Karen L. Bartlett v. Mutual Pharmaceutical Company, Inc.

United States Court of Appeals
For the First Circuit
No. 10-2277
KAREN L. BARTLETT,
Plaintiff, Appellee,
__________
GREGORY S. BARTLETT,
Plaintiff,
v.
MUTUAL PHARMACEUTICAL COMPANY, INC.,
Defendant, Appellant,
__________
UNITED RESEARCH LABORATORIES, INC., n/k/a URL Pharma, Inc.;
BROOKS PHARMACY,
Defendants.
APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF NEW HAMPSHIRE
[Hon. Joseph N. Laplante, U.S. District Judge]
Before
Boudin, Stahl and Thompson,
Circuit Judges.
Joseph P. Thomas with whom Linda E. Maichl, Paul J. Cosgrove,
Ulmer & Berne LLP, Stephen J. Judge, Pierre A. Chabot and Wadleigh,
Starr & Peters PLLC were on brief for appellant.
Joseph P. Lucia, David R. Geiger, Nabeel Ahmad, Foley Hoag LLP
and Hugh F. Young, Jr., Product Liability Advisory Council, Inc.,
on brief for the Product Liability Advisory Council, Inc., Amicus
Curiae.

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Keith M. Jensen with whom Eric N. Roberson, Jensen &
Associates, PLLC, Steven M. Gordon, Christine M. Craig and Shaheen
& Gordon were on brief for appellee.
Louis M. Bograd, Center for Constitutional Litigation, P.C.,
Andru H. Volinsky, Chair, New Hampshire Association for Justice
Amicus Committee, and Bernstein Shur, P.C. on brief for the
American Association for Justice and the New Hampshire Association
for Justice, Amici Curiae.
May 2, 2012

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BOUDIN, Circuit Judge. This products liability case
arises out of severe and permanent injuries sustained by plaintiff
Karen Bartlett after taking sulindac, a generic non-steroidal anti-
inflammatory drug ("NSAID") manufactured by (among others)
defendant Mutual Pharmaceutical Company ("Mutual"). Sulindac is
known to cause, in rare instances, a hypersensitivity reaction
called Stevens-Johnson Syndrome and its more generous cousin toxic
epidermal necrolysis ("SJS/TEN"). In December 2004, Bartlett's
doctor prescribed (for her shoulder pain) sulindac under the brand-
name Clinoril made by the original provider, and her pharmacist
dispensed generic sulindac.
The consequences were disastrous. Bartlett developed
SJS/TEN early in 2005. TEN is diagnosed when 30 percent or more of
the outer skin layer on a patient's total body surface area has
deteriorated, been burned off or turned into an open wound. In
Bartlett's case, the percentage rose to 60-65 percent of her body;
she spent 70 days at Massachusetts General Hospital--including over
50 in its burn unit. Both her suffering and permanent injury,
including permanent near-blindness, are described below in
connection with the award of damages.
Bartlett brought a bevy of claims against Mutual in New
Hampshire state court, including claims for breach of warranty,
fraud, and negligence, as well as the perennial trio of products
liability claims: design defect, failure to warn, and manufacturing
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defect. After Mutual removed the case to federal court on
diversity grounds, all but the design defect claim were dismissed
by the district court on summary judgment or voluntarily by
Bartlett. Bartlett v. Mutual Pharm. Co., No. 08–cv–358, 2010 WL
3659789 (D.N.H. Sept. 14, 2010); Bartlett v. Mutual Pharm. Co., 731
F. Supp. 2d 135 (D.N.H. 2010).
Bartlett originally planned her evidence across a range
of possible claims, including an attack on the adequacy of the
warning label and information that accompanied Mutual's sulindac
drug. It was not until after the trial was completed that further
legal developments (discussed below) foreclosed a direct attack on
the adequacy of the label; but the district court dismissed
Bartlett's warning claim because her prescribing doctor admitted
that he had not read the box label or insert. Bartlett, 731 F.
Supp. 2d at 146-49.
Although Bartlett's experts had prepared their initial
reports to cover multiple theories advanced in the complaint, by
trial the core remaining theory of design defect was narrowed to
this: that sulindac's risks outweighed its benefits making it
unreasonably dangerous to consumers, despite the federal Food and
Drug Administration ("FDA") having never withdrawn its statutory
"safe and effective" designation that the original manufacturer had
secured and on which Mutual was entitled to piggyback. See 21
U.S.C. §§ 355(b)(1), (d) (2006); id. § 355(j)(2)(A).
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A 14-day trial occurred in late August and early
September 2009, during which Bartlett called witnesses to her
suffering and her treatment, including two important experts: a
burn surgeon and--more critical to design defect--a
pharmacologist/toxicologist. The latter expert in particular
sought to show from incident reports made to the FDA and other
information that sulindac had a worse record of causing SJS/TEN
than other available drugs, and a safety profile similar to other
drugs deemed dangerous enough to have been withdrawn from the
market--such as valdecoxib, another NSAID sold under the brand name
Bextra, which was withdrawn in 2005.
Mutual had designated its own expert in the same field as
well as other witnesses but ultimately chose to put on no
affirmative case of its own, although it cross-examined Bartlett's
experts vigorously and offered substantial legal arguments to the
judge as to why it should not be found liable. After several days
of deliberation, the jury found for Bartlett and awarded $21.06
million in compensatory damages. The district court denied
Mutual's motion for judgment as a matter of law, Fed. R. Civ. P.
50(b), and motion for a new trial, Fed. R. Civ. P. 59. Bartlett v.
Mutual Pharm. Co., 760 F. Supp. 2d 220 (D.N.H. 2011).
Mutual now appeals, arguing that the district court
misunderstood New Hampshire law on design defect claims; that such
claims as to generic drugs are preempted under federal law; that
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causation was not proved; that Bartlett's expert evidence was
inadmissible on multiple grounds; that instructions as to label
warnings were inaccurate; that misconduct by Bartlett's counsel
required a new trial; and that damages were excessive and required
a new trial. The standard of review depends upon the issue, the
first two raising strictly issues of law that we review de novo.
U.S. ex rel. Loughren v. Unum Grp., 613 F.3d 300, 307-08 (1st Cir.
2010).
Design Defect. Although courts "traditionally have
refused to review the reasonableness of the designs of prescription
drugs," Restatement (Third) of Torts: Products Liability § 6,
cmt. f, at 156 (1998), this court reads New Hampshire law now to
permit such review, Brochu v. Ortho Pharm. Corp., 642 F.2d 652, 655
(1st Cir. 1981). Brochu is consistent with the New Hampshire
Supreme Court's adoption of Restatement (Second) of Torts § 402A
(1965), see Buttrick v. Lessard, 260 A.2d 111, 113 (N.H. 1969),
which "imposes liability for selling 'any product in a defective
condition unreasonably dangerous to the user or consumer' when the
product causes injury to the user or consumer."
However, Mutual interprets Buckingham v. R.J. Reynolds
Tobacco Co., 713 A.2d 381 (N.H. 1998), to require not merely
unreasonable dangerousness but also proof that there exists an
alternative, safer design for the product (like a new guard on a
motorized table saw), see id. at 384. The claim in Brochu could
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satisfy such a test, because the drug at issue there contained a
mix of progestogen and estrogen, and its unreasonable dangerousness
could be attributed to the design-flaw of an unnecessarily high
proportion of estrogen.
By contrast, Mutual says that Bartlett failed to allege
and prove that sulindac could be made in a different and safer
form, and this almost certainly has to be true: sulindac is a one-
molecule drug; and the variations in suldinac as sold consist of
inactive ingredients that ordinarily do not have significant
pharmacological effects. But Buckingham does not clearly say that
a safer alternative is a necessary element of design defect over
and above an unreasonably dangerous product, and a subsequent
decision disavows any such requirement.
In Vautour v. Body Masters Sports Indus., Inc., 784 A.2d
1178, 1183 (N.H. 2001), which followed after Buckingham, the New
Hampshire Supreme Court held that proof of a safer alternative
design "should be neither a controlling factor nor an essential
element that must be proved in every [design defect] case."
Rather, it said that "a product is defective as designed 'if the
magnitude of the danger outweighs the utility of the product.'"
Id. at 1182 (quoting Keeton et al., Prosser and Keeton on the Law
of Torts § 99, at 699 (5th ed. 1984)).
Buckingham involved a design defect claim against
cigarette manufacturers, and the court dismissed the claim on the
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ground that cigarettes are inherently dangerous and commonly known
to be so. 713 A.2d at 384; see also Restatement (Second) of Torts
§ 402A, cmt. i (danger "beyond that which would be contemplated by
the ordinary consumer"). But an ordinary consumer would hardly
know without further warning that sulindac or any other ordinary
analgesic carries a risk of the kind of ill effects and suffering
that Bartlett encountered.
Accordingly, the district court properly allowed Bartlett
to show that sulindac was in a "defective condition" by showing
that it was "unreasonably dangerous" due to its propensity to cause
SJS/TEN--a harrowing hypersensitivity reaction characterized by
necrosis of the skin and mucous membranes, and often causing
blindness or death. Although Mutual could still have avoided
liability by proving that sulindac was unavoidably unsafe but was
highly useful and had an adequate safety warning, Bartlett, 731 F.
Supp. 2d at 150-51; Restatement (Second) Torts § 402A, cmt. k,
Mutual abandoned that defense on the eve of trial. 1
1Although Mutual has not explained its strategy, the district
court had already rejected Bartlett's claims based on failure to
warn for lack of causation, and Mutual may have hoped to exclude
entirely any evidence of the warnings actually employed by Mutual,
which had listed SJS/TEN as a potential "adverse reaction" in its
package insert without explicitly naming SJS/TEN on the label's
"warnings" section. Or, it may have thought that Bartlett's expert
testimony could be undermined without risking cross-examination of
its own expert who might have had to concede some of the dangers
posited by Bartlett.
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Mutual restates its no-defect argument as an issue of
causation; but given the overwhelming evidence that sulindac
triggered Bartlett's reaction, "but for" cause is plainly
established, Bartlett, 760 F. Supp. 2d at 246. Mutual's position
that "Bartlett could not present evidence that a non-existent
defect in the sulindac proximately caused her injury," merely
restates the argument about New Hampshire law that we have just
rejected.
Preemption. The most far-reaching of Mutual's objections
is that Bartlett's design defect claim is preempted by the Federal
Food, Drug, and Cosmetic Act, 21 U.S.C. § 301 et seq. ("FDCA"),
and--in particular--by the Drug Price Competition and Patent Term
Restoration Act of 1984, Pub. L. No. 98-417, 98 Stat. 1585 (1984)
(codified at 21 U.S.C. § 355(j)(2)(A)) ("Hatch-Waxman Amendments"),
and its regulations. Whether and to what extent the FDCA preempts
design defect claims against generic drug manufacturers is a
question of exceptional importance that the Supreme Court has yet
to decide.
Because prescription drugs and their warnings are closely
regulated by the FDA, Congress might explicitly, or the Supreme
Court by implication, have preempted state design defect or
inadequate warning claims that allow state juries to second-guess
the FDA's seal of approval. But the statute contains no general
preemption provision, and in Wyeth v. Levine, 555 U.S. 555 (2009),
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the Supreme Court rejected implied preemption, saying that
"Congress did not intend FDA oversight to be the exclusive means of
ensuring drug safety and effectiveness," id. at 575, and that state
law serves as a "complementary form of drug regulation," id. at
578.
Although Wyeth's holding was technically limited to
failure-to-warn claims, 2 its logic applies to design defect claims
as well. See Wyeth, 555 U.S. at 574 (state tort suits "motivat[e]
manufacturers to produce safe and effective drugs and to give
adequate warnings") (emphasis added); cf. Wimbush v. Wyeth, 619
F.3d 632, 645 & n.7 (6th Cir. 2010) (negligent marketing claim not
preempted). The lower courts agree that the FDCA does not preempt
state tort suits against drug manufacturers. See Riegel v.
Medtronic, Inc., 552 U.S. 312, 340 n.11, 343 n.16 (2008) (Ginsburg,
J., dissenting) (collecting cases).
However, in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567
(2011), the Court carved out an exception to Wyeth, finding that
the FDCA preempts failure-to-warn claims against generic drug
2More specifically, Wyeth held that the FDCA does not preempt
failure-to-warn claims against brand-name drug manufacturers.
Because the FDA's "changes being effected" regulations, 21 C.F.R.
§ 314.70(c)(6)(iii)(A), (C) (2008), permit brand-name manufacturers
to strengthen their labels unilaterally--albeit temporarily, while
application for permanent change is pending with the FDA--the Court
concluded it is possible for brand-name manufacturers to comply
with both federal labeling requirements and state tort law
effectively requiring a stronger label. 555 U.S. at 568, 573.
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manufacturers. Generic drug manufacturers, unlike brand-name
manufacturers, cannot unilaterally change their labels, 21 C.F.R.
§ 314.94(a)(8)(iv) (2011), and thus cannot comply with both federal
labeling standards and state law requirements deviating from those
standards. PLIVA, 131 S. Ct. at 2578.
There is no doubt that Congress wanted to reduce medical
costs by spurring generic copycat drugs, and accordingly generic
manufacturers do not, after patent protection lapses, need separate
FDA approval to manufacture approved drugs or employ their approved
labeling. See PLIVA, 131 S.Ct. at 2574, id. at 2582; see also 21
U.S.C. § 355(j)(2)(A). But, as the generic maker cannot alter the
labeling, PLIVA held that Congress cannot have wanted the generic
to pay damages under state law for a label that the FDA required.
Mutual argues with some force that the generic maker also
cannot alter the composition of the drug and so PLIVA's policy of
encouraging generics by preempting state tort claims should extend
to design defect as well as claims based on inadequate warning.
But although Mutual cannot legally make sulindac in another
composition (nor is it apparent how it could alter a one-molecule
drug anyway), it certainly can choose not to make the drug at all;
and the FDCA might permit states to tell Mutual it ought not be
doing so if risk-benefit analysis weights against the drug, despite
what the Supreme Court made of similar arguments in the labeling
context.
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This is second-guessing the FDA (unless new information
emerged known to the maker but not the FDA), but Wyeth resolved the
conflict against general preemption. And, not only has the Supreme
Court not yet said it would extend PLIVA's exception to design
defect claims, but--while the generic maker has no choice as to
label--the decision to make the drug and market it in New Hampshire
is wholly its own. Thus, Bartlett having lost her warning claim by
the mere chance of her drug store's selection of a generic, the
Supreme Court might be less ready to deprive Bartlett of her
remaining avenue of relief.
True, such arguments can be turned on their head. 3 To
refuse preemption here is consistent with Wyeth but in tension not
with the holding but with part of PLIVA's rationale; a generic
maker can avoid defective warning lawsuits as well as design defect
lawsuits by not making the drug; and while PLIVA is itself a
limited departure from a general rule of Wyeth, an extension of
PLIVA to design defect claims would comprise a general rule for
generics (although not one PLIVA expressly adopted).
On balance, we conclude that the Court adopted a general
no-preemption rule in Wyeth and that it is up to the Supreme Court
3Cf. In re Darvocet, Darvon & Propoxyphene Prods. Liab.
Litig., No. 2:11–md–2226, 2012 WL 718618, at *2-*3 (E.D. Ky. Mar.
5, 2012); Lyman v. Pfizer, Inc., No. 2:09–cv–262, 2012 WL 368675,
at *4 (D. Vt. Feb. 3, 2012); In re Pamidronate Prods. Liab. Litig.,
Nos. 09–MD–2120, 10–CV–1860, 2012 WL 272889, at *3 (E.D.N.Y. Jan.
30, 2012).
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to decide whether PLIVA's exception is to be enlarged to include
design defect claims. Cf. Khan v. State Oil Co., 93 F.3d 1358,
1362-64 (7th Cir. 1996), vacated and remanded, 522 U.S. 3 (1997).
Given the widespread use of generic drugs and the developing split
in the lower courts, see note 3, above, this issue needs a decisive
answer from the only court that can supply it.
Expert Testimony. Next in the crosshairs are Bartlett's
experts--pharmacologist/toxicologist Randall Tackett and burn
surgeon Roger Salisbury. Mutual argues they were not qualified to
offer their opinions, and that the opinions were either unreliable
or undisclosed in their expert reports. The governing law is set
forth in the Federal Rules of Evidence and Civil Procedure, 4 and
Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993), which
makes the judge the gatekeeper to assure that purported scientific
evidence has legitimate basis. We review for abuse of discretion,
Milward v. Acuity Specialty Prods. Grp., 639 F.3d 11, 13 (1st Cir.
2011), cert. denied, 132 S. Ct. 1002 (2012), and find none here.
Tackett and Salisbury offered a variety of opinions, the
most relevant here relating to sulindac's risks and benefits. The
district court found unreliable any explicit opinion that sulindac
4Fed. R. Evid. 702 (permitting qualified experts with
specialized technical knowledge to provide opinions if based on
application of reliable principles, methods, and data); Fed. R.
Civ. P. 26(a)(2)(B) (expert report must contain "a complete
statement of all opinions the witness will express and the basis
and reasons for them"); Fed R. Civ. P. 37(c)(1) (prohibiting use of
undisclosed information).
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has a higher risk of causing SJS/TEN than other NSAIDs--what it
called an opinion about "relative risk." But otherwise, the
district court allowed Bartlett's experts:
-to opine that sulindac's overall risk/benefit
profile was unfavorable for marketing
-to opine that aspirin and acetaminophen,
which have no known connection to SJS/TEN, are
safer alternatives to sulindac
-to discuss voluntary "adverse event reports"
(AERs) from prescribing doctors to the FDA,
and the limitations of such data
-to opine--based on the number of AERs and an
estimated number of sulindac prescriptions--on
the "reporting rate" of SJS/TEN, and to
compare drugs' reporting rates
-to offer various opinions about the
inadequacy of sulindac's warning to counteract
its dangerousness
-and to opine that the FDA lacks the resources
to ensure that all marketed drugs are safe and
effective.
Mutual argues that the two experts were not qualified,
noting that neither witness ever prescribed an NSAID, and Tackett
is not authorized to prescribe any drugs. But Salisbury is a burn
surgeon with over 35 years' experience who treated more than 400
patients with SJS/TEN. Tackett is a pharmacologist and
pharmacology professor with over 30 years' experience. Both had
some experience with the FDA through their 2005 Citizen's Petition
requesting an SJS/TEN risk assessment and labeling change for
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ibuprofen. And their reports demonstrate substantial familiarity
with the relevant medical literature.
Alternatively, Mutual argues that the opinions lack
scientific basis and were inadmissibly unreliable, focusing on
their use of AERs, voluntary reports from medical professionals and
consumers to the FDA regarding patients' adverse reactions to
pharmaceuticals. The FDA collects this information; and relevant
data for sulindac included 89 reports of SJS/TEN from 1980 to 1997,
increasing to 134 by 2004; 39 cases of death; and one of the
highest SJS/TEN reporting rates among NSAIDs.
Mutual says there are no quality controls on spontaneous
reports; that various biases may increase reporting, including
increased reporting following introduction of a new warning (a
phenomenon called the "Weber effect"); and the difficulty of
determining the number of total prescriptions ("denominator data")
to determine a reporting rate. The FDA itself warns that
"[a]ccumulated case reports cannot be used to calculate incidence
or estimates of drug risk." Mutual also argues there is no
accepted methodology for comparing drugs based on adverse event
data.
But proof that a significant number of adverse reports
exists is part of the calculus and surely relevant input for a
witness who is prepared to opine on the risk-benefit ratio based on
a range of considerations. Mutual's own designated expert, Robert
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Stern, relied on adverse event data and comparative reporting rates
in a peer-reviewed publication designed to quantify the risk of
SJS/TEN associated with the use of NSAIDs ("Mockenhaupt 2003").
And the FDA itself considered the SJS/TEN reporting rate of
Bextra--another NSAID--in recommending its withdrawal, and
published a study comparing SJS/TEN reporting rates among certain
NSAIDs.
As for biases that might distort the level of reporting,
these are usually matters to be developed on cross-examination and
go to the weight of the evidence unless the biases are so
overwhelming as to make the data useless. And, as icing on the
cake, at least one well-recognized limitation of adverse event
data--underreporting--actually works in Bartlett's favor.
Bartlett, 760 F. Supp. 2d at 234. Controlled studies would likely
be superior but apparently none were available to quantify
sulindac's incidence of causing SJS/TEN. Id. at 237.
Mutual is correct that in some cases courts found AERs
and similar case reports insufficient to establish that a drug
caused a certain adverse event, but these involved adverse events
with innumerable possible causes (e.g. suicidal behavior, strokes,
or birth defects). 5 Here, sulindac is a recognized cause of
5E.g., Miller v. Pfizer, Inc., 196 F. Supp. 2d 1062, 1077 (D.
Kan. 2002); Siharath v. Sandoz Pharms. Corp., 131 F. Supp. 2d 1347,
1361 (N.D. Ga. 2001); Wade-Greaux v. Whitehall Labs., Inc., 874 F.
Supp. 1441, 1481 (D.V.I. 1994); DeLuca v. Merrell Dow Pharms.,
Inc., 791 F. Supp. 1042, 1050-51 (D.N.J. 1992).
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SJS/TEN and the evidence is that it caused Bartlett's SJS/TEN. Cf.
Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 815 n.38 (5th Cir.),
cert. denied, 504 U.S. 956 (1992) (10 seizure reports of dubious
connection to the drug at issue).
Further, the district court excluded opinions based on
what Tackett admitted to be unreliable--namely, a direct comparison
of sulindac's risk of SJS/TEN to other NSAIDs (including Bextra).
The district court also admonished counsel not to confuse
"reporting rates" with "actual incidence rates," and instructed the
jury that, while it had heard evidence about sulindac's SJS/TEN
reporting rate, it had not heard evidence about the actual rate at
which sulindac causes SJS/TEN. But it was at least a sufficient
danger that sulindac's labeling, whether adequately or not, warned
doctors about it.
Next, Mutual argues that Bartlett's experts failed to
account for various shortcomings in adverse event data--for
example, that they failed to consider whether the "Weber effect"
increased sulindac's adverse event reporting; that sulindac's
reporting rate in certain years may have been inflated because
prescription data had to be approximated; and that Tackett's
initial report count was inflated by duplicate reports and reports
in which sulindac was not the cause of the adverse effect (Tackett
later supplied corrected data).
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But these objections were raised mid-trial although
apparently known to Mutual much earlier, and Mutual was free
to--and did--highlight the flaws on cross-examination. Mutual was
also free to develop evidence to show lesser benefits or greater
dangers from alternative NSAIDs or similar drugs like
acetaminophen. Mutual finally objects that the experts did not
testify to the ultimate issue of "unreasonable dangerousness," but
that was at the district court's order and was meant to work to
Mutual's benefit.
Finally, Mutual argues that the opinions, bases and
supporting materials used by Bartlett's experts at trial were not
adequately disclosed in the pre-trial disclosures for expert
testimony. The original expert reports focused on some issues--
labeling and marketing in particular--that were downplayed or
dropped as the case was narrowed; but, as the district court
declared, "the reports were filled with opinions about sulindac's
risks and benefits," the weighing of which determines unreasonable
dangerousness and, ultimately, design defect. Bartlett, 760 F.
Supp. 2d at 233. So Mutual was hardly ambushed by the main thrust
of the experts' testimony.
But Mutual does claim that some important underpinnings
were not adequately disclosed in Tackett's expert report which,
together with expert depositions, is what allows the other side to
prepare its own experts and effectively cross-examine at trial.
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Metavante Corp. v. Emigrant Sav. Bank, 619 F.3d 748, 762 (7th Cir.
2010), cert. denied, 131 S. Ct. 1784 (2011). This kind of policing
is primarily a matter for the district judge, Gay v. Stonebridge
Life Ins. Co., 660 F.3d 58, 64 (1st Cir. 2011), but in extreme
cases, appellate review is a backstop, see Licciardi v. TIG Ins.
Grp., 140 F.3d 357, 363-64 (1st Cir. 1998).
In this case, Mutual lays special stress on two
documents. One concerns a 2005 FDA analysis of NSAID risks (the
"Bextra Memo") connected to the ultimate withdrawal of Bextra, a
different NSAID, because of undue SJS/TEN risk. Contrary to
Mutual's assertion, the Bextra Memo was cited in Tackett's report
not merely for the proposition that the FDA had approved NSAID
labeling changes; it also was cited to draw comparisons between
Bextra and sulindac, and Mutual cannot properly claim to have been
ambushed by this use.
More dangerous to Mutual were data relied on by Tackett
from a draft report on NSAID SJS/TEN risk, prepared by Robert Stern
(who, again, was Mutual's designated expert) for the drug company
Pharmacia (the "Pharmacia Report"), in forming his opinion about
sulindac's high reporting rate of SJS/TEN. The Pharmacia Report
has a storied history in this litigation--with Bartlett faulting
Stern for failing to disclose the report during discovery, and the
district court ordering supplemental deposition of Stern about it,
only to discover that Tackett knew about the report all along.
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Tackett at least cited the eventually-published version
("Mockenhaupt 2003") in support of statements in his expert report
that "Sulindac had significantly and substantially higher rates of
reported SJS/TEN reactions relative to the office visits compared
to other NSAIDs," that "Sulindac ranked in the top 5 of all drugs
to cause SJS and TEN between 1980-1997," and "[c]ompared to other
NSAIDs Sulindac had a higher reporting rate of SJS and TEN."
Although the Pharmacia Report added that sulindac may have had the
highest SJS/TEN reporting rate among NSAIDs from 1980 to 1997,
neither the report nor Tackett's opinion about sulindac's high
SJS/TEN reporting rate were a surprise to Mutual by the time of
trial.
Labeling Instructions. Mutual next faults the district
court for telling the jury it could "consider the FDA's
requirements for drug labels" in determining whether sulindac's
warning mitigated its unreasonable dangerousness, and for failing
to instruct the jury that Mutual could not legally change
sulindac's label. Mutual argues that the jury must have inferred,
incorrectly, that it could consider whether Mutual should have
improved the warnings. As already explained, under current law the
original maker, but not the generic provider, can alter the label.
But the label was relevant to the design defect claim
since, although unalterable by Mutual, its arguable inadequacies
put limits on the extent to which its dangerousness was offset by
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adequate warnings; so the lack of a clearer warning made the
product itself more dangerous under the risk-benefit test
prescribed by Vautour. The district court's instructions, in a
section covering "The warning" did make clear that this was the
relevance of the label. 6 If Mutual wanted a further caution in the
instructions, it should have sought it.
Of course, at the time of the trial, PLIVA had not yet
been decided, so such a caution might not have been at the
forefront of Mutual's thoughts. But the legal argument for such a
caution was available to Mutual without PLIVA, cf. note 2; indeed,
Mutual made this very argument in seeking a new trial before PLIVA
was decided. Mutual failed to seek such an instruction before the
jury retired; and the instructions given were not plain error.
Counsel's Conduct. In its motion for a new trial, Mutual
argued that the conduct of plaintiff's counsel was improper in
various respects and that a new trial was justified on this count
alone. In a post-trial motion of this sort, our review is for
abuse of discretion; and where the charges involve judgments about
degrees of impropriety, prejudice and cumulative effect, the trial
judge has a special advantage over a reviewing court.
6Mutual directs us to an allegedly contradictory statement by
the district court that "[l]iability may exist if the manufacturer
did not take available and reasonable steps to lessen or eliminate
the danger of even a useful and desirable product." In context, it
is clear these statements were made regarding product design and
not labeling.
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Hatfield-Bermudez v. Aldanondo-Rivera, 496 F.3d 51, 64 (1st. Cir.
2007).
Of the many charges, several relating to alleged non-
disclosures in the expert reports have already been answered;
others are fairly trivial (a rhetorical claim that sulindac "stole"
Bartlett's freedom) or had no conceivable impact (a sequestration
order violation where Bartlett's husband observed his sister-in-law
testify but in the end did not himself appear as a witness). We
pass over such issues and focus on those that are potentially more
serious.
First, in voir dire Bartlett's counsel asked the jury to
consider whether it could award "$20 million or more in damages";
but Bartlett's counsel had expressed their intent to mention
specific damages figures, and Mutual did not seek to prevent the
question in advance. After Mutual objected at voir dire,
Bartlett's counsel were prohibited from mentioning total dollar
figures again until closing, and the jury was told that any amount
mentioned by counsel was "not evidence in this case." 7
Second, counsel also--despite an order prohibiting
discussion of Mutual's financial condition, Bartlett v. Mutual
7In closing, counsel suggested between $20 and $30 million for
pain and suffering alone. Although allowing counsel to do so was
error under First Circuit precedent, Davis v. Browning-Ferris
Indus., Inc., 898 F.2d 836, 837-38 (1st Cir. 1990), Mutual
apparently assented to counsel doing so, provided the district
court instructed the jury as described, Bartlett, 760 F. Supp. 2d
at 254 n.39.
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Pharm. Co., No. 08-cv-358, 2010 WL 3092649, at *8 (Aug. 2,
2010)--displayed to the jury a silent deposition clip whose
captioning indicated Mutual's $480 million sales figure from 2007,
before that clip skipped ahead to the next admissible
question-and-answer. The parties vigorously dispute whether this
was merely accidental, but we accept the district court's judgment
that this isolated silent deposition clip, never again mentioned,
is not basis enough for a new trial.
Finally, Bartlett's counsel can be faulted in many
instances for their manner of offering evidence. Counsel
frequently led their own witnesses, although perhaps in some
instances to avoid eliciting inadmissible information. Bartlett,
760 F. Supp. 2d at 257. Counsel also mischaracterized the record,
including in closing argument. Counsel left prejudicial images of
Bartlett's injuries visible to the jury for longer than necessary.
And counsel attempted to use other demonstrative aids in a
misleading manner.
The district court frequently reprimanded counsel, on
occasion in front of the jury. Bartlett, 760 F. Supp. 2d at 253.
The judge was pro-active when he noticed Bartlett's counsel
misusing demonstrative and other visual aids, sometimes intervening
even where Mutual had not objected. And in some instances the
judge gave curative instructions to limit or erase any prejudice.
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In the end, weighing the effect on a verdict of various
missteps by counsel is a judgment call, and the district court in
denying the motion for a new trial gave reasoned consideration to
Mutual's arguments based on individual incidents. Given the
comparative strength of Bartlett's expert evidence, the prior
instances of sulindac-SJS/TEN events, and the enormous harm wrought
in this instance, a judgment that misconduct did not cause the
verdict for Bartlett is not unreasonable.
Excessive Verdict. Mutual next argues that the jury's
damages award is excessive. A new trial is warranted where the
jury award is "grossly excessive, inordinate, shocking to the
conscience of the court, or so high that it would be a denial of
justice to permit it to stand." Franceschi v. Hosp. Gen. San
Carlos, Inc., 420 F.3d 1, 5 (1st Cir. 2005). The facts are taken
in the light most favorable to the plaintiff, but nevertheless the
figure must be in the "universe of acceptable awards." Blinzler v.
Marriott Int'l, Inc., 81 F.3d 1148, 1162 (1st Cir. 1996).
The jury awarded Bartlett $26.01 million--$4.56 million
in largely uncontested special damages ($1.25 million past medical
expenses, $2.377 million for future medical expenses, and $933,000
for lost wages), and $16.5 million for pain, suffering, and loss of
enjoyment of life. All but the last figure rest on specific
evidence that the jury accepted; but the last is, of course, the
largest number and the target of Mutual's attack.
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Mutual says that this is the largest award in New
Hampshire history--and more than twice the award against a car
manufacturer, following a crash in which a young child died and
another was left permanently disabled. Trull v. Volkswagen of Am.,
Inc., 320 F.3d 1, 3 (1st Cir. 2002), cert. denied, 540 U.S. 938
(2003). Arguably, the more pertinent comparison is to the
surviving child Nathaniel who, economic damages aside, was awarded
just under $4 million for pain and suffering and other intangible
elements of damage. Id. at 9-10.
Nathaniel suffered a skull fracture and bleeding that
required an operation to remove the fluid, and his experts opined
that the head trauma exacerbated a preexisting condition so that he
would have to live indefinitely under supervised and structured
conditions. Trull, 320 F.3d at 10. The trauma of the crash,
whatever suffering attended recovery from the operation and
intangible losses from a more constrained life were thus valued by
the jury at about a quarter of the amount awarded to Bartlett for
pain and suffering.
Nevertheless, Bartlett's injuries were truly horrific.
She spent almost two months in MGH's burn unit, spent months in a
medically-induced coma, and suffered burns over nearly two-thirds
of her body. Her burn surgeon described the experience as "hell on
earth." She spent a year being tube fed and endured two major
septic shock episodes. She suffered through 12 eye surgeries and
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has many more ahead of her. This is a brief summary of the
suffering detailed for the jury.
In addition, the permanent damage is severe. Bartlett
cannot eat normally due to esophageal burns, cannot have sexual
relations due to vaginal injuries, and cannot engage in aerobic
activities due to lung injuries. She is almost blind now and faces
some likelihood of complete and permanent blindness. She cannot
read or drive or work. And she is seriously disfigured in face and
body. In sum, the jury's award is not so clearly disproportionate
to the harm suffered that a court must set it aside.
The outcome of this case, at least on this record, is not
surprising or, with respect to sulindac, patently alarming. True,
that drug has a minuscule risk of causing SJS/TEN, but sulindac is
a recognized cause of SJS/TEN--potentially a leader among NSAIDs in
that respect--and the drug carries other risks as well. And how
far it has advantages over similar medicines with less or no risk
is unclear in light of the limited defense offered; at most
cross-examination suggested that sulindac may be the only approved
NSAID for certain forms of arthritis.
Whether or not our present regime of drug regulation and
compensation for harm is optimal is debatable; but the ability of
judges to reshape the regime in any fundamental way may be quite
limited. As for the trial itself, the district judge handled a
very difficult case with skill and insight and he deserves this
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court's special thanks for his thoughtful and very helpful
opinions.
Affirmed.
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