Day 1 - Tuesday, December 8, 2020

7:00
Breakfast and Registration
8:00
Opening Remarks
8:15
ACI’s Drug & Med Celebrates 25 Years: Industry Leaders Take a Look Back and a Look Ahead
9:15

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
10:15
Morning Coffee Break
10:30

Covid-19 Impact on Drug & Medical Device Litigation

Embracing the New Normal: Establishing Best Practices for Efficient and Successful Virtual/Remote Trial Practice
11:30
Keynote Address
12:00
Analyzing Recent Changes to FDA Approval Processes and Future Implications on Product Liability Cases
12:45
Luncheon for Speakers and Delegates
1:45

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
2:30

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
3:15
Afternoon Refreshment Break
3:30

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
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
5:30
Conference Adjourns – Cocktail Hour

Day 2 - Wednesday, December 9, 2020

7:45
Continental Breakfast
8:30
Opening Remarks and Recap of Day One
8:45
MDL Case Study: Analyzing the Unique Nuances of Three of 2020’s Most Significant MDLs
9:45
Assessing How Recent Current Events are Impacting Juror Mindsets, Perceptions and Verdicts in Drug and Device Cases
10:30
Morning Coffee Break
11:00
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
12:00
Luncheon for Speakers and Delegates
1:00
An Interview with the Enforcers: Examining Recent Government Enforcement Priorities and Their Link to the Realm of Drug and Device Product Liability Litigation
2:00
Analyzing Risks and Liabilities Associated with New Technologies, Digital Health and Artificial Intelligence
3:00
Refreshment Break
3:15
Interactive Ethics Lab
4:15
Conference Ends

Day 1 - Tuesday, December 8, 2020

7:00
Breakfast and Registration
8:00
Opening Remarks
8:15
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.

9:15

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
10:15
Morning Coffee Break
10:30

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.

11:30
Keynote Address
12:00
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. What findings does the FDA have to make before making such an emergency declaration.

12:45
Luncheon for Speakers and Delegates
1:45

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

A
Applying the Latest Procedural Defense Developments to Your Litigation Strategy: Recent Updates in Personal Jurisdiction, Snap Removals and Forum Non Conveniens

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.

2:30

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

A
State of the Union on Preemption: Examining the Continued Aftermath of Albrecht and the Latest Developments in Medical Device Preemption Efforts

B
(Live Polling) Product Recall Do’s and Don’ts: Identifying Best Practices for Effectively Managing a Product Recall

3:15
Afternoon Refreshment Break
3:30

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

A
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.

B
CASE STUDY: Mitigating Challenges Created by Third-Party Litigation Funding in the Mass Tort Arena

Drug and device cases are particularly attractive to litigation funders given their high visibility and ability to be easily collected en masse. However, the grey area in which third-party litigation currently operates is creating some very real risks for drug and device manufacturers. This panel will set forth a case study which examines the actions that drug and device companies can take to mitigate the challenges created by TPLF in the mass tort arena.

4:15
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.

5:30
Conference Adjourns – Cocktail Hour

Day 2 - Wednesday, December 9, 2020

7:45
Continental Breakfast
8:30
Opening Remarks and Recap of Day One
8:45
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.

9:45
Assessing How Recent Current Events are Impacting Juror Mindsets, Perceptions and Verdicts in Drug and Device Cases
10:30
Morning Coffee Break
11:00
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.

12:00
Luncheon for Speakers and Delegates
1:00
An Interview with the Enforcers: Examining Recent Government Enforcement Priorities and Their Link to the Realm of Drug and Device Product Liability Litigation
2:00
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.

3:00
Refreshment Break
3:15
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.

4:15
Conference Ends

Workshop A — 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

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

Workshop B — Defense Counsel-Only War Room: Examining the Latest Strategies for Defeating Plaintiffs’ Bar Tactics in Drug and Device Cases

Dec 7, 2020 1:30pm – 5:00pm

What is it about?

Open to defense counsel only – Join your peers for a candid discussion of what is currently happening in the defense-counsel trenches of drug and medical device products liability litigation. Setting the stage for topics discussed in depth throughout the main event, this interactive session will feature audience polling to identify the latest challenges being faced by the defense bar as well as valuable takeaways about what your peers from around the country are seeing in plaintiff bar tactics in drug and device cases. Topics for discussion will include:

  • Examining the latest theories of liability plaintiffs are using in products liability cases against drug and device manufacturers around the country
  • What are the new mass torts and MDLS being seen and where is the plaintiffs’ bar headed in these cases?
  • Proactively identifying drugs or devices which may be ripe for mass tort litigation in 2021 and beyond
  • Deconstructing recent noteworthy jury verdicts and identifying what themes are presently resonating with juries
  • Litigation tactics in aggregated cases: strategies for managing and defending multiple plaintiff trials
  • Notable defense success stories seen in motions to dismiss and other dispositive motions
  • Identifying and tackling the latest challenges being faced by the defense bar with regard to discovery
  • The latest defense tactics for handling punitive damages
  • Key players: which plaintiff firms are currently driving litigation, and who are the frequently testifying experts to look out for?
  • Defending against junk science and using good science/literature to bolster your defense