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Proximate cause must be shown in every personal injury claim. Proximate cause exist

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

s if a wrongful act was a substantial factor in bringing about the plaintiff's harm.

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

Examples of combination products may in

Dudley v. USX Corp., 606 A. 2d 916 (Pa. Super. 1992). Defendant's negligence need

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

ot have been the sole cause of the damage, only a substantial factor. Shippen Tp. v

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

Portage Tp., 575 A. 2d 157 (Pa. Cmwlth. 1990). Defendant will be liable in neglig

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

Combination pro

ence for the full amount of damages if defendant's negligence was a substantial fact

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 in producing the injury even though concurrent causes might have contributed to th

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

injury. Monzo v. Com. Dept. of Transportation, 556 A. 2d 493 (Pa. Cmwlth. 1989).

O

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

ce plaintiff produces facts which lead one to reasonably conclude that defendant's a

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

ctions were a substantial factor in bringing about the harm, the fact that some othe

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

cause concurs with the defendant's negligence in producing the injury does not reli

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

Following aspects would a

ve defendant from liability unless he can show that the other cause would have produ

dd to the challenges in developing combination products:

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

ed the injury independently of his negligence. City of Philadelphia v. Massantonio,

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

533 A. 2d 1127 (Pa. Cmwlth. 1987). Defendant's negligence is not a substantial fa

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

tor if the harm would have been sustained even if the defendant had not been neglige

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

t. Henry v. McCrudden, 575 A. 2d 66 (Pa. Cmwlth. 1990).

Probable cause does not ex

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

Professional from academic institutions, pharmaceutical industries, health care indust

st if it is "highly extraordinary" that the defendant's act brought about the harm.

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

White v. Rosenberry, 271 A. 2d 341, 343 (Pa. 1970); Bell v. Irace, 619 A.2d 365, 36

.

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

(Pa. Super. 1993). The cutoff for liability comes at "the point in the causal chai

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

Companies that provide selfless information through particip

when the consequence of the negligent act is no longer reasonably foreseeable". 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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