In Re: Taxotere (Docetaxel) Eye Injury Products Liability Litigation

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Case 2:22-md-03023-JTM-MBN
Document 635 Filed 05/19/26
Page 1 of 5
UNITED STATES DISTRICT COURT EASTERN DISTRICT OF LOUISIANA
IN RE: TAXOTERE
)
MDL No. 22-3023
(DOCETAXEL) EYE INJURY )
PRODUCTS LIABILITY LITIGATION )
)
SECTION: "H" (5)
)
This document relates to: Cases identified in Appendix "A" ) )
ORDER
On February 27 and 28, 2025, Defendants Accord Healthcare, Inc. ("Accord") and Sandoz, Inc. ("Sandoz") separately filed motions for summary judgment, arguing that Plaintiffs' claims were barred by federal preemption. Both Accord and Sandoz manufacture versions of the chemotherapy drug docetaxel and obtained FDA approval through the § 505(b)(2) regulatory pathway in 2011.
On January 16, 2026, this Court issued an Order and Reasons granting Accord's and Sandoz's motions for summary judgment ("Sandoz and Accord Order").1 In doing so, the Court applied the framework established by the Fifth Circuit in Hickey v. Hospira, Inc. for determining whether state-law claims against manufacturers whose drugs were approved through the § 505(b)(2) pathway are preempted by federal law.2 Under Hickey, such claims are not preempted if, after the drug's initial approval, the manufacturer possessed "newly acquired information" revealing "risks of a different type or greater
1 Sandoz and Accord did not originally identify specific plaintiffs in their Motions; however, based on the Sandoz and Accord Order, on January 28, 2026, Accord and Sandoz moved for entry of judgment in their favor and dismissal of Plaintiffs' claims with prejudice. Doc. 598. On March 6, 2026, this Court granted Accord and Sandoz's motion and dismissed Plaintiffs' claims against Accord and Sandoz. Doc. 606.
2 Doc. 598 (citing Hickey v. Hospira, 102 F.4th 748, 750 (5th Cir. 2024)). As the Fifth Circuit clarified, the parties agreed that it is "common practice" to "refer to this provision and its counterparts-§§ 505(b)(2) and (j)-by their location in the FDCA rather than their location in the United States Code." See Hickey, 102 F.4th at 750 n.1.
AUTHENTICATED U.S. GOVERNMENT INFORMATION GPO

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severity or frequency” than those reflected in the “publicly available scientific
literature” that existed before approval.3 In other words, a court must compare
the 	published 	scientific 	literature 	that 	existed 	before 	approval 	with 	the
information 	that 	became 	available 	to 	a 	defendant-manufacturer 	after
approval, 	and 	generally 	only 	the 	latter 	may 	qualify 	as 	“newly 	acquired
information.”4 Applying that framework, this Court found that Accord and
Sandoz did not possess “newly acquired information” after their drugs were
approved in 2011 and accordingly held that Plaintiffs’ claims against them
were preempted.
On March 10, 2026, Hospira Worldwide, LLC; Hospira, Inc. (collectively,
“Hospira”), and Pfizer, Inc. (“Pfizer”) filed an unopposed motion for summary
judgment on the same grounds.5 Like Accord and Sandoz, Hospira and Pfizer
manufacture docetaxel products approved under § 505(b)(2). Hospira’s drug
was approved in 2011, and Pfizer’s in 2013. They argued that the reasoning of
the Sandoz and Accord Order applied equally to them because they relied on
the 	same 	regulatory 	pathway 	and 	materially 	identical 	post-approval
information. On March 18, 2026, this Court granted Hospira and Pfizer’s
motion.6
On April 15, 2026, Actavis LLC f/k/a Actavis, Inc.; Actavis Pharma, Inc.;
and Sagent Pharmaceuticals (collectively, “the Actavis Defendants”) filed the
instant Motion for Summary Judgment on Preemption (Doc. 624). The Actavis
3 Hickey, 102 F. 4th at 756.
4 The Hickey court reasoned that while § 505(b)(2) permitted the defendants to rely on the
brand-name manufacturer Sanofi’s “safety and efficacy data when seeking approval,” it was
undisputed that those defendants “did not have a ‘right of reference’ to that data during the
relevant time period.” Id. at 755 (citing 21 U.S.C. § 355(b)(2)). Further, it was also undisputed
that those defendants “did not have access to Sanofi’s adverse event reports during the
relevant timeframe.” Id. As such, the publicly available literature would have been the only
information that the defendants would have been “aware of and responsive to.” Id. at 756.
5 Doc. 607. Plaintiffs informed the Court that they did not intend to oppose Hospira’s Motion.
6 Doc. 609.
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Defendants’ docetaxel product was approved in 2013 under § 505(b)(2). The
Actavis Defendants raise the same argument previously asserted by Hospira
and Pfizer: that the Court’s reasoning in the Sandoz and Accord Order applies
equally because the governing legal framework, regulatory pathway, and
post-approval 	information 	are 	materially 	identical. 	Plaintiffs 	filed 	no
opposition.
Considering the arguments asserted in the Actavis Defendants’ Motion
for Summary Judgment, and for the reasons set forth in this Court’s January
16, 2026 Order and Reasons, IT IS ORDERED that the Actavis Defendants’
Motion 	for 	Summary 	Judgment 	is 	GRANTED. 	The 	claims 	of 	Plaintiffs
identified 	in 	Appendix 	“A” 	attached 	to 	this 	Order 	against 	the 	Actavis
Defendants are DISMISSED WITH PREJUDICE.
New Orleans, Louisiana, this 19th day of May, 2026.
JANE TRICHE MILAZZO
UNITED STATES DISTRICT JUDGE
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Case 2:22-md-03023-JTM-MBN
Document 635
Filed 05/19/26 Page 4 of 5
Appendix A

Appendix A – Cases Naming Actavis LLC f/k/a Actavis, Inc., Actavis Pharma, Inc.
and/or Sagent Pharmaceuticals1
Plaintiff Name 	Docket Number
Ellen Beasley 	2:22-cv-00585
Leola Carmona 	2:22-cv-00773
Diane Debiasi 	2:22-cv-02707
Jeanne LaForge 	2:22-cv-04464
Karen McMeans 	2:22-cv-01869
Rhonda Micco 	2:22-cv-02263
Shirley Webb 	2:23-cv-00938
Janet Oakley 	2:23-cv-01822
Dawn Porco 	2:23-cv-00118
Mary Tarrant 	2:24-cv-00849
Marilyn Robinson 	2:24-cv-01958
Carole Beaver 	2:25-cv-02081
1 Identified on the respective individual case dockets as Sagent Pharmaceuticals, “Sagent
Pharmaceuticals, Inc”, or “Sagent Pharmaceuticals, Inc.”
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