IN RE: Cutter Laboratories, Inc., "Braunwald-Cutter" Aortic Heart Valve Products Liability Litigation

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LAR |
. MELT Le te Co
BEFORE THE JUDICIAL PANEL TER 28 RETRON ee - Co
. MULTIDISTRICT LITIGATION paTR LT an JemCLERS OF Tet LE
In re Cutter Laboratories, Inc. ) :
"Braunwald-Cutter" Aortic Heart ) Docket No. 367 .
Valve Products Liability Litigation)
OPINION AND ORDER IE
BEFORE MURRAY I. GURFEIN, CHAIRMAN, AND EDWIN A. ROBSON, Te
STANLEY A. WEIGEL, ANDREW A. CAFFREY, ROY W. HARPER, AND o
CHARLES R. WEINER, JUDGES OF THE PANEL.
PER CURIAM
This litigation presently consists of fifteen actions
pending in eleven districts as follows:
Northern District of California 3 actionsl/ oo :
Eastern District of New York 2 actions 0
Southern District of New York 2 actions
Northern District of Alabama 1 action ol
Northern District of Illinois 1 action
District of Kansas 1 action
Eastern District of Michigan 1 action
Western District of Michigan 1 action
Southern District of Mississippi 1 action
Northern District of New York 1 action
Eastern District of North Carolina 1 action
Cutter Laboratories, Inc. (Cutter) is the sole named
defendant in fourteen of the above actions and is co-defendant Co :
with its insurance company in the remaining action. The EE
plaintiffs in each action have all been users or spouses
of users of a certain model of prosthetic heart valve marketed,
until 1974, by Cutter under the trade name ''Braunwald-Cutter."
The valve involved in each of these actions was used in
the aortic position when implanted into a heart.
1/ These actions were originally filed in the Central District	of California and were subsequently transferred to the Northern
District of California pursuant to 28 U.S.C. §1404(a).

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2%, | Generally, the plaintiffs in these actions allege that :« J M CF oo
the valve users suffered severe injuries and/or death resulting
from defects in the valve that caused the valve to wear
out prematurely and to fail when used in the aortic position.
Specific injuries alleged include major embolic complications SE
arising from the premature wearing of the heart valve, premature DE
open heart surgery to replace the heart valve or certain oo
of its component parts, and catastrophic poppet (ball) escape
from the heart valve cage. Liability against Cutter in
J .
each of the fifteen actions is based, inter alia, on theories
of negligence in the design, manufacture, testing and sale : :
of the valve; breach of express and implied warranties; :
and/or strict liability in tort. |
Plaintiffs in the Illinois action move the Panel, pursuant
to 28 U.S.C. §1407, to transfer the thirteen actions pending
in districts other than the Eastern District of New York
to that district for coordinated or consolidated pretrial
proceedings with the two actions pending there.2/ Plaintiffs -
in ten additional actions either join in or support the RE
motion to centralize all actions in the Eastern District
77 In addition to these fifteen actions, an action in the :
Western District of Wisconsin had originally been included
in the motion to transfer. Trial of that action has been
concluded by a judgment in favor of the defendant. Also,
the Panel has been informed of five other filed or soon-to-be-
filed actions which are allegedly related to the actions
in this docket. Plaintiffs in three of these actions have
filed amicus pleadings in support of transfer. Because
of the Panel's disposition herein, these five actions will
be treated as potential tag-along actions. See Rule 10(d),
R.P.J.P.M.L., 78 F.R.D. 561, 568 (1978).

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of New York. Cutter and plaintiffs in the three California
actions oppose transfer. Alternatively, if the Panel finds
transfer under Section 1407 to be appropriate in this litigation,
Cutter favors selection of either the District of Minnesota
or the Northern District of Alabama as the transferee forum.
Plaintiffs in the California actions, in the event transfer
is ordered by the Panel, favor the Northern District of
California.
We find that these actions involve common questions
of fact and that their centralization under Section 1407
in the Eastern District of New York will best serve the
L convenience of the parties and witnesses and promote the
just and efficient conduct of the litigation.
Cutter argues that common questions of fact will not
predominate in this litigation. Cutter urges that discovery
on the issue of damages will be unique to each action and
that, with respect to the issue of causation, Cutter will
seek to establish that valve failure was patient related.
Thus Cutter maintains that discovery in each action will
focus on the following individual factors: the patient's
health and past medical history, the anti-coagulant therapy
administered after the valve implant, and local medical
practices. Cutter also urges that transfer in this litigation
C is unnecessary because most of the actions are proceeding

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expeditiously towards trial, with discovery completed or
nearly completed, and trial dates soon to be set, in several
actions. Finally, Cutter and plaintiffs in the California
actions argue that voluntary cooperation among the parties,
their counsel and the involved courts is a preferable alternative
to transfer under Section 1407.
We are persuaded that centralized pretrial proceedings
under Section 1407 are appropriate in this litigation.
Although we recognize that some individual factual questions
will be present in each action, an analysis of the record
before us reveals a commonality of factual questions concerning
the design, development, manufacture, testing and marketing Qo
of the Braunwald-Cutter valve; the state of medical knowledge
regarding heart valves; the causal relationship between
the use of the Braunwald-Cutter valve in the aortic position
and the severe injuries alleged to have resulted therefrom;
Cutter's knowledge of the allegedly defective condition |
of the valve; and the reasons behind Cutter's decision in
1974 to remove the valve from the market. Thus centralization
under Section 1407 is necessary in order to prevent duplication
of discovery and eliminate the possibility of conflicting
pretrial rulings. Any discovery unique to a particular
party, action or claim can be scheduled by the transferee
judge to proceed concurrently with the common discovery, _
thus enhancing the efficient conduct of the litigation. o
See In re A.H. Robins Co., Inc. '"Dalkon Shield" IUD Products
Liability Litigation, 406 F.Supp. 540, 542 (J.P.M.L. 1975).

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® ooWhile voluntary cooperation among parties and their counsel
is always commendable, transfer under Section 1407 will
result in the assignment of all actions to a single judge
who will be in the best position to determine the manner
and extent of coordination or consolidation of the pretrial
proceedings for the optimum conduct of the litigation as
a whole. See In re Commonwealth 0il/Tesoro Petroleum Securities
Litigation, 458 F.Supp. 225, 229 (J.P.M.L. 1978).
Some parties have suggested that certain actions are
sufficiently advanced to warrant their exclusion from transfer.
All actions, of course, are not at the same stage of discovery,
but based on the information before us, we conclude that
C all actions in this litigation will benefit from centralized
pretrial proceedings under Section 1407. We observe that
if and when an action or claim is, in fact, ready for trial
"or otherwise ready for remand because the transferee judge
finds that the Section 1407 proceedings pertaining to that
action or claim are completed, the transferee judge may
suggest to the Panel that the Panel remand the action or
claim to its transferor court. 28 U.S.C. $§1407(a); Rule
11(c) (ii), R.P.J.P.M.L., 78 F.R.D. 561, 569 (1978). See,
e.g., In re A.H. Robins Co., Inc. "Dalkon Shield" IUD Products
Liability Litigation, 453 F.Supp. 108 (J.P.M.L. 1978).
Also, any discovery heretofore completed in any action may
be made applicable to all actions by utilizing the procedures
@® recommended in the Manual for Complex Litigation, Parts
I and II, §§3.11 (rev. ed. 1977).

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Plaintiffs in the California actions favor selection
of the Northern District of California as the transferee
forum on the ground that many relevant witnesses and documents
will be found in that district because Cutter's main offices
are located there. Cutter, in urging selection of either
the District of Minnesota or the Northern District of Alabama
as the transferee forum, maintains that, of the total number
of Braunwald-Cutter valve implantations in the United States,
nearly 30 percent occurred in the District of Minnesota
at either the Mayo Clinic or the University of Minnesota,
and nearly 25 percent occurred in the Northern District
of Alabama at the University of Alabama. Cutter argues, o
therefore, that a substantial number of medical witnesses
and documents regarding both individual valve implantations
and expert opinion about the Braunwald-Cutter valve will
be found in those two districts.
Though any of the forums that have been suggested by
the parties could be described as an appropriate transferee
forum for this litigation, on balance, we are persuaded
that the Eastern District of New York is the preferable
forum.
Pretrial proceedings in the actions in the Eastern
District of New York are relatively advanced in comparison
to the status of other actions before the Panel. Counsel
in the Eastern District of New York actions has represented ®
to us that he has already assembled massive documentary

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materials in that district including all of Cutter's files
on the Braunwald-Cutter valve, Food and Drug Administration
(FDA) records concerning FDA's investigation of the Braunwald-
Cutter valve, and extensive deposition transcripts from
Cutter employees, Dr. Nina Braunwald and other expert medical
witnesses.
Furthermore, the Honorable Jack B. Weinstein, to whom
we are assigning this litigation, has already supervised
the trial of three product liability actions that involved
the "Wada-Cutter' prosthetic heart valve, another type of
heart valve manufactured by Cutter. Proponents of transfer
C have represented, and no party has refuted, that those threeactions shared many complex technical and medical questions
with the actions now before us. As a result of the expertise
developed by Judge Weinstein from presiding over those three
actions, as well as from the Braunwald-Cutter actions now
before him, Judge Weinstein will be in the best position
to supervise the pretrial proceedings in this litigation
toward their just and expeditious termination. See In re
Griseofulvin Antitrust Litigation, 375 F. Supp. 1402, 1403
(J.P.M.L. 1975). We note also that a majority of the parties
favor selection of the Eastern District of New York as the
transferee forum. See In re Wiring Device Antitrust Litigation,
444 F. Supp. 1348, 1351 (J.P.M.L. 1978).
¢ IT IS THEREFORE ORDERED that, pursuant to 28 U.S.C.

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§1407, the actions listed on the following Schedule A and
pending in districts other than the Eastern District of
New York be, and the same hereby are, transferred to the
Eastern District of New York and, with the consent of that
court, assigned to the Honorable Jack B. Weinstein for co-
ordinated or consolidated pretrial proceedings with the
actions pending there.
®
®

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SCHEDULE A MDL-367
NORTHERN DISTRICT OF ALABAMA
Jo Ann Crabtree v. Cutter Laboratories, Civil Action
NORTHERN DISTRICT OF CALIFORNIA
William Carl Glover v. Cutter Civil Action
Laboratories, Inc. No. C79-0242-SW.
Gary Lynn Wood v. Cutter Laboratories, Civil Action
inc. No. C79-0242-WHO
Hugh Ray Jeter v. Cutter Laboratories. Civil Action
Inc. No. C79-0243-1LHB
NORTHERN DISTRICT OFILLINOIS
CJ Donald Dodson and Claire Dodson Vv. Civil ActionCutter Laboratories, Inc. No. 76-C-3542
DISTRICT OF KANSAS
Eunice McFayden v. Cutter Laboratories, Civil Action
Inc. No. 78-2118
EASTERN DISTRICT OF MICHIGAN
Frank Beznos and Gladys Beznos V. Civil Action
Cutter Laboratories, Inc. No. 77-1494
WESTERN DISTRICT OF MICHIGAN
Phillip D. Symons and Mildred Symons Civil Action
v. Cutter Laboratories, Inc. No. M-76-79
SOUTHERN DISTRICT	OF MISSISSIPPI
Nancy Sue Young v. Cutter Laboratories, Civil Action
® Inc. No. S-78-0042(N)

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Schedule A -- p.2 ®
EASTERN DISTRICT OF NEW YORK
Natale P. and Speranza Menna v. Cutter Civil Action
Laboratories, Inc. No. 77-Civ-2361
Tess Scura and Cosmo Scura v. Cutter Civil Action
Laboratories, Inc. No. 77-Civ-2359
NORTHERN DISTRICT OF NEW YORK
Calvin DeLorimiere and Shirley Civil Action
Delorimiere v. Cutter Laboratories, Inc. No, 78-Cv-45
SOUTHERN DISTRICT OF NEW YORK
Gerald Weintraub and Anne Weintraub Civil Action
v. Cutter Laboratories No. 78-CIiv-2789
Max Lesch v. Cutter Laboratories, Civil Action
Inc. No. 78-CIV-1790
EASTERN DISTRICT OF NORTH CAROLINA
Dorothy Gibbs and Windley Gibbs v. Civil Action
Travelers Indemnity Co., et al. No. 78-68~-CIV-4