Source: s3://data.kl3m.ai/documents/govinfo/USCOURTS/USCOURTS-azd-2_06-cv-02914/USCOURTS-azd-2_06-cv-02914-0/pdf.json

Nature of Suit Code: 362
Nature of Suit: Medical Malpractice
Cause of Action: 28:1346 Tort Claim

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WO

IN THE UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF ARIZONA

Jose Madrigal, et al.,

Plaintiffs, 

vs.

Rafael N. Mendoza, et al., 

Defendant. 

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No. cv-06-2914-PHX-ROS

ORDER

Pending before the Court is the Defendant United States of America’s Motion for

Summary Judgment (Doc. 96), which argues that Plaintiffs’ expert witness must be excluded

and, as a consequence, the case against Defendant dismissed. For the reasons stated herein,

Defendant’s motion will be granted.

BACKGROUND

Plaintiff Maria Elena Madrigal was pregnant with her eighth child. In her six previous

pregnancies (one of which resulted in twins) she had no complications during labor and

delivery. All her prenatal care during the instant pregnancy took place at Clinica Adelante,

a federally supported clinic. Her prenatal care was provided by Dr. Rafael Mendoza, Dr.

Ajaz Rahaman, and Marcia Brickson, a nurse practitioner, all federal employees against

whom any claim is covered under the Federal Tort Claims Act.

On November 26, 2002 then 36 weeks pregnant, Maria Madrigal had an ultrasound

study that estimated the baby’s weight at 4,172 grams (9 pounds, 3 ounces), plus or minus

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743 grams. She was also found to be non-diabetic. She was offered an early induction of

labor at 37 weeks with amniocentesis to confirm lung maturity or a planned induction at 39

weeks otherwise. She chose an induction at 39 weeks.

On December 10, 2002, Dr. Mendoza induced labor. That afternoon he went off duty

and Dr. Rahaman assumed care until around 4:00pm when Dr. Forest took night call for the

Clinica patients. As Dr. Forest delivered the baby, the delivery was complicated by the

development of a shoulder dystocia, a condition that generally occurs when the infant’s

shoulder becomes wedged behind the mother’s pelvic bone. Dr. Forest performed a number

of maneuvers and delivered the baby, Melissa Madrigal, weighing 4,821 grams, or 10

pounds, 10 ounces.

At birth, Melissa Madrigal had a brachial plexus injury. This injury is a reasonably

common consequence of shoulder dystocia and can be, but is usually not, permanent.

Plaintiffs allege that Melissa Madrigal’s injury is permanent and that, as a result, she has only

about 20% use of her left arm. They brought suit alleging that her injury is the result of

medical negligence during the delivery – in particular, that Maria Madrigal should have been

offered a cesarean section and that improper traction was used during delivery. 

STANDARD OF REVIEW

A court must grant summary judgment if the pleadings and supporting documents,

viewed in the light most favorable to the non-moving party, "show that there is no genuine

issue as to any material fact and that the moving party is entitled to a judgment as a matter

of law." Fed. R. Civ. P. 56(c); see Celotex Corp. v. Catrett, 477 U.S. 317, 322-23 (1986).

Substantive law determines which facts are material, and "[o]nly disputes over facts that

might affect the outcome of the suit under the governing law will properly preclude the entry

of summary judgment." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 248 (1986). In

addition, the dispute must be genuine; that is, the evidence must be “such that a reasonable

jury could return a verdict for the nonmoving party." Anderson, 477 U.S. at 248.

“[A] party seeking summary judgment always bears the initial responsibility of

informing the district court of the basis for its motion, and identifying those portions of the

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pleadings, depositions, answers to interrogatories, and admissions on file, together with the

affidavits, if any, which it believes demonstrate the absence of a genuine issue of material

fact.” Celotex, 477 U.S. at 323 (internal quotations and citations omitted). The party

opposing summary judgment “may not rest upon the mere allegations or denials of [the

party’s] pleading, but . . . must set forth specific facts showing that there is a genuine issue

for trial.” Fed. R. Civ. P. 56(e); see Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp.,

475 U.S. 574, 586-87 (1986). There is no issue for trial unless there is sufficient evidence

favoring the non-moving party; "[i]f the evidence is merely colorable, or is not significantly

probative, summary judgment may be granted." Anderson, 477 U.S. at 249-50 (citations

omitted). However, "[c]redibility determinations, the weighing of the evidence, and the

drawing of legitimate inferences from the facts are jury functions, not those of a judge." Id.

at 255. Therefore, "[t]he evidence of the non-movant is to be believed, and all justifiable

inferences are to be drawn in his favor" at the summary judgment stage. Id. 

ANALYSIS

Under the Federal Rules of Evidence, “the trial judge must ensure that any and all

scientific testimony or evidence admitted is not only relevant, but reliable.” Daubert v.

Merrell Dow Pharmaceuticals, 509 U.S. 579, 589 (1993). The obligation is centered around

F.R.E. 702, which provides:

If scientific, technical, or other specialized knowledge will assist the trier of

fact to understand the evidence or to determine a fact in issue, a witness

qualified as an expert by knowledge, skill, experience, training, or education

may testify thereto in the form of an opinion or otherwise, if (1) the testimony

is based upon sufficient facts or data, (2) the testimony is the product of

reliable principles and methods, and (3) the witness has applied the principles

and methods reliably to the facts of the case.

“Scientific” knowledge, the Supreme Court has found, is not meant to denote absolute

certainty – “[i]nstead, it represents a process for proposing and refining theoretical

explanations about the world that are subject to further testing and refinement.” Id. at 590

(quoting Brief for American Association for the Advancement of Science et al. as Amici

Curiae 7-8) (emphasis in original). “[I]n order to qualify as ‘scientific knowledge,’ an

inference or assertion must be derived by the scientific method..” Id. This determination is

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not narrowly circumscribed, but specific factors that will often bear on the admissibility of

a particular theory or technique include:

1) whether it “can be (and has been) tested;” Id. at 593.

2) whether it “has been subjected to peer review and publication.” Id. 3) the known or potential rate of error. Id. at 594.

4) whether it is generally accepted within the relevant scientific community.

Id.

These factors may be relevant to experience-based testimony as well as the more abstract

application of scientific principles. Kumho v. Tire Co. v. Carmichael, 526 U.S. 137, 151

(1999). However, a district court need not consider all factors in all cases; “[r]ather, the law

grants a district court the same broad latitude when it decides how to determine reliability as

it enjoys in respect to its ultimate reliability determination.” Id. at 142. Expert opinions

may be based on otherwise admissible hearsay so long as the facts and data “are of a type

reasonably relied upon by experts in the particular field in forming opinions or inferences

upon the subject.” F.R.E. 703.

There is no question that Dr. Leviss has the background and experience necessary for

an expert witness. In particular, he has an M.D., is board certified in Obstetrics and

Gynecology, and has served as a clinical instructor in such at the Albert Einstein College of

Medicine and the University of Medicine and Dentistry of New Jersey (where he is still on

the faculty). 

His opinions, however, do not pass muster under F.R.E. 702. Plaintiffs admit, for

purposes of this motion, Defendant’s allegations that “[m]edical studies have demonstrated

that shoulder dystocia and brachial plexus injuries are generally not predictable or

preventable.” Def. SoF, ¶ 13. Further, they admit that the American College of Obstetricians

and Gynecologists (“ACOG”) is the leading professional group for women’s health care

providers in the United States and that its publications are often cited as evidence of the

standard of care. The ACOG Practice Bulletin on Shoulder Dystocia states that it is “most

often an unpredictable and unpreventable obstetric emergency.” Def.’s Ex. C. It states also

that a significance proportion – 34-47% – of brachial plexus injuries, the kind of injury

suffered by Melissa Madrigal, are not associated with shoulder dystocia; 4% occur after

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cesarean delivery. Id. Fetal macrosomia and maternal diabetes increase the risk of shoulder

dystocia, but “[i]n one study, the presence of both diabetes and macrosomia accurately

predicted only 55% of cases of shoulder dystocia.” Id.

The ACOG also notes that 

[a] small, randomized trial of 273 patients with an ultrasound-estimated fetal

weight of 4,000-4,500 g comparing labor induction with expectant

management reported no significant difference in the rate of shoulder dystocia

(3.7% versus 4.3%) or brachial plexus palsy (0% versus 1.4%).

Id. Further:

A policy of planned cesarean delivery for suspected macrosomic fetuses

(>4,000 g) in women who do not have diabetes is not recommended.

Ultrasonography is not an accurate predictor of macrosomia. Furthermore,

most macrosomic infants do not experience this complication. Consequently,

if all fetuses suspected of being macrosomic underwent cesarean delivery, the

cesarean delivery rate would increase disproportionately when compared with

the reduction in the rate of shoulder dystocia. . . . Although the diagnosis of

fetal macrosomia is imprecise, prophylactic cesarean delivery may be

considered for suspected fetal macrosomia with estimated fetal weights greater

than 5,000 g in women without diabetes and greater than 4,500 g in women

with diabetes.

Id.

Other studies, one literature review found, concur that “[a]lthough brachial plexus

palsy is frequently associated with shoulder dystocia, evidence suggests that its occurrence

may, in some instances, antedeate the time of delivery.” Def.’s Ex. J. The same article

concludes that “[t]o date, no management algorithm involving selective interventions based

on estimates of fetal weight has demonstrated efficacy in reducing the incidence of either

shoulder dystocia or brachial plaxis injury.” Hence, “incorporating estimates of fetal weight

in the care of nondiabetic pregnant women deemed at risk for macrosomic neonates seems

to be unspported.” Id. Similarly, another such review found that “[i]nduction of labor for

suspected macrosomia has not been shown to alter the incidence of shoulder dystocia among

nondiabetic patients.” Def’s Ex. K. The same review noted that “[t]he concept of

prophylactic cesarean delivery as a means to prevent shoulder dystocia and therefore avoid

brachial plexus injury has not been supported by either clinical or theoretical data.” Id. One

study, for instance, found that “2,345 to 3,695 cesarean deliveries would need to be

performed to prevent one permanent brachial plexus injury among nondiabetic women.” Id.

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Similarly, “[r]etrospective assessment of a policy that recommended cesarean delivery for

fetal weight of more than 4,500 g found an insignificant effect in the incidence of brachial

plexus palsy.” Id. However, the paper also notes that part (though not all) of this is due to

“the fact that 84% of patients did not have the macrosomia diagnosed before birth,” and

therefore the conclusions may not hold as strongly where macrosomia was diagnosed before

birth. 

In its recommendation section, the ACOG Report states that the McRoberts technique

is an appropriate first response to shoulder dystocia.

 In deposition (as well as his report) Dr. Leviss was critical of Dr. Forest’s technique,

stating:

if the maneuvers that he describes were done properly, then, in fact, in my

experience and reading the literature and going to medical meetings and stuff,

that he would not have effected an evulsion, permanent injury to the brachial

plexus. . . . At worst she might have had a transient C5 or C6 palsy which

would have resolved; because we know that when a little traction is used, it is

possible to get a temporary in the nursery which resolves. 

Levis Dep., 48. He also states in deposition that the McRoberts technique was improper, but

admits that it is the standard of care. Leviss Dep., 45. 

This opinion – that proper performance of the maneuvers in question would prevent

brachial plexus injury – is not supported by the scientific evidence presented. Nor does Dr.

Leviss even attempt to claim it is, admitting that he can’t speak to that “globally for any

prospective case.” Leviss Dep. 56. 

In his report, Dr. Leviss also states that “improper traction was employed by Dr.

Forest prior to the maneuvers, which ultimately produced delivery, and that this traction

produced a brachial plexus injury on the left side of Melissa Madrigal.” Any sort of traction

in cases of known or suspected fetal macrosomia, he states, is inappropriate and can lead to

shoulder dystocia. Def.’s Ex. M. Dr. Leviss does not provide the basis for that opinion in

his report. In deposition, however, it appears that Dr. Leviss’s opinion is, once again,

premised on his conclusions that, had the maneuvers in question been done without traction,

the injury would not have occurred. Leviss Dep., 48-50. This does not, however, comport

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with the evidence described above which shows brachial plexus injuries as occasionally

occurring even in births by cesarean. And Dr. Leviss gives no basis for his opinion that this

birth is one where brachial plexis could not have occurred but for improper traction. This

Court cannot accept expert opinions without being able to assess the basis behind them.

Kumho Tire, 526 U.S. at 149. 

Dr. Leviss’s report also takes issue with the decision to induce labor, discussing the

Bishop scoring system on which a total score of more than 8 indicates that “the probability

of vaginal delivery after labor induction is similar to that after spontaneous labor.”

Accordingly, “a Bishop score of 3 [as Maria Madrigal had] is a poor prognosis for successful

vaginal delivery in the face of known fetal macrosomia.” As far as can be read from Dr.

Leviss’s report – all this Court has to go on – the quoted text speaks to the possibility of

cesarean section after induction, not to shoulder dystocia or brachial plexus. Dr. Leviss’s

report, therefore, provides no recognizable support for the proposition that induction

contributed to Melissa Madrigal’s injury. Further, this proposition is contrary to that in the

literature supplied by Defendant, which suggests induction contributes neither positively nor

negatively to shoulder dystocia. 

Finally, Dr. Leviss is critical of Dr. Mendoza for not offering a cesarean section for

fetal macrosomia. As discussed above, the medical evidence presented to this Court

uniformly suggests that a policy of prophylactic cesareans is inappropriate in this context.

Dr. Leviss provides no basis suggesting that his contrary opinion is reliable.

Plaintiffs’ counter-arguments in support of Dr. Leviss’s testimony are not persuasive.

While it is true that studies submitted by Defendant need not – and cannot – be accepted as

true by the Court without qualification, Plaintiffs have failed to present contradictory reliable

evidence that supports Dr. Leviss’s opinions and demonstrates any kind of serious debate in

the medical community. Similarly, while Plaintiffs are correct that guidelines may not apply

equally to every patient, they give no reason why this mother is an exception to the general

rules that define standard of care. Nor are conclusory statements to the effect that the mere

fact of injury demonstrates a violation of the standard of care, when the scientific evidence

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before this Court states that the injury in question occurs unpredictably. Also unsupported

are Dr. Leviss’s statements that the medical literature contrary to his position is biased,

unresearched, and industry funded. 

Accordingly, Dr. Leviss’s opinions lack the indicia of reliability that this Court is

required to look at and shall be excluded. 

Arizona law states that to prove an injury resulted from the failure of a health care

provider to follow the accepted standard of care, a plaintiff must demonstrate both:

1. The health care provider failed to exercise the degree of care, skill and

learning expected of a reasonable, prudent health care provider in the

profession of class to which he belongs within the state acting in the same or

similar circumstances, [and that]

2. Such failure was a proximate cause of the injury.

A.R.S. § 12-563. Defendant points out that a plaintiff must ordinarily demonstrate both

elements through expert medical testimony. See, Barrett v. Harris, 86 P.3d 954, 958 (Ariz.

Ct. App. 2004) (“Ordinarily, a plaintiff in a medical malpractice lawsuit must prove the

causal connection between an act or omission and the ultimate injury through expert medical

testimony, unless the connection is readily apparent to the trier of fact.”). Here, such a

connection is not readily apparent, nor have Plaintiffs provided any evidence outside of the

testimony of Dr. Leviss that might demonstrate that the health care providers in question

“failed to exercise the degree of care, skill and learning expected of a reasonable, prudent

health care provider.” Only their contention that the doctors on call should have been

informed of Plaintiff’s suspected fetal macrosomia and a follow-up ultrasound been

performed to determine fetal weight comes close. However, as Melissa Madrigal was, in

fact, under the 5,000 grams that the ACOG manual recommends for prophylactic cesareans,

there is no evidence that the failure to perform such an ultrasound was a proximate cause of

the injury or that the standard of care would have led or required the doctors involved to

change course. Accordingly,

IT IS ORDERED Defendant’s Motion for Summary Judgment (Doc. 96) is

GRANTED. 

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DATED this 23rd day of July, 2009.

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