Amicus Curiae Brief — Merck Sharp & Dohme Corp., Petitioner v. Doris Albrecht, et al.

No. 17-290

IN THE

Supreme Court of the United States

___________

MERCK SHARP & DOHME CORP.,

v.

Petitioner,

DORIS ALBRECHT, et al.,

Respondents.

___________

On Writ of Certiorari to the

United States Court of Appeals

for the Third Circuit

___________

BRIEF OF WASHINGTON LEGAL FOUNDATION

AS AMICUS CURIAE IN SUPPORT OF PETITIONER

___________

September 20, 2018

CORY L. ANDREWS

Counsel of Record

RICHARD A. SAMP

WASHINGTON LEGAL FOUNDATION

2009 Massachusetts Ave., NW

Washington, DC 20036

(202) 588-0302

candrews@wlf.org

QUESTION PRESENTED

Whether the Federal Food, Drug, and

Cosmetic Act, 21 U.S.C. § 301, et seq., preempts a

state-law failure-to-warn claim when the Food and

Drug Administration has rejected the brand-name

drug manufacturer’s application, which included all

relevant scientific data, to change its drug’s label to

warn about the very risk underlying the claim.

iii

TABLE OF CONTENTS

TABLE OF AUTHORITIES ................................... iv

INTEREST OF AMICUS CURIAE ......................... 1

STATEMENT OF THE CASE ................................. 2

SUMMARY OF ARGUMENT.................................. 5

ARGUMENT ............................................................ 8

I.

II.

RESPONDENTS’

FAILURE-TO-WARN

CLAIM IS PREEMPTED BECAUSE

FEDERAL LAW PROHIBITED MERCK

FROM

PROVIDING A STRONGER

WARNING....................................................... 8

A.

The Third Circuit’s Holding

Flouts This Court’s Preemption

Case Law ............................................. 8

B.

None of Levine’s Case-Specific

Barriers to Preemption Apply

Here ................................................... 13

NO

PRESUMPTION AGAINST PREEMPTION APPLIES HERE ............................ 18

CONCLUSION ....................................................... 25

iv

TABLE OF AUTHORITIES

Page(s)

Cases:

Arizona v. United States,

567 U.S. 387 (2012) ............................................ 23

Bates v. Dow Agrosciences LLC,

544 U.S. 431 (2005) ............................................. 23

Buckman Co. v. Plaintiffs’ Legal Comm.,

531 U.S. 341 (2001) ....................................... 12, 13

Chamber of Commerce of the United States

v. Whiting, 563 U.S. 582 (2011) .......................... 21

City of New York v. FCC,

486 U.S. 57 (1988) ............................................... 22

Crosby v. Nat’l Foreign Trade Council,

530 U.S. 363 (2000) ............................................. 21

Dobbs v. Wyeth Phram.,

797 F. Supp. 2d 1264 (W.D. Okla. 2011) ............ 12

English v. Gen. Elec. Co.,

496 U.S. 72 (1990) ................................................. 8

Felder v. Casey,

487 U.S. 131 (1988) ............................................. 22

Fidelity Fed. Sav. & Loan Ass’n v. de la Cuesta,

458 U.S. 141 (1982) ............................................. 22

v

Page(s)

Fla. Lime & Avacado Growers, Inc. v. Paul,

373 U.S. 132 (1963) ............................................. 22

Fla. State Conference of the NAACP v. Browning,

522 F.3d 1153 (11th Cir. 2008) ........................... 22

Geier v. Am. Honda Motor. Co.,

529 U.S. 861 (2000) ..................... 19, 20, 21, 23, 24

Hillsborough Cnty., Fla. v. Automated Med.

Labs., Inc., 471 U.S. 707 (1985) .......................... 20

In re Sawyer,

360 U.S. 622 (1959) ............................................. 11

Maryland v. Louisiana,

451 U.S. 725 (1981) ............................................... 8

Medtronic, Inc. v. Lohr,

518 U.S. 470 (1996) ............................................. 23

Mut. Pharm. Co. v. Bartlett,

570 U.S. 472 (2013) ......................................... 1, 10

New York v. United States,

505 U.S. 144 (1992) ............................................. 19

ONEOK, Inc. v. Learjet, Inc.,

135 S. Ct. 1591 (2015) ........................................... 1

PLIVA, Inc. v. Mensing,

564 U.S. 604 (2011) ............. 6, 9, 13, 18, 19, 21, 24

vi

Page(s)

Puerto Rico v. Franklin-California-Tax-Free

Trust, 136 S. Ct. 1938 (2016) ............................. 21

Riegel v. Medtronic, Inc.,

552 U.S. 312 (2008) ............................................. 23

United States v. Locke,

529 U.S. 89 (2000) ............................................... 21

Wyeth v. Levine,

555 U.S. 555 (2009) ......................................passim

Constitutional & Statutory Provisions:

U.S. Const. Article VI, cl. 2 ...................................... 18

The Federal Food, Drug, & Cosmetic Act

21 U.S.C. 301, et seq. .............................................. 1

Other Authorities:

21 C.F.R. 314.102 ..................................................... 12

21 C.F.R. 314.110 ....................................................... 3

Mary J. Davis, Unmasking the Presumption in

Favor of Preemption, 53 S.C. L. Rev. 967

(2002) ..................................................................... 20

Viet D. Dinh, Reassessing the Law of

Preemption, 88 Geo. L.J. 2085 (2000) ............. 18, 24

Oliver Wendell Holmes, Jr., Law in Science and

Science in Law, 12 Harv. L. Rev. 443 (1889) ....... 11

vii

Page(s)

Calvin R. Massey, Joltin’ Joe Has Left and Gone

Away: The Vanishing Presumption Against

Preemption, 66 Alb. L. Rev. 759 (2003) ................ 23

Caleb Nelson, Preemption, 86 Va. L. Rev.

225 (2000) .............................................................. 19

Martin R. Scordato, Federal Preemption of State

Tort Claims, 35 U.C. Davis L. Rev. 1 (2001) .. 19, 23

David Sloss, Constitutional Remedies for Statutory

Violations, 89 Iowa L. Rev. 355 (2004) ................. 20

Ernest A. Young, “The Ordinary Diet of the Law”:

The Presumption Against Preemption in the

Roberts Court, 2011 Sup. Ct. Rev. 253 (2012) ...... 24

1

INTEREST OF AMICUS CURIAE *

Washington Legal Foundation is a nonprofit,

public-interest law firm and policy center with

supporters in all 50 states. WLF promotes and

defends free enterprise, individual rights, limited

government, and the rule of law. Since its founding

in 1977, WLF has appeared as amicus curiae in

important preemption cases, urging the Court to

ensure that federal law operates efficiently and

uniformly—as Congress intended. See, e.g., ONEOK,

Inc. v. Learjet, Inc., 135 S. Ct. 1591 (2015); Mut.

Pharm. Co. v. Bartlett, 570 U.S. 472 (2013); Wyeth v.

Levine, 555 U.S. 555 (2009).

WLF believes that individual freedom, the

American economy, and public health all suffer when

state law, including state tort law, interferes or

conflicts with federal regulatory regimes, including

the Federal Food, Drug, and Cosmetic Act (FDCA)

21 U.S.C. § 301, et seq. Conflicting federal and state

duties are not merely inefficient; they make it

impossible for regulated parties to comply with both

state and federal law without incurring serious

liability.

The Supremacy Clause prevents state law

from imposing that Hobson’s choice on anyone. But

the decision below, by denying federal preemption in

the face of clear impossibility, would render the

Supremacy Clause a dead letter.

No party’s counsel authored any part of this brief. No

person or entity, other than WLF and its counsel, helped pay

for the preparation or submission of this brief. All parties have

consented to the filing of WLF’s brief.

*

2

STATEMENT OF THE CASE

In 1995, the FDA approved the prescription

drug Fosamax for treating osteoporosis in older

women. Pet. App. 5a, 12a. Over the next 15 years,

published studies suggested a possible link between

long-term Fosamax use and atypical femoral

fractures. Id. at 13a-14a. Merck, Fosamax’s

manufacturer, alerted the FDA to these studies. Id.

at 13a. In June 2008, the FDA asked Merck to

submit all available information it had linking the

use of bisphosphonates to femoral fractures. Id. at

14a. Merck complied fully. Ibid.

In September 2008, Merck submitted a priorapproval supplement (PAS) seeking the FDA’s

permission to revise portions of Fosamax’s label. Pet.

App. 14a-15a. Under the Adverse Reactions section,

Merck proposed adding “low-energy femoral shaft

fracture” as a potential adverse reaction. Id. at 16a.

Under the Warnings & Precautions section, Merck

proposed adding a new subsection entitled “LowEnergy Femoral Shaft Fracture,” which warned that

“[l]ow-energy fractures of the subtrochanteric and

proximal femoral shaft”—the upper and middle

thigh bone—“have been reported in a small number

of bisphosphonate-treated patients.” Id. at 15a-16a.

The proposed warning added that “some” of those

fractures were “stress fractures * * * occurring in the

absence of trauma.” Ibid.

In April 2009, an FDA liaison instructed

Merck to “hold off” on changing the Warnings &

Precautions label until the FDA could “decide on

language” for a stronger precaution “if it is

warranted.” Pet. App. 17a-18a. Then, in May 2009,

3

the FDA issued its Complete Response Letter, id. at

18a, which reflected “FDA’s complete review of the

data submitted” and described “all of the specific

deficiencies” the agency identified. See 21 C.F.R. 314.

110(a)(1), (2). While the FDA agreed that Merck

could add “low-energy femoral shaft and

subtrochanteric fractures” to the Adverse Reactions

section of the label, it rejected Merck’s proposed

changes to the Warnings & Precautions section. Pet.

App. 18a-19a.

The FDA determined that “[i]dentification of

‘stress fractures’ may not be clearly related” to the

“fractures that have been reported in the literature.”

Pet. App 18a-19a. In the FDA’s view, any “[d]iscussion of the risk factors for stress fractures [was] not

warranted and [was] not adequately supported by

the available literature and post-marketing adverse

event reporting.” Ibid. Following the FDA’s response,

Merck promptly updated the Adverse Reaction

section of Fosamax’s label.

The FDA issued a safety announcement in

March 2010. It confirmed that the available data

still had “not shown a clear connection between

bisphosphonate use and a risk of atypical

subtrochanteric femur fractures.” Pet. App. 19a. In

fact, no study had shown “even that Fosamax use

was definitely associated with atypical fractures.” Id.

at 13a. So the FDA commissioned a task force to

gather more information. Ibid.

In September 2010, the FDA’s task force

reported an “association” between atypical femoral

fractures and long-term bisphosphonate use. Pet

App. 121a. But the task force found nothing “proven

4

to be causal.” Ibid. In response, the FDA announced

that even though causation was “still not clear,” the

agency would begin “considering label revisions.” Id.

at 20a-21a.

In October 2010, the FDA directed bisphosphonate manufacturers to revise the Warnings &

Precautions sections of their labels to disclose the

risk of atypical femoral fractures. Pet. App. 21a.

Even if such fractures were “potentially more closely

related to” long-term use of bisphosphonates, the

FDA still believed it was “not clear” whether

bisphosphonates caused the fractures. Ibid.

Nonetheless, upon obtaining clarification from the

FDA, Merck added the FDA’s approved language to

the Warnings & Precautions section of Fosamax’s

label. Id. at 21a-23a.

After the FDA approved Fosamax’s revised

label, more than 1,200 Fosamax users who had

allegedly suffered an atypical femoral fracture sued

Merck for failing to warn of the risk of that injury.

Pet. App. 23a. These lawsuits were combined in

multi-district litigation (MDL) in the District of New

Jersey. Ibid. Following a bellwether trial, the district

court issued an opinion addressing Merck’s

impossibility-preemption defense. Id. at 25a.

Applying this Court’s decision in Wyeth v.

Levine, the district court found “clear evidence that

the FDA would not have approved a change to the

Precautions section of the Fosamax label” before the

FDA’s task force report. Pet. App. 168a. The district

court then applied that preemption holding to all

MDL cases in which the plaintiff’s alleged injury

occurred before September 14, 2010 (the date of the

5

FDA’s task force report) and granted summary

judgment to Merck in those cases. Id. at 152a.

The Third Circuit vacated and remanded. Pet.

App. 1a-74a. The court announced that Levine, by

requiring “clear evidence” that the FDA would refuse

a label change before a state-law claim arising from

that label will be preempted, imposed a burden of

proof “synonymous with ‘clear and convincing

evidence.’” Id. at 37a. Under this heightened bar, a

defendant must prove that it “is highly probable that

the FDA would not have approved a change to the

drug’s label” to establish a preemption defense. Ibid.

According to the Third Circuit, that

question—whether the FDA would have refused a

label change—is strictly a question of fact for the

jury. Pet. App. 38a-55a. “Because the [Levine] test

requires the factfinder to speculate about

hypothetical scenarios using inferences drawn from

historical facts, reasonable jurors could reach a

broad range of conclusions when confronted with

this record.” Id. at 67a-68a. The panel determined

that “a reasonable jury applying a heightened

standard of proof could conclude” that the FDA

would have allowed the label change if Merck had

worded it differently. Id. at 67a.

SUMMARY OF ARGUMENT

Under the Supremacy Clause, any conflicting

state law must give way to federal law. This Court

has recognized that complying with both federal and

state law is “impossible” for drug manufacturers

when “[i]t was not lawful under federal law for

[them] to do what state law required of them.”

6

PLIVA, Inc. v. Mensing, 564 U.S. 604, 618 (2011).

This case is no exception.

The only way Merck could have avoided

liability under New Jersey tort law would have been

to strengthen Fosamax’s label to warn of an

increased risk of atypical femoral fractures. But

Merck has shown decisively not merely that the FDA

would have rejected a stronger Fosamax warning,

but that the FDA did reject a stronger Fosamax

warning. A “clearer” showing of impossibility

preemption is hard to imagine.

True enough, under this Court’s holding in

Wyeth v. Levine, the FDA’s mere approval of a

brand-name label, standing alone, doesn’t establish a

federal ceiling for drug regulation. But Levine also

makes clear that the FDA’s formal rejection of a

manufacturer’s proposed shift to a stronger label

does just that. Here, no one disputes that before the

FDA’s September 2010 task force report, federal law

and New Jersey law imposed on Merck irreconcilable

labeling duties. So under Levine’s reading of the

Supremacy Clause, New Jersey’s conflicting tort-law

duty must give way to federal law.

But the Third Circuit disagrees. The panel

below held that if a reasonable jury could find that

the FDA would have approved a differently worded

label than the one Merck proposed, the threshold

legal question of preemption goes to the jury, not the

court. In so holding, the appeals court invites a lay

jury not only to second guess the FDA’s labeling

decision but also to speculate on a labeling decision

the FDA might have made. That holding collides

with this Court’s preemption cases.

7

By focusing on what the FDA might have done

rather than on what the FDA did, the decision below

dilutes Levine beyond all recognition. As the United

States has confirmed in its amicus brief, the FDA’s

rejection of Merck’s proposed label turned solely on

the available scientific data, not on Merck’s choice of

words. If the Court were to adopt the Third Circuit’s

view of conflict preemption on this record, it would

render the Supremacy Clause “all but meaningless.”

Bartlett, 570 U.S. at 488. If, on the other hand, the

Court does little more than apply Levine

straightforwardly, the judgment below must be

reversed.

Nor does any presumption against preemption

apply here. In equating Levine’s “clear evidence” rule

with a clear-and-convincing-evidence standard of

proof, the panel below invoked the “presumption

against preemption.” Pet. App. 37a. But no basis

exists in the Constitution for applying a presumption

against preemption—in this or any other case. And

nothing in logic supports such a presumption when,

as here, preemption hinges on the existence of a

genuine conflict between state and federal law. On

the contrary, implied conflict preemption is the

quintessential example of the Supremacy Clause at

work.

8

ARGUMENT

I.

RESPONDENTS’ FAILURE-TO-WARN CLAIM IS

PREEMPTED

BECAUSE

FEDERAL

LAW

PROHIBITED MERCK FROM PROVIDING A

STRONGER WARNING.

Under the Supremacy Clause, state law that

conflicts with federal law is “without effect.”

Maryland v. Louisiana, 451 U.S. 725, 746 (1981).

Even without an express preemption provision in the

federal law, state law is impliedly preempted if it is

“impossible for a private party to comply with both

state and federal requirements.” English v. Gen.

Elec. Co., 496 U.S. 72, 79 (1990). That is this case. As

shown below, because it was impossible for Merck to

comply with New Jersey tort law without

simultaneously violating federal law, any state-law

liability premised on a failure to warn is fully

preempted.

A.

The Third Circuit’s Holding Flouts

This Court’s Preemption Case Law.

1. The leading preemption precedent for

brand-name drug manufacturers is Wyeth v. Levine.

In Levine, a Vermont jury determined that Wyeth’s

“inadequate label” on its drug Phenergan failed to

warn adequately “about the [gangrene] risks of IVpush administration” of that drug. 555 U.S. at 564.

On appeal, Wyeth argued that the “FDA’s approvals”

of Phenergan’s label provided it “with a complete

defense to Levine’s tort claims.” Id. at 558-59.

The Court disagreed. While recognizing that

“the FDA retains authority to reject labeling

9

changes,” Levine emphasized that, under the FDCA,

brand-name drug manufacturers are generally free

to strengthen their drugs’ labels when necessary. Id.

at 571. The Court held that, “absent clear evidence

that the FDA would not have approved a change to

Phenergan’s label,” it could “not conclude that it was

impossible for Wyeth to comply with both federal

and state requirements.” Id. at 572. Put another

way, while the FDA’s mere approval of a brandname label does not, as Wyeth contended, establish a

federal “ceiling for drug regulation,” id. at 573, the

FDA’s denial of a manufacturer’s requested label

change would do precisely that.

Nor is that all. As this Court later clarified in

PLIVA v. Mensing, a plaintiff’s rank speculation

about whether and how a drug manufacturer might

have reconciled its federal and state-law duties is

never enough to defeat preemption. In Mensing, the

generic manufacturers argued that any state-law

duty to strengthen their drug’s label conflicts with

their “ongoing federal duty of ‘sameness,’” which

requires a generic drug’s label to “be the same as the

[brand-name] drug product’s labeling.” 564 U.S. at

613. But the plaintiffs argued that the generic

manufacturers’ independent duty to alert the FDA to

any newly discovered risks for their drugs made it

“certainly possible” that the FDA would have

approved a “safer label” had the manufacturers

bothered to ask for one. Id. at 618-20.

Rejecting that argument, the Court held that

it was “impossib[le]” for generic manufacturers to

honor both their state and federal duties. Ibid.

Because preemption hinges on “whether the private

party could independently do under federal law what

10

state law requires of it,” the plaintiffs’ mere

“conjectures” would not “suffice to prevent federal

and state law from conflicting for Supremacy Clause

purposes.” 564 U.S. at 621. In other words, the

preemption analysis “should not involve speculation

about ways in which federal agencies and thirdparty actions could potentially reconcile federal

duties with conflicting state duties.” Id. at 623

(plurality op.).

This Court applied the above preemption

principles to design-defect claims in Mutual

Pharmaceutical Co. v. Bartlett. There, to avoid

design-defect liability under New Hampshire law,

drug manufacturers had to either design a safer

drug or add a stronger warning to the label. 570 U.S.

at 482-83. The plaintiff argued that, at the very

least, the defendant generic manufacturer could

comply with both federal and state law by simply

pulling its drug from the New Hampshire market

altogether. Ibid. The Court disagreed.

Bartlett concluded that accepting the

plaintiff’s argument would render impossibility

preemption “all but meaningless.” Id. at 488. That is

because federal law prevented the generic

manufacturer from either redesigning the drug or

strengthening the label. And because federal law

“prohibited” the “remedial action required to avoid

liability” under New Hampshire law, the plaintiff’s

design-defect claim was preempted. Id. at 486. Above

all, this Court’s “preemption cases presume that an

actor seeking to satisfy both his federal and statelaw obligations is not required to cease acting

altogether in order to avoid liability.” Id. at 488.

11

As the record here shows, the FDA rejected

the very label Merck needed to avoid state tort

liability. And it is the FDA, not the states, that

Congress gives the final statutory and regulatory

authority to determine a drug’s label. But a statelaw duty to provide a warning that the FDA has

already rejected is a duty to misbrand drugs in

violation of federal law. Under these facts, any

liability that arises from breaching such a state-law

duty is preempted under the Supremacy Clause.

2. In the face of this Court’s preemption

precedents, the respondents argue that the FDA

might have approved a stronger Fosamax warning if

only Merck had worded its supplement application

differently. The Third Circuit agreed, assuming that

a reasonable jury “could find it less than highly

probable” that the FDA would have rejected a

differently phrased warning about atypical femoral

fractures. Pet. App. 56a-57a. According to the

appeals court, the “question for preemption purposes

is whether the FDA would have approved a different

label amendment than the one it actually rejected in

the May 2009 letter.” Id. at 52a.

But Merck’s PAS submission must be viewed

“in its entirety, not distorted as an exercise in

disjointed parsing.” In re Sawyer, 360 U.S. 622, 653

(1959) (Frankfurter, J., dissenting). That is, “[w]e

must think things, not words, or at least we must

constantly translate our words into facts for which

they stand, if we are to keep to the real and the

true.” Oliver Wendell Holmes, Jr., Law in Science

and Science in Law, 12 Harv. L. Rev. 443, 460

(1889). Here, the FDA’s outright rejection of Merck’s

label supplement with no haggling over its wording

12

shows that the FDA believed no additional warning

was appropriate at that time.

And contrary to the respondents’ claim,

nothing in Levine “impos[es] upon [a] drug

manufacturer a duty to continually ‘press’ an

enhanced warning which has been rejected by the

FDA.” Dobbs v. Wyeth Phram., 797 F. Supp. 2d 1264,

1279 (W.D. Okla. 2011). In all events, the relevant

question for preemption purposes isn’t whether

Merck could have asked for a differently worded

warning, but whether the FDA would have approved

one. Levine, 555 U.S. at 618-20. On that crucial

point, there is no need for guesswork.

“If a warning is warranted, FDA will attempt

promptly to identify easily corrected deficiencies in

the proposed text and will then develop final labeling

text with the manufacturer in an iterative process.”

U.S. Cert. Br. 21; see 21 C.F.R. 314.102(b). As the

United States has confirmed, and the FDA’s

Complete Response Letter made clear at the time,

the FDA rejected Merck’s proposed warning “based

on the agency’s determination that the data was

then insufficient to justify such a warning.” U.S.

Cert. Br. 22. Allowing a jury to second guess that

decision based on semantics “would exert an

extraneous pull on the scheme established by

Congress.” Buckman Co. v. Plaintiffs’ Legal Comm.,

531 U.S. 341, 353 (2001).

Levine’s discussion of the history of

Phenergan’s label confirms that the Court

understood its “clear evidence” standard as one that

manufacturers could plausibly meet under an

appropriate set of facts. Although the record in

13

Levine lacked such facts, they are present here—in

spades. In contrast, the Third Circuit’s rule sets the

“clear evidence” bar so high that drug manufacturers

can’t possibly meet it even with a “smoking gun”

rejection letter from the FDA. Pet. App. 55a.

If a plaintiff’s counterfactual speculation

about alternative wording can defeat impossibility

preemption, brand-name drug manufacturers will

leave nothing to chance. They will “have an incentive

to submit a deluge of information that the [FDA]

neither wants nor needs, resulting in additional

burdens on the FDA’s evaluation” of a label’s

adequacy. Buckman, 531 U.S. at 351. Under such a

preemption regime, the FDA will be forced to divert

precious time and resources to responding to

manufacturers’ futile, inexhaustibly worded labelchange requests, rather than protecting the public

health.

By focusing on what the FDA might have done

rather than on what the FDA did, the Third Circuit’s

rule dilutes Levine beyond recognition. If the Court

were to adopt this view of conflict preemption, it

would render the Supremacy Clause “all but

meaningless.” Mensing, 564 U.S. at 621. At the same

time, if the rationale for this Court’s holding in

Levine is to remain viable, the judgment below must

be reversed.

B.

None of Levine’s Case-Specific

Barriers to Preemption Apply Here.

Like many conflict-preemption cases, Levine

turned on its own sui generis facts. In denying

preemption to Wyeth, the manufacturer of

14

Phenergan, the Court stressed that (1) Wyeth never

advised the FDA of the dangers of administering

Phenergan by the IV-push method; (2) Wyeth never

tried to change Phenergan’s label to warn of those

dangers; (3) scant record evidence suggested that the

FDA would have rejected a stronger warning label

for Phenergan; and (4) the FDA never rejected a

stronger warning. None of those fact-bound barriers

to preemption exists here.

1. This case differs from Levine in many

crucial respects. In Levine, for example, Wyeth did

not even “argue that it supplied the FDA with an

evaluation or analysis concerning the specific

dangers posed by the IV-push method.” 555 U.S. at

572-73. If anything, neither Wyeth nor the FDA

“gave more than passing attention to the issue.” Id.

at 563.

Compare that “sparse correspondence,” id. at

561, with Merck’s detailed back-and-forth Merck

with the FDA here. After published studies began

suggesting a possible link between long-term

Fosamax use and atypical femoral fractures, Merck

immediately “submitted a comprehensive safety

update” to the FDA. Pet. App. 13a-14a. And when

the FDA asked Merck for all available information

linking the use of bisphosphonates to such fractures,

Merck complied fully. Id. at 14a.

Unlike in Levine, it is “undisputed that the

FDA was aware of the possible link between

Fosamax and atypical fractures well before

September 2010.” Id. at 60a. Yet because the

“conflicting nature of the literature d[id] not provide

a clear path forward,” the FDA needed “more time”

15

to consider “the issue of a precaution.” Id. at 59a60a.

2. Nothing in Levine’s record suggested that

Wyeth “had ‘earnestly attempted’ to strengthen

[Phenergan’s] intra-arterial injection warning.” 555

U.S. at 561. Though Wyeth proposed language to

warn of the risks of injecting Phenergan intraarterially, “the FDA did not regard the proposed

warning as substantively different.” Id. at 573 n.5.

In other words, Wyeth’s “proposed warning was

different, but not stronger.” Ibid.

At bottom, Wyeth didn’t “argue that it

attempted to give the kind of warning required by

the Vermont jury but was prohibited from doing so

by the FDA.” Id. at 572. For that reason, as the

United States has explained, Levine “did not resolve

how to determine the meaning and effect of an

actual FDA labeling-supplement decision” because

Wyeth never proposed, and the FDA never rejected,

a stronger warning. U.S. Cert. Br. 23.

Not so here. Merck didn’t even wait for the

FDA to fully analyze the available data before

acting. As Merck’s PAS submission makes clear,

Merck formally asked the FDA for permission to

change Fosamax’s label in September 2008. Relying

on nine articles and an analysis of femoral fractures

in Fosamax users, Merck emphasized the

importance of “includ[ing] an appropriate statement”

on the label to “increase physicians’ awareness of

possible fractures * * * and [to] allow early

intervention.” Pet. App. 15a.

16

In particular, Merck proposed adding, under

the Adverse Reactions section of Fosamax’s label,

“low-energy femoral shaft fracture” as a potential

adverse reaction. Id. at 16a. Under the Warnings &

Precautions section, Merck proposed adding a new

subsection entitled “Low-Energy Femoral Shaft

Fracture,” which warned that “[l]ow-energy fractures

of the subtrochanteric and proximal femoral shaft

have been reported in a small number of

bisphosphonate-treated patients.” Id. at 15a-16a.

As the record shows, Merck did everything in

its power to obtain the FDA’s approval for a stronger

warning label. That fact alone distinguishes this

case from Levine.

3. Levine hinged on the “absen[ce of] clear

evidence that the FDA would not have approved a

change to Phenergan’s label.” 555 U.S. at 571.

Though Wyeth “suggest[ed] that the FDA intended

to prohibit it from strengthening the [label],” it

provided little evidence of that intention. As a result,

“both the trial court and the Vermont Supreme

Court rejected [Wyeth’s contention] as a matter of

fact.” Id. at 572.

In contrast here, Merck has adduced ample

evidence that the FDA would not approve a change

to Fosamax’s label. Confronted with Merck’s data,

FDA made clear that any “[d]iscussion of the risk

factors for stress fractures [was] not warranted and

[was] not adequately supported by the available

literature and post-marketing adverse event

reporting.” Pet. App 18a-19a. The agency’s March

2010 safety announcement reiterated that the

available data still had “not shown a clear

17

connection between bisphosphonate use and a risk of

atypical subtrochanteric femur fractures.” Id. at 19a.

And unlike the factfinder in Levine, the

district court explicitly found that “the FDA would

not have approved a change to the Precautions

section of the Fosamax label.” Id. at 168a. Neither

the Third Circuit nor the respondents contested any

of the “undisputed” facts supporting that finding. Id.

at 47a.

4. In Levine, the FDA “had not made an

affirmative decision” to reject a stronger warning for

Phenergan. 555 U.S. at 572. The record “lack[ed] any

evidence that the FDA set a ceiling on this matter.”

Id. at 561. But here no one disputes that the FDA

affirmatively rejected Merck’s attempt to strengthen

its Fosamax label.

While the FDA agreed that Merck could add

“low-energy femoral shaft and subtrochanteric

fractures” to the Adverse Reactions section of the

label, it expressly rejected Merck’s proposed changes

to the Warnings & Precautions section. Pet. App.

18a-19a. An FDA liaison instructed Merck to “hold

off” on changing the Warnings & Precautions label

until the FDA could “decide on language” for a

stronger precaution “if it is warranted.” Id. at 17a18a. As the district court put it, the record

“provide[s] clear evidence that the FDA would have

rejected a stronger Precautions warning because the

FDA did reject a stronger Precautions warning.” Pet.

App. 150a.

Unlike Levine, this record leaves no doubt

that the FDA both considered and rejected the very

18

warning that is the basis for the respondents’

failure-to-warn claim. That isn’t a distinction

without a difference; it is a dispositive fact that

singlehandedly answers the question presented.

II.

NO PRESUMPTION AGAINST PREEMPTION

APPLIES HERE.

In equating Levine’s “clear evidence”

requirement with a clear-and-convincing-evidence

standard of proof, the panel below invoked the

“presumption against preemption.” Pet. App. 37a

(citing Levine, 555 U.S. at 571-73, 565 n.3). But that

presumption has no bearing here. In fact, as shown

below, no presumption attaches when deciding

whether state law conflicts with federal law.

1. No basis exists in the Constitution for

applying a presumption against preemption—in this

or any other case. As “a matter of constitutional

structure, there should be no systematic

presumption against or in favor of preemption.” Viet

D. Dinh, Reassessing the Law of Preemption, 88 Geo.

L.J. 2085, 2092 (2000). The Supremacy Clause

makes Congress’s lawful enactments “the supreme

Law of the Land[,] * * * any Thing in the

Constitution or Laws of any State to the Contrary

notwithstanding.” U.S. Const. art. VI, cl. 2.

That concluding phrase—“any Thing in the

Constitution or Laws of any State to the Contrary

notwithstanding”—is a classic non obstante

provision. In the 18th century, legislatures used non

obstante provisions “to specify that they did not want

courts distorting the new law to accommodate the

old.” Mensing, 564 U.S. at 621-22 (plurality opinion).

19

The Supremacy Clause’s non obstante provision

“indicates that a court need look no further than ‘the

ordinary meanin[g]’ of federal law, and should not

distort federal law to accommodate conflicting state

law.” Id. at 623 (plurality opinion) (quoting Levine,

555 U.S. at 588) (Thomas, J., concurring in

judgment). By going beyond the “ordinary meaning,”

the presumption against preemption distorts federal

law. See Caleb Nelson, Preemption, 86 Va. L. Rev.

225, 304 (2000).

Nor is any such presumption required “to

defend state interests from undue infringement.”

Geier v. Am. Honda Motor. Co., 529 U.S. 861, 907

(2000) (Stevens, J., dissenting). After all, “[i]f a

power is delegated to Congress in the Constitution,

the Tenth Amendment expressly disclaims any

reservation of that power to the States.” New York v.

United States, 505 U.S. 144, 156 (1992). Put

differently, the Constitution itself resolves the

inherent tension between federal and state power

with a straightforward, self-executing rule: federal

law trumps conflicting state law.

2. A presumption against preemption is also

ahistorical. There is “no significant support in

constitutional history for the conclusion that the

[F]ramers intended any such presumption to be read

into Article VI, clause 2.” Martin R. Scordato,

Federal Preemption of State Tort Claims, 35 U.C.

Davis L. Rev. 1, 30 (2001).

On the contrary, the Framers adopted the

Supremacy Clause precisely “to remedy one of the

chief defects in the Articles of Confederation, by

instructing courts to resolve state-federal conflicts in

20

favor of federal law.” David Sloss, Constitutional

Remedies for Statutory Violations, 89 Iowa L. Rev.

355, 402 (2004). By design, the Supremacy Clause

“invalidates” any “interfer[ing]” or “contrary” state

law. Hillsborough Cnty., Fla. v. Automated Med.

Labs., Inc., 471 U.S. 707, 712 (1985) (internal

citations and quotations omitted).

Nor does the presumption against preemption

enjoy a long pedigree. See, e.g., Mary J. Davis,

Unmasking the Presumption in Favor of Preemption,

53 S.C. L. Rev. 967, 974 (2002) (showing that the

Court’s earlier preemption cases “resulted in almost

automatic

preemption

of

concurrent

state

regulation”). On the contrary, it wasn’t until the

1980s that the presumption first arose in field

preemption cases “as a possible reaction to the

[federal government’s] significant and ever-widening

control over so many aspects of our daily lives.” Id.

at 1013. But for most of its history, “the Court has

consistently applied implied preemption doctrine

broadly to support a finding of preemption.” Ibid.

3. Nothing in logic supports a presumption

against preemption in cases—such as this one—

where preemption hinges on the existence of a

conflict between state and federal law. Instead,

every reason exists to presume that Congress always

wishes to preempt state law that conflicts with

federal law. “Why,” after all, “would Congress not

have wanted ordinary pre-emption principles to

apply where an actual conflict with a federal

objective is at stake?” Geier, 529 U.S. at 870. If

courts must presume otherwise, “state law could

impose legal duties that would conflict directly with

21

federal regulatory mandates.” Ibid. That can’t be

right.

This Court has recently abolished any

“presumption against preemption” in expresspreemption cases. In Puerto Rico v. FranklinCalifornia-Tax-Free Trust, the Court held that when

a “statute ‘contains an express pre-emption clause,’

we do not invoke any presumption against preemption.” 136 S. Ct. 1938, 1946 (2016) (quoting

Chamber of Commerce of the United States v.

Whiting, 563 U.S. 582, 594 (2011)). Instead, the

Court simply “‘focus[es] on the plain wording of the

clause, which necessarily contains the best evidence

of Congress’ pre-emptive intent.’” Ibid.

But a presumption against preemption makes

even less sense in conflict-preemption cases. Perhaps

that is why the Court has openly questioned whether

the presumption should ever apply in conflictpreemption cases. See, e.g., Crosby v. Nat’l Foreign

Trade Council, 530 U.S. 363, 374 n.8 (2000) (“We

leave for another day a consideration in this [implied

preemption] context of a presumption against

preemption.”); United States v. Locke, 529 U.S. 89,

108 (2000) (“No artificial presumption [against

preemption] aids us.”). And some members of the

Court have already answered “no.” See, e.g.,

Mensing, 564 U.S. at 622 (Thomas, J.) (plurality

opinion) (explaining that, if anything, “federal law

should be understood to impliedly repeal conflicting

state law”).

Conflict preemption is the quintessential

example of the Supremacy Clause at work. When a

true federal-state conflict exists, preemption is

22

“inescapable and requires no inquiry into

congressional design.” Fla. Lime & Avacado

Growers, Inc. v. Paul, 373 U.S. 132, 142-43 (1963).

That is because “any state law, however clearly

within a State’s acknowledged power, which

interferes with or is contrary to federal law, must

yield.” Felder v. Casey, 487 U.S. 131, 138 (1988)

(emphasis added); Fidelity Fed. Sav. & Loan Ass’n v.

de la Cuesta, 458 U.S. 141, 153 (1982) (“[S]tate law

is nullified to the extent that it actually conflicts

with federal law.”).

Under the Supremacy Clause, “the relative

importance to the State of its own law is not

material when there is a conflict with a valid federal

law.” Ibid. (internal citations and quotations

omitted). And because the scope of the conflict itself

delineates the scope of preemption, “a narrow focus

on Congress’s intent to supersede state law is

misdirected.” City of New York v. FCC, 486 U.S. 57,

64 (1988).

As the Eleventh Circuit has noted, “it is

difficult to understand what a presumption in

conflict preemption cases amounts to, as we are

surely not requiring Congress to state expressly that

a given state law is preempted using some formula

or magic words.” Fla. State Conference of the NAACP

v. Browning, 522 F.3d 1153, 1168 (11th Cir. 2008).

Nor is federal law “obliged to bend over backwards to

accommodate contradictory state laws, as should be

clear from the Supremacy Clause’s blanket

instruction.” Ibid.

4. Even when the Court has applied the

presumption against preemption, it has done so

23

inconsistently. True, in many cases when the Court’s

majority finds no preemption, it will invoke the

presumption. See, e.g., Bates v. Dow Agrosciences

LLC, 544 U.S. 431 (2005) (finding that federal law

regulating pesticides doesn’t preempt state statutory

and common-law claims); Medtronic, Inc. v. Lohr,

518 U.S. 470 (1996) (finding that the FDCA’s

manufacturing and labeling requirements for

medical devices don’t preempt state common-law

claims).

But just as often, when the Court finds state

law preempted, the presumption vanishes without a

trace. See, e.g., Arizona v. United States, 567 U.S.

387 (2012) (preempting Arizona’s efforts at

cooperative enforcement of federal immigration law);

Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)

(preempting New York’s common-law claims under

the FDCA); Geier, 529 U.S. at 906-07 (Stevens, J.,

dissenting) (“[T]he Court simply ignores the

presumption [against preemption].”).

In other words, the Court “continues to

simultaneously repeat and ignore the presumption

against preemption.” Calvin R. Massey, Joltin’ Joe

Has Left and Gone Away: The Vanishing

Presumption Against Preemption, 66 Alb. L. Rev.

759, 764 (2003). But a legal presumption the Court

can wield or withold as it pleases is little more than

a crude parlor trick. It is like preening before a

funhouse mirror; what you see depends on where

you stand. Above all, “the maintenance of a

presumption against preemption” forces the Court

“to treat essentially similar cases in very different

manners.” Scordato, supra, at 30-31.

24

What’s more, the Court’s invocation of the

presumption has become increasingly erratic in

recent years. For example, among the five

preemption cases decided during the 2011 Term,

none discussed the presumption against preemption.

See Ernest A. Young, “The Ordinary Diet of the

Law”: The Presumption Against Preemption in the

Roberts Court, 2011 Sup. Ct. Rev. 253, 331 (2012).

Armed with so pliable a presumption, the Court can

hardly help but act capriciously. And to the extent

the Court “systematically favor[s] one result over

another” when analyzing state and federal conflicts,

it “risk[s] an illegitimate expansion of the judicial

function.” Dinh, supra, at 2092.

***

The Supremacy Clause speaks for itself. The

Court “should not strain to find ways to reconcile

federal law with seemingly conflicting state law.”

Mensing, 564 U.S. at 622. The petitioner deserves to

have its preemption defense evaluated on the best

available evidence of an actual conflict rather than

on a presumption that bears no apparent relation to

that question. As it has done many times before, this

Court should apply “ordinary,” “longstanding,” and

“experience-proved principles of conflict preemption.”

Geier, 529 U.S. at 874. That analysis should be based

on the substantive requirements of state and federal

law—not on the expedient of some a priori rule of

decision.

25

CONCLUSION

The Court should reverse the judgment below.

Respectfully submitted,

September 20, 2018

CORY L. ANDREWS

Counsel of Record

RICHARD A. SAMP

WASHINGTON LEGAL

FOUNDATION

2009 Massachusetts Ave., NW

Washington, DC 20036

(202) 588-0302

candrews@wlf.org