the time the incident in which she was injured occurred.
Presently before the Court is defendant's motion for summary judgment. Although defendant concedes that the Angiocath is capable of causing injury because a sharp instrument is an integral part thereof, defendant contends that the design of the Angiocath is not defective for that reason. Rather, defendant argues that a risk/utility analysis undertaken pursuant to Pennsylvania law demonstrates that the Angiocath is not unreasonably dangerous and, hence, that this Court should not, as a matter of social policy impose the costs of plaintiff's loss upon the manufacturer of the device.
Defendant further contends that the decision of the federal Food and Drug Administration, (FDA), after public hearings and due consideration, not to require a protective sheathing device on all needles preempts the regulation of needles by court decision as a matter of law, or, at least, should be followed as a matter of social policy in this case. Hence, defendant requests that the Court here grant judgment in its favor on plaintiff's strict liability claim.
I. FACTUAL BACKGROUND
The essential facts underlying plaintiff's claim are not in dispute. Plaintiff Lynda Riley received a Bachelor of Science and Nursing degree from York College in May, 1992, and was subsequently employed as an ICU staff nurse at Community Hospital of Lancaster, where initiating I.V. lines was a daily part of her duties. (Deposition of Lynda Riley, Exh. A to Becton Dickinson Vascular Access Inc.'s Motion for Summary Judgment, Doc. #10, at 11, 52).
On September 9, 1992, plaintiff was working in the hospital's intensive care unit when a patient unfamiliar to her was admitted on an emergency basis from the hospital's out-patient clinic. (Id. at 47). Although plaintiff had no information concerning the patient's medical history and condition, plaintiff was specifically instructed to observe "blood and body fluid precautions" and to initiate an I.V. (Id. at 50, 51). To do so, plaintiff obtained the necessary equipment including, inter alia., an Angiocath manufactured by defendant, the only type of I.V. catheter available to her.
Plaintiff initiated the I.V., removed the needle from the catheter, and was preparing to dispose of the needle when the patient's left arm moved, plaintiff reacted to his movement by moving her hand, and the needle penetrated her left palm. (Id. at 67--69).
Plaintiff was immediately given an HIV blood test to establish a baseline and subsequently tested negative for the virus twice. A third test administered on March 31, 1993, however, revealed that she had contracted HIV from the needle stick more than six months before. Plaintiff has been on available medication since May, 1993, and was transferred from patient care to another job in the hospital until she stopped working due to her illness.
II. STRICT LIABILITY CLAIMS
As recently noted in Phillips v. A.P. Green Refractories Co., 428 Pa. Super. 167, 630 A.2d 874 (Pa. Super. 1993), when presented with claims arising under § 402A of the RESTATEMENT (SECOND) OF TORTS, it is necessary for courts applying Pennsylvania law to determine, initially and as a matter of law, whether the product in question is "unreasonably dangerous." See, also, Mackowick v. Westinghouse Electric, 525 Pa. 52, 575 A.2d 100 (Pa. 1990); Azzarello v. Black Bros. Co., Inc., 480 Pa. 547, 391 A.2d 1020 (Pa. 1978); Dambacher by Dambacher v. Mallis, 336 Pa. Super. 22, 485 A.2d 408 (Pa. Super. 1984). Such determination is to be made by weighing the utility of the product against the likelihood and seriousness of the injury claimed and the availability of precautions which might have prevented the injury in order to reach the ultimate conclusion whether, as a matter of social policy, the risk of loss is appropriately placed upon the supplier of the product. Phillips.
The obligation of the trial court in a strict liability action to determine whether the risk of loss for injuries arising from an allegedly defective product should fall on the supplier, i.e., to determine whether the product is "unreasonably dangerous", was also discussed in detail by the Court of Appeals for the Third Circuit in Griggs v. Bic Corporation, 981 F.2d 1429 (1992). In Griggs, the court noted that such determination is to be made prior to permitting a jury to consider plaintiff's evidence of the specific defect alleged and whether such alleged defect was the proximate cause of injury, since a decision against the plaintiff on the threshold inquiry amounts to a judicial conclusion that the product is not defective as a matter of law.
In Nowak v. Faberge, 32 F.3d 755 (3rd Cir. 1994), the Court of Appeals further noted that, although a trial court is required to determine the initial social policy issue prior to permitting the jury to consider the defendant's liability to the plaintiff, the court's decision to send a strict liability case to the jury may qualify as an implicit determination on this matter. Defendant bears the burden of requesting that the trial court make an explicit ruling on this threshold issue if it seeks to have the matter determined at an earlier stage of the litigation.
Since, in Nowak, the Court of Appeals also stressed the value of an explicit ruling on this issue, defendant's pending motion for summary judgment, limited to the question whether the Angiocath is "unreasonably dangerous" as that term is defined by Pennsylvania law, is an appropriate means of seeking the Court's consideration of the question whether the risk of loss from plaintiff's injury should be placed upon defendant. See, also, Childers v. Joseph, 842 F.2d 689, 696, n. 7 (3rd Cir. 1988).
Plaintiff and defendant, and, indeed, the Court of Appeals, agree that Pennsylvania courts have approved weighing the unavoidable danger of a product against its utility in order to determine whether a product is "unreasonably dangerous." Id. at 697. Plaintiff also contends, however, that in addition to the risk/utility analysis, a more global "social policy" test should be applied whereby the Court determines whether imposing liability upon the defendant under the circumstances of a particular case would further the goals of strict product liability. Plaintiff appears to argue that under the broader social policy test, the Court can and should find a product unreasonably dangerous if the manufacturer can distribute the risk of loss from injuries to the public as a cost of doing business, since, in that event, permitting the plaintiff to proceed to a jury with the question whether the product is defective is an appropriate application of the law of strict liability.
We will first consider the danger inherent in the Angiocath under the unquestionably applicable risk/utility analysis to determine whether the product is unreasonably dangerous in light of its utility and the availability of similarly useful devices which might reduce or eliminate the risk to healthcare workers from exposed I.V. catheter needles. We will then consider plaintiff's argument that a broader and more general "social policy" test has been approved by the Pennsylvania courts as an adjunct or alternative to the risk/utility analysis. We will consider, as well, defendant's contention that the FDA's explicit decision not to require protective devices on needles and decision not to ban the use of needles lacking protective devices preempts plaintiff's claim or, at least, should compel the Court to conclude that the Angiocath is not unreasonably dangerous as a matter of law.
III. Risk/Utility Analysis Under Pennsylvania Law
The parties agree that the Pennsylvania courts have adopted a risk/utility test which requires consideration of the following factors in aid of the determination whether a product is unreasonably dangerous:
1. The usefulness and desirability of the product--its utility to the user and to the public as a whole.
2. The safety aspects of a product--the likelihood that it will cause injury, and the probable seriousness of the injury.