Hahn v. Richter
| Decision Date | 24 May 1996 |
| Parties | , Prod.Liab.Rep. (CCH) P 14,566 Charles D. HAHN, Appellant, v. Howard A. RICHTER, M.D. and The Upjohn Company, Appellees. |
| Court | Pennsylvania Supreme Court |
Thomas M. Kittredge, Philadelphia, for H.A. Richter, M.D.
Lane D. Bauer, David W. Brooks (Pro-Hac-Vice), for Upjohn Company.
Edward W. Madeira, Jr., Philadelphia, for P.L.A.C.
Before NIX, C.J., and FLAHERTY, ZAPPALA, PAPADAKOS, CAPPY, CASTILLE and MONTEMURO, JJ.
FLAHERTY 1, 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 ().
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) (), 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.
Today the majority creates an exemption which removes all prescription drugs from the ambit of strict liability failure to warn. Because I find the reasoning employed by the majority to be flawed, I must respectfully dissent.
In support of its holding, the majority relies primarily on two cases: Incollingo v. Ewing, 444 Pa. 263, 282 A.2d 206 (1971) and Baldino v. Castagna, 505 Pa. 239, 244, 478 A.2d 807 (1984). Reliance on these cases is questionable. In both cases, the plaintiffs' actions sounded in negligence, and not strict liability. See Incollingo, 444 Pa. at 269 and 285, 282 A.2d at 211 and 218; Baldino, 505 Pa. at 242, 478 A.2d at 808. Therefore, this Court's employment of a negligence standard in these cases was not, as the majority seems to believe, tantamount to creating a holding that in cases concerning prescription drugs, negligent failure to warn and strict liability failure to warn are coextensive.
Not only are the cases cited by the majority inapposite, but existing case law is actually contrary to the position it adopts. In support of its position that, in the context of prescription drugs, strict liability failure to warn is nothing more than a negligence theory, the majority relies on comment j to § 402A. It fixes its holding on that part of the comment which declares that a seller must warn of risks, not generally known and recognized, "if [the seller] 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." Majority op. at 561, n. 3 (citing comment j). Yet, in utilizing this portion of comment j, the majority fails to note that this Court has not previously adopted this reasoning. 1 To the contrary, this Court has steadfastly refused to adopt any theories which would import negligence concepts into a strict liability cause of action. See, e.g., Kimco Development Corporation v. Michael D's Carpet, 536 Pa. 1, 8, 637 A.2d 603, 606 (1993) () Simply stated, the law in Pennsylvania has...
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