JUN - 7 Randal Digby 2016-0… · 6 procedure and still is a very sophisticated plastic surgery 7...

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DEBORAH S. TAGGART, ESQ. (SBN 96954) [email protected]

Su ri f;fLED ~ld~[.,~~ul..rt ot California

1 - - Oti Angeles RONAN J. DUGGAN, ESQ. (SBN 266619) [email protected] SCHMID & VOILES 333 South Hope Street, 8th Floor Los Angeles, CA 90071

JUN - 7 2016

Tel: (213) 473 8700/Fax: (213) 473 8777

Attorneys for Defendant RANDAL HAWORTH, M.D.

SUPERIOR COURT OF THE STATE OF CALIFORNIA

FOR THE COUNTY OF LOS ANGELES

TESS BROUSSARD,

Plaintiff,

v.

RANDAL HAWORTH, M.D., AND DOES 1 TO 100 I

Defendants.

CASE BC523427 [Assigned to the Hon. Benny Osorio, Dept. 97];

TRIAL BRIEF OF DEFENDANT RANDAL HAWORTH, M.D.

TRIAL DATE: JUNE 13, 2016

TO THE COURT, PARTIES AND ALL COUNSEL OF RECORD:

Defendant RANDAL HAWORTH, M.D., hereby submits the following

Trial Brief regarding the issues, testimony and law applicable to

the trial of this matter.

1. PARTIES

Plaintiff, TESS BROUSSARD

Defendant, RANDAL HAWORTH, M.D.

COUNSEL OF RECORD

Bruce M. Bunch, Esq. LAW OFFICES OF BRUCE M. BUNCH, APC 200 North Westlake Blvd., Suite 204 Westlake Village, CA 91362 Tel (818) 707-8887

Deborah S. Taggart, Esq. Ronan J. Duggan, Esq. SCHMID & VOILES 333 S. Hope Street, 8th Floor Los Angeles, CA 90071 Tel (213) 473-8700

1 TRIAL BRIEF OF DEFENDANT RANDAL HAYWORTH, M.D.

1 2. IDENTIFICATION OF PARTIES

2 The plaintiff in this case is Tess Broussard, also known as

3 Brenda Tess Broussard, age 49. She describes herself as an

4 actress. According to deposition testimony, she is not seeking

5 lost earnings. Tess Broussard was at the time of the subject

6 procedure and still is a very sophisticated plastic surgery

7 patient, having undergone hundreds of plastic surgery procedures.

8 Dr. Randal Haworth is a board certified plastic surgeon who

9 practices in Beverly Hills. He attended LAC-USC Medical School

10 and obtained his MD degree in 1988. He did a one-year internship

11 in general surgery at The New York Hospital/Cornell Medical

12 Center (1988-1989) followed by a residency in general surgery at

13 the same institution (1989-1993). He then did a fellowship in

14 Plastic and Reconstructive Surgery at University of California

15 Los Angeles (1993-1995). He has published scholarly articles in

16 peer-reviewed journals such as Plastic and Reconstructive

17 Surgery. He has been in the private practice of plastic and

18 reconstructive surgery since 1995.

19 3 . OVERVIEW OF CASE

20 This is i medical malpractice action in which plaintiff Tess

21 Broussard alleges negligent failure to obtain informed consent in

22 connection with cosmetic dermal filler injections in her face,

23 resulting in blindness in her right eye due to retinal artery

24 occlusion . . c;:i C''':J ~ .. 25 4. FACTUAL BACKGROUND/EVIDENCE

C.:.? co ..... .,.

t'>,,) 26 Prior to commencing treatment with Dr. Haworth in 2007, Tess

Ci) I-"" 27 <;)")

Broussard had undergone numerous plastic surgery procedures by

28 other physicians. In 1996, she underwent revision rhinoplasty


1 with placement of a nasal silicone graft by plastic surgeon

2 Steven Teitelbaum, M.D., who also performed breast augmentation

3 surgery on her. Dr. Teitelbaum noted in his records that she had

4 previously undergone 4 rhinoplasties. She underwent another

5 breast augmentation surgery by plastic surgeon Frederic Corbin,

6 M.D. She received numerous Botulinum ("Botox") injections into

7 various areas of her face which were off-label (i.e., not FDA

8 approved) uses of this drug. She treated with the late plastic

9 surgeon Frank Ryan, M.D., for unknown plastic surgery procedures.

10 She received injections of dermal fillers including Bovine

11 Collagen, Restylane (Hyaluronic Acid) and Radiesse in various

12 areas of her face by dermatologist Stuart Kaplan, M.D., and Garth

13 Fisher, M.D., before treating with Dr. Haworth. She signed

14 numerous consent forms for these procedures. For example, on

15 81112000, she signed a consent form in Dr. Kaplan's office for

16 Botulinum A Toxin which states that she understood that the FDA

17 had not approved the use of this drug for the cosmetic injections

18 she was to receive. On 1111812004, Ms. Broussard asked Dr.

19 Kaplan to inject Hyaluronic Acid, a dermal filler, into her face.

20 Dr. Kaplan noted in his chart that this filler can be variable,

21 intermittent or catastrophic. He had her sign this statement in

22 the chart before giving the injections. On 312512005, she signed

23 a consent form in Dr. Kaplan's office for the cosmetic filler

24 Radiesse which advised of the risks of death, brain damage, (~'.)

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~-25 quadriplegia, paraplegia, loss of organs, disfigurement, etc.,

q:i fOf.;) 26 .... ,~ and which indicated that Radiesse was not FDA-approved for the i'-,;l

~~;:> 27 , .... r.. procedure. C'l

28 Ill


1 The evidence will show that all cosmetic dermal fillers,

2 including Collagen, Radiesse, Restylane, Juvederm, Sculptra,

3 Hyaluronic Acid, ArteFill, BellaFill, and autologous fat carry a

4 remote risk of blindness. Among dermal fillers, autologous fat

5 transfer is associated with the highest risk of blindness, and

6 fat is not a "drug" or "device" that can be approved for

7 injection by the FDA. Not only cosmetic fillers but injectable

8 Kenalog, a steroid, is associated with the risk of blindness.

9 Tess Broussard began treating with Dr. Haworth in 2007.

10 On 9/17/2007, Dr. Haworth performed plastic surgery on her

11 involving a mid facelift; fat transfer to tear troughs and malar

12 areas, nasolabial folds and temples; and a paranasal upper lip

13 lift. A week prior to the procedure, she signed a consent form

14 advising of risks including blindness.

15 On 12/8/2007, Dr. Haworth performed filler injections to her

16 1 face using ArteFill. Prior to the procedure, she signed a

17 consent form advising of risks including blindness. Above her

18 signature, she initialed the line, "I certify that I have read

19 and understood this consent and that all blanks were filled prior

20 to my signature."

21 Over the next five years, Tess Broussard continued to

22 undergo numerous plastic surgery procedures including cosmetic

23 fillers by Dr. Haworth and other physicians. She signed consent

24 forms for these procedures which disclosed serious risks q;:i C·'1 25 ~. including blindness. For example, on 3/17/11, she underwent CD C•:l 26 ~- surgery by plastic surgeon Steven Svehlak, M.D., involving f'.,)

<P 27 ,..,,~ liposuction of arms, abdomen, flanks, back, inner and outer c-)

28 thighs, and fat grafting to buttock and bilateral temples, among


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other procedures. A week before this surgery, she signed consent

forms for liposuction which set forth risks of serious injury

including death, and for fat grafting which set forth risks

including loss of vision.

The procedure in question in this case was performed by Dr.

Haworth on 1/22/2013. He performed a skin rejuvenation procedure

involving a CIT roller to face and neck, nasal dystopia

correction, upper lip lift, mild liposuction to face, and facial

ArteFill injections. These surgical procedures were each listed

on the consent form she signed for this surgery. This was the

17th time she received ArteFill injections to her facial area by

Dr. Haworth, in addition to other fillers such as fat, Juvederm,

Aquamid and Restylane. Prior to this surgery and others, she

signed consent forms disclosing the risk of blindness. The

subject consent form states:

... I understand that each of the plastic surgical procedures described ... involves varying degrees of risk and complication. After weighing the alternatives and the risks associated with each alternative, I consent to the selected procedures even though there are other procedures which might serve the same or similar purpose.

The consent form also states that she understands there is a

remote risk of death or serious disability with the procedure.

She certified that she read and understood this consent.

In addition to this consent form, she signed an information

sheet for facial contouring which states there is a risk of

blindness. This form states, "I have read and understand the

above consultation information." Her signature appears next to

this statement .

Ill


.e 1 After this surgery, Tess Broussard reported that she could

2 not see out of her right eye. Dr. Haworth referred her

3 immediately to retinal specialist David Boyer, M.D., whose

4 associate Dr. Novack saw her that day. She had sustained the

5 rare and dreaded risk of retinal artery occlusion from one of the

6 dermal filler injections.

7 The evidence will show that embolic blindness from dermal

8 fillers is usually irreversible and the sight in her eye could

9 not be restored. Treatment was provided to her but was not

10 effective in resolving the blindness. Dr. Haworth provided a car

11 and driver for Ms. Broussard for a month following the injury to

12 allow her to acclimate to her condition before resuming driving.

13 He paid for many of her medical expenses.

14 Ms. Broussard continued to treat with Dr. Haworth for a

15 period of time after the surgery in question. In February 2013,

16 within the month after she lost the sight in her right eye, he

17 did laser procedures on her and injected Kenalog for scar tissue

18 treatment after advising Ms. Broussard that Kenalog carries the

19 same risk of blindness as do facial fillers.

20 After the subject surgery, Ms. Broussard continued to

21 receive cosmetic filler injections and other plastic surgery

22 procedures from dermatologist Dr. Stuart Kaplan and plastic

23 surgeons Dr. Steven Svehlak and Dr. Davis Nguyen. She has also

24 received numerous injections of Kenalog. Recently, on 7/14/2015, .s:;:;;;.'J qci 25 ~, Tess Broussard underwent fat grafting and other procedures by Dr. (};)

1::;;:(,.') 26 Svehlak. Prior to this procedure, she signed a consent form for 1·-..)

f,:l;) 27 ""'"' the fat grafting which disclosed the risks of loss of vision and C .. !

28 stroke. She underwent a face lift by Dr. Davis Nguyen two weeks


1 later, on 7/29/15, after giving informed consent, and this

2 surgery was followed by numerous Kenalog injections.

3 5. CONTENTIONS OF THE PARTIES

4 Plaintiff contends that Dr. Haworth failed to obtain

5 informed consent prior to the 1/22/2013 surgical procedure,

6 failed to inform her that the FDA had not approved Artef ill for

7 injection into certain areas of the face, and negligently failed

8 to see her in the recovery room after the surgery.

9 Defendant Dr. Haworth's response to these contentions is

10 that the care he provided to Tess Broussard was appropriate and

11 within the standard of care. Specifically, he contends:

12 A. Tess Broussard was consented for the cosmetic

13 injections before the subject procedure as well as numerous

14 others after being informed of all material risks and potential

15 complications including blindness.

16 B. Off-label use of injectable fillers such as the one

17 used in this case is not only legal, but represents an

18 appropriate physician standard of care.

19 C. The standard of care did not, and does not, require

20 disclosure of the fact that the filler was being used in

21 locations that were off-label, as off-label does not represent a

22 "risk." There is no evidence whatsoever that establishes that

23 off-label use of Artefill is riskier than its use in the

24 locations which are FDA-approved. C:::> CJ 25 D. The dermal filler injections Dr. Haworth q~

1:';.9. 26 ":'':'

administered to Ms. Broussard on 1/22/2013 were performed in the f',,)

!.'.)'.) 27 ,...,. standard manner recommended by experts in the field. The (J"i

28 devastating risk of blindness and other embolic injuries such as


1 stroke are rare but known risks of dermal filler injections that

2 occur despite use of the appropriate methods of injection and

3 regardless of the facial area injected, whether it be the

4 nasolabial folds, around the nose, in the glabella, forehead or

5 in the temples.

6 E. Dr. Hayworth did see the patient in the recovery

7 room after the surgery as per his custom and practice. She did

8 not mention to Dr. Haworth any difficulty with her vision, and

9 may not have been fully awake and alert after anesthesia. The

10 anesthesiologist also saw her after the surgery before she was

11 discharged home and was not told of a visual problem. Regardless

12 of whether she mentioned vision loss in the recovery room, the

13 short window within which there was even a slight possibility of

14 treating the occluded retinal artery had long since passed.

15 6. APPLICABLE LAW

16 In medical malpractice cases, the plaintiff must establish

17 each of the following basic elements: "(1) the duty of the

18 professional to use such skill, prudence, and diligence as other

19 members of his [or her] profession commonly possess and exercise;

20 (2) a breach of that duty; (3) a proximate causal connection

21 between the negligent conduct and the resulting injury; and (4)

22 actual loss or damage resulting from the professional

23 negligence." 1

24 A. STANDARD OF CARE r;:;::'i C"l 25 ~-

The duty of a physician to a patient is to possess that c;;i co 26 ~-

degree of learning and skill ordinarily possessed by reputable f'.,)

.t,::;;;i 27 1-.~ physicians in the same or similar locality under similar ,~:r;

28 1 Gami v. Mulliken Medical Center (1993) 18 Cal.App.4th 870, 877.


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circumstances. 2 This duty is interchangeably referred to in the

medical malpractice community as the applicable "standard of

care" or applicable "standard of practice."

Although the level of skill is sometimes referred to as that

of the "average'' professional, that is misleading insofar as it

suggests that the mid-range level of skill sets the standard. 3

To the contrary, the standard of care is not based upon an

average of the best and worst practitioners, and no comparison is

made to those who exercise an unusually high or low degree of

care. 4 Rather, the standard of care refers to exercising the

level of skill and knowledge possessed of "reasonably careful"

professionals in similar circumstances. 5 The skill and knowledge

levels themselves are not qualified as "average", "above average"

or otherwise. Rather, "the skill" and "the knowledge" required

are the minimum common level of that possessed and used by

similarly situated professionals in like circumstances.

Conceptually, the standard of care is a continuum-it

requires that the physician receive the minimum passing grade,

not an "A". Certain physicians might practice at an A+ level,

but their level of skill is irrelevant in determining negligence

because it is not the standard of care to be imposed on the

defendant. 6 Nor is the standard of care determined by what the

numerical majority of physicians would do. To the contrary, the

"standard of care" is a fluid concept, embracing different

treatment methods by different physicians, even if ultimately

2 Keen v. Prisinzano (1972) 23 Cal.App.3d 275, 279. 3 See, Sims v. Weeks (1935) 7 Cal.App.2d 28, 42. 4 Ibid; Scarano v. Schnoor (1958) 158 Cal.App.2d 612. 5 See, CACI No. 501 and BAJI 6.00.1. 6 Fns. 7-8, supra.

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TRIAL BRIEF OF DEFENDANT RANDAL HAYWORTH, M.D.

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wrong, unsuccessful, or chosen by a minority of reputable

physicians:

"Where there is more than one recognized method of diagnosis or treatment, and no one of them is used exclusively and uniformly by all practitioners of good standing, a physician is not negligent if, in exercising his or her best judgment, he or she selects one of the approved methods, which later turns out to be a wrong selection, or one not favored by certain other practitioners." 7

Thus, the physician's duty, the standard of care applied to

determine medical negligence, is whether or not the physician

possessed and exercised the minimum common learning and skill of

physicians of similarly situated, reputable professionals.

1. Success/Perfection Not Required

While laymen may expect the utmost in medical care, this

expectation is not incorporated into tort law. A doctor is not a

guarantor of results or a warrantor of cures, and will not be

held responsible for untoward results, in the absence of a want

of reasonable care and skill. 8 The law does not hold doctors

liable for every untoward result that may occur. 9 Medical

perfection is not required-a physician is not negligent if he

errs in judgment; if his efforts prove unsuccessful; if he makes

a "mistake;" if his diagnosis is incorrect; or, if he opts for a

recognized method of treatment which with others disagree, or

which in retrospect turns out to be a wrong selection. 10

It is only when the level of learning and skill of the

7 CACI No. 506, BAJI No. 6.03. 8 Sanchez v. Rodriguez (1964) 226 Cal.App.2d 439, 449. 9 Folk v. Kilk (1975) 53 Cal.App.3d 176, 185. 10 CACI No. 505; BAJI No. 6.03.

10. TRIAL BRIEF OF DEFENDANT RANDAL HAYWORTH, M.D.

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physician falls below the minimum expected of reputable

physicians that liability follows, since success and/or

perfection in diagnosis and treatment are not required by law.

2. Expert Testimony is Conclusive

In a general (non-professional) negligence case, if expert

testimony is introduced to assist the jurors, they are free to

give the expert opinion as much weight as it deserves. Absent

special circumstances, expert testimony is generally not binding

upon the trier of fact, who may reject it and substitute its

common knowledge. 11

That rule is different in medical malpractice actions such

as this. Because medicine is practiced by the exercise of

judgment developed through years of specialized education, it is

not within the scope of the jury's knowledge to substitute lay

opinions for expert medical testimony on the standard of care.

Thus, in this case, like the majority 6f medical malpractice

actions, expert testimony is conclusive on the standard of care

jand cannot be disregarded. 12 This expert testimony may include I ;that of the defendant-physician. 13

B. CAUSATION

"In much the same way that laymen are not qualified to judge

whether a doctor has been negligent because of their lack of

common knowledge on the subject, they also are not qualified from

11 Foreman & Clark Corp. v. Fallon (1971) 3 Cal.3d 875, 890. '

12 The ~xception is where a physician's negligence can be evaluated by a layman's "common knowledge", in which case expert testimony is not required to establish breach of the applicable standard of care. (Lawless v. Callaway (1944) 24 Cal.2d 81, 86.) An example of the "common knowledge" exception to the expert testimony requirement is failing to x-ray a traumatic injury. (Agnew v. Los Angeles (1947) 82 Cal.App.2d 616, 619.) 13 CACI No. 501.


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a medical standpoint to determine the effects of the 'negligent'

acts on the plaintiff. 1114

C. INFORMED CONSENT

1. Informed Consent - Definition

A patient's consent to a medical procedure must be

"informed." A patient gives an "informed consent" only after the

plastic surgeon has fully expla1ned the proposed treatment or

procedure.

A plastic surgeon must explain the likelihood of success and

the risks of agreeing to a medical procedure in language that the

patient can understand. A plastic surgeon must give the patient

as much information as she needs to make an informed decision,

including any risk that a reasonable person would consider

important in deciding to have the proposed treatment or

procedure, and any other information skilled practitioners would

disclose to the patient under the same or similar circumstances.

The patient must be told about any risk of death or serious

injury or significant potential complications that may occur if

the procedure is performed. A plastic surgeon is not required to

explain minor risks that are not likely to occur. 15

Case law concerning informed consent provides, "A physician

has a duty to inform a patient in lay terms of the dangers

inherently and potentially involved in a proposed treatment." 16

"A physician is required to disclose 'all information relevant to

14 Barton v. Owen (1977) 71 Cal.App.3d 488, 506, noting this rule is also subject to a "common knowledge" exception, which is not applicable here. lS CACI 532 16 McKinney v. Nash (1981) 120 Cal.App.3d 428, 440, 174 Cal.Rptr. 642.


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a meaningful decisional process. '" 17

Courts have observed that Cobbs v. Grant created a two-part

test for disclosure. "First, a physician must disclose to the

patient the potential of death, serious harm, and other

complications associated with a proposed procedure." 18 "Second,

'[b]eyond the foregoing minimal disclosure, a doctor must also

reveal to his patient such additional information as a skilled

practitioner of good standing would provide under similar

circumstances. ' "19 The doctor has no duty to discuss minor

risks inherent in common procedures when it is common knowledge

that such risks are of very low incidence. 20 "Obviously involved

in the equation of materiality are countervailing factors of the

seriousness and remoteness of the dangers involved in the medical

procedure as well as the risks of a decision not to undergo the

procedure. " 21

The scope of a physician's duty to disclose is measured by

the amount of knowledge a patient needs in order to make an

informed choice. 22

2. Failure to Obtain Informed Consent - Essential Factual

Elements

Plaintiff Tess Broussard claims that Dr. Hayworth was

negligent because he injected a dermal filler into her face

without first obtaining her informed consent. To establish this

claim, Ms. Broussard must prove all of the following:

17 Cobbs v. Grant (1972) 8 Cal.3d 229, 242, 104, Cal.Rptr. 505.)

18 Daum v. SpineCare Med. Group, Inc. (1997) 52 Cal.App.4th 1285, 1301, 61 Cal. Rptr. 2d 260. 19 ( Id. at p. 1302, citation omitted.) 20 (Cobbs, supra, 8 Cal.3d at p. 244.) 21

McKinney, supra, 120 Cal.App.3d at p. 441 (emphasis added). 22

Truman v Thomas (1980) 27 Cal.3d 285, 165 Cal.Rptr.308.


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• (1) That Dr. Hayworth performed a dermal filler procedure

on Ms. Broussard's face;

(2) That Ms. Broussard did not give her informed consent

for the dermal filler procedure;

(3) That a reasonable person in Ms. Broussard's position

would not have agreed to the dermal filler procedure if she had

been fully informed of the results and risks of the procedure;

and

(4) That Ms. Broussard was harmed by a result or risk that

Dr. Haworth should have explained before the dermal filler

injections were performed. 23

"The prudent person test for causation was established to

protect defendant physicians from the unfairness of having a jury

consider the issue of proximate cause with the benefit of the

'20/20 vision of hindsight ... ' 1124

3. Plaintiff Would Have Consented to the Cosmetic

Procedure Even If She Had Been Informed of the Risks

Dr. Hayworth contends that he obtained informed consent from

Ms. Broussard. She was fully informed of the risks of dermal

fillers at the time of subject procedure and on numerous prior

occasions. It is anticipated that plaintiff will deny that she

gave informed consent and will assert that she would not have

consented to the dermal filler had she known of the risk of

blindness. If so, Dr. Hayworth will establish that Ms. Broussard

would have consented to the dermal fillers regardless of the

risks. 25

23 CACI 533 24 Truman v Thomas, supra, 27 Cal.3d 285, 294. 25 CACI 535, 550


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"Whenever appropriate, the court should instruct the jury on

the defenses available to a doctor who has failed to make the

disclosure required by law. 1126

The patient-plaintiff may testify on this subject but the issue extends beyond his credibility. Since at the time of trial the uncommunicated hazard has materialized, it would be surprising if the patient-plaintiff did not claim that had he been informed of the dangers he would have declined treatment. Subjectively he may believe so, with the 20/20 vision of hindsight, but we doubt that justice will be served by placing the physician in jeopardy of the patient's bitterness and disillusionment. Thus, an objective test is preferable: i.e., what would a prudent person in the patient's position have decided if adequately informed of all significant perils. 27

4. Disclosure of Rare and Remote Risks Not Required

Although Dr. Hayworth contends that he disclosed all kno~n

risks, remote and common, to plaintiff, the law does not require

that a physician is required to tell about the dangers of a

simple procedure if it is commonly understood that the dangers

are not likely to occur. 28 The reported number of cases of

blindness due to retinal artery occlusion caused by a dermal

filler is extremely small, especially in light of the volume and

frequency of these procedures throughout the world.

"Disclosure need not be made if the procedure is simple and

the danger remote and commonly appreciated to be remote." 29

5. Disclosure of Off-Label Use Not Required

The notion that off-label use is itself a "risk" is a

misperception. Off-label use is not only legal and ethical, but

26 Cobbs v Grant, 8 Cal.3d at 245. supra, p.

27 Cobbs v Grant, 8 Cal.3d at 245. supra, p.

28 CACI 552. 29

Cobbs v Grant, 8 Cal.3d at 245. supra, p.


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is a common and integral feature of medical practice. New uses

for drugs are often discovered after FDA approves the package

inserts that explain a drug's approved uses. Congress would have

created havoc in the practice of medicine if it had required

physicians to follow the expensive and time-consuming procedures

of obtaining FDA approval before putting drugs and devices to new

uses. Thus Congress exempted the practice of medicine from the

Federal Food, Drug and Cosmetic Act so as not to limit a

physician's ability to treat his/her patients. 30

The FDA has never had the authority to regulate the practice

of medicine; physicians may use legally marketed drugs or devices

in any way that they believe, in their professional judgment,

will best serve their patients. 31

The FDA does require that participants in studies and

clinical trials of drugs and devices (i.e., for research or

~ experimental reasons) be advised that the study involves

research. 32 Apart from investigational or research·purposes,

there is no state or federal requirement that patients must or

should be advised of off-label use of drugs or devices. In fact,

the U.S. Congress enacted section 214 of the FDAMA (Food and Drug

Administration Modernization Act, enacted in 1997) which

explicitly prohibits FDA intrusion into medical practice with

respect to off-label use of devices. 33

Ill

II

30 United States v Algon Chemical, 879 F.2s 1154, 1163 (3d Cir.1989).

31 Klein v Biscup 673 N.E.2d 225, 231 (Ohio 1996).

32 Daum v Spinecare Medical Group, 61 Cal.Rptr.2d 260 (Cal.Ct.App.1997)

33 Pub.L. No. 105-115, §214, 111 Stat. at 2348 (codified at 21 U.S.C. § 396 (FDCA§906)


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• California informed consent requirements ·are limited to

providing medical information. 34 The obligation for physicians

to obtain consent of their patients does not extend to

information that has no bearing on the risks and benefits of

treatment. 35 FDA regulatory status is not a "risk" of surgery.

There is no duty obligating a physician to discuss FDA regulatory

status of products.being used for a particular treatment because

FDA regulatory status is not a risk, benefit, or alternative of

medical treatment, nor does a product's legal status affect the

nature of the treatment. 36 "Off-label" is merely a regulatory

description of the use of a medical device or drug - a legal

status, not a medical fact. 37 Aside from experimental and

investigative research cases governed by federal statute, no

appellate cases have been found holding that a physician's

failure to disclose that the drug therapy was prescribed off-

label violated the duty to obtain informed consent.

7. DAMAGES AND COSTS

Plaintiff has waived a claim for past and future lost

earnings. Her medical expenses associated with her eye injury

were largely paid for by her medical insurance and by Dr.

Haworth.

As to any future damages she may claim, it is the plaintiff

who has the burden of proof to establish such damages, to a

reasonable certainty.

Ill

34 Cobbs v Grant, 8 Cal. 3d at 243, 244. supra, p.

35 Cobbs v Grant, 8 Cal. 3d at 244. supra, p. 36 Klein, 673 N.E.2d at 231. supra, 37

Klein, 673 N.E.2d at 231. supra,


t.:i::i

• 1 On October 28, 2015, defendant Dr. Haworth served an Offer

2 to Compromise for waiver of costs in exchange for dismissal with

3 prejudice. Plaintiff allowed the Offer to Compromise to lapse.

4 Defendant will seek costs and interest from the time of the Off er

5 in the event of a defense verdict.

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DATED: June 7, 2016 SCHMID & VOILES

By DEBORAH S. TAGGART, ESQ. RONAN J. DUGGAN, ESQ. Attorneys for Defendant, RANDAL HAWORTH, M.D.

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PROOF OF SERVICE

STATE OF CALIFORNIA, COUNTY OF LOS ANGELES

I am employed in the County of Los Angeles, State of California. I am over the age of 18 and not a party to the within action; my business address is Schmid & Voiles ("the firm"), 333 South Hope Street, 8th Floor, Los Angeles, CA 90071. I am readily familiar with the business practice for collection and processing mail with the United States Postal Service.

On June 7, 2016, I served the foregoing document described as: TRIAL BRIEF OF DEFENDANT RANDAL HAWORTH, M.D. on the interested parties in this action by placing a copy thereof addressed as follows:

Bruce M. Bunch, Esq. LAW OFFICES OF BRUCE M. BUNCH, APC 200 North Westlake Blvd., Suite 204 Westlake Village, CA 91362 Telephone: (818) 707-8887 Facsimile: (818) 707-8884 ATTORNEYS FOR PLAINTIFF TESS BROUSSARD

By US Mail [CCP §§1013(a) ;1013a] I placed a sealed envelope with postage thereon fully prepaid for deposit with the United States Postal Service by placing it for collection and mailing at my business address on the date stated, following the firm's ordinary business practice. I am aware that on motion of party served, service is presumed invalid if the postal cancellation date or postage meter date is more than one (1) day after the date of deposit for mailing in the affidavit.

I declare under penalty of perjury under the laws of the State of California that the above is true and correct.

Executed June 7, 2016, at Los

EMMY ZHIN Type or Print Name


JUN - 7 Randal Digby 2016-0… · 6 procedure and still is a very sophisticated plastic surgery 7...

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