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 WyethAyerst 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, WyethAyerst 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 

 
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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.