*1 HAHN, Appellant, Charles D. RICHTER, A. M.D.
Howard and The Upjohn Company, Appellees. Supreme Pennsylvania. Court of
Argued Oct. 1994. Decided March 1996. Reargument May 24, Denied Kahn, Norristown, Haines, Jeffrey S. Barton Cynwyd, Bala for C.D. Hahn. *2 Montrose,
Laurence M. Kelly, for amicus—Pa. Trial Law- yers Assoc. Kittredge, Richter,
Thomas M. Philadelphia, for H.A. M.D. Bauer, D. (Pro-Hac-Vice), Lane David W. Brоoks for Up- john Company. Madeira, Jr.,
Edward W. Philadelphia, for P.L.A.C. NIX, C.J., FLAHERTY, ZAPPALA, Before PAPADAKOS, CAPPY, MONTEMURO, CASTILLE and JJ. THE
OPINION OF COURT FLAHERTY1, Justice.
This is appeal by an allowance from an en banc decision of Superior Court which affirmed a judgment in entered favor of the appellee, Upjohn Company (Upjohn), in a negli- gence and strict action brought by apрellant, Charles D. Hahn. The factual background of the case follows.
From 1977 to appellant was treated for pain by back Dr. Howard A. Richter. Treatment included surgical several procedures (into and a number intrathecal spine) injec- tions of Depo-Medrol, a drug by Upjohn. manufactured A package insert accompanying Depo-Medrol provided warning physicians arachnoiditis, that a scarring nerves in the back, lower reported had been when the drug was adminis- Also, tered intrathecally. injection intrathecal was not one of the Federal Drug Administration approved usages for the drug.
Appellant developed In arachnoiditis. an effort to remove scar condition, tissues associated with that further surgery but, was performed, thereof, in the course a nerve root was severed resulting serious and permanent injury. reassigned This case was to this writer. A Upjohn. was Dr. Richter and
In suit filed exchange Richtеr was later executed in release in favor Dr. against Upjohn the claim for valuable consideration. prove that his Appellant attempted to trial. proceeded by Depo-Medrol Upjohn that arachnoiditis was caused regarding adequate warnings physicians to provide failed drug. Extensive evidence was adduced intrathecal use by adequacy as to causation and as to parties both package jury insert. returned warnings provided by judgment entered Upjohn, a verdict favor of was accordingly. the trial court erred its instruction
At issue whether liability. An instruc- regarding theories of jury applicаble appellant’s tion could found if was be failure of injuries negligent Upjohn were caused *3 Depo-Medrol. provide adequate warnings regarding declined, however, liability, to instruct on strict reason- court warnings failure to ing provide that in cases where a sufficient has drugs alleged, negligence prescription relative to been recovery. for only recognized reaching the basis conclusion, placed on our in other reliance was decisions cases, prescription drug liability particularly applying those (Second) and the of Torts comments k of Restatement § 402A find no error and thus affirm. We k, “Unаvoidably products,” unsafe denies
Comment titled products of such as application prescription which, drugs, dangerous they in that not without although are risks, unreasonably are not deemed defective and medical warnings.2 with to what dangerous proper when marketed As provides: k Comment which, products present There are some in the state of human quite knowledge, incapable being are of made safe intended for their drugs. ordinary especially use. These are common in the field of and outstanding example is the the of An vaccine for Pasteur treatment rabies, uncommonly very damaging which not leads to serious and injected. invariably consequences disease when it is Since the itself death, marketing the to a both the and the use of leads dreadful fully notwithstanding high justified, the vaccine are unavoidable degree they product, properly pre- of risk which involve. Such a pared, by proper warning, аccompanied directions and is not proper warnings, j, constitutes comment titled “Directions or risks, warning,” provides that a seller must warn of not generally recognized, known and of which he has or reason- and, further, ably knowledge, should have that it can be warnings assumed that where are they will be read and heеded.3 defective, unreasonably dangerous. nor is it The same is of true vaccines, like, many drugs, many very other and the of which for this legally except physicians, reason cannot be sold or under the physician. particular many of a It is also true in of new which, experimental drugs or as to because of lаck of time and opportunity experience, for sufficient medical there can be no assur- safely, perhaps purity ingredients, ance of or even of but such experience justifies marketing as there is the drug and use of the notwithstanding medically recognizable risk. The seller of such products, again quаlification they with the properly prepared are marketed, proper given, warning where the situation calls it, for is not to be held to strict consequences for unfortunate use, attending merely their supply because he has undertaken to the public apparently product, with an useful and desirable attended with apparently a known but reasonable risk.
(Emphasis original). j provides: 3. Comment prevent product In order to being unreasonably danger- from ous, may required give the seller be warning, directions or on the container, may as to reasonably its use. The seller assume that those strawberries, allergies, example with common eggs as for or will them, be aware required and he is not to warn them. Where, however, ingredient contains an to which a population substantial number of allergic, ingredient are and the known, danger generally is one whose or if known is one which reasonably expect the cоnsumer would product, not to find in the it, required give warning against seller is knowledge, he has if reasonable, application developed foresight human skill and knowledge, should have presence ingredient and the danger. poisonous Likewise in the case drugs, unduly or those *4 of reasons, dangerous warning other may required. as to use be for required But a seller is not respect products, to warn with to or them, ingredients so, only dangerous, which potentially are or time, quantity, when consumed in long period excessive or over a of danger, potentiality danger, when the generally of is known and recognized. Again dangers beverages of alcoholic are an exam- ple, fats, containing as are also those of foods such substances as saturated may period which over a upon of time have a deleterious effect the human heart. warning given, may Where is reasonably the seller assume that it will heeded;
be rеad and bearing warning, and a such a which is followed, condition, safe for use if it is is not in defective nor is it unreasonably dangerous. 562 263, 286-88, 206, Pa. Incollingo
In
444
282 A.2d
Ewing,
(1971),
manufacturer of a prescription drug
219-20
where the
injury
to
alleged
by providing inadequate
have caused
was
dangers
with
warnings
physicians
about
associated
use
duty
the manufacturer’s
exercise
care
drug,
reasonable
adequate
proper warnings
recognized by
was
providing
Negligence,
alleged
not strict
was
liability,
this court.
j
recovery.
noted that
comments
and k
for
We
under
basis
287-88,
444 Pa. at
liability was not
to the case.
applicable
at
further
A.2d
219-20. We
stated:
282
§of
liability
applicable,
the strict
rule
402A is not
Since
§in
required
standard of care
is that set forth
388 of
dealing
supplier
with the
of a
of a
the Restatement
for
dangerous
chattel known
its intended use. Under
be
section, the
has a
to exercise reasonable
supplier
duty
supplied
for
use
care to
those
whose
the article
inform
it
likely
dangerous.
the facts which make
be
added).
9,
444
at 288 n.
A.2d at 220 n.
(emphasis
Pa.
282
8
239,
(1984),
In Baldino v.
505 Pa.
Castagna,
brought
drug
a
manufacturer on
basis of
Suit was
.the
inadequate product warnings. Reaffirming that the
allegedly
in such a case
the failure
exercise
basis
liability,
care rather
than strict
this court
reasonable
stated:
that,
Incollingo
assuming proper preparation
we held
warning,
strictly
a manufacturer of
drugs
liable
consequences attending
for unfortunate
the use
otherwise
products
useful and desirable
which are attended with a
Id.,
apparently
known but
reasonable risk.
at
Rather,
563
k
deny
application
liability.4
247,
strict
Id. at
Incollingo k, well as comments and make it clear that adequacy where the of warnings associated with issue, prescription drugs is at the failure of the manufacturer to exercise i.e., reasonable care to warn of dangers, manufacturer’s negligence, only is the recognized basis of liability. Co., Inc., Accord Mazur v. Merck 1348, & 964 F.2d (3d Cir.1992) 1353-55 (interpreting Incollingo and Baldino as making a prescription drug liability manufacturer’s for failure to warn negligence, rest on not denied, liability), cert. 974, 113 463, 121 506 (1992). U.S. S.Ct. L.Ed.2d 371 Hence, the trial court properly Upjohn instructed that could be found liable if appellant’s injuries by were caused a negli- gent failure to provide adequate product warnings. The court did not err declining give an instruction on strict liability. Superior properly Court affirmed.
Order affirmed. PAPADAKOS, J., MONTEMURO, J., who sitting was by designation, did not participate the decision of this case.
CAPPY, J., files а dissenting opinion joined which CASTILLE, J.
CAPPY, Justice, dissenting. Today 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 majority flawed, to be I respectfully must dissent.
In support of its holding, the majority relies primarily on
two casеs:
Incollingo
v.
444
Ewing,
Pa.
(1984).
questionable.
bоth
on these cases
Reliance
cases,
and not
negligence,
actions sounded
plaintiffs’
*6
285,
Not are the cases cited the only contrary adopts. to the it existing actually position case law is that, in support position of its the context of is more than a drugs, liability nоthing strict failure to warn § on theory, majority j the relies comment 402A. negligence on that of the which declares holding part It fixes its comment risks, not known generally that a must warn of seller knowledge, by applica- “if the recognized, seller] has or [the reasonable, developed foresight tion of human skill and should thе of the knowledge, presence ingredient have the Yet, 561, Majority (citing j). at n. 3 comment danger.” op. j, fails to utilizing portion majority this comment note reasoning.1 not previously adopted that this has this To Court steadfastly adopt any this contrary, Court has refused import into a strict negligence concepts thеories which would See, liability e.g., Corpo- of action. Kimco Development cause 8, 603, 1, ration v. D’s 536 Pa. 637 A.2d 606 Carpet, Michael (1993) (in claim, a failure to analyzing strict warn by only my knowledge, j 1. To comment has been cited this Court three occasion, j proposition cited for that times. On one comment was a wаrning danger, potentiality danger, required is "when the Inc., generally recognized.” Daisy-Heddon, v. known and Sherk 498 594, 597, 615, 617, (1982). 450 A.2d n. 2 On the other two Pa. n. occasions, following portion j was of comment cited: warning given may reasonably it Where is the seller assume that will heeded; bearing warning, and a which be read and such a is followed, safe not in condition nor is it for its use if is defective unreasonably dangerous. 811; Castagna, Incollingo, at Baldino 478 A.2d at at at 219. of these did the Court Pa. On none occasions requires adopt warning to be portion that of comment which a only presence of when seller knew or had reason to know of the dangеr. Court noted that it has been negligence “adamant con- action.”) cepts place have no in a stated, strict Simply the law in Pennsylvania always has negligence been that theory has place no and deserves no in resolving consideration issues of liability.
Apparently, that, majority has concluded at least with regard involving matters drugs, negligence principles are now necessary and I only warranted. Not do vigorously disagree that this divergence from our established case law is I necessary, but believe that this approach clearly unwar- extremely dangerous ranted and potential its to undermine which, precedent clear based public policy, well-ordered sets clear lines of responsibility for harm caused manufactured products. my It considered belief that negligence *7 of concepts comment have no place more where the defective product is a drug they than do where the defec- mower, automobile, tive is a lawn an any other product manufactured and society. sold within our I find to
What be the most of disturbing aspect majori- the ty’s opinion neglect is its analysis reveal its of policy the concerns important attendant to this issue. We have re- peatеdly stated that determining whether situation, apply should policy the relevant concerns See, must Richardscm-Merrell, be addressed. e.g., Coyle v. Inc., 208, 212, (1991). The majority utterly has and inexplicably failed to do this. The majority analyze does not the competing concerns of shielding pharmaceutical the industry and сompensating injured pa- tients and does not balance these concerns one anoth- er; rather, it favors one side of the equation absolutely while the other is unaccountably made to bear the cost. The majority’s failure to provide analysis an of these concerns is incomprehensible.
I can only speculate that in finding for the pharmaceutical company, majority the concluded that protecting pharma- ceutical company’s interests would diminish the society. cost to I believe that majority cannot take comfort the belief safeguarded it has society our frоm a pernicious expense cause logical. Erasing supposition
for such a for failure to warn does not erase the action in strict damages actions. defective associated with these cost future, caused, will cause in the are not drugs have majority’s to allow the eradicated rеfusal magically strictly liable for failure to warn. companies to be their drug Rather, majority expense has thrust defective products onto those whom these were prescription drugs essence, has majority’s holding to aid. creat- supposed I unpaid pigs. find this to be unconscio- guinea ed a class nable. reasons, I respectfully dissent. foregoing
For the J., CASTILLE, joins dissenting opinion. Pennsylvania, Appellee, COMMONWEALTH SMITH, Appellant. Sandra Supreme Pennsylvania. Court
Argued April *8 Decided March