ASPL Pharmacy Law Track
APhA2014
1. Case Law Update
Once again, the U.S. Supreme Court issued several opinions impacting pharmacy and the
pharmaceutical industry. This presentation will summarize these cases and others, including
rulings on cases involving pharmacy board decisions, effect of anti-kickback laws on pharmacy
gift cards and coupons, HIPAA and conflicting state laws, pharmacists’ liability, ERISA and PBM
duties, pharmacists’ employment discrimination claims, any willing provider laws, and more.
Presenters:
Roger Morris, RPh, JD
Quarles & Brady
William Stilling, RPh, MS, JD
Parsons, Behle, Latimer
2. A Prescription for Negligence
This session will provide an overview of malpractice law related to the pharmacy profession.
Common areas of risk will be discussed as well as trends in pharmacy malpractice actions.
Various procedural and process concerns during a malpractice action will be summarized.
Recent pharmacy malpractice cases will be reviewed to highlight the potential for liability.
Presenters:
Kimberly Burns
LECOM School of Pharmacy
Martin Dix
Akerman Senterfitt
3. Current State (or lack thereof) of Civil Liability for Generic Medications
Several recent Supreme Court decisions (Pliva v. Mensing & & Mutual Pharmaceutical Co. v.
Bartlett) have removed liability from generic manufacturers for the content of their labeling and
drug design. The Court’s reasoning is that a generic drug company has no say in the content of
its labeling or drug design; rather, it must match those of the brand-name medication identically.
These rulings have left patients harmed by generic drugs largely without a legal remedy, while
taking a brand-name medication would have preserved these legal remedies. Compounding
this issue is the fact that many generic drugs on the market, no longer have a ‘brand-name’
counterpart to take responsibility for product labeling. This session would aim to inform
pharmacists and regulatory officials of the current state of generic civil liability, and the steps the
FDA is attempting to close these loopholes.
Presenters:
Eli G. Phillips, Jr., PharmD, JD
University of the Incarnate Word
ASPL Pharmacy-Law Sessions
APhA 2014
October 3, 2013
Page 2
W. Thomas Smith, PharmD, JD
University of Florida College of Pharmacy
4. Pharmacy Promotional Activities, Their Impact and Their Future: Coupons, Gift
Cards, Rewards Programs, and Inducements
This session will discuss pharmacy promotional activities and drug manufacturer coupon co-pay
programs. Legal issues regarding these types of programs under state and federal fraud, waste
and abuse and other laws also will be presented.
Presenters:|
Edward Rickert, JD, PharmD
Partner, Krieg Devault LLP
Jaya F. White, JD
Associate, Krieg Devault LLP
5. Hot Law Topics:
A. Prescription Drug Abuse
This session will provide an overview of prescription drug abuse in the United States.
Contributing factors will be discussed as well as current efforts to address the problem. Local
and regional data will also be highlighted.
Presenter:
Kimberly Burns
LECOM School of Pharmacy
B. Current Trends in the Law of Compounding Pharmacy
This hot topic will outline the controlling federal precedents. Pending and recently passed
federal legislation and legal implications for the practice and regulation of compounding
pharmacy will be discussed.
Presenter:
Rachael Pontikes
Duane Morris LLP
C. Pharmacists Corresponding Responsibility
This hot topic will outline what corresponding responsibility means for the pharmacist who fills a
prescription for controlled substance. Learn how to determine if a prescription is legitimate and
what the implications are if a prescription of suspicious origin is filled.
Presenter:
W. Thomas Smith, PharmD, JD
University of Florida College of Pharmacy
ASPL Pharmacy-Law Sessions
APhA 2014
October 3, 2013
Page 3
6. Ethical and Legal Responsibilities of the Pharmacist-in-Charge
This session will explore the legal responsibilities of a pharmacist-in-charge under federal and
state law. Theories of liability under which a pharmacist-in-charge may be held accountable will
be discussed, including circumstances where a pharmacist-in-charge may be found liable for
the actions of a staff pharmacist or technician. Possible ethical situations that may be
encountered by a pharmacist-in-charge will also be discussed, including when company policies
or practices may conflict with federal or state law. Panel members will share their experiences
from the perspectives of community pharmacy and hospital pharmacy, as well as how violations
are viewed and adjudicated by state boards of pharmacy.
Presenters:
Jack (Jay) Campbell, IV
NC Pharmacy Board
Karen Ryle
Massachusetts Board of Registration in Pharmacy
Mike Simko
Walgreens
APhA2014
1. Case Law Update
Once again, the U.S. Supreme Court issued several opinions impacting pharmacy and the
pharmaceutical industry. This presentation will summarize these cases and others, including
rulings on cases involving pharmacy board decisions, effect of anti-kickback laws on pharmacy
gift cards and coupons, HIPAA and conflicting state laws, pharmacists’ liability, ERISA and PBM
duties, pharmacists’ employment discrimination claims, any willing provider laws, and more.
Presenters:
Roger Morris, RPh, JD
Quarles & Brady
William Stilling, RPh, MS, JD
Parsons, Behle, Latimer
2. A Prescription for Negligence
This session will provide an overview of malpractice law related to the pharmacy profession.
Common areas of risk will be discussed as well as trends in pharmacy malpractice actions.
Various procedural and process concerns during a malpractice action will be summarized.
Recent pharmacy malpractice cases will be reviewed to highlight the potential for liability.
Presenters:
Kimberly Burns
LECOM School of Pharmacy
Martin Dix
Akerman Senterfitt
3. Current State (or lack thereof) of Civil Liability for Generic Medications
Several recent Supreme Court decisions (Pliva v. Mensing & & Mutual Pharmaceutical Co. v.
Bartlett) have removed liability from generic manufacturers for the content of their labeling and
drug design. The Court’s reasoning is that a generic drug company has no say in the content of
its labeling or drug design; rather, it must match those of the brand-name medication identically.
These rulings have left patients harmed by generic drugs largely without a legal remedy, while
taking a brand-name medication would have preserved these legal remedies. Compounding
this issue is the fact that many generic drugs on the market, no longer have a ‘brand-name’
counterpart to take responsibility for product labeling. This session would aim to inform
pharmacists and regulatory officials of the current state of generic civil liability, and the steps the
FDA is attempting to close these loopholes.
Presenters:
Eli G. Phillips, Jr., PharmD, JD
University of the Incarnate Word
ASPL Pharmacy-Law Sessions
APhA 2014
October 3, 2013
Page 2
W. Thomas Smith, PharmD, JD
University of Florida College of Pharmacy
4. Pharmacy Promotional Activities, Their Impact and Their Future: Coupons, Gift
Cards, Rewards Programs, and Inducements
This session will discuss pharmacy promotional activities and drug manufacturer coupon co-pay
programs. Legal issues regarding these types of programs under state and federal fraud, waste
and abuse and other laws also will be presented.
Presenters:|
Edward Rickert, JD, PharmD
Partner, Krieg Devault LLP
Jaya F. White, JD
Associate, Krieg Devault LLP
5. Hot Law Topics:
A. Prescription Drug Abuse
This session will provide an overview of prescription drug abuse in the United States.
Contributing factors will be discussed as well as current efforts to address the problem. Local
and regional data will also be highlighted.
Presenter:
Kimberly Burns
LECOM School of Pharmacy
B. Current Trends in the Law of Compounding Pharmacy
This hot topic will outline the controlling federal precedents. Pending and recently passed
federal legislation and legal implications for the practice and regulation of compounding
pharmacy will be discussed.
Presenter:
Rachael Pontikes
Duane Morris LLP
C. Pharmacists Corresponding Responsibility
This hot topic will outline what corresponding responsibility means for the pharmacist who fills a
prescription for controlled substance. Learn how to determine if a prescription is legitimate and
what the implications are if a prescription of suspicious origin is filled.
Presenter:
W. Thomas Smith, PharmD, JD
University of Florida College of Pharmacy
ASPL Pharmacy-Law Sessions
APhA 2014
October 3, 2013
Page 3
6. Ethical and Legal Responsibilities of the Pharmacist-in-Charge
This session will explore the legal responsibilities of a pharmacist-in-charge under federal and
state law. Theories of liability under which a pharmacist-in-charge may be held accountable will
be discussed, including circumstances where a pharmacist-in-charge may be found liable for
the actions of a staff pharmacist or technician. Possible ethical situations that may be
encountered by a pharmacist-in-charge will also be discussed, including when company policies
or practices may conflict with federal or state law. Panel members will share their experiences
from the perspectives of community pharmacy and hospital pharmacy, as well as how violations
are viewed and adjudicated by state boards of pharmacy.
Presenters:
Jack (Jay) Campbell, IV
NC Pharmacy Board
Karen Ryle
Massachusetts Board of Registration in Pharmacy
Mike Simko
Walgreens
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