Hahn v. Richter , 543 Pa. 558 ( 1996 )

OPINION OF THE COURT

FLAHERTY¹, Justice.

This is an appeal by allowance from an en banc decision of the Superior Court which affirmed a judgment entered in favor of the appellee, Upjohn Company (Upjohn), in a negligence and strict liability action brought by the appellant, Charles D. Hahn. The factual background of the case is as follows.

From 1977 to 1980, appellant was treated for back pain by Dr. Howard A. Richter. Treatment included several surgical procedures and a number of intrathecal (into the spine) injections of Depo-Medrol, a drug manufactured by Upjohn. A package insert accompanying Depo-Medrol provided warning to physicians that arachnoiditis, a scarring of nerves in the lower back, had been reported when the drug was administered intrathecally. Also, intrathecal injection was not one of the Federal Drug Administration approved usages for the drug.

Appellant developed arachnoiditis. In an effort to remove scar tissues associated with that condition, further surgery was performed, but, in the course thereof, a nerve root was severed resulting in serious and permanent injury.

In 1982, suit was filed against Dr. Richter and Upjohn. A release in favor of Dr. Richter was later executed in exchange for valuable consideration. In 1989, the claim against Upjohn proceeded to trial. Appellant attempted to prove that his arachnoiditis was caused by Depo-Medrol and that Upjohn failed to provide adequate warnings to physicians regarding intrathecal use of the drug. Extensive evidence was adduced by both parties as to causation and as to the adequacy of warnings provided by the package insert. The jury returned a verdict in favor of Upjohn, and judgment was entered accordingly.

At issue is whether the trial court erred in its instruction to the jury regarding applicable theories of liability. An instruction was given that liability could be found if appellant’s injuries were caused by a negligent failure of Upjohn to provide adequate warnings regarding Depo-Medrol. The court declined, however, to instruct on strict liability, reasoning that in cases where a failure to provide sufficient warnings relative to prescription drugs has been alleged, negligence is the only recognized basis for recovery. In reaching this conclusion, reliance was placed on our decisions in other prescription drug liability cases, particularly those applying comments j and k of the Restatement (Second) of Torts § 402A We find no error and thus affirm.

Comment k, titled “Unavoidably unsafe products,” denies application of strict liability to products such as prescription drugs, which, although dangerous in that they are not without medical risks, are not deemed defective and unreasonably dangerous when marketed with proper warnings.² As to what constitutes proper warnings, comment j, titled “Directions or warning,” provides that a seller must warn of risks, not generally known and recognized, of which he has or reasonably should have knowledge, and, further, that it can be assumed that where warnings are given they will be read and heeded.³

In Incollingo v. Ewing, 444 Pa. 263, 286-88, 282 A.2d 206, 219-20 (1971), where the manufacturer of a prescription drug was alleged to have caused injury by providing inadequate warnings to physicians about dangers associated with use of the drug, the manufacturer’s duty to exercise reasonable care in providing adequate and proper warnings was recognized by this court. Negligence, not strict liability, was alleged as the basis for recovery. We noted that under comments j and k strict liability was not applicable to the case. 444 Pa. at 287-88, 282 A.2d at 219-20. We further stated:

Since the strict liability rule of § 402A is not applicable, the standard of care required is that set forth in § 388 of the Restatement dealing with the liability of a supplier of a chattel known to be dangerous for its intended use. Under this section, the supplier has a duty to exercise reasonable care to inform those for whose use the article is supplied of the facts which make it likely to be dangerous.

444 Pa. at 288 n. 9, 282 A.2d at 220 n. 8 (emphasis added).

In Baldino v. Castagna, 505 Pa. 239, 478 A.2d 807 (1984), Suit was brought against a drug manufacturer on .the basis of allegedly inadequate product warnings. Reaffirming that the basis of liability in such a case is the failure to exercise reasonable care rather than strict liability, this court stated:

In Incollingo we held that, assuming proper preparation and warning, a manufacturer of drugs is not strictly liable for unfortunate consequences attending the use of otherwise useful and desirable products which are attended with a known but apparently reasonable risk. Id., 444 Pa. at 288, 282 A.2d at 221. Rather, such a manufacturer is liable only if he fails to exercise reasonable care to inform those for whose use the article is supplied of the facts which make it likely to be dangerous. Id., 444 Pa. at 288 n. 8, 282 A.2d at 220 n. 8 (citing Section 388 of the Restatement (Second) of Torts).

505 Pa. at 244, 478 A.2d at 810 (emphasis added). Reliance was again placed on the principles set forth in comments j and k to deny application of strict liability.⁴ Id. at 247, 478 A.2d at 811-12.

Incollingo and Baldino, as well as comments j and k, make it clear that where the adequacy of warnings associated with prescription drugs is at issue, the failure of the manufacturer to exercise reasonable care to warn of dangers, i.e., the manufacturer’s negligence, is the only recognized basis of liability. Accord Mazur v. Merck & Co., Inc., 964 F.2d 1348, 1353-55 (3d Cir.1992) (interpreting Incollingo and Baldino as making a prescription drug manufacturer’s liability for failure to warn rest on negligence, not strict liability), cert. denied, 506 U.S. 974, 113 S.Ct. 463, 121 L.Ed.2d 371 (1992).

Hence, the trial court properly instructed that Upjohn could be found liable if appellant’s injuries were caused by a negligent failure to provide adequate product warnings. The court did not err in declining to give an instruction on strict liability. The Superior Court properly affirmed.

Order affirmed.

PAPADAKOS, J., and MONTEMURO, J., who was sitting by designation, did not participate in the decision of this case. CAPPY, J., files a dissenting opinion which is joined by CASTILLE, J.

1 . This case was reassigned to this writer.

2 . Comment k provides:

There are some products which, in the present state of human knowledge, are quite incapable of being made safe for their intended and ordinary use. These are especially common in the field of drugs. An outstanding example is the vaccine for the Pasteur treatment of rabies, which not uncommonly leads to very serious and damaging consequences when it is injected. Since the disease itself invariably leads to a dreadful death, both the marketing and the use of the vaccine are fully justified, notwithstanding the unavoidable high degree of risk which they involve. Such a product, properly prepared, and accompanied by proper directions and warning, is not defective, nor is it unreasonably dangerous. The same is true of many other drugs, vaccines, and the like, many of which for this very reason cannot legally be sold except to physicians, or under the prescription of a physician. It is also true in particular of many new or experimental drugs as to which, because of lack of time and opportunity for sufficient medical experience, there can be no assurance of safely, or perhaps even of purity of ingredients, but such experience as there is justifies the marketing and use of the drug notwithstanding a medically recognizable risk. The seller of such products, again with the qualification that they are properly prepared and marketed, and proper warning is given, where the situation calls for it, is not to be held to strict liability for unfortunate consequences attending their use, merely because he has undertaken to supply the public with an apparently useful and desirable product, attended with a known but apparently reasonable risk.

(Emphasis in original).

3 . Comment j provides:

In order to prevent the product from being unreasonably dangerous, the seller may be required to give directions or warning, on the container, as to its use. The seller may reasonably assume that those with common allergies, as for example to eggs or strawberries, will be aware of them, and he is not required to warn against them. Where, however, the product contains an ingredient to which a substantial number of the population are allergic, and the ingredient is one whose danger is not generally known, or if known is one which the consumer would reasonably not expect to find in the product, the seller is required to give warning against it, if he has knowledge, or by the application of reasonable, developed human skill and foresight should have knowledge, of the presence of the ingredient and the danger. Likewise in the case of poisonous drugs, or those unduly dangerous for other reasons, warning as to use may be required.

But a seller is not required to warn with respect to products, or ingredients in them, which are only dangerous, or potentially so, when consumed in excessive quantity, or over a long period of time, when the danger, or potentiality of danger, is generally known and recognized. Again the dangers of alcoholic beverages are an example, as are also those of foods containing such substances as saturated fats, which may over a period of time have a deleterious effect upon the human heart.

Where warning is given, the seller may reasonably assume that it will be read and heeded; and a product bearing such a warning, which is safe for use if it is followed, is not in defective condition, nor is it unreasonably dangerous.

(Emphasis added).

4 . Compare Coyle v. Richardson-Merrell, Inc., 526 Pa. 208, 212-16, 584 A.2d 1383, 1385-87 (1991) (applying comment k to exclude strict liability for pharmacists who sell prescription drugs with inadequate warnings); Cafazzo v. Central Medical Health Services, Inc., 542 Pa. 526, 536, 668 A.2d 521, 526 (1995) (noting exemption from strict liability for prescription drugs under comment k).