Accredited Psychiatry & Medicine | Harold J. Bursztajn, MD, Forensic Psychiatrist | Clinical Expertise in Medical Product Litigation

Clinical Expertise in Medical Product Litigation

On not "losing in translation"

Harold J. Bursztajn, M.D. Director
Harvard Medical School
Program in Psychiatry & the Law
E-mail: harold_bursztajn@hms.harvard.edu

With thanks to the Harvard Medical School Program in Psychiatry and the Law

Communications counsel provided by Gavin Anderson & Co.
E-mail: millingworth@gavinanderson.com

Merck’s product liability challenge

"Looming lawsuits, angry investors, declining profits: The Vioxx debacle is just the latest setback for the proud pharmaceutical giant." Fortune, November 1, 2004

. . . there was murder before Prozac . . . eg. Cain and Abel

Introduction

Medical Expertise
Legal Expertise
Scientific Expertise

Disparate Disciplines + Different Languages + Adversarial System = Disastrous Consequence

The Goal

Medical/Clinical Expertise + Legal Expertise + Scientific Expertise = Integrated Structured Communications

Who do you hire . . .

. . . to run the Boston Red Sox?

Shakespeare knoweth the books, but, alas, not the baseball

A baseball player knows baseball, but . . . Well, frankly, he's not telling

Answer - Theo Epstein!

What is the clinician's role?

Translation from the Attorney's perspective:

Hired Gun = Credible, Objective Advisor
Exclusivity = Confidentiality
"Cheap" Help = Wise Investment
Attorney's Dummy = Sherlock Holmes

What is the clinician's role?

Translation from the Clinician's perspective:

Find Clinical Cause = Find Medical-Legal Cause

Navigating the continuum

The clinician's role and relationships may exist along a continuum from Hired Gun to Credible, objective advisor
An outside consultation with an "expert's expert" is valuable in moving the relationship from point A to point B

Breaking language barriers

Develop cultural competence
- Identify points of perspective difference
- Work to bridge perspective gap
Identify complementary skill sets
Take the long view of cost-benefit analysis

When to seek an interpreter

Clinical Causation
- Choose the "right" experts
Medical-Legal Causation
- Provide black letter, case law & statutory interpretation

Choosing the "right" expert

Clinical Experience
Integrity
Doctors' Doctor
Ego in Check
Forensic Expertise
Translation Skills

Goal = Attribute Balance

Pitfalls to avoid

Poor Communication
- Occurs because of fear of distortion
- Remedy is careful, precise written communication
- Requires team to take the long view
Focusing on Cost only
- Reasons this occurs
  - Fee structure of attorney-client relationship
  - Fear expert will be mis-characterized as a hired gun
- Remedy = i.d. experts with substantial reduced-fee or pro bono practices made possible by forensic practice
  - Make this explicit in direct examination
Retaining Less Qualified Experts
- Careful screening of experts is required
- The best expert is:
  - Analytical
  - Detail-oriented
  - Articulate
  - Versed in other opinions
  - Critical Thinker
  - Kind and strong
Confusing Superficiality with Simplicity
- The goal should be opinions that are simple and valid
- Retain an expert who can convey complex analysis in simple terms
- Structure the relationship to allow the expert to perform a thorough evaluation

Choose Wisely

Choose an expert and structure the relationship so that the expert can:
- Review, analyze, compare & cross-check data
- Consider strengths & weaknesses of a case
- Review & analyze opinions of other experts
- Synthesize & translate expert opinions
- Articulate underlying methodology & reasoning
- Distinguish between contradictory opinions & different case fact patterns
- Rule out suggestibility & "bandwagon" effects
- Analyze & opine on reliability of other experts' methodologies
- Be kind & strong

Model expert skill set

The "best" expert must be able to see and comprehend a host of factors related to the plaintiff:

Medical & psychiatric history
Life history
School & employment records
Informed consent
Assumption of risk
Inadequacy of treating MD's opinion
Motivation for litigation
Preexisting conditions denied
Misattribution of causality?
Intervening variables
Comparative liability

Remember . . .

Not all side effects are caused by prescribed medications
Clinical experts emphasize irreducible uncertainty

Guiding principles

Opinions will evolve over time
Track data needs as the case progresses
Schedule expert depositions later
Expert becomes consultant after opinion is formulated
Testimony preparation is key
Maintain consulting relationship after testimony
Experts Need to Deliver "IOU's"

Parting Thoughts

The expert as consultant & educator:
- Raises new questions and opens new lines of analysis
- Translates and communicates
- Works toward validity, meaningfulness, and simplicity