This document provides information about an upcoming conference on drug and medical device liability and litigation in Canada. The conference will provide updates on new legal developments, the impact of new legislation, class action trends, and strategies for mitigating risks. Speakers will address topics like the effect of Bill C-17, class action certification standards, managing multi-jurisdictional lawsuits, responsibility for adverse events from generic substitutions, and ensuring compliance with advertising regulations. Attendees will include legal and compliance professionals from pharmaceutical, biotech, and medical device companies as well as representatives from law firms, manufacturers' associations, and patient advocacy groups.

1. EARN
CPD
HOURS
DRUG and MEDICAL DEVICE
LIABILITY and LITIGATION
in CANADA
The Canadian Institute’s
New Trends and Developments:
With an aging population, new drugs in the pipeline and the passage
of Bill C-17, keeping up with the latest developments in this quickly
changing environment has never been more critical. Gain insight
and strategies from thought leaders on:
✜ The impact of new evidentiary standards on class action
certification
✜ How challenging the new obligations contained in Bill C-17
are expected to be for drug and device manufacturers
✜ When adverse events occur through the substitution of
generics for Brand originals, who should take responsibility?
✜ Techniques and strategies for managing risks and pre-
empting potential liability claims in the event a recall
becomes necessary
✜ Assessing whether protocols for managing multi-
jurisdictional actions are working
✜ Benefits gained by improved coordination of Canadian class
actions with the U.S. case proceeding through the MDL
Conference Co-Chairs:
Peter Pliszka
Partner
Fasken Martineau DuMoulin LLP
Anne Tomalin
President
Therapeutic Products Inc.
Hear from a dynamic mix of speakers including:
Jason Balgopal
Ministry of the Attorney General’s Counsel-in-Residence
Law Commission of Ontario
Esther E. Berezofsky
Partner
Williams Cuker Berezofsky, NJ
Heidi Bernhard
National Director
Centre for ADHD Awareness, Canada (CADDAC)
Ray Chepesiuk
Commissioner
Pharmaceutical Advertising Advisory Board (PAAB)
Sylvie Rodrigue
Partner, Torys LLP
Chair, CBA National Task Force on Class Actions
@CI_Legal #drugmed
The Canadian Legal Network
REGISTER NOW • 1-877-927-0718x7372
J.Keitner@CanadianInstitute.com
Supported by:
Sponsored by:

2. Sponsored by:
Fasken Martineau DuMoulin LLP has a premier life sciences practice in Canada.
Faskens represents many of largest and most innovative companies in the
pharmaceutical, medical device, and health sciences industries in all manner of legal
matters—litigation, regulatory, IP and transactions. Faskens is frequently retained to serve as national counsel
for drug and medical device companies in product liability class actions across Canada. In this context, Faskens
has extensive experience working collaboratively with its clients’ US outside counsel in cross-border litigation
proceedings. The depth and breadth of Faskens’ legal expertise across all major business regions of Canada allows
it to provide clients with effective results and business-oriented solutions in a cost-efficient manner. For further
information, please contact Peter Pliszka, partner at ppliszka@fasken.com.
T
here are currently several forces at work that together will have a significant impact on
the potential number of legal cases brought forward involving harm to patients. Simple
demographics make it inevitable that there will be a greater number of Canadians developing
chronic conditions and requiring implantable devices. As Brand pharmaceutical companies add new
products to their pipeline to replace their former blockbuster drugs, and also move more rapidly in
developing drugs for patients with less common conditions, there is a good chance these drugs will
also cause an increase in adverse events reported within their first few years on the market.
Add Bill C-17 to this landscape, with its provision for the mandatory reporting of adverse events,
higher standards of accountability, and punitive fines for manufacturers and what emerges are
extensive challenges on the horizon for both drug and device manufacturers that ratchet up risk levels
and the potential for liability. The significant transformations currently evolving in the market
and legal environment in which drug and device manufacturers operate has created a situation in
which keeping up with the impact of these developments is critical for anyone doing business in
this market today.
Attend this comprehensive program and gain the intelligence you need to develop strategies to stay
on top of emerging developments in this complex arena including:
✜ What impact Bill C-17 (Vanessa’s Law) is expected to have on drug and device manufacturers
✜ How class action cases being tried in more than one jurisdiction and across borders can be
better coordinated and the impact this could have on outcomes for Canadians
✜ Assessing responsibility when harm is caused by a generic that was substituted for the Brand
Are you up to speed on these latest industry developments and the legal impact they
represent?
Register today for this comprehensive event and join the discussion. Don’t miss this opportunity
to network with your peers, gain valuable insights into the transformation of the legal landscape,
and find out how to mitigate risk and prevent litigation that could cause serious harm to your
organization and/or your clients.
SPEAKER FACULTY
Co-Chairs
Peter Pliszka
Partner
Fasken Martineau DuMoulin LLP
Anne Tomalin
President
Therapeutic Products Inc.
Speakers
Jason Balgopal
Ministry of the Attorney General’s
Counsel-in-Residence
Law Commission of Ontario
Esther E. Berezofsky
Partner
Williams Cuker Berezofsky
Heidi Bernhard
National Director
Centre for ADHD Awareness, Canada
(CADDAC)
Ray Chepesiuk
Commissioner
Pharmaceutical Advertising Advisory Board
(PAAB)
Nicholas Kluge
Partner
Gowling Lafleur Henderson LLP
Emily Larose
Partner
Cassels Brock & Blackwell LLP
Jill Lawrie
Partner
Blake, Cassels & Graydon LLP
Doug Lennox
Counsel
Klein Lawyers
Angus McKinnon
Partner
Lerners LLP
Alain Musende (tentative)
Manager, Regulatory Advertising Section
Marketed Health Products Directorate
Health Canada
Harvin Pitch
Partner
Teplitsky Colson LLP
Peter Pliszka
Partner
Fasken Martineau DuMoulin LLP
Jonathan Ptak
Partner
Koskie Minsky LLP
Sylvie Rodrigue
Partner, Torys LLP
Chair, CBA National Task Force on Class Actions
Anne Tomalin
President
Therapeutic Products Inc.
Evan Zelikovitz
Canadian Representative, APCO Worldwide
President, Evan Zelikovitz Consulting
Public Affairs and Strategic Communications
REGISTER NOW ✜ 1-877-927-0718x7292 ✜ J.Keitner@CanadianInstitute.com
Supported by:
Canadian Healthcare Technology is a print and online magazine that helps healthcare
professionals stay current with innovations that improve clinical outcomes and workflow.
Contact Canada publishers of the Canada & USA Drug Development and the Canadian Medical
Technologies Industry Guides are delight to support this leading event. Please pick up your copy of
our 2015 prnt edition at registration, or access the FREE e-book and searchable database formats.
These enable you to produce your own customized directories. www.contactcanada.com
PharmaVOICE magazine provides commentary about the challenges and trends impacting the
life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE’s
more than 41,000 BPA-qualified subscribers are also kept abreast of the latest trends through additional media
resources, including WebSeminars, Podcasts, Videocasts, and White Papers. www.pharmavoice.com
WHO SHOULD ATTEND
From Brand, generic and biotech manufacturing including CRO’s and CMO’s: President, Vice President,
General Counsel, Legal Counsel, Corporate & Legal Affairs, Director, Managing Partner, Investigator,
Manager, Analyst, Officer, Project Manager of:
- Regulatory Affairs
- Compliance
- Drug Safety/Pharmacovigilance
- Quality Control
- Risk Management
- Business Development
- Contract Management
- Clinical Trial Management
- Research and Development
- Plant Operations,
- Technical Director,
- Program Management
From Legal Firms: Partner, Associate, Counsel, Lawyer practicing in:
- Life Sciences
- Product Liability
- Class Action Litigation
and Defense
- Personal Injury
Plus representatives from:
- Manufacturers’ Associations
- Rx&D, CGPA, MEDEC
- Patient Advocacy Groups - Consulting and service
companies

3. REGISTER NOW ✜ 1-877-927-0718x7292 ✜J.Keitner@CanadianInstitute.com
DAY ONE ✜
Registration Opens and Refreshments are Served
Opening Remarks from the Conference Co-Chair
Peter Pliszka
Partner
Fasken Martineau DuMoulin LLP
New Trends and Developments in the Legal Landscape
for Drugs and Medical Device Liability and Litigation
Peter Pliszka
Partner
Fasken Martineau
Doug Lennox
Counsel
Klein Lawyers
• What new case developments are there nationally and
internationally that are instructive for the management of
current Canadian cases?
• The latest developments in the evidentiary requirements to get
a case certified for class action
• Is the Class Action process being bypassed for drug and medical
device liability litigation in Canada?
• Are there hot-button issues in product liability and regulation
in the U.S. and Canada that should be monitored?
Networking Refreshment Break
The Current Review of Ontario’s Class Action Regime:
Are the Legislation and Practice Working as Intended?
Jason Balgopal
Ministry of the Attorney General’s Counsel-in-Residence
Law Commission of Ontario
The Board of Governors of the Law Commission of Ontario approved
a new project on class actions, including a comprehensive review of
the Class Proceedings Act. This session will provide an update on the
progress of the project and of areas that may merit future reform. Topics
will include the scope of the project, the initial research completed,
the discussion paper, the outreach the LCO conducted to solicit
informed opinions regarding this area of the law, the interim paper
and draft recommendations, and a review of the final paper and its
recommendations. A short review will also be done about the database
of class action cases which the LCO has compiled and is analyzing.
Bill C-17 “Protecting Canadians from Unsafe Drugs
Act” (Vanessa’s law): An Update and Its Potential
Impact on Drug and Device Manufacturers
Chad Sheehy
Senior Regulatory Advisor – Inspectorate
Regions and Programs Bureau, Health Canada
Bill C-17 represents the most significant amendment to Canada’s
Food and Drug Act in over 50 years, and includes expanded powers
for Health Canada.
• What impact is it expected to have on manufacturers?
• How will confidential corporate information be handled when/
if it is requested by Health Canada?
• How will this legislation lead to greater patient safety?
Networking Luncheon for Delegates and Speakers
The Role of the Regulator: Should the Regulator
be Held Accountable for the Decisions it Makes to
Approve Drugs and Medical Devices?
Anne Tomalin
President
Therapeutic Products Inc.
Jonathan Ptak
Partner
Koskie Minsky LLP
• Does the regulator have the resources to vet in detail all that
comes before it?
• Are there improvements that could be made to the submission
process that would make it more manageable?
• If a company misrepresents a product even to a minor extent
that results in a material impact on the integrity of the product,
and the regulator does not catch it, should the regulator be
considered to be even partially responsible if the product
approved is later found to be defective?
• Does current policy need to be revised?
• Should the regulator be impressed with a duty of care?
• To what extent can or should the regulator’s approval affect
compliance with the standard of care?
• Should Canada follow the EU’s lead with their establishment
of the European Medicines Agency and collaborate with the
U.S. and Mexico to form a similar North American agency?
Strategies for Preempting Potential Liability Claims
During the Recall Process
Nicholas Kluge
Partner
Gowling Lafleur Henderson LLP
Evan Zelikovitz
Canadian Representative, APCO Worldwide
President, Evan Zelikovitz Consulting
Public Affairs and Strategic Communications
• A review of critical adverse reaction reports
• Impact of Bill C-17 on current procedures
• Keeping control of the story; the necessity of a pro-active
communication strategy
• Lessons learned from previous recalls
Networking Refreshment Break
Ensuring you Have a Drug and Device Safety Program
that Complies with Bill C-17
Emily Larose
Partner
Cassels Brock & Blackwell LLP
The heightened level of oversight introduced by Bill C-17 places much
greater obligations on manufacturers to ensure their products not only
pass pre-market safety requirements, but are continually monitored
throughout their life cycle. With greater vigilance and mandatory
reporting requirements for adverse events by hospitals and other
healthcare professionals, ensuring a product’s safety is now more
complicated. This session will explore the essentials of what needs to be
in place to have an effective safety management program that is now
more critical than ever to get right.

4. CONNECT WITH US:
Duty of Care: Where does Responsibility Lie when
Substituting a Generic for the Brand?
Heidi Bernhard
National Director
Centre for ADHD Awareness, Canada (CADDAC)
Health Canada stipulates that the generic version of Brand name
drugs does not have to be identical, but be the bioequivalent of the
original version. Because generic manufacturers are not required to do
their own clinical testing, potential side effects are not recorded. When
patients are switched from a Brand to the generic version, this can
often result in reduced efficacy, new side effects and possibly adverse
reactions that were not anticipated. In Ontario pharmacists are not
required to alert patients or caregivers that a direct substitution of
their brand name medication to the generic has occurred. They are
also facing increased pressure from provincial governments and
private payers to substitute lower cost generics to help keep healthcare
costs under control.
• When an adverse event occurs due to the direct substitution
with a generic medication, what level of responsibility does
the generic manufacturer, Health Canada and both public and
private payers have?
• If pharmacists deliberately substitute a generic against
the explicit direction of the physician treating the patient
not to substitute the generic, should the pharmacist share
responsibility if the patient has an adverse reaction?
• As more provinces are mandating that generic substitutions be
made for brand products, what impact will this have on patient
groups going forward?
Conference Adjourns for the Day
DAY TWO ✜
Refreshments are Served
Opening Remarks from the Conference Co-Chair
Anne Tomalin
President
Therapeutic Products Inc.
The Management of Multi-Jurisdictional Actions
within Canada and Across Borders
Sylvie Rodrigue
Partner, Torys LLP
Chair, CBA National Task Force on Class Actions
Harvin Pitch
Partner
Teplitsky Colson LLP
Esther E. Berezofsky
Partner
Williams Cuker Berezofsky, NJ
• The CBA and ABA protocols, 2 years later, where are we and
is it working?
• The rise of class actions and collective redress mechanisms
outside of North America: How can defense avoid duplication
and ensure decisions will be enforced?
• Coordinating Canadian class actions with U.S. cases proceeding
through the MDL
Networking Refreshment Break
Lessons Learned from Anderson v. St. Jude Medical
Jill Lawrie
Partner
Blake, Cassels & Graydon LLP
Angus McKinnon
Partner
Lerners LLP
As a landmark Canadian case, Anderson v. St. Jude Medical offers
a rare opportunity to analyze and evaluate what worked and what
didn’t on both sides of the bar. This session will explore key aspects of
the case that had both a positive and negative impact on the outcome
at different stages of its proceeding through the judiciary.
Networking Luncheon for Delegates and Speakers
Fair Warning/Duty to Warn: What Needs to be Included
in Drug and Device Advertising and Marketing Plans to
be Onside with Current Legislation?
Alain Musende (tentative)
Manager, Regulatory Advertising Section
Marketed Health Products Directorate, Health Canada
Ray Chepesiuk
Commissioner
Pharmaceutical Advertising Advisory Board (PAAB)
• Product labeling and communication to end-user; pitfalls to avoid
• Addressing the difference between the pre-clearance requirements
for drugs and devices; is it time to introduce the same advertising
pre-clearance requirements to device manufacturers?
• Duty to warn: properly disclosing side effects for pharmaceuticals
and/whether this is communicated to the end user
• Device manufacturers also have a duty to provide fair warning,
especially if there is a risk of harm
• The “Learned Intermediary Doctrine’ and whether the physician
adequately warns his/her patients about possible side-effects;
Is it possible to ensure the entire chain of communication has
been covered?
Networking Refreshment Break
Understanding and Evaluating Claims of Negligent
Testing: A Primer on Clinical Testing and Product
Development
Speaker TBA
Inevitably when personal injury cases come to trial involving drugs
and medical devices, one of the first questions asked is “was the testing
done properly?” This session will provide a primer on how testing
works so that claims of negligence can be evaluated and defended
• What is required by Health Canada for product approval?
• The different phases of clinical trials and medical device testing,
the purpose of each and risk factors involved
• Clinical trial and device testing logistics (where they happen,
how they are coordinated internationally, the role
of the investigator/company/Health Canada)
• Research Ethics Boards and Health Canada oversight over
clinical trials
• Applicable standards for clinical trials and device testing
• The management of adverse events arising in the context
of clinical trials
• Post-market drug and device testing
@CI_Legal #drugmedThe Canadian Legal Network
CASESTUDY

5. SPONSORSHIP & EXHIBITION OPPORTUNITIES
Maximize your organization’s visibility in front of key decision-makers in your
targetmarket.Formoreinformation,contactDirectorofBusinessDevelopment
Daniel Gellman at 416-927-0718 ext. 7389, toll-free 1-877-927-0718 ext. 7389
or by email at D.Gellman@CanadianInstitute.com
Determining the Fairest Method for Claims
Settlement and the Calculation of Damages in
a Class Action Proceeding
Paul Martin
Senior Partner
Fasken Martineau DuMoulin LLP
• Damages can be calculated based on the following:
- people who suffer damage
- people who suffer no damage
- people who have been exposed to a potential source of
future harm
- medical monitoring
• How much can the damages awarded for similar cases in the
U.S. be relied upon in calculating damages in Canada?
• How does the different approach to class actions in Canada
affect damage awards?
• Should there be funds held in reserve by the manufacturer for
these people in the event their device fails even if they have
not yet been harmed?
• How much weight should they be given in current damage
awards?
• How should class action settlements be structured for these
types of cases?
Conference Concludes
©The Canadian Institute, 2015
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6. TOP REASONS TO ATTEND
✜ Discover the extent of the impact Bill C-17 will have on the drug, medical device and biotech industries and the new standards
and obligations it represents
✜ Realize the lessons learned from Anderson v. St. Jude Medical
✜ Gain insight into whether generics should have the same ‘duty of care’ as Brand pharmaceuticals and be equally responsible
for their products in the marketplace
✜ Learn how to increase coordination of cases in multiple jurisdictions and the benefits you could reap
✜ Join the discussion and weigh in on if it is time for the advertising pre-clearance requirements that currently apply to drug
manufacturers be extended to device manufacturers
4471369
ATTENTION MAILROOM:
5 Easy Ways to Register
PHONE:
1-877-927-0718x7292
EMAIL:
J.Keitner@
CanadianInstitute.com
ONLINE:
J.Keitner@CanadianInstitute.com
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FAX:
1-877-927-1563 or 416-927-1563
MAIL:
The Canadian Institute
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Ontario M5R 2C4
DS-JKR
DRUG and MEDICAL DEVICE
LIABILITY and LITIGATION
in CANADA
The Canadian Institute’s
New Trends and Developments:
DRUG and MEDICAL DEVICE
LIABILITY and LITIGATION
in CANADA
The Canadian Institute’s
New Trends and Developments: