Respondents Brief — Wendy B. Dolin, Petitioner v. GlaxoSmithKline, LLC, fka SmithKline Beecham Corporation

No. 18-803

IN T HE

Supreme Court of the United States

WENDY B. DOLIN,

Petitioner,

v.

GLAXOSMITHKLINE LLC,

Respondent.

On Petition for a Writ of Certiorari

to the United States Court of Appeals

for the Seventh Circuit

BRIEF IN OPPOSITION

ELISABETH S. THEODORE

STEPHEN K. WIRTH

ARNOLD & PORTER

KAYE SCHOLER LLP

601 Mass. Ave., NW

Washington, D.C. 20001

(202) 942-5000

ALAN S. GILBERT

DENTONS US LLP

232 S. Wacker Drive,

Suite 5900

Chicago, IL 60606

(312) 876-8000

LISA S. BLATT

Counsel of Record

J. MATTHEW RICE

WILLIAMS & CONNOLLY LLP

725 Twelfth Street, NW

Washington, D.C. 20005

(202) 434-5000

lblatt@wc.com

ANDREW T. BAYMAN

TODD P. DAVIS

HEATHER M. HOWARD

KING & SPALDING LLP

1180 Peachtree St., NE

Atlanta, GA 30309

(404) 572-4600

QUESTION PRESENTED

Under Wyeth v. Levine, 555 U.S. 555 (2009), federal law preempts a state failure-to-warn claim

where there is clear evidence that the Food & Drug

Administration (FDA) would have rejected the warning that the plaintiff claims state law requires. Under Wyeth and PLIVA, Inc. v. Mensing, 564 U.S. 604

(2011), a state failure-to-warn claim is also preempted if a defendant could not “unilaterally” add the

warning that plaintiff claims state law requires.

The question presented is:

Whether the Seventh Circuit correctly applied

these precedents to the facts of this case, when it

held that no reasonable jury could find that federal

law permitted petitioner’s proposed warning because

(1) FDA repeatedly rejected petitioner’s proposed

warning, and (2) the drug’s manufacturer lacked

newly acquired information that would have permitted it to change the label unilaterally without prior

FDA permission.

i

RULE 29.6 STATEMENT

GlaxoSmithKline LLC is an indirect whollyowned subsidiary of GlaxoSmithKline plc, a publicly

traded company organized under the laws of England.

ii

TABLE OF CONTENTS

Page

Question Presented ..................................................... i

Rule 29.6 Statement ................................................... ii

Table of Authorities ....................................................iv

Opinions Below............................................................1

Jurisdiction ..................................................................1

Statement ....................................................................1

A. Regulatory Background ..................................1

B. Procedural Background...................................4

Reasons for Denying the Petition ...............................7

I. The Seventh Circuit Correctly Applied Wyeth

and Mensing to Undisputed Facts. ......................8

II. The Decision Below Does Not Implicate a

Circuit Split. .......................................................13

III. The Court Need Not Hold this Petition

Pending Merck v. Albrecht. .................................14

IV. Petitioner’s Claim Fails for Several Other

Independent Reasons. ........................................18

Conclusion .................................................................22

iii

TABLE OF AUTHORITIES

Page(s)

Cases

A.W. Huss Co. v. Cont’l Cas. Co.,

735 F.2d 246 (7th Cir. 1984) ................................. 18

Allen v. Wright,

468 U.S. 737 (1984) ............................................... 11

Bell v. Pfizer, Inc.,

716 F.3d 1087 (8th Cir. 2013) ............................... 17

Buckman Co. v. Plaintiffs’ Legal Comm.,

531 U.S. 341 (2001) ............................................... 18

In re Darvocet, Darvon, & Propoxyphene Prods.

Liab. Litig.,

756 F.3d 917 (6th Cir. 2014) ............................17, 18

Dayton v. Peck, Stow & Wilcox Co.,

739 F.2d 690 (1st Cir. 1984).................................. 18

Demahy v. Schwarz Pharma, Inc.,

702 F.3d 177 (5th Cir. 2012) ................................. 17

Ehlis v. Shire Richwood, Inc.,

367 F.3d 1013 (8th Cir. 2004) ............................... 19

Forst v. SmithKline Beecham Corp.,

639 F. Supp. 2d 948 (E.D. Wis. 2009) ..............12, 13

In re Fosamax Prods. Liab. Litig.,

852 F.3d 268 (3d Cir. 2017)..............................14, 15

Foster v. Am. Home Prods. Corp.,

29 F.3d 165 (4th Cir. 1994) ................................... 17

Glastetter v. Novartis Pharm. Corp.,

252 F.3d 986 (8th Cir. 2001) (per curiam)............ 19

Guarino v. Wyeth, LLC,

719 F.3d 1245 (11th Cir. 2013) ............................. 17

Kirk v. Michael Reese Hosp. & Med. Ctr.,

513 N.E.2d 387 (Ill. 1987)..................................... 19

iv

v

Cases—Continued

Page(s)

Lashley v. Pfizer, Inc.,

750 F.3d 470 (5th Cir. 2014) (per curiam)............ 17

Mason v. SmithKline Beecham Corp.,

596 F.3d 387 (7th Cir. 2010) ................................. 12

Mensing v. Wyeth, Inc.,

588 F.3d 603 (8th Cir. 2009) ................................. 17

Moretti v. Wyeth, Inc.,

579 F. App’x 563 (9th Cir. 2014) ........................... 17

Mut. Pharm. Co. v. Bartlett,

570 U.S. 472 (2013) ................................................. 4

PLIVA, Inc. v. Mensing,

564 U.S. 604 (2011) ........................................ passim

Proctor v. Davis,

682 N.E.2d 1203 (Ill. App. Ct. 1997) .................... 19

Rhynes v. Branick Mfg. Corp.,

629 F.2d 409 (5th Cir. 1980) ................................. 18

Rafferty v. Merck & Co.,

92 N.E.3d 1205 (Mass. 2018)................................ 17

Ross v. Moffitt,

417 U.S. 600 (1974) ................................................. 7

Schrock v. Wyeth, Inc.,

727 F.3d 1273 (10th Cir. 2013) ............................. 17

Smith v. Eli Lilly & Co.,

560 N.E.2d 324 (Ill. 1990)..................................... 18

Smith v. Wyeth, Inc.,

657 F.3d 420 (6th Cir. 2011) ................................. 17

Todd v. Societe BIC, S.A.,

21 F.3d 1402 (7th Cir. 1994) (en banc) ................. 18

Tucker v. SmithKline Beecham Corp.,

596 F. Supp. 2d 1225 (S.D. Ind. 2008) .................. 12

United States v. Williams,

504 U.S. 36 (1992) ............................................10, 11

vi

Cases—Continued

Page(s)

Wisniewski v. United States,

353 U.S. 901 (1957) (per curiam) ......................... 12

Wyeth v. Levine,

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

Xerox Corp. v. County of Harris,

459 U.S. 145 (1982) ............................................... 18

Statutes

28 U.S.C. § 1254(1) ...................................................... 1

Food, Drug, and Cosmetic Act,

21 U.S.C. §§ 301-399 ................................................ 1

Regulations

21 C.F.R.

§ 314.3 ..................................................................... 1

§ 314.70 ................................................................. 11

§ 314.70(c)(6)(iii)(A) ................................................ 1

§ 314.70(c)(7) ........................................................... 1

New Drug and Antibiotic Regulations,

47 Fed. Reg. 46,622 (Oct. 19, 1982) ...................... 11

Supplemental Applications Proposing Labeling

Changes for Approved Drugs, Biologics, and

Medical Devices,

73 Fed. Reg. 2848 (Jan. 16, 2008) .......................... 11

Other Authorities

Stern & Gressman, Supreme Court Practice

(10th ed. 2013) ....................................................... 16

OPINIONS BELOW

The opinion of the court of appeals (Pet. App. 129) is reported at 901 F.3d 803. The opinion and order of the district court denying judgment as a matter of law (Pet. App. 30-61) is reported at 269 F. Supp.

3d 851. The opinion and order of the district court

denying summary judgment (Pet. App. 62-66) is unreported.

JURISDICTION

The judgment of the court of appeals was entered

on August 22, 2018. A petition for rehearing was denied on September 20, 2018 (Pet. App. 67-68). The

petition for a writ of certiorari was filed on December

19, 2018. The jurisdiction of this Court is invoked

under 28 U.S.C. § 1254(1).

STATEMENT

A. Regulatory Background

1. Under the Food, Drug, and Cosmetic Act, 21

U.S.C. §§ 301-399, brand manufacturers may not

change their drugs’ labeling without FDA’s prior approval except in very limited circumstances. Wyeth v.

Levine, 555 U.S. 555, 568 (2009); PLIVA, Inc. v. Mensing, 564 U.S. 604, 612-17 (2011). Under FDA’s

“Changes Being Effected” (CBE) regulation, brand

manufacturers may change their labeling unilaterally “[t]o add or strengthen a … warning,” but only to

reflect “newly acquired information” that was “not

previously submitted to [FDA].” 21 C.F.R. §§ 314.3,

314.70(c)(6)(iii)(A); see also Wyeth, 555 U.S. at 568-69.

FDA retains authority to later reject such a change.

21 C.F.R. § 314.70(c)(7). Generic manufacturers, for

their part, must match their labeling to the corre1

2

sponding brand-name labels. Mensing, 564 U.S. at

612-13.

2. Paxil is a brand-name prescription medication

approved by FDA to treat major depressive disorder

and other psychiatric disorders. Pet. App. 3, 37. Paxil’s active ingredient is paroxetine hydrochloride

(paroxetine), a selective serotonin reuptake inhibitor

(SSRI). Id. at 8. Paroxetine and other SSRIs have

improved the lives of hundreds of millions of people

suffering from anxiety and depression. GSK C.A. Br.

2 (Dkt. 24).

GlaxoSmithKline LLC (GSK) manufactured and

marketed Paxil in the United States from 1992 to

2014, when GSK sold Paxil’s New Drug Application

to another company. Pet. App. 7, 9, 15. GSK no

longer manufactures, markets, or profits from any

sale of Paxil in the United States. Generic paroxetine entered the U.S. market in 2003, and by 2010,

Paxil retained only 1% of the market. GSK C.A. Br.

6.

For nearly three decades, FDA has rejected any

association between any SSRIs, including Paxil, and

suicidality past age 24. In 1991, an independent

FDA advisory committee found “no credible evidence”

that the only SSRI then available increased suicidality for any age group. Pet. App. 9. One year later,

FDA approved Paxil’s original label without any paroxetine-specific suicide warning, instead requiring

that the label warn that the possibility of suicide attempts are inherent in depression. Id.

Throughout the 1990s and early 2000s, GSK

submitted safety data on Paxil to FDA. Pet. App. 9.

In 2004, FDA concluded that SSRIs pose an increased suicidality risk for pediatric patients and

mandated that SSRI manufacturers, including GSK,

3

add a warning to that effect on the drug labeling. Id.

at 10. GSK included the mandatory warning and

continued to study the effects of paroxetine on patients of all ages while FDA conducted its own studies on all SSRIs, including Paxil. Id. at 9-11. In

2006, based on GSK’s re-analysis of Paxil adultsuicidality data using a new FDA classification

methodology, GSK unilaterally changed Paxil’s labeling under FDA’s CBE regulation to add a warning

about adult suicidality. Id. at 11-12. Although GSK

did not believe this re-analysis established a “causal

relationship” between paroxetine and suicidality in

adults, D. Ct. Dkt. 589-21, at 4 (Sept. 25, 2017), GSK

added the adult-suicidality warning out of an abundance of caution.

In November 2006, FDA completed an extensive

meta-analysis of 372 placebo-controlled SSRI clinical

trials involving nearly 100,000 adult patients. Pet.

App. 12-13. FDA found “an elevated risk for suicidality and suicidal behavior among adults younger than

25,” but concluded that the “net effect appears to be

neutral on suicidal behavior but possibly protective

for suicidality for adults between the ages of 25 and

64 and to reduce the risk of both suicidality and suicidal behavior in subjects aged 65 years and older.”

Id. at 13.

Based on its meta-analysis, FDA on May 1, 2007,

directed GSK and other SSRI manufacturers to revise their labeling. FDA directed GSK to revise Paxil’s labeling “to ensure standardized labeling pertaining to adult suicidality with all of the drugs to treat

major depressive disorder.” Pet. App. 13. FDA ordered all SSRI labeling to warn of a suicidality risk

in persons 24 or under (as GSK had done since 2006).

Id. FDA also ordered all SSRI labeling, including

Paxil’s, to state the following:

4

Short-term studies did not show an increase

in the risk of suicidality with antidepressants

compared to placebo in adults beyond age 24;

there was a reduction with antidepressants

compared to placebo in adults aged 65 and

older.

D. Ct. Dkt. 589-23, at 2-3 (Sept. 25, 2017); see Pet.

App. 13-14. FDA required all SSRI labeling to include this language “verbatim.” Id. at 14. Paxil’s

warning today contains this identical language. Id.

at 15-16. In other words, since May 1, 2007, FDA has

required manufacturers to disclaim any adultsuicidality risk past age 24 from SSRIs and, a fortiori, has barred manufacturers from unilaterally

changing their labeling to warn of such risk unless

manufacturers comply with the agency’s CBE regulation.

3. Following FDA’s decision to require standardized labeling for all SSRIs, GSK asked FDA four

times for approval to retain a Paxil-specific adultsuicidality warning in addition to the standardized

warning for all SSRIs. Pet. App. 14-15. FDA rejected

each and every request. Id.

B. Procedural Background

1. In 2010, petitioner’s husband, Stewart Dolin,

committed suicide at age 57. At the time, Mr. Dolin

was being treated with generic paroxetine made by a

generic drug manufacturer, Mylan, Inc. Petitioner

filed the instant suit against Mylan and GSK, alleging that paroxetine increases the risk of suicide in

adults, that it caused Mr. Dolin’s suicide, and that

both companies negligently failed to warn of that

risk. Pet. App. 16 & n.1. The district court granted

Mylan’s motion to dismiss under Mensing and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013).

5

Pet. App. 16 & n.1. And although GSK did not make

the drug Mr. Dolin ingested, petitioner claimed that,

because GSK developed Paxil’s labeling and federal

law requires generic paroxetine’s labeling to match

Paxil’s, GSK was responsible for all injuries caused

by a failure to warn regardless of the drug manufacturer. Id. at 16. Following a trial, the jury returned

a $3 million verdict for petitioner. Id. at 2. The district court denied GSK’s motions for judgment as a

matter of law. Id. at 30-61.

2. The court of appeals unanimously reversed in

an opinion authored by Judge Hamilton and joined

by Chief Judge Wood and Judge Sykes. Pet. App. 129. GSK had raised three grounds for reversal: that

brand manufacturers could not be held liable to consumers of generic manufacturers’ drugs; that federal

law preempted the failure-to-warn claim; and that

petitioner presented insufficient evidence to support

the jury’s conclusion that any failure-to warn caused

Mr. Dolin’s suicide. Id. at 4. Because the court of

appeals reversed the jury’s verdict on preemption,

the court did not address GSK’s other contentions.

Id. at 29.

As to preemption, the court acknowledged that

this Court is poised to resolve a disagreement among

the circuits about whether preemption under Wyeth

v. Levine is a factual question for the jury or a legal

question for the court. Pet. App. 20-21 (citing Merck

Sharp & Dohme Corp. v. Albrecht, No. 17-290; In re

Fosamax Prods. Liab. Litig., 852 F.3d 268, 282 (3d

Cir. 2017)). But the court of appeals held that it

“need not determine in this case whether preemption

under Levine involves a factual question for the jury”

because “no reasonable jury could find that the FDA

would have approved an adult-suicidality warning

for Paxil under the CBE regulation.” Id. at 22.

6

Turning to the merits, the court explained that

under Wyeth and Mensing, “Dolin’s state-law claim

against GSK is preempted if GSK could not have

added [petitioner’s proposed] warning” and that “[t]o

add a warning through the CBE regulation, GSK

needed newly acquired information about paroxetine

that would allow it to add a warning about suicide

risk in adults.” Pet. App. 19. The court further recognized that “even if GSK had newly acquired information along these lines, GSK can still succeed on its

preemption defense if there is clear evidence that the

FDA would have rejected the adult-suicidality warning that plaintiff argues was tortiously omitted.” Id.

at 19-20. The court then found for GSK on both of

these issues. The court held that, “as a matter of law,

(1) there is clear evidence that the FDA would have

rejected [petitioner’s proposed] warning in 2007, and

(2) GSK lacked new information after 2007 that

would have allowed it to add an adult-suicidality

warning under the CBE regulation.” Id. at 20.

With respect to the first holding, the court explained that “undisputed evidence” demonstrated

that FDA rejected petitioner’s proposed adultsuicidality warning in 2007. Pet. App. 22. The court

emphasized that FDA “ordered GSK to remove a

paroxetine-specific warning of increased suicide risk

in adults from the paroxetine label,” id., and that

FDA denied GSK’s “four requests [to FDA] to reconsider,” id. at 24. The court explained that “no reasonable jury could find otherwise.” Id. at 23.

The court rejected, as “an unreasonable interpretation of the discussions between the FDA and GSK,”

petitioner’s assertion that FDA objected to the

placement of the suicidality warning within the labeling, but not to its content. Pet. App. 24. The court also rejected out of hand petitioner’s argument that

7

GSK should have requested a formal meeting with

FDA to “persuade[]” the agency to change its mind

“after already asking four times to include that

warning and being told no four times.” Id. at 25-26.

The court of appeals further held that “GSK

lacked new information after 2007 that would have

allowed it to add an adult-suicidality warning under

the CBE regulation.” Pet. App. 20. The court explained that petitioner “failed to offer evidence” that,

between FDA’s rejection of the paroxetine-specific

warning in 2007 and Mr. Dolin’s suicide in 2010, GSK

acquired any new information about Paxil that would

have permitted it to unilaterally change the label

under FDA regulations. Id. at 27.

The court of appeals subsequently denied a petition for rehearing without dissent. Pet. App. 67-68.

REASONS FOR DENYING THE PETITION

The decision below is correct and does not conflict

with the decision of any other court of appeals. The

court of appeals correctly articulated and applied

Wyeth v. Levine and PLIVA v. Mensing in holding

that federal law preempts petitioner’s failure-to-warn

claim because “(1) there is clear evidence that the

FDA would have rejected the warning in 2007, and

(2) GSK lacked new information after 2007 that

would have allowed it to add an adult-suicidality

warning.” Pet. App. 20.

Nor does the Court need to hold this case pending its resolution of Merck Sharp & Dohme Corp. v.

Albrecht, No. 17-290 (argued Jan. 7, 2019). The resolution of that case will not alter the disposition of

this case, both because there are independent bases

for preemption and because the basis for FDA’s rejec-

8

tion of petitioner’s proposed warning is not subject to

reasonable debate.

I.

The Seventh Circuit Correctly Applied Wyeth

and Mensing to Undisputed Facts.

Petitioner seeks this Court’s review largely based

on her view that the court of appeals incorrectly applied settled preemption law to the facts of this case.

But this Court does not sit as a court of error correction. Ross v. Moffitt, 417 U.S. 600, 616-17 (1974). To

the contrary, the Court generally does not grant certiorari where a petition alleges a “misapplication of a

properly stated rule of law” to the facts of a particular case. S. Ct. R. 10. In any event, the unanimous

decision of the court of appeals was manifestly correct.

1. Federal law preempts a state failure-to-warn

claim unless the defendant could “unilaterally

strengthen its [FDA-approved] warning” without preapproval from FDA under the agency’s Changes Being Effected (CBE) regulations. Wyeth, 555 U.S. at

573; see also Mensing, 564 U.S. at 620. The critical

question is “whether the private party could independently do under federal law what state law requires of it.” Mensing, 564 U.S. at 620 (emphasis

added). And even if the defendant could unilaterally

strengthen its warning, federal law still preempts

state failure-to-warn claims where there is “clear evidence” that FDA “would … have” rejected the warning that the plaintiff claims state law requires. Wyeth, 555 U.S. at 571. In either situation, state law is

preempted because “it is impossible for a private party to comply with both state and federal requirements.” Mensing, 564 U.S. at 618 (internal quotation

marks omitted). The court of appeals correctly articulated this standard. Pet. App. 17-19.

9

Here, petitioner’s state-law failure-to-warn claim

was preempted for two independent reasons. First,

“[t]o add a warning through the CBE regulation,

GSK needed newly acquired information about paroxetine that would allow it to add a warning about

suicide risk in adults” and, second, “even if GSK had

newly acquired information along these lines, GSK

can still succeed on its preemption defense if there is

clear evidence that the FDA would have rejected the

adult-suicidality warning that plaintiff argues was

tortiously omitted.” Pet. App. 19-20.

Applying the governing law to the “undisputed

evidence” presented in this case, the court correctly

concluded both that “(1) there is clear evidence that

the FDA would have rejected the warning in 2007,

and (2) GSK lacked new information after 2007 that

would have allowed it to add an adult-suicidality

warning under the CBE regulation.” Pet. App. 20.

With respect to the “clear evidence” holding, the

court noted that “[a]ll four of th[e] evidentiary gaps

in Levine were filled here.” Pet. App. 23. GSK’s “four

requests” to allow an enhanced warning and four rejections from FDA were “clearly documented” and

“not subject to reasonable dispute.” Pet. App. 24.

Moreover, from 2007, when FDA required all SSRI

manufacturers, including GSK, to revise their labels

to make clear that SSRIs do not present a suicide

risk past age 24, through 2010, when Mr. Dolin

committed suicide, federal law required Paxil’s label

to carry the FDA-mandated warning. Pet. App. 1314, 27. Here, “[petitioner] failed to offer evidence

that GSK acquired new information” after 2007 that

would have permitted GSK to change Paxil’s label

under FDA’s CBE regulations. Pet. App. 27. Thus,

GSK more than amply showed it was impossible to

10

revise its label to include the warning that petitioner

contended state law required.

2. Petitioner’s fact-bound assertions to the contrary lack merit.

First, Petitioner asserts that the court of appeals

failed to comply with Rule 50 of the Federal Rules of

Civil Procedure by “view[ing] the evidence and

draw[ing] all inferences in a manner most favorable

to GSK.” Pet. 28-30; see also Pet. 26, 29-30 (pointing

out that the opinion did not expressly discuss the

Rule 50 standard). But regardless of whether the

panel expressly recited Rule 50’s well-established

standard, the court unquestionably applied the governing legal standard. The court relied on “undisputed” documentary evidence, meaning that no inferences of any sort were drawn because the court had

no reason to do so. Pet. App. 22, 27. And its holding—that “no reasonable jury could find that the

FDA would have approved an adult-suicidality warning for Paxil”—demonstrates that the court was well

aware of and applied Rule 50’s “reasonable jury”

standard. Pet. App. 22.

Petitioner similarly complains about the court’s

analysis of the evidence. Specifically, petitioner contends that the court disregarded evidence that FDA

had not rejected the petitioner’s proposed warning

outright but rather rejected GSK’s label because

GSK proposed warning of adult suicidality in the

wrong place on the label. Pet. 30-32, 36-37. That is

incorrect. The court of appeals expressly acknowledged petitioner’s contention, and found her interpretation of FDA’s action “unreasonable.” Pet. App.

24. The court recited the undisputed evidence showing that GSK “ask[ed] four times to include [a] warning” and was “told no four times” by FDA. Id. at 25-

11

26. The Seventh Circuit put it bluntly: “Plaintiff

asks us to believe that the FDA—after deciding

against an adult-suicidality warning based on its

own analysis—rejected GSK’s warning only because

GSK proposed putting it in the wrong place. That is

unreasonable.” Id. at 25.

Petitioner also for the first time in this case argues that allowing GSK to show that it lacked “newly

acquired information” to change the Paxil labeling

unilaterally constitutes a retroactive application of

FDA’s 2008 CBE regulations. Pet. 33-34 (citing 21

C.F.R. § 314.70). But the Court does not grant certiorari to address questions that were neither pressed

nor passed upon below. See, e.g., United States v. Williams, 504 U.S. 36, 41 (1992). This prudent principle

is all the more important here, where petitioner has

not identified any court of appeals that has even addressed this waived question.

Petitioner’s waived retroactivity argument lacks

merit in any event. Petitioner concedes that, beginning on September 22, 2008, FDA’s regulations required GSK to possess newly acquired information to

unilaterally change the Paxil labeling under FDA’s

CBE regulation. Pet. 33. And petitioner notably does

not dispute the Seventh Circuit’s determination that

GSK lacked any newly acquired information after

2007. Pet. App. 26-28. Petitioner rather appears to

theorize that GSK could somehow have altered its

labeling sometime after FDA’s mandated class-wide

warning in 2007 but before the 2008 CBE regulation

took effect.

That is wrong for multiple reasons. For one, the

2008 CBE regulation codified existing practice. As

the Solicitor General explained to this Court in Wyeth, “FDA interpret[ed] [the pre-2008 CBE] regula-

12

tion to permit changes without prior approval only to

address ‘newly discovered risks’ for which there is

sufficient evidence of causal association with the

drug.”1 Moreover, the retroactivity issue is wholly

academic, as resolution of the question does not alter

the outcome of this case. Had GSK attempted unilaterally to employ the CBE process prior to September 22, 2008, FDA would have rejected the proposed

warning, and so petitioner’s claims would be

preempted for that reason alone. FDA had warned

GSK in 2007 that “[f]ailure to” implement the class

warning “could make your product misbranded.” D.

Ct. Dkt. 589-49, at 2 (Sept. 25, 2017). FDA would not

have suddenly reversed course in 2008 without any

new evidence.

Finally, petitioner asserts that GSK’s preemption

defense should be adjudicated in light of the First

Amendment. Pet. 37-38. This one-paragraph argument was neither pressed nor passed upon below.

See, e.g., Williams, 504 U.S. at 41. And petitioner further fails to develop her theory in the petition. Indeed, it is unclear what petitioner is even arguing.

No one is restricting petitioner’s speech, and petitioner does not have standing to assert GSK’s First

1

Brief for the United States as Amicus Curiae Supporting Petitioner at 4, Wyeth v. Levine, 555 U.S. 555 (2009) (No. 06-1249);

see also New Drug and Antibiotic Regulations, 47 Fed. Reg.

46,622, 46,623 (Oct. 19, 1982) (“These supplements would describe changes placed into effect to correct concerns about newly

discovered risks from the use of the drug.”); Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices, 73 Fed. Reg. 2848, 2850 (Jan. 16,

2008) (amending CBE regulation “to make explicit the agency’s

understanding that a sponsor may utilize the limited CBE provisions only to reflect newly acquired safety information”).

13

Amendment rights. See Allen v. Wright, 468 U.S. 737,

751 (1984).

In sum, petitioner offers no reason for this Court

to revisit the Seventh Circuit’s application of settled

law to the evidence presented in this case. The fact

that petitioner disagrees with the outcome hardly

gives rise to an issue that warrants this Court’s review.

II. The Decision Below Does Not Implicate a

Circuit Split.

Petitioner asserts that the decision conflicts with

a prior Seventh Circuit decision, Mason v.

SmithKline Beecham Corp., 596 F.3d 387 (7th Cir.

2010). Pet. 36-37. But intracircuit disagreements do

not warrant this Court’s review. See, e.g., Wisniewski

v. United States, 353 U.S. 901, 902 (1957) (per curiam). Mason, in any event, does not conflict with the

decision below. Quite to the contrary, the court of appeals cited extensively to Mason to support its decision. Pet. App. 18-19, 21, 23, 28. The facts and relevant time period in Mason were materially different.

Mason involved a patient under the age of 24, meaning that the patient would have fallen within the

scope of the class-wide warnings for pediatric suicide

ordered by FDA. Id. at 26 n.3 (distinguishing Mason). And the suicide at issue occurred before FDA

rejected GSK’s proposed labeling changes and ordered SSRI manufacturers to remove any adultsuicidality warning for adults over age 24. Id.

Petitioner further argues that the court of appeals’ decision diverges from decisions of district

courts within the Seventh Circuit. Pet. 34-36. Any

such conflict would not warrant this Court’s review.

S. Ct. R. 10. In any event, this contention, too, lacks

merit. Tucker v. SmithKline Beecham Corp., 596 F.

14

Supp. 2d 1225, 1236 (S.D. Ind. 2008) (Hamilton, J.)

(Pet. 34-35), predated both Wyeth and Mensing and,

like Mason, involved a suicide that occurred years

before FDA rejected GSK’s proposed labeling changes. Pet. App. 26 n.3 (distinguishing Tucker). Forst v.

SmithKline Beecham Corp., 639 F. Supp. 2d 948 (E.D.

Wis. 2009) (Pet. 35-36), is similarly irrelevant. The

suicide attempt in Forst occurred in 2004—again,

years before 2007. Id. at 954. Nor did the district

court offer any reasoning for its conclusion that FDA

in 2007 “did not preclude Paxil-specific language

changes” outside the class-wide warning. Id.

III. The Court Need Not Hold this Petition Pending

Merck v. Albrecht.

This Court need not hold this petition pending

this Court’s resolution of Merck Sharp & Dohme

Corp. v. Albrecht, No. 17-290 (argued January 7,

2019), because the outcome will have no effect on this

case.

1. Albrecht implicates only one aspect of this

case: whether there is clear evidence under Wyeth

that FDA rejected petitioner’s proposed warning. As

previously stated, in addition to the “clear evidence”

that FDA would have rejected the petitioner’s proposed warning, Pet. App. 22-26, after 2007, when

FDA mandated a class-wide warning and rejected

GSK’s proposed modifications to such warning, GSK

lacked newly acquired information that would have

permitted it to change the label unilaterally, id. at

26-28. To be sure, the court of appeals noted that

even with its “clear evidence” holding, the CBE regulations permitted GSK to unilaterally change its label had it acquired new evidence of such risks. Id. at

26-27. But the point remains that FDA’s mandatory

class-wide labeling for all SSRIs removed GSK’s

15

adult-suicidality warning, and, as the court of appeals explained, FDA’s CBE regulations barred GSK

from unilaterally changing this class-wide warning

without new evidence. Id. The court recognized that

this preemption ground was distinct from the “clear

evidence” ground, stating that “even if GSK had newly acquired information” it “[could] still succeed” on a

preemption defense as long as the evidence is clear

that FDA definitely rejected an alleged link between

paroxetine and adult suicidality. Id. at 20; cf. Pet. 34

(arguing that the court of appeals recognized that

GSK needed new information from 1992 onward to

change its label unilaterally). The decision before

the Court in Albrecht does not analyze preemption

based upon the CBE regulation requiring newlyacquired evidence to change the label unilaterally.

Regardless of the outcome, GSK has an independent

basis for preemption that is not at issue in Albrecht.

2. In any event, even the Court’s resolution of

the clear evidence question in Albrecht will have no

impact here. Albrecht involves a dispute between the

parties as to whether FDA rejected a manufacturer’s

proposed label because the manufacturer allegedly

proposed warning only about relatively benign stress

fractures instead of more serious atypical femoral

fractures. The Third Circuit held that a reasonable

juror could conclude that there was no clear evidence

FDA would have rejected a warning about the latter

type of injury. In re Fosamax, 852 F.3d at 295-300.

This Court’s resolution of that dispute, however, will

not affect the outcome here. The court of appeals

here found that the “undisputed evidence” regarding

FDA’s decision-making was subject to only one reasonable interpretation:

FDA, after exhaustively

studying the issue for years, definitely and repeatedly rejected an adult-suicidality warning based on

16

substance and science; indeed, FDA still today requires all SSRI manufacturers, including Paxil’s

manufacturer, to disclaim any such risk. Pet. App. 9,

22-25.

Petitioner raises three issues, none of which have

any merit. First, petitioner contends that this case

implicates the question of whether Wyeth’s “clear evidence” standard is a question of fact for the jury or a

question of law for the court. Pet. 27-28. But the

court of appeals expressly declined to decide that

question, holding that GSK would prevail regardless

of the outcome of that question:

We need not determine in this case whether

preemption under Levine involves a factual

question for the jury. As the Third Circuit

noted, “when no reasonable jury applying the

clear-evidence standard” could “conclude that

the FDA would have approved a label

change,” then “the manufacturer will be entitled to judgment as a matter of law.” In re

Fosamax, 852 F.3d at 282. That is the case

here. … [G]iven the facts in this case, no reasonable jury could find that the FDA would

have approved an adult-suicidality warning

for Paxil under the CBE regulation between

2007 and Stewart Dolin’s suicide in 2010.

Pet. App. 22. This Court’s resolution of the factversus-law question is thus irrelevant to the Wyeth

preemption analysis in this case and to whether GSK

“waived” its right to “have its preemption defense

submitted to the jury.” Pet. 27. Even were this Court

in Albrecht to hold that the Third Circuit correctly

held that a jury must assess “why the FDA rejected

17

[a] proposed warning,” Pet. i (No. 17-290), the Court’s

decision would not alter the result below.2

Second, petitioner suggests that this Court might

articulate Wyeth’s “clear evidence” requirement in accordance with the Third Circuit’s articulation of the

standard as requiring a defendant to show that it is

“highly probable” that FDA would have rejected a

plaintiff ’s preferred warning. Pet. 28. But the Third

Circuit made clear that its “highly probable” formulation was nothing but a restatement of the “clear evidence” standard already announced in Wyeth. See In

re Fosamax, 852 F.3d at 285-86. The court used the

phrase “highly probable” simply because that is how

Black’s Law Dictionary defines “clear evidence.” Id.

In any event, GSK would prevail under any formulation. The court of appeals held that “[i]t is hard to

imagine clearer evidence that … ‘the FDA would not

have approved a change’ to the paroxetine label” and

“[n]o reasonable jury could find otherwise.” Pet. App.

22-23. Indeed, petitioner does not even argue that

the outcome of her case would be different under the

Third Circuit’s articulation of “clear evidence.” See

Pet. 28. Thus, whether this Court embraces a “highly

probable” standard or a lower standard to establish

clear evidence, the decision below will stand.

Third, petitioner asserts that the court below

reached the wrong outcome in this case, which she

claims has a similar “factual pattern” to Albrecht, because the decision below failed to draw all reasonable

inferences in petitioner’s favor and failed to properly

consider the evidence presented. Pet. 28-32. As ex2

Moreover, petitioner joined GSK in arguing in the district

court that Wyeth preemption is a question of law for the court.

Pet. App. 20. Thus, petitioner herself has waived any argument

that preemption is a question for the jury.

18

plained above, these erroneous assertions mischaracterize the Seventh Circuit’s decision. See supra pp.

10-11. Moreover, Albrecht will have no bearing on

the requirements of Rule 50 of the Federal Rules of

Civil Procedure. As petitioner recognizes, Albrecht

involves summary judgment under Rule 56.

IV. Petitioner’s Claim Fails for Several Other

Independent Reasons.

In addition to being preempted on multiple

grounds under Wyeth and Mensing, the claims fail as

a matter of law on additional grounds. Each of these

additional grounds is an independent reason to deny

review. See Stern & Gressman, Supreme Court Practice 362 (10th ed. 2013) (citing dismissals as improvidently granted where the judgment was “clearly correct on another ground”).

1. GSK did not produce, market, distribute, or

profit from the drug Mr. Dolin ingested. Rather, Mr.

Dolin took a generic drug manufactured by a generic

drug manufacturer. Pet. App. 16. Thus, in order to

sue GSK, petitioner “advanced a new theory of liability,” coined “innovator liability,” under which brand

manufacturers could be held liable for “injuries

caused by taking generic drugs.” Id. at 3. Because

petitioner’s claims were preempted, the court below

did not address the viability of petitioner’s theory.

Id. at 29. But such a theory of liability is untenable.

Holding brand manufacturers liable for injuries allegedly caused by generic manufacturers would upend tort principles, deter medical innovation, and require brand manufacturers to insure an entire industry when their patents have long since expired and

they no longer profit from the drug.

For these reasons, an “overwhelming national

consensus” has rejected innovator liability. Guarino

19

v. Wyeth, LLC, 719 F.3d 1245, 1252 (11th Cir. 2013).

Seven federal courts of appeals have considered innovator liability under the laws of 24 states, rejecting

that theory every time.3 Overall, more than 100

state and federal decisions have rejected innovator

liability under the laws of 29 states. D. Ct. Dkt. 56123 (Apr. 16, 2017) (collecting cases through August

2016); but see T.H. v. Novartis Pharm. Corp., 407 P.3d

18, 29 (Cal. 2017); Rafferty v. Merck & Co., 92 N.E.3d

1205, 1219-20 (Mass. 2018) (recognizing innovator liability based on “reckless” conduct). And federal

courts, in particular, may not expand state tort law.

See Todd v. Societe BIC, S.A., 21 F.3d 1402, 1412 (7th

Cir. 1994) (en banc); Dayton v. Peck, Stow & Wilcox

Co., 739 F.2d 690, 694 (1st Cir. 1984); A.W. Huss Co. v.

Cont’l Cas. Co., 735 F.2d 246, 253 (7th Cir. 1984);

Rhynes v. Branick Mfg. Corp., 629 F.2d 409, 410 (5th

Cir. 1980).

Petitioner brought her tort claims under Illinois

law, Pet. App. 4, 29, and under ordinary Illinois tort

principles, manufacturers owe a duty only to their

own customers. See Smith v. Eli Lilly & Co., 560

N.E.2d 324, 340-44 (Ill. 1990). For this reason, the

Sixth Circuit, applying Illinois law, has rejected peti3

See Foster v. Am. Home Prods. Corp., 29 F.3d 165, 168, 170

(4th Cir. 1994); Lashley v. Pfizer, Inc., 750 F.3d 470, 476-78 (5th

Cir. 2014) (per curiam); Demahy v. Schwarz Pharma, Inc., 702

F.3d 177, 183-84 (5th Cir. 2012); In re Darvocet, Darvon, &

Propoxyphene Prods. Liab. Litig., 756 F.3d 917, 941-54 (6th Cir.

2014); Smith v. Wyeth, Inc., 657 F.3d 420, 424 (6th Cir. 2011);

Bell v. Pfizer, Inc., 716 F.3d 1087, 1092-94 (8th Cir. 2013);

Mensing v. Wyeth, Inc., 588 F.3d 603, 612-14 (8th Cir. 2009),

rev’d in part on other grounds sub nom PLIVA, Inc. v. Mensing,

564 U.S. 604 (2011); Moretti v. Wyeth, Inc., 579 F. App’x 563,

565 (9th Cir. 2014); Schrock v. Wyeth, Inc., 727 F.3d 1273, 1285

(10th Cir. 2013); Guarino, 719 F.3d at 1252.

20

tioner’s theory. In re Darvocet, Darvon, & Propoxyphene Prods. Liab. Litig., 756 F.3d 917, 944 (6th Cir.

2014) (“Under Illinois law, a plaintiff must ‘identify

the supplier of the product and establish a causal

connection between the injury and the product.’ ”).

Even if Illinois law recognized innovator liability,

that theory would be preempted because it stands as

an obstacle to the Hatch-Waxman Act’s careful statutory balance between pharmaceutical competition

and innovation. Instead of receiving patent and regulatory exclusivities in exchange for easier generic

entry, brand manufacturers also would have to insure generic sales against state tort claims. Petitioner’s theory would take one piece of the HatchWaxman regime—generic manufacturers’ duty to

match brand labels—and hijack it to create marketwide liability Congress never imagined. See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 34853 (2001). Indeed, innovator liability could impose

costs “large enough … to offset substantially the very

benefits Congress intended to confer.” Xerox Corp. v.

County of Harris, 459 U.S. 145, 153 (1982).

2. Petitioner also failed to present evidence from

which a reasonable jury could conclude that paroxetine causes suicide in patients over age 24. That

should come as no surprise; the absence of such evidence is precisely why FDA prohibited GSK from

adding the warning petitioner seeks. Pet. App. 8-9.

For example, petitioner’s general-causation expert,

Dr. David Healy, based his conclusions principally on

uncontrolled case reports and relatedness assessments. See GSK C.A. Br. 45-50. Federal courts

overwhelmingly reject such evidence as “not scientifically valid proof of causation.” Glastetter v. Novartis

Pharm. Corp., 252 F.3d 986, 990 (8th Cir. 2001) (per

curiam).

21

Likewise, even if Paxil could cause suicide in

adults over age 24, GSK had no duty to warn under

Illinois law because Dr. Sachman, Mr. Dolin’s prescribing physician, testified that he independently

knew of the purported risk and actually warned Mr.

Dolin and petitioner about it. GSK C.A. Br. 51-54;

see Proctor v. Davis, 682 N.E.2d 1203, 1211 (Ill. App.

Ct. 1997) (“[T]here is no duty to warn of a risk that is

already known by those to be warned.”); Kirk v. Michael Reese Hosp. & Med. Ctr., 513 N.E.2d 387, 392

(Ill. 1987) (duty to warn runs to doctor, not patient).

The fact that Dr. Sachman specifically warned Mr.

Dolin also breaks the chain of causation. See Ehlis v.

Shire Richwood, Inc., 367 F.3d 1013, 1016 (8th Cir.

2004).

In short, this case should have never been

brought. FDA precluded GSK from warning against

the risk of suicidality in adults over age 24. GSK did

not make the drug that petitioner claims caused her

husband’s tragic death. And Mr. Dolin and his physician were aware of paroxetine’s alleged risks. The

court of appeals thus correctly overturned the jury’s

verdict in this case.

22

CONCLUSION

The petition for a writ of certiorari should be denied.

Respectfully Submitted,

ELISABETH S. THEODORE

STEPHEN K. WIRTH

ARNOLD & PORTER

KAYE SCHOLER LLP

601 Mass. Ave., NW

Washington, D.C. 20001

(202) 942-5000

ALAN S. GILBERT

DENTONS US LLP

232 S. Wacker Drive,

Suite 5900

Chicago, IL 60606

(312) 876-8000

LISA S. BLATT

Counsel of Record

J. MATTHEW RICE

WILLIAMS & CONNOLLY LLP

725 Twelfth Street, NW

Washington, D.C. 20005

(202) 434-5000

lblatt@wc.com

ANDREW T. BAYMAN

TODD P. DAVIS

HEATHER M. HOWARD

KING & SPALDING LLP

1180 Peachtree St., NE

Atlanta, GA 30309

(404) 572-4600

Counsel for Respondent

March 25, 2019