Tersigni v. Wyeth

United States Court of Appeals
For the First Circuit

No. 14-1927

MICHAEL J. TERSIGNI,

Plaintiff, Appellant,

v.

WYETH, a/k/a Wyeth, LLC, f/k/a American Home Products Corp.;
AMERICAN HOME PRODUCTS, INC.; WYETH AYERST LABORATORIES; WYETH
PHARMACEUTICALS, a/k/a Wyeth Pharmaceuticals, Inc., f/k/a Wyeth-
Ayerst Pharmaceuticals, Inc.; f/k/a Ayerst Laboratories, Inc.;
WYETH-AYERST PHARMACEUTICALS, INC.; AHP SUBSIDIARY HOLDING
CORPORATION, f/k/a Wyeth-Ayerst Laboratories Company, a division
of Wyeth; AYERST LABORATORIES, INC., a division of Wyeth, Wyeth-
Ayerst Pharmaceuticals, Inc.,

Defendants, Appellees.

APPEAL FROM THE UNITED STATES DISTRICT COURT
FOR THE DISTRICT OF MASSACHUSETTS

[Hon. Richard G. Stearns, U.S. District Judge]

Before

Lynch, Circuit Judge,
Souter, Associate Justice,*
and Stahl, Circuit Judge.

Louis M. Bograd, with whom Center for Constitutional
Litigation, P.C., Gregory J. Bubalo, Paula S. Bliss, and Bubalo
Goode Sales & Bliss, PLC were on brief, for appellant.

_________________

* Hon. David H. Souter, Associate Justice (Ret.) of the
Supreme Court of the United States, sitting by designation.
 Theodore V.H. Mayer, with whom William J. Beausoleil, Michael
D. Tiger, Hughes Hubbard & Reed LLP, Peter L. Welsh, Jesse M.
Boodoo, and Ropes & Gray LLP were on brief, for appellees.

March 23, 2016
 STAHL, Circuit Judge. For a period of time in 1997, the

appellant, Michael Tersigni, was prescribed Pondimin, a weight

loss drug developed and sold by the appellee, Wyeth.1 Tersigni

later sued Wyeth, alleging that Pondimin caused him to develop a

dangerous condition known as primary pulmonary hypertension

("PPH"). The district court entered summary judgment for Wyeth on

most of Tersigni's claims, including his claim for negligent

design, and allowed only a single claim for negligent failure to

warn to go to trial. In separate rulings, the district court

denied a pair of motions in limine in which Tersigni sought to

exclude reference at trial to his past incarceration and use of

cocaine.

The jury returned a verdict for Wyeth on Tersigni's

surviving negligent failure to warn claim. In this appeal,

Tersigni claims that the district court erred by entering summary

judgment for Wyeth on the negligent design claim and by denying

his motions in limine. After careful consideration, we AFFIRM.

I. Facts and Background

From 1989 until 1997, Wyeth marketed Pondimin as a

medication to promote weight loss. In the mid-1990s, however,

clinical research began to emerge linking Pondimin to an elevated

1 "Wyeth" refers collectively to Wyeth and its many
subsidiaries and other affiliates (and their current and former
pseudonyms) listed in the case caption above.

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risk for valvular heart disease and PPH.2 Eventually, in July

1997, the Food and Drug Administration ("FDA") required Wyeth to

warn doctors of these risks and to add a so-called "Black Box"

warning to Pondimin's label. Soon thereafter, the FDA ordered

that Wyeth withdraw Pondimin from the market entirely.

Tersigni was one of millions of Americans to receive a

prescription for Pondimin. He was prescribed (and apparently took)

the drug for an approximately six-month period beginning in early

1997, and ending in July 1997, when Tersigni's doctor learned of

the FDA's required Black Box warning.

In 2011, several years after Tersigni stopped taking

Pondimin, he was diagnosed with PPH. Thereafter, he sued Wyeth in

federal district court in Massachusetts, asserting claims for,

inter alia, negligent design3 and negligent failure to warn. In

effect, Tersigni's negligent design claim alleged that Wyeth knew,

2 Valvular heart disease refers to a group of conditions which
cause a disruption in the normal structure and function of the
heart valves. PPH is a disease affecting pulmonary circulation
and is characterized by scarring and fibrosis of the pulmonary
arteries. PPH is "relentlessly progressive" and "leads to death
in virtually all circumstances." See Brown v. Am. Home Prods.
Corp., (In re Diet Drugs (Phentermine, Fenfluramine,
Dexfenfluramine) Prods. Liab. Litig.), Nos. 1203, 99-20593, 2000
WL 1222042, at *16 (E.D. Pa. Aug. 28, 2000).

3 Tersigni's negligent design claim has taken on many guises.
For example, in his opening brief, Tersigni refers to this claim
interchangeably as one for "negligent marketing," "negligent
failure to discontinue marketing," and "negligent design." When
pressed at oral argument, counsel clarified that Tersigni is, in
fact, pursuing a claim for "negligent design."

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or should have known, that Pondimin was unreasonably dangerous,

but nonetheless continued to market it.

Wyeth moved for summary judgment on most of Tersigni's

claims. The district court granted this motion, reasoning in

relevant part that Massachusetts courts would not recognize a cause

of action for the negligent design of a prescription drug. See

Tersigni v. Wyeth-Ayerst Pharm., Inc., No. 11-10466-RGS, 2014 WL

7464759, at *1 (D. Mass. June 25, 2014). Following the entry of

summary judgment, only Tersigni's claim for negligent failure to

warn remained for trial.

Separately, Tersigni moved to preclude reference at the

trial both to his previous incarceration in 2008 for non-payment

of child support, and to his occasional use of cocaine several

decades earlier. Wyeth opposed both motions, arguing that this

evidence was relevant to the defense's theory that cocaine use and

the stress associated with Tersigni's incarceration contributed to

his cardiopulmonary symptoms. The district court denied

Tersigni's motions, ruling that, subject to certain restrictions,

evidence of the cocaine use and incarceration could be offered.

Following an eleven-day trial on Tersigni's negligent

failure to warn claim, the jury found in Wyeth's favor, concluding

that Wyeth had not negligently failed to warn Tersigni's doctor of

the risks posed by Pondimin. Consequently, the jury did not reach

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the separate question of whether Pondimin caused Tersigni to

develop PPH. This appeal followed.

II. Analysis

A. Negligent Design

We review the district court's order granting summary

judgment on Tersigni's negligent design claim de novo, assessing

the record in the light most favorable to Tersigni and resolving

all reasonable inferences in his favor. Bingham v. Supervalu,

Inc., 806 F.3d 5, 9 (1st Cir. 2015). "In so doing, 'we are not

bound by the district court's decisional calculus but, rather, may

affirm the decision . . . on any ground made manifest by the

record.'" Ocasio-Hernández v. Fortuño-Burset, 777 F.3d 1, 7 (1st

Cir. 2015) (quoting Ruiz v. Bally Total Fitness Holding Corp., 496

F.3d 1, 5 (1st Cir. 2007)). The entry of summary judgment is

appropriate where "there is no genuine dispute as to any material

fact and the movant is entitled to judgment as a matter of law."

Bingham, 806 F.3d at 9 (quoting Fed. R. Civ. P. 56(a)).

By way of background, Section 402A of the Restatement

(Second) of Torts subjects to strict liability certain sellers of

products which are "in a defective condition unreasonably

dangerous to the user or consumer." Evans v. Lorillard Tobacco

Co., 990 N.E.2d 997, 1011 (Mass. 2013) (quoting Restatement

(Second) of Torts § 402A (1965)). However, Comment K to Section

402A ("Comment K") offers an exception and exempts from strict

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liability the manufacturer of certain products (including drugs)

that are highly beneficial but may carry known risks:

There are some products which . . . are quite
incapable of being made safe for their intended and
ordinary use. . . . The seller of such products,
. . . with the qualification that they are properly
prepared and marketed, and proper warning is given,
. . . is not to be held to strict liability . . .
merely because he has undertaken to supply the
public with an apparently useful and desirable
product, attended with a known but apparently
reasonable risk.

Restatement (Second) of Torts § 402A cmt. k.

In granting summary judgment to Wyeth on Tersigni's

negligent design claim, the district court reasoned that because

the Supreme Judicial Court ("SJC") had previously adopted Comment

K, Massachusetts courts would not recognize a negligent design

claim where the product in question is a prescription drug. See

Payton v. Abbott Labs, 437 N.E.2d 171, 189-90 (Mass. 1982)

(adopting Comment K).

As both parties acknowledge, Massachusetts courts do

recognize claims predicated on the negligent design of a variety

of consumer products and other goods. For example, in Smith v.

Ariens Co., 377 N.E.2d 954 (Mass. 1978), the SJC permitted a claim

to go forward where the plaintiff sought to prove that the

negligent design of a snowmobile had caused her to sustain injury.

Id. at 957; see also Evans, 990 N.E.2d at 1010 (cigarettes);

Vassallo v. Baxter Healthcare Corp., 696 N.E.2d 909, 912 (Mass.

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1998) (silicone breast implants); McDonough v. Whalen, 313 N.E.2d

435, 440-41 (Mass. 1974) (septic system).

The parties dispute, however, whether Massachusetts

courts would recognize a negligent design claim involving a

prescription drug. This is a seemingly straight-forward question,

but it lacks an obvious answer. On the one hand, as Wyeth points

out, Massachusetts courts have yet to formally recognize such a

claim.4 But, on the other hand, as Tersigni fairly argues, neither

has the SJC expressly ruled the claim out. In fact, in the context

of claims for the negligent design of other products, the SJC has

repeatedly cited not to Section 402A, involving strict liability,

but to Restatement (Second) of Torts Sections 395 and 398, which

pertain to the negligent design and manufacture of chattel. See

Smith, 377 N.E.2d at 957-58; McDonough, 313 N.E.2d at 439 n.7. At

a minimum, this raises the possibility that Massachusetts courts

might consider a negligent design claim related to a prescription

drug, notwithstanding the SJC's embrace of Comment K. See Toner

4 Tersigni reaches far into the annals of Massachusetts
jurisprudence and directs our attention to Norton v. Sewall, 106
Mass. 143 (1870), where an apothecary was found liable for the
negligent sale of a deadly poison, which he had mistaken for a
harmless medicinal tincture. Id. at 144. Norton, however, tells
us little about how Massachusetts courts would treat a claim for
the negligent design of a prescription drug. As an initial matter,
the apothecary's liability was premised merely on his negligent
sale, rather than his design or manufacture, of the poison. Id.
Beyond that, Norton was decided more than a century prior to the
SJC's adoption of Comment K, leaving open the question of whether
Comment K would bar the claim Tersigni seeks to bring.

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v. Lederle Labs., 732 P.2d 297, 311 (Idaho 1987) ("[C]omment [K]

does not shield sellers of products from negligence claims."); see

also Restatement (Second) of Torts § 402A cmt. a ("[Section 402A]

does not preclude liability based upon the alternative ground of

negligence . . . .").

It is thus quite uncertain whether Massachusetts courts

would recognize Tersigni's negligent design claim. We need not

decide this issue, however, because even if we were to assume that

such a claim is cognizable under Massachusetts law, the claim would

nonetheless fail based on Tersigni's inability to proffer evidence

of a reasonable alternative design.5 See Evans, 990 N.E.2d at 1024

("In claims alleging negligence in the design of a product, . . .

the plaintiff must show an available design modification which

would reduce the risk without undue cost or interference with the

performance of the product . . . ." (alterations, citations, and

internal quotation marks omitted)); Gillespie v. Sears, Roebuck &

Co., 386 F.3d 21, 26 (1st Cir. 2004) (applying Massachusetts law

and finding that "[a]n essential element of . . . a design flaw

claim is that there be a safer alternative design"); 1 Mass. Super.

Ct. Civil Practice Jury Instructions § 11.2.3 (Mass. Continuing

5 For the same reason, we acknowledge but need not consider
the parties' dispute as to whether Tersigni's negligent design
claim under state law is preempted by federal regulation of
pharmaceutical drugs.

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Legal Educ. 3d ed. 2014) (requiring plaintiffs to show an available

design modification as an element of a negligent design claim).

Tersigni does not contend here, nor did he contend before

the district court, that there exists a reasonable alternative

design which would have made Pondimin less likely to cause PPH or

otherwise safer. Rather, he argues first that Wyeth may be held

liable because, at the time Pondimin was marketed, there were

other, safer methods of weight loss available. This argument,

however, misconstrues the focus of the reasonable alternative

design inquiry, which requires the plaintiff to show that the

product in question could have been more safely designed, not that

a different product was somehow safer. See Evans, 990 N.E.2d at

1016, 1024 (noting that the plaintiff must offer proof of an

available design modification of "the product" (emphasis added)

(alteration omitted)); Caterpillar, Inc. v. Shears, 911 S.W.2d

379, 385 (Tex. 1995) ("A motorcycle could be made safer by adding

two additional wheels and a cab, but then it is no longer a

motorcycle.").

Tersigni also argues that Massachusetts courts would, on

the basis of Restatement (Third) of Torts: Products Liability

§ 6(c) (1998) - which Massachusetts courts have not yet adopted -

find that proof of a reasonable alternative design is not required

where the product in question is a prescription drug. Thus, in

effect, Tersigni asks us to assume, in the absence of any

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applicable precedent, that Massachusetts courts would recognize

his negligent design claim, and that having done so, those same

courts would grant a heretofore unrecognized exception to the

general requirement of proof of a reasonable alternative design.

This is a bridge too far, and we decline to cross it.

As a federal court applying Massachusetts law, we are

bound to apply state law as it exists, not as it may become, or as

the plaintiff wishes it to be. See Ryan v. Royal Ins. Co. of Am.,

916 F.2d 731, 744 (1st Cir. 1990). Here, we need not attempt to

foretell whether Massachusetts courts will one day embrace a claim

for the negligent design of a prescription drug. Rather, even

assuming that they would, Tersigni's claim fails because he cannot

offer proof of a reasonable alternative design, as Massachusetts

law plainly requires. Thus, summary judgment properly entered in

Wyeth's favor.6

6 Tersigni urges that we certify to the SJC the question of
whether his claim for negligent design is cognizable under
Massachusetts law. See Mass. S.J.C. R. 1:03. We decline to do
so. Tersigni chose to bring suit in federal court despite obvious
uncertainty as to whether Massachusetts courts would recognize his
cause of action. This undermines his request for certification.
See Cantwell v. Univ. of Mass., 551 F.2d 879, 880 (1st Cir. 1977)
("[O]ne who chooses the federal courts in diversity actions is in
a peculiarly poor position to seek certification. We do not look
favorably, either on trying to take two bites at the cherry by
applying to the state court after failing to persuade the federal
court, or on duplicating judicial effort.").

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 B. Evidentiary Rulings

We turn next to Tersigni's claim that the district court

erred by denying his motions in limine seeking to exclude evidence

of his prior incarceration and cocaine use. Our review is for

abuse of discretion. See Fryar v. Curtis, 485 F.3d 179, 182 (1st

Cir. 2007). We may affirm in spite of an erroneous evidentiary

ruling if the error was harmless, meaning that "it is highly

probable that the error did not affect the outcome of the case."

McDonough v. City of Quincy, 452 F.3d 8, 19-20 (1st Cir. 2006).

i. Incarceration

Tersigni moved to exclude reference to his past

incarceration for non-payment of child support, evidence Wyeth

argued was relevant to prove that Tersigni had undergone a

stressful event which contributed to his cardiopulmonary symptoms.

The district court denied Tersigni's motion, allowing testimony

"limited to the fact of incarceration, the effect on [Tersigni's]

blood pressure, and that the incarceration was based on a child

support issue and not any crime of violence." During the ensuing

eleven-day trial, the jury heard a total of four sporadic

references to Tersigni's incarceration. Tersigni argues that this

evidence should have been excluded because its prejudicial effect

of undermining his character substantially outweighed its

probative value. See Fed. R. Evid. 403.

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 We need not decide whether the district court abused its

discretion by admitting this evidence because any error - if indeed

there was one at all - was harmless. The jury was given a verdict

form in which it was first asked to determine whether Tersigni had

established that Wyeth negligently failed to warn his doctor of

the risks associated with Pondimin. The jury answered this

question in the negative. Consequently, the jury did not reach

the second question, which asked whether Tersigni had established

that he developed PPH as a result of taking Pondimin, a causation

issue to which Tersigni's incarceration was arguably relevant.

In our view, evidence of Tersigni's incarceration likely

had no effect on the jury's consideration of whether Wyeth

negligently failed to warn physicians of Pondimin's risks, the

only issue on which the jury was required to pass. See McDonough,

452 F.3d at 19-20. The nature of this inquiry simply left no room

for consideration of Tersigni's reliability as a witness or his

overall character. Thus, if an error occurred, it was harmless.

ii. Cocaine Use

Tersigni also sought to exclude evidence that, several

decades earlier, he had occasionally used cocaine. Again, Wyeth

claimed that this evidence was relevant to show alternative causes

of Tersigni's symptoms. The district court denied Tersigni's

motion, pending its "evaluation of expert testimony that the abuse

of cocaine . . . is related to the issue of specific causation."

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The district court, however, was not required to conduct any such

evaluation because Tersigni's counsel chose to raise the cocaine

use herself, referencing it twice during her opening statement and

again during direct examination of two of Tersigni's witnesses.

We have previously held that a party which seeks to

"remove the sting" by preemptively introducing damaging evidence

thereby waives the right to appeal the admission of that evidence.

See Gill v. Thomas, 83 F.3d 537, 541 (1st Cir. 1996); see also

Ohler v. United States, 529 U.S. 753, 760 (2000). Tersigni tries

to circumvent our holding in Gill by noting that it predated the

amendment, in 2000, of Federal Rule of Evidence 103, which governs

the manner by which parties must preserve claims of evidentiary

error. This attempt cannot succeed, however, because the Advisory

Committee Notes accompanying that amendment provide that the

amendments "do[] not purport to answer whether a party who objects

to evidence that the court finds admissible in a definitive ruling,

and who then offers the evidence to 'remove the sting' of its

anticipated prejudicial effect, thereby waives the right to appeal

the trial court's ruling." Fed. R. Evid. 103 advisory committee's

notes to 2000 amendment (citing, inter alia, Gill, 83 F.3d at 540).

Thus, Gill remains good law and the admission of evidence of

Tersigni's cocaine use does not merit reversal.7

7 Tersigni argues that the cumulative effect of admitting
evidence of both his incarceration and cocaine use requires

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 III. Conclusion

The judgment of the district court is AFFIRMED.

reversal. See United States v. Stokes, 124 F.3d 39, 43 (1st Cir.
1997) (discussing the cumulative error doctrine). Here, we have
found that there was, at worst, one arguable error, and thus we
need not consider its potential cumulative effect.

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