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In several instances, personal injury claims are settled before they reach the court. But if the

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

negotiations fail, the plaintiff’s (the injured person who is making the claim) lawyer takes the

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

Examples of combination products may in

ecessary steps to file a civil lawsuit.

The first question is to decide on the jurisdiction. In

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

imple language this means the court to which the complaint or petition is to be submitted. This c

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

n be rather complicated. Primarily, the state court where the incident leading to the injury took

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

Combination pro

place has the jurisdiction. If the plaintiff lives in Los Angeles and the other party lives in a

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

other state, the complaint has to be submitted before the U.S. District Court in Los Angeles. If

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

he demand is for a small amount, it should go to the appropriate small claims court.

The petitio

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

should briefly state the facts of the case. Then, documents have to be produced and depositions

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

made. After that comes the trial. First of all, a jury has to be selected. In claims involving la

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

ge amounts, this process could be a heated one. Once the jury is settled, the witnesses are exami

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

Following aspects would a

ed, followed by cross- examination. There could be two types of witnesses in personal injury laws

dd to the challenges in developing combination products:

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

its. One is a direct witness, that is, a person who actually saw the incident that led to the inj

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

ury. The other is an expert witness.

Then there are arguments and counter-arguments. Directions

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

o the jury by the presiding judge follow this. After that, the jury contemplates all aspects of t

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

e case and, more often than not, arrives at a verdict.

A claim for damages in a personal injury

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

Professional from academic institutions, pharmaceutical industries, health care indust

ase can originate on three grounds: negligence, strict liability (which also covers defective pro

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

ducts), and intentional action. To win a personal injury lawsuit it has to be proved that one of

.

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

hese grounds existed, and caused the plaintiff’s injury.

As is the case with all lawsuits, the p

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

Companies that provide selfless information through particip

aintiff’s total support to his attorney is essential for the successful outcome of the litigation

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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