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Most veteran trial lawyers will agree that while a case is not always won in jury selection, it can easily be lost there. It is one of the three m

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

ost critical junctures of any trial (the other two being opening statement and cross-examination of the first witness), yet voir dire usually is re

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

legated to the proverbial back burner, only to be attended to in the waning days—or even hours—just before trial begins.

IF YOU’VE WAITED UNTIL T

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

HE WEEKEND BEFORE TRIAL TO PLAN YOUR VOIR DIRE, YOU’VE WAITED TOO LONG The construction of voir dire needs to start weeks before your case gets to

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

trial, after you’ve conducted your pre-trial research (you have conducted pre-trial research, haven’t you?) and you are starting to prepare your c

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

ase-in-chief in earnest. If you find yourself waiting until Saturday or Sunday before trial, jotting some questions down on a pad and then getting

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

up in court on Monday and conducting your voir dire, without the benefit of research-based profiles or of rehearsal, you could well be missing out

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

on the opportunity to educate your jurors and to weed out those most dangerous to you.

THE PURPOSE OF VOIR DIRE IS NOT TO DETERMINE IF JURORS CAN

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

BE FAIR AND IMPARTIAL!

Sorry, but there is no such thing as an impartial juror. Every person who arrives in the courtroom—juror, lawyer, judge,

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

clerk, court reporter, bailiff—brings two things:
1. Life experiences.
2. The attitudes that are a result of those life experiences.

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

So, the purpose of voir dire is to uncover those attitudes and experiences, get jurors to talk about them, and then send home the folks who have at

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

titudes that are hostile to your case and/or your client.

The Key Purposes of Voir Dire

• Find and dismiss jurors who will be harmful to your

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

case
• Get the themes of your case in front of jurors
• Find out who your jurors are and what they have to say about the issues, so that

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

you have a better idea of how to communicate with them during your case.

Your Goals in Voir Dire

• Get them to talk!
• Get them to talk

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

about your themes
• Get them to talk themselves off the jury, if they are hostile to your case

IF YOU ONLY REMEMBER ONE THING FROM THIS

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

ARTICLE, THIS IS IT

Do you go into trial without practicing your opening statement? Then why not spend time rehearsing the part of the trial when

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

you speak to jurors first? If you don’t practice your voir dire, why not? If you do practice voir dire, do you practice with people in the room?

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

If you practice with people in the room, are these laypeople? If these are laypeople in the room, do you ask them for their feedback on how this

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

voir dire made them feel? If you ask them for feedback, do you apply it to your voir dire going into trial?

The bottom line is, your voir dire—n

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

ot your opening statement—is when you make your first impression on the jurors. Make the most of the opportunity. Practice, refine your voir dire

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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The consumer has become the source of value and our wealth and wellbeing has become of great importance to them. Their yearnings are what now drive the marketplace and therefore, the creation of wealth.

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