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One litigant typically seeks to impeach the credibility of the opposing litigation or his witnesses. Of

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

ten this impeachment is attempted with regard to matters that are not germane to the case.

Pennsylvania

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

Examples of combination products may in

Rule of Evidence 403 states: Although relevant, evidence may be excluded if its probative value is out

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

weighed by the danger of unfair prejudice, confusion of the issues, or misleading the jury, or by consid

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

erations of undue delay, waste of time, or needless presentation of cumulative evidence.

Witnesses can

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

Combination pro

be contradicted only on matters germane to issues being tried in the case. The General Equipment Manufa

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

ctures vs. Westfield Insurance Company, 635 A.2d 173 (Pa. Super. 1993). The test of materiality of a fa

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

ct brought out on cross examination is whether the party cross examining would be entitled to prove the

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

fact that part of his own case. Id.

Witnesses may not contradicted upon collateral matters. Commonweal

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

th v. Johnson, 638 A.2d 940 (Pa. 1994). A collateral matter is one, which has no relationship to the ma

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

tter on trial. Id. Credibility of witnesses may not be impeached on collateral matters and the grounds

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

Following aspects would a

for contradicting a witness must be germane to issues at trial. Walley v. Iraca, 520 A 2d. 886 (Pa. Su

dd to the challenges in developing combination products:

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

per. 1987).

No witness can be contradicted on everything he testified to in order to test credibility.

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

McGoldrick v. The Pennsylvania Railroad Company, 241 A.2d 90(Pa. 1968). The witness my not be contradic

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

ted on collateral matters. Id. Pivitol trial issues cannot be sidetracked for determination of wheth

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 a witness lied in making a statement about something which has no relationship to the case on trial.

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

Professional from academic institutions, pharmaceutical industries, health care indust

Id.

Contradicting evidence is collateral for purposes of the rule that a witness may not be contradict

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

ed on collateral matters, if it may not be admitted at trial for any purpose independent of the contradi

.

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

ction. Id. If the contradiction concerns a matter which is collateral because it is unreasonably prej

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

Companies that provide selfless information through particip

udicial to one of the parties, a trial court abuses its discretion by admitting that contradiction. Id.

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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