Intuitive Surgical vs. Zarick

8/18/2019 Intuitive Surgical vs. Zarick

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I NTUITIVE'S TRIAL BRIEF CASE NO. 1-12-CV-237723

ALLEN RUBY (State Bar No. 47109)S. SHERYL LEUNG (State Bar No. 238229)

SKADDEN, ARPS, SLATE, MEAGHER & FLOM LLP525 University Avenue, Suite 1400

Palo Alto, California 94301

Telephone: (650) 470-4500Facsimile: (650) 470-4570

LISA M. GILFORD (State Bar No. 171641)

SKADDEN, ARPS, SLATE, MEAGHER & FLOM LLP300 South Grand Avenue Suite 3400

Los Angeles, California 90071Telephone: (213) 687-5000

Facsimile: (213) 687-5600

Attorneys for DefendantINTUITIVE SURGICAL, INC.

SUPERIOR COURT OF CALIFORNIA

COUNTY OF SANTA CLARA

MICHELLE ZARICK and RYAN ZARICK,

Plaintiffs,

v.

INTUITIVE SURGICAL INC. and DOES 1through 100, inclusive,

Defendants.

CASE NO.: 1-12-CV-237723

DEFENDANT INTUITIVE SURGICAL'S

TRIAL BRIEF

Trial Date: April 5, 2016

Time: 9:00 a.m.Place: Dept. 9

Action Filed: December 12, 2012

E-FILEDApr 1, 2016 1:15 PM

David H. YamasakiChief Executive Officer/Clerk

Superior Court of CA, County of Santa Clara

Case #1-12-CV-237723 Filing #G-82442

By R. Walker, Deputy


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iI NTUITIVE'S TRIAL BRIEF CASE NO. 1-12-CV-237723

TABLE OF CONTENTS

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

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

A.

Plaintiffs Cannot Meet Their Burden to Establish The NecessaryElements 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

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

2.

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

D. Plaintiff Ryan Zarick Cannot Recover From Intuitive Damages For

Loss of Consortium For Injuries He Inflicted On His Wife ........................ 14

E. Motions ..................................................................................................... 14

IV. CONCLUSION ..................................................................................................... 15

E-FILED: Apr 1, 2016 1:15 PM, Superior Court of CA, County of Santa Clara, Case #1-12-CV-237723 Filing #G-82442


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TABLE OF AUTHORITIES

Page(s)

CASES

Adams v. I-Flow Corp., No. CV09-09550 R(SSx), 2010 WL 1339948 (C.D. Cal. Mar. 30, 2010) .......................... 13

All West Electronics, Inc. v. M-B-W , Inc.,64 Cal. App. 4th 717 (1998) .............................................................................................. 12

Barker v. Lull Engineering Co.,

20 Cal. 3d 413 (1978) ......................................................................................................... 6

Blanco v. Baxter Healthcare Corp.,

158 Cal. App. 4th 1039, 1058 (2008) ................................................................................ 13

Brown v. Superior Court ,44 Cal. 3d 1049 (1988) ....................................................................................................... 9

Chandler v. Chiron Corp.,

No. C-96-1047 SI, 1997 WL 464827 (N.D. Cal. July 28, 1997),

aff'd , 176 F.3d 481 (9th Cir. 1999) .................................................................................... 13

Chavez v. Glock, Inc.,

207 Cal. App. 4th 1283 (2012) .......................................................................................... 11

Crayton v. Rochester Medical Corp.,

No. 1:07 – CV – 1318 OWW GSA,

2011 WL 475009 (E.D. Cal. Feb. 4, 2011),aff'd , 548 F. App'x 483 (9th Cir. 2013) .............................................................................. 13

Evraets v. Intermedics Intraocular, Inc.,

29 Cal. App. 4th 779 (1994) .............................................................................................. 13

Huitt v. Southern California Gas Co.,

188 Cal. App. 4th 1586 (2010) ............................................................................................ 9

Johnson v. American Standard, Inc.,

43 Cal. 4th 56 (2008) .................................................................................................... 9, 10

Ladd v. County of San Mateo,12 Cal. 4th 913 (1996) ...................................................................................................... 10

McCarty v. Johnson & Johnson,

No. 1:10-CV-00350 OWW-DLB,

2010 WL 2629913 (E.D. Cal. June 29, 2010) .................................................................... 13

Merrill v. Navegar, Inc.,89 Cal. Rptr. 2d 146, 176 (1999) ......................................................................................... 6



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28iii


Quatela v. Stryker Corp., No. C 10 – 03422, 2010 WL 7801786 (N.D. Cal. Dec. 17, 2010) ........................................ 13

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

187 Cal. App. 4th 1220 (2010) ............................................................................................ 7

Sherman v. Stryker Corp., No. SACV 09 – 224 JVS (ANx),2009 WL 2241664 (C.D. Cal. March 30, 2009) ................................................................. 13

Smallwood v. Am. Trading & Transp. Co.,

839 F. Supp. 1377, 1388 (1993) ........................................................................................ 14

Soule v. General Motors Corp.,

8 Cal. 4th 548 (1994) .......................................................................................................... 6

Vanhooser v. Superior Court ,

206 Cal. App. 4th 921 (2012) ............................................................................................ 14

Weinstat v. Dentsply International, Inc.,

180 Cal. App. 4th 1213 (2010) .......................................................................................... 12



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1


I. INTRODUCTION

This is a products liability case brought by Plaintiff Michelle Zarick after she suffered

complications following a robotically assisted laparoscopic hysterectomy using the da Vinci

surgical system. Ms. Zarick seek to recover money damages for her injuries from Defendant

Intuitive Surgical, Inc. ("Intuitive"), the manufacturer of the da Vinci surgical system.

Ms. Zarick alleges that her post-operative complications were caused by a malfunction of

the Endowrist monopolar curved scissors and tip cover accessory sold by Intuitive and used in her

surgery. Ms. Zarick claims that the malfunction allowed stray energy from the electrosurgical

instrument to burn her internally more than five weeks after her hysterectomy, necessitating a

repair surgery. However, Ms. Zarick cannot support her allegations with evidence. Instead, the

evidence in the case, including testimony by her surgeon, points to the conclusion that Ms. Zarick

probably suffered her post-operative complication because she failed to comply with her surgeon's

instructions to refrain from sexual activity for 6-8 weeks following her hysterectomy.

Alternatively, prior to suing Intuitive in 2012, Ms. Zarick attributed the cause of her post-operative

complications to physical violence from her husband, Plaintiff Ryan Zarick, who asserts claims for

loss of consortium against Intuitive.

This trial brief (i) provides background regarding the parties and the medical issues in this

case (ii) describes Plaintiffs' claims; and (iii) discusses the absence of legal and evidentiary support

for Plaintiffs' claims.

II. STATEMENT OF FACTS

A. The Parties

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

Plaintiff Ryan Zarick is the husband of Michelle Zarick.

Defendant Intuitive is based in Sunnyvale, California and is the global leader in robotic-

assisted minimally invasive surgery. Intuitive designs and manufactures the da Vinci surgical

system and Endowrist instruments. The Da Vinci surgical system is a multi-armed, remote-

controlled surgical device manufactured by Intuitive Surgical that has been utilized by surgeons in



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hospitals across the country for over a decade. The da Vinci surgical system is comprised of a

surgeon console, patient-side cart, and vision system. During a robotically assisted hysterectomy,

laparoscopic instruments are inserted through small abdominal incisions in the patient who is

positioned at the patient-side cart and controlled through three or four robotic arms on the patient-

side cart that carry out the surgeon's commands. The surgeon sits at the surgeon console a few feet

away from the patient-side cart and views the surgical field inside the patient's abdomen in a high-

definition, 3D image while the motions of her fingers on the master controls are translated into

movements of the surgical instruments inside the patient's body. The vision system displays a 2D

view of the procedure for the other members of the operating room.

Picture of surgeon at surgeon console, nurse at patient-side cart, and vision system.

B.

Plaintiff's February 3, 2009 Hysterectomy

In February 2009, Plaintiff Michelle Zarick had been diagnosed with multiple fibroids and

was suffering from severe menorrhagia (abnormally heavy bleeding). Treatment by birth control

pills had failed to alleviate the pain and discomfort of her condition. Ms. Zarick consulted her OB-



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GYN for additional treatment options. Her OB-GYN at the time, Dr. Rita Biesen-Bradley, advised

her of the risks and benefits of a laparoscopic total vaginal hysterectomy with robotic assistance.1

Dr. Biesen-Bradley explained that the procedure carried with it risks "ranging from trivial to fatal,"

including the risk of "pain, bleeding, infection, poor healing, hernia, or formation of adhesions" and

unintended injury to "other pelvic or abdominal structures." (See Ex. A, 1/29/09 Hysterectomy

Consent Form, ZAR 00090-91.) Dr. Biesen-Bradley also explained during a pre-operative

consultation that hysterectomy surgery carried with it a risk of dehiscence, where the vaginal cuff

wound opens and the organs inside the abdomen can expel. (Ex. D, Biesen-Bradley Tr. 10:9-22.)

Ms. Zarick accepted the risks and benefits and signed the consent form stating that she understood

she would not be fully recovered from the hysterectomy for approximately six to eight weeks.

During the February 3, 2009 robotically assisted laparoscopic hysterectomy, Dr. Biesen-

Bradley experienced no difficulties with the da Vinci surgical system or instruments and she noted

no complications with the surgery. There was no indication at the time or after that the da Vinci

surgical equipment malfunctioned in any way. Ms. Zarick did well throughout the surgery. Ms.

Zarick was discharged on February 5, 2009 with instructions for a re-check in 2 weeks and for

"pelvic rest, no lifting > 15 lbs, no vacuum x 6 weeks." (Ex. B, 2/6/09 Discharge Instructions,

Mercy San Juan 000013-15.) On February 16, 2009, Ms. Zarick returned for a post-operative

check-up by Dr. Biesen-Bradley, who noted that Ms. Zarick's wounds were healing well, with no

evidence of any post-surgical problems. Dr. Biesen-Bradley testified that, for this particular patient,

she knew that Ms. Zarick's husband had a job in the Middle East and that the couple was "very

close" so she specifically reminded Ms. Zarick that there was to be "nothing in the vagina for eight

weeks postop." Ms. Zarick indicated that she understood. (Ex. D Biesen-Bradley Tr. 13:16-24.)

1 A laparoscopic total vaginal hysterectomy with robotic assistance refers to a procedurewherein 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 performedlaparoscopically 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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C. Plaintiff's March 11, 2009 Laparotomy

On March 11, 2009, five weeks and one day after Ms. Zarick's hysterectomy, the Zaricks

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

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

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 theintercourse 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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sparse coagulase negative staphylococcus. The pathology report of the excised right fallopian tube

and ovary noted several times that there was "acute inflammation" of the surface serosa of the

fallopian tube and ovary.

As defense expert witness Dr. Katherine Hsiao testified, staphylococcus is not a bacteria

that is ordinarily found in a woman's vaginal tract. Rather, it is found abundantly on external skin,

such as the hand, penis or abdomen. Furthermore, the term "acute inflammation" is a pathology

finding that refers to a current and recent infection. In contrast, pathologists would use the term

"chronic" to describe an infection that has been ongoing for some time. Dr. Hsiao thus opined that

it was very unlikely that Ms. Zarick's tubo-ovarian infection and vaginal cuff dehiscence could

have been caused by a thermal injury that occurred at the time of her hysterectomy more than five

weeks prior. Dr. Hsiao agreed with Dr. Biesen-Bradley's opinion that Ms. Zarick's post-operative

vaginal cuff dehiscence was likely caused by resuming sexual relations prematurely and prior to

the period of time designated by her surgeon.

Dr. Hsiao further explained that it was especially important for Ms. Zarick to have followed

her surgeon's directions to refrain from sexual activities prior to the time the vaginal cuff is fully

healed because Dr. Biesen-Bradley used Vicryl sutures to sew Ms. Zarick's vaginal cuff. Vicryl

suture is a synthetic braided suture that can act like a wick to transmit bacteria up into the pelvis if

it is exposed to bacteria inside the vagina. Plaintiffs have no expert witness to testify that the da

Vinci surgical equipment caused or contributed to Ms. Zarick's complications.

D. Recovery

Following her discharge from Methodist Hospital on March 15, 2009, Ms. Zarick claims

that she was required to recuperate at home for six weeks. She seems to have made a full recovery.

Her October 12, 2012 annual exam with Dr. Cueto showed that she was a "healthy 41 year old

woman" and the Plaintiff admitted that she considered herself healthy in October 2012.



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III. Plaintiff's Claims Lack Any Merit

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

Products Liability Claim

Ms. Zarick's product liability claims are without merit. Although Plaintiffs have not

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. Plaintiffs Cannot Prove Their Design Defect Claims

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

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

her injury, then Defendant must establish that on balance, the benefits of the challenged design

2 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 formand 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 at570 (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 severalobscure components of the car under the complex circumstances of a particular car

accident).



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outweigh the risk of danger inherent in such design. Saller v. Crown Cork & Seal Co., 187 Cal.

App. 4th 1220, 1233 (2010). In such cases, "the jury must evaluate the product's design by

considering the gravity of the danger posed by the design, the likelihood such danger would occur,

the feasibility of a safer alternative design, the financial cost of an improved design, and the

adverse consequences to the consumer resulting from an alternative design." Id.

Here, Plaintiffs cannot pass their initial hurdle – causation. There is simply no evidence

that Ms. Zarick's March 11, 2009 vaginal cuff dehiscence was caused by an injury Plaintiff

sustained during her surgery, let alone one caused by a design defect. The only evidence in the

case as illustrated through the testimony of Drs. Hsiao and Biesen-Bradley and Ms. Zarick's

medical records, affirmatively establishes that Plaintiffs are responsible for Ms. Zarick's injuries by

prematurely resuming sexual activity contrary to her surgeon's orders. The evidence demonstrates

that the Zarick's decision to engage in sexual activity before Ms. Zarick was completely healed

from her hysterectomy probably allowed bacteria to be introduced into the surgery wound site,

causing an infection and weakening of the tissue on the vaginal cuff. The wound was further

aggravated by the mechanical trauma of intercourse, leading to the breakdown of the cuff.

Furthermore, Plaintiffs will not be calling their own experts to offer a different theory of

causation. Instead, Plaintiffs claim that they will rely on Intuitive's employees, Dr. Hsiao and

"percipient witnesses" to prove the defect. (Plaintiffs' Combined Opposition to Defendant's Motion

in Limine, Filed March 30, 2016.) However, Intuitive expects that Plaintiffs will not be able to

develop the evidence necessary to establish their claim. First, as demonstrated by Dr. Hsiao's

deposition testimony, Dr. Hsiao does not believe that Ms. Zarick's vaginal cuff dehiscence was

caused by the da Vinci surgical system or instruments. Second, none of the Intuitive employees

subpoenaed and/or noticed for attendance at trial have any percipient information concerning Ms.

Zarick's surgery or the specific MCS and tip cover used in her surgery. Finally, to the extent

Plaintiffs intend to rely on Ms. Zarick's treating physicians to opine as to causation, such evidence

will be not be admissible. This is because Plaintiffs elected not to serve Code-Compliant expert

disclosures designating any treating physicians as expert witnesses by the statutory deadlines and

failed to identify treating physicians as witnesses until March 25, 2016, more than 10 days after the



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deadline for parties to meet and confer over witness lists. See Complex Civil Guidelines XI.;

Intuitive's MIL No. 2. Thus, Plaintiffs will be unable to muster any testimonial or documentary

evidence to support a linkage between Ms. Zarick's specific post-operative complication and the

MCS and tip cover used in her February 3, 2009 hysterectomy.

Plaintiff herself attributed the vaginal cuff dehiscence and resulting laparotomy to her

husband's domestic violence. (See Ex. C, Aug. 16, 2010 Request and Order for Free Service of

Restraining Order.) In August 2010, Plaintiff filed a Request for Order (Domestic Violence

Prevention) in the Superior Court of California County of Sacramento, Family Law Division. In

the petition, Ms. Zarick requested that the Court issue a stay away order directed to Mr. Zarick on

the grounds that he has physically abused her multiple times. (Ex. C. at 16.) In her own

handwriting, Ms. Zarick attested under the penalty of perjury that "In March 2009, he hurt me so

badly I ended up in the hospital for a week due to recently having major surgery." ( Id. at 18.)

At her deposition, Ms. Zarick confirmed that the injuries referenced in her statement that "he hurt

me so badly I ended up in the hospital for a week" was her small bowel evisceration and that she

believed that statement to be true at the time she submitted the request. The evidence will show

that contrary to Dr. Biesen-Bradley's instructions to refrain from lifting and to "take it easy" during

her recovery period, the Zaricks physically fought each another and Mr. Zarick inflicted blunt force

trauma to Ms. Zarick's mid-section two days before her vaginal cuff evisceration.

Moreover, while there is evidence in the record concerning the relative benefits of the MCS,

Plaintiffs have not introduced any evidence of the risk of danger inherent in the design. Dr.

Biesen-Bradley testified that monopolar energy allows the surgeon to perform a procedure with

less bleeding. She had previously tried ultrasonic energy instruments in laparoscopically assisted

vaginal hysterectomies and did not find these instruments useful. Dr. Hsiao similarly testified that

monopolar energy is precise and efficient for controlling bleeding. She testified that she had tried

using a laparoscopic ultrasonic energy instrument before to perform a colpotomy and found the

tool unsatisfactory because it caused more bleeding which actually required the application of more

electrocautery to control the bleeding. She also explained that bipolar instruments are very

inefficient for cutting tissue, and that most laparoscopic surgeons use monopolar instruments to



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perform colpotomies whether the case is robotically-assisted or not. Dr. Hsiao further testified that

there is nothing fundamentally unsafe about monopolar energy instruments as opposed to other

energy forms and that it was possible to burn or injure a patient with any form of energy. Plaintiffs

offer no competing evidence to the contrary and no evidence of the risk of danger inherent in the

MCS design as compared to any other type of energized surgical instrument's design.

Because Plaintiffs cannot prove that the da Vinci surgical system or instruments caused her

March 9, 2011 injuries, or refute the evidence that the relative benefits of the MCS outweighs any

risk of its design, Plaintiff's design defect claim fails.

2. Plaintiffs Cannot Prove Their Failure to Warn Claim

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

liable in California, even under a strict liability theory, the plaintiff must prove that the defendant's

failure to warn was a substantial factor in causing his or her injury." Huitt v. S. Cal. Gas Co., 188

Cal. App. 4th 1586, 1604-05 (2010) (directing trial court to enter judgment for defendant because

plaintiffs have not established the defendant gas company's failure to warn was a cause in fact of

their injuries). Manufacturers have a duty to warn consumers about hazards inherent in their

products so that consumers can refrain from using the product altogether or evade its dangers by

careful use. Johnson v. Am. Standard, Inc., 43 Cal. 4th 56, 64, 74 (2008) (holding that plaintiff's

status as sophisticated user negated the manufacturer's duty to warn). For medical products, “[i]t

is well established that a manufacturer fulfills its duty to warn if it provides adequate warning to

the physician.” Brown v. Superior Court , 44 Cal. 3d 1049, 1060-62 & n.9 (1988) (holding that

manufacturers could not be liable for failing to warn about alleged defects that were neither known

by defendants nor scientifically knowable at the time the drug was distributed). Thus, in order to

prevail on a theory of products liability based on failure to warn, Plaintiffs must prove that

Intuitive's warnings with respect to the MCS and tip cover were inadequate, and that the

inadequacy of the warning caused Ms. Zarick's injury.

As discussed above, Ms. Zarick's vaginal cuff dehiscence probably was caused by her

failure to comply with her surgeon's instructions for post-operative care, and thus no warning

concerning the MCS or tip cover to Dr. Biesen-Bradley or Ms. Zarick herself could have changed



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Ms. Zarick's outcome because her injuries were not proximately caused by the hysterectomy in the

first place.

Furthermore, there is no duty to warn of risks or obvious dangers that are known to

sophisticated users. "For those individuals or members of professions who do know or should

know about the product's potential dangers, that is, sophisticated users, the dangers should be

obvious, and the defense should apply." Johnson, 43 Cal. 4th at 67. Thus, "a manufacturer need

not warn members of a trade or profession (sophisticated users) about dangers generally known to

that trade or profession." Id.

Here, the evidence demonstrates that there was no need to warn Dr. Biesen-Bradley of any

alleged "dangers" of Intuitive's monopolar energy instrument and accessory because Dr. Bradley

already knew of the risk vaginal cuff dehiscence and, in fact, she had specifically warned the

Plaintiff of this risk prior to her hysterectomy. (Ex. D, Biesen-Bradley Tr. 10:2-25; 14:1-8.) Dr.

Bradley further testified that she had used monopolar energy devices in laparoscopic surgery

before she ever started performing da Vinci hysterectomies (id. at 67:24-68:8) and that she did not

need training on how to perform colpotomies when she attended Intuitive technology training

sessions on how to use the da Vinci surgical system because that was something she had already

been doing do for years. ( Id. at 45:8-13.) Thus, Intuitive had no duty to warn Dr. Biesen-Bradley,

a sophisticated user, of dangers that were obvious and already known to her.

Because Plaintiffs will not be able to demonstrate causation, or even establish that Intuitive

had a duty to warn Dr. Biesen-Bradley as a sophisticated user, this claim will fail.

B. Plaintiffs' Negligence Claims Will Fail

Plaintiffs fare no better with their negligence claim, which also requires Plaintiffs to prove

that her injury was caused by Intuitive. The elements of a cause of action for negligence are well

established. They are: "'(a) a legal duty to use due care; (b) a breach of such legal duty; and (c) the

breach as the proximate or legal cause of the resulting injury.'" Ladd v. County of San Mateo,

12 Cal. 4th 913, 917 (1996) (emphasis added) (citation omitted). The test of negligent design

involves a "'balancing of the likelihood of harm to be expected from a machine with a given design

and the gravity of harm if it happens against the burden of the precaution which would be effective



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to avoid the harm.'" Chavez v. Glock, Inc., 207 Cal. App. 4th 1283, 1305 (2012). Thus, "'most of

the evidentiary matters'" relevant to apply the risk/benefit test in strict liability cases are "'similar to

the issues typically present in a negligent design test. '" Id. at 1315 (citation omitted).

As with the strict liability theory of design defect, because Plaintiffs will not be able to

establish causation, and because Plaintiffs have not developed any evidence that harm can be

expected from the MCS and tip cover as designed, Plaintiffs will not be able to prove that the MCS

and tip cover were negligently designed.

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

manufacturer or distributor did not warn of a particular risk for reasons which fell below the

acceptable standard of care, i.e., what a reasonably prudent manufacturer would have known and

warned about.'' Chavez , 207 Cal. App. 4th at 1305, 1313, 1323-24 (citation omitted) (remanding

with instructions to enter an order of summary adjudication in favor of defendants on Plaintiff's

failure to warn causes of action under both strict liability and negligence theories because Plaintiff

was a sophisticated user of the gun and holster at issue given his years of firearm training as a

United States Marine and police officer). As previously discussed, because Dr. Biesen-Bradley

was a sophisticated user as a surgeon with years of training and experience using monopolar

laparoscopic instruments, Intuitive had no duty to warn her of dangers that were obvious and

known to her.

Given the lack of any evidence to support a negligent design defect or negligent failure to

warn claim, Plaintiffs may rely on their claim that Intuitive undertook to proctor and train Dr.

Biesen-Bradley on the safe use of the da Vinci surgical equipment and failed to do so. (Compl. ¶

65.) This claim is baseless. Dr. Biesen-Bradley testified that prior to her being able to operate on

the da Vinci surgical system without a proctor, Mercy San Juan hospital required her to perform 25

procedures that were proctored by Drs. Elliot and Fowler, two GYN oncologists at Mercy San Juan

who were already trained on the use of the da Vinci. In addition, Dr. Biesen-Bradley also testified

that she had assisted Drs. Elliot and Fowler in another 20 cases so she could to learn from their

techniques. The evidence demonstrates that while Intuitive trained Dr. Biesen-Bradley on the

technical aspects of using the robot, Dr. Bradley's proctoring and surgical training were performed



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by Drs. Elliot and Fowler at Mercy San Juan Hospital. Indeed, Dr. Biesen-Bradley specifically

denied that she would need training from Intuitive on how to perform a colpotomy because that

was a procedure she had done for years before she ever used the da Vinci surgical system.

Accordingly, Plaintiffs' negligence theories will fail as well.

C. 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

that: (1) Intuitive made an “affirmation of fact or promise” regarding the da Vinci surgical system

and the tip cover accessory, (2) the promise was “part of the basis of the bargain,” and (3) that the

warranty was breached. Weinstat v. Dentsply Int’l, Inc., 180 Cal. App. 4th 1213, 1227 (2010)

(citing Cal. Comm. Code § 2313(1)(a)).

Plaintiff cannot meet any of these requirements of proof. In discovery she was unable to

identify any statement, let alone any "affirmation of fact or promise" made by Intuitive with any

specificity. While plaintiffs' complaint recites a rote list of sources for Intuitive's alleged

“warranties” including "its labeling, advertising, marketing materials, detail persons [sic], seminar

presentations, surgeon training sessions, publications, notice letters, and regulatory submissions"

( see Compl. ¶ 69), Ms. Zarick did not allege that they formed the basis of her decision to have her

doctor perform her hysterectomy using the da Vinci surgical system. Rather, Ms. Zarick testified

that it was her doctor who advised her to have a robotic hysterectomy, that she relied on that advice,

and that the only research she did on robotic surgery occurred after her procedure via searches on

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.)

Plaintiff cannot introduce any evidence at trial that would allow her to recover for breach of

express warranty.

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

of the California Commercial Code where, as here, she is not in vertical privity with the defendant.

All W. Elecs., Inc. v. M-B-W , Inc., 64 Cal. App. 4th 717, 725 (1998) ("Privity of contract is a



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D. Plaintiff Ryan Zarick Cannot Recover From Intuitive Damages For Loss of

Consortium For Injuries He Inflicted On His Wife

Finally, Plaintiff Ryan Zarick's loss of consortium claim depends on proof of causation as

well. There are four elements to a cause of action for loss of consortium: (1) a valid and lawful

marriage between the plaintiff and the person injured at the time of the injury; (2) a tortious injury

to the plaintiff's spouse; (3) loss of consortium was suffered by the plaintiff; and (4) the loss was

proximately caused by the defendant's act. Vanhooser v. Superior Court , 206 Cal. App. 4th 921,

927 (2012) (instructing that "'a cause of action for loss of consortium is, by its nature, dependent on

the existence of a cause of action for tortious injury to a spouse'" (citation omitted)). The concept

of consortium includes such elements as "love, companionship, comfort, affection, society, sexual

relations, solace and more." Smallwood v. Am. Trading & Transp. Co., 839 F. Supp. 1377, 1388

(1993).

Here, as discussed above, Ms. Zarick's personal injury claims are defective and thus Mr.

Zarick will not be able to demonstrate a "tortious injury" to his spouse, a required element of the

claim. Ms. Zarick herself believed that her injuries were caused by her husband. His attempt to

recover from Intuitive money damages for injuries that he inflicted upon his wife should be

rejected. Nor can he assert that he has suffered a loss of consortium. As Mr. Zarick admitted at his

deposition, his marital relationship with Ms. Zarick is "way better" than it was back in February

2009. Accordingly, Mr. Zarick cannot prevail on his loss of consortium claim.

E. Motions

As the Honorable Peter Kirwan stated at the parties' final pre-trial conference, discovery

orders are to be enforced. Judge Kirwan stated that the Court would not allow Plaintiffs' counsel to

withhold documents responsive to Defendants' discovery requests and to disclose and use them for

the first time at trial on the grounds that such documents are intended to serve as "impeachment

documents."



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Intuitive has filed several motions in limine to ensure an orderly trial based on the evidence

that have been properly disclosed and produced to date in accordance with the California

Discovery Code:

1. Defendant Intuitive Surgical's Motion in Limine No. 1 To Exclude DocumentsResponsive To Intuitive Surgical's Requests For Production That Have Not Been

Previously Produced

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 OrProduce For Deposition

3. Defendant Intuitive Surgical's Motion in Limine No. 3 To Exclude Evidence RelatingTo Intuitive Surgical's Communications With The U.S. Food And Drug Administration

4.

Defendant Intuitive Surgical's Motion in Limine No. 4 To Exclude Evidence Of OtherLawsuits Against Intuitive Surgical

5. Defendant Intuitive Surgical's Motion in Limine No. 5 To Exclude Testimony OfPlaintiff's Future Lost Income

6. Defendant Intuitive Surgical's Motion in Limine No. 6 To Exclude Evidence RelatingTo Medical Bills Unaccompanied By Evidence Of Payment

7. Defendant Intuitive Surgical's Motion in Limine No. 7 To Exclude Evidence Of PriorMedical Malpractice Lawsuits Against Dr. Biesen-Bradley

Intuitive has also filed a motion to quash the notice to appear at trial and trial subpoenas of

11 witnesses who are not employees of Intuitive and four witnesses who reside out of state.

IV. CONCLUSION

Following her robotically assisted hysterectomy, Ms. Zarick suffered a rare, but recognized

complication of a total hysterectomy. The medical records and opinions of her treating physician

indicate that Ms. Zarick's post-operative vaginal cuff dehiscence was probably caused by her non-

compliance with her surgeon's instructions. While unfortunate, the inescapable reality is that Ms.

Zarick's injuries were caused by her own negligence or her husband's conduct. There has been no

evidence in the case to suggest that her injuries were related in any way to ill-effects from her

hysterectomy, let alone any malfunction or design defect of the Endowrist monopolar curved

scissors and tip cover accessory used in Ms. Zarick's hysterectomy.



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DATED: April 1, 2016 SKADDEN, ARPS, SLATE, MEAGHER & FLOM LLP

By: Allen Ruby/s/ ALLEN RUBY

Attorneys for DefendantINTUITIVE SURGICAL, INC.


Intuitive Surgical vs. Zarick

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