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.,

Petitioner,

v.

DORIS ALBRECHT, ET AL.,

Respondents.

__________

On Writ of Certiorari

to the United States Court of Appeals

for the Third Circuit

__________

BRIEF OF TORT LAW PROFESSORS

JOHN C. P. GOLDBERG AND BENJAMIN C. ZIPURSKY

AS AMICI CURIAE

IN SUPPORT OF RESPONDENTS

__________

TARA D. SUTTON

GARY L. WILSON

ROBINS KAPLAN LLP

800 LaSalle Avenue

Suite 2800

Minneapolis, MN 55402

(612) 349-8577

November 21, 2018

EARL LANDERS VICKERY

Counsel of Record

VICKERY & SHEPHERD

10000 Memorial Drive

Suite 750

Houston, TX 77024-3485

(713) 526-1100

(lanny@justiceseekers.com)

TABLE OF CONTENTS

Page

TABLE OF AUTHORITIES ...................................... iii

INTEREST OF AMICI CURIAE ................................ 1

SUMMARY OF ARGUMENT .................................... 2

ARGUMENT ............................................................... 4

I. RESPECT FOR STATE TORT LAW REQUIRES A RESTRAINED APPROACH

TO IMPLIED PREEMPTION ANALYSIS .................................................................... 4

II. PETITIONER’S PREEMPTION ARGUMENT WOULD REQUIRE THIS COURT

TO INTERFERE UNDULY WITH A

CORE AREA OF STATE TORT LAW ........... 10

A. Failure-To-Warn Law Provides the

Primary Line of Defense Against

Unduly Dangerous Prescription Drugs

by Requiring Manufacturers To Warn

Adequately of Dangerous Side-Effects ...... 11

B. Petitioner’s Proposed Warning to

FDA Bears All the Hallmarks of an

Inadequate Warning ................................. 16

C. FDA’s Rejection of a Proposed Label

That Merely Mentions a Risk of

Injury Cannot Be the Basis for an

Implied Preemption Defense Based

on “Impossibility” ...................................... 18

1. The Mere Fact of FDA’s Rejection

of Petitioner’s Proposed Label

Cannot Suffice To Establish

Impossibility ........................................ 19

ii

2. Defendant Cannot Bear the Burden Set Forth in Levine of Showing That a Proposed Label That

Contains an Adequate Warning

Would Have Been Rejected by

FDA ...................................................... 20

III. STATES HAVE AMPLE RESOURCES

WITHIN TORT LAW TO KEEP

FAILURE-TO-WARN TORT LITIGATION IN CHECK ........................................... 24

A. Counterfactuals ........................................ 24

B. State Tort Law Provides Multiple

Layers of Protection To Respect

Federal Regulation and To Prevent

Jury Determination of Unwarranted

Questions .................................................. 26

1. Prescribing

Physician/Learned

Intermediary ........................................ 27

2. Regulatory Compliance ....................... 28

3. Scientific Reliability ............................ 29

CONCLUSION.......................................................... 31

iii

TABLE OF AUTHORITIES

Page

CASES

Anderson v. Abbott Labs., No. 3:11-CV-1825-L,

2012 WL 4512484 (N.D. Tex. Sept. 30, 2012) ...... 26

Ashcroft v. Iqbal, 556 U.S. 662 (2009)...................... 26

Avandia Mktg., Sales Practices & Prods. Liab.

Litig., In re, 639 F. App’x 874 (3d Cir. 2016) ...... 28

Bell Atl. Corp. v. Twombly, 550 U.S. 544 (2007) ....... 26

Benedi v. McNeil-P.P.C., Inc., 66 F.3d 1378 (4th

Cir. 1995) ............................................................. 16

BMW of N. Am., Inc. v. Gore, 517 U.S. 559

(1996) ..............................................................5, 7, 8

Canterbury v. Spence, 464 F.2d 772 (D.C. Cir.

1972)..................................................................... 12

Cipollone v. Liggett Group, Inc., 505 U.S. 504

(1992) ..................................................................... 9

CSX Transp., Inc. v. McBride, 564 U.S. 685

(2011) ................................................................... 26

Daubert v. Merrell Dow Pharm., Inc., 509 U.S.

579 (1993) .......................................................29, 30

Erie R.R. Co. v. Tompkins, 304 U.S. 64 (1938) ..... 5, 6,

9, 31

Exxon Shipping Co. v. Baker:

552 U.S. 989 (2007) ............................................... 8

554 U.S. 471 (2008) ........................................... 8, 9

Gertz v. Robert Welch, Inc., 418 U.S. 323 (1974)..... 6, 7

Guenther v. Novartis Pharm. Corp., 990 F.

Supp. 2d 1299 (M.D. Fla. 2014) .......................... 16

iv

Lipitor (Atorvastatin Calcium) Mktg., Sales

Practices & Prods. Liab. Litig., In re, 892

F.3d 624 (4th Cir. 2018) ...................................... 30

MacPherson v. Buick Motor Co., 111 N.E. 1050

(N.Y. 1916) ........................................................... 11

Michael v. Warner/Chilcott, 579 P.2d 183 (N.M.

Ct. App. 1978) ...................................................... 16

Milkovich v. Lorain Journal Co., 497 U.S. 1

(1990) ................................................................. 7, 9

New York Times Co. v. Sullivan, 376 U.S. 254

(1964) ................................................................. 5, 6

Phillip Morris USA Inc. v. Williams, 556 U.S.

178 (2009) .......................................................... 8, 9

PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) ....... 4, 9,

20, 21, 23

Seley v. G.D. Searle & Co., 423 N.E.2d 831

(Ohio 1981)......................................................15, 16

State Farm Mut. Auto. Ins. Co. v. Campbell, 538

U.S. 408 (2003) ...................................................... 8

Swift v. Tyson, 41 U.S. (16 Pet.) 1 (1842) ............ 5, 31

Thomas v. Winchester, 6 N.Y. 397 (1852) ................ 11

Winter v. Novartis Pharm. Corp., 882 F. Supp.

2d 1113 (W.D. Mo. 2012), aff’d, 739 F.3d 405

(8th Cir. 2014).................................................12, 16

Wyeth v. Levine, 555 U.S. 555 (2009) ........... 2, 3, 9, 10,

19, 20, 21,

22, 23, 24, 31

Zoloft (Sertraline Hydrochloride) Prods. Liab.

Litig., In re, 858 F.3d 787 (3d Cir. 2017) ............ 30

v

CONSTITUTION, STATUTES, AND RULES

U.S. CONST.:

ART. VI, CL. 2 (Supremacy Clause) ........................ 1

AMEND. I ............................................................. 6, 7

AMEND. VI ............................................................ 24

AMEND. VII .......................................................... 24

Federal Food, Drug, and Cosmetic Act, 21 U.S.C.

§ 301 et seq. ......................................................... 24

§ 331(a) ................................................................. 24

§ 332(b) ................................................................. 24

§ 334(b) ................................................................. 24

§ 352(a) ................................................................. 24

§ 352(f ) ................................................................. 24

Hatch-Waxman Act, Pub. L. No. 98-417, 98

Stat. 1585 ........................................................... 4, 9

ARK. CODE ANN. § 16-116-205................................... 29

COLO. REV. STAT. § 13-21-403 ................................... 29

FLA. STAT. § 768.1256 ............................................... 29

IND. CODE § 34-20-5-1 ............................................... 29

KAN. STAT. ANN. § 60-3304(a) ................................... 29

MICH. COMP. LAWS § 600.2946(4) ............................. 29

N.J. STAT. ANN. § 2A:58C-4 ...................................... 29

N.D. CENT. CODE § 28-01.3-09 .................................. 29

TENN. CODE ANN. § 29-28-104 .................................. 29

TEX. CIV. PRAC. & REM. CODE ANN. § 82.007 ............ 29

WASH. REV. CODE § 7.72.050(2) ................................ 29

Fed. R. Evid. 702 .................................................. 29-30

vi

Sup. Ct. R.:

Rule 37.3(a) ............................................................ 1

Rule 37.6 ................................................................ 1

OTHER MATERIALS

David G. Owen, A Decade of Daubert, 80 DENV.

U.L. REV. 345 (2002) ............................................ 30

2 DAVID G. OWEN & MARY J. DAVIS, OWEN & DAVIS ON PRODUCTS LIABILITY (4th ed. May

2018 Update) ..................................................15, 16

RESTATEMENT (THIRD) OF TORTS, PRODUCTS LIABILITY (1998) .............................................13, 28, 29

INTEREST OF AMICI CURIAE 1

John C.P. Goldberg is the Carter Professor of General Jurisprudence at Harvard Law School. Benjamin

C. Zipursky is the James H. Quinn ’49 Professor in

Legal Ethics at Fordham Law School. Amici are coauthors on a leading casebook, TORT LAW: RESPONSIBILITIES AND REDRESS (4th ed. 2016), and of a condensed treatise, THE OXFORD INTRODUCTIONS TO U.S.

LAW: TORTS (2010). They have also authored dozens

of articles and book chapters on tort law, including

products liability and preemption. Their writings focus

on the nuts and bolts of doctrine, as well as history

and theory, emphasizing – in contrast to economicand justice-based approaches – the traditional American understanding of tort as law that defines injurious

wrongs and empowers victims to obtain a civil form of

redress from those who wrongfully injure them.

Amici have no stake in the outcome of this case

other than their academic interest in the rational

development of the law. They have serious concerns

that the rule proposed by Petitioner in this case, if

adopted by the Court, would constitute an intrusion

into state tort law that is unnecessary to give full

effect to the Supremacy Clause, at odds with basic

principles of federalism, and inconsistent with our

legal and political traditions, which have always

recognized the right of victims of legally recognized,

injurious wrongs to an avenue of civil recourse against

wrongdoers through state common law.

1 Pursuant to Supreme Court Rule 37.6, counsel for Amici

represent that they (and Amici ) authored this brief in its entirety

and that none of the parties or their counsel, nor any other person

or entity other than Amici or their counsel, made a monetary contribution intended to fund the preparation or submission of this

brief. Pursuant to Rule 37.3(a), counsel for Amici also represent

that all parties have consented to the filing of this brief.

2

SUMMARY OF ARGUMENT

Federal preemption of tort law involves the recognition that state common law must give way to federal

regulatory law when federal law expressly displaces

state law or when there is an actual conflict between

them. Yet because, within our federal system, the

common law of torts overwhelmingly is the province

of the states, this Court has been careful to treat the

federal regulatory domain and the state common law

domain as largely complementary, not conflicting.

Similarly, this Court has avoided unduly interfering with state tort law even where legitimate

constitutional concerns have justified setting certain

limits on it, as in the law of defamation and punitive

damages. In the area of preemption, this pattern

continued in Wyeth v. Levine, 555 U.S. 555 (2009), in

which the Court found no preemption of failure-towarn claims involving brand-name drugs. Petitioner

now attempts an end-run around Levine by arguing

that FDA’s rejection of Petitioner’s proposed label

demonstrates that it was “impossible” for Petitioner

to give the adequate warnings required to avoid tort

liability. Given the absence of any statutory prohibition on Petitioner’s ability to issue enhanced warnings

of newly discovered medical risks, and given that

Petitioner’s proposed warning contained deficiencies

in the dimensions of adequacy that state law deems

significant (deficiencies that FDA also recognized in

its rejection), the Court should not credit this argument. Indeed, it cannot do so without adopting an

unstructured, expansive notion of “impossibility” that

would efface the line between legitimately ensuring

that state tort law operates within constitutional

confines and illegitimately undertaking to fashion a

general common law of failure-to-warn liability.

3

An examination of failure-to-warn law for prescription drugs reveals that Petitioner is asking the Court

for an unnecessary and inappropriate displacement of

state law. Whether a warning is adequate involves

considerations such as the nature and magnitude of

the risk and the clarity and communication of the

warning. The warning proposed by Petitioner was

almost certainly not adequate as a matter of law, and

in any event posed a fact issue for resolution at trial.

FDA’s rejection of Petitioner’s understated and muddled warning in no way indicates that the agency

would have rejected a warning of the risk of atypical

femoral fractures that was adequate in the relevant

dimensions. Indeed, FDA’s rejection of a proposed

warning in Levine (which this Court found had no

preemptive effect) was considerably stronger than the

proposal rejected by FDA in this case, thus underscoring the insufficiency of Petitioner’s showing.

There is no indication in this case that FDA’s “rejection” foreclosed an attempt to add a warning that

would be adequate under state law. In short, it was

entirely possible for Petitioner to comply with both

federal and state law by simply proposing or adding

an adequate warning.

Finally, Petitioner’s dire prediction that, without

further federal court oversight, state law will thwart

federal regulations by allowing juries to run wild is

simply overblown. Insofar as juries hearing failureto-warn claims against Petitioner will be required to

answer a “counterfactual” question about whether

FDA would have approved an adequate warning, this

is the sort of thing juries are entrusted to do every day.

Moreover, they do it in a context that has significant,

existing protections to ensure proper deference to

prescribing physicians’ expertise and appropriate

4

judgments by FDA, and to ensure the reliability of the

scientific evidence presented to them. The learned

intermediary rule, the defense of regulatory compliance, and trial judges’ screening of proposed expert

testimony are robust protections against overreach.

These and other checks built into the operation of

state tort law are more than sufficient to negate any

need for further federal court oversight.

ARGUMENT

I.

RESPECT FOR STATE TORT LAW REQUIRES A RESTRAINED APPROACH TO

IMPLIED PREEMPTION ANALYSIS

Petitioner, the manufacturer of a brand-name

prescription drug, seeks to persuade this Court that

it deserves to win failure-to-warn claims brought

against it without any determination as to the

adequacy of the warnings it issued. It claims that

the doctrine of “impossibility” preemption allows for

such a result. However, unlike defendants who raise

express preemption arguments, as well as those who

raise implied preemption arguments that turn on

clear statutory text – see PLIVA, Inc. v. Mensing, 564

U.S. 604 (2011) (Hatch-Waxman Act’s prohibition on

unilateral label changes by generic drug manufacturers makes it impossible for them to comply with conflicting state-law requirements) – Petitioner’s implied

preemption argument has no statutory anchor whatsoever. If the Court accepts Petitioner’s invitation to

craft an impossibility- based escape-hatch from state

tort liability, it will be cutting too deeply into state tort

law without a sufficient federal basis.

The application of implied preemption doctrine

untethered from any guiding text carries a great risk of

undermining federalism values. That is the principal

5

reason for submitting this Amicus brief. With no text

to control the determination of federal preemption in

this case, the degree to which state common law

remains available to provide redress to victims of

injurious misconduct depends entirely on this Court

and lower federal courts exercising self-restraint.

This brief does not challenge the federal courts’

authority to engage in implied preemption analysis. It

does, however, point out that the approach to implied

preemption that would be necessary for the Court to

rule for Petitioner in this case presupposes a conception of that authority that is inconsistent with its

role within a federalist system. Crafting the rules

that federal judges prefer, rather than applying the

common law of the state, would mark a return to the

days of Swift v. Tyson, 41 U.S. (16 Pet.) 1 (1842). Basic

principles of federalism and Erie Railroad Co. v.

Tompkins, 304 U.S. 64 (1938), call for great caution.

This is not the first time that state common law

has been imperiled by tort litigation that found its way

to the Supreme Court. Constitutional attacks on

defamation law and punitive damages awards have

cut deeply into these areas of state law – sometimes

too deeply, as has been observed by many Justices,

including Chief Justice Rehnquist, as well as Justices

Ginsburg, Scalia, Thomas, and White. In those areas

– following New York Times Co. v. Sullivan, 376 U.S.

254 (1964), and BMW of North America, Inc. v. Gore,

517 U.S. 559 (1996) (respectively) – the Court eventually chose to reject aggressive construction of prodefendant constitutional protection in order to remain

true to its federalist commitments. That is what it

should do here, too.

A few examples will illustrate the present point.

New York Times Co. v. Sullivan remains emblematic

6

of the Court’s power and obligation to ensure tort law

operates within constitutional boundaries. The advertisement at issue in Sullivan did not mention any

individual official, yet the plaintiff, a city commissioner, brought suit and won a huge punitive damages

verdict. In these circumstances, the Court looked past

the form of the litigation and identified it for what it

really was – a seditious libel prosecution. It rightly

shielded the New York Times from tort liability under

the First Amendment.

Sullivan’s progeny tell a different story. Media

defendants pressed for “elaboration” of Sullivan’s

holding. The Court soon articulated a sprawling

constitutional jurisprudence. In the eyes of some

Justices, the Court’s burgeoning case law threatened

to run afoul of Erie and its federalist underpinnings.

Most notably, in Gertz v. Robert Welch, Inc., 418 U.S.

323 (1974), Justice White penned an impassioned

dissent, arguing that the Court was experiencing

substantial mission creep:

For some 200 years – from the very founding

of the Nation – the law of defamation and right

of the ordinary citizen to recover for false publication injurious to his reputation have been

almost exclusively the business of state courts

and legislatures. . . .

But now, using [the First] Amendment as

the chosen instrument, the Court, in a few

printed pages, has federalized major aspects

of libel law by declaring unconstitutional in

important respects the prevailing defamation

law in all or most of the 50 States.

Id. at 369-70 (White, J., dissenting).

7

Regardless of whether one agrees with Justice

White that Gertz would have been the right moment

to stem the expansion of federal defamation law,

he was surely right to sound a cautionary note. His

warning was eventually heeded. Sixteen years after

Gertz, media defendants asked the Court to hold that

the First Amendment precluded tort liability for

anything that could be characterized as a statement

of opinion. It declined. Writing for a 7-2 majority in

Milkovich v. Lorain Journal Co., 497 U.S. 1, 20-21

(1990), Chief Justice Rehnquist recognized that there

was already opinion protection within state common

law, that powerful First Amendment liability limits

had already been crafted by the Court, and that the

analytical case for a new and broad additional federallaw shield simply did not hold up to scrutiny. The

Court had done enough to ensure that state defamation law operated with proper respect for rights of free

speech; doing more would threaten to efface the line

between constitutional law and general common law.

A similar pattern has unfolded in the constitutional law of punitive damages, in which federalist

concerns have been flagged from the start. In BMW of

North America, Inc. v. Gore, the majority identified

a “notice” problem with a $2 million punishment for

nondisclosure of an invisible flaw in the paint of a

luxury car. 517 U.S. at 574. In their dissents, Justice

Scalia and Justice Ginsburg contended that the Court

had allowed the anomalousness of the punitive

damages claim in that particular case to spawn an

analytically unsound doctrine that cut unduly into

state common law. See id. at 605 (Scalia, J., joined

by Thomas, J., dissenting); id. at 612 (Ginsburg, J.,

joined by Rehnquist, C.J., dissenting).

8

The defense victory in Gore gave litigants an incentive to press to federalize state punitive damages law.

A majority of the Justices continued to respond, with

the high-water mark being set by State Farm Mutual

Automobile Insurance Co. v. Campbell, 538 U.S. 408

(2003), which once again garnered dissenting opinions.

See id. at 429 (Scalia, J., dissenting); id. at 429-30

(Thomas, J., dissenting); id. at 430 (Ginsburg, J., dissenting). In the years following Campbell, the Court

received numerous certiorari petitions encouraging

it to set a hard-and-fast numeric ratio of punitive

to compensatory damages, even in cases involving

wrongful death or massive environmental harm.

In part through denial of petitions, the Roberts

Court halted the development of constitutionalexcessiveness doctrine in punitive damages law. In

Exxon Shipping Co. v. Baker, 554 U.S. 471 (2008), the

Court denied Exxon’s certiorari petition on constitutional excessiveness, Exxon Shipping Co. v. Baker, 552

U.S. 989 (2007) (mem.) (granting certiorari only on

other issues in the case), and used its unquestioned

authority in federal maritime law to decide the case

on other grounds. In Phillip Morris USA Inc. v.

Williams, 556 U.S. 178 (2009), the Court repeatedly

declined to address the constitutional-excessiveness

issue and ultimately permitted a very large Oregon

punitive damages verdict to stand. In light of the dissenting opinions over the years of Justices Thomas

and Ginsburg (and the clear choice of Justice Breyer

to utilize procedural, not substantive excessiveness,

concepts), the halting of constitutional-excessiveness

decisions can be seen as a deliberate, federalistinspired effort to respect state tort law through

restraint and analytical rigor.

9

Preemption law presents parallel issues of restraint,

as the various Justices’ opinions on preemption vividly

display. The font of modern preemption jurisprudence

as it relates to tort law is an express preemption case

rather than an implied preemption case. In Cipollone

v. Liggett Group, Inc., 505 U.S. 504 (1992), a majority

of the Justices concluded that Congress’s adoption

of highly specific statutory warnings for cigarettes

preempted state failure-to-warn claims, but not other

claims, including for fraud. Ever since, members

of the Court have articulated worries that defense

arguments have sometimes succeeded when restraint

and respect for state tort law might have been the

better path.

From a (concededly academic) perspective, Wyeth

v. Levine, 555 U.S. 555 (2009), can be seen as having

drawn a line in the sand based on recognition of postErie limits on the federal courts’ lawmaking authority.

Even though of course interpreting a different constitutional provision, the Court’s Levine ruling resembled

its refusal to constitutionalize opinion protection in

Milkovich and its resistance to fixing rigid rules for

constitutional excessiveness in Williams and Exxon.

Preemption of all failure-to-warn claims for FDAapproved drugs was for drug manufacturers the brass

ring, but six Justices decided that close analysis of the

statutory and regulatory framework did not justify the

ruling Wyeth sought. Moreover, as Justice Thomas

observed in his concurrence, an expansive implied preemption doctrine threatened to undercut the authority of the states to fashion rules of tort law. Although

Justice Thomas concluded two years later in Mensing

that impossibility preemption applies to claims against

generic drug manufacturers, that result was driven

by the clear language of the Hatch-Waxman Act and

10

the absence of a counterpart in it to the CBE provision

relied upon in Levine.

In its briefs before the Court in this case, Petitioner

is taking another shot at eliminating a broad range

of failure-to-warn claims against manufacturers of

brand-name drugs, hoping that what the Court was

unwilling to do in Levine it might do today in a slightly

different form. But the Court was right to reject impossibility preemption in Levine because it would have

undermined the states’ traditional power to provide

redress to those who can prove their common law

claims. Having shown restraint a decade ago to preserve this domain of state sovereignty and individual

rights, the Court should not reverse course now, on

what is (as Respondents’ brief and the discussion

below show) a much weaker set of facts.

Unfortunately, Petitioner’s brief does not provide

the Court with a basic model of the workings of the

state failure-to-warn law that it would be displacing

were it to find preemption. It similarly overlooks

the range of doctrinal and statutory resources that

state tort law currently supplies to prescription drug

manufacturers to protect them from unwarranted

liability and litigation. Parts II and III, infra, aim to

plug these gaps.

II. PETITIONER’S PREEMPTION ARGUMENT

WOULD REQUIRE THIS COURT TO INTERFERE UNDULY WITH A CORE AREA OF

STATE TORT LAW

Understanding failure-to-warn law in the pharmaceutical context is a necessary prelude to analyzing

Petitioner’s preemption argument. When one does so,

however, the weakness of that argument becomes

evident.

11

A. Failure-To-Warn Law Provides the Primary

Line of Defense Against Unduly Dangerous Prescription Drugs by Requiring

Manufacturers To Warn Adequately of

Dangerous Side-Effects

Redressing injuries caused by improperly labeled

medicines has long been a central concern of state

tort law. Indeed, the landmark decision of Thomas

v. Winchester, 6 N.Y. 397 (1852), was such a case.

Thomas in turn set the stage for then-Judge Cardozo’s

decision in MacPherson v. Buick Motor Co., 111 N.E.

1050 (N.Y. 1916), which is widely regarded as the font

of modern products liability law. Requiring commercial sellers of drugs properly to warn of their products’

hidden dangers is and has always been central to state

tort law.

Modern products liability law focuses on whether

a product that has injured a consumer left the seller’s

hands in a defective condition because of a design

defect, a manufacturing defect, or a failure to warn.

Because products often cannot be designed in a way

that eliminates their dangers without destroying their

benefits, in many cases what determines whether a

product is unduly dangerous are the warnings and

instructions that accompany it. Just as they count

on manufacturers to adopt non-defective designs,

product users justifiably rely on manufacturers to

provide adequate warnings. And just as design-defect

law requires manufacturers to refrain from adopting

unreasonably dangerous designs, so too failure-towarn law requires them to provide clear, comprehensive, accurate information that is not encumbered by

distractions or confusions, and that is presented with

sufficient urgency and prominence. In the language

of state tort law, manufacturers are required to

12

provide adequate warnings about their products’

dangers.2

For two reasons – one of principle, and one of policy

– the provision of adequate warnings is an especially

important issue in the prescription drug context.

First, as a matter of principle, because pharmaceuticals are typically administered in connection with

medical treatment, this area of a failure-to-warn law

bears a close resemblance to the “informed consent”

branch of medical malpractice law. See Canterbury v.

Spence, 464 F.2d 772, 780 & n.15 (D.C. Cir. 1972). The

ingestion of a drug implicates one’s right to control

what goes into one’s body. Yet, the invasiveness that

comes with the use of drugs is, of course, what renders

them immensely valuable. The law of informed consent, which addresses the same invasiveness/health

tradeoff in the context of decisions to undergo surgeries

and other medical procedures, squares this circle

by requiring physicians to make full disclosure of

material information and by having judges and juries

scrutinize these disclosures carefully. Likewise, in

failure-to-warn law as applied to prescription drugs,

adequacy of disclosure is crucial to ensuring that drug

2 Some states recognize failure-to-warn claims that sound in

negligence rather than strict products liability. The differences,

if any, between the two causes of action are for most purposes

modest. When suit is brought for negligent failure-to-warn, the

same adequacy issue arises, though here it is framed as the

question of whether the defendant failed to provide the warnings

and information that a reasonably prudent manufacturer would

have provided. See, e.g., Winter v. Novartis Pharm. Corp., 882 F.

Supp. 2d 1113, 1117-18 (W.D. Mo. 2012) (describing the standard

for adequate warning under Missouri negligent failure-to-warn

law), aff’d, 739 F.3d 405 (8th Cir. 2014). Accordingly, this brief

will treat strict products liability and negligent failure-to-warn

claims interchangeably.

13

users gain access to valuable products, but on terms

that duly protect their bodily integrity and safety.

Second, courts have long appreciated that designdefect law fits pharmaceutical products awkwardly.

This is not only because the dangers of many drugs,

like their potential benefits, are substantial. It is also

because the health risks of a drug may outweigh the

benefits for some subset of consumers even though

there is another subset of consumers for whom the

benefits outweigh the risks. Liability for design defect

for pharmaceutical products – if it leads manufacturers to take certain products off the market – thus

poses the risk that a minority of consumers who would

greatly benefit from a drug lose access to it because

some other group of consumers would not benefit from

it. The rational policy solution to which the common

law has largely converged is to diminish design-defect

liability for prescription drugs while keeping failureto-warn liability in place. See, e.g., RESTATEMENT

(THIRD) OF TORTS: PRODUCTS LIABILITY § 6(c) (1998)

(adopting a special and highly restrictive test for

design defect for prescription drugs, under which a

drug is defectively designed only if a reasonable

health-care provider, knowing of a drug’s foreseeable

risks and benefits, would not prescribe the drug for

any class of patients). These same considerations

make it all the more important that drug manufacturers provide adequate warnings and information

about their products. The primary way in which tort

law promotes drug safety is by requiring manufacturers to provide adequate information of the risks

posed by their drugs.3

3 The learned intermediary rule that applies to failure-towarn claims concerning prescription drugs in no way diminishes

14

As noted, a failure-to-warn case turns fundamentally on whether the product in question lacked

“adequate” warnings and thereby was rendered

unduly dangerous. Under state law, adequacy is a

function of the accuracy and completeness of the

information accompanying a product, as well as the

prominence, clarity, and urgency with which that

information is presented. Although there is some

variation in how different states have defined

adequacy (which is part of why federalism is truly in

play in this case), the variation is not vast.

In their products liability law treatise, Professors

Owen and Davis summarize the relevant principles as

applied to prescription drugs in particular:

The principles of adequacy applicable to

warnings generally . . . apply to prescription

pharmaceuticals. All material information on

possible risks must be conveyed to the relevant

medical care provider and be comprehensible to

the specialist as well as the general practitioner. The sufficiency of the seller’s discharge

of its informational obligation is measured in

terms of whether the cautionary information

conveys the nature, the scope, and the severity

the importance of adequate warnings. Prescription drugs reach

the consumer through his or her treating physician. By requiring

a drug company to directly warn only the treating physician, the

learned intermediary rule shifts the target of the warning from a

consumer, who might lack the knowledge and the appreciation

of context necessary to interpret it, to the physician, who is

presumed to have both. Simply put, doctors have the professional expertise and responsibility to read, absorb, and convey

warnings, and they face legal liability for not doing so. That

physicians are expected to take manufacturers’ warnings very

seriously in informing, advising, and treating their patients

makes “adequacy” more important, not less so.

15

of the risk, together with a plain statement of

how the user may avoid such risks and safely

use the product.

2 DAVID G. OWEN & MARY J. DAVIS, OWEN & DAVIS

ON PRODUCTS LIABILITY § 19:14 (4th ed. May 2018

Update) (”OWEN & DAVIS”) (footnote omitted).

A bare mention of a general class of risks associated with a prescription drug does not satisfy the

requirement of adequacy. Instead, a drug’s warning

must accurately and clearly describe the conditions

under which the relevant risks might be realized,

the precise complications that might result from the

realization of such risks, and the consequences for

patients of a failure to heed the warning. Moreover,

this information must be communicated in a manner

that is likely to alert a reasonably prudent prescribing

physician to the danger. As the Ohio Supreme Court

has explained:

The fact finder may find a warning to be unreasonable, hence inadequate, in its factual

content, its expression of the facts, or the

method or form in which it is conveyed. The

adequacy of such warnings is measured not

only by what is stated, but also by the manner

in which it is stated. A reasonable warning

not only conveys a fair indication of the nature

of the dangers involved, but also warns with

the degree of intensity demanded by the nature

of the risk. A warning may be found to be unreasonable in that it was unduly delayed, reluctant in tone or lacking in a sense of urgency.

Seley v. G.D. Searle & Co., 423 N.E.2d 831, 837 (Ohio

1981) (citation omitted). As the previous citation

indicates, the adequacy question is usually for the

16

jury. Id. See also OWEN & DAVIS § 19:14 (question of

adequacy is for the finder of fact).

Whatever the precise standard of adequacy applied

in a given jurisdiction, it is abundantly clear that a

drug manufacturer’s mere mention of its product’s

dangers (on a product label or in a package insert) is

insufficient to satisfy state tort law and avoid liability.

Indeed, examples abound of instances in which manufacturers have faced liability for warnings that, while

mentioning the relevant health risk, did so in a way

that inadequately warned of the risk. See, e.g., Benedi

v. McNeil-P.P.C., Inc., 66 F.3d 1378, 1387 (4th Cir.

1995) (applying Virginia law) (jury issue presented on

whether manufacturer was required to warn of health

risks from use of acetaminophen in combination with

alcohol); Guenther v. Novartis Pharm. Corp., 990 F.

Supp. 2d 1299, 1303-06 (M.D. Fla. 2014) (applying

Florida law and affirming a jury finding of liability

in a failure-to-warn case alleging injuries caused by

bisphosphonate); Winter, 882 F. Supp. 2d at 1117-20

(applying Missouri law and finding sufficient evidence

for jury on failure-to-warn negligence case involving

bisphosphonate); Michael v. Warner/Chilcott, 579

P.2d 183, 187 (N.M. Ct. App. 1978) (pharmaceutical

product’s warning that product “may damage the

kidneys” presents jury issue on adequacy).

B. Petitioner’s Proposed Warning to FDA

Bears All the Hallmarks of an Inadequate

Warning

As explained in detail in Respondents’ merits

brief, the proposed language submitted by Petitioner

to FDA – in the best case – failed to provide a clear

articulation of the risk of atypical femoral fracture

associated with its drug. Petitioner’s proposed language

confusingly associated a particular and grave risk

17

(the risk of atypical femoral fracture) with a distinct

and distinctly less grave risk (the risk of minor stress

fractures of the sort that are normally cured by rest).

In fact, Petitioner’s proposed language was even more

problematic, for it added that “stress fractures with

similar clinical features also have occurred in patients

not treated with bisphosphonate.” JA707. This statement compounded the false equivalence of atypical

femoral fractures and garden-variety stress fractures.

The latter typically occur in younger people as a result

of athletic activity. C.A.App. 1573. That is not a

population that typically suffers from osteoporosis. In

asserting that the majority of (garden-variety) stress

fractures seen by physicians appear in patients who

are not taking bisphosphonate, Petitioner’s proposed

language further diluted what little information it

might otherwise convey about the risk to users of its

product of atypical femoral fractures.

Even assuming for purposes of argument that

there is a biological link between stress fractures

and atypical femoral fractures (making it arguably

appropriate to mention both in the same label), the

particular way in which Petitioner’s proposed label

associated these two very different injuries has an

obvious potential to distract and confuse. Language

that is cluttered, that conflates more serious with less

serious risks, that “buries the lede,” or that is otherwise prone to misinterpretation is at the very core

of the adequacy issue in failure-to-warn litigation.

As noted above, the question in such cases often is

not whether any warning was given, but whether

the warning that was given was adequate. And it is

precisely the characteristics on display in Petitioner’s

proposed language that would support a finding of

inadequacy.

18

C. FDA’s Rejection of a Proposed Label That

Merely Mentions a Risk of Injury Cannot

Be the Basis for an Implied Preemption

Defense Based on “Impossibility”

Petitioner’s argument boils down to this: FDA’s

rejection of a proposed label that plainly could be

deemed to provide inadequate warnings under state

tort law nonetheless suffices to establish that it would

not have approved a clearer, stronger, and more obviously adequate warning. This argument comes in two

variants: one is that the mere rejection of a proposed

label mentioning the risk suffices to ground impossibility preemption (the “mere rejection” version), and

a second is that the rejection of the proposed label

provides evidence of further facts, which themselves

ground impossibility preemption (the “further facts”

version).

As shown below, Petitioner’s argument fails

whether on the “mere rejection” version or the “further

facts” version. Needless to say, Petitioner should not

be able to claim its prize of implied preemption by

toggling between these two versions, either. In the

end, however, the reason neither version works is

basically the same: Merck’s confusion of atypical

femoral fractures with much different and much less

serious “stress fractures” rendered its proposed

warning the very opposite of what patients and their

physicians need from a warning. That is why the

warning might well be deemed inadequate by a jury

applying the common law of torts; it is also why FDA

rejected Merck’s warning.

19

1. The Mere Fact of FDA’s Rejection of Petitioner’s

Proposed Label Cannot Suffice To Establish

Impossibility

As indicated, Petitioner’s proposed label mentioned

in an oblique, anything-but-clear manner the risk of

atypical femoral fracture associated with the use of

Fosamax. FDA rejected this label. There is at least a

suggestion from Petitioner and supporting Amici that

these facts alone suffice to establish impossibility

preemption – that FDA’s rejection of a proposed drug

label that in some manner mentions the relevant risk

establishes that FDA would have likewise rejected

any attempt to warn of that risk.

Such a suggestion is obviously untenable. To establish the defense of federal preemption, a defendant in

a failure-to-warn case such as this one must prove

that it was impossible to rectify the deficiencies in its

warning under state law because federal law clearly

prevented it from doing so. See Levine, 555 U.S. at

569. The fact that FDA rejected a warning that a jury

would surely be entitled to deem inadequate in no way

suggests that the defendant was unable to issue an

adequate warning, for there is no reason to suppose

that federal law rendered Petitioner unable to provide

an adequate warning as to the danger of atypical

femoral fractures. FDA’s rejection of a proposed drug

label leaves the manufacturer completely at liberty to

propose or add a better warning. A drug manufacturer thus does not establish that it was blocked

by federal regulatory law from complying with state

failure-to-warn law simply by showing that its

proposed warning was rejected. Again: such a

showing quite obviously leaves open the possibility

that a clearer or more compelling warning – one that

20

would have been adequate and thus avoided liability

– would not have been rejected by FDA.

This version of Petitioner’s impossibility argument

is practically pernicious, not just conceptually unsound.

Were it adopted, prescription drug manufacturers

would have available to them a simple formula for

avoiding liability for failures to warn about previously

unknown or underestimated risks. Essentially, all

that they would need to do to enjoy the shield of

federal preemption is to propose a tepid and inadequate warning. Not only would the acceptance of this

argument thus reward subterfuge, it would result in

a severe encroachment onto traditional state tort

law without any corresponding benefit to a federal

regulatory regime that aims to ensure that prescription drugs are properly labeled.

2. Defendant Cannot Bear the Burden Set Forth in

Levine of Showing That a Proposed Label That

Contains an Adequate Warning Would Have

Been Rejected by FDA

As just demonstrated, there cannot be impossibility preemption merely on a showing of FDA’s rejection

of a proposed label that facially mentions the relevant

risk. In this context, the impossibility question instead

concerns whether it would have been possible for

Petitioner to adopt a warning that would be deemed

adequate under state tort law and that FDA would

not reject. If it would have been possible, then there

cannot be impossibility preemption.

As explained in Mensing, this Court’s prior decision in Levine places on the manufacturer the burden

of establishing clearly that it would have been barred

by FDA from giving an adequate warning: “The Court

in [Levine] asked what the drug manufacturer could

21

independently do under federal law, and in the

absence of clear evidence that Wyeth could not have

accomplished what state law required of it, found no

pre-emption.” 564 U.S. at 624 n.8 (italics added).

Only a manufacturer that can clearly establish that

FDA would have rejected a proposed adequate label

stands to obtain the protection afforded by the

demanding defense of impossibility preemption. A

manufacturer whose proposed warning is rejected

for other reasons can “accomplish[ ] what state law

require[s] of it” by providing an adequate warning,

and can do so “independently.” Id.

As Respondents’ brief establishes, this is the very

position Petitioner was in. Contrary to Petitioner’s

contention, FDA’s plain language in its rejection of the

proposal concerned the running-together of atypical

femoral fractures and ordinary stress fractures, not

whether there was a scientific basis to justify some

strengthening of the existing warning of the association between atypical femoral fractures and long-term

bisphosphonate use.

The Court’s analysis of the record in Levine itself

highlights the weakness of this variant of Petitioner’s

implied preemption argument. Diana Levine lost her

arm when an IV-push injection of Phenergan entered

her artery. Levine, 555 U.S. at 559. She claimed that

the labeling of Phenergan inadequately warned of the

risks of IV-push administration as opposed to the

use of IV-drip or some other method. Id. at 564-65.

Justice Alito’s dissenting opinion reviewed in detail

the relevant FDA-approved label, noting that FDA

had expressly considered whether to prohibit IV-push

as a method of administration but had not done

so, and had instead approved warnings with respect

to that method of administration. Id. at 613-17 (Alito,

22

J., dissenting). Instead, the label warned that “INADVERTENT INTRA-ARTERIAL INJECTION CAN

RESULT IN GANGRENE OF THE AFFECTED

EXTREMITY.” Id. at 618. According to Justice Alito,

it was thus “demonstrably untrue” that, in 2000 (when

Phenergan was administered to Levine), its “labeling

did not contain a specific warning about the risks of

IV-push administration.” Id. at 619.

The majority and dissent parted ways concerning

what had happened 12 years earlier, in 1988. They

agreed that Wyeth had proposed “different language

for Phenergan’s warning about intra-arterial injection”

and that FDA had rejected the proposal. Id. at 572

n.5 (majority); id. at 605 n.1 (Alito, J., dissenting).

The dissent emphasized plaintiff ’s admission that

the 1988 proposal would have prevented Ms. Levine’s

injury by requiring the IV-drip method, rather than

allowing IV-push administration, and argued, therefore, that Wyeth “did propose an adequate warning.”

Id. at 605 n.1 (Alito, J., dissenting). By contrast,

the majority acknowledged the plaintiff ’s admission,

but relied on findings that the proposed warning was

not substantively different than the existing warning

in holding that this situation did not result in a

preemptive conflict. Id. at 572 n.5.

It is undisputed that, for Phenergan, Wyeth had

proposed an added warning addressing the exact risk

at issue and that FDA had rejected the proposed warning. Although the majority and dissent disagreed as

to whether the proposed warning was substantively

different from the existing warning, six members of

this Court found that FDA’s rejection of a proposed

warning addressing the same method of administration that injured Ms. Levine failed to provide a

sufficient basis on which to displace state failure-to-

23

warn law. This was much “clearer evidence” of a

preemptive regulatory act than FDA’s rejection of

Wyeth’s proposed warning with respect to Fosamax.

The Levine Court obviously understood that the issue

was not whether there was a proposal and rejection of

a warning that facially concerned the relevant risk –

indisputably, there was – but whether the proposed

warning that FDA rejected was adequate. Id. at 572

(“[Wyeth] does not argue that it attempted to give the

kind of warning required by the Vermont jury but was

prohibited from doing so by the FDA.”). Evidence of

a rejection of an adequate warning is the “clear

evidence” that was missing in Levine, id. at 571-72,

and is likewise missing in the case at bar.

The actual proposal and rejection in Levine removed

that case from the “hypothetical” or “counterfactual”

realm. See Mensing, 564 U.S. at 624 n.8. Furthermore, the warning that FDA rejected in Levine was

quite obviously stronger than the one Merck proposed

regarding the risk of atypical femoral fractures in the

case at bar. The irony of Petitioner’s current position

is apparent. Even though this Court concluded in

Levine that Wyeth could constitutionally be subject

to failure-to-warn liability despite the fact that its

proposed warning was actually rejected by FDA,

and despite the fact the warning that it did give was

comparatively clear and strong, it now asks the Court

to immunize it entirely from liability on the basis of

the agency’s rejection of a considerably less clear and

compelling warning.

24

III. STATES HAVE AMPLE RESOURCES

WITHIN TORT LAW TO KEEP FAILURETO-WARN TORT LITIGATION IN CHECK

Petitioner paints a picture of a world in which state

tort law leaves drug companies unprotected from the

whims of uninformed citizen juries. The real world is

nothing like that.

A. Counterfactuals

Petitioner and the government claim that a jury

should not decide whether the Levine exception was

met because that exception presents a question of law.

As the Third Circuit recognized, however, this Court’s

articulation of the exception indicates that it is a

question of fact. See Levine, 555 U.S. at 571. Of

course, Petitioner might mean “question of law” in a

conclusory way; they might mean that juries should

not be permitted to decide whether a defendant has

proved that FDA would have rejected a proposed

warning (even if it is in essence a question of fact in

every particular case). That is presumably why much

of Petitioner’s brief seems to relate to juries.

Petitioner pours a lot of energy into trying to incite

fears of juries. E.g., Pet. Br. 40 (describing “practical

nightmare” of permitting multiple juries to use their

“ ‘intuitions’ ”). The fear is inappropriate, given the

centrality of the right to jury trial to our legal system,

as evidenced by its enshrinement in the federal and

state constitutions. U.S. CONST. AMENDS. VI, VII.

More to the point, the Federal Food, Drug, and

Cosmetic Act itself provides that juries determine

whether a drug is “misbranded” based on an inadequate warning. See 21 U.S.C. §§ 331(a), 332(b),

334(b), 352(a), (f ); Levine, 555 U.S. at 570 (“the statute

contemplates that federal juries will resolve most

misbranding claims”). Juries play an integral role

25

in the federal system, and Congress itself expressed

confidence in juries’ ability to evaluate warnings on

prescription drugs.

Petitioner foments distrust of juries in its repeated

use of the term “counterfactual,” which appears a

whopping 13 times in its brief. The insinuation is that

our legal system courts disaster by allowing juries

to conduct an inquiry of the form “What would have

happened if the defendant had done what the plaintiff contends it should have done, but did not do?”

Petitioner’s hyperbolic language about “counterfactual

quagmires” not only insults the venerable institution

of the jury but also displays disregard for basic

tort law that is taught each year to 1Ls around the

country. Typically – in what many lawyers would

regard as a pro-defendant treatment of cause-in-fact

doctrine when compared to treatments that emphasize

the more open-ended language of “substantial factor”

– students are taught: (a) the jury ordinarily decides

the question of cause-in-fact in a negligence or products

liability case; (b) cause-in-fact is usually determined

by the but-for test; and (c) the but-for test requires

the jury to decide what would have happened if the

defendant had not acted negligently or had not sold

a defective product. On this traditional approach,

a counterfactual question lies at the very heart of the

jury’s role. It is emblematic of Petitioner’s eagerness

for the Court to forget state tort law that it suggests,

bizarrely, that juries are incapable of handling questions with which they are routinely entrusted.

Of course, there are limits on the issues that

juries should decide. State judges and legislators

possess and implement many devices to constrain jury

discretion, reflecting the considered judgment of a

particular state’s government concerning how these

cases should proceed. Proper determination of the

26

question of fact comes only after proper instruction

on the applicable law, as well as vetting to ensure that

submission of the question is proper in the first

instance. This is a basic principle of state law as well

as federal law. See, e.g., CSX Transp., Inc. v. McBride,

564 U.S. 685, 704 (2011) (“Properly instructed on

negligence and causation, and told, as is standard

practice in FELA cases, to use their ‘common sense’ in

reviewing the evidence, juries would have no warrant

to award damages in far out ‘but for’ scenarios.

Indeed, judges would have no warrant to submit such

cases to the jury.”) (citation omitted). There are also

myriad protections to ensure that only appropriate

questions reach the jury in the first instance.

B. State Tort Law Provides Multiple Layers

of Protection To Respect Federal Regulation and To Prevent Jury Determination

of Unwarranted Questions

Defendants in failure-to-warn cases enjoy the

same general protections available in other suits. For

example, this Court established heightened pleading

requirements in Bell Atlantic Corp. v. Twombly, 550

U.S. 544 (2007), and Ashcroft v. Iqbal, 556 U.S. 662

(2009). These requirements certainly apply to federal

courts sitting in diversity and can lead to dismissal on

the pleadings. See, e.g., Anderson v. Abbott Labs.,

No. 3:11-CV-1825-L, 2012 WL 4512484 (N.D. Tex.

Sept. 30, 2012) (dismissing claims of failure to warn

of the association between the rheumatoid arthritis

drug Humira and pediatric leukemia). Claims in which

there are no genuine issues of material fact are subject

to summary judgment. And courts can correct error

post-trial with motions for judgment as a matter of

law, motions for new trial, and appeals. In addition

to such general protections, however, states have

put in place three targeted protections for failure-to-

27

warn cases that respect the prescribing physician’s

expertise, defer to appropriate judgments by FDA, and

guard scientific integrity.

1. Prescribing Physician/Learned Intermediary

Failure-to-warn cases involving prescription drugs

have a unique feature that enables juries to assess

with considerable reliability the existence and causal

significance of an omitted adequate warning. Barring

some extraordinary circumstance, there will be sworn

testimony, either live or by deposition, of the prescribing physician. This provides an actual look at how a

particular warning functioned in the real world.

For many decades, the overwhelming majority of

state courts have applied the “learned intermediary

doctrine” in prescription drug cases. They have held

fast to this rule even in the face of criticism and a few

prominent decisions questioning it. According to this

doctrine, a drug company generally has no duty to

warn a patient directly, but can discharge its duty

by giving an adequate warning to the physician. The

products liability provisions of the Third Restatement

of Torts summarize the doctrine as follows:

(d) A prescription drug or medical device is

not reasonably safe due to inadequate instructions or warnings if reasonable instructions or

warnings regarding foreseeable risks of harm

are not provided to:

(1) prescribing and other health-care

providers who are in a position to reduce

the risks of harm in accordance with the

instructions or warnings; or

(2) the patient when the manufacturer

knows or has reason to know that healthcare providers will not be in a position to

28

reduce the risks of harm in accordance with

the instructions or warnings.

RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY

§ 6(d). “The rationale supporting this ‘learned intermediary’ rule is that only health-care professionals

are in a position to understand the significance of the

risks involved and to assess the relative advantages

and disadvantages of a given form of prescriptionbased therapy.” Id., cmt. b.

The prescribing physician is always a critical

witness. His or her testimony gives real-world insight

into the adequacy of a warning as interpreted by

an actual physician. But this testimony can also end

the litigation as a matter of law. Generally, unless

the prescribing physician testifies that a different

warning would have made a difference – by causing

the physician to modify the prescription, to give the

patient additional warnings, or not to prescribe the

drug at all – the drug company will file a motion

for summary judgment based on lack of causation,

and some courts will deem such evidence sufficient to

justify granting the motion. See, e.g., In re Avandia

Mktg., Sales Practices & Prods. Liab. Litig., 639 F.

App’x 874, 878 (3d Cir. 2016) (“[s]ummary judgment

is properly granted on a failure to warn claim where

the record ‘is devoid of evidence to support [the] argument that a different warning would have altered [the

physician’s] prescribing methods’ ”) (citation omitted;

first alteration added).

2. Regulatory Compliance

Because FDA regulates prescription drugs, virtually every drug company in a failure-to-warn case

emphasizes at trial that it operates within a regulated

industry; that it cannot distribute a drug until FDA

29

approves it; and that FDA has approved the drug’s

label. The Third Restatement of Torts puts forward

the principle that, while compliance with safety

statutes and regulations is proper for a jury to

consider with respect to certain risks, see RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 4(b),

the “traditional view” is that such regulations “provide

only minimum standards.” Id. § 4 cmt. e (“Thus, most

product safety statutes or regulations establish a floor

of safety below which product sellers fall only at their

peril, but they leave open the question of whether a

higher standard of product safety should be applied.”).

As is characteristic of our federal system in the

domain of torts, however, there is variation among the

states, and some have enacted – not without controversy – statutes incorporating a regulatory compliance defense, or giving greater weight to evidence of

compliance than is traditionally given under common

law rules. See, e.g., ARK. CODE ANN. § 16-116-205;

COLO. REV. STAT. § 13-21-403; FLA. STAT. § 768.1256;

IND. CODE § 34-20-5-1; KAN. STAT. ANN. § 60-3304(a);

MICH. COMP. LAWS § 600.2946(4); N.J. STAT. ANN.

§ 2A:58C-4; N.D. CENT. CODE § 28-01.3-09; TENN.

CODE ANN. § 29-28-104; TEX. CIV. PRAC. & REM. CODE

ANN. § 82.007; WASH. REV. CODE § 7.72.050(2). Such

statutes reflect a policy choice by these jurisdictions to

dampen certain forms of tort liability and litigation.

These states’ erection of new barriers to tort liability

is a further reason that the doctrinal tool Petitioner

hopes the Court will create here is neither necessary

nor constitutionally appropriate.

3. Scientific Reliability

In Daubert v. Merrell Dow Pharmaceuticals, Inc.,

509 U.S. 579, 597 (1993), this Court held that Federal

30

Rule of Evidence 702 assigns district judges the role

of “gatekeep[ers]” who must screen scientific evidence

to ensure its reliability. “Post-Daubert, the federal

district courts, exercising their newly appointed ‘gatekeeper’ function, have scrutinized expert testimony

more closely, often holding rigorous pre-trial ‘Daubert

hearings’ – that are often outcome determinative –

to determine the admissibility of proffered expert

testimony.” David G. Owen, A Decade of Daubert,

80 DENV. U.L. REV. 345, 362 (2002).

The majority of states have now adopted some form

of that standard, with the result that almost every

failure-to-warn case includes a separate proceeding

within the overall litigation to determine scientific

reliability and the consequent admissibility of expert

testimony. This can be a major hurdle for failure-towarn plaintiffs. See, e.g., In re Lipitor (Atorvastatin

Calcium) Mktg., Sales Practices & Prods. Liab. Litig.,

892 F.3d 624, 632-45 (4th Cir. 2018) (no abuse of

discretion in excluding three of plaintiffs’ experts

under Daubert, effectively dismissing more than 3,000

claims); In re Zoloft (Sertraline Hydrochloride) Prods.

Liab. Litig., 858 F.3d 787, 795-800 (3d Cir. 2017) (no

abuse of discretion in excluding plaintiffs’ expert and

granting summary judgment, effectively disposing

of 315 claims). Again, recognition of an existing and

effective check on liability belies Petitioner’s overblown claims about the pressing need for a federal-law

immunity from liability.

31

CONCLUSION

State tort law requires prescription drug manufacturers to provide adequate warnings of their drugs’

harmful side-effects. Nothing in federal law prohibits

manufacturers from providing such warnings and

thus avoiding liability. Nor is there any reason to

believe that state courts are administering failure-towarn law in a way that threatens the sort of interference with federal interests that might justify further

federal-court oversight to rein them in. For the past

80 years – since moving from Swift v. Tyson to Erie

Railroad Co. v. Tompkins – this Court has kept out of

the business of shaping the precise contours of state

tort law. Consistent with this commitment, the Court

declined to interfere with state failure-to-warn claims

against brand-name drug manufacturers almost a

decade ago in Wyeth v. Levine. In today’s case, Petitioner invites the Court to engage in an untethered

form of implied preemption analysis, in effect, asking

the Court to abandon the balanced and sensible

position it staked out in Levine. When the content

of state failure-to-warn law is adequately recognized

and the defendant-protective resources of today’s state

tort law are fully appreciated, it becomes apparent

that federalizing this area of law is neither necessary

nor appropriate.

Respectfully submitted,

TARA D. SUTTON

GARY L. WILSON

ROBINS KAPLAN LLP

800 LaSalle Avenue

Suite 2800

Minneapolis, MN 55402

(612) 349-8577

November 21, 2018

EARL LANDERS VICKERY

Counsel of Record

VICKERY & SHEPHERD

10000 Memorial Drive

Suite 750

Houston, TX 77024-3485

(713) 526-1100

(lanny@justiceseekers.com)