Actual - Legal

If you have been injured in any type of accident and another person/party is at fault, you are entitled to bring a claim against that person/party to recover compensation

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

for your injuries. This is what is called a “Personal Injury” claim.

The first step is to hire an experienced personal injury attorney. The attorney typically will not

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

Examples of combination products may in

harge you for a consultation and will not charge you any fee unless they recover something. I have found that many people attempt to handle their own injury cases by thems

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

elves without the help of an attorney. That is a huge mistake. Statistics show that an experienced attorney will recover many times over the amount that you can recover o

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

your own. In addition, without an attorney, you may be waiving or signing away rights and entitlements to which you should have pursued.

Once you have retained an attorn

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

Combination pro

ey, he will send what is called a letter of representation to the responsible party(s) and their insurance companies. The purpose of this is two-fold. The first is to le

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

the other side know that you are serious about your claim. The second is to make sure that no one bothers you during your healing process.

The attorney will likely do so

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

me information gathering at that point, perhaps hiring an investigator if needed, interviewing witnesses and so on. He will not begin any real substantive settlement discu

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

sions with the responsible parties until you have fully recovered or have reached maximum recovery. It is important to wait until full recovery (or maximum recovery) becau

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

se you only get one bite at the apple. What I mean is that you only get one opportunity to settle a claim, i.e. after you settle it, you cannot ask for more. Part of the

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

ay an injury claim is valued is based upon medical treatment and recovery time. It would be foolish to settle or attempt to settle a claim prematurely.

After healing is c

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

Following aspects would a

ompleted, your Attorney will begin settlement negotiations with the responsible party. This often can become acrimonious when the two parties place vastly different figure

dd to the challenges in developing combination products:

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

on the value of your claim. The two issues that are argued over in negotiations are Liability and Damages. Liability is the “who is at fault, and how much” aspect of an

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

injury claim. You argue that the other side is at fault, and they argue that you are at fault. The Damage aspect is essentially “what is the value of these injuries?” “Ho

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

much is an injury of that type worth?”. If a settlement cannot be reached, your Attorney will have to file a civil lawsuit against the responsible party. This often tim

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

es is a very good thing, because it forces the responsible party (or their insurer) to retain an attorney to defend the claim. The gives for a second set of eyes to review

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

Professional from academic institutions, pharmaceutical industries, health care indust

your claim and may lead to further settlement negotiations.

Should the negotiations fail, its on to the meat of the litigation. The other side will want to review all of

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

your medical information, perhaps schedule your deposition (a deposition is where the other side’s attorney asks you a multitude of questions about the accident, about your

.

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

injuries and about your treatment). The other side may also request that you undergo an Independent Medical Examination (IME) with a doctor of their choosing to review you

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

Companies that provide selfless information through particip

r medical status and treatment. This will usually set forth one final set of negotiations before trial. Should that fail, its into the courtroom for a trial on the merits

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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Knowledge processes cannot be managed following the standard business process management paradigm. In the following article some guidelines are given for organizations willing to better manage their knowledge processes.

Those who understand that the environment they compete in is constantly changing will be able to take advantage of the future. Those who resist change will be wondering what happened to them.

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