The revised virtual agenda is currently in development. Check back for updates as we finalize the virtual conference agenda.

Pre-Conference Workshop

Virtual Workshop — Think Tank on the “5 Cs” of Successful In-House Counsel – Law Firm Partner Relationships: Cost, Competency, Communication, Collaboration and Culture

Dec 7, 2020 9:00am – 12:30pm

Speakers

Charna Gerstenhaber
Vice President, Head of Litigation & Investigations
Novartis Pharmaceuticals (East Hanover, NJ)

Veronica M. Lei
Assistant General Counsel - Litigation and Legal Compliance
Eli Lilly and Company (Indianapolis, IN)

Richard W. Silbert
V.P., Chief Legal Strategist
Purdue Pharma L.P. (Stamford, CT)

Patricia A. Barbieri
SVP, General Counsel and Secretary Legal and Corporate Affairs
Daiichi Sankyo (Basking Ridge, NJ)

Julie M. Lewis
General Counsel & Corporate Secretary
Carestream Health (Rochester, NY)

Day 1 - Tuesday, December 8, 2020

8:45
Opening Remarks from the Co-Chairs
9:00
ACI’s Drug & Med Celebrates 25 Years: Industry Leaders Take a Look Back and a Look Ahead
10:00
Morning Break with Opportunities for Virtual “Meet and Greets”
10:30

Covid-19 Impact on Drug & Medical Device Litigation

Analyzing the Implications of Prep Act Immunity on Future Drug and Device Litigation and Assessing Potential Covid-19 Related MDLs
11:30

Covid-19 Impact on Drug & Medical Device Litigation

Embracing the New Normal: Establishing Best Practices for Efficient and Successful Virtual/Remote Trial Practice
12:30
Lunch Break
Presentation & Networking Hosted by:
1:30
Keynote Address
2:00
Analyzing Recent Changes to FDA Approval Processes and Future Implications on Product Liability Cases
2:45
Break with 1:1 Networking Opportunities
3:15

BREAKOUT SESSIONS (CHOOSE A OR B)

TRACK A: The Practice of Drug and Medical Device Litigation: Strategies for Combatting the Complexities of Today’s Products Liability Landscape

TRACK B: The Business of Drug and Medical Device Litigation: Understanding the True Costs of the New Products Liability Environment
4:15

BREAKOUT SESSIONS (CHOOSE A OR B)

TRACK A: The Practice of Drug and Medical Device Litigation: Strategies for Combatting the Complexities of Today’s Products Liability Landscape

TRACK B: The Business of Drug and Medical Device Litigation: Understanding the True Costs of the New Products Liability Environment
5:15
Conference Adjourns
Networking Hour Sponsored by:king-spalding_logo

Day 2 - Wednesday, December 9, 2020

8:45
Opening Remarks and Recap of Day One
9:00
MDL Case Study: Analyzing the Unique Nuances of Three of 2020’s Most Significant MDLs
10:00
Morning Break with Virtual Networking Opportunities
10:30
Assessing How Recent Current Events are Impacting Juror Mindsets, Perceptions and Verdicts in Drug and Device Cases
11:15
A View From the Bench: Judicial Insights on How this Year’s Events Have Impacted Dockets, Court Functions, Judicial Proceedings and the JPML in General
12:45
Lunch Break
1:45
Diversity & Inclusion Town Hall: An Honest Discussion About Drivers of Successful D&I Initiatives and the Latest Challenges Faced by Law Firms and Life Sciences Companies
2:45
Understanding the Use of Data Analytics in the Management of MDLs
3:45
Networking Break
4:00
Analyzing Risks and Liabilities Associated with New Technologies, Digital Health and Artificial Intelligence
4:45

LIVE POLLING

Interactive Ethics Lab
5:45
Conference Ends

Day 1 - Tuesday, December 8, 2020

8:45
Opening Remarks from the Co-Chairs
9:00
ACI’s Drug & Med Celebrates 25 Years: Industry Leaders Take a Look Back and a Look Ahead

As ACI’s Drug & Medical Device Litigation conference celebrates its 25th year, our esteemed in-house counsel and law firm panelists will engage in an interactive discussion of the most significant legal and business developments that have impacted drug and device litigation in the last quarter century, as well as their implications and influence on future decisions, trends and strategies in this arena.

10:00
Morning Break with Opportunities for Virtual “Meet and Greets”
10:30

Covid-19 Impact on Drug & Medical Device Litigation

Analyzing the Implications of Prep Act Immunity on Future Drug and Device Litigation and Assessing Potential Covid-19 Related MDLs

  • Examining the impact of Covid-19 on existing and future litigation
  • PREP Act immunity: how is it being interpreted and applied in cases related to Covid-19 treatments, diagnostics, PPE, ventilators, vaccines, etc.?
    • Interpreting what qualifies as “covered countermeasures”
    • What are the key limitations/qualifications on immunity protection
    • Will “off-label” uses qualify for immunity absent an express exemption?
  • How should clients be counseled in the face of much grey area and uncertainty around this?
  • What types of drug and device product liability claims stemming from Covid-19 are likely to turn into MDLs?
    • Assessing whether the particular subject matter will be ripe for an MDL
  • Identifying specific considerations for PPE product liability claims

11:30

Covid-19 Impact on Drug & Medical Device Litigation

Embracing the New Normal: Establishing Best Practices for Efficient and Successful Virtual/Remote Trial Practice

Due to this year’s pandemic, many attorneys and courts have had to quickly embrace a “new normal” which relies largely on virtual and remote trial practice. As we all become more comfortable with virtual proceedings and procedures, we may likely see a more permanent shift in this direction in the longer term. This panel will share strategies that can be employed to conduct successful and efficient virtual or remote trial practice going forward. Tune in as the panelists address:

  • How has Covid-19 affected drug and medical device litigation practice from a practical standpoint?
  • How are we likely to refocus how we’re approaching trial practice in the longer term?
  • Strategies and best practices for:
    • Remote discovery
    • Preparing witnesses remotely
    • Engaging in virtual depositions, mediations, oral arguments, etc.
  • Identifying the biggest challenges to virtual trial practice and tools for overcoming them
  • Assessing whether the value of seeing someone in person is outweighed by the economic savings of not traveling and doing things virtually/remotely

12:30
Lunch Break
Presentation & Networking Hosted by:
1:30
Keynote Address

Robert P. Charrow
General Counsel
U.S. Department of Health and Human Services (HHS)

2:00
Analyzing Recent Changes to FDA Approval Processes and Future Implications on Product Liability Cases

In connection with the Covid-19 pandemic, there have been certain changes to the processes for securing FDA approval of virus relates therapeutics, testing and preventative materials that have needed to get to market in a more expedited fashion. This panel will provide a clear understanding of:

  • The ways the government has altered FDA review and approval processes this year in order for certain products to get to market
  • The FDA’s use of “Emergency Use Authorizations” (EUAs) in connection with bringing certain products to market
    • What does the EUA process entail?
    • What findings does the FDA have to make before making such an emergency declaration
  • Understanding what you can and cannot do in terms of marketing a product governed by an EUA
    • Specific considerations and pitfalls to avoid when marketing a product that is FDA approved for one particular use and EUA approved for a new/different use
  • Assessing the different guidances issued by the FDA exercising its discretion to suspend certain enforcement actions with respect to certain product categories
  • How will the last year’s events impact the FDA in the next year and their priorities and initiatives moving forward?
  • What implications may this have on future product liability litigation?

2:45
Break with 1:1 Networking Opportunities
3:15

BREAKOUT SESSIONS (CHOOSE A OR B)

TRACK A: The Practice of Drug and Medical Device Litigation: Strategies for Combatting the Complexities of Today’s Products Liability Landscape

TRACK B: The Business of Drug and Medical Device Litigation: Understanding the True Costs of the New Products Liability Environment

Track A:
Applying the Latest Procedural Defense Developments to Your Litigation Strategy: Recent Updates in Personal Jurisdiction, Snap Removals and Forum Non Conveniens
  • Analyzing the latest developments in personal jurisdiction rulings and defenses and incorporating them into your trial practice
  • Assessing recent decisions and developments addressing the procedural steps necessary to complete snap removals
  • Identifying and applying the latest strategies for forum non conveniens arguments
Track B:
Strengthening Your Future Crisis Management Capabilities: Lessons Learned from Covid-19 on Combatting Business Disruption and Enhancing Your Crisis Management Response

The COVID-19 pandemic has caused life sciences companies to adapt to supply chain, R&D and clinical development disruptions and financial challenges that would have previously been unfathomable. The challenges involved in such a crisis often require a comprehensive view of multiple disciplines to develop effective solutions. This panel will discuss how an organization can most effectively focus its response to a crisis while minimizing business disruption. Topics to be discussed are:

  • Strengthening your crisis response and management capabilities
  • Managing challenges related to supply chain and manufacturing
  • Responding to road bumps in research and development
  • Workforce strategies
  • Financial and downturn planning
  • Financial reporting and tax issues
  • Best practices for dealing with media and court of public opinion

4:15

BREAKOUT SESSIONS (CHOOSE A OR B)

TRACK A: The Practice of Drug and Medical Device Litigation: Strategies for Combatting the Complexities of Today’s Products Liability Landscape

TRACK B: The Business of Drug and Medical Device Litigation: Understanding the True Costs of the New Products Liability Environment

Track A:
State of the Union on Preemption: Examining the Continued Aftermath of Albrecht and the Latest Developments in Medical Device Preemption Efforts
  • Examining the latest preemption rulings and emerging theories and defenses
  • Assessing the current status of Albrecht and how it has been being interpreted and applied by the lower courts
    • What successes have the plaintiffs’ bar been seeing in avoiding the preemption defense?
    • Which defense arguments work and which don’t?
    • Examining the latest 510(k) preemption efforts and strategies for navigating preemption motions for PMA devices
Track B:
LIVE POLLING: Product Recall Do’s and Don’ts: Identifying Best Practices for Effectively Managing a Product Recall
  • Identifying best practices for coordinating your team and minimizing damage to your company in the face of a nationwide product recall
  • Tips for identifying early warning signs and getting out in front of a recall early
  • Key actions to consider when conducting a product recall and how to execute them carefully and thoroughly
  • Understanding the different roles of in-house counsel, outside counsel, company witnesses, investigators, etc; and how everyone should work together to manage the recall and its effects
  • Best practices for
    • Conducting a health-hazard assessment
    • Planning your course of action
    • Contacting the FDA
    • Getting the word out/ crafting your recall communication
    • Talking to third-party vendors

5:15
Conference Adjourns
Networking Hour Sponsored by:king-spalding_logo

Day 2 - Wednesday, December 9, 2020

8:45
Opening Remarks and Recap of Day One
9:00
MDL Case Study: Analyzing the Unique Nuances of Three of 2020’s Most Significant MDLs

This panel will examine three MDLs that the pharmaceutical and medical device industries have been very closely watching – Hernia Mesh (In Re: Davol, Inc./C.R. Bard, Inc., Polypropylene Hernia Mesh Products Liability Litigation – MDL No. 2846), Valsartan (Valsartan MDL No. 2875) and Zantac (In Re: Zantac (Ranitidine) Products Liability Litigation – MDL No. 2924). The panelists will compare and contrast the unique elements of these MDLs, and provide insights on:

  • Each of their distinctive elements and litigation challenges
  • Successful plaintiff tactics and defense strategies
  • Notable judicial rulings and key takeaways
  • Nuances with MDLs involving Rx versus OTC drugs

10:00
Morning Break with Virtual Networking Opportunities
10:30
Assessing How Recent Current Events are Impacting Juror Mindsets, Perceptions and Verdicts in Drug and Device Cases

  • Examining how events from this year, such as the pandemic and the recent presidential election, will affect juror mindsets in drug and medical device litigation going forward
  • Are jurors viewing big pharma and device companies more favorably since Covid-19?
  • Will juries have as big of an appetite to award big damages in the post-Covid 19 recession era?
  • Will jurors have more understanding of things like science, epidemiology and causation after watching these things play out each day in the news over the last year? If so, how do we approach dealing with “smarter” juries?
  • Strategies for how to shape your statements and narratives to the jury in light of possible new juror perceptions of big pharma and device companies

11:15
A View From the Bench: Judicial Insights on How this Year’s Events Have Impacted Dockets, Court Functions, Judicial Proceedings and the JPML in General

In light of this year’s crisis, we have seen courts take measures such as temporarily suspending oral arguments, ramping up the use of virtual tools to conduct hearings, and even holding socially distanced jury trials. Hear from this panel of esteemed judges on how this year’s events have impacted their current dockets, court functions and the JPML as a whole, as well as what to expect in their courtrooms going forward. Topics to be discussed include:

  • How are the judges adjusting to the continued effects of this year’s pandemic on their dockets?
  • Following the suspension of speedy trial demands and cases being pushed, how are they reorganizing and reprioritizing the order of trial dates?
  • What implications are being seen from courts temporarily suspending oral arguments?
  • How can attorneys help judges who are experiencing an increased backlog of cases?
  • Will this lead to more courts requiring mediation or early dispute resolution?
  • Will we see more courts demanding other mechanisms to lighten the load of cases?
  • How are the courts handling virtual hearings, trial practice and the like?

12:45
Lunch Break
1:45
Diversity & Inclusion Town Hall: An Honest Discussion About Drivers of Successful D&I Initiatives and the Latest Challenges Faced by Law Firms and Life Sciences Companies

Successful diversity and inclusion initiatives are far more complex than merely generating a list of general objectives. Implementing effective D&I programs often require a dedication to building increased equity, diversity, and inclusion into your company’s DNA and operating behaviors. As many in the industry have seen however, this is not always as simple as it sounds, and many further question whether financial investments in D&I initiatives by law firms and life sciences companies may suffer as a result of this year’s economic downturn. Join this panel in a discussion of what D&I initiatives are currently working to yield lasting effects and overcoming the latest challenges companies are facing on this front. Let your voice be heard in this unique open floor session, designed to give all attendees an opportunity to add to the dialogue.

2:45
Understanding the Use of Data Analytics in the Management of MDLs

Embracing an idea floated by the defense bar, judges in at least three recent prominent MDLs have ordered lawyers to prescreen some of the lawsuits through an “initial census” process. The use of initial census forms as an early vetting process to weed out meritless lawsuits will seemingly become more and more common, however there are now many questions about how the information is being collected and used, and how this will impact MDLs moving forward. This panel will discuss topics including:

  • How the data and analytics from these forms are being used in the management of MDLs
  • How the data is impacting judicial decisions and future proceedings
  • Who has access to the data?
  • How is the information collected and protected?
  • How are the costs of this allocated amongst the parties involved?
  • How will this impact MDLs moving forward?

3:45
Networking Break
4:00
Analyzing Risks and Liabilities Associated with New Technologies, Digital Health and Artificial Intelligence

Digital health technologies, including tools incorporating AI, are offering profound benefits to the life sciences industry and opportunities to improve patient care. However, they also carry the inescapable burden of new mistakes and liability risks. This panel will shed light on the full spectrum of implications of these new technologies and how counsel can manage these changes to minimize future product liability.

  • Assessing the ways in which AI is becoming an important part of drug development and marketing strategies, disease diagnosis processes, and beyond
  • Understanding the various new liability risks introduced by new digital health and AI advances
  • Examining how drug and medical device product liability counsel can prepare to minimize future liabilities associated with these new technologies

4:45

LIVE POLLING

Interactive Ethics Lab

Test your ethical skills with a series of anonymous polling questions on sensitive, complex hypothetical scenarios. Discover how your approach to tackling ethical dilemmas in drug and medical device litigation compares to your peers, and benefit from a practical discussion of the polling results and important takeaways for your practice.

5:45
Conference Ends

Virtual Workshop — Think Tank on the “5 Cs” of Successful In-House Counsel – Law Firm Partner Relationships: Cost, Competency, Communication, Collaboration and Culture

Dec 7, 2020 9:00am – 12:30pm

Charna Gerstenhaber
Vice President, Head of Litigation & Investigations
Novartis Pharmaceuticals (East Hanover, NJ)

Veronica M. Lei
Assistant General Counsel - Litigation and Legal Compliance
Eli Lilly and Company (Indianapolis, IN)

Richard W. Silbert
V.P., Chief Legal Strategist
Purdue Pharma L.P. (Stamford, CT)

Patricia A. Barbieri
SVP, General Counsel and Secretary Legal and Corporate Affairs
Daiichi Sankyo (Basking Ridge, NJ)

Julie M. Lewis
General Counsel & Corporate Secretary
Carestream Health (Rochester, NY)

What is it about?

Join us for a unique conversation with our in-house counsel faculty designed to shed light on the expectations of in-house counsel from their law firm partners with regard to things like cost control and budgeting, demonstrating competency, value and efficiency, effective and succinct communication, meaningful collaboration and aligning cultures. This workshop will also serve as a vehicle for other in-house counsel to benchmark their current “5C’s” strategies with the workshop presenters.

Cost
  • Monitoring legal spend, balancing the budget and establishing best practices for cost reduction
  • Engaging in budgeting discussions that establish transparency early on and enhance predictability for cash flow purposes
  • Identifying processes and electronic systems to assist with budgeting, fee arrangements, billing and matter management
  • Implementing creative pricing solutions and tactics such as alternative fee arrangements, fixed-fee retainer agreements and stratified staffing models

Competency
  • Considerations in selecting outside counsel and strategies for finding the right talent
  • Evaluating the appropriateness of work product
  • Reconciling firm capabilities versus individual attorney reputation and ability
  • Understanding the importance of relaying business acumen as well as legal expertise

Communication
  • Communicating value and collaboration between corporate legal and outside counsel
  • Establishing the desired level of commitment, availability and responsiveness early-on in the relationship
  • Succinctly focusing on shared, pragmatic business goals
  • Determining preferences for formality of correspondence and practical versus academic guidance

Collaboration
  • Embracing a holistic representation style: engaging market leading law firms and well respected outside vendors to join forces and collaborate for the benefit of the company
  • Enhancing collaboration amongst lawyers within the organization to maximize efficiency
  • Emphasizing the capabilities and skill sets of individual lawyers or groups to help create new ideas for client offerings
  • Learning your client-company’s business and using internal counsel input as a resource

Culture
  • Taking opportunities to foster interaction, align culture and build trust between the firm and client
  • Identifying what is important to those with whom you are working and finding meaningful connections
  • Finding opportunities to collaborate on industry, political, social or charitable endeavors