Court Opinion

ID: 5649589
Source: CourtListenerOpinion
Date Created: 2022-01-11 22:00:26.600943+00
Date Added: 2024-06-11T08:38:31.286559
License: Public Domain

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 28 U.S.C. § 1332.

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

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

Bros. v. Schein, 416 U.S. 386, 391 (1974).        And we have no business

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

Invs., Inc., 147 F.3d 7, 12 (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.,

699 F.3d 93, 101 (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,

421 U.S. 684, 691 (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., 544

F.3d 50, 53 (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., 958 F.2d 622, 623 (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, 518 U.S. 470, 477 (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, 518 U.S. at 477.

            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, 977 F.3d 1155, 1156 n.1 (11th Cir. 2020).
                                  - 5 -
§ 360e(c)(1); see also Lohr, 518 U.S. at 477.       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 21

C.F.R. § 803.50(a)(1).     And if they fail to comply, the FDA can

withdraw approval.   Id. § 814.82(c).

          The   scheme   Congress   created   reflects   a   weighing   of

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

Inc., 784 F.3d 1335, 1336 (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."          Id.     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."      Id.   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[.]"       Id.   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, 476 U.S. 355,
368 (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, 518 U.S. at 495;

accord Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (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, 518 U.S. at 495)).

            A state-law claim not expressly preempted by the FDCA

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

Legal Comm., 531 U.S. 341, 352-53 (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 21 U.S.C.

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

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

Buckman Co., 531 U.S. at 352.        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., 934 F.3d 35, 42 (1st Cir. 2019)

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

Litig., 623 F.3d 1200, 1204 (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., 517 F. Supp. 3d 76, 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, 2018 WL 1542361, 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, 2018 WL 1542361,

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., 93 N.E.3d 1205, 1211 (Mass. 2018);

accord H.P. Hood & Sons, Inc. v. Ford Motor Co., 345 N.E.2d 683,

688 (Mass. 1976); see also Back v. Wickes Corp., 378 N.E.2d 964,

970-71       (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, 2007 WL 1089337 (Mass. Super.

Ct. Apr. 9, 2007); and an SJC decision, Dunn v. Genzyme Corp., 161

N.E.3d 390 (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 2007 WL 1089337, 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."               Id. at *10.

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 2007 WL 1089337, 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, 2012 WL

3641487, 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., 930 F.3d

116, 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., 475 N.E.2d 65, 68 (Mass. 1985) (quoting Carter v.

Yardley & Co., 64 N.E.2d 693, 697 (Mass. 1946)) — but "only in the

limited instances in which the manufacturer's reliance on an

intermediary is reasonable," see id. (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., 8 F.4th 26, 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,

507 F.3d 1233, 1236 (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, 742 F.2d 847, 851 (5th Cir.

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

7 Cumb. L. Rev. 455, 455 (1977)).       So given the absence of any SJC

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

judicial federalism," see Lehman Bros., 416 U.S. at 391 (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, 544 F.3d at 57, we opt to

certify, see Pyle v. S. Hadley Sch. Comm., 55 F.3d 20, 22 (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, 544 F.3d at 57 (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., 6

F.4th 229, 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 -