Wendell et al v. Johnson & Johnson et al
Filing
204
ORDER by Judge Claudia Wilken GRANTING 177 , 179 , 183 , 185 MOTIONS FOR SUMMARY JUDGMENT. (ndr, COURT STAFF) (Filed on 12/15/2011)
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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 and LISA WENDELL,
as successors in interest to MAXX
WENDELL, deceased,
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United States District Court
For the Northern District of California
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Plaintiffs,
v.
No. C 09-04124 CW
ORDER GRANTING
MOTIONS FOR
SUMMARY JUDGMENT
(Docket Nos. 177,
179, 183 and 185)
JOHNSON & JOHNSON; CENTOCOR,
INC.; ABBOTT LABORATORIES;
SMITHKLINE BEECHAM d/b/a
GLAXOSMITHKLINE; TEVA
PHARMACEUTICALS USA; GATE
PHARMACEUTICALS, a division of
TEVA PHARMACEUTICALS USA; PAR
PHARMACEUTICAL, INC.,
Defendants.
________________________________/
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This is a pharmaceutical product liability case in which
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Plaintiffs Stephen and Lisa Wendell have sued as successors-in-
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interest to their son, Maxx Wendell, the decedent.
20
allege claims for negligence and strict liability, asserting that
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Defendants Abbott Laboratories, GlaxoSmithKline LLC (GSK),1 TEVA
The Wendells
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Pharmaceuticals USA, Gate Pharmaceuticals, a division of TEVA
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24
Pharmaceuticals, and PAR Pharmaceuticals, Inc. failed adequately
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to warn about certain risks posed by their products, specifically
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two prescription drugs: Humira and mercaptopurine (also known as
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28
1
GSK was formerly known as and erroneously served and sued
in this action as SmithKline Beecham d/b/a GlaxoSmithKline.
1
6-mercaptopurine, 6-MP and Purinethol).
2
each separately moved for summary judgment, arguing that the
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Wendells cannot show evidence of proximate causation necessary to
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establish liability for failure to warn.
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183 and 185.
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These Defendants have
Docket Nos. 177, 179,
Having considered all of the parties' submissions
and oral argument, the Court GRANTS the motions.
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BACKGROUND
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Abbott is the alleged manufacturer, marketer and distributor
United States District Court
For the Northern District of California
10
of Humira in California.
GSK and TEVA are purportedly the
11
manufacturers, and the California marketers and distributors of 6-
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MP, sold under the brand name Purinethol.
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manufacturer, marketer and distributor of 6-MP in California.
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Wendells have also sued Johnson & Johnson and its wholly owned
PAR is allegedly a
The
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subsidiary, Centocor, Inc., both of which are allegedly involved
16
in the manufacture, marketing, sale and distribution of Remicade.
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18
Johnson & Johnson and Centocor have not moved for summary
19
judgment.
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In the fall of 1998, Maxx was diagnosed with inflammatory
21
bowel disease (IBD), and began receiving treatment from Dr. Edward
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Rich, a pediatric gastroenterologist at Kaiser Permanente in San
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Francisco.
Rich Dep. at 50:5-10, 59:22-60:1, 74:23-25.2
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26
27
28
Dr. Rich testified that it was not his "regular practice to
look at drug labeling."
Id. at 192:6-7.
2
He received information
The complete transcript of the deposition is located at
Docket No. 199.
2
1
on medications from multiple sources, including meetings, other
2
professionals in the field, articles and occasional meetings with
3
drug representatives.
4
I'm looking at drug labeling or the PDR in medicines that I'm less
5
familiar with."
6
Id. at 192:7-14.
He explained, "Generally
Dr. Rich could not remember whether he ever
relied on labeling information for 6-MP before prescribing it to
7
patients.
Id. at 282:2-283:2.
8
9
With respect to the impact of drug labeling on his decisions
United States District Court
For the Northern District of California
10
regarding treatment, Dr. Rich testified, "Drug labeling is
11
sometimes something I rely on when making decisions on drug use
12
for patients."
13
labeling, it's one of the things that is part of my decision-
14
making process.
Id. at 190:21-23.
He stated, "When I read the
Id. at 191:20-22.
15
Initially, Dr. Rich prescribed Prednisone, a steroid, and
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Asacol, an aspirin, anti-inflammatory drug, to treat Maxx's IBD.
17
18
Id. at 75:8-12, 79:22-25, 82:6-8.
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sought to wean Maxx from Prednisone, due to the significant side
20
effects and the weakness of the drug as a long-term therapy,
21
replacing it with 6-MP, an immunosuppressive therapy.
22
82:9-83:16, 86:16-22.
23
After several months, Dr. Rich
In June 1999, Maxx began taking 6-MP.
Id. at
Id. at 105:14-15.
24
Rich prescribed varying dosages of 6-MP, while attempting to
25
26
eliminate gradually Maxx's need for Prednisone.
However, as of
27
May 2002, Maxx was still taking Prednisone and 6-MP.
28
117:4-11.
3
Id. at
Dr.
1
At the time Dr. Rich prescribed 6-MP he was aware of a paper
2
reporting the occurrence of lymphoma in adults taking the drug.
3
Id. at 89:12-90:17.
4
lymphoma occurrences reported in the study was one in one hundred
5
adult patients taking 6-MP.
6
According to Dr. Rich, the frequency of
Id. at 89:23-90:4.
Dr. Rich found
this "significant," prompting him to warn patients of a "small but
7
non-zero increased risk of serious infections or malignancies"
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9
when discussing 6-MP treatment with patients.
Id. at 89:2-90:17.
United States District Court
For the Northern District of California
10
Dr. Rich testified that he may or may not have included the word
11
"lymphoma" when providing the warning.
12
Id. at 89:7-12.
At an appointment with Maxx on May 8, 2002, Dr. Rich
13
discussed in detail prescribing Remicade.
14
Again, the goal in changing Maxx's medication at this time was to
Id. at 117:4-118:1.
15
take him off steroids.
Id. at 151:17-152:9.
On July 10, 2002,
16
Maxx received his first infusion of Remicade.
Id. at 147:24-
17
18
148:16.
19
three months, in combination with 6-MP.
20
170:12-21.
21
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23
Maxx received infusions of Remicade approximately every
Id. at 155:4-12, 157:9,
Dr. Rich considered Remicade, as well as Humira, part of a
class of anti-tumor necrosis factor drugs, also known as "anti-TNF
drugs" and "TNF inhibitors."
Id. at 175:10-14, 176:9-17, 264:24-
24
25, 265:2-3.
He testified that he "virtually always" informed his
25
26
patients of a "nonzero increased risk" of serious infections and
27
malignancies related to "immunosuppressives and anti-tumor
28
necrosis factor drugs."
Id. at 123:6-10.
4
Dr. Rich's notes did
1
not mention specific warnings as to malignancies and lymphomas,
2
but he testified that such discussions "might not be documented."
3
Id. at 214:5-9.
4
Maxx of side effects.
5
6
Other notations indicate that he had informed
It is not entirely clear when Dr. Rich began warning his
patients about a “nonzero increased risk” of malignancies
7
connection with Remicade.
According to Dr. Rich, at a point in
8
9
time he could not recall, he became aware of a study involving
United States District Court
For the Northern District of California
10
approximately 700 patients on Remicade therapy, a majority of whom
11
had rheumatoid arthritis and a minority of whom had Crohn's
12
disease.
13
serious infections and malignancies, including lymphomas, within
14
that patient population.
Id. at 125:13-19.
The study reported incidences of
Id. at 125:20-126:1.
An entry regarding
15
Remicade in the 2002 Physicians' Desk Reference included mention
16
of a clinical study involving 771 patients, seven of whom
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18
developed new or recurrent malignancies, including lymphoma.
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at 133:2-12.
20
rates and incidents [of these malignancies] were similar to those
21
expected for the population."
22
Rich, in 2002 there were no reports on the risk of therapies
23
Id.
However, the PDR also stated that "the observed
combining Remicade and 6-MP.
Id. at 133:10-12.
According to Dr.
Id. at 132:10-12.
24
In about November 2005, Dr. Rich began to consider
25
26
discontinuing Maxx's Remicade treatment and discussed Humira with
27
him.
Id. at 170:24-173:5.
28
2005" he became aware of a "complication" associated with
Dr. Rich also testified that in "late
5
1
Remicade, namely the occurrence of hepatosplenic T-cell lymphoma
2
in adolescent and young adult patients taking Remicade with 6-MP.
3
Id. at 204:21-205:22, 215:3-4.
4
knowledge about "this complication" led him to consider taking
5
Maxx off Remicade.
6
Dr. Rich did not testify that new
Maxx received an infusion of Remicade in November 2005 and
7
then his final dose of Remicade in March 2006.
Id. at 182:15-14;
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197:16-199:7.
In May 2006, Maxx underwent a colonoscopy that
Id. at 198:1-199:14.
According to Dr.
United States District Court
For the Northern District of California
10
revealed no signs of IBD.
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Rich, a decision to discontinue Remicade or use an alternative
12
medication would have been made at the time of the colonoscopy,
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based on the results of the examination.
14
received no further infusions of Remicade.
Id. at 172:10-12.
Maxx
15
Also in May 2006, the FDA approved Remicade for an additional
16
indication for the treatment of pediatric Crohn's disease, but
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required a black box warning about the drug.
19
The warning alert
physicians to the following:
24
RARE POSTMARKETING CASES OF HEPATOSPLENIC T-CELL
LYMPHOMA HAVE BEEN REPORTED IN ADOLESCENT AND YOUNG
ADULT PATIENTS WITH CROHN'S DISEASE TREATED WITH
REMICADE. THIS TYPE OF T-CELL LYMPHOMA HAS A VERY
AGGRESSIVE DISEASE COURSE AND IS USUALLY FATAL. ALL OF
THESE HEPATOSPLENIC T-CELL LYMPHOMAS WITH REMICADE HAVE
OCCURRED IN PATIENTS ON CONCOMITANT TREATMENT WITH
AZATHIOPRINE OR 6-MERCAPTOPURINE.
25
Declaration of Kevin Haverty in Support of Plaintiffs' Opposition
26
to GSK's Motion for Summary Judgment, Ex. 3.
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6
1
Dr. Rich testified that he would have received this black box
2
warning in the form of a letter or other notification at about the
3
time it was issued.
4
noted that he had learned of this "complication" earlier, in late
5
2005, as previously stated.
6
Rich Dep. at 214:23-215:3.
However, he also
By November 2006, Maxx experienced a relapse.
On November
7
22, 2006, he received his first prescription for Humira, taking
8
9
the drug in combination with 6-MP.
Id. at 217:14-16.
Dr. Rich
United States District Court
For the Northern District of California
10
testified that he first treated patients with Humira in early 2005
11
or 2006 when two sixteen year old female patients with IBD
12
received the drug.
13
a rheumatologist, wrote Maxx's first prescription for Humira
14
because, when Humira was first placed on the Kaiser formulary, it
Id. at 193:3-7; 173:19-25.
Dr. Aileen Dillon,
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was placed under limited release, only through rheumatologists.
16
Id. at 217:14-218:6.
Dr. Rich testified that when he first began
17
18
prescribing Humira to his patients, he warned them of a "nonzero
19
but increased risk of serious infections and malignancies."
20
at 193:23-194:11.
21
literature he had reviewed and discussions he had had with other
22
physicians.
23
His awareness of this risk was based on
Id. at 194:12-18.
When asked why he did not treat Maxx with Remicade in
24
November 2006, Dr. Rich responded,
25
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27
28
Id.
So in November '06, we had been aware for some time of
complication of hepatosplenic T-cell lymphoma, so that
would have been part of my discussion with the family.
Ease of therapy is always a discussion with Humira
versus Remicade.
7
1
2
Id. at 218:13-23.
Dr. Rich explained that Humira may be
administered by the patient or a family member at home through
3
subcutaneous injections, while Remicade requires a patient to
4
5
6
7
visit a facility for two to three hour infusions.
Id. at 174:15-
19, 267:5-23.
When asked whether he opted for Humira because of the black
8
box warning concerning Remicade, Dr. Rich testified, "I think that
9
the concern of hepatosplenic T-cell lymphoma would have been part
United States District Court
For the Northern District of California
10
of my discussion with the family and it would have been part of my
11
thinking about the use of this disease (verbatim)."
Id. at
12
13
219:16-22.
Dr. Rich did not recall any similar warning regarding
14
Humira's use in combination with 6-MP and hepatosplenic T-cell
15
lymphoma.
16
would have forgone prescribing Humira in November 2006, had he
17
learned of a black box warning or similar alert regarding the use
18
of Humira, alone or in combination with 6-MP, and the occurrence
19
Id. at 219:23-220:2.
Dr. Rich did not state that he
of hepatosplenic T-cell lymphoma.
20
In deposition, Dr. Rich was asked whether his drug
21
22
recommendation was informed by the fact that one drug had a black
23
box warning about a rare, aggressive cancer, while the other drug
24
did not.
25
26
27
28
Dr. Rich responded,
I don't think the black box would have been a primary
driving point in the use of medicine, just as FDA
indication or not is not a driving point, as FDA
doesn't indicate very much of anything in pediatrics.
Id. at 220:1-15.
8
1
Later, Dr. Rich was asked again whether information that he
2
had about the cases of hepatosplenic T-cell lymphoma associated
3
with Remicade and 6-MP combination use informed in any way his
4
recommendation that Maxx start Humira in November 2006.
5
answered,
6
7
8
9
United States District Court
For the Northern District of California
10
He
The occurrence of hepatosplenic T-cell lymphomas and
the information and knowledge about that would have
been part of many things that would have gone into my
own thinking on how to use this--these medications and
my discussion with the patients on how to use these
medications.
Id. at 225:7-113.
11
In addressing whether all anti-TNF drugs carry the same
12
13
risks, Dr. Rich testified that Humira was "entirely humanized,"
14
whereas Remicade was "75 percent humanized and 25 percent mouse."
15
Id. at 194:24-25.
16
counsel,
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19
20
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22
Dr. Rich engaged in the following exchange with
A: So I presented [anti-TNF] medications always as
having an increased but nonzero increased risk. And
if I was asked by a patient, "Why do you use one
versus the other," or why we were considering Humira,
it may have come up in discussions that Humira was
fully humanized and may have--my statement would have
--would have been, "It may have a better safety
profile."
23
Q: What was the basis of your thinking that it may
have a better safety profile?
24
A: That it was fully humanized.
25
Q: What--
26
A: That there are allergy side effects to these
medicines.
27
28
9
1
2
Q: Okay. Other than allergies, did the fact that
Humira was fully humanized, monoclonal antibody, as
opposed to Remicade, affect, in your mind, the risk of
malignancies?
3
4
5
6
7
8
9
United States District Court
For the Northern District of California
10
A: I can't recall whether I thought that or not. The
fact that there--I'm not an immunologist, and I'm not
sure they can answer that question. But the fact that
there is no mouse suggests that it might have been a
consideration in my thinking, that it's a possibility.
Id. at 195:13-196:12.
Based on Dr. Rich's recommendation, Maxx took Humira for at
least eight months.
In mid-July 2007, Maxx was diagnosed with
hepatosplenic T-cell lymphoma.
In December 2007, he passed away.
11
After Maxx's death and as part of this litigation, Ms.
12
13
Wendell testified, "I didn't know that there had been a black box
14
warning on Remicade . . . [W]e were not informed of that and there
15
would have been no reason for [Dr. Rich] to inform us of that
16
because [Maxx] wasn't taking Remicade at the time."
17
Ex. 2, Lisa Wendell Dep. at 77:4-8.
18
Rich told her that Humira offered the convenience of self-
19
Haverty Dec.,
Ms. Wendell recalled that Dr.
injection and had a better safety profile.
Id. at 77:9-13.
The
20
issue of convenience was considered because Maxx was moving to
21
22
Davis to attend college.
Id. at 76:20-24.
She answered
23
affirmatively when asked whether she would have discontinued the
24
use of any of the medications if she had been told that there was
25
a risk of hepatosplenic T-cell lymphoma.
26
27
Id. at 75:8-12.
During 2007 Dr. Rich continued to treat patients using
therapies combining anti-TNF drugs with 6-MP, although he could
28
10
1
not recall whether the "combination therapy" consisted of 6-MP
2
combined with Remicade or 6-MP combined with Humira or both.
3
Dep. at 208:11-209:5.
4
using "mono-therapy," treating patients with an anti-TNF drug
5
alone without concomitant use of 6-MP.
6
16.
Rich
Most likely in 2008, Dr. Rich switched to
Id. at 208:16-17, 288:13-
Maxx's case played an "important role" in influencing Dr.
7
Rich's decision to use monotherapy as opposed to combination
8
9
therapy.
Id. at 230:16-20.
Dr. Rich reported that the majority
United States District Court
For the Northern District of California
10
of practitioners, including many pediatric gastroenterologists,
11
use combination therapy, although that is no longer his practice.
12
Id. at 230:12-15.
13
LEGAL STANDARD
14
Summary judgment is properly granted when no genuine and
15
disputed issues of material fact remain, and when, viewing the
16
evidence most favorably to the non-moving party, the movant is
17
18
clearly entitled to prevail as a matter of law.
19
56.
20
Eisenberg v. Ins. Co. of N. Am., 815 F.2d 1285, 1289 (9th Cir.
21
1987).
22
the party against whom summary judgment is sought.
23
Fed. R. Civ. P.
Celotex Corp v. Catrett, 477 U.S. 317, 322-23 (1986);
The court must draw all reasonable inferences in favor of
Matsushita
Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986);
24
Intel Corp. v. Hartford Accident & Indem. Co., 952 F.2d 1551, 1558
25
26
27
28
(9th Cir. 1991).
Material facts which would preclude entry of summary judgment
are those which, under applicable substantive law, may affect the
11
1
outcome of the case.
The substantive law will identify which
2
facts are material.
Anderson v. Liberty Lobby, Inc., 477 U.S.
3
242, 248 (1986).
4
DISCUSSION
5
6
Under the learned intermediary doctrine, a manufacturer of a
prescription drug is obliged to warn doctors, not patients, of
7
potential side-effects associated with its pharmaceutical
8
9
products.
Carlin v. Superior Court, 13 Cal. 4th 1104, 1116
United States District Court
For the Northern District of California
10
(1996).
A plaintiff asserting causes of action for failure to
11
warn must prove not only that no warning was provided or that the
12
warning was inadequate, but also that the inadequacy or absence of
13
a warning caused the plaintiff's injury.
14
Laboratories, 819 F.2d 349, 358 (2d Cir. 1987) (applying
Plummer v. Lederle
15
California law).
16
Under Motus v. Pfizer, Inc., 358 F.3d 659, 661 (9th Cir.
17
18
2004), "a product defect claim based on insufficient warnings
19
cannot survive summary judgment if stronger warnings would not
20
have altered the conduct of the prescribing physician."
21
the treating physician testified unequivocally that he neglected
22
to read the published warnings and did not rely on information
23
In Motus
from Pfizer's detail men before prescribing the drug that
24
allegedly induced the decedent to commit suicide.
385 F.3d at
25
26
661.
On this basis, the plaintiff could not establish a causal
27
connection between the representations or omissions that
28
accompanied the product and the plaintiff's injury.
12
1
The present action is distinguishable from Motus because Dr.
2
Rich testified that he sometimes read drug labeling, in particular
3
when dealing with unfamiliar drugs.
4
6-MP during his training, there is evidence that Humira was
5
relatively new to Dr. Rich as a treatment for IBD when he
6
Although Dr. Rich learned of
prescribed it to Maxx.
7
However, even assuming that Dr. Rich would have read a
8
9
warning on the labels of Humira and 6-MP, summary judgment in
In Plummer, the Second Circuit,
United States District Court
For the Northern District of California
10
favor of Movants is warranted.
11
applying California law, found that judgment should have been
12
entered for the defendant, because the physician knew of the risk
13
for which the plaintiff sought a warning, and yet the physician
14
still failed to warn the patient's mother about the risk.
819
15
F.2d at 358-59.
Plummer, citing Rosburg v. Minnesota Mining &
16
Mfg. Co., 181 Cal. App. 3d 726, 730 (1986), concluded that "no
17
18
harm could have been caused by failure to warn of a risk already
19
known."
20
risk of malignancies associated with 6-MP and Humira, but still
21
prescribed the medication.
22
to create a material dispute of fact as to whether the warnings
23
819 F.2d at 359.
As in Plummer, Dr. Rich knew of the
Thus, there is insufficient evidence
that Plaintiffs contend should have been given would have changed
24
Maxx's treatment.
25
26
A. 6-MP
27
The Wendells assert that GSK, TEVA and PAR, allegedly
28
involved in the manufacture, marketing and distribution of 6-MP,
13
1
negligently failed to discover and/or provide an adequate warning
2
about the risk of hepatosplenic T-cell lymphoma posed by 6-MP when
3
used singly or in combination with Remicade or Humira.
4
however, was already aware of a significant risk of lymphomas
5
associated with 6-MP treatment.
6
drug.
Dr. Rich,
Yet he continued to prescribe the
It appears that Dr. Rich's knowledge of this risk prompted
7
him to warn his pediatric patients about the nonzero increased
8
9
risk of developing malignancies or lymphomas while taking the
United States District Court
For the Northern District of California
10
medication, but there is no evidence that the risk persuaded him
11
to cease recommending or prescribing the drug.
12
Moreover, there is insufficient evidence for a jury to infer
13
that Dr. Rich ceased treating Maxx with Remicade because of the
14
May 2006 black box warning regarding the risk of lymphoma
15
associated with therapy combining Remicade and 6-MP.
Dr. Rich
16
began considering taking Maxx off Remicade in November 2005,
17
18
before the black box warning was issued.
19
testified that black box warnings were not the driving force in
20
making decisions about the prescription of medication.
21
Remicade black box warning does not provide a basis from which to
22
infer that, had Dr. Rich received a similar warning regarding
23
In addition, he
Thus, the
Humira and 6-MP prescribed in combination, he would have ceased
24
treating Maxx with that combination of drugs.
25
26
Nor is there evidence that a warning specific to pediatric
27
patients or specific to treatments combining 6-MP with TNF-
28
blockers would have led Dr. Rich to stop prescribing 6-MP alone or
14
1
in combination with Remicade or Humira.
2
contention, evidence that Dr. Rich ceased prescribing TNF-blockers
3
in combination with 6-MP after Maxx was diagnosed with
4
hepatosplenic lymphoma does not prove that he would have changed
5
his prescription practices based on the warning they suggest.
6
Contrary to the Wendells'
A
warning about rare occurrences of hepatosplenic lymphoma
7
associated with therapy combining 6-MP and Remicade is bound to
8
9
United States District Court
For the Northern District of California
10
11
have less persuasive power than an instance of the disease
affecting a doctor's own patient followed that therapy.
Because there is insufficient evidence for a reasonable jury
12
to find that the failure to warn of the risk of hepatosplenic T-
13
cell lymphoma posed by 6-MP when used singly or in combination
14
with Remicade or Humira proximately caused Maxx's death, summary
15
judgment is granted in favor of GSK, TEVA and PAR.
16
The Wendells also argue that it is premature to grant summary
17
18
judgment in favor of GSK because further discovery may reveal that
19
Dr. Rich relied on information from GSK concerning the risks
20
associated with 6-MP.
21
response to a request for documents, and the Wendells had not had
22
time to sift through the discovery.
23
Apparently, GSK served a voluminous
However, the Wendells have
not demonstrated how documents from GSK could prove proximate
24
causation in this case, where the undisputed fact is that Dr. Rich
25
26
was already aware of the risk of lymphomas associated with 6-MP,
27
but still chose to prescribe the drug.
28
lack evidence that any further warning regarding the use of 6-MP,
15
Furthermore, Plaintiffs
1
such as a warning about its use in combination with Humira, would
2
have changed the manner in which Dr. Rich treated Maxx.
3
judgment is not premature.
Summary
4
B. Humira
5
The Wendells claim that Abbott should have provided a label
6
warning Dr. Rich about the risk of hepatosplenic T-cell lymphoma
7
associated with treatment combining Humira and 6-MP.
However,
8
9
none of the evidence that the Wendells point to is sufficient to
United States District Court
For the Northern District of California
10
create a dispute of fact as to whether the warning would have
11
altered Dr. Rich's decision to treat Maxx with Humira and 6-MP.
12
First, for the reasons already explained above, Dr. Rich's
13
subsequent decision to prescribe anti-TNF drugs alone, rather than
14
in combination with 6-MP, is not probative of whether a warning
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about risks associated with Humira, used singly or in combination
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with 6-MP, would have altered Maxx's treatment.
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Next, Dr. Rich's testimony regarding Humira's comparatively
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better safety profile is not helpful to the Wendells' case.
20
read in context, Dr. Rich's testimony indicates that he believed
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that Humira may have had a better safety profile based on the fact
22
that it was fully humanized and, thus, had fewer allergy side
23
When
effects.
24
Evidence that Dr. Rich did not warn Maxx about the risk of
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26
combination therapy is not sufficient to establish proximate
27
causation with respect to Humira.
28
black box warnings were not the primary driver for his decisions
16
Rather, Dr. Rich testified that
1
regarding medication.
2
discontinue treating Maxx with Remicade is not evidence that a
3
black box warning as to Humira would have changed the course of
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Maxx's treatment.
5
discontinue Maxx's Remicade treatment before the black box warning
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The timing of Dr. Rich's decision to
Dr. Rich began considering whether to
issued in May 2006.
These grounds are insufficient to raise a
7
dispute of fact that a warning would have made a difference in
8
9
Maxx's treatment.
That Dr. Rich did not suspect Humira as a cause of Max's
United States District Court
For the Northern District of California
10
11
lymphoma after his diagnosis fails to establish that a warning
12
about Humira would have persuaded him to stop prescribing the
13
medication.
14
risk with Humira while the warning had not yet been announced does
In other words, that Dr. Rich did not associate a
15
not mean that, had the warning been provided, Dr. Rich would have
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associated such a strong risk with Humira that he would have
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18
decided against prescribing the drug.
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Furthermore, Ms. Wendell's testimony that the family would
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have discontinued the drug treatment if they had been warned is
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insufficient.
22
received Humira in November 2006, he was twenty years old.
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Maxx was born on August 20, 1986.
At the time Maxx
There
is no evidence that Ms. Wendell made health care decisions for
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Maxx.
Ms. Wendell's statement as to what Maxx would have done
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lacks foundation.
27
//
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//
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1
Because the Wendells have failed to provide sufficient
2
evidence to raise a dispute of fact as to the element of proximate
3
causation, summary judgment in favor of Abbott is warranted.
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5
6
CONCLUSION
The Wendells' loss of their son is tragic.
However, because
they have failed to provide sufficient evidence of proximate
7
causation by GSK, TEVA, PAR and Abbott, the motions for summary
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9
judgment submitted by these Defendants are granted.
In the event
United States District Court
For the Northern District of California
10
that the Wendells or remaining Defendants move for summary
11
judgment, the motions shall be noticed for January 26, 2012.
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IT IS SO ORDERED.
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Dated: 12/15/2011
CLAUDIA WILKEN
United States District Judge
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