United States Court of Appeals For the First Circuit No. 21-1145

WILLIAM PLOURDE, individually and as administrator of the estate of Allison Plourde; FREDA MERRILL,

Plaintiffs, Appellants,

v.

SORIN GROUP USA, INC.; SORIN GROUP CANADA, INC.; CARBOMEDICS, INC.,

Defendants, Appellees,

LIVANOVA PLC,

Defendant.

APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF MASSACHUSETTS [Hon. Allison D. Burroughs, U.S. District Judge]

Before Lynch, Thompson, and Kayatta, Circuit Judges.

David Randolph Smith, with whom Adam Combies, Matt Hanson, David Randolph Smith & Associates, and Combies Hanson, P.C., were on brief, for appellants. Katy E. Koski, with whom Jennifer H. Wang, Lea G. James, and Foley & Lardner LLP were on brief, for appellees.

January 11, 2022 THOMPSON, Circuit Judge. Today's appeal raises a knotty

and important question of Massachusetts law on which Massachusetts

should have the last word and for which Massachusetts offers us a

way to get it.

Thanks to diversity jurisdiction, we federal judges can

hear and decide issues of Massachusetts law. See

.

We are not experts in that area, however, though Massachusetts's

high court — the Supreme Judicial Court ("SJC") — is. See Lehman

Bros. v. Schein,

(1974). And we have no business

"steering state law into uncharted waters." See Siedle v. Putnam

Invs., Inc.,

(1st Cir. 1998) (quotation marks

omitted). On consequential matters — like defining or restricting

state causes of actions — any decision by us will not bind

Massachusetts courts: they can (under principles of federalism)

reach their own conclusions, "tell[ing] us that we are all wet

. . . and wip[ing] away what we have written" should they so

choose. See Candelario Del Moral v. UBS Fin. Servs. Inc. of P.R.,

(1st Cir. 2012). Contrastingly, the SJC is the

final decider of Massachusetts law, binding us and lower

Massachusetts courts with its rulings. See Mullaney v. Wilbur,

(1975). So — as discussed shortly — when we (as

here) face a serious question of Massachusetts law with no on-

point authority, we can ask the SJC for help.

- 2 - And this we can do because an SJC rule says that the SJC

may answer certified legal questions (as they are called) from us

that "may be determinative of the cause then pending . . . to which

it appears to" us that "there is no controlling [SJC] precedent."

See Mass. S.J.C. R. 1:03. Plus our own caselaw says that

certification is "particularly appropriate" when "the answers to

these questions may hinge on policy judgments best left to the

Massachusetts court" and which could benefit future litigants too

(be they in state or federal court). See In re Engage, Inc.,

(1st Cir. 2008). The SJC has been gracious in answering

our certified questions before. And convinced that this case meets

all the prerequisites — we never want to abuse this process "lest

we wear out our welcome," see Transcon. Pipeline Corp. v. Transp.

Ins. Co.,

(5th Cir. 1992) — we politely ask the

SJC's favor in answering the question certified below in Part III.

The SJC's rule requests "a statement of all facts

relevant to the question certified," a description of "the nature

of the controversy in which the question arose," and a declaration

of "the question of law to be answered." See Mass. S.J.C. R. 1.03.

We proceed accordingly.

- 3 - I

A

Appellants William Plourde and Freda Merrill had a child

in 1991, a daughter they named Allison.1 Allison was born with

DiGeorge Syndrome, a chromosomal disorder associated with heart

defects. Her doctors also later diagnosed her with aortic arch

and ventricular septal defects.

In June 2012, Allison's medical team explained that she

would die if she did not get a heart-valve replacement. A doctor

described the different valve options available. And that same

month — June 2012 — he implanted a Mitroflow Model LX heart valve

in her body. The Mitroflow is a "bioprosthetic" valve, consisting

of "a single piece of bovine pericardium sewn onto a polyester

stent." Appellees listed in the case caption — referred to

collectively as "Sorin" — manufacture and sell the Mitroflow.

B

We pause in narrating the case's background to summarize

some legal concepts that play a major role here (their significance

will become clear later).

The Mitroflow is a class III medical device under the

Food, Drug, and Cosmetic Act ("FDCA"), as amended by the Medical

1We use Allison's first name from now on not out of disrespect but to distinguish between William and Allison Plourde. - 4 - Devices Amendments of 1976.2 The FDCA divides the realm of medical

devices into three classes, according to the amount of regulation

believed necessary to provide reasonable assurance of each

device's safety and effectiveness. See 21 U.S.C. § 360c(a)(1).

Class III devices, the most strictly regulated of the classes, are

devices "that either 'presen[t] a potential unreasonable risk of

illness or injury,' or which are 'purported or represented to be

for a use in supporting or sustaining human life or for a use which

is of substantial importance in preventing impairment of human

health.'" Medtronic, Inc. v. Lohr,

(1996)

(alteration by Lohr Court and quoting 21 U.S.C. § 360c(a)(1)(C)).

Because these devices are so risky, a manufacturer looking to put

them on the market must prove their safety and efficacy to the

liking of the Food and Drug Administration ("FDA") — through a

complex and costly premarket approval ("PMA") process. See 21

U.S.C. § 360e(a); see also Lohr,

.

During the PMA process, the FDA — spending an average of

1200 hours on each application — analyzes the product's design,

manufacturing, and labeling (among other things). See 21 U.S.C.

2 Acronyms are a staple of opinions in this area of the law. And while we prefer simple words to awkward initialisms, we use some abbreviations here "because doing so nets out on the side of clarity and helps keep the opinion flowing." See United States v. Iriele,

, 1156 n.1 (11th Cir. 2020). - 5 - § 360e(c)(1); see also Lohr,

. After getting PMA

approval, manufacturers must comply with certain requirements,

including informing the FDA of incidents where a device "[m]ay

have caused or contributed to a death or serious injury." See

(a)(1). And if they fail to comply, the FDA can

withdraw approval.

§ 814.82(c).

The scheme Congress created reflects a weighing of

competing policy concerns. See, e.g., Caplinger v. Medtronic,

Inc.,

(10th Cir. 2015) (Gorsuch, J., for the

court). On the one hand Congress wanted to "ensur[e] that proposed

medical devices are carefully scrutinized for safety."

But

on the other Congress hoped to "preserv[e] the freedom of patients

and doctors to use potentially life-saving technology as they see

fit without delay."

A flash point in the "legislative

process" concerned "to what extent (if any) should states be able

to layer additional rules on top of Congress's[.]"

Using its

power under the Constitution's Supremacy Clause, id.,3 Congress

struck a balance it thought reasonable:

Except as [authorized by the FDA], no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement —

3 See generally La. Pub. Serv. Comm'n v. FCC,

(1986) (explaining that the Supremacy Clause — U.S. Const. art. VI, cl. 2 — empowers Congress to preempt state law with national law). - 6 - (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under [the FDCA].

See 21 U.S.C. § 360k(a). To paraphrase that provision's crucial

part, a state-law claim is expressly preempted under § 360k(a)

when the FDCA imposes a federal requirement on the device and the

contested state or local rule imposes any obligation that differs

from or adds to those in the FDCA.4 Importantly, though, "[n]othing

in § 360k denies [states] the right to provide a traditional

damages remedy for violations of common-law duties when those

duties parallel federal requirements." See Lohr,

;

accord Riegel v. Medtronic, Inc.,

(2008) (finding

state-law claims expressly preempted because they alleged that the

at-issue device "violated state tort law notwithstanding

compliance with the relevant federal requirements" (ergo, the

state requirements implicit in these claims differed from or added

to the federal requirements) — but stressing how "§ 360k does not

prevent a State from providing a damages remedy for claims premised

4 With apologies to Professor Karl Llewellyn, who said "[n]ever paraphrase a statute." See https://chicagounbound.uchicago.edu/cgi/viewcontent.cgi?article= 1622&context=lsr. - 7 - on a violation of FDA regulations; the state duties in such a case

'parallel,' rather than add to, federal requirements" (quoting

Lohr,

)).

A state-law claim not expressly preempted by the FDCA

may be impliedly preempted, however. See Buckman Co. v. Pls.'

Legal Comm.,

(2001). With exceptions not

applicable here, § 337(a) of the FDCA provides that "proceedings

for the enforcement, or to restrain violations, of [the FDCA] shall

be by and in the name of the United States." See

(a). That language shows "that Congress intended that the

[FDCA] be enforced exclusively by the Federal Government." See

Buckman Co.,

. So § 337(a) preempts any state-law

claim that exists "solely by virtue" of an FDCA infraction — like,

for example, a claim against a manufacturer for violating the

FDCA's ban on making false statements to the FDA during the PMA

process. See id. at 353. On the flip side, a state-law claim

based on "traditional state tort law" that happens to "parallel"

the FDCA is outside of § 337(a)'s preemptive scope. See id.

Working in tandem, § 360k(a) and § 337(a) leave

plaintiffs with a

narrow gap through which [their] state-law claim must fit if it is to escape express or implied preemption: the plaintiff[s] must be suing for conduct that violates the FDCA (or else [their] claim is expressly preempted by [§ 360k(a)], but [they] must not be suing - 8 - because the conduct violates the FDCA (such a claim would be impliedly preempted [by § 337(a)]).

Dumont v. Reilly Foods Co.,

(1st Cir. 2019)

(quoting In re Medtronic, Inc., Sprint Fidelis Leads Prods. Liab.

Litig.,

(8th Cir. 2010)) (quotations omitted

and emphases in original).

C

Now back to this action.

The FDA gave Sorin the necessary approval for the Model

LX, including signing off on the device's label — which warned

that "[c]linical experience described in the medical literature

suggests that . . . patients . . . who are 55 years of age or less

may experience accelerated calcification of bioprosthetic heart

valves." Allison's implanting surgeon knew about these risks and

had a practice of explaining them to his patients and their

families (appellants write that "although he was aware of

calcification in younger patients, he was not aware of rapid valve

deterioration . . . in one to two years").

About 18 months after the implantation, Allison — in

January 2014 — had emergency surgery to remove the Mitroflow valve

and replace it with a mechanical one. Sadly, she never regained

consciousness and died weeks later after doctors took her off life

support.

- 9 - Appellants sued Sorin in Massachusetts state court.

Plourde v. Sorin Group USA, Inc.,

, 80 (D. Mass.

2021). As relevant to this appeal, their complaint alleged

negligence and failure-to-warn claims predicated on Sorin's not

reporting adverse events to the FDA concerning Mitroflow

malfunctions in young patients. Had Sorin made the required

reports, the theory goes, Allison's doctor would not have

recommended or implanted the Mitroflow.

Sorin removed the lawsuit to federal court under

diversity jurisdiction and then moved to dismiss for failure to

state a claim. See id.; see also Plourde v. Sorin Group USA, Inc.,

No. 17-cv-10507,

, at *1 (D. Mass. Mar. 29, 2018).

Of relevance here, the district judge ruled that "to the extent

Plaintiffs allege that [Sorin] had a duty under Massachusetts law

to report studies and adverse events that occurred after the

[v]alve received premarket approval [from] the FDA, those claims

are not preempted" — though the judge quickly added that "at this

time," she "ma[de] no determination as to whether Massachusetts

law actually imposes such a duty." See Plourde,

,

at *8.

The judge later issued an order granting summary

judgment to Sorin. See Plourde, 517 F. Supp. 3d at 95. Pertinently

for present purposes, the judge concluded that appellants "failed

- 10 - to identify a parallel duty under Massachusetts law that would

have required [Sorin] to make reports to the FDA coextensive with

the requirements of federal law." Id. at 92. Based on that

ruling, the judge deemed their negligence and failure-to-warn

claims preempted. See id. at 88-92.

II

The core of appellants' case — as we just stated, and as

they themselves concede — is that Sorin allegedly failed both to

report adverse events to the FDA (which forms the basis of their

negligence claim) and to warn the FDA of adverse events (which

forms the basis of their failure-to-warn claim). The parties focus

most of their energy on the question whether Massachusetts law

imposes a duty on medical-device manufacturers to report adverse

events to the FDA that does no more than parallel the FDCA and FDA

regulations. Appellants answer yes. Sorin answers no. We

summarize their key arguments broadly.

A

Surveying Massachusetts's legal landscape, appellants

see a non-preempted duty of care that Sorin owed to Allison — a

duty they say Sorin breached by "failing to comply with federal/FDA

adverse event reporting requirements."

Appellants, for starters, highlight Massachusetts's

common-law duty requiring manufacturers to act with reasonable

- 11 - care to prevent foreseeable injury — such as by "warn[ing]

consumers of the dangers arising from the use of their products

where the manufacturers know or should have known of the dangers."

See Rafferty v. Merck & Co.,

(Mass. 2018);

accord H.P. Hood & Sons, Inc. v. Ford Motor Co.,

(Mass. 1976); see also Back v. Wickes Corp.,

(Mass. 1978) (explaining that Massachusetts holds a

manufacturer to the expectable knowledge of an "ordinary,

reasonably prudent manufacturer in like circumstances"). To

appellants' way of thinking, "[a] reasonably prudent manufacturer"

in Sorin's shoes "would not violate a federally mandated duty to

report adverse events to the FDA."

From there, appellants principally cite to and quote

from two Massachusetts cases: a superior court decision, Brown

v. DePuy Spine, Inc., Nos. BRCV2006-00208, BRCV2006-00209,

BRCV2006-00211, & BRCV2006-00630,

(Mass. Super.

Ct. Apr. 9, 2007); and an SJC decision, Dunn v. Genzyme Corp.,

(Mass. 2021). The Brown plaintiffs sued a medical-

device manufacturer under Massachusetts law for (among other

claims) "breach[ing] its duty to comply with FDA regulations."

See

, at *1. Denying the company's preemption-

based bid for summary judgment, the superior court ruled — in words

our appellants spotlight — that "[a]ll of the plaintiffs' claims

- 12 - are based on traditional state causes of action; plaintiffs do not

seek recovery merely for a violation of federal law."

.

Likewise invoking Massachusetts law, the Dunn plaintiff sued a

medical-device manufacturer for negligent failure to warn (among

other theories). See 161 N.E.3d at 392. The SJC reversed the

superior court's decision denying the company's dismissal motion,

holding that the plaintiff had insufficiently pled her claims.

See id. at 393. But in doing so, the SJC noted — in language our

appellants emphasize — that her "claims . . . all can be

interpreted as coextensive with the comprehensive Federal

requirements imposed on [the company] under the [FDCA]." See id.

at 396. Appellants read these decisions as imposing a state duty

to warn on medical-device manufacturers that parallels duties

found in the FDCA.

Also as part of their multifaceted approach, appellants

note that Massachusetts follows section 388 of the Restatement

(Second) of Torts — which imposes a duty on manufacturers to warn

third parties if a product "is or is likely to be dangerous." And

according to them, a breach of that duty can constitute "a parallel

non-preempted claim to the federal duty to report adverse events

to the FDA."

- 13 - B

Unsurprisingly (given how the parties are in the throes

of appellate litigation), Sorin's overarching argument is that

"the Commonwealth does not recognize" — as appellants contend —

"an independent state law duty to make [adverse-events] reports to

the FDA."

To that end, Sorin first attacks appellants' use of

Massachusetts cases discussing a manufacturer's general duty of

care to avoid foreseeable dangers. Seeking to downplay their

significance, Sorin labels these decisions "inapposite" because

they do not deal "with the duties of device manufacturers under

Massachusetts law."

Sorin then says that Brown — the superior court opinion

— is not an authoritative guide to Massachusetts law, insisting,

for example, that Brown simply noted that if a parallel state-law

duty to report or warn the FDA exists, the plaintiffs' claims might

survive preemption. As support, Sorin harps on the Brown court's

saying that "there ha[d] not yet been any significant discovery"

and that "[w]here an underlying question of law is subject to

doubt, the preferable practice is to decide the question on a full

record of facts." See

, at *13. And Sorin adds

that a different superior court opinion — Phillips v. Medtronic,

Inc. — more recently held that a Massachusetts tort claim based on

- 14 - a failure to report to the FDA is "impliedly preempted because it

is premised solely on a duty created by the [FDCA] which did not

exist in the common law." See No. SUCV2009-05286-A,

, at *10 (Mass. Super. Ct. July 10, 2012). Turning next to

Dunn — the SJC decision — Sorin insists that the high court there

did not hold that the plaintiff's state-law claims paralleled

federal requirements. We assume what Sorin has in mind is the

italicized part of the quotation (set out above) — plaintiff's

"claims . . . all can be interpreted as coextensive with the

comprehensive Federal requirements imposed on [the company] under

the [FDCA]." See 161 N.E.3d at 396 (emphasis added).

Sorin next brings up the learned-intermediary doctrine,

a common-law rule adopted in Massachusetts that (generally

speaking) allows medical-device manufacturers to discharge their

duty by warning physicians of the risks instead of the patients

themselves. See, e.g., Knowlton v. Deseret Med., Inc.,

, 120 n.2 (1st Cir. 1991) (applying Massachusetts law). As

Sorin sees it, given this doctrine, Massachusetts law cannot

require manufacturers to also warn the FDA — "[t]he FDA," argues

Sorin, "is not a healthcare provider and therefore not a learned

intermediary."

Which segues into Sorin's attempt to counter appellants'

Restatement-based theory. Quoting Massachusetts caselaw, Sorin

- 15 - asserts that when it comes to the duty to warn, "a manufacturer

may be absolved from blame because of a justified reliance upon

. . . a middleman" to communicate risks, see MacDonald v. Ortho

Pharm. Corp.,

(Mass. 1985) (quoting Carter v.

Yardley & Co.,

(Mass. 1946)) — but "only in the

limited instances in which the manufacturer's reliance on an

intermediary is reasonable," see

(citing Restatement (Second)

of Torts § 388 cmt. n). And to hear Sorin tell it, while

"manufacturers may discharge their duty to warn the patient by

adequately warning doctors directly," nothing in "[s]ection 388"

or in "Massachusetts case law supports the proposition that a

manufacturer can reasonably rely on the FDA to communicate [adverse

events] to physicians much less to patients."

III

As intimated several pages ago, we try not to bother our

busy state colleagues with every difficult state-law issue that

comes our way, see Patel v. 7-Eleven, Inc.,

, 29 (1st

Cir. 2021) — if there is "a reasonably clear and principled course,

we will seek to follow it ourselves," see Pino v. United States,

(10th Cir. 2007) (Gorsuch, J., for the court).

But the caselaw outlined in Part II gives us no definitive

guidance. And we "hesitate to 'trade judicial robes for the garb

of prophet' . . . when an available certification procedure

- 16 - renders the crystal ball or divining rod unnecessary." See

Boardman v. United Servs. Auto Ass'n,

(5th Cir.

1984) (quoting John R. Brown, Certification — Federalism in Action,

, 455 (1977)). So given the absence of any SJC

decision directly on point — and in the spirit of "cooperative

judicial federalism," see Lehman Bros.,

(indicating

that state (and not federal) courts should decide state-law policy

when doable) — rather than hazard a guess about the meaning of

state law in this "importan[t] and complex[]" area that may be

outcome-determinative, see In re Engage,

, we opt to

certify, see Pyle v. S. Hadley Sch. Comm.,

(1st

Cir. 1995) (relying on Lehman Bros. for the notion that

"uncertainty or difficulty regarding state law . . . may be enough

to counsel certification where that procedure is available"); see

generally In re Engage,

(certifying a question to

the SJC after noting that "[t]his is not a case in which the policy

arguments line up solely behind one solution" (quotation marks

omitted)).

Satisfied that this case meets the SJC's certification

standard and ours, we respectfully pose the following question to

the only court that can give an authoritative answer — which will

allow us and the parties to be certain that we are applying genuine

state law:

- 17 - Does a manufacturer's failure to report adverse events to a regulator — such as one like the FDA — give rise to liability under Massachusetts law?

Our question is similar to a question the Second Circuit asked the

Connecticut Supreme Court in a case involving "the scope of federal

preemption of" that state's "tort law claims based on injuries

caused by a medical device." See Glover v. Bausch & Lomb Inc.,

, 232, 241, 244 (2d Cir. 2021) (querying "[w]hether a

cause of action exists under the negligence or failure-to-warn

provisions of the Connecticut Product Liability Act . . ., or

elsewhere in Connecticut law," arising from "a manufacturer's

alleged failure to report adverse events to a regulator like the

FDA following approval of the device, or to comply with a

regulator's post-approval requirements").5 And we chose this

phrasing to give the SJC maximum flexibility — we do not wish to

handcuff the SJC's consideration of the issue and would welcome

any additional comments about Massachusetts law the SJC may care

to offer (assuming of course that the SJC accepts our request).

The clerk of this court shall forward to the SJC (under

official seal) our opinion, as well as the parties' appellate

briefs and appendices. We retain jurisdiction and award no costs

5The Connecticut high court "accepted" the certification request. See Order, Glover v. Bausch & Lomb Inc., No. 20-1156cv (Conn. Aug. 3, 2021). - 18 - at this time (we may revisit costs after we hear back from the

SJC).

- 19 -