Answers - Legal

You will notice on our firm website that many of our cases are settled out of court, rather than trying the case in court with a jury. This is not a cop out by any means and settling

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

a case is almost always more beneficial to the client than taking the case before a jury.

Settling a case prior to trial saves the client and family the stress of going to trial. It

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

Examples of combination products may in

s hard enough for clients to re-tell their experience to their attorney but often much worse to tell it again in front of 7 jurors who are strangers. The details of the case can also

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

be kept more private. When you take a case to trial, the court documents become public record and anyone can go look at them – the local newspaper or your neighbor. When you settle a

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

ase, most of the details are kept out of the court documents, and are not public record. Many settlement agreements also have confidentiality agreements as part of the settlement, so

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

Combination pro

he case will not be talked about in public.

Settling a case rather than taking the case to trial will also save our clients money. For every case we try, there are at least two exper

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

t witnesses testifying on our client’s behalf. These expert witnesses are paid for their time spent reviewing the case, giving depositions, and testifying in court. If a case settles

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

rior to trial, the client has already incurred the cost of the expert’s review of the records, but they will not incur the cost of travel and time spent at a trial. A settlement also

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

aves the client, because they do not have to take time off from their jobs to attend a trial. Unlike experts, who are usually present and testifying for a few hours, the client must b

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

e present for the entire trial, which can run from 2 or 3 days to a week or more. So the client has to take this time off from their jobs, perhaps losing pay or vacation time in doing

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

so.

A jury trial is a very uncertain thing. You are letting people you do not know decide the outcome. While they are impartial to the parties in the case, aspects of their own lives

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

Following aspects would a

affect how they view the evidence in the case. You cannot control how they analyze the details of the case or how they reach a verdict. A settlement is much more certain and much quic

dd to the challenges in developing combination products:

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

ker than having to wait for a jury trial to reach a conclusion, which decision can then be appealed by the losing party making the process even longer. Most cases last from 1 – 3 year

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

, sometimes even longer if an appeal is involved.

When case goes to trial, there are very strict guidelines as to what can be said in court. When you settle a case, there is more lee

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

ay in what can be said to, or requested of, the defendant. For example, in a trial, the family is limited to questions asked by the attorneys, which are limited to the facts. The fami

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

ly cannot explain how they feel about what happened and they can not ask for an apology from the doctor or nursing home. In the process of settlement outside of court, the family may

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

Professional from academic institutions, pharmaceutical industries, health care indust

ave the opportunity to tell the defendant how they feel and the family can request an apology as part of the settlement.

In conclusion, we will never take on a client if we do not be

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

ieve their case can be won in front of a jury. We never take a case in which we are not willing and prepared to try before a jury. However, we do attempt to settle our cases prior to

.

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

going to trial if it is in the client’s best interest. If the defendant is unwilling to resolve the case by making a settlement offer which recognizes our client’s in

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

Companies that provide selfless information through particip

uries and damages, we will not hesitate to try the case before a jury. Ultimately, the case belongs to our clients and it is our clients who have the final say on this important issue

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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