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S. Shanks v. The Upjohn Co. (6/26/92), 835 P 2d 1189
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Notice: This is subject to formal
correction before publication in the Pacific
Reporter. Readers are requested to bring
typographical or other formal errors to the
attention of the Clerk of the Appellate
Courts, 303 K Street, Anchorage, Alaska
99501, in order that corrections may be made
prior to permanent publication.
THE SUPREME COURT OF THE STATE OF ALASKA
SHARON L. SHANKS, Personal )
Representative of the Estate ) Supreme Court File Nos.
of Harvey Hale Rice, ) S-3729/S-3760
) Superior Court File No.
Appellant/ ) 1PE-86-101 Civil
Cross-Appellee, )
v. ) O P I N I O N
)
THE UPJOHN COMPANY, )
Appellee/ )
Cross-Appellant. ) [No. 3850 - June 26, 1992]
______________________________)
Appeal from the Superior Court of the
State of Alaska, First Judicial District,
Petersburg, Thomas M. Jahnke, Judge.
Appearances: James M. Powell, Hughes,
Thorsness, Gantz, Powell & Brundin,
Anchorage, and Joseph S. Slusser, Hughes,
Thorsness, Gantz, Powell & Brundin,
Fairbanks, for Appellant/Cross-Appellee.
Theodore M. Pease, Jr., Burr, Pease & Kurtz,
Anchorage, Richard L. Josephson, Baker &
Botts, Houston, Texas, and Earl B. Austin,
Baker & Botts, Dallas, Texas, for
Appellee/Cross-Appellant.
Before: Rabinowitz, Chief Justice,
Burke, Matthews, Compton and Moore, Justices.
MOORE, Justice.
Shanks represents the estate of a decedent who
committed suicide shortly after he began taking a prescription
drug manufactured by The Upjohn Company. Shanks sued Upjohn
under negligence, negligence per se, strict liability design
defect, strict liability failure to warn, and breach of warranty
theories. On Upjohn's motions for partial summary judgment, the
superior court dismissed all but Shanks' strict liability failure
to warn claim. At trial, the superior court instructed the jury
on negligence principles alone. After a jury verdict for Upjohn
and an award of costs and attorney's fees against the estate,
Shanks' personal representative appeals. We vacate the award of
attorney's fees and reverse and remand for a new trial on the
issues of strict liability design defect and failure to warn.
I. Introduction
On August 29, 1984, Harvey Rice, complaining of back
pain, made a visit to his physician, Dr. Richard K. Dobyns. Dr.
Dobyns prescribed two drugs, Xanax1 and Tylenol #3,2 and advised
Mr. Rice to return in two days for a follow-up examination. The
doctor warned Mr. Rice, a pilot, that the drugs would cause
sedation and that he should not fly, drive or operate machinery.3
The following evening, after taking the medication, Mr. Rice shot
himself in the head following an argument with his wife. He died
in the hospital a few hours later. Tests performed on Mr. Rice
at the hospital indicated the presence in his system of Xanax,
Tylenol, and codeine as well as another CNS depressant,
meprobromate.
Sharon L. Shanks, as personal representative of Mr.
Rice's estate, sued the Upjohn Company, the manufacturer of
Xanax.4 In her second amended complaint, the operative pleading
at the time of trial, Shanks alleged that Mr. Rice's taking of
Xanax was the proximate cause of his death. Shanks asserted
claims against Upjohn under several theories, including strict
products liability, breach of warranty, and negligence. In her
strict liability claim, Shanks alleged that Xanax was defective
both in its design and in its failure to include adequate
warnings. Shanks also alleged that Upjohn was "both strictly
liable per se and negligent per se"based on a failure to warn in
violation of AS 17.20.290(1) of the Alaska Food, Drug and
Cosmetic Act. The complaint sought damages for wrongful death
and for the decedent's pain and suffering, as well as punitive
damages.
Upjohn filed separate motions for partial summary
judgment as to all of Shanks' claims. The superior court granted
Upjohn's motions dismissing the design defect, warranty,
negligent failure to warn and the negligence per se claims. Thus
the strict liability failure to warn claim was the only claim
remaining at the time of trial.
During trial, the parties introduced conflicting
evidence on the issue of whether Xanax posed a risk of causing
suicidal ideation and hostile behavior. Shanks introduced
evidence that Upjohn knew of numerous episodes of patients who
had exhibited suicidal tendencies or who had committed suicide
while undergoing treatment with Xanax, both before and after Mr.
Rice's suicide. Upjohn offered expert testimony that Xanax does
not cause suicidal ideation and behavior. The parties also
introduced conflicting evidence regarding the adequacy of the
warnings on the Xanax package insert.
Both parties submitted proposed jury instructions to
the superior court. Among those proposed by Shanks were separate
instructions on negligence, strict products liability and
negligence per se. The superior court, over the objections of
Shanks' counsel, refused to instruct the jury on strict liability
design defect and negligence per se. The superior court also
rejected Shanks' proposed instructions Nos. 8 and 9 on strict
liability failure to warn. Instead, purporting to instruct on
the strict liability failure to warn theory, the superior court
instructed the jury on negligence principles alone.
The jury returned a verdict for Upjohn. By special
verdict, the jury found that Upjohn was not negligent in failing
to adequately warn and direct Mr. Rice's physician regarding the
effects of Xanax. Based on the verdict, the superior court
entered judgment for Upjohn. In its final judgment, the superior
court assessed costs and attorney's fees against the estate,
refusing to assess them against Mr. Rice's widow and three minor
children, as requested by Upjohn. The superior court ordered the
estate to pay Upjohn $225,000.00 in attorney's fees. Shanks'
motion for J.N.O.V. or in the alternative for new trial, in which
she alleged misconduct by Upjohn's counsel, was denied.
Shanks appeals, challenging the grant of summary
judgment and the denial of her motion for new trial. Upjohn
cross-appeals, challenging the superior court's refusal to assess
costs and fees against the statutory beneficiaries of the estate.
The issues on appeal are: 1) whether the superior court erred in
its conclusion that prescription drugs are exempt from strict
products liability claims alleging a design defect; 2) whether
the superior court erred in its jury instructions on Shanks'
strict liability failure to warn claim by introducing negligence
concepts; 3) whether the superior court committed reversible
error in dismissing Shanks' negligence per se claims based on the
Alaska Food, Drug and Cosmetic Act; and 4) whether the superior
court erred in denying Shanks' motion for a new trial based on
allegations of attorney misconduct.
II. Strict Products Liability
A. Design Defect
Shanks' first assignment of error is that the superior
court improperly dismissed her strict liability design defect
claim on Upjohn's motion for partial summary judgment. Upjohn
urges us to adopt a rule of law which would exempt manufacturers
of prescription drugs from such claims. Specifically, Upjohn
argues that we should adopt the approach of the California
Supreme Court in Brown v. Superior Court, 751 P.2d 470 (Cal.
1988). We decline to do so.
A party is entitled to summary judgment if there is no
genuine issue as to any material fact and the moving party is
entitled to judgment as a matter of law. Alaska R. Civ. P.
56(c). Where, as here, an appeal raises questions of law and
policy, this court is not bound by a trial court's resolution of
questions of law, but instead is required to adopt the rule of
law which is most persuasive in light of precedent, reason and
policy. CTA Architects v. Active Erectors, 781 P.2d 1364, 1365
(Alaska 1989).
It is well established that "[a] manufacturer is
strictly liable in tort when an article he places on the market,
knowing that it is to be used without inspection for defects,
proves to have a defect that causes injury to a human being."
Clary v. Fifth Ave. Chrysler Center, 454 P.2d 244, 247 (Alaska
1969) (quoting Greenman v. Yuba Power Products, Inc., 377 P.2d
897, 900 (Cal. 1962)). A product may be defective because of a
manufacturing defect, a defective design, or a failure to contain
adequate warnings. Caterpillar Tractor Co. v. Beck, 593 P.2d
871, 878 n.15 (Alaska 1979).
In Beck, we adopted the two-prong defective design test
set forth by the California Supreme Court in Barker v. Lull Eng'g
Co., 573 P.2d 443, 457-58 (Cal. 1978). Beck, 593 P.2d at 886.
There we held that the trial court may instruct the jury that a
product is defectively designed if:
(1) the plaintiff proves that the
product failed to perform as safely as an
ordinary consumer would expect when used in
an intended or reasonably foreseeable manner,
or (2) the plaintiff proves that the
product's design proximately caused injury
and the defendant fails to prove, in light of
the relevant factors, that on balance the
benefits of the challenged design outweigh
the risk of danger inherent in such design.
Id. (quoting Barker, 573 P.2d at 452).
In dismissing Shanks' design defect claim, the superior
court relied on the California Supreme Court's opinion in Brown
v. Superior Court, 751 P.2d 470 (Cal. 1988). Specifically, the
superior court relied on that portion of the Brown opinion in
which the California Supreme Court held that the liability of
prescription drug manufacturers for design defects should not be
measured by the Barker design defect test. Brown, 751 P.2d at
477-80. Reasoning that consumers of prescription drugs lack any
expectations about the performance safety of the drugs other than
those related by the physician, the Brown court stated that "the
_consumer expectation_ aspect of the [Barker] test is
inappropriate to prescription drugs." Id. at 477. While it saw
no difficulty with the applicability of the "risk/benefit"prong
to prescription drugs, it concluded that to apply the second
prong to prescription drugs was violative of the public interest.
Id. at 478-80. In reaching this conclusion, the court cited
several rationales, including the unique and important nature of
prescription drugs, the cost of insurance and defending against
lawsuits, and the effect of the latter in deterring manufacturers
from bringing new products to market. Id.
The issue of the applicability of the Barker test in
the context of prescription drugs is before this court for the
first time. With respect to the first prong, Shanks argues that
the "consumer expectation"prong of the Barker test should be
consistently applied in all cases, regardless of the nature of
the product involved.5 We disagree.
We question the significance of the expectations of the
ordinary consumer in determining whether strict liability should
be imposed on the manufacturer of the typical prescription drug.
Consumers vary widely in their knowledge, sophistication, and
ability to understand and evaluate the risks associated with the
use of prescription drugs, making it extremely difficult to
ascertain the expectations of the "ordinary" consumer. A
prescription drug's performance safety depends on many variables,
including the nature of the drug itself, the patient's medical
history, dosage, and combination with other medications, whose
complex interplay is beyond the comprehension of the ordinary
consumer. Furthermore, it is doubtful that the average consumer
has the information necessary to form a reasonable expectation
regarding the performance safety of most prescription products,
since neither the common law nor the Federal Food Drug and
Cosmetic Act require prescription drug manufacturers to provide
full warning information directly to the patient/consumer.6
Under a consumer expectation test, a drug manufacturer might be
held strictly liable because the drug performed in a way
unexpected by the "ordinary consumer,"even though the drug
performed in a manner which was well within the expectations of
the prescribing physician and the manufacturer. In short, the
expectations of the "ordinary consumer,"even if ascertainable,
are in most cases irrelevant to whether strict liability is to be
imposed.
However, rather than completely discard an expectation
prong, we believe one can be tailored to reflect the unique
nature of prescription drugs and the role of the doctor in the
decision to use a particular drug. In a sense, prescribing
doctors are the consumers of prescription drugs. It is the
doctor's evaluation of the patient's condition and consideration
of the available treatment alternatives which leads to the choice
of a specific prescription drug product. Also, the doctor has
ready access to the FDA-approved warning information contained in
the package insert and the Physicians' Desk Reference. Thus it
is the doctor's expectation, and not that of the patient,
regarding the performance and safety of prescription drugs which
is the relevant inquiry in the imposition of strict liability.
In light of this, we conclude that a prescription drug is
defectively designed and strict liability should be imposed on
its manufacturer if the prescription drug failed to perform as
safely as an ordinary doctor would expect, when used by the
patient in an intended and reasonably foreseeable manner.7
As to the second prong of the Barker test, we find the
reasoning of the Brown court in declining to apply the
"risk/benefit"analysis in the prescription drug context to be
unpersuasive, and we decline to follow it. While the social
utility and value of prescription drugs as a class of products
may exceed that of most other classes of products, we do not
believe that this generalization warrants granting "the same
protection from liability to those who gave us thalidomide as to
the producers of penicillin." 751 P.2d at 481. Furthermore, we
find it speculative at best that restricting strict liability
design defect claims against prescription drug manufacturers will
serve the public interest by enhancing the availability and
affordability of prescription drugs.8 While we recognize that
the threat of products liability litigation in general may impair
the ability of drug manufacturers to obtain liability insurance
and may cause beneficial drugs to be withdrawn from the market,
it is far from obvious that strict liability doctrines, rather
than the awards of compensatory and punitive damages in
negligence actions, are responsible. Products liability suits
against drug manufacturers are almost invariably brought under
both negligence and strict liability theories. See McClellan,
Strict Liability for Drug Induced Injuries: An Excursion Through
the Maze of Products Liability, Negligence and Absolute
Liability, 25 Wayne L. Rev. 1, 1 (1978). There is nothing in the
record of this case to indicate, nor does the Brown court
explain, the impact of design defect claims alone on the cost of
products liability litigation, on the cost to drug manufacturers
of liability insurance or on the availability and affordability
of prescription drugs. Finally, we find it consistent with the
purposes underlying strict products liability that manufacturers
should be deterred from marketing certain products and that the
cost of the defense of strict products liability litigation and
any resulting judgments should be borne by the manufacturer who
is able to spread the cost through insurance and by charging more
for its products. See 751 P.2d at 478.
We find the language of the Eighth Circuit Court of
Appeals, explicitly rejecting the policy basis of the Brown
decision in Hill v. Searle Laboratories, 884 F.2d 1064, 1069 (8th
Cir. 1989), to be particularly apt. There the court stated that
the premise generally relied on by those
courts [exempting all prescription drugs from
strict liability design defect claims] --
that the public interest in the development
of prescription drug products requires the
user to bear all the costs of injury unless
the drug product was negligently manufactured
or designed or unaccompanied by proper
warnings -- is unconvincing. In our view,
this policy has no greater relevance to
prescription drug products than to other
products having life-saving or life-bettering
characteristics.
Id. The public policy concerns underlying the doctrine of strict
products liability9 must be balanced with, rather than yield to,
the public interest in the availability and affordability of safe
prescription drugs. We believe that these interests are best
balanced and served by applying the risk/benefit prong of the
Barker test in determining the liability of prescription drug
manufacturers. We hold that the superior court erred in not
doing so.
In deciding whether a defendant has met the burden of
proving that the benefits of the design outweigh the risk, we
stated in Beck that the fact finder must consider competing
factors, including but not limited to
the gravity of the danger posed by the
challenged design, the likelihood that such
danger would occur, the mechanical
feasibility of a safer alternative design,
the financial cost of an improved design, and
the adverse consequences to the product and
to the consumer that would result from an
alternative design.
593 P.2d at 886 (quoting Barker, 573 P.2d at 455). We believe
these factors, with some modification and additions, should be
considered in making the same determination in cases involving
prescription drugs. Rephrasing these factors in language more
appropriate to prescription drug products, the fact finder should
consider the seriousness of the side effects or reactions posed
by the drug, the likelihood that such side effects or reactions
would occur, the feasibility of an alternative design which would
eliminate or reduce the side effects or reactions without
affecting the efficacy of the drug, and the harm to the consumer
in terms of reduced efficacy and any new side effects or
reactions that would result from an alternative design. In
evaluating the benefits, the fact finder should be permitted to
consider the seriousness of the condition for which the drug is
indicated. In summary, what the trier of fact should determine
in balancing these factors is whether the drug confers an
important benefit and whether the interest in its availability
outweighs the interest in promoting the enhanced accountability
which strict products liability design defect review provides.
See Kearl v. Lederle Laboratories, 218 Cal. Rptr. 453, 464 (Cal.
App. 1985).10
On appeal, the parties extensively briefed the issue of
the applicability and scope of comment k to 402A of the
Restatement (Second) of Torts.11 Most courts that have considered
the issue have adopted comment k to 402A.12 See Brown, 751 P.2d
at 476. Upjohn now urges us to adopt comment k and follow the
Brown court in interpreting it to grant immunity from strict
liability design defect claims to manufacturers of all
prescription drugs. Id. at 481-83.
While we accept the soundness of the policy underlying
comment k that manufacturers of certain highly beneficial
products which have inherent unavoidable risks of which the user
is adequately warned should not be held strictly liable for
injuries resulting from their products, we decline to formally
adopt comment k for three reasons. First, we believe that
comment k has contributed to the confusion which permeates this
area of law and blurs the distinctions between negligence and
strict liability principles, a distinction we believe warrants
preservation.13
Secondly, courts are unable to agree as to the
comment's scope. Some courts have interpreted comment k to
exempt all prescription drugs from strict liability design defect
claims. See, e.g., Brown, 751 P.2d at 473-83. In Grundberg v.
Upjohn Co., 813 P.2d 89 (Utah 1991), the most recent case
addressing this issue, the Utah Supreme Court arrived at the same
conclusion but refused to rely on a strained interpretation of
the plain language of comment k to reach this result. Id. at 95.
Other courts, without confronting the issue squarely, discuss
comment k as if it applies to all prescription drugs. See, e.g.,
Lindsay v. Ortho Pharmaceutical Corp., 637 F.2d 87, 90 (2d Cir.
1980); McKee v. Moore, 648 P.2d 21, 24 (Okla. 1982); Terhune v.
A.H. Robbins Co., 577 P.2d 975, 977-78 (Wash. 1978). Still other
courts interpret comment k to provide the exemption only to those
prescription drugs determined on a case-by-case basis to be
"unavoidably dangerous." See, e.g., Hill v. Searle Laboratories,
884 F.2d 1064, 1068 (8th Cir. 1989); Amore v. G.D. Searle & Co.,
748 F. Supp. 845, 853 (S.D. Fla. 1990); West v. Searle & Co., 806
S.W.2d 608, 612 (Ark. 1991); Toner v. Lederle Laboratories, 732
P.2d 297, 308 (Idaho 1987); Savina v. Sterling Drug, Inc., 795
P.2d 915, 924-26 (Kan. 1990); Castrignano v. E.R. Squibb & Sons,
Inc., 546 A.2d 775, 779-81 (R.I. 1988). By declining to adopt
comment k, we hope to avoid contributing to this confusion.
Finally, we believe that the risk/benefit prong of the
Barker test offers the manufacturers of those products intended
to be protected by comment k an opportunity to avoid liability
for strict liability claims based on a design defect theory. For
these reasons, we find it undesirable and unnecessary to impose
the additional layer of comment k on an area of law which is
already strained under its own doctrinal weight. We recognize
that by holding that the liability of drug manufacturers should
be measured by the second prong of the Barker test, we are taking
a position similar to those jurisdictions which apply comment k
to prescription drugs on a case-by-case basis. However, we
arrive at this result without specifically relying on comment k.
In summary, the superior court erred in its conclusion
that prescription drugs are exempt from strict liability design
defect claims. Alaska recognizes such claims and makes no
exception for prescription drugs. Neither policy nor reason
supports the approach taken by some courts in barring such
claims. We believe the "ordinary doctor expectation" test we
adopt today is a workable adaptation of the first prong of the
Barker test which sufficiently takes into account the special
character of prescription drug products. Although we need not
reach the issues of the applicability or interpretation of
comment k to 402A of the Restatement (Second) of Torts, we note
that the policy underlying comment k is fostered in the
application of the second prong of the Barker test in design
defect strict liability cases involving prescription drugs.
Because issues of material fact exist as to whether Rice used
Xanax in an intended or reasonably foreseeable manner, whether
the drug performed as safely as an ordinary doctor would expect,
whether the design of Xanax proximately caused Rice's injury, and
whether the benefits of the drug outweigh any risks inherent in
its design, this case must be remanded to the superior court for
resolution of these issues.
B. Failure to Warn
While it dismissed all but Shanks' strict liability
failure to warn claim before trial, the superior court's jury
instructions presented only a negligence theory to the jury.14
Shanks argues that the superior court erred when it introduced
negligence principles while instructing the jury on the strict
liability failure to warn claim. Upjohn argues that the superior
court was correct in applying only negligence principles in
instructing the jury on this claim.
We recognize the conceptual problems that exist in
determining the boundary between negligent and strict liability
failure to warn and the practical difficulties facing courts and
juries in applying these principles. See W. Page Keeton et al.,
Prosser and Keeton on the Law of Torts 99, at 697-98 (5th ed.
1984). See also Allan E. Korpela, Failure to Warn as Basis of
Liability Under Doctrine of Strict Liability in Tort, 53 A.L.R.3d
239 (1973); Henderson & Twerski, Doctrinal Collapse in Products
Liability: The Empty Shell of Failure to Warn, 65 N.Y.U. L. Rev.
265, 273-74 (1990). Negligence-like language inevitably creeps
into strict liability failure to warn analysis,15 both in the
context of determining which risks require a warning and in
determining whether a warning is adequate. However, we believe
that the policy underlying strict liability warrants preserving
the distinction between the doctrines.
Shortly after adopting the rule of strict products
liability, we stated that
the focus of attention in strict
liability cases is not on the conduct of the
defendant, but rather on the existence of the
defective product which causes injuries.
Liability is attached, as a matter of policy,
on the basis of the existence of a defect
rather than on the basis of the defendant's
negligent conduct.
Bachner v. Pearson, 479 P.2d 319, 329 (Alaska 1970). We later
held that it is reversible error to instruct the jury by focusing
on negligence concepts in strict liability failure to warn cases.
See Patricia R. v. Sullivan, 631 P.2d 91, 102 (Alaska 1981). In
Patricia R. v. Sullivan, we disapproved of the trial court's jury
instruction
because it focuses on such negligence
concepts and issues as whether the
manufacturer had reason to know of the hazard
involved in the use of the product, [and] the
manufacturer's duty to use reasonable care in
giving a warning. . . .
We are in accord with those
authorities which hold that in strict
liability cases the need for and the
sufficiency of a warning should be expressed
without reference to negligence principles.
Id. at 102.
In the present case, the jury instructions were
defective in two respects. First, instruction Nos. 19 & 20
expressly present Shanks' strict liability failure to warn claim
to the jury as a negligence claim in contravention of our holding
in Patricia R. Secondly, instruction No. 19 impermissibly placed
on Shanks the burden of showing that the risks inherent in Xanax
were risks which Upjohn knew or should have known of at the time
of Rice's death. Under a strict liability failure to warn
theory, if the plaintiff proves that the product as marketed
posed a risk of injury to one who uses the product in a
reasonably foreseeable manner and the product is marketed without
adequate warnings of the risk, the product is defective. See
Prince v. Parachutes, Inc., 685 P.2d 83, 88 (Alaska 1984). If
such a defect is the proximate cause of the plaintiff's injuries,
the manufacturer is strictly liable unless the defendant
manufacturer can prove that the risk was scientifically
unknowable at the time the product was distributed to the
plaintiff. See Heritage v. Pioneer Brokerage & Sales, Inc., 604
P.2d 1059, 1063-64 (Alaska 1979); see also Caterpillar Tractor
Co. v. Beck, 624 P.2d 790, 792 (Alaska 1981). The superior court
committed reversible error in only presenting a negligent failure
to warn theory to the jury and in depriving Shanks of her strict
liability failure to warn claim.
Shanks does not directly challenge instruction No. 21
defining "adequate warnings and directions."16 Nonetheless, to
guide the superior court on retrial on the issue of strict
liability failure to warn, we will briefly address the
sufficiency of this instruction.
In most cases, for a warning to be adequate, it should:
1) clearly indicate the scope of the risk or danger posed by the
product; 2) reasonably communicate the extent or seriousness of
harm that could result from the risk or danger; and 3) be
conveyed in such a manner as to alert the reasonably prudent
person. See First National Bank of Albuquerque v. Nor-Am
Agricultural Products, Inc., 537 P.2d 682, 691-93 (N.M. 1975).
In the case of prescription drugs, the warnings should be
sufficient to put the physician on notice of the nature and
extent of any scientifically knowable risks or dangers inherent
in the use of the drug. See Polley v. Ciba-Geigy Corp., 658 F.
Supp. 420 (D. Alaska 1987). As strict liability may also be
predicated on the inadequacy of the directions or instructions
for the safe use of the product, see Gosewisch v. American Honda
Motor Co., 737 P.2d 376 (Ariz. 1987), the focus in instruction
No. 21 on the adequacy of both the warning and the directions was
proper. In determining the adequacy of the warnings and
directions in the context of typical prescription drugs, it is
appropriate for the trier of fact to consider that the warnings
and directions were directed to the prescribing physician rather
than to the patient.17 However, in an instruction on the adequacy
of warnings or directions under a strict liability theory, courts
should avoid focusing on the negligence concepts and issues found
objectionable in Patricia R. See Patricia R., 631 P.2d at 101-
102.
III. Negligence Per Se
Shanks also assigns error to the superior court's
refusal to instruct the jury on her negligence per se and "strict
liability per se" claims under AS 17.20.290(1) and AS
17.20.090(6).18
In Ferrell v. Baxter, 484 P.2d 250 (Alaska 1971), we
adopted the doctrine of negligence per se as set forth in the
Restatement (Second) of Torts 286, 288A, and 288B (1965).
Under the doctrine, a court may adopt as the standard of conduct
of a reasonable person the requirements of a statute whose
purpose is to protect the class of persons to which the plaintiff
belongs, to protect the particular interest invaded, to protect
that interest against the kind of harm which resulted, and to
protect that interest against the particular hazard from which
the harm results, and that the unexcused violation of such a
statute is negligence in itself. Ferrel, 484 P.2d at 263-64. In
determining whether to give a negligence per se instruction, the
trial court must first "determine whether the conduct at issue
lies within the ambit of the statute or regulation in question,
by applying the four criteria set out in the Restatement (Second)
of Torts 286 (1965)." State Mechanical, Inc. v. Liquid Air,
Inc., 665 P.2d 15, 18 (Alaska 1983) (footnote omitted). If the
trial court concludes that the statute is applicable, the court
has the limited discretion to refuse to give the negligence per
se instruction only if it determines that "the rule of law is so
obscure, unknown, outdated, or arbitrary as to make inequitable
its adoption as a standard of reasonable care," State
Mechanical, Inc., 665 P.2d at 19, or where a statute is too vague
or arcane to be used as a reasonable standard of care, or amounts
to little more than a duplication of the common law tort duty to
act reasonably under the circumstances. Harned v. Dura Corp.,
665 P.2d 5, 12 (Alaska 1983). Such a determination will only be
reversed on appeal if it constitutes an abuse of discretion. Id.
We cannot say that the superior court abused its
discretion. The language of these statutes merely prohibits the
manufacture or sale of drugs without adequate warnings, therefore
adding little to the common law duty to adequately warn. Also,
the statutes are vague as to their requirements in the context of
prescription drugs. Because the standard for determining the
adequacy of a warning may differ depending on whether the warning
is directed to the medical community as with prescription drugs
or to the public in the case of over-the-counter drugs, there is
the potential for confusion in using these statutes to define the
standard of care in both contexts.19
The superior court submitted the negligent failure to
warn issue to the jury, which found no negligence on the part of
Upjohn. Thus we see no reason to remand on the negligence issue.
IV. Attorney Misconduct
On appeal, Shanks contends that the misconduct of
counsel for Upjohn deprived Shanks of a fair trial.20 Though not
stated as such, this is essentially a challenge to the superior
court's denial of Shanks' motion for new trial.
The denial of a motion for new trial rests in the sound
discretion of the trial court and this court will not disturb the
trial court's decision except in exceptional circumstances to
prevent a miscarriage of justice. Buoy v. ERA Helicopters, Inc.,
771 P.2d 439, 442 (Alaska 1989). We conclude that the grounds
asserted by Shanks in her motion for new trial did not amount to
attorney misconduct, nor did the superior court's decision to
deny the motion result in a miscarriage of justice.
V. Conclusion
The superior court erred in dismissing Shanks' strict
liability design defect claim. The superior court also erred in
failing to present Shanks' strict liability failure to warn claim
to the jury. However, it acted properly in declining to instruct
the jury on Shanks' negligence per se claim and in denying her
motion for new trial based on attorney misconduct.
The judgment of the superior court is REVERSED and
REMANDED for further proceedings consistent with this opinion.
The award of attorney's fees is VACATED.
_______________________________
1. Xanax is the manufacturer's trade name for the drug
Alprazolam, a member of the benzodiazepine class of drugs. It is
a central nervous system (CNS) depressant used for the treatment
of anxiety disorders and anxiety associated with depression.
2. Tylenol #3 is the trade name for acetaminophen with
codeine. Codeine is a CNS depressant.
3. Prescription drugs such as Xanax are accompanied by a
"package insert" containing warnings and directions for use
approved by the United States Food and Drug Administration (FDA).
The information contained in the insert, also published in the
Physicians' Desk Reference, is intended for the use of the
physician, not the patient.
The Xanax package insert warns that because of its CNS
effect, patients using Xanax "should be cautioned against
engaging in hazardous occupations"and "about the simultaneous
ingestion of . . . other CNS depressant drugs during treatment
with XANAX." In the section of the insert labeled "Precautions"
is the following:
As with other psychotropic medications,
the usual precautions with respect to
administration of the drug and size of the
prescription are indicated for severely
depressed patients or those in whom there is
reason to expect concealed suicidal ideation
or plans.
4. The trial court approved a settlement between the Estate
and Dr. Dobyns, the hospital, and their insurer. Though
originally named as a defendant, the dispensing pharmacy was
dismissed by stipulation of the parties.
5. In support of this argument, Shanks cites that portion
of the dissent in Finn v. G.D. Searle & Co., 677 P.2d 1147, 1166
(Cal. 1987), wherein Chief Justice Bird advocated the blanket
application of the "consumer expectation" prong in cases
involving prescription drugs.
6. Under the "learned intermediary"rule, a prescription
drug manufacturer satisfies the duty to warn if it provides
adequate warnings to the prescribing physician. See, e.g.,
Polley v. Ciba-Geigy Corp., 658 F. Supp. 420, 422-23 (D. Alaska
1987).
Section 503 of the Federal Food Drug and Cosmetics Act
exempts drugs dispensed on a prescription from the rigorous
labeling requirements of section 502 of the act. See 21 U.S.C.S.
352, 353(b)(2) (1984).
7. With certain types of prescription drugs, the role of
the doctor in the decision to use a specific product is
significantly reduced. Examples of such atypical prescription
products include contraceptives, where the patient initiates and
directs the usage, drugs typically administered in a clinical
setting with little or no physician involvement, or drugs
marketed under a strategy designed to appeal directly to the
consuming public. These are areas where courts have held that
manufacturers have a duty to warn patients directly. See infra
note 17. In strict liability design defect cases involving such
products, it may be appropriate to apply the "ordinary consumer
expectation" test rather than the "ordinary doctor expectation"
test.
8. The Brown court states that "[w]e are aware of only one
decision that has applied the doctrine of strict liability to
prescription drugs." Id. at 476 (citing Brochu v. Ortho
Pharmaceutical Corp., 642 F.2d 652, 654-57 (1st Cir. 1981)). Yet
the court goes on to discuss the adverse effect of products
liability litigation on the availability and cost of prescription
drugs. Id. at 479-80. If, as the Brown court claims, theories
other than strict liability have been the basis of recovery under
these claims in the past, it is unclear how limiting strict
liability causes of action will serve the policy interest in
enhancing the availability and affordability of prescription
drugs in the future.
9. In Beck we stated the policy reasons for imposing strict
liability:
[t]he purpose of imposing such strict
liability on the manufacturer and retailer is
to insure that the cost of injuries resulting
from defective products are borne by the
manufacturers that put such products on the
market rather than by the injured persons who
are powerless to protect themselves.
593 P.2d at 878 (quoting Clary v. Fifth Ave. Chrysler Center, 454
P.2d 244, 248 (Alaska 1969)). We went on to observe that
one of the major goals of strict
products liability is to relieve the
plaintiff of the burdensome evidentiary
requirements of the negligence cause of
action . . . .
593 P.2d at 882.
10. We reject Upjohn's argument that courts should defer to
the determination of the Food and Drug Administration as to the
safety and efficacy of a prescription drug. While a deferential
standard of review is appropriate when directly reviewing an
agency decision, see, e.g., Pan American Petroleum Corp. v. Shell
Oil Co., 455 P.2d 12, 20-23 (Alaska 1969), we feel that such
deference in the face of allegations of serious injuries caused
by FDA-approved drugs would amount to an abdication of judicial
responsibility. See Grundberg v. Upjohn Co., 813 P.2d 89, 100-04
(Utah 1991) (Stewart, J., dissenting).
11. Section 402A sets out the rule of strict products
liability. Restatement (Second) of Torts 402A (1965).
Alaska's rule of strict liability is essentially a modified
version of the rule. Alaska rejects the requirement of 402A
that a plaintiff must prove the product at issue is "unreasonably
dangerous." See Butaud v. Suburban Marine & Sporting Goods,
Inc., 543 P.2d 209, 213-14 (Alaska 1975) (following Cronin v.
J.B.E. Olson Corp., 501 P.2d 1153 (Cal. 1972)).
12. Comment k to 402A provides:
k. Unavoidably unsafe products.
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 safety, 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.
Restatement (Second) of Torts 402A cmt. k (1965).
13. The Brown court recognized this confusion when it stated
that
[c]omment k has been analyzed and
criticized by numerous commentators. While
there is some disagreement as to its scope
and meaning, there is a general consensus
that, although it purports to explain the
strict liability doctrine, in fact the
principle it states is based on negligence.
Brown, 751 P.2d at 475.
14. The trial court's jury instruction No. 19 read:
The plaintiff's theory of recovery
is that the plaintiff's loss was caused by
the negligence of Upjohn in failing to give
adequate warnings and directions about XANAX.
In order for plaintiff to win, you must find
by a preponderance of the evidence each of
the following:
1. That the drug XANAX
had certain effects that were a
legal cause of the decedent's
conduct which led to his death;
2. That Upjohn knew, or
it was reasonably scientifically
knowable, that XANAX would have
those effects;
3. That Upjohn
negligently failed to adequately
warn and direct Dr. Dobyns
concerning those effects;
4. That Harvey Rice's
estate suffered an actual loss; and
5. That Upjohn's
negligence was a legal cause of the
loss to the estate of the decedent.
These are the essential elements of plaintiff's
claim. All five must be established by a preponderance
of the evidence for plaintiff to win; if one or more
of these elements are not established, you must find
for Upjohn.
I will define "negligence"and "legal cause"for
you in a moment.
The trial court's jury instruction No. 20 read:
I will now define negligence for
you. Negligence is the failure to use
reasonable care. Reasonable care is that
amount of care that a reasonably prudent
person would use under similar circumstances.
Negligence may consist of doing something
which a reasonably prudent person would not
do, or it may consist of failing to do
something which a reasonably prudent person
would do. A reasonably prudent person is not
the exceptionally cautious or skillful
individual, but a person of reasonable and
ordinary carefulness.
In this case, you must decide
whether Harvey Rice, Kathy Rice and Upjohn
used reasonable care under the circumstances.
15. See Phillips v. Kimwood Machine Co., 525 P.2d 1033, 1039
(Or. 1974).
16. Instruction No. 21 reads:
"Adequate warnings and directions"
are verbal or written warnings and directions
that, under the circumstances then existing,
provide a doctor with reasonable notice of
the intended effects, side effects, and
adverse effects of a drug and clear
directions for the safe use of the drug. In
judging the reasonableness of the notice and
the clarity of the directions, the jury
should consider that the notice and
directions were directed to a health care
professional.
A drug manufacturer is required to
give adequate warnings and directions
concerning all effects of the drug and all
aspects of its use, but only if those effects
and aspects are known or reasonably
scientifically knowable to the manufacturer.
The manufacturer cannot be held liable if it
has provided adequate warnings and directions
to the doctor and the doctor does not follow
them.
17. See Polley v. Ciba-Geigy Corp., 658 F. Supp. 420 (D.
Alaska 1987) stating in pertinent part:
Every single court which has considered
the issue in the context of prescription
medicines-- except for oral contraceptives or
mass immunization, situations in which the
physician's traditional role as a learned
intermediary is minimized-- has concluded
that there is no duty on the part of the
manufacturer to warn the patient directly of
risks inherent in the prescription medicine.
Id. at 422-23. See also Hill v. Searle Laboratories, 884 F.2d
1064, 1070-71 (8th Cir. 1989); Plummer v. Lederle Laboratories,
819 F.2d 349, 356-57 (2d Cir. 1987). While warnings to both the
prescribing physician and the patient directly would further both
the interest in safe drug use and the ability of patients to make
informed decisions regarding their health care, the law does not
recognize such a duty except in the limited situations mentioned
in Polley. Because these exceptions do not apply here, any of
Shanks' claims or arguments predicated on a duty of a drug
manufacturer to warn the consumer directly must be rejected.
18. AS 17.20.290(1) of the Alaska Food, Drug and Cosmetic
Act prohibits the manufacture or sale of misbranded drugs. AS
17.20.090(6) states that a drug is misbranded unless its labeling
bears adequate directions and adequate warnings.
19. Shanks argues that our opinion in Ross Laboratories v.
Thies, 725 P.2d 1076 (Alaska 1986), is dispositive of the issue.
There, we affirmed a ruling that the manufacturer of a liquid
glucose product was negligent per se for failing to include a
warning in violation of AS 17.20.290(1) and AS 17.20.090(6). We
declared that the Food, Drug and Cosmetic Act
was clearly designed to protect
consumers of drugs from unappreciated dangers
and thus it properly may form the basis for
civil liability in tort.
Id. at 1079-80. However, Thies is distinguishable in that the
product there was available "over-the-counter" without a
prescription. Id. at 1078.
20. Shanks contends that Upjohn's counsel engaged in
attorney misconduct by referring during opening arguments to two
documents, which were ultimately not admitted into evidence and
by contacting a person identified in documents filed with the
court as an expert witness for Shanks, but whom Shanks had not
yet retained as an expert at the time of the contact.
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