FILED: February 3, 1999
IN THE COURT OF APPEALS OF THE STATE OF OREGON
PATRICIA E. GRIFFITH,
Appellant,
and
PADDY O. GRIFFITH,
Plaintiff,
v.
PHILIP E. BLATT, M. D.; and REED
& CARNICK, a division of BLOCK DRUG, INC.,
a foreign corporation,
Defendants,
and
WILLIAM A. STOUT, doing business as
Hollywood Prescriptions; and RUGBY
LABORATORIES, INC., a foreign corporation,
Respondents.
(9502-01211; CA A93458)
Appeal from Circuit Court, Multnomah County.
Ann Fisher, Judge pro tempore, on judgment
entered January 8, 1996; George M. Joseph, Senior Judge, on judgment of
dismissal entered May 10, 1996.
Argued and submitted on April 14, 1998.
Lindsey H. Hughes argued the cause for appellant. With her
on the brief was Hallmark, Keating & Abbott, P. C.
G. Kenneth Shiroishi argued the cause for respondent
William A. Stout, doing business as Hollywood Prescriptions. With him on the
brief were Joan O'Neill and Dunn, Carney, Allen, Higgins & Tongue.
Franklin Hunsaker argued the cause for respondent Rugby
Laboratories, Inc. With him on the brief were Ronald E. Bailey, Marilyn E.
Litzenberger, and Bullivant, Houser, Bailey, Pendergrass & Hoffman.
Before De Muniz, Presiding Judge, and Haselton and Linder,
Judges.
HASELTON, J.
Affirmed.
HASELTON, J.
Plaintiff(1) appeals,
assigning error to the granting of summary judgment against her
products-liability based claims against defendants Rugby Laboratories, Inc., the
manufacturer of Lindane lotion, and William Stout, dba Hollywood Prescriptions,
a pharmacist who filled plaintiff's prescription for Lindane lotion.(2)
The trial court concluded that plaintiff's strict liability claims against Rugby
and Stout were barred by the two-year general statute of limitations for product
liability civil actions, ORS 30.905(2), and that her claim against Stout for
negligent failure to warn did not state a legally cognizable claim. We conclude
that plaintiff's claim against Rugby is time-barred; that her strict liability
claim against Stout is precluded under the "learned intermediary"
doctrine; and that, with respect to negligent failure to warn, plaintiff failed
to controvert Stout's proof that he had not breached the standard of care.
Consequently, we affirm.
Viewing the summary judgment record most favorably to
plaintiff as the nonmoving party, Jones v. General Motors Corp., 325 Or
404, 420, 939 P2d 608 (1997), the material facts are as follows:
On February 26, 1993, plaintiff visited Dr. Philip Blatt,
seeking treatment for a skin condition. Blatt gave plaintiff a prescription for
two ounces of Lindane, one percent lotion, instructing the pharmacist to fill
the prescription and to type "As directed" on the label. Plaintiff
took that prescription to Stout, who filled the prescription, placing the lotion
in a plain prescription bottle which bore generic "For external use
only" and "Shake well" labels. In accordance with Blatt's
instructions, Stout typed the notation "As directed" on the
prescription label and affixed that label to the bottle. The bottle bore no
other instructions or warnings. There is no evidence that Stout gave plaintiff
any verbal instructions or warnings concerning the lotion including,
particularly, any warnings pertaining to frequency or duration of use.
Plaintiff applied the lotion over her entire body once a
day, after her daily shower for five or six days until she had used the entire
bottle. After each application, plaintiff did not shower for the next 24 hours.
Properly used, Lindane lotion should be applied no more than two times and
should be washed off within 12 hours after any application.
Within a week to two weeks after beginning to use the
Lindane lotion, plaintiff began to suffer medical problems, including
convulsions, dizziness, weight loss, hair loss, sleep disturbance, and cognitive
disfunction. On June 10, 1993, plaintiff watched a segment of the television
program "Good Morning America," which featured a report about a child
who had suffered convulsions after overexposure to Lindane lotion. Immediately
after that program, plaintiff retrieved her empty bottle of Lindane lotion and
told her husband, "This is the same stuff." In August 1993, plaintiff
consulted with a physician, who diagnosed her symptoms to be the result of
central nervous system toxicity due to overexposure to Lindane lotion.
On February 23, 1995, plaintiff filed her original
complaint, naming as defendants Blatt, Stout and Reed & Carnick, whom she
mistakenly believed had manufactured the Lindane lotion. That complaint alleged:
(1) a strict liability claim against Reed & Carnick, alleging that Lindane
lotion was unreasonably dangerous in that it was sold without adequate
instructions "reasonably calculated to reach the ultimate user"
regarding its safe use or warnings that its use could lead to central nervous
system toxicity and related health problems; (2) a medical malpractice claim
against Blatt for, inter alia, prescribing the Lindane lotion and for
failing to warn plaintiff of the dangers of its overuse; and (3) a negligence
claim against Stout for failing to instruct plaintiff on the proper use of
Lindane lotion and to warn her of the dangers of its overuse.
Plaintiff subsequently discovered that Rugby, not Reed
& Carnick, was the manufacturer of the Lindane lotion that she had received
and, consequently, dismissed Reed & Carnick. On July 21, 1995, plaintiff
filed an amended complaint. That amended complaint named Rugby as a defendant,
asserting the same strict liability/failure to warn allegations that had been
directed against Reed & Carnick. The amended complaint also alleged a strict
liability claim against Stout, in addition to the original negligence claim.
Those allegations were reiterated in plaintiff's second amended complaint, which
was the object of Stout's summary judgment motion. (3)
On October 24, 1995, Stout moved for summary judgment or,
in the alternative, to dismiss plaintiff's claims against him. Stout asserted
that plaintiff's strict liability claim against him was time-barred because it
was first alleged more than two years after plaintiff had experienced her
symptoms within days of using the product--and, indeed, more than two years
after the June 10, 1993, "Good Morning America" program. See
ORS 30.905(2) (4); Dortch
v. A. H. Robins Co., Inc., 59 Or App 310, 650 P2d 1046 (1982) (applying
"discovery rule" to product liability civil actions). Stout further
asserted that both the strict liability claim and the negligence claim against
him (whose timeliness he did not dispute) were precluded, as a matter of law, by
the "learned intermediary" doctrine. See McEwen v. Ortho
Pharmaceutical, 270 Or 375, 385-86, 528 P2d 522 (1974) (describing
doctrine). While acknowledging that the question was unresolved in Oregon, Stout
emphasized that most of the jurisdictions that had addressed the issue had
concluded that, under the so-called "learned intermediary" doctrine,
pharmacists could not be held either strictly liable or liable in negligence for
failure to warn with respect to prescription drugs.
The trial court granted Stout's motion for summary
judgment against both claims. The court determined that the strict liability
claim was time-barred (5)
and that the negligent failure to warn claim was barred by the "learned
intermediary" doctrine.
In April 1996, Rugby moved for summary judgment, arguing inter
alia that plaintiff had failed to bring her strict liability claim against
it within the two-year statute of limitations. ORS 30.905(2). Like Stout, Rugby
contended that plaintiff's strict liability claim accrued no later than the date
she saw the "Good Morning America" program and that claimant had
failed to bring that claim within two years of that date. Plaintiff opposed the
motion, arguing only that conduct by defense counsel had resulted in a
"procedural delay" that prevented her from timely filing her claim
against Rugby and that, in all events, she did not actually discover that Rugby
was the source of the Lindane lotion until her husband received certain
information from the federal Food and Drug Administration in March 1996. (6)
The trial court rejected plaintiff's arguments and agreed with Rugby that the
claim accrued by no later than the date of the "Good Morning America"
program and, consequently, granted Rugby's motion for summary judgment.
Plaintiff appeals, assigning error to the trial court's
allowance of summary judgment for both Rugby and Stout. We first summarily
reject plaintiff's arguments as to Rugby. As noted, plaintiff's arguments to the
trial court in opposing summary judgment on the basis of the statute of
limitations were limited and precise. On appeal, plaintiff does not rely on
those arguments but, instead, advances new and qualitatively different arguments
which, if raised below, might well have affected the development of the
evidentiary record. Because plaintiff's arguments differ so substantially from
her arguments to the trial court, we decline to address them and affirm the
allowance of summary judgment for Rugby. See generally State v. Hitz,
307 Or 183, 188, 766 P2d 373 (1988); J. Arlie Bryant, Inc. v. Columbia River
Gorge Comm., 132 Or App 565, 567-68, 889 P2d 383, rev den 321 Or
47 (1995).
Turning to plaintiff's claims against Stout, plaintiff
argues, as she did before the trial court, that, because of relation back, her
strict liability claim is not time-barred and that the "learned
intermediary" doctrine precludes neither her strict liability nor her
negligence claim. We conclude, for the reasons that follow, that, even assuming
that plaintiff's strict liability claim was timely, proper application of the
"learned intermediary" doctrine bars that claim. We further conclude
that, because plaintiff failed to offer any expert testimony controverting
Stout's evidence that he had not breached any applicable standard of care for
pharmacists pertaining to warning of dangers of prescription drugs, summary
judgment against plaintiff's negligence claim was also proper. See Docken v.
Ciba-Geigy, 101 Or App 252, 256, 790 P2d 45, rev den 310 Or 195
(1990) (Docken II).
Under the "learned intermediary" doctrine, a
manufacturer of a prescription pharmaceutical product satisfies its duty to warn
of the risk associated with the use of that product if it communicates adequate
warnings to the prescribing physician. Thus, "the duty of the ethical drug
manufacturer is to warn the doctor, rather than the patient." McEwen,
270 Or at 386-87. Nevertheless, "the manufacturer is directly liable to the
patient for a breach of such duty." Id. In Terhune v. A. H.
Robins Co., 89 Wash 2d 9, 577 P2d 975 (1978), the court explained the
doctrine's underpinnings:
"Where a product is available only on prescription or
through the services of a physician, the physician acts as a 'learned
intermediary' between the manufacturer or seller and the patient. It is his duty
to inform himself of the qualities and characteristics of those products which
he prescribes for or administers to or uses on his patients, and to exercise an
independent judgment, taking into account his knowledge of the patient as well
as the product. The patient is expected to and, it can be presumed, does place
primary reliance upon that judgment. The physician decides what facts should be
told to the patient. Thus, if the product is properly labeled and carries the
necessary instructions and warnings to fully apprise the physician of the proper
procedures for use and the dangers involved, the manufacturer may reasonably
assume that the physician will exercise the informed judgment thereby gained in
conjunction with his own independent learning, in the best interest of the
patient." 89 Wash 2d at 14.
See also McEwen, 270 Or at 387 ("The
manufacturer's compliance with this duty enables the prescribing physician to
balance the risk of possible harm against the benefits to be gained by the
patient's use of that drug.").
No Oregon appellate decision has addressed the application
of the "learned intermediary" doctrine to claims arising from a
pharmacist's failure to warn of the risks associated with a prescription drug. (7)
Indeed, only two Oregon cases have discussed the doctrine in detail in any
context: McEwen and Oksenholt v. Lederle Laboratories, 51 Or
App 419, 424-26, 625 P2d 1357 (1981), aff'd as modified 294 Or 213, 656
P2d 293 (1982). Beyond their general endorsement of the "learned
intermediary" principle, neither of those cases affords particular guidance
here.(8)
Notwithstanding the paucity of Oregon law, courts in
several other jurisdictions have considered whether pharmacists should be
strictly liable for failure to warn of a prescription drug's dangerous
propensities. Invoking the "learned intermediary" doctrine, those
courts, apparently without exception, have refused to impose such liability. See,
e.g., Raynor v. Richardson-Merrell, Inc., 643 F Supp 238, 246-47 (DDC
1986); Ramirez v. Richardson-Merrell, Inc., 628 F Supp 85, 87-88 (ED Pa
1986); Batiste v. American Home Products Corp., 32 NC App 111, 231 SE2d
269, 275, cert den 292 NC 466, 233 SE2d 921 (1977); Bichler v.
Willing, 58 App Div 2d 331, 334, 397 NYS2d 57, 59 (1977); Leesley v.
West, 165 Ill App 3d 135, 140, 518 NE2d 758, 762, app den 119 Ill
2nd 558, 522 NE2d 1246 (1988).
Ramirez is exemplary. There, the plaintiffs
asserted, inter alia, a strict liability claim against a pharmacist,
alleging that the pharmacist had failed to warn of the risk of birth defects
associated with the prescription drug Bendectin. The court allowed summary
judgment against that claim. After noting that, under the "learned
intermediary" doctrine, "the warning required [of the manufacturer] is
not to the general public or to the patient, but to the prescribing
physician," Ramirez, 628 F Supp at 87, the court applied that
doctrine:
"It would be illogical and unreasonable * * * to
impose a greater duty on the pharmacist or druggist who properly fills the
prescription than is imposed on the manufacturer. Holding that the pharmacist
has a duty to warn the patients directly of the potential hazards when the
manufacturer does not have that duty would be to impose that greater duty.
Similarly, although a prescription drug may be considered defective if the
manufacturer fails to warn the prescribing physician adequately, thereby
subjecting the manufacturer to strict liability, this warning need not accompany
the product to the patient. * * * It follows therefore that the product
dispensed by the pharmacist is not defective because of the absence of a
warning." Id.
Similarly, in Leesley, the Illinois Court of
Appeals held that a pharmacist could not be liable on a strict liability theory
for failing to warn of risks associated with use of the prescription drug
Feldene. After reviewing the "learned intermediary" doctrine, the
court concluded:
"[T]he manufacturer's duty to warn extends only to
prescribing physicians. We must conclude, therefore, that where the manufacturer
gives the required warnings to the prescribing physician and the drug is
distributed in the usual manner (i.e., prescribed for the plaintiff by
a physician), the drug is not an unreasonably dangerous product. * * * To
illustrate, Pfizer [the manufacturer] shipped a bulk container of Feldene to
[the pharmacy] with only a single package insert. Because Pfizer had no duty to
provide warnings directly to customers, the product as shipped was not
unreasonably dangerous (and would not have been even if no inserts had been
included at all). We would have to conclude that the product somehow became
unreasonably dangerous in [the pharmacy's] hands in order to hold [the pharmacy]
was nevertheless required, at the risk of being held strictly liable, to provide
every customer whose prescription was filled from that bulk container with a
copy of the information contained in that single package insert. Such a
conclusion would obviously be unreasonable. We therefore conclude that it would
be illogical and inequitable under a strict liability theory to impose a duty on
the pharmacist with respect to a prescription drug that is not imposed the
drug's manufacturer." Leesley, 165 Ill App 3d at 140.
We find that reasoning persuasive and consistent with
Oregon's endorsement of the "learned intermediary" principle.
Accordingly, we affirm the trial court's dismissal of plaintiff's strict
liability claim against defendant Stout.
Plaintiff's alternative claim for negligent failure to
warn fails for a different reason: Plaintiff failed to proffer expert testimony
"as to the standard of care [for pharmacists] for warning of dangers of a
prescription drug." Docken II, 101 Or App at 256.
The Docken litigation involved claims arising
from the death of one sibling who had ingested medication prescribed for another
sibling. The plaintiff brought an action against the drug manufacturer, the
prescribing physician, and the pharmacy that filled the prescription, alleging
claims of strict liability based on "inadequate labeling and insufficient
warnings" and negligent failure to warn. Docken I, 86 Or App at
279. The trial court dismissed those claims.
On appeal, in Docken I, we affirmed in part and
reversed in part. With respect to the pharmacy, we affirmed the dismissal of the
strict liability claim because the plaintiff had failed to allege that the
pharmacy was "in the business of selling the drug." Id. at
282. (9) However, we
reversed the dismissal of the negligent failure to warn claims, rejecting the
defendants' argument that they did not "owe[] a duty of care to someone for
whom the drug is not prescribed if injur[y] result[s] from that person's taking
the drug." Id. at 280. Thus, in Docken I, we recognized
the viability of a claim against a pharmacist for negligent failure to warn.(10)
In so holding, we relied solely on the freshly-minted Fazzolari
"reasonable foreseeability" standard. See id. at 280-81.
On remand, the jury returned a defense verdict for the
pharmacy on the negligence claims. The plaintiff appealed, contending that the
trial court had given erroneous jury instructions. The pharmacy cross-assigned
error, asserting that the court had erroneously denied its motion for a directed
verdict because "plaintiff provided no evidence of one of the elements of
her cause of action, a breach of the standard of care in the community." Docken
II, 101 Or App at 255. We agreed with the pharmacy that the trial court had
so erred and, consequently, affirmed on that alternative ground. In so holding,
we described the parties' contending positions in terms that are directly
applicable to this appeal:
"Plaintiff argues that the jury could determine
without the aid of experts that a prescription drug is dangerous and requires a
pharmacist independently to warn of its hazards, regardless of the instructions
of the prescribing physician or any statutory requirements to warn. Plaintiff
provided evidence that an overdose of Imipramine was potentially fatal and that
there was no warning by defendant's pharmacy. Plaintiff argues that, with that
evidence, the jury could find that a duty to warn existed and was breached.
Defendant argues that expert testimony is required to prove the community
standard of care for a pharmacist and that plaintiff provided no evidence that
the community standard was not met. Because no expert testified that the
standard in the professional community required a pharmacist to warn of the
hazards of this prescription drug, defendant argues that no breach of due care
could be found, even if the warning were lacking." Id. at 255.
We then concluded:
"In the earlier appeal in this case, we did not
discuss what evidence would be required to show that the standard of care had
not been met. Considering the complex relationship between a physician, the
patient and a pharmacist, we hold that an expert must testify as to the standard
of care in the community for warning of dangers of a prescription drug before a
jury may determine that such a standard was breached." Id. at 256. (11)
See also Tiedemann v. Radiation Therapy Consultants,
299 Or 238, 242-45, 701 P2d 440 (1985); Getchell v. Mansfield, 260 Or
174, 179, 489 P2d 953 (1971) (both addressing requirements of expert testimony
in professional malpractice actions).
That reasoning is decisive here. In moving for summary
judgment, defendant Stout submitted an affidavit averring that, as a pharmacist,
he was "familiar with the reasonable standard of care of pharmacists in the
same or similar circumstances in this community" and that "all of
[his] actions as related to dispensing the prescription and warnings in this
case were within the reasonable standard of care for pharmacists in this
community." Plaintiff offered no expert testimony controverting those
averments. (12)
Consequently, the trial court correctly granted summary judgment. See Tiedemann,
299 Or at 242-45; Docken II, 101 Or App at 255.
Affirmed.
1. "Plaintiff" in this
opinion refers only to Patricia Griffith. Paddy Griffith, her husband, filed a
claim for loss of consortium, but the disposition of that claim is not at issue
on appeal.
Return to previous location.
2. Plaintiff also asserted claims
against two other defendants, Philip Blatt, M.D., and Reed & Carnick. The
disposition of those claims is not at issue on appeal.
Return to previous location.
3. The only difference between the
first and second amended complaints was a minor amendment by interlineation in
response to a Rule 21 motion by Blatt.
Return to previous location.
4. ORS 30.905(2) provides, in part,
that "a product liability civil action shall be commenced not later than
two years after the date on which the death, injury or damage complained of
occurs."
Return to previous location.
5. In so holding, the court rejected
plaintiff's argument that her strict liability claim related back to the filing
of the original complaint. Given that disposition, the trial court characterized
Stout's "learned intermediary" contention with respect to the strict
liability claim as "moot."
Return to previous location.
6. Plaintiff did not explain why she
named Rugby as a defendant in July 1995 if she could not reasonably have known
that Rugby was the source of the allegedly defective product until March 1996.
Return to previous location.
7. As described more fully below, in Docken
v. Ciba-Geigy, 86 Or App 277, 739 P2d 591 (1987) (Docken I), aff'd
following remand in Docken II, the plaintiff alleged negligence and strict
liability claims against a pharmacist for failing to warn of a prescription
drug's dangerous propensities. However, in affirming the dismissal of the strict
liability claim in Docken I, and in affirming the defense verdict on
the negligence claim in Docken II, we did not refer to the
"learned intermediary" doctrine.
Return to previous location.
8. In McEwen, the plaintiff,
who had become blind in one eye, brought a negligence action against two
manufacturers of oral contraceptives, asserting that they had failed to
adequately warn the medical profession of potential adverse effects,
specifically including retinal hemorrhaging. A jury trial resulted in judgments
against both defendants. On appeal, the Supreme Court affirmed. Central to the
court's holding was its analysis of the scope of the manufacturer's duty to warn
and, in describing that duty, the court endorsed the "learned
intermediary" doctrine. McEwen, 270 Or at 386-407 (adopting
"learned intermediary" doctrine and concluding that manufacturers had
failed to convey adequate warnings to prescribing and treating physicians).
In Oksenholt, we reversed dismissal of the
plaintiff physician's negligence action against the defendant drug manufacturer
for damages resulting from loss of reputation, earning capacity and income, that
allegedly arose from the manufacturer's failure to warn him that the defendant's
drug, which the plaintiff had prescribed, could cause blindness. In so holding,
we rejected the defendant's argument that its duty to warn a prescribing
physician was "solely for the protection of the patient and, therefore,
breach of the duty gives rise to a cause of action in the patient alone." Oksenholt,
51 Or App at 424. On review, the Supreme Court held that we had erred in "analyz[ing]
the problem solely in terms of foreseeability," Oksenholt v. Lederle
Laboratories, 294 Or 213, 219, 656 P2d 293 (1982), and concluded that the
physician's claim against the manufacturer was appropriately analyzed as a claim
for negligence per se, arising out of the manufacturer's breach of
certain federal regulations prescribing the content of drug warnings. Id. at
219-20.
Return to previous location.
9. Because of that disposition, we had
no occasion to consider the pharmacy's alternative argument, presented in its
briefs, that the "learned intermediary" doctrine precluded imposition
of strict liability.
Return to previous location.
10. As noted, see n 7 supra,
our opinion in Docken I did not refer to the "learned
intermediary" doctrine or consider the appropriate relationship between
that doctrine and Fazzolari's analysis.
Return to previous location.
11. We qualified that conclusion with
an observation:
"We do not comment on the standard of care in other
circumstances, such as when a pharmacist sells a nonprescription substance or
when a pharmacist has personal knowledge of a customer's medical
condition." Docken II, 101 Or App at 256 n 4.
Neither of those circumstances is present here.
Return to previous location.
12. Compare, e.g., Lasley v.
Shrake's Country Club Pharmacy, 179 Ariz 583, 880 P2d 1129, 1134 (Ariz App
Div I 1994) (reversing dismissal of negligent failure to warn claim against
pharmacist where plaintiff presented an expert affidavit describing the standard
of care as including a duty to warn in the particular circumstances presented,
as well as excerpts from the American Pharmaceutical Association Standards of
Practice for the Profession of Pharmacy).Source
Return to previous location.
CHEMICAL CHEMICAL
NAME 009001 Lindane
COMPANY# 000059 COOPERS ANIMAL HEALTH INC DIRECTOR OF REGULATORY AFFAIRS *
DATA TYPES * 421 EAST HAWLEY ST EU AT EC FW EF OT MUNDELEIN IL XX XX 60060
COMPANY# 000239 THE SCOTTS COMPANY D/B/A THE ORTHO GROUP * DATA TYPES *
BOX 1749 EU AT EC FW EF OT COLUMBUS OH XX XX XX 43216 COMPANY# 000935
OCCIDENTAL CHEMICAL
CORPORATION * DATA TYPES * BOX 809050 EU AT EC FW EF OT DALLAS TX XX 75380
COMPANY# 001516 CURTS LABORATORIES INC * DATA TYPES * 812 WOODSWETHER ROAD
EU AT EC FW EF OT KANSAS CITY MO XX 64105 COMPANY# 002217 PBI/GORDON CORP
ATTN: CRAIG MARTENS * DATA TYPES * BOX 014090 EU AT EC FW EF OT KANSAS
CITY MO XX 64101 COMPANY# 003696 DOWBRANDS L.P. * DATA TYPES * BOX 68511
EU AT EC FW EF OT INDIANAPOLIS IN XX 46268 COMPANY# 007273 CROWN CHEMICAL
INDUSTRIES * DATA TYPES * P.O. BOX 7532 EU AT EC FW EF OT MADISON WI XX
53707 COMPANY# 071754 BEVERIDGE & DIAMOND, LLP AGENT FOR: OUTDOOR
RESIDENTIAL EXPOSURE * DATA TYPES * 1350 I STREET, N.W. EU AT EC FW EF OT
WASHINGTON DC XX 20005 COMPANY# 071755 BEVERIDGE & DIAMOND, LLP AGENT
FOR: AGRICULTURAL RE-ENTRY TASK FO * DATA TYPES * 1350 I STREET, N.W. EU
AT EC FW EF OT WASHINGTON DC XX 20005
|
|
|