Actual - Legal

In 2005 Kelly was partially blinded in one eye when she was hit by a car. Her body was slammed to the street face first. Sonia

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

was trying to cross a busy urban street while her light was red. Nevertheless, Kelly obtained a settlement in excess of $300,00

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

Examples of combination products may in

0.00. With the settlement, Kelly was able to pay her medical bills, get expert assistance with her activities of daily living a

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

nd put money in the bank.

CAN YOU HANDLE YOUR CASE WITHOUT A LAWYER?

I was recently contacted by Betty, an insurance claims 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

juster, about a car crash she was involved in. She decided to try to represent herself. Her familiarity with insurance claims m

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

Combination pro

ade this appealing. I told her that I would be happy to answer her questions, but that I preferred that she actually retain my

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

services. Betty was reluctant since she was worried that my percentage of the settlement would leave her with less money than

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

if she handled the case herself.

About two months later Betty contacted me again crying and frantic. The combined stress of he

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

injury and dealing one on one with the insurance company left her psychologically scarred and physically drained. She began t

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

o relax and heal immediately upon retaining my services. By letting go of the control of her case she was also able to let go o

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

f pressures that were blocking her healing process. Betty was content during the entire course of her case about her decision t

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

Following aspects would a

o retain my services. Even when I deducted my share from the settlement money, she expressed only thanks.

YOU NEED A LAWYER YO

dd to the challenges in developing combination products:

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

CAN TRUST.

What Betty and many others have a hard time appreciating is that even the attorney takes her fee, your share of th

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

e settlement generally is much higher than if you represented yourself. If your lawyer settles your case for $250,000 and take

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

s a third, you’ll still be much better off than if you settled your own case for $100,000. Relieved of the stress of represent

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

ing yourself, you will be able to relax and focus on healing your body and your mind from your traumatic injuries.

Frank e-mai

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

Professional from academic institutions, pharmaceutical industries, health care indust

ed me a while back and asked me to take his eye injury case. Frank was new to the Philadelphia area and didn’t know where to f

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

ind the right lawyer. He was confused and frightened. He considered ads in the Yellow Pages, but this just left him more trou

.

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

bled. Finally, he found the Eye and Brain Injury Legal Information Center. He e-mailed some questions about his case. He als

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

Companies that provide selfless information through particip

o expressed his concern that he didn’t any lawyers and asked why he should trust any particular with his important legal rights

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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