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I was recently contacted by an individual who had managed to obtain an offer of $50,000 to settle her son’s case. This person wanted to know if it was safe to take the mon

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

ey without retaining a lawyer. He was afraid that if a lawyer was brought into the case that the lawyer might settle the case for $55,000 and take one third of the proceed

; 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. My advice was to meet with several lawyers in order to work out the best possible arrangement. I told the client to insist that the first $50,000 was for her son and th

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

at the lawyer’s fee would come out of any amount he could negotiate above and beyond that amount.

This is a creative solution to a seemingly difficult problem. You need t

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

o think your situation through carefully so that you can come up with these kinds of solutions. There are plenty of unscrupulous lawyers who will steal you blind if you do

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

Combination pro

n’t act with care. These kinds of creative solutions will win you the respect of the lawyer you finally retain.

It is an illusion to think that an insurance company will

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

offer an unrepresented person the same kind of settlement money they would offer a person represented by a capable personal injury lawyer. There is virtually no way for yo

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

u to know the value of a personal injury case. These values are based upon years of jury verdicts and insurance settlements. Only an experienced personal injury attorney c

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

an accurately assess the maximum amount an insurance company is likely to pay for a particular injury.

The company knows very well that it possesses superior knowledge an

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

d bargaining power. It will not hesitate to use this knowledge and power to its advantage and your disadvantage. Insurance companies pay only what they feel they will be c

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

ompelled to pay by a jury. A strong personal injury lawyer on your side acts like a hammer over the head of the insurance company. The company pays far more when it fears

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

Following aspects would a

the outcome that an experienced personal injury attorney can secure for the client. Insurance companies do not fear unrepresented individuals because of the individual’s l

dd to the challenges in developing combination products:

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

ack of knowledge about how to inflict pain upon the company if it does not settle the case. It’s like fighting a war without modern weapons. The other side is not likely t

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

o listen seriously to your terms of surrender if you have no ability to effectively wage the battle.

The insurance company will also know that even if the facts and justi

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

ce are on your side, your unfamiliarity with the legal procedures involved may allow the company to beat your claim on a legal technicality. Although the courts generally

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

relax the rules of procedure for unrepresented parties, you can’t count on this. The rules are made by lawyers for use by lawyers. It is extremely hard to dot all the i’s

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

Professional from academic institutions, pharmaceutical industries, health care indust

and cross all the t’s in just the right way when it comes to a personal injury lawsuit. Again, my advice is to retain an honest, energetic personal injury specialist at th

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

e first possible opportunity.

Cases involving property damage alone can be settled fairly without the assistance of an attorney. It may be better here to handle the case

.

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

yourself and spare yourself the expense of an attorney. There are books available which set forth the value of cars. These accepted values establish guidelines which the i

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

Companies that provide selfless information through particip

nsurance company should follow. There are no such clear cut guidelines concerning the "value" of pain and suffering in a serious injury case. That’s why you need a lawyer.

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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