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The defendants have the burden of proving the existence of contributory negligence. Defendants must prove that plaintiff acted unreasonably under the circumstances and that her

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

conduct was a substantial factor in causing her injuries. Hanlon v. Sorenson, 289 Pa. Super. 268, 433 A.2d 60 (1981). It is not plaintiff’s burden to prove her freedom from any

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

Examples of combination products may in

such negligence.

Contributory negligence can be found as a matter of law only in clear cases. Arco v. Goodstein, 265 A.2d 783 (1970); Dolin v. J.J. Newberry Company, 466 A.2d

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

174 (Pa. Super. 1983). There can be “no room for fair and reasonable disagreement as to its existence.” Skalos v. Higgins, 449 A. 2d 601, 604 (Pa. Super. 1982.) Plaintiff is r

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

equired to use only the ordinary care that a prudent person would use under the circumstances. Peair v. Home Associations of Enola Legion #751, 430 A.2d 655 (Pa. Super. 1981).

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

Combination pro

Defendants often cite the Restatement (Second) of Torts § 343A in concluding that plaintiff was contributorily negligent for an accident. Section 343A protects possessors of l

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

and from liability from “known” or “obvious” dangers, “unless the possessor should anticipate the harm despite such knowledge or obviousness.”

To be “known”, the danger must “no

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

t only be known to exist, but … also be recognized that it is dangerous and the probability and gravity of the threat and harm must be appreciated.” Berman v. Radnor Rolls, Inc.

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

542 A.2d. 525, 531 (Pa. Super. 1988), citing, Carrender v. Fitterer, 469 A.2d. 120, 124 (Pa. 1983).

What constitutes an “obvious” danger is an issue of fact for the jury’s dete

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

rmination, requiring denial of a Motion for Summary Judgment. Brown v. Sears Robuck and Company, E.D. Pa; Hutton, J.; July 18, 1990; no. 89-3556; slip op. “A danger is deemed

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

to be ‘obvious’ when ‘both the condition and the risk are apparent to and would be recognized by a reasonable man, in the position of the visitor, exercising normal perception, i

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

Following aspects would a

ntelligence and judgment.” Id., citing Carrender, at 123 (emphasis added.) It is, therefore, crucial to consider the perception, intelligence and judgment of a plaintiff at the

dd to the challenges in developing combination products:

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

time of this accident in order to determine whether the danger presented by the sign frame was “obvious” to her.

In Berman, supra, the Superior Court ruled that the trial cour

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

t’s refusal to charge the jury on the issues of “known” or “obvious” dangers was proper. In Berman, the plaintiff was roller skating. After he was bumped by another skater, thi

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

s plaintiff lost his balance, skating through an opening in a railing onto a carpet area and down a six-inch drop off in the floor level. Ultimately he struck his head against a

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

cabinet or shelf which protruded beyond vending machines. The condition of the rink, the wide entrance, the six-inch drop off and the placement of the vending machines were a

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

Professional from academic institutions, pharmaceutical industries, health care indust

ll apparent. None of the conditions were concealed in any way. Nevertheless, the Court could not say that these conditions would be “known” or “obvious” to a reasonable person

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

in the position of the plaintiff. The court carefully considered that this skater lost and regained his balance while traveling at a good rate of speed. He did not have an adeq

.

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

uate opportunity under the circumstances to recognize the danger the six-inch step posed to him.

The Court in Berman concluded that while the skater was charged with the general

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

Companies that provide selfless information through particip

risks of skating, he was not charged with knowledge of how the risk to him was increased above that caused by normal skating by the physical lay out of the building. Id. at 536

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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