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For over 30 years I have been representing claimants before the Virginia Workers Compensation Commission. Often, I have been asked to review adverse decisions by the Commission for a possible appeal. More likely than no

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

t I have to decline representation. These are the reasons why:

The Claim for Benefits. When there is an injury at work, the claimant is required to file a Claim for Benefits with the Commission. The Commission wi

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

Examples of combination products may in

ll issue a 20 day Order to the insurance company requesting a response. If the claim is denied, it will be scheduled for a hearing before a hearing commissioner.

Evidence. The Commission issues an instruction re

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

uesting the claimant to file all of his/her evidence that supports the claim with the Commission. This usually means “all” medical evidence has to be filed with the Commission prior to the hearing.

Discovery. Ea

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

ch side is allowed under the Commission Rules to discover prior to the hearing everything that party wants to know about the other side’s case. This is usually done by written questions called “interrogatories” and by “

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

Combination pro

depositions.” A deposition is testimony under oath in front of a court reporter prior to the actual hearing about the case. The deposition allows either side to know exactly what a witness will be testifying to before t

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

ial.

Medical Evidence. Most of the time doctors do not go to the hearing. The Commission allows medical evidence to be filed by written reports. If there still is a question about the medical evidence, either p

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

arty can take a doctor’s deposition and file that deposition as the doctor’s evidence in the case. The main reason doctors do not go to the hearing is the expense.

Hearing. At the hearing no argument is allowed.

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

The hearing is just for the purpose of submitting evidence. As indicated above, the medical evidence is submitted by written reports. The claimant and his witnesses testify under oath and the insurance company will have

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

its witnesses testify under oath.

The Decision. The hearing commissioner will issue his/her decision in writing some time after the hearing based on the medical records and the testimony at the hearing.

Appe

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

al. If either side disagrees with the decision, there is a right of appeal to have the hearing commissioner’s decision reviewed by three (3) commissioners. But on the appeal, no “new” evidence is allowed. The appeal

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

Following aspects would a

only considers the evidence that was submitted to the hearing commissioner.

Standard for Review of Appeals. On appeal, there are some standards the Commission has adopted over the years. One critical standard is

dd to the challenges in developing combination products:

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

that the three (3) commissioners will almost never second-guess the hearing commissioner on credibility decisions. This is so because the hearing commissioner is the only one who actually hears “live testimony” and is ab

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

le to consider the “demeanor” of the witnesses. Another critical standard is that the claimant has the “burden of proof.” This means the claimant has to prove at least by a preponderance of the evidence (at least 51%) t

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

hat he/she should win. If the evidence is not there or incomplete, the claimant loses.

My Review. Thus, if the claimant comes to me with an adverse decision based on credibility, I have to tell the claimant I d

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

cline representation due to the above Standard of Review. Also, if the claimant loses because the evidence is incomplete, I also have to decline representation because evidence cannot be added to the case on appeal.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Representation. The biggest mistake claimants make is to do the hearing themselves without experienced representation hoping to correct any errors by an appeal. As Abraham Lincoln once said, he who represents himse

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

lf has a fool for an attorney. There is just no substitute for not obtaining representation when your claim has been denied and a hearing is necessary. This is my advice. After an insurance comany denies the claim, call

.

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

n experienced Workers Compensation Lawyer right away.

Copyright© 2006, Gerald G. Lutkenhaus. ALL RIGHTS RESERVED

This may be considered AN ADVERTISEMENT or Advertising Material under the Rules of Professional Conduct g

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

Companies that provide selfless information through particip

overning lawyers in Virginia. This note is designed for general information only. The information 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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