Intuitive Surgical vs. Zarick

1 ALLEN RUBY (State Bar No.
47109)
S. SHERYL LEUNG (State Bar No. 238229)
2 SKADDEN, ARPS, SLATE, MEAGHER & FLOM LLP
3 525 University Avenue, Suite 1400
Palo Alto, California 94301
(650) 470-4500
4 Telephone:
Facsimile:
(650) 470-4570
5
E-FILED
Apr 1, 2016 1:15 PM
David H. Yamasaki
Chief Executive Officer/Clerk
Superior Court of CA, County of Santa Clara
Case #1-12-CV-237723 Filing #G-82442
By R. Walker, Deputy
6 LISA M. GILFORD (State Bar No. 171641)

SKADDEN, ARPS, SLATE, MEAGHER & FLOM LLP
7 300 South Grand Avenue Suite 3400
8 Los Angeles, California 90071
Telephone:
(213) 687-5000
(213) 687-5600
9 Facsimile:
10 Attorneys for Defendant
INTUITIVE SURGICAL, INC.
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SUPERIOR COURT OF CALIFORNIA
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COUNTY OF SANTA CLARA
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MICHELLE ZARICK and RYAN ZARICK,
CASE NO.: 1-12-CV-237723
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Plaintiffs,
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v.
INTUITIVE SURGICAL INC. and DOES 1

20 through 100, inclusive,
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Defendants.
DEFENDANT INTUITIVE SURGICAL'S

TRIAL BRIEF
Trial Date: April 5, 2016

Time: 9:00 a.m.
Place: Dept. 9
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Action Filed:
December 12, 2012
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INTUITIVE'S TRIAL BRIEF
CASE NO. 1-12-CV-237723
E-FILED: Apr 1, 2016 1:15 PM, Superior Court of CA, County of Santa Clara, Case #1-12-CV-237723 Filing #G-82442
TABLE OF CONTENTS
2 TABLE OF CONTENTS ................................................................................................................I

3
I.
INTRODUCTION................................................................................................... 1
II.
STATEMENT OF FACTS ...................................................................................... 1
A.
The Parties ................................................................................................... 1
B.
Plaintiff's February 3, 2009 Hysterectomy ................................................... 2
C.
Plaintiff's March 11, 2009 Laparotomy ........................................................ 4
D.
Recovery ..................................................................................................... 5
III.
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PLAINTIFF'S CLAIMS LACK ANY MERIT ........................................................ 6

A.
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Plaintiffs Cannot Meet Their Burden to Establish The Necessary

Elements of A Products Liability Claim ....................................................... 6
1.
Plaintiffs Cannot Prove Their Design Defect Claims ........................ 6
2.
Plaintiffs Cannot Prove Their Failure to Warn Claim ....................... 9
B.
Plaintiffs' Negligence Claims Will Fail ...................................................... 10
C.
Plaintiffs' Breach of Warranty Lack Merit .................................................. 12
16
1.
Plaintiffs Cannot Establish Any Express Warranty ......................... 12
2.
Plaintiffs' Implied Warranty Claim Fails For Lack Of Privity ......... 12
17
D.
Plaintiff Ryan Zarick Cannot Recover From Intuitive Damages For

Loss of Consortium For Injuries He Inflicted On His Wife ........................ 14
E.
Motions ..................................................................................................... 14
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IV.
CONCLUSION ..................................................................................................... 15
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CASE NO. 1-12-CV-237723
TABLE OF AUTHORITIES
Page(s)
2
CASES
3
4
Adams v. I-Flow Corp.,

No. CV09-09550 R(SSx), 2010 WL 1339948 (C.D. Cal. Mar. 30, 2010) .......................... 13
5 All West Electronics, Inc. v. M-B-W, Inc.,

64 Cal. App. 4th 717 (1998) .............................................................................................. 12
6
7 Barker v. Lull Engineering Co.,
20 Cal. 3d 413 (1978) ......................................................................................................... 6
8
Blanco v. Baxter Healthcare Corp.,
158 Cal. App. 4th 1039, 1058 (2008) ................................................................................ 13
9
10 Brown v. Superior Court,
44 Cal. 3d 1049 (1988) ....................................................................................................... 9
11
Chandler v. Chiron Corp.,
12
No. C-96-1047 SI, 1997 WL 464827 (N.D. Cal. July 28, 1997),
aff'd, 176 F.3d 481 (9th Cir. 1999) .................................................................................... 13
13
Chavez v. Glock, Inc.,
14
207 Cal. App. 4th 1283 (2012) .......................................................................................... 11
15 Crayton v. Rochester Medical Corp.,
No. 1:07CV1318 OWW GSA,
16
2011 WL 475009 (E.D. Cal. Feb. 4, 2011),
aff'd, 548 F. App'x 483 (9th Cir. 2013) .............................................................................. 13
17
18 Evraets v. Intermedics Intraocular, Inc.,
29 Cal. App. 4th 779 (1994) .............................................................................................. 13
19
Huitt v. Southern California Gas Co.,
20
188 Cal. App. 4th 1586 (2010) ............................................................................................ 9
21 Johnson v. American Standard, Inc.,
43 Cal. 4th 56 (2008) .................................................................................................... 9, 10
22
Ladd v. County of San Mateo,
23
12 Cal. 4th 913 (1996) ...................................................................................................... 10
24 McCarty v. Johnson & Johnson,
No. 1:10-CV-00350 OWW-DLB,
25
2010 WL 2629913 (E.D. Cal. June 29, 2010) .................................................................... 13
26
Merrill v. Navegar, Inc.,
89 Cal. Rptr. 2d 146, 176 (1999) ......................................................................................... 6
27
28
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CASE NO. 1-12-CV-237723
Quatela v. Stryker Corp.,

No. C 1003422, 2010 WL 7801786 (N.D. Cal. Dec. 17, 2010) ........................................ 13
2 Saller v. Crown Cork & Seal Co., Inc.,

187 Cal. App. 4th 1220 (2010) ............................................................................................ 7
3
4 Sherman v. Stryker Corp.,
No. SACV 09224 JVS (ANx),
2009 WL 2241664 (C.D. Cal. March 30, 2009)................................................................. 13
5
6 Smallwood v. Am. Trading & Transp. Co.,
839 F. Supp. 1377, 1388 (1993) ........................................................................................ 14
7
Soule v. General Motors Corp.,
8
8 Cal. 4th 548 (1994) .......................................................................................................... 6
9 Vanhooser v. Superior Court,
206 Cal. App. 4th 921 (2012) ............................................................................................ 14
10
Weinstat v. Dentsply International, Inc.,
11
180 Cal. App. 4th 1213 (2010) .......................................................................................... 12
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14
15
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CASE NO. 1-12-CV-237723
1 I.
INTRODUCTION
This is a products liability case brought by Plaintiff Michelle Zarick after she suffered
3 complications following a robotically assisted laparoscopic hysterectomy using the da Vinci

4 surgical system. Ms. Zarick seek to recover money damages for her injuries from Defendant
5 Intuitive Surgical, Inc. ("Intuitive"), the manufacturer of the da Vinci surgical system.
6
Ms. Zarick alleges that her post-operative complications were caused by a malfunction of
7 the Endowrist monopolar curved scissors and tip cover accessory sold by Intuitive and used in her
8 surgery. Ms. Zarick claims that the malfunction allowed stray energy from the electrosurgical
9 instrument to burn her internally more than five weeks after her hysterectomy, necessitating a
10 repair surgery. However, Ms. Zarick cannot support her allegations with evidence. Instead, the
11 evidence in the case, including testimony by her surgeon, points to the conclusion that Ms. Zarick
12 probably suffered her post-operative complication because she failed to comply with her surgeon's
13 instructions to refrain from sexual activity for 6-8 weeks following her hysterectomy.
14 Alternatively, prior to suing Intuitive in 2012, Ms. Zarick attributed the cause of her post-operative
15 complications to physical violence from her husband, Plaintiff Ryan Zarick, who asserts claims for
16 loss of consortium against Intuitive.
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This trial brief (i) provides background regarding the parties and the medical issues in this
18 case (ii) describes Plaintiffs' claims; and (iii) discusses the absence of legal and evidentiary support
19 for Plaintiffs' claims.
20 II.
STATEMENT OF FACTS
21
A.
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Plaintiff Michelle Zarick is an individual residing in Sacramento County, California.
The Parties
23 Plaintiff Ryan Zarick is the husband of Michelle Zarick.

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Defendant Intuitive is based in Sunnyvale, California and is the global leader in robotic-
25 assisted minimally invasive surgery. Intuitive designs and manufactures the da Vinci surgical
26 system and Endowrist instruments. The Da Vinci surgical system is a multi-armed, remote27 controlled surgical device manufactured by Intuitive Surgical that has been utilized by surgeons in
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CASE NO. 1-12-CV-237723
1 hospitals across the country for over a decade. The da Vinci surgical system is comprised of a
2 surgeon console, patient-side cart, and vision system. During a robotically assisted hysterectomy,
3 laparoscopic instruments are inserted through small abdominal incisions in the patient who is
4 positioned at the patient-side cart and controlled through three or four robotic arms on the patient5 side cart that carry out the surgeon's commands. The surgeon sits at the surgeon console a few feet
6 away from the patient-side cart and views the surgical field inside the patient's abdomen in a high7 definition, 3D image while the motions of her fingers on the master controls are translated into
8 movements of the surgical instruments inside the patient's body. The vision system displays a 2D
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view of the procedure for the other members of the operating room.
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Picture of surgeon at surgeon console, nurse at patient-side cart, and vision system.
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B.
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In February 2009, Plaintiff Michelle Zarick had been diagnosed with multiple fibroids and
Plaintiff's February 3, 2009 Hysterectomy
25 was suffering from severe menorrhagia (abnormally heavy bleeding). Treatment by birth control
26 pills had failed to alleviate the pain and discomfort of her condition. Ms. Zarick consulted her OB27
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CASE NO. 1-12-CV-237723
1 GYN for additional treatment options. Her OB-GYN at the time, Dr. Rita Biesen-Bradley, advised
2 her of the risks and benefits of a laparoscopic total vaginal hysterectomy with robotic assistance. 1
3 Dr. Biesen-Bradley explained that the procedure carried with it risks "ranging from trivial to fatal,"
4 including the risk of "pain, bleeding, infection, poor healing, hernia, or formation of adhesions" and
5 unintended injury to "other pelvic or abdominal structures." (See Ex. A, 1/29/09 Hysterectomy
6 Consent Form, ZAR 00090-91.) Dr. Biesen-Bradley also explained during a pre-operative
7 consultation that hysterectomy surgery carried with it a risk of dehiscence, where the vaginal cuff
8 wound opens and the organs inside the abdomen can expel. (Ex. D, Biesen-Bradley Tr. 10:9-22.)
9 Ms. Zarick accepted the risks and benefits and signed the consent form stating that she understood
10 she would not be fully recovered from the hysterectomy for approximately six to eight weeks.
11
During the February 3, 2009 robotically assisted laparoscopic hysterectomy, Dr. Biesen-
12 Bradley experienced no difficulties with the da Vinci surgical system or instruments and she noted
13 no complications with the surgery. There was no indication at the time or after that the da Vinci
14 surgical equipment malfunctioned in any way. Ms. Zarick did well throughout the surgery. Ms.
15 Zarick was discharged on February 5, 2009 with instructions for a re-check in 2 weeks and for
16 "pelvic rest, no lifting > 15 lbs, no vacuum x 6 weeks." (Ex. B, 2/6/09 Discharge Instructions,
17 Mercy San Juan 000013-15.) On February 16, 2009, Ms. Zarick returned for a post-operative
18 check-up by Dr. Biesen-Bradley, who noted that Ms. Zarick's wounds were healing well, with no
19 evidence of any post-surgical problems. Dr. Biesen-Bradley testified that, for this particular patient,
20 she knew that Ms. Zarick's husband had a job in the Middle East and that the couple was "very
21 close" so she specifically reminded Ms. Zarick that there was to be "nothing in the vagina for eight
22 weeks postop." Ms. Zarick indicated that she understood. (Ex. D Biesen-Bradley Tr. 13:16-24.)
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A laparoscopic total vaginal hysterectomy with robotic assistance refers to a procedure

wherein the cervix is removed along with the uterus through the vagina but the separation
of the ligaments and connective tissues holding the uterus in place is performed
laparoscopically with the assistance of robotic instruments. The part of the vagina that was
previously attached to the cervix is sewn together and becomes the "vaginal cuff."
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CASE NO. 1-12-CV-237723
C.
On March 11, 2009, five weeks and one day after Ms. Zarick's hysterectomy, the Zaricks
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engaged in sexual intercourse contrary to Dr. Biesen-Bradley's instructions. According to her

medical records, Ms. Zarick experienced vaginal bleeding and excruciating pain after intercourse.
Shortly thereafter, Ms. Zarick noticed bowel protruding from her vagina. Ms. Zarick was then
rushed to Methodist Hospital, where she underwent a laparotomy by Dr. Zenja Watkins to repair
her vaginal cuff dehiscence.
During the procedure, Dr. Watkins noted the right tube and ovary were "involved in active
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infection" and removed the infected tissue. She also noted that there was a breakdown on the left
side of the vaginal cuff where there was clear evidence of infection. To repair the vaginal cuff
dehiscence, Dr. Watkins debrided infected tissue along the vaginal cuff and re-sutured the cuff.
Finally, she confirmed that Ms. Zarick's bowels were "healthy and pink with no evidence of
infection, infarction or any untoward event." She copiously irrigated the abdominal cavity with
saline and concluded the surgery. Ms. Zarick was treated with IV antibiotics and by March 15,
2009, Ms. Zarick was feeling comfortable for discharge.
On March 25, 2009, Ms. Zarick returned to Dr. Biesen-Bradley for her second follow-up
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Plaintiff's March 11, 2009 Laparotomy
appointment. At this visit, Ms. Zarick told Dr. Biesen-Bradley about her vaginal cuff dehiscence
and repair surgery on March 11, 2009. Ms. Zarick admitted to Dr. Biesen-Bradley that she had
engaged in sexual intercourse prior to her vaginal cuff dehiscence. Dr. Biesen-Bradley testified
that she formed the opinion at the time of treating Ms. Zarick that the likely cause of Ms. Zarick's
vaginal cuff dehiscence was having intercourse too soon after the procedure. Dr. Biesen-Bradley
explained that if a hysterectomy patient engages in intercourse before the wound is fully healed,
there was a risk that intercourse could introduce infection into the site of the surgery, and that the
intercourse itself can disrupt the healing of the wound and reverse the vaginal cuff's ability to
adhere.
Consistent with Dr. Biesen-Bradley's opinion, the lab reports from the March 11, 2009
laparotomy demonstrate that the cause of Ms. Zarick's infection was very recent and from an
external source. The wound culture of the vaginal cuff tissue from Ms. Zarick's laparotomy grew
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CASE NO. 1-12-CV-237723
1 sparse coagulase negative staphylococcus. The pathology report of the excised right fallopian tube
2 and ovary noted several times that there was "acute inflammation" of the surface serosa of the
3 fallopian tube and ovary.
4
As defense expert witness Dr. Katherine Hsiao testified, staphylococcus is not a bacteria
5 that is ordinarily found in a woman's vaginal tract. Rather, it is found abundantly on external skin,
6 such as the hand, penis or abdomen. Furthermore, the term "acute inflammation" is a pathology
7 finding that refers to a current and recent infection. In contrast, pathologists would use the term
8 "chronic" to describe an infection that has been ongoing for some time. Dr. Hsiao thus opined that
9 it was very unlikely that Ms. Zarick's tubo-ovarian infection and vaginal cuff dehiscence could
10 have been caused by a thermal injury that occurred at the time of her hysterectomy more than five
11 weeks prior. Dr. Hsiao agreed with Dr. Biesen-Bradley's opinion that Ms. Zarick's post-operative
12 vaginal cuff dehiscence was likely caused by resuming sexual relations prematurely and prior to
13 the period of time designated by her surgeon.
14
Dr. Hsiao further explained that it was especially important for Ms. Zarick to have followed
15 her surgeon's directions to refrain from sexual activities prior to the time the vaginal cuff is fully
16 healed because Dr. Biesen-Bradley used Vicryl sutures to sew Ms. Zarick's vaginal cuff. Vicryl
17 suture is a synthetic braided suture that can act like a wick to transmit bacteria up into the pelvis if
18 it is exposed to bacteria inside the vagina. Plaintiffs have no expert witness to testify that the da
19 Vinci surgical equipment caused or contributed to Ms. Zarick's complications.
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D.
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Following her discharge from Methodist Hospital on March 15, 2009, Ms. Zarick claims
Recovery
22 that she was required to recuperate at home for six weeks. She seems to have made a full recovery.
23 Her October 12, 2012 annual exam with Dr. Cueto showed that she was a "healthy 41 year old
24 woman" and the Plaintiff admitted that she considered herself healthy in October 2012.
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CASE NO. 1-12-CV-237723
III.
Plaintiff's Claims Lack Any Merit

A.
Plaintiffs Cannot Meet Their Burden to Establish The Necessary Elements of A

Products Liability Claim
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Ms. Zarick's product liability claims are without merit. Although Plaintiffs have not
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articulated their theory of liability with any specificity, it appears that they are claiming that the
Endowrist Monopolar Curved Scissors ('MCS") and tip cover accessory ("tip cover") sold by
Intuitive and used in Michelle Zarick's hysterectomy were defectively designed. Plaintiffs also
allege that Intuitive failed to give healthcare providers adequate information to weigh the risks of
serious injury to a patient of using monopolar current to perform robotic hysterectomies,
specifically the risks of thermal injury to the bladder, ureter, bowel, vaginal cuff and blood vessels
when performing a colpotomy. (Compl. 45f, m, w, 53-54.)
1.
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A manufacturer, distributor or retailer is "liable in tort if a defect in the . . . design of its
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product caused injury while the product is being used in a reasonably foreseeable way." Soule v.
Gen. Motors Corp., 34 Cal. 4th 548, 560 (1994). In order to prove a strict liability design defect
claim, (1) a plaintiff must demonstrate that the product's design proximately caused her injury;
and (2) the defendant fails to establish in light of relevant factors that, on balance, the benefits of
the challenged design outweigh the risk of danger inherent in such design. 2 Barker v. Lull Eng'g
Co., 20 Cal. 3d 413, 432 (1978), superseded by statute on other grounds as stated in Merrill v.
Navegar, Inc., 89 Cal. Rptr. 2d 146, 176 (1999); (see Compl. 44-45, 53-54.)
If, and only if, Plaintiff can demonstrate that the design of the product proximately caused
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Plaintiffs Cannot Prove Their Design Defect Claims
her injury, then Defendant must establish that on balance, the benefits of the challenged design
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The reasonable consumer test would not apply in this case because Plaintiffs' theory of
design defect involves technical and mechanical detail, implicating the voltage, wave form
and type of energy current used during specific portions of Plaintiff's surgery that are
beyond the ordinary experience and understanding of consumers. See Soule, 8 Cal. 4th at
570 (holding ordinary consumer expectation test was inappropriate for design defect claim
where the theory of defect would require juror to examine the precise behavior of several
obscure components of the car under the complex circumstances of a particular car
accident).
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CASE NO. 1-12-CV-237723
1 outweigh the risk of danger inherent in such design. Saller v. Crown Cork & Seal Co., 187 Cal.
2 App. 4th 1220, 1233 (2010). In such cases, "the jury must evaluate the product's design by
3 considering the gravity of the danger posed by the design, the likelihood such danger would occur,
4 the feasibility of a safer alternative design, the financial cost of an improved design, and the
5 adverse consequences to the consumer resulting from an alternative design." Id.
6
Here, Plaintiffs cannot pass their initial hurdle causation. There is simply no evidence
7 that Ms. Zarick's March 11, 2009 vaginal cuff dehiscence was caused by an injury Plaintiff
8 sustained during her surgery, let alone one caused by a design defect. The only evidence in the
9 case as illustrated through the testimony of Drs. Hsiao and Biesen-Bradley and Ms. Zarick's
10 medical records, affirmatively establishes that Plaintiffs are responsible for Ms. Zarick's injuries by
11 prematurely resuming sexual activity contrary to her surgeon's orders. The evidence demonstrates
12 that the Zarick's decision to engage in sexual activity before Ms. Zarick was completely healed
13 from her hysterectomy probably allowed bacteria to be introduced into the surgery wound site,
14 causing an infection and weakening of the tissue on the vaginal cuff. The wound was further
15 aggravated by the mechanical trauma of intercourse, leading to the breakdown of the cuff.
16
Furthermore, Plaintiffs will not be calling their own experts to offer a different theory of
17 causation. Instead, Plaintiffs claim that they will rely on Intuitive's employees, Dr. Hsiao and
18 "percipient witnesses" to prove the defect. (Plaintiffs' Combined Opposition to Defendant's Motion
19 in Limine, Filed March 30, 2016.) However, Intuitive expects that Plaintiffs will not be able to
20 develop the evidence necessary to establish their claim. First, as demonstrated by Dr. Hsiao's
21 deposition testimony, Dr. Hsiao does not believe that Ms. Zarick's vaginal cuff dehiscence was
22 caused by the da Vinci surgical system or instruments. Second, none of the Intuitive employees
23 subpoenaed and/or noticed for attendance at trial have any percipient information concerning Ms.
24 Zarick's surgery or the specific MCS and tip cover used in her surgery. Finally, to the extent
25 Plaintiffs intend to rely on Ms. Zarick's treating physicians to opine as to causation, such evidence
26 will be not be admissible. This is because Plaintiffs elected not to serve Code-Compliant expert
27 disclosures designating any treating physicians as expert witnesses by the statutory deadlines and
28 failed to identify treating physicians as witnesses until March 25, 2016, more than 10 days after the
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CASE NO. 1-12-CV-237723
1 deadline for parties to meet and confer over witness lists. See Complex Civil Guidelines XI.;
2 Intuitive's MIL No. 2. Thus, Plaintiffs will be unable to muster any testimonial or documentary
3 evidence to support a linkage between Ms. Zarick's specific post-operative complication and the
4 MCS and tip cover used in her February 3, 2009 hysterectomy.
5
Plaintiff herself attributed the vaginal cuff dehiscence and resulting laparotomy to her
6 husband's domestic violence. (See Ex. C, Aug. 16, 2010 Request and Order for Free Service of
7 Restraining Order.) In August 2010, Plaintiff filed a Request for Order (Domestic Violence
8 Prevention) in the Superior Court of California County of Sacramento, Family Law Division. In
9 the petition, Ms. Zarick requested that the Court issue a stay away order directed to Mr. Zarick on
10 the grounds that he has physically abused her multiple times. (Ex. C. at 16.) In her own
11 handwriting, Ms. Zarick attested under the penalty of perjury that "In March 2009, he hurt me so
12 badly I ended up in the hospital for a week due to recently having major surgery." (Id. at 18.)
13 At her deposition, Ms. Zarick confirmed that the injuries referenced in her statement that "he hurt
14 me so badly I ended up in the hospital for a week" was her small bowel evisceration and that she
15 believed that statement to be true at the time she submitted the request. The evidence will show
16 that contrary to Dr. Biesen-Bradley's instructions to refrain from lifting and to "take it easy" during
17 her recovery period, the Zaricks physically fought each another and Mr. Zarick inflicted blunt force
18 trauma to Ms. Zarick's mid-section two days before her vaginal cuff evisceration.
19
Moreover, while there is evidence in the record concerning the relative benefits of the MCS,
20 Plaintiffs have not introduced any evidence of the risk of danger inherent in the design. Dr.
21 Biesen-Bradley testified that monopolar energy allows the surgeon to perform a procedure with
22 less bleeding. She had previously tried ultrasonic energy instruments in laparoscopically assisted
23 vaginal hysterectomies and did not find these instruments useful. Dr. Hsiao similarly testified that
24 monopolar energy is precise and efficient for controlling bleeding. She testified that she had tried
25 using a laparoscopic ultrasonic energy instrument before to perform a colpotomy and found the
26 tool unsatisfactory because it caused more bleeding which actually required the application of more
27 electrocautery to control the bleeding. She also explained that bipolar instruments are very
28 inefficient for cutting tissue, and that most laparoscopic surgeons use monopolar instruments to
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CASE NO. 1-12-CV-237723
1 perform colpotomies whether the case is robotically-assisted or not. Dr. Hsiao further testified that
2 there is nothing fundamentally unsafe about monopolar energy instruments as opposed to other
3 energy forms and that it was possible to burn or injure a patient with any form of energy. Plaintiffs
4 offer no competing evidence to the contrary and no evidence of the risk of danger inherent in the
5 MCS design as compared to any other type of energized surgical instrument's design.
6
Because Plaintiffs cannot prove that the da Vinci surgical system or instruments caused her
7 March 9, 2011 injuries, or refute the evidence that the relative benefits of the MCS outweighs any
8 risk of its design, Plaintiff's design defect claim fails.
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2.
Plaintiffs Cannot Prove Their Failure to Warn Claim
Similarly, proximate cause is a requirement of Plaintiffs' failure to warn claim. "To be
11 liable in California, even under a strict liability theory, the plaintiff must prove that the defendant's
12 failure to warn was a substantial factor in causing his or her injury." Huitt v. S. Cal. Gas Co., 188
13 Cal. App. 4th 1586, 1604-05 (2010) (directing trial court to enter judgment for defendant because
14 plaintiffs have not established the defendant gas company's failure to warn was a cause in fact of
15 their injuries). Manufacturers have a duty to warn consumers about hazards inherent in their
16 products so that consumers can refrain from using the product altogether or evade its dangers by
17 careful use. Johnson v. Am. Standard, Inc., 43 Cal. 4th 56, 64, 74 (2008) (holding that plaintiff's
18 status as sophisticated user negated the manufacturer's duty to warn). For medical products, [i]t
19 is well established that a manufacturer fulfills its duty to warn if it provides adequate warning to
20 the physician. Brown v. Superior Court, 44 Cal. 3d 1049, 1060-62 & n.9 (1988) (holding that
21 manufacturers could not be liable for failing to warn about alleged defects that were neither known
22 by defendants nor scientifically knowable at the time the drug was distributed). Thus, in order to
23 prevail on a theory of products liability based on failure to warn, Plaintiffs must prove that
24 Intuitive's warnings with respect to the MCS and tip cover were inadequate, and that the
25 inadequacy of the warning caused Ms. Zarick's injury.
26
As discussed above, Ms. Zarick's vaginal cuff dehiscence probably was caused by her
27 failure to comply with her surgeon's instructions for post-operative care, and thus no warning
28 concerning the MCS or tip cover to Dr. Biesen-Bradley or Ms. Zarick herself could have changed
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CASE NO. 1-12-CV-237723
1 Ms. Zarick's outcome because her injuries were not proximately caused by the hysterectomy in the
2 first place.
3
Furthermore, there is no duty to warn of risks or obvious dangers that are known to
4 sophisticated users. "For those individuals or members of professions who do know or should
5 know about the product's potential dangers, that is, sophisticated users, the dangers should be
6 obvious, and the defense should apply." Johnson, 43 Cal. 4th at 67. Thus, "a manufacturer need
7 not warn members of a trade or profession (sophisticated users) about dangers generally known to
8 that trade or profession." Id.
9
Here, the evidence demonstrates that there was no need to warn Dr. Biesen-Bradley of any
10 alleged "dangers" of Intuitive's monopolar energy instrument and accessory because Dr. Bradley
11 already knew of the risk vaginal cuff dehiscence and, in fact, she had specifically warned the
12 Plaintiff of this risk prior to her hysterectomy. (Ex. D, Biesen-Bradley Tr. 10:2-25; 14:1-8.) Dr.
13 Bradley further testified that she had used monopolar energy devices in laparoscopic surgery
14 before she ever started performing da Vinci hysterectomies (id. at 67:24-68:8) and that she did not
15 need training on how to perform colpotomies when she attended Intuitive technology training
16 sessions on how to use the da Vinci surgical system because that was something she had already
17 been doing do for years. (Id. at 45:8-13.) Thus, Intuitive had no duty to warn Dr. Biesen-Bradley,
18 a sophisticated user, of dangers that were obvious and already known to her.
19
Because Plaintiffs will not be able to demonstrate causation, or even establish that Intuitive
20 had a duty to warn Dr. Biesen-Bradley as a sophisticated user, this claim will fail.
21
B.
22
Plaintiffs fare no better with their negligence claim, which also requires Plaintiffs to prove
Plaintiffs' Negligence Claims Will Fail
23 that her injury was caused by Intuitive. The elements of a cause of action for negligence are well
24 established. They are: "'(a) a legal duty to use due care; (b) a breach of such legal duty; and (c) the
25 breach as the proximate or legal cause of the resulting injury.'" Ladd v. County of San Mateo,
26 12 Cal. 4th 913, 917 (1996) (emphasis added) (citation omitted). The test of negligent design
27 involves a "'balancing of the likelihood of harm to be expected from a machine with a given design
28 and the gravity of harm if it happens against the burden of the precaution which would be effective
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CASE NO. 1-12-CV-237723
1 to avoid the harm.'" Chavez v. Glock, Inc., 207 Cal. App. 4th 1283, 1305 (2012). Thus, "'most of
2 the evidentiary matters'" relevant to apply the risk/benefit test in strict liability cases are "'similar to
3 the issues typically present in a negligent design test.'" Id. at 1315 (citation omitted).
4
As with the strict liability theory of design defect, because Plaintiffs will not be able to
5 establish causation, and because Plaintiffs have not developed any evidence that harm can be
6 expected from the MCS and tip cover as designed, Plaintiffs will not be able to prove that the MCS
7 and tip cover were negligently designed.
8
Similarly, "'[n]egligence law in a failure-to-warn case requires a plaintiff to prove that a
9 manufacturer or distributor did not warn of a particular risk for reasons which fell below the
10 acceptable standard of care, i.e., what a reasonably prudent manufacturer would have known and
11 warned about.'' Chavez, 207 Cal. App. 4th at 1305, 1313, 1323-24 (citation omitted) (remanding
12 with instructions to enter an order of summary adjudication in favor of defendants on Plaintiff's
13 failure to warn causes of action under both strict liability and negligence theories because Plaintiff
14 was a sophisticated user of the gun and holster at issue given his years of firearm training as a
15 United States Marine and police officer). As previously discussed, because Dr. Biesen-Bradley
16 was a sophisticated user as a surgeon with years of training and experience using monopolar
17 laparoscopic instruments, Intuitive had no duty to warn her of dangers that were obvious and
18 known to her.
19
Given the lack of any evidence to support a negligent design defect or negligent failure to
20 warn claim, Plaintiffs may rely on their claim that Intuitive undertook to proctor and train Dr.
21 Biesen-Bradley on the safe use of the da Vinci surgical equipment and failed to do so. (Compl.
22 65.) This claim is baseless. Dr. Biesen-Bradley testified that prior to her being able to operate on
23 the da Vinci surgical system without a proctor, Mercy San Juan hospital required her to perform 25
24 procedures that were proctored by Drs. Elliot and Fowler, two GYN oncologists at Mercy San Juan
25 who were already trained on the use of the da Vinci. In addition, Dr. Biesen-Bradley also testified
26 that she had assisted Drs. Elliot and Fowler in another 20 cases so she could to learn from their
27 techniques. The evidence demonstrates that while Intuitive trained Dr. Biesen-Bradley on the
28 technical aspects of using the robot, Dr. Bradley's proctoring and surgical training were performed
11
CASE NO. 1-12-CV-237723
1 by Drs. Elliot and Fowler at Mercy San Juan Hospital. Indeed, Dr. Biesen-Bradley specifically
2 denied that she would need training from Intuitive on how to perform a colpotomy because that
3 was a procedure she had done for years before she ever used the da Vinci surgical system.
4
Accordingly, Plaintiffs' negligence theories will fail as well.
C.
6
7
Plaintiffs' Breach of Warranty Lack Merit

1.
Plaintiffs Cannot Establish Any Express Warranty
To prevail on a claim for breach of an express warranty, Ms. Zarick must allege and prove
8 that: (1) Intuitive made an affirmation of fact or promise regarding the da Vinci surgical system
9 and the tip cover accessory, (2) the promise was part of the basis of the bargain, and (3) that the
10 warranty was breached. Weinstat v. Dentsply Intl, Inc., 180 Cal. App. 4th 1213, 1227 (2010)
11 (citing Cal. Comm. Code 2313(1)(a)).
12
Plaintiff cannot meet any of these requirements of proof. In discovery she was unable to
13 identify any statement, let alone any "affirmation of fact or promise" made by Intuitive with any
14 specificity. While plaintiffs' complaint recites a rote list of sources for Intuitive's alleged
15 warranties including "its labeling, advertising, marketing materials, detail persons [sic], seminar
16 presentations, surgeon training sessions, publications, notice letters, and regulatory submissions"
17 (see Compl. 69), Ms. Zarick did not allege that they formed the basis of her decision to have her
18 doctor perform her hysterectomy using the da Vinci surgical system. Rather, Ms. Zarick testified
19 that it was her doctor who advised her to have a robotic hysterectomy, that she relied on that advice,
20 and that the only research she did on robotic surgery occurred after her procedure via searches on
21 the Internet. (Ex. E Zarick 4/12/13 Tr. at 22:6-18; Ex. F, Zarick 2/11/16 Tr. at 76:4-7; 84:1-3.)
22 Plaintiff cannot introduce any evidence at trial that would allow her to recover for breach of
23 express warranty.
24
25
2.
Plaintiffs' Implied Warranty Claim Fails For Lack Of Privity
It is well settled that a plaintiff cannot state an implied warranty claim under section 2314
26 of the California Commercial Code where, as here, she is not in vertical privity with the defendant.
27 All W. Elecs., Inc. v. M-B-W, Inc., 64 Cal. App. 4th 717, 725 (1998) ("Privity of contract is a
28
12
CASE NO. 1-12-CV-237723
1 prerequisite in California for recovery on a theory of breach of implied warranties of fitness and
2 merchantability.").
3
Numerous courts agree that there is no privity between a medical device manufacturer and a
4 patient. See Adams v. I-Flow Corp., No. CV09-09550 R (SSx), 2010 WL 1339948 at *4 (C.D. Cal.
5 Mar. 30, 2010) (dismissing breach of warranty claims with prejudice because no plausible
6 inference can be drawn that any purchase of a product at issue was based on a warranty from the
7 manufacturer to the plaintiff given the fact that the pain pumps at issue were administered post8 surgery in a hospital environment). In the context of prescription medical devices and
9 pharmaceuticals, the transaction is between the manufacturer and the physician, not the patient.
10 Id. (citing Blanco v. Baxter Healthcare Corp., 158 Cal. App. 4th 1039, 1058 (2008)). Where a
11 plaintiff relies on a learned intermediary like a doctor to select a suitable product for her, she
12 cannot sue the manufacturers of said product on an implied warranty of fitness theory because
13 there is no privity between plaintiffs and the manufacturer of the subject product. See Evraets v.
14 Intermedics Intraocular, Inc., 29 Cal. App. 4th 779, 788 (1994) (holding no implied warranty claim
15 could stand where plaintiff relied upon his physician's skill or judgment to select or furnish a
16 suitable product); Crayton v. Rochester Med. Corp., No. 1:07-cv-1318 OWW GSA, 2011 WL
17 475009, at *15-16 (E.D. Cal. Feb. 4, 2011) (holding no implied warranty where plaintiff relied on
18 the advice of his doctors); Quatela v. Stryker Corp. 820 F. Supp. 2d 1045, 1047-48 (N.D. Cal.
19 2010) (same); McCarty v. Johnson & Johnson, No. 1:10-CV-00350 OWW-DLB, 2010 WL
20 2629913, at *6 (E.D. Cal. June 29, 2010) (same); Sherman v. Stryker Corp., No. SACV 09-224
21 JVS (ANx), 2009 WL 2241664, at *3 (C.D. Cal. Mar. 30, 2009) (following Evraets); Chandler v.
22 Chiron Corp., No. C-96-1047 SI, 1997 WL 464827, at *8 (N.D. Cal. July 28, 1997) (same), aff'd,
23 176 F.3d 481 (9th Cir. 1999).
24
It is undisputed that the da Vinci system was manufactured by Intuitive and sold to
25 hospitals for use by surgeons. (Compl. 80, 85.) Plaintiff relied on the advice, expertise and skill
26 of her doctor in choosing to have her hysterectomy performed using the da Vinci surgical system.
27 Therefore, her claim for breach of the implied warranty against Intuitive must fail.
28
13
CASE NO. 1-12-CV-237723
D.
Plaintiff Ryan Zarick Cannot Recover From Intuitive Damages For Loss of
Consortium For Injuries He Inflicted On His Wife
2
Finally, Plaintiff Ryan Zarick's loss of consortium claim depends on proof of causation as
4 well. There are four elements to a cause of action for loss of consortium: (1) a valid and lawful
5 marriage between the plaintiff and the person injured at the time of the injury; (2) a tortious injury
6 to the plaintiff's spouse; (3) loss of consortium was suffered by the plaintiff; and (4) the loss was
7 proximately caused by the defendant's act. Vanhooser v. Superior Court, 206 Cal. App. 4th 921,
8 927 (2012) (instructing that "'a cause of action for loss of consortium is, by its nature, dependent on
9 the existence of a cause of action for tortious injury to a spouse'" (citation omitted)). The concept
10 of consortium includes such elements as "love, companionship, comfort, affection, society, sexual
11 relations, solace and more." Smallwood v. Am. Trading & Transp. Co., 839 F. Supp. 1377, 1388
12 (1993).
13
Here, as discussed above, Ms. Zarick's personal injury claims are defective and thus Mr.
14 Zarick will not be able to demonstrate a "tortious injury" to his spouse, a required element of the
15 claim. Ms. Zarick herself believed that her injuries were caused by her husband. His attempt to
16 recover from Intuitive money damages for injuries that he inflicted upon his wife should be
17 rejected. Nor can he assert that he has suffered a loss of consortium. As Mr. Zarick admitted at his
18 deposition, his marital relationship with Ms. Zarick is "way better" than it was back in February
19 2009. Accordingly, Mr. Zarick cannot prevail on his loss of consortium claim.
20
E.
21
As the Honorable Peter Kirwan stated at the parties' final pre-trial conference, discovery
Motions
22 orders are to be enforced. Judge Kirwan stated that the Court would not allow Plaintiffs' counsel to
23 withhold documents responsive to Defendants' discovery requests and to disclose and use them for
24 the first time at trial on the grounds that such documents are intended to serve as "impeachment
25 documents."
26
27
28
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CASE NO. 1-12-CV-237723
Intuitive has filed several motions in limine to ensure an orderly trial based on the evidence
2 that have been properly disclosed and produced to date in accordance with the California
3 Discovery Code:
4
1. Defendant Intuitive Surgical's Motion in Limine No. 1 To Exclude Documents

Responsive To Intuitive Surgical's Requests For Production That Have Not Been
Previously Produced
5
6
2. Defendant Intuitive Surgical's Motion in Limine No. 2 To Exclude Opinions Of Experts

That Plaintiffs Failed To Disclose According To The California Discovery Code Or
Produce For Deposition
7
8
3. Defendant Intuitive Surgical's Motion in Limine No. 3 To Exclude Evidence Relating

To Intuitive Surgical's Communications With The U.S. Food And Drug Administration
9
10
4. Defendant Intuitive Surgical's Motion in Limine No. 4 To Exclude Evidence Of Other

Lawsuits Against Intuitive Surgical
11
5. Defendant Intuitive Surgical's Motion in Limine No. 5 To Exclude Testimony Of

Plaintiff's Future Lost Income
12
13
6. Defendant Intuitive Surgical's Motion in Limine No. 6 To Exclude Evidence Relating

To Medical Bills Unaccompanied By Evidence Of Payment
14
15
16
7. Defendant Intuitive Surgical's Motion in Limine No. 7 To Exclude Evidence Of Prior

Medical Malpractice Lawsuits Against Dr. Biesen-Bradley
17
Intuitive has also filed a motion to quash the notice to appear at trial and trial subpoenas of
18 11 witnesses who are not employees of Intuitive and four witnesses who reside out of state.
19 IV.
CONCLUSION
20
Following her robotically assisted hysterectomy, Ms. Zarick suffered a rare, but recognized
21 complication of a total hysterectomy. The medical records and opinions of her treating physician
22 indicate that Ms. Zarick's post-operative vaginal cuff dehiscence was probably caused by her non23 compliance with her surgeon's instructions. While unfortunate, the inescapable reality is that Ms.
24 Zarick's injuries were caused by her own negligence or her husband's conduct. There has been no
25 evidence in the case to suggest that her injuries were related in any way to ill-effects from her
26 hysterectomy, let alone any malfunction or design defect of the Endowrist monopolar curved
27 scissors and tip cover accessory used in Ms. Zarick's hysterectomy.
28
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CASE NO. 1-12-CV-237723
1 DATED: April 1, 2016
SKADDEN, ARPS, SLATE, MEAGHER & FLOM LLP
2
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By:
Allen Ruby/s/
ALLEN RUBY
Attorneys for Defendant
INTUITIVE SURGICAL, INC.
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526334-PALSR01A - MSW
CASE NO. 1-12-CV-237723

Intuitive Surgical vs. Zarick

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Intuitive Surgical vs. Zarick

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1 ALLEN RUBY (State Bar No.

6 LISA M. GILFORD (State Bar No. 171641)

COUNTY OF SANTA CLARA

MICHELLE ZARICK and RYAN ZARICK,

CASE NO.: 1-12-CV-237723

INTUITIVE SURGICAL INC. and DOES 1

DEFENDANT INTUITIVE SURGICAL'S

Trial Date: April 5, 2016

December 12, 2012

INTUITIVE'S TRIAL BRIEF

CASE NO. 1-12-CV-237723

2 TABLE OF CONTENTS ................................................................................................................I

STATEMENT OF FACTS ...................................................................................... 1

The Parties ................................................................................................... 1

Plaintiff's February 3, 2009 Hysterectomy ................................................... 2

Plaintiff's March 11, 2009 Laparotomy ........................................................ 4

PLAINTIFF'S CLAIMS LACK ANY MERIT ........................................................ 6

Plaintiffs Cannot Meet Their Burden to Establish The Necessary

Plaintiffs Cannot Prove Their Design Defect Claims ........................ 6

Plaintiffs Cannot Prove Their Failure to Warn Claim ....................... 9

Plaintiffs' Negligence Claims Will Fail ...................................................... 10

Plaintiffs' Breach of Warranty Lack Merit .................................................. 12

Plaintiffs Cannot Establish Any Express Warranty ......................... 12

Plaintiffs' Implied Warranty Claim Fails For Lack Of Privity ......... 12

Plaintiff Ryan Zarick Cannot Recover From Intuitive Damages For

CASE NO. 1-12-CV-237723

Adams v. I-Flow Corp.,

5 All West Electronics, Inc. v. M-B-W, Inc.,

CASE NO. 1-12-CV-237723

Quatela v. Stryker Corp.,

2 Saller v. Crown Cork & Seal Co., Inc.,

CASE NO. 1-12-CV-237723

3 complications following a robotically assisted laparoscopic hysterectomy using the da Vinci

Plaintiff Michelle Zarick is an individual residing in Sacramento County, California.

23 Plaintiff Ryan Zarick is the husband of Michelle Zarick.

CASE NO. 1-12-CV-237723

Plaintiff's February 3, 2009 Hysterectomy

CASE NO. 1-12-CV-237723

A laparoscopic total vaginal hysterectomy with robotic assistance refers to a procedure

CASE NO. 1-12-CV-237723

engaged in sexual intercourse contrary to Dr. Biesen-Bradley's instructions. According to her

Plaintiff's March 11, 2009 Laparotomy

CASE NO. 1-12-CV-237723

CASE NO. 1-12-CV-237723

Plaintiff's Claims Lack Any Merit

Plaintiffs Cannot Meet Their Burden to Establish The Necessary Elements of A

A manufacturer, distributor or retailer is "liable in tort if a defect in the . . . design of its

Plaintiffs Cannot Prove Their Design Defect Claims

INTUITIVE'S TRIAL BRIEF

CASE NO. 1-12-CV-237723

CASE NO. 1-12-CV-237723

CASE NO. 1-12-CV-237723

Plaintiffs Cannot Prove Their Failure to Warn Claim

Similarly, proximate cause is a requirement of Plaintiffs' failure to warn claim. "To be

CASE NO. 1-12-CV-237723

Plaintiffs' Negligence Claims Will Fail

CASE NO. 1-12-CV-237723

Similarly, "'[n]egligence law in a failure-to-warn case requires a plaintiff to prove that a

CASE NO. 1-12-CV-237723

Accordingly, Plaintiffs' negligence theories will fail as well.

Plaintiffs' Breach of Warranty Lack Merit

Plaintiffs Cannot Establish Any Express Warranty

Plaintiffs' Implied Warranty Claim Fails For Lack Of Privity

CASE NO. 1-12-CV-237723