CATHOLIC HEALTHCARE WEST 3 rd Annual Perinatal Safety Collaborative Defending Safe Care and...

CATHOLIC HEALTHCARE WEST3rd Annual Perinatal Safety Collaborative

Defending Safe Care andEvidence-Based Practices

CATHOLIC HEALTHCARE WEST3rd Annual Perinatal Safety Collaborative

September 12, 2010Sacramento, California

David R. Lucchese, J.D.Galloway, Lucchese, Everson &

PicchiWalnut Creek, CA

AVOID OR MITIGATE CLAIMS?

Lawsuits against healthcare providers and healthcare facilities cannot always be avoided, even when appropriate or evidence-based practice was rendered to the patient.

AVOID OR MITIGATE CLAIMS? (cont’d.)

At present, there is no “immunity from lawsuits” if care provided meets evidence-based guidelines.

AVOID OR MITIGATE CLAIMS? (cont’d.)

The more extensive and more costly a disability caused by medical care, the more likely there will be a lawsuit – financial need.

BETTER ANALYSIS: REDUCE CHANCE OF LAWSUIT

Conduct yourself in a manner that appreciates that a lawsuit can come out of any patient encounter – be aware of the danger!

BETTER ANALYSIS: REDUCE CHANCE OF LAWSUIT (cont’d.)

For doctors – attempt to follow established best practices, evidence-based management of patient encounters. For nurses, be sure to now and follow established hospital practices.

BETTER ANALYSIS: REDUCE CHANCE OF LAWSUIT (cont’d.)

Make complete and timely entries in the written or electronic record.

Be polite, friendly and honest (without admitting wrongdoing) with patients.

ARE PERINATAL PROVIDERS STILL THE TARGETS IN MALPRACTICE CASES?

YES!

In the PIAA malpractice claims closed analysis, between 1985 and 2007, obstetrical claims ranked first among all specialties for the number of claims reported and the total amount of indemnity paid.

Closed claims involving the brain-damaged infant had the highest average payment at $565,152.

ARE PERINATAL PROVIDERS STILL THE TARGETS IN MALPRACTICE CASES?(cont’d.)

Verdict Search each year publishes the top 100 top civil cases in the United States (all types):

2004 – 7 of top 100 civil cases were perinatal brain injury cases, ranging from $23 million to $63 million.

2005 – 7 of the top 100 civil cases were perinatal brain injury cases, ranging from $17 to $212 million.

WHY ARE THE SETTLEMENTS AND VERDICTS IN PERINATAL BRAIN INJURY CASES SO LARGE?

Although in California, general damages for pain and suffering are limited to $250,000, there is no limitation on the collection of economically- related injuries.

WHY ARE THE SETTLEMENTS AND VERDICTS IN PERINATAL BRAIN INJURY CASES SO LARGE? (cont’d.)

Perinatal brain injury cases have high economic damages.


These cases involve injuries to babies who during their childhood and adulthood are usually severely disabled secondary to their brain injuries, requiring: extensive medical care expensive and constant assistive care for

ADLs recovery for loss of their adult earning

capacity


Medical and assistive care have some of the highest rates of inflation.

Because of extensive care, these children often have a relatively long life expectancy.

THE FACTORS IN THE ECONOMIC EQUATION

General damages for pain, suffering and loss of enjoyment of life, etc. = $250,000 (limited by Section 3333.2, Civil Code)

Economic damages – according to proof at trial

THE FACTORS IN THE ECONOMIC EQUATION - Economic Damages (cont’d.)

Medical and assistive care costs: Level of care needed – fee per hour (doctor, RN,

LVN, CNA)

X Frequency of care required (# hours per day)

X Number of days per year service needed gives

annual cost

X Estimated life expectancy of the child

THE FACTORS IN THE ECONOMIC EQUATION - Economic Damages (cont’d.)

Loss of earning capacity - what the jury finds would have been the level of academic achievement of the child if not disabled; then a forensic economist applies US Bureau of Labor Statistics for the average work life earnings of persons with that level of education

DAMAGES - FOUR Y/OLD QUADRAPLEGIC $13.5M (PCV)

Male: 4 years oldCondition: spastic quadriplegiaLife expectancy: 56 years

General Damages(past and future)

ECONOMIC DAMAGESFuture (Present Cash Value)

$250K

2% of Total Value

$691KMed.Care

5% of TotalValue

$622KMed.Supplies

4% of Total Value

$451KEducation

3% of Total Value

$105KHouse Modifications

$0

Past

0.1% of Total Value

$8.9MAttendantCare

66% of Total Value

$2.5MLoss of EarningCapacity4 Yr. College

19% of Total Value

MOST FREQUENT LEGAL ISSUES

Opinion of Clark, et. al (2008) in a review of 189 closed perinatal claims of a major insurance carrier between 2005 and 2005, 79% of those cases involved “substandard care.”

MOST FREQUENT LEGAL ISSUES (cont’d.)

In my own 30 + years of experiencedefending perinatal providers: Prenatally (mostly involving the perinatologist

and the ob) Diagnosing and treating gestational

diabetes – causing later problems during delivery

Missing abnormalities in ultrasound tests Diagnosis and treatment of preeclampsia Management of post-date pregnancies


Intrapartum Induction and augmentation-related problems,

including uterine tachysystole Failure to diagnose a failure to progress and then

section Fetal heart rate interpretation – misinterpreting the

maternal heart rate for the fetal heart rate Fetal heart rate interpretation – failure to diagnose

FHR pattern requiring immediate intervention for fetal intolerance to labor


Intrapartum (cont’d.) Improper use of vacuum or forceps Failure to diagnose and avoid a potential shoulder

dystocia; or failure to properly resolve a shoulder dystocia

Failure in the face of a fetal indication for section to start the procedure in “a reasonable time” after the decision to section

Failure to continued FHR monitoring in the operating room


Intrapartum (cont’d.) For CNMs: failure to follow hospital guidelines for

interface with the “supervising physician,” or need to transfer care

For L&D nurses: not following nursing protocols; failure to notify ob or CNM of significant abnormalities in the mother or fetus

Failure of the obs, and/or nurses to alert the nursery of potential problems for a soon to be delivered baby – so they will be present

Regarding resuscitation of the newborn, if needed: failure to have necessary staff present and failure to follow NRP guidelines in the resuscitation

HOW TO REDUCE RISK AND IMPROVE CHANCE OF DEFENSE

Better documentation – the key to later explanation This is constantly mention, but not always

followed. Especially needed if there is an emergency –

should someone be a scribe, and document as if during a code.

Physician progress notes need to be more frequent during labor, an use a SOAP format; the plan is especially important if labor progress is slow.

HOW TO REDUCE RISK AND IMPROVE CHANCE OF DEFENSE (cont’d.)

Shared understanding of FHR interpretation among providers

Instill in providers the importance of teamwork and communication between providers on the maternal and fetal condition

Have a higher awareness of potential danger during the second stage of labor


Have drills for obstetrical emergencies, including shoulder dystocias; and/or have an OB rapid response team

When a cesarean section is called make sure that everyone knows the indication, the rapidity at which the baby needs to be delivered, and have the section start as soon as the circumstances merit – continue monitoring the fetus


If there is any belief the fetus may be depressed at birth, alert the nursery to have necessary resuscitators and care providers at delivery

If possible cord blood gasses should be obtained on every delivery, but for sure if the baby is at all depressed at birth; and, if the baby is depressed the placenta should be retained and examined.

PERINATAL BRAIN INJURY CASES CAN BE DEFENDED IN COURT, OR THE SETTLEMENT CAN BE SIGNIFICANTLY LOWERED, IF CERTAIN ELEMENTS ARE PRESENT

There are some perinatal injury cases where truly the baby experienced peripartum hypoxic-ischemic brain injury and the totality of the facts make the case one that cannot be defended at trial Those cases are settled – often for very significant amounts of money in the millions of dollars.

PERINATAL BRAIN INJURY CASES CAN BE DEFENDED IN COURT, OR THE SETTLEMENT CAN BE SIGNIFICANTLY LOWERED, IF CERTAIN ELEMENTS ARE PRESENT (cont’d.)

I have won most of the perinatal brain injury cases that I have tried in court or in arbitration.

In my review of jury verdicts and settlements in other states there are many of these cases that are being tried in court, rather than settled, and many are being won as well.

PERINATAL BRAIN INJURY CASES CAN BE DEFENDED IN COURT, OR THE SETTLEMENT CAN BE SIGNIFICANTLY LOWERED, IF CERTAIN ELEMENTS ARE PRESENT (cont’d.)

There is a trend to try these cases if the content of the medical records can be opined by expert witnesses to demonstrate that the actions of the perinatal healthcare professionals were in compliance with the standard of care, and there also clinical evidence to support an expert witness opinion that the infant’s brain injury did not occur during the intrapartum period.

THE CAUSATION ARGUMENT:

Failure in Acute

management 1 intrapartum 2 Cerebral palsy

of labor hypoxic event

CAUSATION

WERE THE ACTIONS BY THE DELIVERY TEAM THE CAUSE (SUBSTANTIAL

FACTOR) OF THE BABY’S BRAIN INJURY?

Stevenson, et al: Fetal and Neonatal Brain Injury: Mechanisms, Management and the Risks of Practice (1989):

“The human brain is susceptible to a wide variety of genetic, developmental, and acquired abnormalities and insults.”

“Criteria to Define an Acute Intrapartum Hypoxic Event as Sufficient to Cause Cerebral Palsy”

From Neonatal Encephalopathy and Cerebral Palsy, ACOG and AAP, January 2003

Steps to Take to Investigate and Prove an Unpreventable Fetal/Neonatal Brain Injury

1. Obtain a complete and comprehensive set of the medical records of the mother and the baby, including the neonatal and pediatric records.

2. Obtain the complete and clear copy of all ultrasounds of the pregnancy, and all neuroscans available, including any intrauterine scans, if any, plus all postpartum CTs, ultrasounds and MRIs of the brain.

Steps to Take to Investigate and Prove an Unpreventable Fetal/Neonatal Brain Injury (cont’d.)

3. Have the films of the baby reviewed by a pediatric neuroradiologist, and if correlation to fetal/neonatal brain development is required, a pediatric neuropathologist.

4. Have the pregnancy evaluated by a perinatologist, and the child's neonatal and pediatric development evaluated by a pediatric neurologist.

5. Have placental slides evaluated by a placental pathologist.

IMAGING STUDIES

Injury has already occurred at time of first imaging study dated January 9, 2005.

Clinical events of January 13th, reveal no significant effects on the brain as demonstrated by imaging.

SUMMARY

Patient’s first brain scan on Day Two of life, reveals brain injury has already occurred.

Final scan reveals expected residual scarring from this original in-utero insult.

DEFENSE CAUSATION EXPERTS

Defense experts: (a) pediatric neurologist looks at 14 hour ultrasound of baby’s brain – showed the changes in the brain caused by hypoxic injury, but weeks before labor; and (b) placental pathologist who showed a blowup of slide of placental tissue which demonstrated structural changes in the villi – chorioangiosis (much increased number of blood vessels) that was caused by hypoxic injury weeks before labor.

WRITTEN RULING BY ARBITRATORS FOR DEFENSE (5/30/06):

“The arbitration panel is particularly impressed with the fact that the testimony of Dr. Machin and Dr. Barakos on visible structural abnormalities, which they testified could not have occurred without a hypoxic injury preceding labor, was not disputed by plaintiff with contrary expert opinions in these areas….Accordingly, the majority of the panel finds that plaintiffs have failed to sustain their burden of proof either on the issues of causation or standard of care.”

TO HAVE A DEFENSE DAMAGES PRESENTATION OR NOT? In a multimillion dollar, policy limit busting

case, foolish if not to have an alternative damages case.

The defense attorney must work with the defense damage team early in the litigation process on regarding reasonable future care scenarios – cafeteria style presentation.

How to emphasize the reasonableness of the defense future care plan.

““C’mon, c’mon – it’s either one or the other.C’mon, c’mon – it’s either one or the other.

PAGE v. CARPER (Alameda County, 2003) Perinatal brain injury secondary to uterine

rupture 3 year old - severe cerebral palsy – G tube

fed; totally dependent for all activities of daily living

Life expectancy disputed: P = 50+; D = 22 years

Court granted Ds’ MIL to limit future damages to only gross value only – no present cash value

PAGE v. CARPER (Alameda County, 2003) Plaintiff – only one life care plan Defendants – options to choose from Economists testified for both sides; defense

used bar graphs showing effect of plaintiff’s economist’s opinion regarding future inflation in costs v. the defendant’s economists opinions

Child Care Needs

26.3

3.1

8.5

0

5

10

15

20

25

30

$$ M

ILL

ION

S

TABLE #2 CHILD'S CARE NEEDS

PLANTIFF

DEFENDANT

JURY

Future Earning Capacity

25.8

4.8

13.05

6.1

0

5

10

15

20

25

30

$$ M

ILL

ION

STABLE #3 FUTURE EARNING CAPACITY

PLANTIFF

DEFENDANT

JURY

Life Expectancy of Child

48

20

32

0

10

20

30

40

50

YE

AR

STABLE #1 LIFE EXPECTANCY OF CHILD

Plaintiff

Defendant

Jury

Total Damages

52.1

57.9

7.9

16.2 14.6

0

10

20

30

40

50

60

$$

MIL

LIO

NS

TABLE #4 TOTAL DAMAGES

PLANTIFF

DEFENDANT

JURY

References

American College of Obstetricians and Gynecologists. “Professional Liability and Risk Management: An Essential Guide for Obstetrician-Gynecologists (2005) 187 pages.

Chauhan SP, Klauser CK, et al. “Intrapartum nonreassuring fetal heart rate tracing and prediction of adverse outcomes: interobserver variability” American Journal of Obstetrics and Gynecology (2008) 199(6): 623.

Clark EA, Misher J. “Team training/simulation” Clinical Obstetrics and Gynecology (2010) 53(1):265-277.

Clark SL, Belfast MA, Dildy GA. “Reducing Obstetric Litigation through Alterations in Practice Patterns. Obstetrics and Gynecology (2008) 112(6): 1279-1283.

Crofts JF, Fox R, Ellis D, et al. “Observations from 450 shoulder dystocia simulations: lessons for skills training” Obstetrics & Gynecology (2008) 112(4) 906-912.

Druzin ML, El-Sayed YY. “Cesarean delivery on maternal request: wise use of finite resources? A view from the trenches” Seminars in Perinatology (2006) 30(5): 305-308.

References (cont’d.)

Fahey JO, Mighty HE. “Shoulder dystocia: using simulation to train providers and teams” Journal of Perinatal-Neonatal Nursing (2008) 22(2):114-122.

Fox M, Kilpatrick S, King T, Parer JT. “Fetal heart rate monitoring: interpretation and collaborative management” Journal of Midwifery and Womens Health (2000) 45(6):498-507.

Graham, EM, Petersen SM, et al. “Intrapartum electronic fetal heart rate monitor4ing and the prevention of perinatal brain injury” Obstetrics & Gynecology (2006) 108:656-666.

Gherman RB, Chauhan S, et al. “Shoulder dystocia: the unpreventable obstetric emergency with empiric management guidelines” American Journal of Obstetrics and Gynecology (2006) 195(3):657-672.

Lerner S, Magrane D, Friedman E. “Teaching teamwork in medical education” Mt. Sinai Journal of Medicine (2009) 76(4): 318-329.

Leonard M, Graham S, Bonacum D. “The human factor: the critical importance of effective teamwork and communication in providing safe care” Quality Safety Health Care (2004) 13 Supp: 85-90.


Lucchese DR. “Defending the perinatal brain injury lawsuit: trending toward trial.” For The Defense (2007) 56-70, 83.

MacLennan A, Nelson KB, Hankins G, et al. “Who will deliver our grandchildren? Implications of cerebral palsy litigation” JAMA (2005) 294(13):1688-1690.

Macones GA, Hankins GDV, Spong CY, et al. “The 2008 National Institute of Child Health and Human Development Workshop Report on Electronic Fetal Monitoring: update on definitions, interpretation, and research guidelines” Obstetrics & Gynecology (2008) 112(3) 661-665.

McCool WF, Guidera M, et al. “The role of litigation in midwifery practice in the United States: results from a nationwide survey of certified nurse-midwives/certified midwives” Midwifery and Women’s Health (2007) 52(5):458-464).

Miller, David A. “Intrapartum fetal monitoring: Maximizing benefits and minimizing risks.” Contemporary Ob/Gyn (February, 2010). 55(2):26-36.


Parer JT, Ikeda T. "A framework for standardized management of intrapartum fetal heart rate patterns" American Journal of Obstetrics & Gynecology (2007): 26.e1-26.e6.

Phelan JP, Korst LM, Martin GI. “Causation – fetal brain injury and uterine rupture” Clinics in Perinatology (2007) 34:409-438.

Physician Insurers Association of America. Risk Management Review (2008 Edition).

Schifrin BS, Cohen WR. “Medical legal issues in fetal monitoring” Clinical Perinatology (2007) 34(2):329-343.

Simpson KR, Knox GE. “Common areas of litigation related to care during labor and birth: recommendations to promote patient safety and decrease risk exposure” Journal of Perinatal-Neonatal Nursing (2003) 17(2):110-125.

Willis Healthcare Practice. Health Trek (September, 2008) 1-10.

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