Pre-Conference Workshop

A 50-State Drug & Med Survey: Drilling Down into the State-Specific Legislation that Impacts Drug & Medical Device Litigation [including preemption, consumer fraud and patient safety]

Monday, December 9, 2013
9:30 a.m. – 12:30 p.m. (Registration and Continental Breakfast at 8:45 a.m.)

Howard Dorfman
Vice President and General Counsel
Ferring Pharmaceuticals, Inc. (Parsippany, NJ)



Edward W. Gerecke
Shareholder
Carlton Fields (Tampa, FL)


With preemption at the forefront of all litigators’ minds, it can be difficult to keep track of all the different state legislation that can impact your trial strategy. Additionally, practitioners struggle with consumer fraud concerns and patient efficacy claims. This Pre-Conference Workshop will serve as an invaluable foundation for the remainder of the conference. Experts will discuss:

Preemption

  • Applying preemption decisions in other industries to the drug and device industries
  • Understanding the interplay between preemption and the FDA regulatory process
  • Dealing with state court judges in different jurisdictions
  • Minimizing the risks of penalizing innovative drug manufacturers
  • Pleading around preemption and how these cases are being defended
  • Analyzing the Stengel decision and its application to medical device preemption
  • Updating labels to conform with brand manufacturers
  • Addressing parallel claims

Consumer Fraud

  • Analyzing fraud on the FDA allegations
  • Preventing plaintiffs from presenting fraud on the FDA evidence
  • Insulating the manufacturer from liability for failure to warn claims when it has complied with FDA standards
  • Seeking a broad application of the Buckman fraud on the FDA preemption decision to all claims that a manufacturer fraudulently withheld information from FDA

Patient Safety

  • Exploring manufacturers’ duty with respect to patient safety
  • Determining what information must be communicated to the public
  • Educating plaintiff’s counsel on a product’s efficacy
  • Proactively approaching FDA to update a product’s label/black box warning

Post-Conference Business Development Master Class:

On Selecting and Evaluating Outside Counsel

Wednesday, December 11, 2013
3:30 p.m. – 5:30 p.m. (Registration begins at 3:15 p.m.)

Patricia A. Barbieri
Deputy General Counsel,
Litigation and Employment
Legal Affairs
Daiichi Sankyo, Inc. (Parsippany, NJ)
Kathleen Erickson DiGiorno
Senior Legal Director
Medtronic, Inc (Minneapolis, MN)
Heidi Kraus
Partner
Fanelli Haag and Kilger PLLC
(former General Counsel
Abon Pharmaceuticals LLC)

The process of selecting of outside counsel is crucial to the success or failure of legal services performed by law firms for corporations. The drug or device manufacturer needs to carefully vet potential law firms and define the needs brought on by various cases. In-house counsel will give rarely heard insights on:

  • What is the process for becoming a manufacturer’s preferred provider? How do the “little guys” get in the game?
  • Strategies for increasing outside counsel performance while decreasing cost
  • What measures are in place to continue to optimize resources?
    • metrics for effectiveness and efficiency
  • What is an effective and fair way to assess counsel’s performance?
  • Negotiating fee arrangements and monitoring performance and billing practices of outside counsel
    • outlining expectations
  • How important are Chambers rankings and surveys?
  • In-house counsel pet peeves of their outside counsel – what behavior/activities/style should be avoided?
  • How do companies select which of their preferred providers works on which case?
  • Understanding the growing partnership between the general counsel and the CEO
  • Matching the unique skill set of the attorney to the technical and legal demands of the matter in order to maximize the results of your legal spend