Actual - Legal

You have had an accident at work. The Employer immediately sends you for a urine test. The urine test registers positive for a drug

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

such as cocaine or marijuana. Does flunking this test mean you “lose” your claim for any compensation?

First, the Employer may wel

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

Examples of combination products may in

l try to deny your claim based on the failed urine test. The Employer will probably back this denial by hiring a physician who will

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

claim the drug found in your urine caused or contributed to your accident.

Second, if the accident occurred as a result of a fall fr

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

om a height, it may be easy for the Employer to suggest the illegal drug caused a loss of balance or dizziness (that contributed to t

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

Combination pro

e fall from the ladder, scaffold, or roof). Even if it is not the sole factor causing the fall, the worker still may lose his/her cla

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

im if the illegal drug is merely contributes to the fall.

Third, an illegal drug can remain in one’s system for a long time. This i

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

true even if has been days or even weeks since the drug was used. The unfortunate fact is that the residual drug in one’s system cou

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

ld result in a failed urine test.

Fourth, many Employers also have a policy stating a failed urine test will mean a termination for

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

isconduct. Thus, even if the accident does not result in disability, it could result in termination of employment for misconduct. I

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

t does not matter the illegal drug was never used in the work place.

Fifth, the best course of conduct for Workers is never to use

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

Following aspects would a

illegal drugs; therefore, one would never fail a urine test.

Sixth, but if a failed urine test does occur after an accident, the Inj

dd to the challenges in developing combination products:

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

red Worker, must realize he/she is in big trouble. He/she must immediately talk to an experienced Workers’ Compensation Attorney.

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

He/she must not give a recorded statement to the Insurance Company. The Attorney may be able to have your urine test examined by ano

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

her doctor. Hopefully, the doctor can dispute the Employer’s or Insurer’s doctor giving the Injured Worker a chance at winning his/h

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

er claim.

In summary, a failed urine test is no laughing matter and can result in a denied accident claim. The best policy is to re

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

Professional from academic institutions, pharmaceutical industries, health care indust

rain from the use of illegal drugs. However, if a failed urine test does occur, then all is not lost if the Injured Worker seeks hel

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

.

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

rial under the Rules of Professional Conduct governing lawyers in Virginia. This note is designed for general information only. The i

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

Companies that provide selfless information through particip

nformation presented in this note 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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