Wendell et al v. Johnson & Johnson et al
Filing
368
ORDER GRANTING 319 MOTION FOR SUMMARY JUDGMENT; DENYING 355 MOTION FOR LEAVE TO FILE MOTION FOR RECONSIDERATION. ***Civil Case Terminated.*** Signed by Judge Claudia Wilken on 6/30/2014. (ndr, COURT STAFF) (Filed on 6/30/2014)
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IN THE UNITED STATES DISTRICT COURT
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FOR THE NORTHERN DISTRICT OF CALIFORNIA
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STEPHEN WENDELL, et al.,
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Plaintiffs,
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v.
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JOHNSON & JOHNSON, et al.,
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Defendants.
________________________________/
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United States District Court
For the Northern District of California
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ORDER GRANTING
MOTION FOR SUMMARY
JUDGMENT; DENYING
MOTION FOR LEAVE
TO FILE MOTION FOR
RECONSIDERATION
(Docket Nos. 257,
319, 355)
Plaintiffs Stephen and Lisa Wendell brought this action as
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No. C 09-4124 CW
successors-in-interest to their deceased son, Maxx Wendell.
They
asserted claims for negligence and strict liability against
Defendants Johnson & Johnson, Centocor, Inc., Abbott Laboratories,
Teva Pharmaceuticals USA, GlaxoSmithKline, and Par Pharmaceutical,
Inc.
1
In January 2014, Defendants Johnson & Johnson, Centocor,
Abbott Labs, and Teva moved jointly for summary judgment on all
claims against them; however, shortly after the Court took this
motion under submission, Plaintiffs reached a settlement in
principle of their claims against Johnson & Johnson, Centocor, and
Abbott Labs.
June 2014.
The parties finalized their settlement agreements in
As a result, Teva is now the only Defendant remaining
in this action and the only party still seeking summary judgment.
Plaintiffs oppose Teva’s motion for summary judgment.
After
considering the parties’ submissions and oral argument, the Court
grants the motion.
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1
27
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Plaintiffs also initially brought suit against Gate
Pharmaceuticals. However, because Gate is merely a division of Teva,
rather than a separate entity, the Court construes the claims against
Gate as claims against Teva.
1
BACKGROUND
2
The following facts are undisputed except where otherwise
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noted.
Maxx Wendell was diagnosed with inflammatory bowel disease
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(IBD) in 1998 when he was twelve years old.
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began receiving treatment from Dr. Edward Rich, a pediatric
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gastroenterologist, at Kaiser Permanente in San Francisco,
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California.
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Soon afterward, he
In June 1999, Dr. Rich prescribed a six-mercaptopurine (6MP)
United States District Court
For the Northern District of California
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drug to treat Maxx’s IBD.
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GlaxoSmithKline, then known as SmithKline Beecham, and marketed
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under the brand name Purinethol.
The drug was manufactured by
13
Three years later, in July 2002, while Maxx was still taking
14
Purinethol, Dr. Rich prescribed him an anti-tumor necrosis factor
15
(anti-TNF) drug called Remicade, which was manufactured, marketed,
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and distributed by Centocor.
17
In July 2003, GlaxoSmithKline sold its distribution rights
18
for Purinethol to Teva and ceased distributing the drug.
19
continued to take the Teva-distributed Purinethol until July 2004
20
when he switched to a generic 6MP drug distributed by Par
21
Pharmaceutical, Inc.
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until April 2007.
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Maxx
Maxx continued to take the generic 6MP drug
In May 2006, after Maxx’s IBD symptoms had subsided, Dr. Rich
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directed Maxx to stop taking Remicade.
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after Maxx’s symptoms returned, Dr. Rich prescribed him another
26
anti-TNF drug called Humira.
27
is manufactured, marketed, and distributed by Abbott Labs, until
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June 2007.
In November 2006, however,
Maxx continued to take Humira, which
2
1
One month later, in July 2007, Maxx was diagnosed with a
2
rare, incurable, and aggressive form of cancer known as
3
hepatosplenic T-cell lymphoma (HSTCL).
4
2007 at the age of twenty-one.
5
He passed away in December
Plaintiffs initiated the present lawsuit in July 2009 and
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filed their fourth amended complaint (4AC) in April 2011.
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No. 165, 4AC.
8
HSTCL as a result of taking the combination of drugs that he was
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prescribed between 2002 and 2007 -- specifically, the combination
Docket
In their 4AC, they alleged that Maxx had developed
United States District Court
For the Northern District of California
10
of 6MP and anti-TNF drugs.
11
manufacturers and distributors of those drugs failed to issue
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adequate warnings about the risks associated with taking 6MP drugs
13
in combination with anti-TNF drugs.
14
California law for negligence and strict liability against Johnson
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& Johnson, Centocor, Abbott Labs, GlaxoSmithKline, Par, and Teva.
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4AC ¶¶ 62-101.
17
Plaintiffs further alleged that the
They asserted claims under
In 2011, Defendants Abbott Labs, GlaxoSmithKline, Teva, and
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Par moved for summary judgment.
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December 2011, finding that Plaintiffs had failed to produce
20
sufficient evidence to support an inference that different warning
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labels would have changed Dr. Rich’s decision to prescribe the
22
specific combination of drugs at issue in this case.
23
based its decision, in part, on the undisputed evidence “that Dr.
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Rich was already aware of the risk of lymphomas associated with 6–
25
MP, but still chose to prescribe the drug” to Maxx in combination
26
with an anti-TNF drug.
27
Order, at 15.
The Court granted the motion in
The Court
Docket No. 204, Dec. 2011 Summary Judgment
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3
Plaintiffs subsequently moved for reconsideration of the
2
December 2011 ruling after they discovered new evidence suggesting
3
that Dr. Rich may not have known about the risks associated with
4
these drugs before prescribing them.
5
the Court granted Plaintiffs’ motion for reconsideration and
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withdrew its December 2011 summary judgment order.
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after reviewing Plaintiffs’ new evidence, the Court denied Teva’s,
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Par’s, and Abbott Labs’ motions for summary judgment.
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granted summary judgment to GlaxoSmithKline, however, because it
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United States District Court
For the Northern District of California
1
found that Plaintiffs had presented “insufficient evidence for a
11
reasonable jury to find that, before July 1, 2003 when
12
[GlaxoSmithKline] discontinued distribution of Purinethol, it had
13
a duty to warn of the risk of hepatosplenic T-cell lymphoma.”
14
Docket No. 232, July 2012 Summary Judgment Order, at 27.
15
later, the Court granted Par’s unopposed motion for summary
16
judgment.
17
Based on this new evidence,
In July 2012,
The Court
One year
Docket No. 293, May 2013 Summary Judgment Order, at 1.
In January 2014, the four remaining Defendants -- Johnson &
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Johnson, Centocor, Abbott Labs, and Teva -- filed the instant
19
motion for summary judgment.
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subsequently settled their claims against all of these Defendants
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other than Teva.
As noted above, Plaintiffs
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LEGAL STANDARD
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Summary judgment is properly granted when no genuine and
24
disputed issues of material fact remain, and when, viewing the
25
evidence most favorably to the non-moving party, the movant is
26
clearly entitled to prevail as a matter of law.
27
P. 56; Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986);
28
4
Fed. R. Civ.
1
Eisenberg v. Ins. Co. of N. Am., 815 F.2d 1285, 1288-89 (9th Cir.
2
1987).
3
The moving party bears the burden of showing that there is no
4
material factual dispute.
5
true the opposing party’s evidence, if supported by affidavits or
6
other evidentiary material.
7
815 F.2d at 1289.
8
in favor of the party against whom summary judgment is sought.
9
Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574,
Therefore, the court must regard as
Celotex, 477 U.S. at 324; Eisenberg,
The court must draw all reasonable inferences
United States District Court
For the Northern District of California
10
587 (1986); Intel Corp. v. Hartford Accident & Indem. Co., 952
11
F.2d 1551, 1558 (9th Cir. 1991).
12
Material facts which would preclude entry of summary judgment
13
are those which, under applicable substantive law, may affect the
14
outcome of the case.
The substantive law will identify which
15
facts are material.
Anderson v. Liberty Lobby, Inc., 477 U.S.
16
242, 248 (1986).
17
of proof on an issue at trial, the moving party may discharge its
18
burden of production by either of two methods:
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20
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23
24
25
26
27
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Where the moving party does not bear the burden
The moving party may produce evidence negating
an essential element of the nonmoving party’s
case, or, after suitable discovery, the moving
party may show that the nonmoving party does
not have enough evidence of an essential
element of its claim or defense to carry its
ultimate burden of persuasion at trial.
Nissan Fire & Marine Ins. Co., Ltd., v. Fritz Cos., Inc., 210 F.3d
1099, 1106 (9th Cir. 2000).
If the moving party discharges its burden by showing an
absence of evidence to support an essential element of a claim or
defense, it is not required to produce evidence showing the
5
1
absence of a material fact on such issues, or to support its
2
motion with evidence negating the non-moving party’s claim.
3
see also Lujan v. Nat’l Wildlife Fed’n, 497 U.S. 871, 885 (1990);
4
Bhan v. NME Hosps., Inc., 929 F.2d 1404, 1409 (9th Cir. 1991).
5
the moving party shows an absence of evidence to support the non-
6
moving party’s case, the burden then shifts to the non-moving
7
party to produce “specific evidence, through affidavits or
8
admissible discovery material, to show that the dispute exists.”
9
Bhan, 929 F.2d at 1409.
United States District Court
For the Northern District of California
10
Id.;
If
If the moving party discharges its burden by negating an
11
essential element of the non-moving party’s claim or defense, it
12
must produce affirmative evidence of such negation.
13
F.3d at 1105.
14
burden then shifts to the non-moving party to produce specific
15
evidence to show that a dispute of material fact exists.
16
Nissan, 210
If the moving party produces such evidence, the
Id.
If the moving party does not meet its initial burden of
17
production by either method, the non-moving party is under no
18
obligation to offer any evidence in support of its opposition.
19
Id.
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ultimate burden of persuasion at trial.
This is true even though the non-moving party bears the
21
22
Id. at 1107.
DISCUSSION
As previously noted, Plaintiffs assert claims against Teva
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for negligence and strict liability.
24
claims must fail because Plaintiffs have failed to present
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sufficient evidence to support an inference that Purinethol,
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either alone or in combination with anti-TNF drugs, caused Maxx to
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develop HSTCL.
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sufficient evidence to support an inference that it had a duty to
Teva contends that these
Teva further contends that Plaintiffs lack
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1
warn about the risks associated with taking Purinethol.
2
these arguments is addressed separately below.
Each of
3
A.
4
“An essential element in claims for product strict liability
Causation
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and negligence is causation.”
6
1160486, at *5 (S.D. Cal.).
7
she was personally injured by a pharmaceutical product must
8
“establish that the substance at issue was capable of causing the
9
injury alleged (general causation), and that the substance caused,
Cox v. Depuy Motech, Inc., 2000 WL
Thus, a plaintiff claiming that he or
United States District Court
For the Northern District of California
10
or was a substantial factor in causing, the specific plaintiff’s
11
injury (specific causation).”
12
Trust, 633 F.3d 828, 836 (9th Cir. 2011).
13
“‘causation must be proven within a reasonable medical probability
14
based upon competent expert testimony.’”
15
Ortho Pharmaceutical Corp., 163 Cal. App. 3d 396, 402 (1985)).
16
Avila v. Willits Envtl. Remediation
Under California law,
Id. (citing Jones v.
Here, Plaintiffs rely on the opinions of two experts to show
17
causation: Drs. Dennis Weisenburger and Andrei Shustov.2
18
Weisenburger and Shustov are both medical doctors who opined in
19
their expert reports that the combination of 6MP drugs and anti-
20
TNF drugs prescribed to Maxx increased his likelihood of
21
developing HSTCL and, ultimately, caused his death.
22
opinions are not based on sufficiently reliable scientific data,
23
they are not admissible under Federal Rule of Evidence 702 and do
24
not support an inference of causation.
Drs.
Because these
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26
27
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2
Because Plaintiffs’ third expert, Dr. David Ross, has not offered
any opinions on causation, the Court does not discuss the admissibility
of his opinions here. See Docket No. 337, Pls.’ Opp. 24 (“Plaintiffs
are not, however, offering Dr. Ross as a medical causation expert, but
as an expert on the FDA’s regulatory requirements.”).
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1
2
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Rule 702 permits an expert to offer opinion testimony on a
subject if
(a)
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(b)
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(c)
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(d)
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the expert’s scientific, technical, or
other specialized knowledge will help the
trier of fact to understand the evidence
or to determine a fact in issue;
the testimony is based on sufficient facts
or data;
the testimony is the product of reliable
principles and methods; and
the expert has reliably applied the
principles and methods to the facts of the
case.
Fed. R. Evid. 702.
In short, expert opinion testimony is only
United States District Court
For the Northern District of California
10
admissible if the opinion the expert seeks to offer is both
11
relevant and reliable.
12
509 U.S. 579, 589 (1993) (Daubert I); Kumho Tire Co., Ltd. v.
13
Carmichael, 526 U.S. 137, 141 (1999).
14
dispute that the opinions of Drs. Weisenburger and Shustov are
15
relevant here, it contends that they are not reliable.
16
Daubert v. Merrell Dow Pharmaceuticals,
Although Teva does not
To evaluate the reliability of expert opinion testimony, a
17
court must consider the factors set out in Daubert I, which
18
include “whether the theory or technique in question can be (and
19
has been) tested, whether it has been subjected to peer review and
20
publication, its known or potential error rate and the existence
21
and maintenance of standards controlling its operation, and
22
whether it has attracted widespread acceptance within a relevant
23
scientific community.”
24
reliability is ‘flexible,’ and Daubert’s list of specific factors
25
neither necessarily nor exclusively applies to all experts or in
26
every case.”
27
The focus, in other words, “must be solely on principles and
509 U.S. at 593–94.
The “test of
Kumho Tire, 526 U.S. at 141 (citations omitted).
28
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1
methodology, not on the conclusions that they generate.”
2
I, 509 U.S. at 595.
3
Daubert
The opinions of Drs. Weisenburger and Shustov do not meet
4
this standard.
5
independent research or published any studies on the specific
6
relationship between 6MP and anti-TNF drugs and the development of
7
HSTCL.
8
that their opinions on this subject were based on a reasonable
9
degree of medical certainty, they also conceded that their
First, neither doctor has ever conducted any
Although both conclusorily stated during their depositions
United States District Court
For the Northern District of California
10
opinions would not satisfy the standards required for publication
11
in peer-reviewed medical journals.
12
Weisenburger was asked whether his opinions in this case would be
13
publishable in a medical article, he replied that the standard for
14
publication would “probably be more rigorous” than the standard he
15
applied in forming his opinions.
16
4, Weisenburger Depo. 118:22-119:4.
17
testified that he would not be comfortable publishing his opinions
18
in this case regarding the alleged causal link between 6MP and
19
anti-TNF drugs and HSTCL.
20
The fact that both of Plaintiffs’ causation experts are reluctant
21
to publish their opinions -- and appear to have developed their
22
opinions specifically for the purposes of this litigation -- casts
23
doubt the reliability of their methodologies under Rule 702.
24
Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311, 1317 (9th Cir.
25
1995) (Daubert II) (“One very significant fact to be considered
26
[under Rule 702] is whether the experts are proposing to testify
27
about matters growing naturally and directly out of research they
For instance, when Dr.
See Docket No. 320, Defs.’ Ex.
Similarly, Dr. Shustov
Defs.’ Ex. 6, Shustov Depo. 74:4-75:9.
28
9
See
1
have conducted independent of the litigation, or whether they have
2
developed their opinions expressly for purposes of testifying.”).
3
So, too, does their failure to identify any animal studies or
4
epidemiological studies showing a causal link between HSTCL and
5
the combination of 6MP and anti-TNF drugs prescribed to Maxx.
6
Plaintiffs admit that they have not identified any such studies,
7
arguing instead that such studies are impossible to conduct
8
because HSTCL is an “exceedingly rare” disease.
9
349, March 13, 2014 Hrg. Tr. 16:18-:22 (“If it were possible to do
See Docket No.
United States District Court
For the Northern District of California
10
the kind of epidemiological study that the Defendants insist is
11
required here, that would have been done a long time ago.
12
has done it.”).
13
however, does not relieve Plaintiffs of their obligation to
14
present evidence of causation.
15
is especially important here in light of the fact that more than
16
seventy percent of observed HSTCL cases are idiopathic, meaning
17
that they have no known cause.
18
Shustov Depo. 106:5-:24.
19
cases, Plaintiffs cannot reasonably eliminate other potential
20
causes of Maxx’s HSTCL without some reliable evidence of a
21
positive link between the drugs at issue and the disease.
22
II, 43 F.3d at 1319 (finding expert testimony inadmissible under
23
Rule 702 where expert offered “no tested or testable theory to
24
explain how, from [] limited information, he was able to eliminate
25
all other potential causes”).
26
Nobody
The difficulty of conducting these studies,
Indeed, the need for such evidence
Weisenburger Depo. 174:4-:15;
Given this high rate of idiopathic
Daubert
This is precisely why courts often exclude expert medical
27
testimony under Rule 702 when the expert fails to cite any
28
specific epidemiological studies suggesting that a given drug
10
1
caused a disease with a high rate of idiopathic cases.
2
v. Wyeth-Ayerst Labs., for instance, this Court excluded the
3
testimony of a medical expert under Rule 702 because his testimony
4
was not based on reliable epidemiological evidence and failed to
5
“eliminate all other potential causes” of the plaintiff’s
6
condition.
7
(9th Cir. 1998).
8
rule out other possible causes of the plaintiff’s Guillain–Barre
9
Syndrome (GBS) was “particularly troubling in light of [the
In Lopez
1996 WL 784566, at *3 (N.D. Cal.), aff’d, 139 F.3d 905
The Court found that the expert’s failure to
United States District Court
For the Northern District of California
10
expert]’s statement that 30 to 40% of the GBS cases have
11
idiopathic or unknown causes.”
12
noted that the defendant’s expert had presented “uncontroverted
13
testimony that there has been no epidemiological study showing
14
increased incidence of GBS in persons receiving a non-swine flu
15
vaccine,” like the one that the plaintiff alleged had caused him
16
to develop GBS.
17
present case from Lopez nor from any of the other cases where
18
courts have excluded expert medical evidence under Rule 702 for
19
failing to eliminate potential alternative causes of the
20
plaintiff’s harm.3
21
605 F. Supp. 2d 1142, 1163 (E.D. Wash. 2009) (“[B]ecause [the
22
expert]’s methodology employed fails to adequately account for the
23
possibility that [plaintiff]’s AML was idiopathic, the court finds
24
that his conclusion that prolonged exposure to benzene in gasoline
25
was the cause of his AML is unreliable and therefore
Id.
Id.
The Court also specifically
Plaintiffs have not distinguished the
See, e.g., Henricksen v. ConocoPhillips Co.,
26
3
27
28
Plaintiffs failed to discuss Lopez in their briefs and, when
asked to distinguish the case at the hearing, noted simply that Lopez
was decided “a long time ago.” March 13, 2014 Hrg. Tr. 35:3-:13. This
is not a relevant distinction.
11
1
inadmissible.”); Soldo v. Sandoz Pharm. Corp., 244 F. Supp. 2d
2
434, 567 (W.D. Pa. 2003) (excluding expert testimony under Rule
3
702 because it did not “reliably rule out reasonable alternative
4
causes of [the plaintiff’s condition] or idiopathic causes”).
5
Although Plaintiffs cite a handful of studies and case
6
reports discussing possible causes of HSTCL, none of these
7
purports to show that the specific combination of drugs prescribed
8
to Maxx actually causes HSTCL.
9
of which are actually cited in Plaintiffs’ expert reports
Rather, the studies -- only some
4
--
United States District Court
For the Northern District of California
10
contain statistics about the incidence of HSTCL among different
11
patient populations, including patients with IBD.
12
contend that these statistics, viewed as a whole, show that
13
patients exposed to a combination of 6MP and anti-TNF drugs are
14
more likely to develop HSTCL than other patients.
15
Plaintiffs have not shown that all of the observed differences in
16
these incidence rates are statistically significant or that they
17
account for plausible alternative causes of HSTCL, such as IBD
18
itself.
19
deposition that the studies he reviewed failed to control for IBD
20
as a possible risk factor.
21
he and Dr. Weisenberger both stated that they do not believe IBD
22
is a risk factor for HSTCL, they have not presented any scientific
23
evidence to support that opinion.
24
Inc., 167 F.3d 146, 156 (3d Cir. 1999) (“‘[W]here a defendant
25
points to a plausible alternative cause and the doctor offers no
Plaintiffs
However,
Indeed, Dr. Shustov himself acknowledged during his
Shustov Depo. 25:19-26:12.
Although
See Heller v. Shaw Indus.,
26
27
28
4
Neither Dr. Weisenberger nor Dr. Shustov appears to have cited
the 2010 letter-to-the-editor written by David Kotlyar et al. or the
2013 article written by Prakkal Deepak et al.
12
1
explanation for why he or she has concluded that was not the sole
2
cause, that doctor’s methodology is unreliable.’” (quoting In re
3
Paoli Railroad Yard PCB Litig., 35 F.3d 717, 759 n.27 (3d Cir.
4
1994))); Casey v. Ohio Med. Products, 877 F. Supp. 1380, 1385
5
(N.D. Cal. 1995) (explaining that “case reports are not reliable
6
scientific evidence of causation, because they simply describe[]
7
reported phenomena without comparison to the rate at which the
8
phenomena occur in the general population or in a defined control
9
group” and “do not isolate and exclude potentially alternative
United States District Court
For the Northern District of California
10
11
causes”).
In sum, the opinions of Drs. Weisenburger and Shustov do not
12
provide sufficiently reliable evidence of causation and must be
13
excluded under Rule 702.
14
admissible evidence sufficient to support an inference of “a
15
reasonable causal connection” between the combination of
16
Purinethol and anti-TNF drugs and the development of Maxx’s HSTCL.
17
Jones, 163 Cal. App. 3d at 399, 402 (recognizing that causation
18
“must be proven within a reasonable medical probability based upon
19
competent expert testimony” and that “[m]ere possibility alone is
20
insufficient to establish a prima facie case”); see also Avila,
21
633 F.3d at 836 (quoting same).
22
summary judgment on all of Plaintiffs’ remaining claims against it
23
for negligence and strict liability.
Plaintiffs have not presented any other
Accordingly, Teva is entitled to
24
B.
25
Plaintiffs’ failure to produce any admissible evidence of
Duty to Warn
26
causation is sufficient to preclude them from prevailing on any of
27
their claims under a failure-to-warn theory.
28
Searle & Co., 35 Cal. 3d 691, 701 (1984) (“The strength of the
13
See Finn v. G. D.
1
causal link thus is relevant both to the issue of whether a
2
warning should be given at all, and, if one is required, what form
3
it should take.”).
4
on Plaintiffs’ claims under this theory for another, independent
5
reason: specifically, because they have not adduced any evidence
6
to suggest that Dr. Rich actually relied on Teva’s warning labels
7
before prescribing Purinethol to Maxx.
8
9
But Teva is also entitled to summary judgment
Dr. Rich testified during his deposition that he cannot
recall reading the Purinethol label in making his decision to
United States District Court
For the Northern District of California
10
prescribe the drug and that it is “not [his] regular practice to
11
look at drug labeling.”
12
283:13-:15 (“I don’t remember specifically reading the label for
13
Purinethol 6-MP or generic [sic] at any particular time.”).
14
Plaintiffs have not identified any evidence to contradict this
15
testimony or otherwise suggest that Dr. Rich actually relied on
16
the Purinethol warning label.
17
their negligence claim under a failure-to-warn theory.
18
Wyeth, Inc., 168 Cal. App. 4th 89, 112 (2008) (“There can be no
19
proximate cause where, as in this case, the prescribing physician
20
did not read or rely upon the allegedly inadequate warnings
21
promulgated by a defendant about a product.”); Motus v. Pfizer
22
Inc., 358 F.3d 659, 661 (9th Cir. 2004) (“Because the doctor
23
testified that he did not read the warning label that accompanied
24
Zoloft or rely on information provided by Pfizer’s detail men
25
before prescribing the drug to [plaintiff], the adequacy of
26
Pfizer’s warnings is irrelevant to the disposition of this
27
case.”).
28
against Teva for negligent misrepresentation, that claim fails for
Defs.’ Ex. 1, Rich Depo. 192:6-:7; id.
Accordingly, they cannot prevail on
Conte v.
To the extent that Plaintiffs have asserted a claim
14
1
the same reason.
2
Partners, LLC, 158 Cal. App. 4th 226, 243 (2007) (recognizing that
3
one of the “elements of negligent misrepresentation” is
4
“justifiable reliance on the misrepresentation”).
5
therefore entitled to summary judgment on all of Plaintiffs’
6
claims based on a failure-to-warn theory.
Apollo Capital Fund, LLC v. Roth Capital
7
8
9
5
Teva is
CONCLUSION
For the reasons set forth above, Teva’s motion for summary
judgment (Docket No. 319) is GRANTED.
Plaintiffs’ request to
United States District Court
For the Northern District of California
10
strike the supplemental declarations of Teva’s experts, Drs.
11
Robert Valuck and Andrew Place, is DENIED as moot as the Court did
12
not rely on either of these supplemental declarations in reaching
13
its decision.
14
In addition, Plaintiffs’ motion for leave to file
15
supplemental material (Docket No. 355) is DENIED.
16
failed to establish that the March 2014 statements and documents
17
issued by Health Canada and Teva Canada, neither of which is a
18
party in this action, are admissible.
19
statements and documents were admissible, they would not alter the
20
outcome of this case.
21
government under an unidentified regulatory standard is not
22
sufficient to support an inference of causation here, particularly
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when the warning notice only pertains to Purinethol, rather than
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the full combination of drugs at issue in this case.
Plaintiffs have
Furthermore, even if the
A warning notice issued by a foreign
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Plaintiffs conceded at the hearing that they cannot prevail on
their strict liability claims against Teva under a failure-to-warn
theory. March 13, 2014 Hrg. Tr. 50:24-:25 (Plaintiffs’ Counsel: “What I
agree is we can’t hold Teva liable under strict liab[ility].”).
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Finally, Plaintiffs’ motion for leave to file a motion for
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reconsideration of the Court’s July 2012 order granting summary
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judgment to GlaxoSmithKline (Docket No. 257) is DENIED as moot.
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Plaintiffs cannot prevail on their claims against GlaxoSmithKline
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for the same reasons they cannot prevail on their claims against
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Teva: once again, they have not presented sufficient evidence to
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support an inference of (1) a causal link between the combination
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of 6MP and anti-TNF drugs and HSTCL; nor (2) actual reliance by
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Dr. Rich on the warning label for Purinethol.
Maxx’s untimely
United States District Court
For the Northern District of California
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death was tragic but, without this evidence, Teva cannot be held
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liable as its cause.
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The clerk shall close the file and the parties shall bear
their own costs.
IT IS SO ORDERED.
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Dated: 6/30/2014
CLAUDIA WILKEN
United States District Judge
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