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December 27, 1995

LYNDA RILEY, R.N., Plaintiff

The opinion of the court was delivered by: TROUTMAN

 The above-captioned action arises from a tragic accident in which the plaintiff, a twenty-three year old nurse, contracted the HIV virus as a result of being stuck with an I.V. catheter needle after initiating an I.V. in a patient in the Intensive Care Unit of Community Hospital of Lancaster where she was employed. *fn1"

 Plaintiff asserts that defendant, Becton Dickinson Vascular Access, Inc., is strictly liable for her injury in that the I.V. catheter, an Angiocath manufactured by defendant and used by plaintiff to initiate the I.V., is unsafe for its intended use because the needle, contaminated by the patient's blood, remains exposed after it is withdrawn from the catheter, thus permitting a needle-stick accident to occur. Plaintiff contends that such design is defective and that an available and feasible alternative design of the catheter, in which the needle is retracted into a plastic sheath as it is withdrawn, would have prevented her accident and consequent injury if she had been using such alternative device at the time the incident in which she was injured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. *fn2" 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.


 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.


 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.

 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.
3. The availability of a substitute product which would meet the same need and not be as unsafe.
4. The manufacturer's ability to eliminate the unsafe character of the product without impairing its usefulness or making it too expensive to maintain its utility.
5. The user's ability to avoid danger by the exercise of care in the use of the product.
6. The user's anticipated awareness of the dangers inherent in the product and their avoidability, because of general public knowledge of the obvious condition of the product, or of the existence of suitable warnings or instructions.
7. The feasibility, on the part of the manufacturer, of spreading the loss of setting the price of the product or carrying liability insurance.

 Fitzpatrick v. Madonna, 424 Pa. Super. 473, 623 A.2d 322 (Pa. Super. 1993); Dambacher, 485 A.2d at 423, n. 5.

 In Barker v. Deere & Co., 60 F.3d 158, 166 (3rd Cir. 1995), the Court of Appeals cited a somewhat simpler formulation of the appropriate risk/utility analysis, likewise found in Fitzpatrick and Dambacher, as the definitive statement of the law of Pennsylvania on this matter:

Furthermore, the court in Fitzpatrick observed that factors to be considered when undertaking this analysis include: "[1] the gravity of the danger posed by the challenged design; [2] the likelihood that such danger would occur; [3] the mechanical feasibility of a safer design; [4] the financial cost of a safer design; and [5] the adverse consequences to the product that would result from a safer design.

 (Citations omitted). Since the expanded list of factors cited by both parties to this action provides no more than a detailed parsing of the same considerations cited in Barker, we will first consider the issue in terms of the more expansive list of risk/utility factors.

 Although the parties agree on the applicable legal standards, they obviously disagree as to the outcome when such standards are properly applied in this action. Upon review of the parties' respective arguments, it appears that their differing conclusions are based upon the different emphasis placed by each party on the various factors.

 Plaintiff focuses almost exclusively upon the devastating potential effects of a needle stick accident which, as here, can lead to the transmission of a serious, even deadly, blood-borne disease, as well as upon the ready availability of an alternative design, already on the market, which plaintiff contends is feasible and eliminates the danger inherent in the design of the Angiocath.

 Defendant, on the other hand, argues that although each needle stick accident involving HIV exposure is potentially very serious, there are very few accidents given the widespread use of the product. Defendant also contends that the alternative product touted by plaintiff does not meet the same equipment needs as the Angiocath and does not eliminate the potentially serious risk of needle sticks or other blood exposure. Defendant also notes that because the equipment available to medical personnel in a hospital is selected by hospital staff members, the manufacturer of such equipment should not, as a matter of law, be held liable to a person injured by the equipment selected for a particular task. Thus, defendant argues that it is not appropriate to place the risk of loss in this case upon the manufacturer of the product, since such a course would require that the cost of plaintiff's injury be borne by all users of the Angiocath, despite the fact that it may be the best product to use in many situations, and despite the fact that plaintiff's use of the Angiocath resulted entirely from the decision of her employer not to make an alternative product available to her. In essence, defendant argues that the utility of the Angiocath far outweighs its actuarially small, albeit grave risks, and asks whether, as a matter of social policy, the manufacturer should bear the high costs resulting from the relatively rare risks inherent in the product.

 It is difficult, but absolutely essential, for the Court to be completely dispassionate in weighing the risks and benefits of the Angiocath in order to make the required social policy determination concerning the allocation of the risk of loss resulting from an accident such as that here involved. The social policy issue before the Court is not whether plaintiff deserves compensation for a terrible accident, but whether the manufacturer of the device through which she was injured is appropriately subject to liability for the accident, and, therefore, can be required to provide such compensation.

 We also note that defendant bears the burden of proof on the threshold determination of allocation of risk. Monahan v. The Toro Company, 856 F. Supp. 955 (E.D. Pa. 1994), and that all of the evidence on the threshold issue must be viewed in the ...

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