IN RE: PET FOOD PRODUCTS LIABILITY LITIGATION

Filing 194

NOTICE by CHEMNUTRA, INC. of Motion and Motion to Destroy Retained Wheat Gluten (BRAZIL, ANTHONY)

IN RE: PET FOOD PRODUCTS LIABILITY LITIGATION

Doc. 194

UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY
IN RE PET FOODS PRODUCTS LIABILITY LITIGATION
MDL DOCKET NO. 1850 Case No. 07-2867 (NHL) Judge Noel L. Hilman

CHEMNUTRA,INC.'S NOTICE OF MOTION AND MOTION TO DESTROY RET AI NED WHEAT GLUTEN ; DECLARATION OF KAREN M. FIRSTENBERG; DECLARATION OF ANTHONY G. BRAZIL AND DECLARATION OF STEPHEN S. MILLER; AND (PROPOSED) ORDER
PLEASE TAKE NOTICE that pursuant to Fed. R. Civ. P. 26(b)(2)(C)(iii) and 26(c)(1),
and upon any additional briefing that may be determined by this Court, Defendant ChemNutra,

Inc. ("ChemNutra") wil and does hereby move in the United States District Cour, for the
District of

New Jersey, Michell H. Cohen Building & U.S. Courthouse, 4th Street & Cooper

Streets, Room 1050, Camden, New Jersey 08101, before the Honorable Noel L. Hilman, U.S.
D.J. for an Order allowing ChemNutra to destroy the recalled raw wheat gluten purchased from

XuZhou Anying Biologic Technology Development Co. Ltd. ("XuZhou Anying") (collectively
"Wheat Gluten") that ChemNutra is currently storing in compliance with preservation orders
previously issued by this Court.
ChemNutra now moves to seek modification of

this Court's prior preservation orders to

allow ChemNutra to destroy the recalled Wheat Gluten that it has been storing because (1) the
FDA has already conducted reliable, independent and valid sampling and testing ofChemNutra's
Wheat Gluten, the results of which are publically available and attached hereto; (2) the FDA has

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Dockets.Justia.com

requested that ChemNutra destroy the recalled Wheat Gluten in its possession due to public health and safety concerns associated with the continued storage of large quantities of recalled

wheat gluten, including but not limited to cross-infestation and inadvertent re-entry into the
stream of commerce; (3) the substantial financial burden and costs associated with retaining
ChemNutra's Wheat Gluten far exceed any benefit to retaining the Wheat Gluten since the FDA
has already conducted reliable, independent and valid sample and testing of

the Wheat Gluten;

(4) both the FDA and the US Attorneys office support ChemNutra's request to destroy its Wheat
Gluten, (5) the destruction would be done in accordance with and under the supervision of

the

FDA.

Accordingly, ChemNutra seeks an Order allowing it to destroy its Wheat Gluten in
accordance with and under the supervision of

the FDA.

PLEASE TAKE FURTHER NOTICE that in support of

its Motion, ChemNutra wil rely

upon the accompanying Memorandum of Points and Authorities; the Declaration of Karen M.

Firstenberg, Declaration of Anthony G. Brazil and Declaration of Stephen S. Miler, and all other

papers fied with this Court in this litigation and (proposed) Order.

DATED: September~, 2008

,-

MORRIS POLICH & PURDY LLP

ATONY G. B it, SQ.
KAREN M. FIRSTENB RG, ESQ. 1055 W. Seventh Street, 24th Floor Los Angeles, CA 90017
Telephone: [phone] Facsimile: [phone]

Email: abrazilêmpplaw.com

kfirstenbergêmpplaw.com
Counsel for Defendant CHEMNUTRA INC.

. . .'

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MEMORANDUM OF POINTS AND AUTHORITIES IN SUPPORT OF CHEMNUTRA. INC.'S UNOPPOSED MOTION TO DESTROY ITS INVENTORY OF WHEAT GLUTEN

I. INTRODUCTION AND SUMMARY
On April

2, 2007 ChemNutra, Inc. ("ChemNutra") recalled its entire raw wheat gluten

inventory that had been supplied by XuZhou Anying Biologic Technology Development Co.

Ltd. ("XuZhou Anying") (collectively "Wheat Gluten") due to possible contamination. It is this

recall that serves as the basis ofChemNutra's inclusion in this litigation. Since this recall,
ChemNutra has retained, pursuant to the preservation order of this Court, its remaining inventory

of Wheat Gluten in three warehouses located in Missouri, New Jersey and Pennsylvania. See

Declaration of Stephen S. Miler ("Miler") irir 2 and 3.
In December, 2007, this Court granted Motions by Menu Foods and DelMonte related to a sampling, testing and destruction plan for the retained inventory pet food products recalled and
retained by those companies. Pursuant to this Cour's order, representative samples of

the

allegedly containment pet foods to which pets were exposed were to be retained and the

remainder of which was authorized for destruction. It is the contents of those finished product
samples that wil determine whether or not a specific pet consumed contaminated food.
ChemNutra now seeks an order to destroy its remaining inventory of

recall Wheat Gluten

since commencing in March, 2007, the Food and Drug Administration ("FDA") commenced a

detailed and independent sampling and inspection ofChemNutra's Wheat Gluten. This
inspection resulted in the FDA obtaining samples and testing of

various bags ofChemNutra's

Wheat Gluten. The FDA's sampling and tests resulted in reliable, independent and valid results,
all of

which are publically available from the FDA and attached hereto.

Accordingly, ChemNutra now seeks to destroy its remaining Wheat Gluten that is

currently being stored in Missouri, New Jersey and Pennsylvania. Good cause supports the
granting of

this Motion since (1) the FDA has already conducted reliable, independent and valid
which are publically available

sampling and testing ofChemNutra's Wheat Gluten, the results of

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and attached hereto; (2) the FDA has requested that ChemNutra destroy the recalled Wheat Gluten in its possession due to public health and safety concerns associated with the continued
storage of large quantities of recalled wheat gluten, including but not limited to cross-infestation

and inadvertent re-entry into the stream of commerce; (3) the substantial financial burden and costs associated with retaining ChemNutra's Wheat Gluten far exceed any benefit to retaining the Wheat Gluten since the FDA has already conducted reliable, independent and valid sample
and testing of

the Wheat Gluten; (4) both the FDA and the US Attorneys office support

ChemNutra's request to destroy its Wheat Gluten, (5) the destruction would be done in
accordance with and under the supervision of the FDA.

Accordingly, ChemNutra requests that this Court grant ChemNutra's Motion and Order
that its Wheat Gluten be destroyed in accordance with and under the supervision of

the FDA.

II. GOOD CAUSE SUPPORTS THE ORDER ALLOWING CHEMNUTRA TO DESTROY ITS WHEAT GLUTEN
This Cour has broad power to limit discovery when good cause is shown. Fed. R. Civ.
P. 26(b)(2), 26(C)(2), 26(c)(4); United States v. Princeton Gamma-Tee (D.N.J.) 817 F.Supp. 488,

493 (granting motion to limit discovery). This cour may limit discovery when "the burden or
expense of

the proposed discovery outweighs its likely benefit" to the part seeking discovery.

Maertin v. Armstrong World Indus., Ine. No. 01-5321,2007 U.S. Dist. LEXIS 20561, at *4, 6
(D. N.J. Mar. 8, 2007)(Schenieder, J.)(internal quotation marks omitting)(rejecting request for
insurer's claims files, which were located in 27 offces, because of

the "burden and expense to

obtain the requested discovery").

Courts have agreed to limit discovery to statistical samples where, like here, the burden
of full production outweigh its potential benefits. E.g. Benson v. St. Joseph Reg

'i Health etr.,

No. H-04-04323, 2006 U.S. Dist. LEXIS 34815, at *4-7 (S.D. Tex. May 17, 2006)(permitting
defendant health center to produce only 350 of

the 1,336 requests patient chars - a

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"representative sample" because "imposing the full expense of

producing all

1,336 chars upon

Defendants would be undue and unfair")
Here, more than in Benson, the need to destroy the remaining supply of ChemNutra's

Wheat Gluten is more compelling. ChemNutra continues to store its Wheat Gluten in three

warehouse facilities located in Missouri, New Jersey and Pennsylvania. Miler irir 3, 4,6 and 7.
This burden and expense associated with the continued storage ofChemNutra's Wheat Gluten
far exceeds any benefit since ChemNutra's Wheat Gluten has already undergone independent,
reliable and valid sampling and testing by the FDA, the results of

which are publically available.

Moreover, since conducting these samplings and testing, the FDA has requested that ChemNutra

destroy its Wheat Gluten for public health reasons. Both the FDA and the US Attorneys offce
support ChemNutra's request to destroy its Wheat Gluten and the destruction would be done in
accordance with and under the supervision of

the FDA. In fact, ChemNutra's grounds for

requesting this relief are even more compelling than the requests of Menu and Del Monte

previously granted by this Cour in that the sampling and testing plan for ChemNutra's Wheat
Gluten has already been independently created and completed by the FDA and the results thereof
have been provided to the Plaintiffs and this Court.

A. The FDA Has Conducted An Independent Reliable Sampling and Testing Of
ChemNutra's Wheat Gluten.

Commencing in March, 2007 the FDA developed and implemented a detailed sampling,
inspection and testing of ChemNutra' s Wheat Gluten stored at its MoKan Container Service,

Inc.'s warehouse located in Kansas City, Missouri. Miler, ir 5. The FDA's methodology and
plan for sampling and testing the Wheat Gluten was thorough and consistent with the plans previously proposed by co-defendants retained expert, Dr. McCabe and previously approved by
this Court in connection with its Orders pertaining to retained inventory of finished products.
See Declaration of Anthony G. Brazil ("Brazil"), ir 5; See Declaration of

Karen M. Firstenberg

("Firstenberg"), ir 4.

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As evidenced by the final report consisting of 134 pages (See Exhibit 2 to Firstenberg

Dec.) the FDA was methodical in documenting its sampling and testing procedures. These test

reports contain, inter alia, the following information: (a) the date of collection; (b) product code;
(c) PIS sample number; (d) hours spent related to each sampling; (e) country of origin for each sample; (f) a product description; (g) batch identification; (h) reason for each sampling; (i) lot
size; G) description of sample; (k) method of collection; (1) preparation procedures for each

sampling; (m) remarks; and (n) lab conclusions. See Firstenberg, ir 3; Exhibit 2 to Firstenberg
Dec.

Pursuant to Fed. R. Evid. 201 (b), ChemNutra requests this Court to take judicial notice of the FDA's final report attached as Exhibit 2 to Firstenberg Dec. See Noble Asset Management v.

Alios Therapeuties, Ine. (D, Colo. 2005) 2005 WL 161977, *2 (holding that a court may take
judicial notice of

FDA documents which are publically available).

The FDA's testing and sampling results generated reliable, independent and valid results,
all of

which are publically available and were obtained by request to the FDA by means ofthe

Freedom of Information Act. See Firstenberg, ir 2; See also Exhibit A to Firstenberg Dec.
Since the FDA's sampling plan and tests were conducted as an independent, federal

agency these results are reliable and valid. See Referenee Manual on Seientife Evidence (pp. 98 - 102, 2d ed. 2000) expressly approving analytical testing on sample units to measure the larger

population, as long as the sampling is not biased. For example, in criminal drug cases, chemist
are used to analyze a representative sample of

the seized items to "determine the total quantity of

illcit drugs in all of

the items seized." The Referenee Manual on Seientife Evidence, p. 99, n.
representative samples, even in

45. Courts consistently use results based on the testing of

criminal cases that "warrant() special concern." E.g. United States v. Shonubi (E.D.N.Y. 1995)

895 F.Supp.460, 465,518,519-521,524 (for sentencing purposes, relying on statistical data from

representative samples, in par, in finding that defendant "smuggled between 1,000 and 3,000
grams on his eight trips"); see also NutraSweet Co. v. X-L Eng'g Co. (7th Cir. 2000) 227 F.3d

776, 782, 787, 792 (affrming the District Cour's conclusion that defendant was liable to
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NutraSweet for polluting NutraSweets property where NutraSweets expert tested soil samples
to measure the amount of contamination).

Accordingly, since the FDA has already conducted independent, reliable and valid
sampling and testing, the results of which have been well documented, provided herein and are
publically available, good cause now supports the destruction of ChemNutra's Wheat Gluten.
B. The FDA Has Indicated That It Believes That ChemNutra's Retained

Raw Wheat Gluten Is A Public Health Hazard And That
ChemNutra's Wheat Gluten Should Be Destroyed
As par of the FDA's active investigation related to ChemNutra's recall of

its Wheat

Gluten, the FDA specifically informed ChemNutra by letter that ChemNutra should not continue
to store its Wheat Gluten for fear of

public safety. Specifically, on or bout June 29,2007, the

FDA sent to ChemNutra a letter expressing its concerns regarding the "public health risks"
associated with ChemNutra's storing of their approximately 430 metric tons of

wheat gluten.

The FDA stated that "until the product is destroyed, there is a risk of reintroduction into
interstate commerce, whether intentional or not, and/or risk of expert." The FDA then urged
ChemNutra to "seek whatever relief

is appropriate from the Cour." Miler, ir 8; see also Exhibit
the FDA's request for destruction of

A to Miler Dec. (emphasis added). Since receipt of

its

Wheat Gluten, ChemNutra has received numerous follow up requests seeking the status of

destruction of its Wheat Gluten.. Miler, ir 9. Counsel for ChemNutra has been working for over
six months with co-defendants, plaintiffs counsel and the FDA's offce of chief counsel in efforts
to comply with the FDA's requests to ChemNutra to destroy its inventory of

Wheat Gluten.

Brazil, ir 2.

The FDA has the authority to issue its letter, as the Federal Food, Drug and Cosmetic Act

requires the FDA to keep foods "for man or other animals. . . safe, wholesome, (and) sanitary."
21 U.S.C. §§ 321, 393. This Court should take judicial notice of

the FDA's letter dated June 29,

2007 and defer to the FDA's conclusion that the current quantity ofraw wheat gluten stored is
creating health risks to the public and recommendations that ChemNutra destroy its inventory of
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wheat gluten. See In re Wellbutrin SR/Zyban Antitrust Litig., (E.D. Pa. 2003) 281 F.Supp.2d
751,755 n.2 (taking

judicial notice ofa FDA report published on its website). See also Sandoz

Pharms. Corp. v. Riehardson-Vieks, Ine. (3rd Cir. 1990) 902 F.2d 222, 230-31 (because agency

decisions are frequently of a discretionary nature or frequently require expertise, the agency should be given the first chance to exercise that discretion or to apply that expertise." (quoting
MeKart v. United States (1996) 395 U.S. 185, 194; see also Wells Fargo Bank of

Tex. NA v.

James (E.D. Pa. 2006)484 F.Supp.2d 289,308-17 (giving "significant deference" to the FDA).
ChemNutra seeks to follow the FDA's sound advice. Since ChemNutra's Wheat Gluten
has been appropriately sampled, well tested and documented, good cause now supports the

destruction ofChemNutra's Wheat Gluten and its Motion should be granted. Both the FDA and
the US Attorneys offce have approved of

this request for destruction by ChemNutra. Brazil,

irir5, 6.

C. The Financial Costs And Expense For ChemNutra To Store Its Wheat

Gluten Far Exceed Any Potential Benefits And The Wheat Gluten

Should Be Destroyed.
Despite the independent, reliable sampling and testing conducted by the FDA,

ChemNutra continues to store its Wheat Gluten in three warehouses located in Missouri, New

Jersey and Pennsylvania. Miler, ir3.
The majority of ChemNutra's Wheat Gluten is being stored at MoKan Container Service,
Inc. located in Kansas City, Missouri, where there is over 277 metric tons of

Wheat Gluten.

ChemNutra incurs great expense and costs each month associated with the storage of this Wheat

Gluten. Miler irir 4, 10.
ChemNutra is also storing Wheat Gluten at the Steven Shannon Warehouse in
Bloomsburg, Pennsylvania. All of

the wheat gluten at this location comes from the XuZhou
the wheat

Batch Number 20070106. ChemNutra did not sell, distribute or supply any portion of

gluten from Batch Number 20070106 to any person or entity. Therefore, no pets would have

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been exposed to food containing ChemNutra supplied wheat gluten from this Batch number.

Miler, ir 7.
In addition, approximately 80 metric tons of Wheat Gluten are being stored by

ChemNutra at the Standard Warehouse and Distribution Co., Ltd. ("Standard Warehouse") in

Pennsauken, New Jersey. For over six months, Standard Warehouse has demanded that ChemNutra immediately remove its Wheat Gluten from this facility. As of July 1, 2008,
Standard Warehouse substantially increased its storage costs. These increased storage costs as
well as the on going storage costs for the Missouri and Pennsylvania facilities have been a severe
economic burden on ChemNutra.

In addition to the storage facility costs, if ChemNutra is required to continue its retention

of its Wheat Gluten, ChemNutra would be compelled to incur additional costs and great
expenses.

In light of the testing conducted by the FDA and the availability of such testing to the

Plaintiffs herein, this Court should weight ChemNutra's "economic considerations. . . to remain
faithful to its responsibilities to prevent 'undue burden and expense' to it. MePeek v. Asheroft
(D.D.C. 2001) 202 F.R.D. 31,34 (limiting additional discovery to a sampling or test ru of data

on backup tapes); see also Powell v. S. Jersey Marina, Ine. (M.D. Pa. Aug. 1,2007) No. 3:CV04-2611,2007 U.S. Dist. LEXIS 55849 at *18-20 (denying motion to compel deposition
testimony of defendant's president because plaintiffs already had discovery on the issue, holding
that the "benefit to (p )laintiffs' case appear( ed) non-existent"). Significantly, because there are

documents available detailing the sampling and testing conducted by the FDA, there remains no
good reason for ChemN utra to continue to incur the great expense and burden to continue to

store its Wheat Gluten and ChemNutra's Motion should be granted.
D. This Motion Is Supported By the FDA and the US Attorneys Offce

Neither the FDA's Office of Chief Counsel nor the US Attorneys office opposes
ChemNutra's Motion. Brazil, irir 5 and 6. Furher, it is agreed that if

this Court grants
its Wheat Gluten in

ChemNutra's Motion, ChemNutra wil implement the destruction of

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accordance with and under the supervision of

the FDA. Brazil, irir 2,5,6; see also Exhibits "C"

and "D" to Brazil Dec.; see also Miler, ir 12.

III. CONCLUSION
ChemNutra respectfully requests that this Court issue an Order allowing ChemNutra to destroy its XuZhou Anying Wheat Gluten in accordance with and under the supervision of the

FDA. A proposed Order is attached as Exhibit 1 to this Memorandum.

DATED: September-£ 2008

MORRIS POLICH & PURDY LLP

A TH NY G. BRAI " E Q.
KAREN M. FIRSTENBE G, ESQ. 1055 W. Seventh Street, 24th Floor Los Angeles, CA 90017
Telephone: [phone] Facsimile: [phone]

Email: abrazilêmpplaw.com kfirsstenbergêmplaw.com
Counsel for Defendant CHEMNUTRA INC.

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