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There are certain legal standards that apply when one litigation requests that the court permit a jur

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

y to visit an accident scene. A jury viewing is seldom necessary and, if it is warranted, a jury can

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

Examples of combination products may in

be bussed to the locale. Johns v. First Union, 777 A.2d 489 (Pa. Super. 2001). The paucity of recen

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

t case law is evidence of the rarity with which a jury view is ordered.

If there are many photograph

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

of the accident scene and the visits to the scene by the expert witnesses, several lay witnesses hav

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

Combination pro

also been to the accident scene and can testify about the conditions, the jury will be able to weigh

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

this evidence and make proper findings of fact without visiting the scene itself. Although photogra

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

hs are never as revealing as the reality they depict, juries are called upon to rely on photographic

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

evidence in virtually every trial. There is no reason why the jury will not be able to do so.

Any j

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

ry view would have to take place in the month of the accident to simulate the conditions. The jury vi

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

w would have to take place on a day with weather conditions similar to those present at the time of t

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

Following aspects would a

he accident. Since it will be impossible to produce the same amount of ambient light during a jury v

dd to the challenges in developing combination products:

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

ew, such a view will necessarily confuse the jury. T

In exercising its discretion, the court may c

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

onsider the potential benefit of the view to the jury in its deliberations, as weighed against the di

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

ficulty and expense of arranging for the view and the evidence already adduced at trial. Higgins, su

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

ra. Regardless of the venue of the trial, it is extremely unlikely that the court would trouble the

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

Professional from academic institutions, pharmaceutical industries, health care indust

jury to travel to the accident site to view what is already shown in the photographs and described in

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

detail by the expert and lay witnesses. Given the time commitment and unnecessary expenses necessita

.

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

ted by bussing the jurors, counsel and the trial judge to the accident location, and the danger of co

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

Companies that provide selfless information through particip

fusing the jury, defendant’s request for a jury view of the accident site should ordinarily be denied

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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