Washington Court of Appeals Reports

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ESTATE OF SANDRA LAMONTAGNE v. SQUIBB, 53489-1-I (Wash.App. 4-4-2005)
ESTATE OF SANDRA LAMONTAGNE, DONALD LAMONTAGNE, as Personal Representative
of the Estate, DONALD LAMONTAGNE, Individually and as Heir of the Estate;
LYNN DOLLMEYER, Individually and as Heir of the Estate; JULIANN DOLLMEYER,
Individually and as Heir of the Estate, MERRILEE BUCKLEY, Individually and
as Heir of the Estate, MARLEE RIGGIN, Individually and as Heir of the
Estate, JUNE MEEHAN, Individually and as Heir of the Estate, DECEMBER
LAMONTAGNE, Individually and as Heir of the Estate, SCOTT LAMONTAGNE,
Individually and as Heir of the Estate, Appellants, v. BRISTOL-MEYERS
SQUIBB, a Corporation with its principal place of business in the State of
Connecticut; JOSEPH ESCHBACH, MD and JANE DOE ESCHBACH, his wife and their
marital community; ADRIAN CALL, MD and JANE DOE CALL, his wife and their
marital community; JOHN DOE NO. 1, AND JANE DOE NO. 1, his wife and their
marital community; JOHN DOE NO. 2 and JANE DOE NO. 2, his wife and their
marital community; JOHN DOE NO. 3, a manufacturer of generic metformin,
Respondents.
No. 53489-1-I
The Court of Appeals of Washington,
Division One.
Filed: April 4, 2005
UNPUBLISHED OPINION

Appeal from Superior Court of King County. Docket No.
00-2-19742-0. Judgment or order under review. Date filed:
11/14/2003. Judge signing: Hon. Cheryl B Carey.

Counsel for Appellant(s), Ralph David Pittle, Medical Legal
Consultants of WA, 14205 SE 36th St Ste 100, Bellevue, WA
98006-1553.

Counsel for Respondent(s), Timothy Dwight Benedict, Attorney at
Law, 500 Galland Bldg, 1221 2nd Ave, Seattle, WA 98101-3435.

Michael Ramsey Scott, Hillis Clark Martin & Peterson, 500
Galland Bldg, 1221 2nd Ave, Seattle, WA 98101-2925.

SCHINDLER, J.

Juliann Dollmeyer, the personal representative of the Estate of
Sandra LaMontagne (the Estate) appeals the trial court's decision
on summary judgment to dismiss the Estate's prescription drug
product liability claims against Bristol-Myers Squibb Company
(BMS). The Estate contends there are material issues of fact
about whether the "contraindication" section of the package
insert for the prescription drug Glucophager adequately warned
doctors of the risks of lactic acidosis for Type II diabetic
patients who also have kidney dysfunction. The Estate also
contends there are material issues of fact about whether the
negligence of BMS was the proximate cause of Sandra LaMontagne's
death and whether the Estate's lawsuit is barred by the statute
of limitations. We conclude the warnings contained in the
Glucophager package insert repeatedly and unmistakably warn
doctors of the risk of lactic acidosis and the risks of using
Glucophager for patients with kidney dysfunction. We affirm.

FACTS[fn1]

Sandra LaMontagne, a 58-year-old woman, suffered from a number
of long standing health problems including Type II diabetes,
kidney dysfunction, liver impairment, obesity, and congestive
heart failure.

In 1995-96, LaMontagne experienced several serious episodes of
dangerous blood sugar level fluctuations. Despite using insulin
for her diabetes, LaMontagne's blood sugar levels were abnormal
and she experienced increased edema (swelling). Her primary
physician, Dr. Adrian Call, testified that he was having
difficulty successfully treating and controlling LaMontagne's
diabetes.

On January 9, 1997, LaMontagne was admitted to Northwest
Hospital for anemia and hyperkalemia (elevated potassium levels)
and was given blood transfusions. LaMontagne was also continuing
to suffer from edema that resulted in a weight gain in one month
of 30-40 pounds. According to laboratory tests taken on January
17, LaMontagne an elevated creatinine level of 2.0 mg/dL. For
females, a creatinine level above 1.4 mg/dL is abnormal and
indicates kidney dysfunction.[fn2] The laboratory tests also
indicated liver impairment with a GGT level of 740. A GGT level
for a healthy person is 0-40.

On January 20, Dr. Call prescribed Glucophager to control
LaMontagne's diabetes. In 1997, Glucophager was a relatively new
drug used to treat insulin-resistant diabetic patients. Dr. Call
learned about Glucophager from reading articles and lectures and
had previously used Glucophager to treat 10-20 other diabetic
patients.

BMS manufactures the drug metformin under the brand name of
Glucophager. After receiving Federal Drug Administration (FDA)
approval, BMS began marketing Glucophager in the United States in
1995. When metformin accumulates in the blood, it can cause
lactic acidosis, a serious and sometimes fatal condition.
Metformin is primarily removed from the body by the kidneys. The
risk of lactic acidosis significantly increases when a patient
has kidney dysfunction. Other risk factors include liver
impairment and heart problems including congestive heart failure.

LaMontagne took Glucophager from January until June 1997. The
testimony of LaMontagne's doctors and the medical records
establish that they prescribed Glucophager even though she had
kidney dysfunction, the primary risk factor identified for lactic
acidosis. During the entire time LaMontagne took Glucophager, her
creatinine level never dropped below 2.0 mg/dL.

Dr. Call testified that he knew when he prescribed Glucophager
that LaMontagne had known risk factors including kidney
dysfunction, liver impairment and congestive heart disease and he
knew her creatinine levels were elevated.

Q: Now, first of all, did you have any concern at
that time that she had any evidence of renal
impairment?

A: I did have concern about her renal function. She
had had some blood work done in January of '97,
January 9th of "97, where her creatnine was 2.5. And
she had one subsequent to that visit on January 28,
'97 where her creatinine value was 2.3.[fn3]

. . . .

Q: When you started her on Glucophage she had a known
risk factor for lactic acidosis, that being renal
impairment, evidenced by elevated creatinine levels,
correct?

A: Yes.[fn4]

. . . .

Q: Another risk factor for lactic acidosis in
patients receiving Glucophage is congestive heart
failure, is that correct?

A: Yes.

Q: Did Sandra LaMontagne have congestive heart
failure during the time that she was receiving
Glucophage under your prescription?

A: Yes, I believe that she did have congestive heart
failure.[fn5]

But in Dr. Call's clinical judgment, Glucophager was the only
option left to try and manage LaMontagne's diabetes. At the time
there were only three drugs available to control her diabetes and
the first two had failed. Shortly after prescribing Glucophager,
Dr. Call referred LaMontagne to Dr. Joseph Eschbach, a
nephrologist, for an evaluation of her kidney dysfunction and
edema. Dr. Eschbach knew LaMontagne's creatinine level had
elevated to 2.3 mg/dL, and also understood the risks in using
Glucophager. Dr. Eschbach also testified that Glucophager was the
only viable option to manage her diabetes and its benefits out
weighed the risks:

Q: Did you understand in January of 1997 that
metformin was expressly contraindicated in patients
with creatinine levels as high as 2.3?

. . . .

A: I understood the risk involved.

Q: Did you have any concern that the risks exceeded
the benefits of metformin as a choice of managing Ms.
LaMontagne's diabetes?

A: This had to be put in perspective. It was the only
the drug that was managing her diabetes. There were
only three drugs available at that time to manage
diabetes. The first two failed to do so, and that is
why she was placed on metformin. And her husband made
it very clear that this drug was the only drug that
was controlling her diabetes.[fn6]

. . . .

Q: So then did she have three things going on that
made her lactic acidosis risk elevated; one, some
renal impairment; two, some congestive heart failure;
and, three, some liver impairment?

A: Those are all considered risk factors.[fn7]

When Dr. Eschbach saw LaMontagne on February 13, LaMontagne
reported that she felt better and had lost 40 pounds but her
creatinine level was 2.9 mg/dL. LaMontagne saw Dr. Call and Dr.
Eschbach again on February 27. Her creatinine level was 3.5 mg/dL
and her liver function was abnormal. Dr. Eschbach also noted that
LaMontagne had increased her Glucophager dosage on her own.

Q: Did it concern you that increasing dosages of
metformin increased the risk of lactic acidosis?

A: Yes.

. . . .

A: The problem was that we clearly recognized the
risk involved with the medication, and yet there was
no other option in terms of trying to control her
blood sugars, which were well controlled. I was
trying to make sure her renal function was
well-monitored, and that her liver function was
optimized as best we could, in order to try to reduce
whatever risk there was to her from the
metformin.[fn8]

Between April and June 1997 the laboratory reports show that
LaMontagne's creatinine levels remained elevated between 2.1 and
2.5 mg/dL. On June 17, LaMontagne was admitted to Northwest
Hospital. Her metformin level was fourteen times the maximum
therapeutic level and her creatinine level was 4.9 mg/dL.
LaMontagne was diagnosed with metformin-induced lactic acidosis
causing an acute renal failure and was aggressively treated with
antibiotics. She recovered from lactic acidosis and was
discharged on July 7 but was readmitted on July 15 with low blood
pressure and an overwhelming bloodstream infection (sepsis). On
July 26, 1997, LaMontagne died from sepsis.

On July 25, 2000, the Estate sued Dr. Call, Dr. Eschbach, and
BMS. The Estate alleged that BMS did not adequately inform her
doctors of the risks associated with the use of Glucophager and
the failure to adequately warn was a proximate cause of
LaMontagne's death. The Estate alleged that if BMS's warnings
were adequate, then Dr. Call and Dr. Eschbach were negligent in
using Glucophager and failing to inform LaMontagne of the risks
involved.[fn9]

BMS moved for summary judgment. BMS claimed the warnings were
adequate as a matter of law because the Glucophager package
insert warned about lactic acidosis and the use of Glucophager
for patients like LaMontagne. BMS also argued that the warnings
were not the proximate cause of LaMontagne's death and the
Estate's lawsuit was barred by the statute of limitations. The
trial court granted summary judgment and dismissed the Estate's
claims against BMS.

ANALYSIS

LaMontagne argues there is a material issue of fact as to
whether listing renal impairment under the "Contraindications"
heading in the Glucophager package insert adequately warns
doctors that Glucophager should never be used in patients with
mild-to-moderate kidney dysfunction. LaMontagne also argues there
is a material issue of fact as to whether the Glucophager insert
warning was the proximate cause of Sandra's death and whether the
Estate's lawsuit is barred by the statute of limitations. On
review of a decision to grant summary judgment, this court
engages in the same inquiry as the trial court and reviews the
motion for summary judgment de novo. Reynolds v. Hicks,
134 Wn.2d 491, 495, 951 P.2d 761 (1998). Summary judgment is appropriate if
the pleadings and affidavits, if any, show there is no genuine
issue of any material fact and the moving party is entitled to
judgment as a matter of law. CR 56. The moving party bears the
burden of demonstrating there is no genuine dispute as to any
material fact. Green v. A.P.C., 136 Wn.2d 87, 100, 960 P.2d 912
(1998). The court must view the facts and all reasonable
inferences in the light most favorable to the nonmoving party.
Right-Price Recreation, LLC v. Connells Prairie Cmty. Council,
146 Wn.2d 370, 381, 46 P.3d 789 (2002). Generally, the adequacy
of a warning will be a question of fact. See Little v. PPG
Indus., Inc., 92 Wn.2d 118, 123, 594 P.2d 911 (1979) (citing
Haysom v. Coleman Lantern Co., 89 Wn.2d 474, 573 P.2d 785
(1978)). But a question of fact can be determined as a matter of
law when reasonable minds can reach only one conclusion from the
admissible evidence. Smith v. Safeco Ins. Co., 150 Wn.2d 478,
485, 78 P.3d 1274 (2003).

Glucophager Package Insert Warnings

Whether a prescription drug manufacturer provides adequate
warnings to physicians is governed by the negligence standard
under the Restatement (Second) of Torts sec. 402A, cmt. k (1965).
Comment k, adopted by the Washington Supreme Court in Terhune v.
A.H. Robins Co., 90 Wn.2d 9, 12-13, 577 P.2d 575 (1978), is an
exception to strict liability for unavoidably unsafe products.
See also Ruiz-Guzman v. Amvac Chem. Corp., 141 Wn.2d 493,
7 P.3d 795 (2000). Comment k imposes a duty on a drug manufacturer to
warn of the known dangers and risks associated with prescription
drugs:

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.

A warning for a prescription drug may be adequate as a matter
of law if it provides specific and detailed information about the
risks of using the drug. Restatement (Second) of Torts sec. 402A,
cmt. k (1965). To determine whether a warning is adequate
requires an analysis of the warnings as a whole and the language
used in the package insert. The court must examine the meaning
and context of the language and the manner of expression to
determine if the warning is accurate, clear and consistent and
whether the warning portrays the risks involved in taking the
prescription drug. Martin v. Hacker, 83 N.Y.2d 1, 10-11,
628 N.E.2d 1308 (1993); cf. Little v. PPG Indus., Inc., 92 Wn.2d 118,
121-22, 594 P.2d 911 (1979) (determining the adequacy of a
warning by examining whether the warning sufficiently attracted
the attention of the product users and informed them of the
dangers of the product).

In addressing whether a drug manufacturer has met its duty to
give adequate warnings for prescription drugs, Washington has
adopted the "learned intermediary" doctrine. See Terhune,
90 Wn.2d at 13-14. Under the learned intermediary doctrine a drug
manufacturer satisfies its duty "to warn of dangers involved in
use of a product . . . if it gives adequate warning to the
physician who prescribes it." Id. at 13. The Terhune Court
explained that when a product that is available only through
prescription 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 informed judgment thereby gained in conjunction with his
own independent learning, in the best interest of the
patient.[fn10]

To ensure that a prescription drug is reasonably safe, a
manufacturer has a duty to provide warnings or instructions
commensurate with its harm and the risk. RCW 7.72.030(1)(b).
Because the Food and Drug Administration regulations provide only
the minimum requirements for drug manufacturers, compliance with
those regulations does not necessarily establish warnings were
adequate. See Wash. State Physicians Ins. Exchange & Assoc. v.
Fisons Corp., 122 Wn.2d 299, 328-29, 858 P.2d 1054 (1993).

The Estate argues that the testimony of Dr. Frederick Wolff and
Dr. Call supports a reasonable inference that BMS failed to
adequately warn of the risks of prescribing Glucophager to
patients with mild-to-moderate kidney dysfunction for two
reasons: (1) because BMS failed to clearly communicate to
physicians in the "contraindications" section that the risks of
using Glucophager outweigh its benefits in patients with
mild-to-moderate kidney dysfunction and (2) BMS did not expressly
warn physicians that Glucophager should never be used in these
circumstances.[fn11]

The CONTRAINDICATIONS section of the BMS package insert for
Glucophager provides:

CONTRAINDICATIONS:

GLUCOPHAGE is contraindicated in patients with:

1. Renal disease or renal dysfunction (e.g., as
suggested by serum creatinine levels >1.5 mg/dL
[males], >1.4 mg/dL [females] or abnormal creatinine
clearance) which may also result from conditions such
as cardiovascular collapse (shock), acute myocardial
infarction, and septicemia (see also WARNINGS and
PRECAUTIONS).

The Estate admits the Glucophager package insert
clearly states that "the use of Glucophager for any
patient exhibiting signs of significant renal
impairment, such as, creatinine level of 1.4 mg/dL or
above," is "contraindicated" and that the package
insert complies with FDA regulations. But, the Estate
contends the "contraindictions" section of the
package insert fails to communicate that the risks of
using Glucophager clearly outweigh its benefits in
patients with mild-to-moderate kidney dysfunction and
should never be used with these patients.[fn12]
According to the FDA regulations, "contraindications"
refers to "situations in which the drug should not be
used because the risk of use clearly outweighs any
possible benefit." 21 C.F.R. sec. 201.57(d) (emphasis
added). The Estate relies on the testimony of Dr.
Wolff and Dr. Call to argue that in common medical
practice physicians do not interpret
"contraindications" as an absolute concept like the
FDA; rather, contraindication is commonly understood
as a relative concept, with gradations. Consequently,
the Estate argues physicians would not interpret
"contraindications" as listed in the Glucophager
warning label to mean the risks of using Glucophager
clearly outweigh any possible benefits to be expected
from its use. Dr. Wolff testified:

I believe . . . that physicians . . . are generally
not aware of the precise manner in which the FDA uses
[contraindications] when it is used in a package
insert and because of their failure to recognize how
much greater the risk of lactic acidosis would be for
patients who had one or more of the recognized
contraindications. . . . [I]n my experience, most
physicians never receive any training concerning FDA
regulations and consequently have no idea about how
the FDA views contraindications. I believe that most
physicians interpret the word to include "relative"
contraindications rather than "absolute"
contraindications.[fn13]

Dr. Call also testified about his understanding of
"contraindications": We use the word "contraindication" at
various levels. There are absolute contraindications, there are
relative contraindications, and there are gradations, and there
are clinical judgments. But in a general sense the word
"contraindication" would be a reason not to use a
medication.[fn14]

Additionally, the Estate contends that Dr. Call and Dr.
Eschbach's continued use of Glucophager with knowledge of
LaMontagne's kidney dysfunction shows that neither doctor
understood "contraindications" to mean that the risks clearly
outweigh the benefits. But even if we assume that the Estate
presented evidence of material issues of fact about whether the
"contraindications" section alone adequately warned doctors of
the risks associated with prescribing Glucophager, the Estate
fails to address the additional warnings in the other sections of
the package insert. The Estate does not dispute that the
additional warnings in the insert explicitly describe the
circumstances that led to lactic acidosis in LaMontagne and that
the repeated and additional warnings unmistakably warned doctors
about the risks of using Glucophager with a patient who has
kidney dysfunction.

The package insert sets forth information under the following
headings in the order listed: DESCRIPTION; CLINICAL PHARMACOLOGY;
INDICATIONS AND USE; CONTRAINDICATIONS; WARNINGS; SPECIAL WARNING
ON INCREASED RISK OF CARDIOVASCULAR MORTALITY; PRECAUTIONS;
ADVERSE REACTIONS; DRUG ABUSE AND DEPENDENCE; OVERDOSAGE; and
DOSAGE AND ADMINISTRATION.[fn15] The following sections
address the risks associated with use of Glucophager in patients
with kidney dysfunction: CONTRAINDICATIONS; WARNINGS;
PRECAUTIONS; and ADVERSE REACTIONS. These sections are listed
below in relevant part, using the same type face as the actual
insert.[fn16]

CONTRAINDICATIONS:

GLUCOPHAGE is contraindicated in patients with:

1. Renal disease or renal dysfunction (e.g., as
suggested by serum creatinine levels >1.5 mg/dL
[males], >1.4 mg/dL [females] or abnormal creatinine
clearance) which may also result from conditions such
as cardiovascular collapse (shock), acute myocardial
infarction, and septicemia (see also WARNINGS and
PRECAUTIONS).

. . . .

WARNINGS

Lactic Acidosis:

Lactic acidosis is a rare, but serious, metabolic
complication that can occur due to metformin
accumulation during treatment with GLUCOPHAGE; when
it occurs, it is fatal in approximately 50% of cases.
. . .

The reported incidence of lactic acidosis in patients
receiving metformin hydrochloride is very low
(approximately 0.03 cases/1,000 patient-years, with
approximately 0.015 fatal cases/1,000 patient-years).
Reported cases have occurred primarily in diabetic
patients with significant renal insufficiency,
including both intrinsic renal disease and renal
hypoperfusion, often in the setting of multiple
concomitant medical/surgical problems and multiple
concomitant medications. The risk of lactic acidosis
increases with the degree of renal dysfunction and
the patient's age. The risk of lactic acidosis may,
therefore, be significantly decreased by regular
monitoring of renal function in patients taking
GLUCOPHAGE and by use of the minimum effective dose
of GLUCOPHAGE. . . . (see also
PRECAUTIONS).[fn17]

. . . .

. . . .

PRECAUTIONS

General:

Monitoring of renal function — GLUCOPHAGE (metformin
hydrochloride tablets) is known to be substantially
excreted by the kidney, and the risk of metformin
accumulation and lactic acidosis increases with the
degree of impairment of renal function. Thus,
patients with serum creatinine levels above the upper
limit of normal for their age should not receive

GLUCOPHAGE. . . .

Before initiation of GLUCOPHAGE therapy and at least
annually thereafter, renal function should be
assessed and verified as normal. In patients in whom
development of renal dysfunction is anticipated,
renal function should be assessed more frequently and
GLUCOPHAGE discontinued if evidence of renal
impairment is present.

. . . .

ADVERSE REACTIONS

Lactic Acidosis: See WARNINGS, PRECAUTIONS and
OVERDOSAGE Sections.[fn18]

The CONTRAINDICATIONS Section clearly states that the physician
should also review the WARNINGS and PRECAUTIONS sections of the
package insert. The insert not only warns of the general risks of
lactic acidosis in patients with kidney dysfunction in the
WARNINGS section, but in the PRECAUTIONS section the insert
unequivocally states that "patients with serum creatinine levels
above the upper limit of normal for their age should not receive
GLUCOPHAGE"; that "[b]efore initiation of GLUCOPHAGE therapy and
at least annually thereafter, renal function should be assessed
and verified as normal"; and finally that "renal function should
be assessed more frequently and GLUCOPHAGE discontinued if
evidence of renal impairment is present."

Dr. Call and Dr. Eschbach testified that in January 1997 they
knew LaMontagne's creatinine level at 2.3 mg/dL was well above
normal. Despite the express warnings in the Glucophager package
insert that "lactic acidosis increases with the degree of
impairment of renal function" and that "renal function should be
assessed and verified as normal" before beginning Glucophager
therapy, Dr. Call prescribed Glucophager to LaMontagne because
there were no other options to treat her diabetes. As a result,
LaMontagne suffered the very injury that the package insert
warned of, lactic acidosis.[fn19]

The explicit warnings in the Glucophager package insert as a
whole go beyond communicating that the risks clearly outweigh any
possible benefit — the warnings instruct physicians that
Glucophager should not be used in patients with creatinine levels
in the upper limit of normal. Whether physicians, like Dr. Call
and Dr. Eschbach, choose to follow the warnings is a matter of
medical judgment. See Terhune, 90 Wn.2d at 14; accord Adams v.
Synthes Spine Co., 298 F.3d 1114 (9th Cir. 2002).[fn20]

Failure to Provide Information on a Safety Surveillance Test
The Estate also asserts Dr. Wolff's testimony creates an
inference that BMS was negligent in omitting information
regarding the availability of a safety surveillance test in the
package insert. BMS used a blood serum test, referred to as a
safety surveillance test, to measure metformin levels in patients
receiving Glucophager. BMS used the test for private safety
surveillance and research purposes only, and not for patient
care. According to Dr. Wolff, BMS should have made its serum test
available to physicians and informed physicians of availability
of the test in its package insert.[fn21] But the Estate
provides no legal or factual support for this argument and relies
on a false assumption — that the metformin test was available for
clinical use.[fn22] As Dr. Wolff recognized in his
declaration, BMS uses the test for private studies only and it is
not currently available for clinical use.

CONCLUSION

We conclude, the BMS warnings in the Glucophager package insert
unequivocally warned doctors of the risks and were adequate as a
matter of law. We affirm the trial court's decision to grant
summary judgment and dismiss the Estate's product liability
claims against BMS.[fn23]

COX and BAKER, JJ. concur.

[fn1] The facts are not disputed.

[fn2] See Exhibit A to Steven Bass Declaration; National
Institutes of Health, Medline Plus Medical Encyclopedia, at
http://www.nlm.nih.gov/medlineplus/ency/article/000500.htm#
Alternative%20Names.

[fn3] Clerk's Papers (CP) 48-49.

[fn4] CP at 52.

[fn5] CP at 53.

[fn6] CP at 59.

[fn7] CP at 60.

[fn8] CP at 60.

[fn9] Dr. Call and Dr. Eschbach settled with the Estate.

[fn10] Terhune, 90 Wn.2d at 14.

[fn11] LaMontagne does not provide any authority for requiring
such a high standard for a manufacturer's warnings, which tends
to contradict the duty and the reasoning in Terhune. See Terhune,
90 Wn.2d at 14. Reviewing courts are not required to address
arguments that are not supported by authority. See Cowiche Canyon
Conservancy v. Bosley, 118 Wn.2d 801, 809, 828 P.2d 549 (1992);
State v. Johnson, 119 Wn.2d 167, 171, 829 P.2d 1082 (1992); RAP
10.3(a)(5).

[fn12] Brief of Appellant at 14, 16.

[fn13] CP at 198.

[fn14] CP at 176.

[fn15] See Exhibit A to Steven Bass Declaration. The Glucophager
package insert was also published verbatim in the Physician's
Desk Reference.

[fn16] Because the insert exhibit is only a photocopy, it is
difficult to determine whether some of the language has been
bolded. Certain language has been italicized for emphasis.

[fn17] The WARNINGS section is actually enclosed in a box. This
is referred to as a black-box warning and is used when specified
by the FDA. See 21 C.F.R. sec. 201.57(e).

[fn18] Exhibit A to Steven Bass Declaration.

[fn19] Where the manufacturer warns of the injury the plaintiff
suffered, other jurisdictions have found a manufacturer's
warnings adequate as a matter of law. See, e.g., Anderson v.
McNeilab, Inc., 831 F.2d 92, 93 (5th Cir. 1987); Caveny v.
Ciba-Geigy Corp., 818 F. Supp. 1404, 1406 (D. Col. 1992); Cather
v. Catheter Tech. Corp., 753 F. Supp. 634, 640 (S.D. Miss. 1991);
Bealer v. Hoffman-LaRoche, Inc., 729 F. Supp. 43, 45 (E.D. La.
1990); Jones v. Lederle Labs., 695 F. Supp. 700, 708 (E.D.N.Y.
1988); Upjohn Co. v. MacMurdo, 562 So. 2d 680, 683 (Fla. 1990).

[fn20] In Adams, the plaintiff was injured when a plate
surgically implanted into his spine broke. Adams,
298 F.3d at 1118. The manufacturer of the surgically implanted Synthes Spine
plate, recommended removal of the plate because the plate could
break — the precise harm that the plaintiff suffered. Id. at
1118. The court in Adams applied Washington law and decided the
warnings were adequate as a matter of law because a reasonable
jury could not reach any other conclusion. See id. at 1115-16,
1118. The fact that the physicians in Adams did not follow the
manufacturer's recommendations did not show that they "couldn't
or didn't read it and understand it, just that in their medical
judgment, it wasn't wise to follow it." Id.

[fn21] CP at 201.

[fn22] Reviewing courts will not address issues not supported by
authority. See Cowiche Canyon Conservancy v. Bosley,
118 Wn.2d 801, 809, 828 P.2d 549 (1992); State v. Johnson, 119 Wn.2d 167,
171, 829 P.2d 1082 (1992); RAP 10.3(a)(5).

[fn23] Because we conclude the Glucophager package insert
warnings were adequate as a matter of law, we do not need to
address the proximate cause and statute of limitations
arguments.



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