Answers - Insurance

For over 30 years I have been representing injured workers for work place accidents in Virginia workers compensation pro

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

ceedings and there are some basic errors that injured workers make time and time again which result in denied claims. I

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

Examples of combination products may in

is particularly sad to see claimants lose good claims as a result of simple mistakes.

First, it is common for injured

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

workers to ignore a serious injury for a day or even for a couple of days. This can be a serious mistake because the wo

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

kers compensation insurance company will often deny a claim that is not promptly reported to an employer. Thus, every t

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

Combination pro

pe of injury should be reported and in writing if possible.

Second, the injured worker will delay going to an doctor fo

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

r his/her injury. This can be a serious error because the longer you wait the harder it is for the doctor to establish

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

causal link between the accident and the injury.

Third, the insurance company will often want to take a recorded state

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

ent from the worker right after the injury. Giving this statement without legal advice can result in the loss of a legit

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

imate claim.

Fourth, the injured worked will not follow the guidelines set by the doctor. This can be a serious error.

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

For example, if the doctor specifies certain lifting restrictions and these are violated by the injured worker it can re

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

Following aspects would a

ult in loss of benefits.

Fifth, the injured worker will be asked to take a drug test often right after the injury. A fa

dd to the challenges in developing combination products:

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

ilure of this drug test can result in termination of employment and loss of compensation. Often, injured workers do not

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

now that marijuana can still in one system for weeks after smoking resulting in a postive drug test.

Sixth, the injured

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

worker who has a serious injury fails to consult an experienced workers compensation lawyer. Not every attorney knows wo

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

rkers comp law, shop carefully. If the attorney is listed "AV" by Martindale-Hubbell, you can can feel confident you ha

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

Professional from academic institutions, pharmaceutical industries, health care indust

e an attorney who has been rated the best in his field.

IN SUMMARY, avoiding these simple mistakes will greatly enhance

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

your chance of winning your claim.

This may be considered AN ADVERTISEMENT or Advertising Material under the Rules of P

.

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

rofessional Conduct governing lawyers in Virginia. This note is designed for general information only. The information p

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

Companies that provide selfless information through particip

esented at this site should not be construed to be formal legal advice nor the formation of a lawyer/client relationship

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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Answers - What To Do When You Suffer An Injury On The Job?

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