Court Opinion

ID: 4189729
Source: CourtListenerOpinion
Date Created: 2017-07-26 21:00:44.261187+00
Date Added: 2024-06-11T13:25:43.253001
License: Public Domain

United States Court of Appeals
                      For the First Circuit

No. 16-1442

  UNITED STATES, ex rel., ANTONI NARGOL and DAVID LANGTON; STATE
     OF ARKANSAS, STATE OF CALIFORNIA, CITY OF CHICAGO, STATE OF
  COLORADO, STATE OF CONNECTICUT, STATE OF DELAWARE, DISTRICT OF
  COLUMBIA, STATE OF FLORIDA, STATE OF GEORGIA, STATE OF HAWAII,
    STATE OF ILLINOIS, STATE OF INDIANA, STATE OF IOWA, STATE OF
       LOUISIANA, STATE OF MARYLAND, STATE OF MICHIGAN, STATE OF
      MINNESOTA, STATE OF MONTANA, STATE OF NEVADA, STATE OF NEW
  JERSEY, STATE OF NEW MEXICO, STATE OF NEW YORK, STATE OF NORTH
    CAROLINA, STATE OF OKLAHOMA, STATE OF RHODE ISLAND, STATE OF
   TENNESSEE, STATE OF TEXAS, COMMONWEALTH OF VIRGINIA, STATE OF
     WISCONSIN, COMMONWEALTH OF MASSACHUSETTS, CITY OF NEW YORK,
 STATE OF NEW HAMPSHIRE, STATE OF MISSOURI, STATE OF WASHINGTON,
               ex rel., ANTONI NARGOL and DAVID LANGTON,

                     Plaintiffs, Appellants,

                                v.

              DEPUY ORTHOPAEDICS, INC.; DEPUY, INC.;
                JOHNSON & JOHNSON, SERVICES, INC.,

                      Defendants, Appellees.

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

         [Hon. F. Dennis Saylor IV, U.S. District Judge]

                              Before

                Torruella, Thompson, and Kayatta,
                         Circuit Judges.

     Russell L. Kornblith, with whom David W. Sanford, Ross B.
Brooks, Sanford Heisler, LLP, Kevin M. Kinne, and Cohen Kinne
Valicenti & Cook, LLP, were on brief, for appellants.
     Mark D. Seltzer, with whom D. Danielle Pelot, Hannah R.
Bornstein, and Nixon Peabody LLP were on brief, for appellees.

                        July 26, 2017
            KAYATTA, Circuit Judge.               In this action brought by two

private individuals under the False Claims Act ("FCA"), 31 U.S.C.

§   3729,   and    various   state    analogues,          we   review   de   novo    the

dismissal     of    a    complaint        under     Federal       Rules      of     Civil

Procedure 9(b) and 12(b)(6).              Applying and extending our holding

in United States ex rel. D'Agostino v. ev3, Inc., 845 F.3d 1 (1st

Cir. 2016), we affirm the dismissal of the complaint to the extent

it relies on the alleged falsity of statements made by the product

manufacturer in securing approval from the U.S. Food and Drug

Administration ("FDA") to market a hip-replacement device.                        At the

same time, we reverse the district court's dismissal of the

complaint    to    the   extent      it    rests     on    allegations       that    the

manufacturer palmed off latently defective versions of its FDA-

approved product on unsuspecting doctors who sought government

reimbursement for the defective products.

                               I.     Background

            Doctors Antoni Nargol and Robert Langton (together,

"Relators") claim to be experts in hip-replacement techniques and

devices.    They brought this qui tam suit in May 2012 against DePuy

Orthopaedics, Inc., DePuy, Inc., and Johnson & Johnson Services,

Inc. (collectively, "DePuy") and filed an amended complaint under

seal in November 2013.        As in all other qui tam actions under the

FCA, see Vt. Agency of Nat. Res. v. United States ex rel. Stevens,

529 U.S. 765, 769 (2000), the U.S. Department of Justice was given

                                          - 3 -
time to conduct an investigation to determine whether the United

States would intervene.          In July 2014, it declined to do so.

Relators then filed a second amended complaint (for our purposes,

the "complaint") in May 2015. This is the complaint we now review,

because it was the one the district court found lacking and

dismissed with prejudice.       Quite unhelpfully, it is 168 pages long

and contains over 800 paragraphs of allegations, from which we

distill the following:

            Total hip replacement surgery involves replacing the

bone components of the joint--the ball-like femoral head and the

cup-like acetabulum--with artificial substitutes.          In addition, a

standard prosthetic hip replaces the bit of femur directly below

the femoral head with an artificial "femoral stem," the top of

which is connected to a "trunnion" that inserts into a "taper" in

the artificial head (this union is known as the "taper trunnion"

or the "taper junction").       Hip replacements also typically include

liners that form a buffer between the artificial cup and the

artificial head.      The particular hip-replacement device at issue

on   this   appeal   is   a   so-called   metal-on-metal   ("MoM")   device

employing a metal artificial acetabular cup and a metal artificial

femoral head.        DePuy marketed the device under its "Pinnacle"

product line.    We will use the name "Pinnacle MoM device" to refer

to this device, as distinguished from other DePuy hip-replacement

devices.

                                    - 4 -
            To ensure that hip-replacement devices work properly and

do not unexpectedly degrade over time, all of the components must

be carefully designed and manufactured to be consistently and

correctly sized, shaped, and smoothed.     This is especially true

for MoM devices because any time two metal components of an MoM

device put pressure on or rub against one another, tiny metal

shavings can make their way into the recipient's bloodstream,

causing pain and Adverse Response to Metal Debris (ARMD), a soft-

tissue reaction similar to a tumor, and requiring medical treatment

or "revision" surgery (a surgery in which a hip-replacement device

must itself be replaced).    Friction between components of an MoM

device can also cause the artificial cup to prematurely loosen,

and can cause the device to corrode, leading to the same type of

pain and difficulty walking that gave rise to the need for hip

arthroplasty in the first place.

            In December 2000, DePuy received FDA approval under

section 510(k) of the Federal Food, Drug, and Cosmetic Act, 21

U.S.C. § 360e(b)(1)(B)(ii), to market and sell the Pinnacle MoM

device.    Ordinarily, a medical device like the Pinnacle MoM device

would be required to undergo an extensive premarket approval

process.    The Pinnacle MoM device, however, was approved by way of

a different, less arduous process because DePuy represented to the

FDA that the Pinnacle MoM device was "substantially equivalent" to

the "ASR," an earlier MoM hip-replacement device for which DePuy

                                - 5 -
had previously received premarket approval.      Although Relators

describe both the ASR and the Pinnacle MoM device throughout their

complaint, only the Pinnacle MoM device is at issue in this case.

           Relators allege two types of fraud in DePuy's marketing

of the Pinnacle MoM device.     First, Relators allege that DePuy

made a series of false statements to the FDA and doctors, but for

which the FDA would not have approved the Pinnacle MoM device for

hip replacements or would have withdrawn that approval, and doctors

would not have certified the devices for government reimbursement.

Second, Relators allege that DePuy falsely palmed off devices that,

due to latent manufacturing defects, materially deviated from the

design specification of the FDA-approved Pinnacle MoM device.

           The alleged manufacturing defects at issue are of two

types.   One defect occurred when the sizes as manufactured of the

artificial femoral head and its acetabular cup caused them to fit

too snugly, impeding the cushioning intervention of bodily fluid

that precluded the head and cup from rubbing directly against each

other.   According to the complaint, "DePuy's manufacturing process

fail[ed] to produce implant heads within specification 14.93% of

the time and implant liners 50.41% of the time." The second defect

occurred when the surface of the taper trunnion that interacted

with the taper emerged from the manufacturing process with too

much roughness. This roughness increased friction and the shedding

of small metal debris when the trunnion moved against the taper.

                               - 6 -
Over fifty percent of the Pinnacle MoM devices as sold allegedly

suffered from this defect and were "well outside of their required

manufacturing specifications."        Combined with the first defect, it

caused the devices sold as Pinnacle MoM devices to have a five-

year failure rate of nearly fifteen percent, as compared to a five-

year failure rate of 4.5% or lower as claimed by DePuy (and

characteristic of or superior to the failure rates of other

competing devices).

            Relators allege that DePuy made direct claims to the

federal government and various state governments seeking payment

for some of the defectively manufactured Pinnacle MoM devices.

They also allege that DePuy was indirectly responsible for the

claims for payment that healthcare providers submitted to the

federal and state governments for reimbursement for defectively

manufactured Pinnacle MoM devices that the healthcare providers

had purchased from DePuy.

            The district court found that Relators failed to plead

false claims under either the FCA or the cited state-law versions

of the FCA with the particularity required by Federal Rule of Civil

Procedure   9(b).     See   United    States   ex   rel.   Nargol   v.   DePuy

Orthopaedics, Inc., 159 F. Supp. 3d 226, 248–55, 259–60 (D. Mass.

2016).1   In so finding, the district court bifurcated its analysis

     1 The district court also dismissed Relators' claim that DePuy
and its officers and employees conspired to defraud the government

                                     - 7 -
by focusing first on all direct claims submitted by DePuy to the

government, and then on indirect claims made through health care

providers.    The court found that the complaint's allegations

concerning   "direct"   claims   for   payment   that   DePuy   allegedly

submitted to the Department of Veterans Affairs, the Naval Medical

Center, and the Department of the Army failed to plead that the

claims for government payment were for the Pinnacle MoM device at

issue in this suit (as opposed to other hip-replacement devices)

and failed to identify any specific false claims.        See id. at 247–

52.   As for the "indirect" false claims for payment that DePuy

caused others to submit, the district court found that Relators

failed to identify even a single representative false claim for

payment for a defective Pinnacle MoM device, and that the complaint

did not cite sufficient "other factual and statistical evidence to

strengthen the inference of fraud beyond a mere possibility."        Id.

at 252.   Noting that the case had been pending for nearly four

years and that Relators, even after their third try at drafting a

compliant complaint, had yet to particularly plead a cognizable

claim for relief under the FCA, the district court dismissed the

complaint with prejudice, entered judgment in favor of DePuy, and

in violation of 31 U.S.C. § 3729(a)(1)(C), a claim the court
determined was not cognizable.  See Nargol, 159 F. Supp. 3d at
258–59.   Relators have not challenged on appeal the district
court's ruling on this issue.

                                 - 8 -
rejected Relators' motion to reconsider its judgment by allowing

the filing of a third amended complaint.      Id. at 262.

          Relators now appeal.    They argue that the district court

should have found that they plausibly and particularly alleged

that every claim submitted to the government for payment, directly

or indirectly, was false because the Pinnacle MoM device was

dangerously designed.   They also contend that the district court

erred in dismissing their claims arising out of indirect sales

because the Rule 9(b) requirements for pleading fraud in connection

with government reimbursements of intermediary parties is "more

flexible," United States ex rel. Duxbury v. Ortho Biotech Prods.,

L.P., 579 F.3d 13, 30 (1st Cir. 2009) (quoting United States ex

rel. Gagne v. City of Worcester, 565 F.3d 40, 46 (1st Cir. 2009)),

than the district court realized.      Relators further argue that the

district court erred in denying them leave to amend their complaint

a third time, and in rejecting their motion to reconsider that

denial.

                         II.     Discussion

                                  A.

          Rather than initially separating Relators' allegations

into those involving "direct" false claims for government payment

and those involving "indirect" false claims, we focus first on all

of Relators' claims, whether direct or indirect, that rest on the

allegation that DePuy misrepresented the safety and effectiveness

                                 - 9 -
of the product's design in order to secure or maintain FDA approval

for the Pinnacle MoM device.    We recently dealt with an analogous

claim in D'Agostino, in which we held that "the FDA's failure

actually to withdraw its approval of [the device at issue] in the

face of [the relator's] allegations precludes [the relator] from

resting his claims on a contention that the FDA's approval was

fraudulently obtained."    845 F.3d at 8.   The claim in this case is

not quite on all fours with the claim we confronted in D'Agostino

because the FDA does not independently assess the safety and

effectiveness of a medical device that qualifies for approval under

section 510(k).     See Medtronic, Inc. v. Lohr, 518 U.S. 470, 493

(1996).    Rather, the process under section 510(k) allows a device

manufacturer to piggyback on the full-scale review and approval of

another    device   by   demonstrating   that   the   new   device   is

"'substantially equivalent' to a predicate device" which itself

may be marketed pending the completion of a full premarket approval

process.    Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341,

345 (2001) (quoting 21 U.S.C. § 360e(b)(1)(B)).

            Nevertheless, the process constitutes the government's

method of determining whether a device is safe and effective as

claimed.   That determination is what makes the product marketable,

and Relators offer no suggestion that government reimbursement

rules require government health insurance programs to rely less on

section 510(k) approval than they do other forms of FDA approval.

                                - 10 -
The FDA, in turn, possesses a full array of tools for "detecting,

deterring, and punishing false statements made during . . .

approval processes." Id. at 349. Its decision not to employ these

tools in the wake of Relators' allegations so as to withdraw or

even suspend its approval of the Pinnacle MoM device leaves

Relators with a break in the causal chain between the alleged

misstatements and the payment of any false claim.      D'Agostino, 845

F.3d at 8.     It also renders a claim of materiality implausible.

See id. at 7.      The FCA's "materiality standard is demanding."

Universal Health Servs., Inc. v. United States, 136 S. Ct. 1989,

2003 (2016).      Even in an ordinary situation not involving a

misrepresentation of regulatory compliance made directly to the

agency paying a claim, when "the Government pays a particular claim

in full despite its actual knowledge that certain requirements

were violated, that is very strong evidence that those requirements

are   not   material."   Id.   Such   very   strong   evidence   becomes

compelling when an agency armed with robust investigatory powers

to protect public health and safety is told what Relators have to

say, yet sees no reason to change its position.        In such a case,

it is not plausible that the conduct of the manufacturer in

securing FDA approval constituted a material falsehood capable of

proximately causing the payment of a claim by the government.

Ruling otherwise would "turn the FCA into a tool with which a jury

of six people could retroactively eliminate the value of FDA

                               - 11 -
approval       and   effectively    require     that   a    product      largely       be

withdrawn from the market even when the FDA itself sees no reason

to do so."       D'Agostino, 845 F.3d at 8.

               Here, as in D'Agostino, there is no allegation that the

FDA withdrew or even suspended product approval upon learning of

the alleged misrepresentations.             To the contrary, the complaint

alleges that Relators told the FDA about every aspect of the design

of the Pinnacle MoM device that they felt was substandard, yet the

FDA allowed the device to remain on the market until DePuy, on its

own   volition,       discontinued    the   device     in     2013.          There    are

allegations that an FDA official sent a letter in 2005 that

"imposed an affirmative obligation on DePuy to provide the FDA

with updated information if . . . data indicated that DePuy's

'change or modification to the device or its labeling could

significantly affect the device's safety or effectiveness and thus

require    submission     of   a   new   510(k),'"      and       that   a    2011    FDA

Establishment        Inspection    Report   concerning        a    DePuy      plant   in

Indiana determined that DePuy was not adequately reporting adverse

events    or    investigating      complaints    of    device      failure.          Such

evidence does show that the FDA was paying attention.                          But the

lack of any further action also shows that the FDA viewed the

information, including that furnished by Relators, differently

than Relators do.

                                      - 12 -
             Admittedly, the complaint does seem to posit a second

twist that we did not encounter in D'Agostino:                In theory, a

product may be sufficiently "safe" and "effective" to secure FDA

approval for a given use, 21 U.S.C. § 360e(d)(2), yet its use might

nonetheless not be sufficiently "reasonable and necessary" for

patient care to warrant Medicare reimbursement for its use, 42

U.S.C. § 1395y(a)(1)(A).        See United States ex rel. Petratos v.

Genentech Inc., 855 F.3d 481, 487–88 (3d Cir. 2017); Int'l Rehab.

Sci. Inc. v. Sebelius, 688 F.3d 994, 1002 (9th Cir. 2012) ("FDA

clearance . . . is necessary, but not sufficient, for Medicare

coverage.    FDA review and Medicare coverage review have different

purposes." (citations omitted)); Almy v. Sebelius, 679 F.3d 297,

308   (4th   Cir.   2012)   (approving      Secretary's    decision   not   to

reimburse    because   device   was   not    "reasonable    and   necessary,"

despite device's approval under section 510(k)).           Assuming that to

be so, then it is possible that a particular attribute of a product

would not be required to secure FDA approval, yet it would be

necessary to secure reimbursement.             In such circumstances, a

manufacturer's false statement that its product possesses such an

attribute might in theory both cause the presentment of a claim

and be material to the government's decision to pay the claim in

a way that involves no second guessing of the government's still-

extant FDA approval of the product.

                                  - 13 -
          In Relators' complaint, this theory takes the form of

allegations that DePuy told doctors that the Pinnacle MoM device

had a failure rate of 0.1% at five years, as opposed to the more

modest 4%–4.5% claimed in DePuy's FDA filings.           The complaint is

devoid of particularized allegations, though, that any doctor

submitted a claim he or she would not have submitted if DePuy's

0.1%-failure-rate boast had not been made.              More importantly,

Relators level no allegation that the difference between 0.1% and

4%–4.5% was the difference between being reimbursable by the

government   (as   "reasonable    and     necessary")    and   not   being

reimbursable.   Rather, on that crucial point the complaint admits

that a 4%–4.5% failure rate would suffice because it is less than

the five-percent maximum failure rate provided under industry

guidelines, and alleges only that the true five-year failure rate

(purportedly much greater than five percent) rendered the product

not reasonable and necessary.     And that allegation (as far as the

design-defect-based claims are concerned) simply runs Relators

back into their claim that DePuy misled the FDA to obtain or

maintain approval for the Pinnacle MoM device.

          Relators additionally argue that their causal theory

posits a chain running not just through the FDA, but also directly

from DePuy to doctors precisely because DePuy repeated to doctors

the statements it made to the FDA.        We see no reason, though, why

such a likely and customary repetition of the statements made to

                                 - 14 -
the FDA renders it more plausible that a materially false statement

caused the payment of a claim that would not have been made

otherwise.    The government, having heard what Relators had to say,

was still paying claims not because of what was said to or by the

doctors, but because the government through the FDA affirmatively

deemed the product safe and effective.      And, absent some action by

the FDA, we can see no plausible way to prove to a jury that FDA

approval was fraudulently procured. See D'Agostino, 845 F.3d at 8.

             Finally, Relators seem to suggest that we should revisit

our holding in D'Agostino because a panel in the Ninth Circuit

recently reversed the dismissal of an FCA claim predicated in part

on allegations that the defendant misled the FDA.          See United

States ex rel. Campie v. Gilead Scis., Inc., No. 15-16380, 2017 WL

2884047, at *13 (9th Cir. July 7, 2017).      Of course, one panel of

this court may not revisit the holding of a prior panel merely

because another circuit disagrees.       In any event, we find nothing

in Campie to warrant revisiting D'Agostino. The example of a valid

claim given in Campie2, see id. at *10 n.8, would be a valid claim

under D'Agostino too, since it rests not on lying to the FDA but

rather on palming off one product as another.       Additionally, the

record in Campie lacked what we have here:       a situation in which

the FDA was not alleged to have ever withdrawn its approval, even

     2   Supplying FDA-approved Tylenol rather than Atripla.

                                - 15 -
long after it acquired full knowledge of Relators' claims.            Id. at

*11.       Otherwise, Campie offers no rebuttal at all to D'Agostino's

observation that six jurors should not be able to overrule the

FDA.       See D'Agostino, 845 F.3d at 8.     And it offers no solution to

the problems of proving that the FDA would have made a different

approval decision in a situation where a fully informed FDA has

not itself even hinted at doing anything.         Instead, it decides not

to deem these problems to be fatal on a Rule 12(b)(6) motion, even

if, apparently, no plausible solutions can be envisioned, even in

theory.

               For these reasons, the district court did not err in

dismissing any claim based on Relators' design-defect theory of

fraud.3

                                       B.

               We now arrive at Relators' principal theory of fraud

raised on this appeal:            that DePuy often sold to health care

providers       a   defectively   manufactured   product   that   materially

differed from the device the FDA approved.         Specifically, Relators

point to the allegations in their complaint that, based on data

       3
       The district court dismissed these claims for failure to
plead them with the particularity required under Rule 9(b). See
Nargol, 159 F. Supp. 3d at 255. Relators urge us to vacate and
remand so that the district court can consider whether the
complaint complies with Rule 12(b)(6). We are not bound, however,
by the reasoning of the district court, and we "may affirm an order
of dismissal on any ground evident from the record." MacDonald v.
Town of Eastham, 745 F.3d 8, 11 (1st Cir. 2014).

                                     - 16 -
"representative of the outcomes of DePuy's manufacturing process,"

Relators'        statistical       analysis      suggested     that     DePuy's

manufacturing process produced a surface-roughness defect in the

taper trunnion junction in more than half of DePuy's Pinnacle MoM

devices     and     "fail[ed]      to     produce   explant     heads   within

specification 14.93% of the time and 50.41% of the time for the

explant liner."         This theory--that DePuy got FDA approval for a

device and then palmed off a defective version of that device both

directly on the government itself and on unsuspecting doctors and

patients, who then submitted claims for payment to unsuspecting

government payors--is a theory of actionable misconduct under the

FCA, to which D'Agostino poses no impediment. See, e.g., Universal

Health Servs., 136 S. Ct. at 2001–02.            The key question is whether

this theory has been pled with the requisite particularity.

            The complaint in this case contains a description of

just one actual sale of a defectively manufactured product to a

provider that sought government reimbursement.               Specifically, the

complaint alleges that a surgeon at Stony Brook University Medical

Center in New York implanted a Pinnacle MoM device in a patient in

November 2007.          The device failed "as a result of manufacturing

defects     in    the    device,   including     nonconforming     diametrical

clearance dimensions." Not knowing that the device was defectively

manufactured, "Stony Brook University Medical Center submitted a

                                        - 17 -
claim to Medicaid for [the patient's] Pinnacle hip device and

implant surgery."

           The district court observed that the complaint alleges

no "specific representations or materials that the doctor received

and relied upon, nor does it allege the specific DePuy device for

which the doctor filed a claim."      Nargol, 159 F. Supp. 3d at 254.

As to the first point, the plain, specific misrepresentation

(assuming the allegations to be true) was that the device was the

Pinnacle   MoM   device,   an   FDA-approved   product,    rather   than   a

defectively manufactured, nonconforming variant.          As to the second

point, we read the complaint's description of a DePuy Pinnacle hip

implant which contained use instructions for the "Pinnacle MoM" as

fairly identifying the Pinnacle MoM device.

           The question remains, however, whether identifying this

single exemplar false claim is sufficient to clear the hurdle

imposed by Federal Rule of Civil Procedure 9(b). Rule 9(b) applies

because FCA actions sound in fraud.        See United States ex rel.

Karvelas v. Melrose-Wakefield Hosp., 360 F.3d 220, 228 (1st Cir.

2004), abrogated on other grounds by Allison Engine Co. v. United

States ex rel. Sanders, 553 U.S. 662 (2008); see generally John T.

Boese, Civil False Claims and Qui Tam Actions § 5.04[C] (4th ed.

2016) (collecting cases).       FCA complaints must therefore "state

with particularity the circumstances constituting fraud."           Fed. R.

Civ. P. 9(b).

                                  - 18 -
                The drafters of Rule 9(b) left us only a few hints of

the purposes sought to be furthered by the rule. The 1937 advisory

committee           notes   state    only:      "See    English    Rules    Under    the

Judicature Act (The Annual Practice, 1937) O. 19, r. 22."                         Fed. R.

Civ. P. 9(b) advisory committee's note (1937) .                   That source, while

voicing a roughly similar rule,4 offers no express insight into

the rule's purpose.            Nor does further excavation provide any firm

evidence of what the drafters of our Federal Rules of Civil

Procedure meant to accomplish with the words they used.                              See

generally Christopher M. Fairman, An Invitation to the Rulemakers-

-Strike Rule 9(b), 38 U.C. Davis L. Rev. 281, 287 (2004).                            The

only        other    tidbit   gleaned    by     academic   review    of     the   rule's

provenance is that Judge Charles E. Clark, the advisory committee's

first       reporter,       once    opined    that    "[w]hile    useful,    this   rule

probably states only what courts would do anyhow and may not be

considered absolutely essential."                 Id. (quoting Charles E. Clark,

Simplified Pleading, 2 F.R.D. 456, 463–64 (1943)).

                Like nature upon encountering a vacuum, courts have

since filled this gap with a list of purposes inferred to be the

objects of the rule's aim.               In our own circuit, we have ascribed

        4
       "Fraud must be distinctly alleged and proved.      The acts
alleged to be fraudulent must be stated, otherwise no evidence in
support of them will be received."     Jeff Sovern, Reconsidering
Federal Rule 9(b): Do We Need Particularized Pleading Requirements
in Fraud Cases?, 104 F.R.D. 143, 146 n.19 (1985).

                                             - 19 -
to Rule 9(b) the purposes of "[giving] notice to defendants of the

plaintiffs' claim, [protecting] defendants whose reputation may be

harmed   by    meritless   claims   of   fraud,   [discouraging]   'strike

suits,' and [preventing] the filing of suits that simply hope to

uncover relevant information during discovery."            Karvelas, 360

F.3d at 226 (quoting Doyle v. Hasbro, Inc., 103 F.3d 186, 194 (1st

Cir. 1996)).     To this list the Fifth Circuit has added the purpose

of ensuring that qui tam complaints include only as-yet nonpublic

information that the government may need in order to decide whether

to take the case over.        United States ex rel. Russell v. Epic

Healthcare Mgmt. Grp., 193 F.3d 304, 308–09 (5th Cir. 1999).5

              The circuits have varied, though, in their statements of

exactly what Rule 9(b) requires in a qui tam action.               Of most

relevance here, a consensus has yet to develop on whether, when,

and to what extent a relator must state the particulars of specific

examples of the type of false claims alleged.         See Foglia v. Renal

Ventures Mgmt., LLC, 754 F.3d 153, 155–56 (3d Cir. 2014) (surveying

circuits).

              Following the lead of the Eleventh Circuit, our circuit

staked out its general position in Karvelas, which concerned

allegations that a hospital subverted government standards but

     5 To be precise, this purpose would seem to be less a purpose
for Rule 9(b) and more a policy reason for applying it to qui tam
complaints. Whether the FCA supports such a policy we need not
decide.

                                    - 20 -
claimed it was in full compliance when it billed Medicare and

Medicaid for services rendered. 360 F.3d at 223. As we explained:

          In a case such as this, details concerning the
          dates of the claims, the content of the forms
          or bills submitted, their identification
          numbers, the amount of money charged to the
          government, the particular goods or services
          for which the government was billed, the
          individuals involved in the billing, and the
          length of time between the alleged fraudulent
          practices and the submission of claims based
          on   those   practices   are  the   types   of
          information that may help a relator to state
          his or her claims with particularity. These
          details do not constitute a checklist of
          mandatory requirements that must be satisfied
          by each allegation included in a complaint.
          However, like the Eleventh Circuit, we believe
          that "some of this information for at least
          some of the claims must be pleaded in order to
          satisfy Rule 9(b)."

Id. at 233 (quoting United States ex rel. Clausen v. Lab. Corp. of

Am., 290 F.3d 1301, 1312 n.21 (11th Cir. 2002)); see United States

ex rel. Ge v. Takeda Pharm. Co., 737 F.3d 116, 123–25 (1st Cir.

2013).

          In   applying   this   general   rule   over   time,   we   have

nevertheless recognized at least one exception to the expectation

that a relator should be able to allege the essential particulars

of at least some actual false claims that were in fact submitted

to the government for payment.       "[W]e have . . . recognized a

difference between qui tam actions alleging that the defendant

made false claims to the government and those alleging that the

defendant induced third-parties to file false claims with the

                                 - 21 -
government."     Lawton ex rel. United States v. Takeda Pharm. Co.,

842 F.3d 125, 130 (1st Cir. 2016) (citing Duxbury, 579 F.3d at

29). We apply a "more flexible" standard in actions of the latter,

indirect type:      where the defendant allegedly "induced third

parties to file false claims with the government . . . a relator

could satisfy Rule 9(b) by providing 'factual or statistical

evidence to strengthen the inference of fraud beyond possibility'

without necessarily providing details as to each false claim."

Duxbury, 579 F.3d at 29 (quoting United States ex rel. Rost v.

Pfizer, Inc., 507 F.3d 720, 733 (1st Cir. 2007)); see Ge, 737 F.3d

at 123–24.    Such evidence must pair the details of the scheme with

"reliable indicia that lead to a strong inference that claims were

actually submitted."    Id. (quoting United States ex rel. Grubbs v.

Kanneganti, 565 F.3d 180, 190 (5th Cir. 2009)).

             Seeking to take advantage of this increased flexibility

for indirect claims, relators in actions alleging unlawful, off-

label marketing of prescription drugs have often sought to rely on

the following reasoning:      Drug was approved for Use X; Company

successfully marketed it also for Use Y; lots of Drug has been

prescribed in the United States; a significant number of U.S.

patients are covered by government insurance; therefore it is

rational to assume that some payments for off-label use of Drug

have been made or reimbursed by the government.

                                - 22 -
             Rost was the first case in which we considered this line

of reasoning.     We agreed that the claimed inference generated by

such reasoning was "not irrational."            Rost, 507 F.3d at 732.     The

strength   of   the    inference,     though,    depended    on   an   unstated

assumption    that    physicians    or   patients    would   improperly   seek

government reimbursement for the off-label prescription, rather

than paying out of pocket.         And the record in Rost showed that, in

fact, "[i]n most, if not all, instances," patients paid out-of-

pocket for off-label prescriptions.          Id. (alteration in original).

Accordingly, the inference that false claims were filed rose to

the level of a "possibility" only.           Id. at 733.     This holding has

controlled our subsequent disposition of qui tam pleadings in at

least four other cases alleging unlawful marketing for off-label

uses or off-label dosages. See, e.g., United States ex rel. Booker

v. Pfizer, Inc., 847 F.3d 52, 57–58 (1st Cir. 2017); D'Agostino,

845 F.3d at 11; Lawton, 842 F.3d at 132; United States ex rel.

Kelly v. Novartis Pharm. Corp., 827 F.3d 5, 15 (1st Cir. 2016).6

             In one instance, on de novo review we did reverse a

Rule 9(b) dismissal of a qui tam action.            See Duxbury, 579 F.3d at

     6 Of course, our case selection is quite skewed because we
generally only see the weaker complaints. This is because almost
all of the qui tam cases that reach our court are ones in which a
capable district court, after briefing, has found the complaint
lacking. Conversely, rulings sustaining the sufficiency of the
stronger complaints are generally not appealable until after final
judgment, and few complex civil cases go the whole nine yards.

                                    - 23 -
32.   The fraudulent scheme alleged in Duxbury involved the payment

of kickbacks to health care providers in a manner designed to

artificially    inflate     the   reported    price      of   a   pharmaceutical

product.   Id. at 17.      The kickbacks took the form, in large part,

of free product given to providers "so that" they could submit the

free product for reimbursement at the reported price, pocketing

the payment.      Id. at 31.      The relator did "not identify specific

claims." Id. at 30. He did, however, identify "as to each of . . .

eight medical providers (the who), the illegal kickbacks (the

what), the rough time periods and locations (the where and when),

and the filing of the false claims themselves."                     Id.     These

allegations were sufficient to show "that false claims were in

fact filed by the medical providers [the relator] identified, which

further support[ed] a strong inference that such claims were also

filed nationwide."        Id. at 31.

           What    most    distinguishes     Duxbury      from    our   off-label

marketing cases is the nature of the conspiracy. In Rost, we found

no strong reason to believe that patients provided drugs for off-

label use would seek reimbursement where the use was not eligible

for reimbursement.        Rost, 507 F.3d at 732.          In Duxbury, though,

the entire purpose of giving doctors free product was so that they

would seek reimbursement to realize the kickback.                  Duxbury, 579

F.3d at 31.     The alleged scheme would have made little sense had

reimbursement     not   been   sought.       And   the    added    detail   about

                                    - 24 -
transactions involving eight providers, while not claim-specific

within the sense described in Karvelas, made the filing of some

claims "beyond possib[le]."      Id. (quoting Rost, 507 F.3d at 733).

            Here, Relators press yet a third type of alleged fraud,

which involves neither off-label marketing nor kickbacks.              The

fraudulent scheme alleged here--after our rejection of claims

based on the FDA-approved product design--is that DePuy knowingly

palmed off, as the approved Pinnacle MoM device, devices that

materially deviated from the approved specifications in a manner

that materially increased the risk of patient harm.            There is no

suggestion in the pleadings--and no reason to infer based on the

allegations--that the minute but material manufacturing defects

were known to the doctors, the patients, or the government.            Nor

would the defects in this particular instance have manifested

themselves during surgery. Cf. D'Agostino, 845 F.3d at 12 (finding

insufficient a pleading that false claims were likely submitted

for    government   payment    for    defectively   manufactured   devices

because the complaint alleged not "a latent manufacturing defect

that manifested itself only after the surgery was completed and

the claim for reimbursement submitted," but rather a "defect [that]

caused the device to fail as the surgeons tried to use it, and

thus    before   any   claim    for    reimbursement   might   have   been

submitted").     Unlike in our off-label marketing cases, there is

therefore no reason to suspect that physicians did not seek

                                     - 25 -
reimbursement for defective Pinnacle MoM devices.                 Additionally,

it is very likely that every sale of a Pinnacle MoM device was

accompanied by an express or plainly implicit representation that

the product being supplied was the FDA-approved product, rather

than a materially deviant version of that product.                Finally, given

the nature of a total hip replacement, it is also highly likely

that the expense is not one that is primarily borne by uninsured

patients in most instances.                Importantly, the complaint also

alleges the sale and use of thousands of Pinnacle MoM devices,

making it virtually certain that the insurance provider in many

cases was Medicare, Medicaid, or another government program.7

              To summarize, Relators allege that, over a five-year

period, several thousand Medicare and Medicaid recipients received

what their doctors understood to be Pinnacle MoM device implants;

that       more   than   half   of    those     implants   fell    outside   the

specifications approved by the FDA; and that the latency of the

defect was such that doctors would have had no reason not to submit

claims      for   reimbursement      for   noncompliant    devices.     In   this

context, where the complaint essentially alleges facts showing

that it is statistically certain that DePuy caused third parties

       7
       For example, the complaint alleges that approximately 18,750
Pinnacle MoM devices were sold to Medicare patients alone between
2005 and 2009, and that those patients made up roughly half of the
total number of people who received Pinnacle MoM devices during
that timeframe.

                                       - 26 -
to submit many false claims to the government, we see little reason

for Rule 9(b) to require Relators to plead false claims with more

particularity than they have done here in order to fit within

Duxbury's "more flexible" approach to evaluating the sufficiency

of fraud pleadings in connection with indirect false claims for

government payment.   In short, we have in this case a complaint

that alleges the details of a fraudulent scheme with "reliable

indicia that lead to a strong inference that claims were actually

submitted," Duxbury, 579 F.3d at 29 (quoting Grubbs, 565 F.3d at

190), for government reimbursement from the United States and from

the state of New York.8

                                C.

          While the foregoing suffices to sustain Relators' claims

under the FCA9 and New York's state-law analogue for indirect false

     8 Whether the one pleaded example offered here is necessary
we need not and do not decide.

     9 This includes both count 1 (alleging that DePuy violated 31
U.S.C. § 3729(a)(1)(A)) and count 2 (alleging that DePuy violated
31 U.S.C. § 3729(a)(1)(B)).      As Relators observe, the district
court stated:     "The First Circuit has distinguished pleading
standards for direct claims, or sales to the government, which are
governed by 31 U.S.C. § 3729(a)(1)(A), from indirect claims to the
government where a defendant causes third-parties to submit false
claims, which are governed by 31 U.S.C. § 3729(a)(1)(B)." Nargol,
159 F. Supp. 3d at 252. This is incorrect: neither § 3729(a)(1)(A)
nor § 3729(a)(1)(B) applies only to direct or indirect claims for
government payment.    Section 3729(a)(1)(A) imposes liability on
defendants who directly "present[] . . . a false or fraudulent
claim for payment or approval," and defendants who indirectly
"cause[] to be presented[] a false or fraudulent claim for payment
or   approval."      31   U.S.C.   §   3729(a)(1)(A).    Likewise,

                              - 27 -
claims for government payment, it does not sustain Relators' claims

alleging that DePuy directly submitted false claims for payment to

the government, or any of Relators' claims at all under the other

state laws cited in the complaint.          With regard to direct claims,

Relators    make   no   argument   that   the   "more   flexible"   standard

articulated in Duxbury and Gagne applies, or that their allegations

satisfactorily plead the transactional particulars required under

Karvelas.    They argue only that they need offer no transactional

particulars because all sales were fraudulent.               Yet, Relators

themselves concede that not all of the Pinnacle MoM devices were

manufactured defectively, and we have in turn rejected their

argument that their design-defect theory works.           In short, this is

not a case in which every claim for payment was by definition

fraudulent, so we need not decide how we might rule in such a case.

            With respect to payments by states other than New York,

Relators for the most part have made conclusory allegations that

state and municipal analogues to the FCA were violated when claims

section 3729(a)(1)(B) similarly prohibits both directly "mak[ing
or] us[ing] . . . a false record or statement material to a false
or fraudulent claim" and "caus[ing] to be made or used[] a false
record or statement material to a false or fraudulent claim." Id.
§ 3729(a)(1)(B).     Relators allege that doctors certified to
Medicare that the device they implanted was reasonable and
necessary for patient care because it was the Pinnacle MoM device
that the FDA had approved, and that such certifications were
frequently false because manufacturing defects made the implanted
device materially different from the one the FDA approved. This
is sufficient to particularly plead a cause of action under both
§ 3729(a)(1)(A) and § 3729(a)(1)(B).

                                   - 28 -
for reimbursement were submitted for covered patients in a handful

of states and municipalities, but the complaint does nothing to

allege that Pinnacle MoM devices were advertised to and implanted

by physicians in Arkansas, California, Colorado, Chicago, or any

other state or municipality except for the state of New York.

Relators do not allege that DePuy made the Pinnacle MoM device

available to surgeons and their patients in those places, much

less how many of such devices (if any) were ordered and implanted

in patients, how many total-hip-replacement surgeries (if any)

were performed in these places, or how many people in these places

were covered by government healthcare programs during the relevant

timeframe.

             The exception, again, is New York.   Relators do allege

that between 2005 and 2010, "New York State Medicaid paid for an

average of approximately 1280 claims each year for total hip

replacement devices," fifty percent of each of which the United

States paid; that MoM hip-replacement devices made up a large

percentage of devices being prescribed and installed during that

time; and that given both DePuy's general market share and the

specific market share of the Pinnacle MoM device, "nearly 425

Pinnacle devices bearing the diametrical-clearance manufacturing

defect would have been paid for by New York State Medicaid," and

the United States, "between 2005 and 2010."       This is enough for

Relators' manufacturing-defect-based indirect claims under New

                                - 29 -
York's analogue to the FCA to satisfy Rule 9(b)'s particularity

requirement.

                                       D.

            Finally, Relators argue that the district court should

have permitted them leave to amend so that they could file yet

another (i.e., a fourth) version of their complaint that would

comply with the strictures of Rules 9(b) and 12(b)(6).             But see In

re Biogen Inc. Sec. Litig., 857 F.3d 34, 45 (1st Cir. 2017)

(explaining that we review denials of motions to amend and for

reconsideration     for   abuse   of        discretion,   discouraging   "any

expectation that there will be leisurely repeated bites at the

apple" (internal citation omitted)).            Relators contend that they

made this request both before and after the district court entered

judgment against them, first by seeking leave to amend under Rule

15(a) and then by seeking reconsideration and leave under Rules 59

and 60.

            The relevant gist of the proposed fourth complaint is

the addition of transactional particulars for some indirect claims

for government payment for Pinnacle MoM devices.             Those details do

nothing to overcome the defect in Relators' fraud-on-the-FDA,

design-defect claims, or the absence of transactional particulars

for the alleged direct claims that Relators do not argue are within

Duxbury's   "more   flexible"     exception       to   the   requirements   of

Karvelas.   The proposed amendments are also unnecessary to rescue

                                  - 30 -
the manufacturing-defect claims under federal and New York state

law that we have already found were properly pleaded.    And they do

nothing to cure the defects we have identified in Relators' claims

under the laws of other states.       In short, the proposed amended

complaint is either futile or redundant.

                           III.   Conclusion

             We vacate the dismissal of Relators' claims that DePuy

caused physicians to submit claims to the United States and New

York for payment for Pinnacle MoM devices that did not materially

comport with the specifications of the FDA approval for those

devices in violation of the FCA, 31 U.S.C. § 3729(a)(1)(A)–(B)

(counts 1 and 2), and its New York state analogue, N.Y. State Fin.

Law § 189(1)(a)–(b) (count 27).       We affirm the dismissal of all

other claims, and of the denial of further requests to amend the

complaint.      We remand the case solely for resolution of the

surviving claims.    All parties shall bear their own costs on this

appeal.

                                  - 31 -