Kelso, Ted v. Bayer Corporation ( 2005 )

In the
United States Court of Appeals
For the Seventh Circuit
____________
No. 04-2532
TED KELSO,
Plaintiff-Appellant,
v.
BAYER CORPORATION,
Defendant-Appellee.
____________
Appeal from the United States District Court
for the Northern District of Illinois, Eastern Division.
No. 02 C 8601—James F. Holderman, Judge.
____________
ARGUED DECEMBER 7, 2004—DECIDED FEBRUARY 18, 2005
____________
Before BAUER, MANION, and WILLIAMS, Circuit Judges.
MANION, Circuit Judge. Ted Kelso sued Bayer Corpora-
tion for strict product liability, alleging that the warning
Bayer provided on its Neo-Synephrine 12 Hour Extra
Moisturizing Spray was defective. The district court granted
Bayer summary judgment. Kelso appeals. We affirm.
I.
Ted Kelso began using Neo-Synephrine 12 Hour Extra
Moisturizing Spray in 1990. He used Neo-Synephrine con-
tinuously for more than three years. After learning that his
continued use of the product caused permanent nasal tissue
2 No. 04-2532
damage requiring multiple sinus surgeries, he sued Bayer,
the manufacturer of Neo-Synephrine, alleging Bayer failed
to adequately warn him of the dangers associated with Neo-
Synephrine.
Bayer moved for summary judgment, arguing that the
warning it provided, as follows, was adequate, as a matter
of law:
“Do not exceed recommended dosage.”
***
“Stop use and ask a doctor if symptoms persist. Do
not use this product for more than 3 days. Use only
as directed. Frequent or prolonged use may cause
nasal congestion to recur or worsen.”
The district court agreed and granted Bayer summary
judgment. Kelso appeals.
II.
On appeal, Kelso argues that the district court erred
in granting Bayer summary judgment on his failure-to-
warn claim. This court reviews a grant of summary judg-
ment de novo. Williams v. REP Corp., 302 F.3d 660, 662
(7th Cir. 2002). Summary judgment is appropriate if there
are no genuine issues of material fact and the moving party
is entitled to judgment as a matter of law. Id. The parties
agree that Illinois law governs this diversity action.
Kelso argues that summary judgment was inappropri-
ate because he presented sufficient evidence to recover in a
product liability action against Bayer. “To recover in a
product liability action, a plaintiff must plead and prove
that the injury resulted from a condition of the product,
that the condition was an unreasonably dangerous one, and
that the condition existed at the time the product left the
manufacturer’s control.” Sollami v. Eaton, 772 N.E.2d 215,
No. 04-2532 3
219 (Ill. 2002). A product may be unreasonably dangerous
because of a design defect, a manufacturing defect, “or a
failure of a manufacturer to warn of a danger or instruct on
the proper use of the product as to which the average
consumer would not be aware.” Id.Kelso claims the Neo-Synephrine was unreasonably
dangerous because Bayer’s warning was confusing as
to whether or not the product could be used safely for
more than three days, when such use was effective in
relieving his congestion. As Kelso explained in his affidavit,
he interpreted the warning as meaning not to exceed three
days use if the product failed to relieve the congestion; he
only needed to see a physician if the product did not work
to relieve the congestion. Also, because the container
included much more than three days’ dosage, Kelso insists
that he had good reason to believe that he could safely use
Neo-Synephrine for more than three days.
However, Kelso’s personal reaction to the warning is
not the test. Whether a warning is sufficient “is determined
using an objective standard, i.e., the awareness of an
ordinary person.” Klen v. Asahi Pool, Inc., 643 N.E.2d 1360,
1363 (Ill. App. Ct. 1994). Id. (“The duty to warn analysis,
which is an objective one, should focus on the typical user’s
perception and knowledge.”). Here, the plain, clear and
unambiguous language of the warning states: “Do not use
this product for more than 3 days.” Period. That the
Neo-Synephrine container included doses sufficient to treat
multiple users or multiple colds in no way takes away from
the clear impact of the warning. Moreover, the warning
clearly informs users to: “Stop use and ask a physician
if symptoms persist.” The warning was clear. Yet Kelso
continued using the product well beyond the three days. It
is unreasonable to create an ambiguity that excuses
extended use when the warning against such use is un-
equivocal.
4 No. 04-2532
Kelso also argues that the warning was inadequate
because it did not warn users that the product could also
cause permanent nasal tissue damage and also had a risk of
habituation (meaning that users would become dependent
on the product, causing them to use the product for more
than three days). However, under Illinois law, a manufac-
turer need not warn of all possible consequences of failing
to follow a primary warning. Todd v. Societe BIC S.A., 9
F.3d 1216, 1218-19 (7th Cir. 1993). Here, the primary
warning told consumers “not [to] use this product for
more than 3 days.” That was sufficient under Illinois law.
However, Bayer’s warning went even further, informing
consumers of the consequence of extended use, stating:
“[f]requent or prolonged use may cause nasal conges-
tion to recur or worsen.” Although Kelso believes the
warning should have provided him with more detailed
information, Illinois law does not require more. Id. There-
fore, Kelso’s defective warning claim fails.
Moreover, as Bayer points out, the Food and Drug
Administration has issued a monograph that dictates
the language that manufacturers must use for labeling
topical nasal decongestants such as Neo-Synephrine. 59
Fed. Reg. 43386, 43396 (Aug. 23, 1994) (“All OTC drug
labeling required by a monograph or other regulation (e.g.,
statement of identity, warnings, and directions), must
appear in the specific wording established under the
OTC drug monograph or other regulation where exact
language has been established and identified by quota-
tion marks . . . .”). Bayer maintains that because its warn-
ing, excerpted above, complied with the FDA-required
warning, Kelso cannot challenge the adequacy of the
warning.1 For this added reason, we conclude that the
1
The warning provided differed slightly from the current labeling
(continued...)
No. 04-2532 5
warning provided was adequate as a matter of law.2
Kelso also seemingly presents a design defect claim,
arguing that Neo-Synephrine was unreasonably dangerous
because it contained benzalkonium chloride, which is
an antimicrobial preservative used in nasal sprays so that
bacteria will not grow in the product. Kelso argues that the
warning would have been adequate had Bayer deleted the
preservative, benzalkonium chloride, from the Neo-
Synephrine, and that without this ingredient, Kelso would
not have been injured. Kelso, however, failed to raise the
issue of a design defect until his reply brief, and even then
he failed to cite any legal support or develop any legal
argument in support of his position. Therefore, Kelso has
waived any claim of a design defect.3 See Wilson v. Giesen,
956 F.2d 738, 741 (7th Cir. 1992) (“This argument is
waived, however, as the plaintiff failed to raise it until his
reply brief, leaving the defendants no chance to respond.”);
1
(...continued)
requirements, in that it stated: “Stop use and ask a doctor if
symptoms persist,” at the beginning of the warning, whereas the
current regulation requires the warning to end with the sentence:
“If symptoms persist, consult a doctor.” 59 Fed. Reg. at 43388.
Bayer explained during oral argument that at the time it manu-
factured the product used by Kelso, the warning label complied
with the FDA’s specifications.
2
Bayer does not argue that Kelso’s warning defect claim is
preempted by federal law because federal law specified the
required warning. Because we conclude that the warning provided
is adequate under Illinois law, we need not reach the question of
preemption.
3
Kelso also argues that Bayer mislabeled Neo-Synephrine by
listing benzalkonium chloride as an inactive ingredient, when it
was in fact an active ingredient. Bayer counters that the FDA has
listed benzalkonium chloride as an inactive ingredient. However,
because Kelso does not present a misrepresentation claim,
whether benzalkonium chloride is active or inactive is irrelevant.
6 No. 04-2532
Thompson v. Boggs, 33 F.3d 847, 854 (7th Cir. 1994) (“[The
appellant] has failed to develop his argument or cite any
legal authority, thus, under our Circuit’s precedent, the
argument is waived.”).
III.
Kelso used Neo-Synephrine for more than three years,
resulting in permanent injury. However, because Bayer
clearly and explicitly warned consumers not to use Neo-
Synephrine for more than three days, Kelso’s product
liability claim for failure to warn fails. We AFFIRM.
A true Copy:
Teste:
________________________________
Clerk of the United States Court of
Appeals for the Seventh Circuit
USCA-02-C-0072—2-18-05