In re Valsartan Losartan & Irbesartan Prods. Liab. Litig.

• Decision Date: 08 February 2023
• Docket Number: Master Docket 19-2875 (RBK/SAK)
• Parties: In re VALSARTAN, LOSARTAN, AND IRBESARTAN PRODUCTS LIABILITY LITIGATION This Document Applies to All Actions Daily Dosage Duration VCD Active Pharmaceutical Ingredient [“API”] Defendants' Class Certification Expert ECF No. / (Exhibit No.) of Defendants' Expert's Report Opposed? Opposed? / ECF No. of Plaintiffs' Motion to Preclud Class Plaintiffs' Class Certification Expert Opposed ? / ECF No. of Defendants' Motion to Preclude
• Court: U.S. District Court — District of New Jersey

In re VALSARTAN, LOSARTAN, AND IRBESARTAN PRODUCTS LIABILITY LITIGATION This Document Applies to All Actions

Master Docket No. 19-2875 (RBK/SAK)

United States District Court, D. New Jersey, Camden Vicinage

February 8, 2023

OPINIONS ON CERTIFICATION OF PROPOSED CLASSES UNDER FRCP RULE 23 AND ON CLASS CERTIFICATION EXPERT REPORTS UNDER FRE 702

Honorable Robert B. Kugler, United States District Judge.

Before the Court in this multidistrict litigation (“MDL” or “Valsartan MDL”) are several motions: from All plaintiffs: a motion to certify two economic loss classes, each having a number of subclasses, as well as medical monitoring classes; and from Third Party Payor [“TPP”] plaintiffs: a separate motion to certify a TPP economic loss class.

In addition to these are motions from both defendants and plaintiffs seeking to preclude the reports of the class certification experts of the opposing party.

Table 1 lists the outstanding plaintiffs' motions for class certification and the motions to preclude that this opinion resolves. An Order of this date accompanies this Opinion.

The Valsartan MDL arose from an extensive Food and Drug Administration [“FDA”] recall in the U.S. of generic hypertensive, prescription drugs [“Valsartan” or “Valsartan-containing drugs” or “VCDs”]. To be clear, as used herein, the term “VCD” refers to valsartan-containing drugs that were contaminated with probable genotoxic human carcinogens in the form of nitrosamines, N-nitrosodimethylamine (“NDMA”) and N- N-nitrosodiethylamine (“NDEA”).

Beginning in July 2018 and upon the FDA's discovery that VCDs sold in the U.S. were contaminated with these nitrosamines, the FDA continued to recall VCDs into 2021. The recalls concerned VCDs manufactured and/or finished into pills by several defendants not headquartered in the U.S., including: in China: Zhejiang Huahai Pharmaceuticals Ltd.[“ZHP”]; in India: Mylan Pharmaceuticals Ltd. [“Mylan”]; Aurobindo Pharmaceuticals Ltd.[“Aurobindo”]; Hetero Pharmaceuticals Ltd. [“Hetero”]; and Torrent Pharmaceuticals Ltd. [“Torrent”]; and in Israel: Teva Pharmaceuticals [“Teva”]. Most of the foreign drug manufacturers also have U.S. subsidiaries that either put the drugs in finished form or sold/distributed them in the U.S.

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Table 1: Motions This Opinion Resolves

ECF No.	Movant	Relief Sought
1747	All Plaintiffs	Motion to Certify Consumer Economic Loss Class, and to Certify Third Party Payor Class, and to Certify Medical Monitoring
1749	Third Party Payor Plaintiffs	Motion to Certify Third Party Payor Class
2024	Defendants	Motion to Preclude Report of Plaintiffs' Class Expert, Edward Kaplan, M.D.
2032	Defendants	Motion to Preclude Report of Plaintiffs' Class Expert, Zirui Song, M.D., PhD
2033	Defendants	Motion to Preclude Report of Plaintiffs' Class Expert, Ron Najafi, PhD
2034	Defendants	Motion to Preclude Report of Plaintiffs' Class Expert, Kaliopi Panagos, PharmD, RPh
2035	Defendants	Motion to Preclude Report of Plaintiffs' Class Expert, John Quick, MBA
2036	Plaintiffs	Motion to Preclude Report of Defendants' Class Expert, Eric Sheinin, PhD
2037	Wholesaler Defendants	Motion to Preclude Report of Plaintiffs' Class Expert, Rena Conti, PhD
2038	Plaintiffs	Motion to Preclude Report of Defendants' Class Expert, David Chesney
2040	Defendants	Motion to Preclude Report of Plaintiffs' Class Expert, Rena Conti, PhD
2041	Plaintiffs	Motion to Preclude Report of Defendants' Class Expert, Punam Keller, PhD
2043	Plaintiffs	Motion To Strike New And Altered General Causation Opinions of Defendants' Expert Michael Bottorff, PhD
2044	Plaintiffs	Motion to Preclude Report of Defendants' Class Expert, William Lambert, Ph.D.
2045	Plaintiffs	Motion to Preclude Report of Defendants' Class Expert, Mark Robbins, PhD
2046	Plaintiffs	Motion to Preclude Report of Defendants' Class Expert, Lauren Stiroh, PhD
2047	Plaintiffs	Motion to Preclude Report of Defendants' Class Expert, Jason Clevenger, PhD
2048	Plaintiffs	Motion to Preclude Report of Defendants' Class Expert, Timothy Kosty, MBA, RPh
2069	Defendants	MOTION for Leave to File Instanter Sur-reply Briefs In Further Opposition To Plaintiffs Motions For Class Certification, And Request For A Class Certification Hearing

The COURT HAVING REVIEWED the parties' submissions without a hearing in accordance with Loc.R. 78.1 (b), for the reasons stated below, and for good cause shown, THE COURT ORDERS regarding the motions to preclude, or strike, the reports of the parties' class certification experts:

Plaintiffs' Motion to Strike (ECF. No. 2043) New and Altered General Causation Opinions in the

Report at ECF No. 2084, Exh. 2 of Michael Bottorff, PharmD is GRANTED, and in particular the following opinions of Dr. Bottorff are precluded:

1. “Oral doses at the levels detected in the generic valsartan at issue in this litigation are

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metabolized in the liver almost completely, preventing exposure to other tissues and organs” (Bottorff Class Certification Report at 48:761-762);

2. “NDMA/NDEA in valsartan will not reach systemic circulation” (Bottorff Class Certification Report at 47: 779); and

3. “DNA repair mechanisms in humans can be as much as 10 times higher than that in rats, indicating a more active DNA repair in humans compared to rats” (Bottorff Class Cert. Report at 52:830-831).

Plaintiffs' Motion to Preclude (ECF No. 2038) the Class Certification Report of David Chesney, BA, MSJ, is GRANTED IN PART AND DENIED IN PART. Only Mr. Chesney's opinions on page 5 and immediately following in his Class Certification Report and which are limited to the issue of ZHP's compliance with FDA current Good Manufacturing Practices and based solely on his review of ZHP documents have been considered here. The opinions and discussion in the rest of Mr. Chesney's report have been precluded.

Plaintiffs' Motion to Preclude (ECF No. 2047) the Class Certification Report of Jason Clevenger, PhD, is GRANTED.

Plaintiffs' Motion to Preclude (ECF No. 2041) the Class Certification Report of Punam Keller, PhD, is GRANTED IN PART AND DENIED IN PART. Dr. Keller's opinions on pages 30 to 45 in her Report have been precluded. Her opinions regarding scholarly literature on consumer health decisionmaking in pages 1-29 of her Report have been considered but only to the extent that these opinions are based on actual consumer surveys and real world consumer research.

Plaintiffs' Motion to Preclude (ECF No. 2048) the Class Certification Report of Timothy Kosty, RPh, MBA, is GRANTED IN PART AND DENIED IN PART. The information and opinions in pages 4999 of Mr. Kosty's Report have been precluded. Mr. Kosty's discussion of the workings of the U.S. pharmaceutical industry in pages 15-48 of his Class Certification Report has been considered.

Plaintiffs' Motion to Preclude (ECF No. 2044) the Class Certification Report of William Lambert, PhD, is GRANTED IN PART AND DENIED IN PART. The following opinions in Dr. Lambert's Report have been precluded:

• Dr. Lambert's opinion about the “worthlessness” of the VCDs, couched in terms of bioequivalence, is an unqualified economics opinion

• Any of Dr. Lambert's opinions that the FDA's Orange Book does or not establish / create manufacturer warranties. By excluding these opinions of Dr. Lambert's the Court is not expressly deciding one way or another whether the Orange Book creates manufacturer warranties; rather, the

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Court finds that Dr. Lambert is not a legal expert qualified to opine on such an issue.

• Any of Dr. Lambert's opinions that plaintiffs failed to apply correct standards in determining for bioequivalence and pharmaceutical equivalence.

• Dr. Lambert's opinions at ¶38 of his Class Certification Report; and

• Dr. Lambert's opinions at ¶88 and ¶90 of his Class Certification Report.

Any other of Dr. Lambert's opinions in his Report has been considered.

Plaintiffs' Motion to Preclude (ECF No. 2045) the Class Certification Report of Mark Robbins, PhD, JD is DENIED.

Plaintiffs' Motion to Preclude (ECF No. 2036) the Class Certification Report of Eric Sheinin, PhD is GRANTED IN PART AND DENIED IN PART. Paragraph 69, and paragraphs 79 to 102 in Dr.

Sheinin's Report have been precluded. Paragraphs 25 to 68, and paragraphs 70-78 in Dr. Sheinin's Report have been considered but only as BACKGROUND information, and NOT as reliable expert opinion on class certification, liability, damages, etc. issues.

Plaintiffs' Motion to Preclude (ECF No. 2046) the Class Certification Report of Lauren Stiroh, PhD is DENIED.

Defendants' Motions (ECF Nos. 2040 [“General Motion”] and 2037 [‘Wholesalers Motion”]) to Preclude the Class Certification Report of Rena Conti, PhD are DENIED.

Defendants' Motion to Preclude (ECF No. 2033) the Class Certification Report of Ron Najafi, PhD is GRANTED.

Defendants' motion to Preclude (ECF No. 2035) the Class Certification Report of John Quick, MBA, is GRANTED IN PART AND DENIED IN PART. Mr. Quick's opinions on pp. 6-7 of his Report regarding the terms “adulterated” and “misbranded” and whether the VCDs were “adulterated” and “misbranded” have been precluded; the other opinions in Mr. Quick's Report have been considered.

Defendants' Motion to Preclude (ECF No. 2034) the Class Certification Report of Kaliopi

Panagos, PharmD and RPh, is GRANTED IN PART AND DENIED IN PART. Dr. Panagos's opinions at paragraphs 47, and 52-59 in her Report and in the Summary...