it evolves during the approvalprocess. Also, manufacturers should considerif and when to update labels based on adverseevents under the “changes being effected”regulation (21 C.F.R. § 314.70(c)(6)(iii))which allows labeling changes under certaincircumstances.
Susan Bichler Trujillo, J.D., is an associate in thehealth care law group at Quarles & Brady’sPhoenix offices.
plan. We are currently setting priorities for thenext few years as we pursue our Vision of being“The first and best source for information onpharmacy law.”
We are also looking to expand ourconnections with other pharmacyorganizations. ASPL has a long history ofaffiliation with APhA and we have in the pastworked with the National CommunityPharmacists Association (NCPA), the NationalAssociation of Chain Drug Store (NACDS) andthe National Association of Boards of Pharmacy(NABP). This November we will hold our20th Annual Developments in Pharmacy LawSeminar in Naples, Florida in conjunction with
President’s MessageContinued from page 1
a meeting of the National Alliance of StatePharmacy Associations (NASPA).
The relationship with NASPA isparticularly important to me. I have come toknow many of the state pharmacy associationleaders during my years as legal counsel for theCalifornia Pharmacists Association and I haveattended a few NASPA meetings over the years.State pharmacy associations still have strongconnections to independent pharmacy owners.As a pharmacy owner myself, I recognize theneed of this group for a simple andstraightforward understanding of the laws thatapply to their practice of pharmacy. I knowthat ASPL can help fill that need.
ASPL will continue to reach out to theseand other pharmacy groups to promote theSociety and its members as valuable resourcesin the area of pharmacy law. We hope this year
to expand the opportunities for you share yourprofessional talents. We’ll report on our effortsas they move forward. I hope you willparticipate as a Member of ASPL and possiblya future leader in the Society. Please contactme with your ideas and comments at:[email protected].
Errata: The citations for the two Medi-Calcases reported by John Cronin in Rx IpsaLoquitur Vol. 36, No. 1 (Jan-Feb 2009) wereinadvertently omitted. The correct citationsare (1) California Pharmacists Association etal. v. Maxwell-Jolly, No. 2:09-cv-00722-CAS-MAN, C.D. Cal., filed 1/29/2009, and(2) Managed Pharmacy Care v. Maxwell-Jolly, C.D. Cal., No. 2:09-cv-00382-CAS-MAN, filed 1/16/2009.
American Society for Pharmacy Law 3
Simonsmeier AwardThe ASPL Simonsmeier Award recognizes outstanding scholarshiprelated to pharmacy law published during the previous two years and isnamed in honor of Larry Simonsmeier, former editor of Rx Ipsa Loquitur,ASPL’s newsletter.
The 2008 Simonsmeierrecipients are Kim Burns and AlanSpies for their paper A Pharmacist’sDuty to Warn: Promoting theAcceptance of a Consistent Legal andProfessional Standard published inthe Duquesne Law Review.
Kim is a pharmacist and anattorney. She is currently an AssociateProfessor at the LECOM school ofPharmacy in Erie, PA and Of Counselwith the Carpenter Law Firm.
Alan is a pharmacist and an attorney. He is currently an AssistantProfessor at the McWhorter School of Pharmacy at Samford Universityin Birmingham.
Joseph L. Fink III Founders AwardThe 2008 Joseph L. FinkIII Founders Award wasawarded to Jesse Vivian torecognize his sustainedand outstanding serviceand contributions to theprofessions of pharmacyand law.
Jesse is a Professor atWayne State UniversityCollege of Pharmacy andHealth Sciences in Detroit,Michigan where he teachescourses on PharmacyJurisprudence and HealthCare Ethics and Professional Responsibility. He is also General Counselwith the Michigan Pharmacists Association and Of Counsel atCummings, McClorey, Davis & Acho, PC in Livonia.
ASPL Presents AwardsArizona Health Associations File Suit against Stateover Regulatory Boards’ FundingThirteen health professional associations and an equal number ofpractitioners have sued Arizona’s Governor and State Treasurer seekingdeclaratory and injunctive relief related to the Legislature’s enactment ofHB 2620 and HB 2209 that transferred funds from the State’s regulatoryboards into the general fund. The suit argues that by taking these funds,paid as license fees to be used to regulate the professions and promotepublic safety, the State has created a tax that is contrary to the Arizonaconstitution and existing statutes. It seeks an order that the transferredfunds be returned to the various boards. Lead attorney for plaintiffs isASPL past-president Roger Morris (Quarles & Brady). ArizonaAssociation of Chiropractic et al. v. Brewer, No. CV2009-011326, Ariz.Super. Ct., Maricopa County, filed April 8, 2009.
Montana Court Rules Statute Banning Physician-Assisted Suicide Violates Montana ConstitutionIn December 2008, Montana District Court Judge Dorothy McCarterruled that Article II, section 4 of Montana’s Constitution specificallyholds that “the dignity of the human being is inviolable.” Therefore,under a strict scrutiny test, the State’s interests in preserving human life,protecting vulnerable groups from abuses, and protecting the integrityand ethics of the medical profession, while compelling, “can be protectedwhile preserving a patient’s right to die with dignity.” Noting that theLegislature could easily pass legislation similar to statutes adopted inOregon and Washington, the Court granted summary judgment toplaintiffs and declared that application of homicide statutes to physician-assisted suicide violates Montana’s Constitution. The case is now onappeal to the Montana Supreme Court, and at least one amicus brief hasalready been filed. Baxter v. State, No. ADV-2007-787, Mont. 1st Jud.Dist. (Lewis and Clark County), December 5, 2008; Montana Supr. Ct.No. DA 09-0051.
Washington Medicaid Rescinds Proposed Cuts inPharmacy ReimbursementIn response to a TRO issued by a federal district court, the WashingtonState Department of Social and Health Services announced on April 17that it is rescinding its announced reimbursement changes for the periodfrom April 1 through June 30, 2009. Pharmacies will continue to bereimbursed at AWP less 14% for branded drugs, rather than the plannedAWP less 20%. The Washington State Pharmacy Association and otherplaintiffs are now awaiting the scheduled release of the 2009-11 biennialbudget on April 26 to learn what future proposed cuts may be in store.Additional information is available at www.wsparx.org.
News From the States
FDA Accedes to District Judge’s Plan B Order – Will Allow Plan B OTC for 17 or OverThe FDA announced on April 22 that the government will not appeal a federal court order issued on March 23, and has notified themanufacturer of Plan B that “it may, upon submission and approval of an appropriate application, market Plan B without a prescription towomen 17 years of age and older.” The order, issued in Tummino v. Torti by the Eastern District of NY, was reviewed as the lead post in the April2009 Pharma-Law e-News. The FDA announcement can be found at http://www.fda.gov/cder/drug/infopage/planB/default.htm.
L to R: Joseph L. Fink III, John Cronin,Jesse Vivian
American Society for Pharmacy Law4
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PAIDSpringfield, IL
Permit No. 250American Society for Pharmacy Law3085 Stevenson Drive, Suite 200Springfield, IL 62703
Editor:William E. Fassett, PhD, RPhProfessor of Pharmacy Law & EthicsWashington State [email protected]
Contributing Editors:Del Konnor, PharmMSDEA Solutions Group, [email protected]
Roger Morris, JDQuarles & Brady, [email protected]
ASPL Business Office:3085 Stevenson Drive, Suite 200Springfield, IL 62703217-529-6948 Phone
BOARD OF DIRECTORS
PRESIDENT
John Cronin
PRESIDENT ELECT
Kimberly Burns
TREASURER
William Fassett
IMMEDIATE PAST PRESIDENT
Jay Campbell
DIRECTORS
Donna Horn
Mary Ellen Kleiman
Gary Peters
William Stilling
EXECUTIVE DIRECTOR
Nathela [email protected]
Rx Ipsa LoquiturMarch/April 2009
©2009, American Society for Pharmacy Law
All rights reserved. No part of thispublication may be reproduced ortransmitted in any form or by any meanswithout the written permission of thecopyright holder.
Complete Board contactinformation can be found on the
ASPL website
www.aspl .org
Developments inPharmacy Law Seminar XX
In conjunction withNational Alliance of State Pharmacy Associations
November 12 - 15, 2009Naples Beach Hotel & Golf Club
Naples, FloridaSponsored by:American Society for Pharmacy LawWWWWWatcatcatcatcatch wwwh wwwh wwwh wwwh www.aspl.or.aspl.or.aspl.or.aspl.or.aspl.org fg fg fg fg for deor deor deor deor detttttails!ails!ails!ails!ails!
ASPL’s 35th Anniversary!Join Us!
