In re: Acetaminophen - ASD-ADHD Products Liability Litigation

Filing 65

MEMORANDUM OPINION AND ORDER: Walmart's November 28, 2022 motion for reconsideration and certification is denied. (Signed by Judge Denise L. Cote on 4/27/2023) (vfr)

Case 1:22-mc-03043-DLC Document 65 Filed 04/27/23 Page 1 of 5

UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF NEW YORK
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:
IN RE: Acetaminophen – ASD-ADHD
:
Products Liability Litigation
:
:
This Document Relates To:
:
Hatfield et al. v. Wal-Mart Stores,
:
Inc., 22cv9011
:
Roberts et al. v. Wal-Mart Stores,
:
Inc., 22cv9012
:
:
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22md3043
22mc3043
22cv9011
22cv9012

(DLC)
(DLC)
(DLC)
(DLC)

MEMORANDUM
OPINION AND ORDER

DENISE COTE, District Judge:
On November 14, 2022, motions to dismiss two individual
actions in this multidistrict litigation (“MDL”) on the ground
of preemption were denied.

In re Acetaminophen - ASD-ADHD

Prods. Liab. Litig., No. 22md3043 (DLC), 2022 WL 17348351
(S.D.N.Y. Nov. 14, 2022) (“November Opinion”).

On November 28,

the defendant, Walmart Inc. (“Walmart”), filed a motion for
reconsideration of the November Opinion and a request for
certification under 28 U.S.C. § 1292(b).

On December 12,

Johnson & Johnson Consumer Inc. (“JJCI”), a co-defendant in this
MDL, requested that the Court defer ruling on or, alternatively,
deny Walmart’s request to certify the November Opinion for
interlocutory appeal because JJCI intended to move to dismiss
the complaints asserted against it on the ground of preemption.
On February 10, 2023, JJCI and the Retailer Defendants,
including Walmart, moved to dismiss all of the complaints

Case 1:22-mc-03043-DLC Document 65 Filed 04/27/23 Page 2 of 5

asserted against them on the grounds of preemption and other
reasons.

On April 20, the Court denied JJCI’s motion to dismiss

1

on the ground of preemption.

In re Acetaminophen - ASD-ADHD

Prods. Liab. Litig., No. 22md3043 (DLC), 2023 WL 3026412
(S.D.N.Y. Apr. 20, 2023).
Walmart’s November 28, 2022 motion for reconsideration is
denied.

The standard for reconsideration is well established

and will not be repeated here.

See Rodriguez v. Capra, No.

19cv4171 (DLC), 2023 WL 2366884, at *2 (S.D.N.Y. Mar. 6, 2023).
Walmart argues that the November Opinion overlooked the
FDA’s determination that the general pregnancy warning required
for all over-the-counter (“OTC”) drugs intended for systemic
absorption (the “Pregnancy Warning”) was exclusive and
preemptive.

Not so.

The November Opinion described the

rulemaking process that led to the regulation containing the
Pregnancy Warning, 21 C.F.R. § 201.63 (“Pregnancy Warning
Regulation”), and squarely rejected Walmart’s argument that the
FDA’s statements during that process supported preemption.

See

November Opinion, 2022 WL 17348351, at *9.
Walmart’s arguments for reconsideration fail for other
reasons as well.

Walmart’s motion for reconsideration largely

Given the pendency of this motion for reconsideration, Walmart
did not move on February 10 to dismiss the two individual
actions that were the subject of the November Opinion.

1

2

Case 1:22-mc-03043-DLC Document 65 Filed 04/27/23 Page 3 of 5

relies on the following statement made by the FDA in the
rulemaking process.

In response to comments about the Pregnancy

Warning Regulation’s preemptive effect, the FDA stated:
[A] single national pregnancy-nursing warning with a
specified text is necessary to ensure that OTC drugs
are used safely and for their intended purposes. A
single national warning will help ensure that
consumers receive clear, unambiguous, and consistent
information on the labeling of OTC drugs concerning
use by pregnant or nursing women. Differing State
requirements could conflict with the Federal warning,
cause confusion to consumers, and otherwise weaken the
Federal warning. FDA believes that differing State
OTC drug pregnancy-nursing warning requirements would
prevent accomplishment of the full purpose and
objectives of the agency in issuing the regulation and
that, under the doctrine of implied preemption, these
State requirements are preempted by the regulation as
a matter of law.
Pregnant or Nursing Women; Delegations of Authority and
Organization; Amendment of Labeling Requirements for Over-theCounter Human Drugs, 47 Fed. Reg. 54750, 54756 (Dec. 3, 1982)
(emphasis supplied).

Walmart asserts for the first time in its

motion for reconsideration that the FDA’s interpretation of its
regulation as having preemptive power is entitled to deference
under Auer v. Robbins, 519 U.S. 452 (1997).
As a preliminary matter, Walmart’s argument regarding Auer
deference is a new argument and therefore is not entitled to
“reconsideration”.

See Analytical Survs., Inc. v. Tonga

Partners, L.P., 684 F.3d 36, 52 (2d Cir. 2012).

Putting that

aside, the FDA statement about preemption is inapposite.

3

Case 1:22-mc-03043-DLC Document 65 Filed 04/27/23 Page 4 of 5

The FDA’s discussion of preemption is not addressed to a
manufacturer’s duty to ensure that the labels on its drug
products are adequate, which is the duty at the heart of this
MDL.

See Wyeth v. Levine, 555 U.S. 555, 570-71 (2009).

The FDA

was addressing instead whether States can modify the Pregnancy
Warning or replace it with their own version.

Here, the

plaintiffs are not requesting that the Pregnancy Warning be
altered or omitted.
Notably, in making its observation about the doctrine of
implied preemption, the FDA did not say that it would be
impossible for a manufacturer or retailer to comply with both
the Pregnancy Warning Regulation -- which applies to all
systemically absorbed OTC drugs and drug products -- and a state
law duty to add a warning to their drug labels regarding the
risk of the use during pregnancy of a specific drug and any
particular health condition.

Accordingly, the FDA’s statement

is largely irrelevant to the plaintiffs’ claims.
Walmart’s reference to Auer deference is misplaced for
another reason as well.

When determining whether to defer to an

agency’s interpretation of its own regulation, a court must
first decide, using “all the traditional tools of” statutory
interpretation, whether “the regulation is genuinely ambiguous.”
Kisor v. Wilkie, 139 S. Ct. 2400, 2415 (2019); Walsh v. Walmart,
Inc., 49 F.4th 821, 827-28 (2d Cir. 2022).
4

Only if there is

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