Laurie A. Stupak v. Hoffman-LaRoche Inc. ( 2009 )

[DO NOT PUBLISH]
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT
________________________
FILED
No. 07-15980 U.S. COURT OF APPEALS
ELEVENTH CIRCUIT
________________________ JUNE 10, 2009
THOMAS K. KAHN
D. C. Docket No. 05-00926-CV-T-30-TBM CLERK
LAURIE A. STUPAK,
Plaintiff-Appellant,
versus
HOFFMAN-LA ROCHE, INC.,
ROCHE LABORATORIES INC.,
Defendants-Appellees.
________________________
Appeal from the United States District Court
for the Middle District of Florida
_________________________
(June 10, 2009)
Before BARKETT, ANDERSON and COX, Circuit Judges.
PER CURIAM:
Plaintiff Laurie A. Stupak appeals the district court’s grant of summary
judgment to Defendants-Appellees Hoffman-La Roche, Inc. and Roche
Laboratories, Inc. (hereinafter collectively “Roche”). Stupak brought a wrongful
death claim against Roche in the state of Wisconsin for the suicide death of her son
Bartholomew (“B.J.”) Stupak in 2000. Specifically, Laurie Stupak claimed that
Roche was liable under negligence and strict liability for failing to warn that its
prescription acne medication Accutane could cause suicide without premonitory
symptoms. Because Stupak has failed to identify any evidence in the record that
Roche knew or should have known that Accutane could cause suicide without
premonitory symptoms, we affirm the district court’s grant of summary judgment.
I. FACTS
B.J. Stupak was prescribed Accutane for his acne condition in December
1999 by his dermatologist. Accutane is a medicine used to treat severe nodular
acne which has not responded to other treatments. At the time that B.J. Stupak was
prescribed Accutane, the product had the following FDA-approved warnings,
which appeared in the 1998 physician package insert, in a 1998 “Dear Doctor
Letter,” and in the 1999 Physician’s Desk Reference:
Psychiatric Disorders: Accutane may cause depression, psychosis and, rarely,
suicidal ideation, suicide attempts and suicide. Discontinuation of Accutane
therapy may be insufficient; further evaluation may be necessary. No
2
mechanism of action has been established for these events (see ADVERSE
REACTIONS).
...
ADVERSE REACTIONS: . . .
In the post-marketing period, a number of patients treated with Accutane
have reported depression, psychosis and, rarely, suicidal ideation, suicide
attempts and suicide. Of the patients reporting depression, some reported
that the depression subsided with discontinuation of therapy and recurred
with reinstitution of therapy (see WARNINGS).
Roche also produced a patient information brochure including the following
warning at the time that B.J. Stupak took Accutane:
During your treatment
...
YOU SHOULD BE AWARE THAT ACCUTANE MAY CAUSE SOME
LESS COMMON, BUT MORE SERIOUS, SIDE EFFECTS. BE ALERT
FOR ANY OF THE FOLLOWING: . . .
...
! CHANGES IN MOOD
...
IF YOU EXPERIENCE ANY OF THESE SYMPTOMS OR ANY OTHER
UNUSUAL OR SEVERE PROBLEMS, DISCONTINUE TAKING
ACCUTANE AND CHECK WITH YOUR DOCTOR IMMEDIATELY.
THEY MAY BE THE EARLY SIGNS OF MORE SERIOUS SIDE
EFFECTS WHICH, IF LEFT UNTREATED, COULD POSSIBLY RESULT
IN PERMANENT EFFECTS.
The patient information brochure warning set forth above was also printed directly
on the blister pack in which B.J. Stupak’s Accutane prescription was packaged.
In May 2000, while still taking Accutane, B.J. Stupak committed suicide. He
3
was seventeen years old. His family asserts that he exhibited no suicidal symptoms
or changes in mood prior to his suicide. His mother, Laurie Stupak, initiated this
lawsuit against Roche in the Eastern District of Wisconsin in May 2003. Laurie
Stupak asserted in her complaint that B.J. Stupak’s suicide resulted from his taking
Accutane. She asserted that Roche was negligent and strictly liable for failing to
adequately warn of the risks of suicide from taking Accutane.
The case was transferred to the Middle District of Florida for discovery as a
part of In re Accutane Products Liability Litigation pursuant to a multi-district
litigation order. On completion of discovery, Roche moved for summary judgment.
The district court granted summary judgment to Roche on Stupak’s negligence
claim, finding that the warning provided regarding suicide was adequate and that
Stupak could not demonstrate proximate cause. The district court later determined
that there is no difference under Wisconsin law in the standard of proof required
between a negligence failure to warn claim and a strict liability failure to warn
claim, and thus the finding that the warning was adequate also disposed of the strict
liability failure to warn claim. The district court ordered the case closed. Stupak
appealed to this Court.
II. STANDARD OF REVIEW
We review the grant of Roche’s motion for summary judgment de novo,
4
applying the same legal standards as the district court. Pipkins v. City of Temple
Terrace, Fla., 267 F.3d 1197, 1199 (11th Cir. 2001). We view all facts in the light
most favorable to Stupak, the non-moving party. Id. “Summary judgment is only
proper if there are no genuine issues of material fact and the moving party is
entitled to judgment as a matter of law.” Frederick v. Sprint/United Mgmt. Co.,
246 F.3d 1305, 1311 (11th Cir. 2001). We are limited, in our review, to the
evidence that was before the district court at summary judgment. Welch v. Celotex
Corp., 951 F.2d 1235, 1237 n.3 (11th Cir. 1992).
III. DISCUSSION
This case is a tort suit arising under Wisconsin law.1 Laurie Stupak argues
that Roche’s warning regarding suicide associated with Accutane use was not
adequate as a matter of law because it did not warn of the risk of suicide without
premonitory symptoms at the time that her son B.J. took Accutane.2 Stupak also
argues that even if the suicide warning were adequate as a matter of law, her strict
liability claim is distinct from her negligence claim and would survive summary
1
Stupak does not challenge the district court’s application of Wisconsin law.
Although Roche would have preferred the application of Michigan law, our resolution of the case
in its favor under Wisconsin law moots Roche’s arguments. In any event, we see no error in the
district court’s decision to apply Wisconsin law to this claim.
2
This is the only arguably viable challenge that Stupak makes to the adequacy of
the warnings, and thus the only one we discuss.
5
judgment on the negligence claim.3 Therefore, Stupak argues that the district court
erred in granting summary judgment to Roche. Because Stupak has failed to direct
this Court to any evidence in the record to satisfy the requirement for a negligence
claim that Roche knew or should have known that Accutane could cause suicide
without symptoms, and because under Wisconsin law a plaintiff must satisfy that
same requirement for a strict liability claim based on failure to warn, we affirm the
district court’s grant of summary judgment to Roche.
A. Wisconsin Failure to Warn Law
Wisconsin recognizes failure to warn claims arising under both negligence
and strict liability. See, e.g., Mohr v. St. Paul Fire & Marine Ins. Co., 674 N.W.2d
576, 583, 588 (Wis. Ct. App. 2003) (analyzing a failure to warn claim arising under
both negligence and strict liability). Laurie Stupak has raised her failure to warn
claim under both negligence and strict liability theories.
Under Wisconsin law, “[a] negligence action requires the proof of four
elements: (1) A duty of care on the part of the defendant; (2) a breach of that duty;
(3) a causal connection between the conduct and the injury; and (4) an actual loss
or damage as a result of the injury.” Green v. Smith & Nephew AHP, Inc., 629
3
However, it is clear that Stupak’s strict liability claim is based on an alleged
failure to provide an adequate warning. Stupak has not argued that the product was defective or
unreasonably dangerous in any respect other than the inadequacy of the warning.
6
N.W.2d 727, 745 (Wis. 2001). Wisconsin has adopted the Restatement (Second) of
Torts § 388 (1965), which “addresses the duty of a manufacturer to warn in
negligence actions.”4 Strasser v. Transtech Mobile Fleet Service, Inc., 613 N.W.2d
142, 154 (Wis. 2000). See also Vogt v. S.M. Byrne Construction Co., 115 N.W.2d
485, 486-87 (Wis. 1962), modified, 117 N.W.2d 362 (Wis. 1962) (adopting
Restatement (Second) of Torts § 388). The Wisconsin Supreme Court has
summarized the connection between foreseeability and the manufacturer’s duty to
warn: “The standard of care for a ‘manufacturer’ of a product is to warn of dangers
that he or she knows or should know are associated with the proper use of the
product. This duty exists whether or not the product was properly designed.”
Strasser, 613 N.W.2d at 154. Therefore, any negligence action arising under
Wisconsin law premised upon the failure of a manufacturer to adequately warn of a
product’s danger must establish that the manufacturer either knew or should have
known of the danger.
4
The Restatement (Second) of Torts § 388 provides: “One who supplies directly or
through a third person a chattel for another to use is subject to liability to those whom the
supplier should expect to use the chattel with the consent of the other or to be endangered by its
probable use, for physical harm caused by the use of the chattel in the manner for which and by a
person for whose use it is supplied, if the supplier (a) knows or has reason to know that the
chattel is likely to be dangerous for the use for which it is supplied, and (b) has no reason to
believe that those for whose use the chattel is supplied will realize its dangerous condition, and
(c) fails to exercise reasonable care to inform them of its dangerous condition or of the facts
which make it likely to be dangerous.” Mohr, 674 N.W.2d at 583 (emphasis added).
7
The Wisconsin Supreme Court has also held that a manufacturer may be
strictly liable for failure to warn. The Wisconsin Supreme Court first adopted the
Restatement (Second) of Torts § 402A,5 which provides for the “special liability of
seller of product for physical harm to user or consumer,” in Dippel v. Sciano, 155
N.W.2d 55, 63 (Wis. 1967). The Supreme Court of Wisconsin in Dippel read
§402A to require the plaintiff to prove:
(1) that the product was in defective condition when it left the possession or
control of the seller, (2) that it was unreasonably dangerous to the user or
consumer, (3) that the defect was a cause (a substantial factor) of the
plaintiff’s injuries or damages, (4) that the seller engaged in the business of
selling such product . . . and (5) that the product was one which the seller
expected to and did reach the user or consumer without substantial change in
the condition it was when he sold it.
Dippel, 155 N.W.2d at 63. Thus, “strict products liability focuses not on the
defendant’s conduct, but on the nature of the defendant’s product.” Green, 629
N.W.2d at 745. Because the focus in strict liability claims is upon the defective or
unreasonably dangerous nature of the product, and not upon the manufacturer’s
5
Section 402(A) of the Restatement (Second) of Torts states: “One who sells any
product in a defective condition unreasonably dangerous to the user or consumer or to his
property is subject to liability for physical harm caused to the ultimate user or consumer, or to his
property, if (a) the seller is engaged in the business of selling such a product, and (b) it is
expected to and does reach the user or consumer without substantial change in the condition in
which it is sold. (2) The rule stated in subsection (1) applies although (a) the seller has exercised
all possible care in the preparation and sale of his product, and (b) the user or consumer has not
bought the product from or entered into any contractual relation with the seller.” Dippel, 155
N.W.2d at 63.
8
actions, foreseeability is usually not an element of a strict liability claim. Green,
629 N.W.2d at 746 (“In other words, strict products liability imposes liability
without regard to negligence and its attendant factors of duty of care and
foreseeability”).
However, the Supreme Court of Wisconsin held in Schuh v. Fox River
Tractor Co. that a jury could find that the failure to provide an adequate warning on
a product could cause a product to become “unreasonably dangerous and defective
in its design.” Schuh v. Fox River Tractor Co., 218 N.W.2d 279, 284 (Wis. 1974).
Thus, the failure to adequately warn can lead to strict liability in Wisconsin law.
For strict liability claims based on a failure to warn, the Wisconsin courts have
premised the manufacturer’s potential liability on a duty to warn. See Schuh, 218
N.W.2d at 285 (“[T]he likelihood of an accident’s taking place and the seriousness
of the consequences are always pertinent matters to be considered with respect to
the duty to provide a sufficient warning label . . .”); Kozlowski v. John E. Smith’s
Sons Co., 275 N.W.2d 915, 921-22 (Wis. 1979) (holding that under strict liability
and common law negligence inquiry, whether there was a duty to warn was a jury
question because the defect may have been open and obvious). Based on the
inclusion of the “duty to warn” requirement in these strict liability cases, the
Wisconsin Court of Appeals has held that foreseeability is an element of a strict
9
liability failure to warn claim. The Wisconsin Court of Appeals has considered the
issue of foreseeability in strict liability failure to warn cases, and explained that
“[t]he shift in emphasis from the manufacturer’s conduct to the character of the
product is true for strict liability based on product design but not for strict liability
based on failure to warn. The duty to warn involves foreseeability . . . .” Krueger v.
Tappan Co., 311 N.W.2d 219, 223 (Wis. Ct. App. 1981). Furthermore, the Krueger
court held “a product sold without an adequate warning of danger is in a defective
condition. . . . Notwithstanding that apparent merging of defective design and
inadequate warning in the ‘condition’ of the product, the duty to warn arises if the
seller has, or should have, knowledge of a dangerous use.” Id. (citing Restatement
(Second) of Torts § 402A cmts. h & j). See also Tanner v. Shoupe, 596 N.W.2d
805, 812 (Wis. Ct. App. 1999) (“If a product is designed and manufactured to be as
safe as possible, but still contains a hidden danger, the manufacturer has a duty to
warn the consumer of the hidden danger. . . . The duty to warn arises when the
manufacturer has, or should have, knowledge of a dangerous use.”) (internal
quotations and citations omitted).
Therefore, under both negligence and strict liability failure to warn claims,
the duty to warn arises from the foreseeability of the harm encountered by the user.
Hence, in order to maintain an action against a manufacturer for harm arising from
10
the manufacturer’s failure to warn of a danger, whether pursuant to a negligence
theory or a strict liability theory, the plaintiff must prove that the manufacturer
knew or should have known of the danger which caused the harm at issue.6
B) Evidence That Roche Knew or Should Have Known
There is no question that, by the time B.J. Stupak was prescribed Accutane,
the warnings issued by Roche included a warning that Accutane “may cause . . .
suicidal ideation, suicide attempts and suicide.” B.J. Stupak committed suicide.
The district court concluded that the warning regarding suicide issued at the time of
B.J.’s prescription was adequate as a matter of law, because the district court noted
that suicide often occurs without premonitory symptoms. Therefore, the district
court found that the warning that Accutane may cause suicide adequately warned of
6
While Laurie Stupak argues that we should certify a question to the Supreme
Court of Wisconsin on whether a product could still be rendered defective and unreasonably
dangerous even if the manufacturer has provided an adequate warning, based on the Wisconsin
court’s ruling in Green v. Smith & Nephew AHP, Inc., 629 N.W.2d 727, we find such
certification unnecessary. Laurie Stupak has not argued to this Court that Accutane was
defective or unreasonably dangerous in any respect other than the inadequacy of the warning.
We agree with the Wisconsin Court of Appeals in Mohr, 674 N.W.2d at 590 n.10, that Green did
not overrule the foreseeability requirement of the strict liability failure to warn analysis. Green
arose in the context of a claim that a product was defective and unreasonably dangerous because
of an excessive amount of a particular substance; Green did not involve a strict liability claim
based on a failure to warn. Indeed, the opinion in Green distinguished its context from that of a
strict liability failure to warn claim, citing Krueger with apparent approval. Green, 629 N.W.2d
at 746 (citing Krueger, 311 N.W.2d 219 (Wis. Ct. App. 1981)). Therefore, under Wisconsin law
strict liability failure to warn claims, like negligence failure to warn claims, continue to require
the plaintiff to prove that the manufacturer knew or should have known of the danger arising
from use of the product that caused the plaintiff’s injury.
11
the harm suffered. In other words, the district court apparently held that because
suicide frequently occurs without premonitory symptoms, doctors would know
from the simple suicide warning that a risk of suicide without premonitory
symptoms was an encompassed risk. We need not either accept or reject the
district court’s statement that suicide often occurs without premonitory symptoms.7
Instead, we analyze Laurie Stupak’s claim while assuming arguendo that suicide
without premonitory symptoms is materially distinct from “normal” suicide, and
therefore that Roche could have a duty to separately warn of this danger.
As explained above, Roche can only be negligent or strictly liable for a
failure to warn if it had a duty to warn, and Roche only had a duty to warn of
dangers of which it knew or should have known. While Stupak has asserted that
Roche knew or should have known that Accutane could cause suicide without
premonitory symptoms, to survive a motion for summary judgment, a party must do
7
One matter on which the parties were directed to file supplemental briefs was
whether or not the medical literature indicated that suicide does occur with frequency without
premonitory symptoms, and if so why the simple suicide warning actually given would not have
encompassed the thus included risk of suicide without premonitory symptoms. Stupak’s
supplemental brief failed to address the issue. However, Roche’s supplemental brief provides
considerable citations to information in the public domain and available to doctors indicating that
doctors would have known that suicides in general do occur with frequency without premonitory
symptoms. Thus, although we need not (and do not) so decide, it appears that there may well
have been considerable evidence in the public domain to support the district court’s belief that
doctors would know from a simple suicide warning that a risk of suicide without premonitory
symptoms was encompassed. There is no evidence in this record that persons who have taken
Accutane are subject to any different risk (i.e. different from the general public) with respect to
suicide without premonitory symptoms.
12
more than make conclusory allegations. “This court has consistently held that
conclusory allegations without specific supporting facts have no probative value . .
. . One who resists summary judgment must meet the movant’s affidavits with
opposing affidavits setting forth specific facts to show why there is an issue for
trial.” Leigh v. Warner Bros., Inc., 212 F.3d 1210, 1217 (11th Cir. 2000) (internal
citation omitted). Furthermore, as noted above, we are limited in our review to the
evidence that was before the district court at summary judgment. Welch v. Celotex
Corp., 951 F.2d at 1237 n.3. In her response to Roche’s motion for summary
judgment on the issue of warning adequacy, Stupak did not provide the district
court with any indication that there was evidence in the record to support an
inference that Roche knew or should have known that Accutane could cause
suicide without premonitory symptoms. The only mention of evidence that Stupak
provided to the district court in response to Roche’s motion for summary judgment
was an oblique reference to “case reports” of patients who committed suicide
without premonitory signs of depression while taking Accutane. Stupak did not
provide these case reports to the district court, nor did she indicate where in the
record they could be located.8
8
After the district court granted Roche’s motion for summary judgment on warning
adequacy, Stupak filed a motion for reconsideration of summary judgment. In that motion,
Stupak referred to “at least 17 reports of accomplished suicides in Accutane patients who
13
In an abundance of caution, this Court directed Stupak to file a supplemental
letter brief pointing to any evidence in the record and indicating where in the
record it could be found that Roche knew or should have known that Accutane may
cause suicide without overt premonitory signs or symptoms. Stupak’s
supplemental brief refers to three items, and attaches a copy of each as an exhibit to
the supplemental brief. However, notwithstanding our clear direction to indicate
where in the record such evidence could be found, Stupak failed to do so. Roche
argues that the three items are not in the underlying record. “Neither the district
court nor this court has an obligation to parse a summary judgment record to search
out facts or evidence not brought to the court’s attention.” Atlanta Gas Light Co. v.
UGI Utilities, Inc., 463 F.3d 1201, 1208 n.11 (11th Cir. 2006). Accordingly, for
this reason alone, we can conclude that Stupak has failed to adduce evidence that
Roche knew or should have known that Accutane could cause suicide without
premonitory symptoms, and that the district court’s judgment granting summary
judgment to Roche should be affirmed.
exhibited no signs of depression prior to their suicides” located in “a December 21, 1999
Psychiatric Disorder Work-up.” Stupak did not provide the “work-up” or the “17 reports” to the
district court, nor did she indicate where the reports could be located in the record. As discussed
in the text of this opinion, Roche argues that this “work-up” is not in the record. Therefore, we
cannot say that these reports were before the district court at summary judgment. Nonetheless, as
discussed fully in the text, we have considered these reports and have found that they would not
be sufficient to defeat summary judgment.
14
In any event, the three items to which Stupak’s supplemental brief refers are
insufficient to create a genuine issue of fact that Roche knew or should have known
that Accutane could cause suicide without premonitory symptoms. Only the third
item – Roche’s internal Psychiatric Disorder Issue Work-up dated December 21,
1999 and authored by Robert Nelson – deserves discussion.9 This work-up or
report contains a chart from which Stupak extracts information and asserts that the
chart “identified at least 17 reports of accomplished suicides in Accutane patients
who exhibited no signs of depression before their suicides.” These are apparently
the case reports to which Stupak made reference in the district court. Even if we
considered these case reports, they provide no more than a “scintilla of evidence”
to support Stupak’s claim that Roche knew or should have known that Accutane
9
The first of the items to which Stupak’s supplemental brief refers is a February 23,
1998, internal FDA memorandum. This memorandum was not brought to the district court’s
attention, nor is there any evidence that (or even any assertion by Stupak that) Roche would have
had a copy of this memorandum before B.J. Stupak’s suicide. Moreover, the portion of the
memorandum on which Stupak relies is an unanalyzed comment that of twelve case studies
reviewed a majority had “no antecedent history of depression and the patients were not noted or
known to be depressed in the time period prior to their suicide.” Even if Roche had access to this
internal FDA memorandum, and even if the twelve case reports are different from the seventeen
discussed in the text, they are insufficient for the same reasons discussed in the text with respect
to the seventeen case reports. The second item to which Stupak’s supplemental brief refers is a
November 24, 1997, FDA letter to Roche suggesting a labeling change to the effect that: “These
adverse reactions have been reported for patients with and without previous psychiatric
symptoms. It is not known whether a history of psychiatric disorder or pre-existing depression
increases the risk associated with Accutane.” This suggested statement in no way addresses
whether those individuals committed suicide without displaying premonitory symptoms. Rather,
the suggested statement refers to whether a person had a history of psychiatric disorder or
depression prior to taking Accutane.
15
could cause suicide without premonitory symptoms. Therefore, they are
insufficient to defeat a motion for summary judgment. Anderson v. Liberty Lobby,
Inc., 477 U.S. 242, 252, 106 S. Ct. 2505, 2512 (1986). After reviewing the case
reports, it is clear that they are anecdotal, and do not establish whether the
seventeen suicides reported were in fact asymptomatic, or whether the symptoms
were simply not recorded in some of the case reports. Indeed, the Nelson work-up
or report (from which Stupak extracted the seventeen case reports) expressly
discounts the case reports: “The reports of completed suicides were among the
most poorly documented cases reviewed. In the typical case, very little detail was
presented and nothing close to a psychological autopsy was performed on any
case.” Seventeen such inconclusive case reports (out of millions of Accutane
prescriptions) is simply insufficient to support an allegation that Roche knew or
should have known that Accutane could cause suicide without premonitory
symptoms. See McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1254 (11th Cir.
2005) (“Simply stated, case reports raise questions; they do not answer them”);
Rider v. Sandoz Pharmaceuticals Corp., 295 F.3d 1194, 1199 (11th Cir. 2002)
(“[W]hile they may support other proof of causation, case reports alone ordinarily
cannot prove causation”). Therefore, even if these case reports were in the record,
the reports are insufficient to establish that Roche knew or should have known that
16
Accutane could cause suicide without symptoms.
Stupak has simply not provided any evidence from the record that Roche
knew or should have known that Accutane could cause suicide without
premonitory symptoms. Without any evidence that Roche knew or should have
known that Accutane could cause suicide without premonitory symptoms, Stupak
cannot maintain a claim that Roche had a duty to provide a separate warning of that
danger. Because the duty to warn is a necessary element of both negligence and
strict liability failure to warn claims under Wisconsin law, Stupak’s failure to meet
that element requires that we uphold the district court’s grant of summary
judgment. Earley v. Champion Int’l Corp., 907 F.2d 1077, 1080 (11th Cir. 1990)
(“[T]he non-moving party still bears the burden of coming forward with sufficient
evidence on each element that must be proved. . . . If on any part of the prima facie
case there would be insufficient evidence to require submission of the case to a
jury, we must affirm the grant of summary judgment for the defendant”) (internal
punctuation and citations omitted). Accordingly,10 the judgment of the district
court is AFFIRMED.
10
Stupak’s other arguments on appeal are rejected without need for further
discussion, either because our conclusions above moot the argument or because Stupak failed to
provide factual support or legal support for the argument.
17