AIEGVoice Magazine Winter 2020

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AIEGVOICE WINTER 2020 / MEDICAL MALPRACTICE EDITION

CURRENT EVENTS

SETTLEMENTS & VERDICTS

TECHNOLOGY

2020 BOARD OF DIRECTORS OFFICERS

Melissa N. Abrams

Mike Eidson

Andy Payne

Noah B. Abrams

Stewart J. Eisenberg

Darren Penn

Robert E. Ammons

J. Kent Emison

Eric T. Penn

Patrick M. Ardis

Mark Emison

Russell Reiner

Drew Ashby

Kyle Farrar

Jason Robinson

Khaldoun A. Baghdadi

Benjamin Fields

Mark P. Robinson, Jr.

Kila B. Baldwin

R. Douglas Gentile

James S. Rogers

Wesley Todd Ball

Julian C. Gomez

John D. Rowell

Lydia Joann Barrett

Jaime A. Gonzalez, Jr.

Adam Shea

Scott S. Bethune

Lee “Tad” Griffin

Daniel Sherry

EXECUTIVE COMMITTEE

Rachel N. Boden

Amy Gunn

William S. Stone

J. Greg Allen, At-Large Member

LaBarron Boone

Jeffrey R. Harris

April A. Strahan

Lance Cooper, At-Large Member

Brian D. Chase

Michelle Hockers

Christopher Stucky

Thadd Llaurado, At-Large Member

Robert D. Cheeley

L. Lee Javins

C. Tab Turner

Bradley D. Kuhlman, Immediate Past President

Curt Clausen

Paul J. Komyatte

Todd Walburg

Lee Brown, Past President

Cale Conley

David L. Kwass

S. Scott West

Christine Spagnoli, Past President

Michael Cowen

Robert L. Langdon

Thomas P. Willingham

Daniel Dell’Osso, Past President

Ronnie Crosby

Theodore J. Leopold

Paula A. Wyatt

Robert M. N. Palmer, Past President

Steven J. Crowley

Brenden Leydon

Donald H. Slavik, Past President

Jay W. Dankner

Wendell “Chip” Martens

EMERITUS:

James L. Gilbert, Past President

Kevin Dean

Mary Leah Miller

Randy Barnhart

Daniel T. DeFeo

Dennis Mulvihill

Raymond Paul Johnson

Richard L. Denney

Andrew D. Nebenzahl

James Lowe

Michael D. Denton, Jr.

C. Richard Newsome

Leon Russell

Anne Dieruf

John E. Osborne

PRESIDENT

Jaime D. Jackson P R E S I D E N T- E L E C T

Terrence E. McCartney TREASURER

Julie Braman Kane CHIEF LEGAL OFFICER

Larry E. Coben

S TA F F EXECUTIVE DIRECTOR

NEW & RETURNING MEMBERS

Jane Giattina

S E M I N A R C O O R D I N AT O R , OFFICE MANAGER

Laura Pinola

D O C U M E N T D ATA B A S E M A N A G E R

Jill Martin

M E M B E R S H I P C O O R D I N AT O R , M A R K E T I N G , A I E G Vo i c e D E S I G N PRODUCTION

&

Amber Hanes

DOCUMENT ACQUISITION COORDINATOR

Melissa Martin

D ATA E N T R Y S P E C I A L I S T

Mark Algorri - CA

Raina Newsome - TX

Nicholas R. Barry - TN

Taylor M. Norman - WV

Kristen Blake - BC

Michael J. O'Neill - PA

Brent Brown - VA

Gregory Pinski - MT

Jake Cohen - CA

Daniel Purtell - PA

Kenneth W. Elwood - NJ

Justin C. Roberts - TX

John Escamilla - TX

Sarah Rogers - TX

Perry Fisher - NC

M. Michael Stephenson - IN

Kim Kutler - PA

Audrey Tolson - GA

Alex Ledbetter - MO

Greg W. Turman - TX

Rebecca Ledford - MO

Aub Ward - LA

Stephanie V. Lemoine - TX

Gregory Webb - VA

Teresa Burkes

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AIEGVoice Magazine

CONTENTS

4/

6/

7/

Letter from AIEG

What is an AIEG Trial Laywer?

A Poem

President Jaime D. Jackson

by Jaime D. Jackson

by Larry E. Coben

8/

10 /

14 /

Upcoming CLE Events

2021 AIEG Spring Seminar

Negligent Credentialing

Agenda and Event Information

by Amy Collignon Gunn & Elizabeth S. Lenivy

22 /

30 /

39 /

Litigating a Lack of Informed

The Electronic Medical Record:

Liability for Hemorrhages

Consent Case

More Than What is Produced

by Bruce R. Pfaff

by Andrew D. Nebenzahl

by Sara M. Davis

44 /

50 /

54 /

Winning a Spinal Epidural

Settlements & Verdicts

2020: A Banner Year for

Abscess Case

eDiscovery Case Law

by Bruce L. Braley

by Jeff Dreiling

58 / Scenes from the 2020 AIEG Virtual Symposium

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AIEG Friend s There is one thing for certain: we can always count on AIEG and our AIEG friends when we need anything, whether it be cutting-edge information, guidance, documents, following and improving a trail blazed by someone before us, or just a friend to talk to when the waters of life are at their roughest moments. Make no mistake, AIEG and our AIEG friends are here for us.

You are never alone; someone has got your back. No matter where we go, whatever happens to us, or how we stumble on our journey, we can count on our AIEG friends to prop us back up and get us going again.

There were many pearls of wisdom and insights to take away from the first-ever AIEG Virtual Symposium, but perhaps what struck me most was the way James Lowe’s smile lit up the screen just being with AIEG friends again. Pure joy, and a brighter smile than any little kid

A LETTER from the President

on Christmas. That’s the spirit of AIEG. That’s what AIEG gives us and what we give back.

Together there is nothing AIEG cannot accomplish. We are all capable, and with AIEG’s support and resources, there is no case or situation we cannot handle, be it auto products, consumer products, trucking, roadway safety, medical malpractice, or any other kind of Plaintiffs’ case.

The inequalities between the positions of a plaintiff and defendant in a defective products case have always been vast, and there always seems to be one obstacle after another. AIEG, however, helps level that playing field and in fact gives us the upper hand when we work together.

Aristotle once said, “the antidote for 50 enemies is one friend.” In our products litigation, the antidote for countless obstreperous, evasive, deceitful, well-financed defendants and defense lawyers is AIEG. It never matters how many of “them” there are on the other side because we have AIEG. 4

AIEGVoice Magazine

Eventually, execution beats luck. Consistency beats intensity. Kind beats clever, and together beats alone. With AIEG, we are never alone.

Since its inception some forty years ago by a group of tenacious trial lawyers who banded together to share information and support each other to fight Ford and the other auto manufacturers, AIEG has been the lead resource available to members to successfully pursue automotive products liability cases on behalf of their clients.

Over the years, with the changes in the litigation landscape and types of cases being litigated by AIEG members, AIEG has adapted and applied its document and information gathering and sharing skills to other areas of litigation, such as consumer products, trucking, highway safety and medical malpractice cases. With the advent and development of the listserv and ability to communicate with any one of AIEG’s 900 members, there is no question that could not be answered, or no problem that cannot be solved with the help of fellow AIEG members.

In the ultramarathon of life, we all have ups and downs, highs and lows, the long drawn out grinds, the times we are unstoppable, and the times we just want to lie down and quit. We must remember to put one foot in front of the other, no matter what, and just keep buggering on, until we get our mojo back.

No matter where we are on our own journeys, AIEG always helps us get our mojo back. One thing is for sure, you can’t get through the ultramarathon of life totally solo; sometimes you need to fly solo, but you need your crew, you need your family, and we all need AIEG. Jerry Garcia may have sung, “I will get by, I will survive,” but, not only will AIEG help us get by and survive, one thing is for certain, it will help us thrive no matter what the defendants or life throws at us.

As we continue this Holiday Season and head into 2021, take some time with your AIEG friends and family and prop yourselves up, re-charge, rejuvenate, re-invigorate and keep on pressing forward as we help make ourselves and AIEG just a little bit better every day.

Jaime D. Jackson AIEG President

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What is an AIEG Trial Lawyer?

Jaime D. Jackson

Someone who will lie to win their case.

Predatory.

Greedy.

Ambulance-chaser...

We have all heard the stereotypes, and for some lawyers, these sadly hold true. But like most stereotypes, this dangerous misperception of the whole profession is based on inaccurate or incomplete information, at least as it relates to most of us, and everyone I know in AIEG. I am proud to be an AIEG trial lawyer, and you should be too! We strive to make the world a safer place. We help families of victims of wrongdoing, whose lives have been blindsided and thrown into chaos through no fault of their own. We strive to improve the lives of everyone we meet. We help enforce safety rules that protect us, and we hold those that violate safety rules accountable for the damage they have caused.

We deter repeated violations of safety rules so that preventable tragedies do not repeat themselves— because if negligent wrongdoers get away with it, conduct rewarded is conduct repeated, and, with business as usual, next time it may be your family that ends up in Miseryland. For example, more than 400,000 patients die each year in hospitals due to medical errors, according to a recent study published in the Journal of Patient Safety. Without trial lawyers holding hospitals and doctors accountable for these systems failures, the number of preventable deaths will increase.

The Ford Pinto, the Exxon Valdez oil spill, Ford Explorer/Firestone tires, and the Takata exploding airbags are all examples of tragedies where the government was unable to hold corporations accountable for their violation of safety rules and damages caused. However, trial lawyers and juries were, while also deterring other corporations from similar conduct— helping make our families safe. AIEG Trial lawyers hate injustice. We reject the notion that might makes right.

We AIEG trial lawyers go to court for our clients to help repair the damage done to their lives, to help make sure safety rules are followed, and to deter future violations. Most lawyers desperately try to avoid going to court, but we AIEG trial lawyers are a different breed. We give our all—sometimes to our own and our families’ detriment—missing important family events or sacrificing our own health as we put in the necessary time to prepare and provide our clients the best preparation possible for their day in court.

As much as we pour ourselves into our clients’ cases, as much as we care about our clients, and even with all the sleepless nights, time away from our families, missed meals, and sometimes a late night beer or glass of wine, we AIEG trial attorneys must also take care of ourselves so that, in turn, we can better take care of our clients and our families.

One of my favorite books is "Touching the Void" by Joe Simpson. It narrates the ordeals faced by Joe and his climbing 6

AIEGVoice Magazine

partner, Simon, as they were the first to climb Siula Grande in the Peruvian Andes. There are many parallels to the life of a trial lawyer in their story, from the preparation to the hard work to the life-altering falls. There are also many lessons, like the realization that the greatest danger may come when we least expect it, or when we think we may have already overcome the hardest parts. But to me, the most important lesson is in the following quotes that apply to us as AIEG trial lawyers, as well as moms and dads, neighbors and friends: "Ultimately, we all have to look after ourselves, whether on mountains or in day-to-day life...[T]hat is not a license to be selfish, for only by taking good care of ourselves are we able to help others...[I]n the complexity of everyday life, the price of neglecting this responsibility might be marriage breaking down, a disruptive child, a business failing, or a house repossessed."

"The trick is to anticipate all the possible consequences of what you set out to do so that, if things do go wrong, you are better able to stay in control."

We share our clients’ pain; we listen quietly to stories of misery from those who have lost a son, daughter, husband, wife, or parent, or have been paralyzed, burned or brain-damaged by someone’s violation of safety rules or by dangerous products.

We take our clients’ problems and miseries home with us, because we AIEG trial lawyers care. But we must also not forget to take care of ourselves and our own families. This means getting enough sleep, eating healthily, perhaps drinking in greater moderation, meditating, finding time with our own families, going to cross-country meets, and watching lacrosse games and tennis matches. We must also keep ourselves physically fit, work out and keep ourselves in shape. Trials and the preparation that goes along with them are emotionally and physically demanding—the AIEG trial lawyer’s ultramarathon.

So this is who we are. We are the ones whose faces are marred by dust and sweat and blood. We are the ones who know the great enthusiasms, the great devotion; who spend ourselves over and over again in worthy causes to right another wrong, to find justice and put it where it belongs, to save a family and protect our community. We are the champions who will help hold those who violate our safety rues accountable for damages caused, and keep our families safe.

Awake my friend, it’s a new dawn Awake my friend, the sun rises on new opportunities Awake my friend, you’re healthy and safe Awake my friend, those you love love you back Awake my friend, good friends hold hands and walk together Awake my friend, share your abundance with those in need Awake my friend, hold dear those who matter and smile Awake my friend, Democracy prevails over autocracy Awake my friend, compassion prevails over narcissism Awake my friend, you are stronger because we are friends.

Give Thanks.

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/UPCOMING CLE EVENTS

2021 VIRTUAL PARALEGAL SYMPOSIUM

2021 VIRTUAL TRUCKING SEMINAR

February 4, 2021

February 11, 2021

Agenda TBA

Agenda TBA

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AIEGVoice Magazine

2021 SPRING SEMINAR

2021 FALL CONFERENCE

asheville north carolina

NAPA VALLEY California

April 14-16, 2021

October 26-28, 2021

The Grove Park Inn |

Vista Collina at Meritage Resort |

(800) 438-5800

(855) 998-6861

Room Block Deadline: March 14, 2021

Room Block Deadline: Sept. 25, 2021

Agenda & Event Information on next page

Agenda & Event Information TBA

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AIEGVoice Magazine

2021 SPRING SEMINAR

April 14-16, 2021

asheville north carolina

AGENDA WEDNESDAY, APRIL 14TH Board of Director's Meeting 7:00 am Heritage Room C, The Grove Park Inn

The Grove Park Inn | (800) 438-5800

Registration, Breakfast and Spouse Coffee Hour 8:00 am President's Lounge Genevieve Zimmerman 8:30 am Medical Device Cases: Experts and Approaches Bob Langdon 8:50 am Engine Fires and Firewalls Chris Spagnoli 9:10 am Proving Damages to Post-Pandemic Juries Scott Kline, ARCCA 9:30 am Heavy Construction Equipment Defects Jeff Dreiling 9:50 am Latest Issues in E-Discovery Brian Chase 10:10 am Door Openings in Rollover Break 10:30 am

John Campbell, Empirical Jury 10:40 am Crash Avoidance Technology Juror Research: Juror Attitudes — Identifying Case Selection Criteria, Strongest and Weakest Cases, and Case Framing Concepts Malorie Peacock 11:30 am Trucking: Failure to Train and Industry Standards Kyle Farrar 11:50 am Update on Jurisdiction: USSC Ruling, Venue Selection Concerns, and Jurisdictional Discovery Lee Brown 12:10 pm Voir Dire Techniques Using the AIEG Jury Project Questions Lunch - Changing of the Guard 12:30 pm

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AIEGVoice Magazine

THURSDAY, APRIL 15TH

FRIDAY, APRIL 16TH

Breakfast and Spouse Coffee Hour 8:00 am President's Lounge

Breakfast and Spouse Coffee Hour 8:00 am President's Lounge

Stewart Eisenberg 8:30 am Safety Canopies in High Speed Rollovers

Michael Gillis 8:30 am Primer in Liquor Liability

Expert Speaker TBA 8:50 am Understanding Accident Reconstruction

Sara Davis 8:50 am Medical Malpractice Cases Post-COVID

Larry Coben 9:10 am CAT Defects: Recent Testing

Jason McCormick 9:10 am Zero Turn Lawnmowers

Jaime Gonzalez 9:30 am How to Work Up a Trucking Case

Kate Llaurado 9:30 am The Crash Test Bias: How the Auto Industry is Failing Women and How it Impacts Our Cases

Russ Reiner, Thadd Llaurado, Amy Gunn, Scott West 9:50 am Strategies for Adapting Your Practice to Offset COVID-Related Income Challenges

Stuart Ollanik 9:50 am How to Take a Dynamite Remote Deposition

Speaker TBA 10:10 am Proving TBI/Closed Head Injuries

Leon Russell 10:10 am CAT in Heavy Trucks

Break 10:30 am

Break 10:30 am

Jim Waldenberger 10:40 am Trial in COVID-World

Shawn Harrington, Forensic Rock 10:40 am Infotainment System Downloads: Vehicle and Cell Phone Information You Can Obtain

Wes Ball 11:10 am G670 Tire Cases and Testing

Patt Ardis, Randy Rhodes, Anne Dieruf 11:00 am Ethics Hour: How to Get Sharing Protective Orders, Morris Inquiries, Avoiding CAT Preemption and More

Renowned Neurosurgeon 11:30 am Debunking "Diving" Injuries

Round Table Discussion with Moderators 12:00 pm How to Push Manufacturers to the Table in the Absence of a Trial Date: What Has Worked and What Has Not

James Gilbert 12:00 pm Heavy Truck Fuel Systems Julie Kane 12:20 pm Final Five: Closing Rebuttal Adjourn 12:40 pm

Adjourn 12:30 pm

WEDNESDAY EVENTS:

THURSDAY EVENTS:

Afternoon Golf Outing Details TBA

Tour of Biltmore Museum Details TBA

Evening Reception hosted by McCartney Stucky, LLC Grove Park Inn Pavilion 5:30 - 7:00 pm 11

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Evening Reception 5:30 - 7:30 pm

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MEDICAL MALPRACTICE ISSUE

AIEGVoice Magazine

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Hospitals

off the hook, Patients ...

out of luck.

Amy Collignon Gunn & Elizabeth S. Lenivy

M

any of us are familiar with the story of Dr. Christopher Duntsch, the former Texas neurosurgeon who earned the nickname “Dr. Death� after maiming over 30 of his patients, at least two of whom died.1 In 2015, Duntsch was arrested and charged with one count of injury to an elderly individual and five counts of assault, all as a result of surgeries he had performed.2 In 2017, a jury sentenced him to life in prison, marking the first time a doctor in the United States befell

such a punishment for his medical practice.3

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However, a larger question loomed beyond Duntsch’s actions: how could these hospitals have let this maniac into their institutions in the first place? Through investigations into his case, it was shown that Duntsch maintained privileges at multiple locations, most notably Baylor Scott & White Medical Center in Plano which, despite disturbing patient outcomes including one patient who bled to death, permitted Duntsch to resign and did not report him to the National Practitioner Data Bank or the Texas Medical Board.4 State health authorities later investigated the hospital for its decision not to report the review it had done of Duntsch’s work, which led to the hospital being hit with a citation and $100,000 fine.5 However, the citation and fine were dropped a year later with no explanation from the state.6

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Negligent Credentialing

Per the Joint Commission, credentialing is “the process

While Duntsch is a celebrated example, those of us who

of obtaining, verifying, and assessing the qualifications

litigate medical malpractice matters on behalf of injured

of a practitioner to provide care or services in or for a

patients and their families know that doctors who lack the skill

health care organization.”19 Credentials are documented

and competency to practice or continue practicing can still

evidence of licensure, education, training, experience, or

get and keep their privileges at hospitals. However, whether

other qualifications.20 Privileging is the process whereby

a hospital can be found liable for the negligence of one of

the specific scope and content of patient care services are

its privileged doctors varies from state to state. In a wave of

authorized for a healthcare practitioner by the health care

tort reform following the 2016 election, the Missouri state

organization based on its evaluation of the practitioner’s

legislature passed Senate Bill 237, which included a new

credentials and performance.21 When a hospital fails to

definition for “physician employee”, effectively eliminating

follow these processes, patients can suffer serious, even

liability against hospitals for the actions of physicians under

deadly, consequences. But for states that recognize (or at

a theory of vicarious liability. SB 237 was the legislature’s

least have not outright eliminated) corporate liability for

direct response to the case Jefferson v. Missouri Baptist

hospitals, establishing these claims, especially causation,

Medical Center, a 2014 decision by the Missouri Court of

can be a complicated task.

Appeals, Eastern District. In Jefferson, the reviewing court 7

reversed and remanded a trial court’s grant of summary

For example, in Michigan, an appeals court ruled that

judgment to a defendant hospital that had been sued solely

summary judgment should have been granted to a hospital

under a theory of vicarious liability for the negligence of a

that credentialed a surgeon because the plaintiff’s claim that

privileged radiologist.

the hospital’s failure to investigate the surgeon’s history of

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medical malpractice lawsuits was insufficient in establishing Missouri joins at least four other states — Colorado,9 Georgia,10

legal cause and cause in fact.22 In Mississippi, the state’s

Kansas,11 and West Virginia12 — that have eliminated vicarious

supreme court found that where a doctor lied on portions

liability for hospitals based on the negligence of its doctors.

of his reapplication that were not directly tied to his ability

Thus in these other states, the only claim that can be pursued

to perform surgery, but which the hospital still failed to

against a hospital related to a physician’s malpractice is

verify, the hospital could not be liable.23 The court reasoned

negligent credentialing or privileging. Conversely, at least

that even though the hospital failed to uncover the lie and

six states — Arkansas, Iowa, Kentucky, Maine, Texas,

17

even if the discovery of the lie had resulted in a denial of

and Utah — either do not recognize claims of negligent

privileges, the offending surgeon may still have operated on

credentialing against hospitals or have eliminated liability for

the patient, just at another hospital.24

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14

15

16

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negligent credentialing completely.

"While Duntsch is a celebrated example, those of us who litigate medical malpractice matters on behalf of injured patients and their families know that doctors who lack the skill and competency to practice or continue practicing can still get and keep their privileges at hospitals."

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"Other courts have found that hospitals can be found liable for negligent credentialing where they may know about a physician’s issues but fail to investigate further."

The Missouri Supreme Court recently ruled in a similar

on her foot and culminated in her foot being amputated.30

fashion. In Tharp v. St. Luke’s Surgicenter-Lee’s Summit, LLC,

Through discovery, plaintiff learned that the defendant

which was handed down after SB 237, the court reversed a

doctor had been granted surgical privileges despite not

plaintiff’s verdict against a hospital that had granted privileges

meeting the requirements for those level of privileges,

to a surgeon who failed to list all of his malpractice actions

specifically not completing a 12-month podiatric surgical

in his application, which was in breach of the hospital’s

residency and not receiving board certification as required

bylaws.

The court first reasoned that the hospital’s duty

by the Joint Commission.31 The court noted that plaintiffs’

was to credential “competent and careful physicians”, and the

expert testified that there were multiple failures by the

surgeon’s failure to list all of his lawsuits was not sufficient

defendant surgeon, which went to his lack of experience and

to show he was unqualified or incompetent.26 Additionally,

lack of competence, both in performing the surgery and in

the court found that this evidence did not support a finding

failing to recognize and treat the complications.32

25

of proximate cause because the plaintiff’s injuries were not “within the scope of foreseeable risk” created by the

Other courts have found that hospitals can be found

hospital’s act of credentialing.27 Nonetheless, the court

liable for negligent credentialing where they may know

remanded the case based on the plaintiffs’ argument that

about a physician’s issues but fail to investigate further.33

they had additional evidence on which a submissible case

In Bell v. Sharp Cabrillo Hospital, a California jury awarded

could be made, primarily the surgeon’s low scores on

a plaintiff’s verdict in a wrongful death action against a

continuing medical education exams as well as evidence that

hospital for negligent credentialing of a general surgeon

showed an increase in the number of malpractice suits filed

wherein the hospital failed to investigate warnings of his

against the surgeon as he aged.

possible incompetence, including his disclosure that he

28

had not had his privileges renewed at another hospital, Conversely, one of the most notable examples of a successful

that a second hospital had suspended his privileges seven

negligent credentialing plaintiff’s verdict is the Illinois case

years prior, denied his request for lift of the suspension,

Frigo v. Silver Cross Hospital and Medical Center. In Frigo, the

and recommended revocation of his surgical privileges, and

plaintiff was awarded over $7,000,000 in damages resulting

that he did not carry medical malpractice insurance.34 The

from the negligent credentialing of a surgeon who operated

jury was not swayed by the hospital’s argument that it had

29

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approved the defendant doctor’s application in light of his long tenure with the hospital, had relied on its familiarity with his work, and assumption that it would have been aware of any deficiency in his work at the hospital in light of that tenure.35 Hospitals have also been found negligent even when the physician was dishonest with the hospital. In Johnson v.

Misericordia Community Hosp., the Wisconsin Supreme Court affirmed a verdict for a plaintiff who suffered a permanent paralytic injury during a hip surgery and against the hospital for negligently credentialing the defendant physician.36 At trial, it was shown that the hospital had failed to investigate the surgeon’s application before appointing him to the medical staff and that, had they done so, they would have discovered several misrepresentations on his application, including his denial or restrictions of privileges at hospitals listed in his application.37

What to Look for in Negligent Credentialing Cases Claims for negligent credentialing stem essentially from two situations: either the hospital did not have a sufficient procedure in place to ensure that a physician had the needed competency to be granted privileges or the hospital had a sufficient procedure in place but failed to follow through with it. Although each potential case is different, general issues that should be looked into for each case include:

1. The Joint Commission standards

"Hospitals have

The Joint Commission has performance standards for credentialing designed to identify fraudulent applications.

also been found

Although the Joint Commission does not require any defined qualifications and expects individual organizations to make

negligent even when

those determinations, it is one of the best resources to begin with in any negligent credentialing claim in order to check

the physician was

for any deviations from the general standards set.

2. The hospital’s policies and procedures for applications of

dishonest with the

privileges

hospital."

The hospital’s policies and procedures must be examined 18

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closely to determine whether its credentialing procedure

of stay trends, post-procedure infection rates, compliance

is sufficient in determining competency and discovery

with medical staff rules and regulations, and proper

must be taken to ensure that the hospital followed its own

documentation — to show the performance quality of

procedures. Questions regarding what sort of investigation

medical staff.40 The information learned from this evaluation

the hospital did prior to granting privileges include:

should then be used in determining whether to continue, limit, or revoke any existing privileges.

a. Did the hospital actually follow-up with the doctor’s

references and prior hospitals to confirm his education,

When investigating a potential negligent re-credentialing

training and ability and, if so, what documentation do

claim, it is important to know what guidelines for OPPEs the

that they have to prove this?

hospital had in place, whether it was sufficiently collecting data and analyzing the data, and how the hospital responded

b. Did the hospital make any type of inquiry to medical

to any negative trends observed from the data.

boards, the National Practitioner Data Bank, the Drug Enforcement

Administration,

and/or

the

doctor’s

malpractice insurance carrier?

Additionally, a Focused Professional Practice Evaluation (FPPE) is a process whereby the medical staff evaluates the privilege-specific competence of a practitioner that

c. Did the hospital know of or could it have known of

lacks documented evidence of competently performing

previous lawsuits against the doctor for malpractice? If

the requested privileges at the organization.41 This process

so, did the hospital investigate those cases and attempt to

may be used when a question arises of a currently-

determine whether action was warranted? Additionally,

privileged practitioner’s ability to provide safe, high quality

was there a noticeable trend in the frequency of those

patient care.42 The Joint Commission notes that a period

lawsuits that may indicate that a physician’s capabilities,

of FPPE is also required for all new privileges, including

either mental or physical, are in decline?

privileges requested by new applicants and all newlyrequested privileges for existing practitioners, and “[t]here

d. Were there any inaccuracies in the doctor’s application

is no exemption based on board certification, documented

or reapplication that could have been discovered by the

experience, or reputation.”43 The same type of qualitative and

hospital had the hospital done its due diligence?

quantitative data analyzed for OPPEs should be analyzed for FPPEs.44

3. OPPEs and FPPEs It is important to confirm whether an FPPE was in place for Another potential important area to explore are internal

a newly privileged physician or whether any incident at the

evaluations of the physician, known as OPPEs and FPPEs.

hospital could have raised questions regarding a doctor’s

Per the Joint Commission, an Ongoing Professional Practice

competency, thereby triggering the need for an FPPE. If a

Evaluation (OPPE) identifies professional practice trends

previous incident could arguably trigger an FPPE but no plan

that may impact the quality and safety of care.

“A well-

was put into place, it is imperative to learn how that decision

designed process supports early detection and response

was reached, who was involved in making that decision, and

to performance issues that could negatively impact patient

whether this choice followed hospital policy.

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outcomes.”

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The purpose of the OPPE is to continuously

collect and analyze qualitative data — such as the quality and

4. The causal link between the negligent credentialing to the

accuracy of a doctor’s documentation, patient outcomes,

patient’s injury?

patient complaints, peer recommendations, and discussions with other staff — and quantitative data — such as length 19

Establishing proximate cause between a hospital’s negligent AIEGVoice Magazine

credentialing and a patient’s injury is one of the most

lack of competency will be crucial.

challenging aspects of a negligent credentialing claim. As cited above, courts have ruled that it is not sufficient to make

Conclusion

the argument that had the hospital not credentialed the

Just as patients and their families must trust their doctors’

physician in the first place, the physician would have never

judgment and skill, they must trust the hospitals that

operated on the patient and the patient’s injuries would

allow these physicians to practice medicine within their

have never happened. Instead, the plaintiff must show that

institutions. Patients have the right to expect a hospital

the physician lacked the competency to provide care that

to take the proper steps to ensure the competency of all

he or she appeared to have, at least on paper, and that this

medical staff, especially physicians. Legislatures that seek

specific incompetency (not just general negligence) caused

to shield hospitals from lawsuits do so to the detriment of

the patient’s harm.

patients (also known as their constituents) who have suffered severe and costly injuries, often at the hands of physicians

Although these cases are difficult, they are still possible. As in

with insufficient insurance coverage. We as advocates must

Tharp where the plaintiffs’ case was remanded, investigating

not only continue zealously fighting for our injured clients

attorneys can look to physician’s low or failed test results

by fully investigating every potential claim against health

as potential evidence of incompetence. For example, even

care providers and their hospitals, but must also stay alert

if board certification is not a prerequisite for credentialing,

to legislative efforts aimed at limiting or eliminating liability

a doctor’s repeated failure of board examinations could be

for these same, already overly-protected interests. Less

considered evidence of his lack of competence.

responsibility means we are all less safe.

Attorneys should also delve into the hospital’s knowledge

1. Laura Beil, “A Surgeon So Bad It Was Criminal”,

regarding the physician’s mental and physical abilities to

ProPublica (Oct. 2, 2018), https://www.propublica.org/

practice medicine, including history of substance abuse or

article/dr-death-christopher-duntsch-a-surgeon-so-

injury. For example, surgeons require fine motor skills and

bad-it-was-criminal

dexterity to safely perform operations. If the hospital is

2. Id.

aware of a surgeon who may be showing signs of loss of

3. Id.

this physical ability, that could potentially be evidence that

4. Id.

the physician’s physical incompetence caused the patient’s

5. Id.

injury.

6. Id. 7. See “Legal Alert: Missouri Tort Reform Bill to Narrow

Finally, it is probable that if a physician committed malpractice

Definition of Employee in Medical Negligence Actions”,

due to a lack of competency, there will be several other

Lathrop GPM (Apr. 19, 2017), https://www.lathropgpm.

actions he or she took during the patient’s care and treatment

com/newsletter-207.html; “The Missouri Legislature

that show questionable judgment. Although these actions

Narrows the Scope of Liability for Hospitals and

individually may not constitute a breach in the standard of

Other Health Care Providers”, Hamilton Weber LLC

care, the cumulative nature of these actions may show a

(Oct. 18, 2017), https://hamiltonweber.com/missouri-

pattern of incompetence that bolsters the claim. For this, it

legislature-narrows-scope-liability-hospitals-health-

is important to prepare your physician malpractice standard

care-providers/.

of care expert to testify on these specific details regarding

8. 447 S.W.3d 701 (Mo. App. E.D. 2014).

the patient’s care. Moreover, enlisting a credentialing expert

9. See Smith v. Surgery Center at Lone Tree, LLC, 2020 WL

to discuss specific failures on the part of the hospital as well as the connection between those failures and the doctor’s 20

6066273 (Col. App. Ct. Oct. 15, 2020).

10. Ga. Code Ann., § 51-2-5.1.

AIEGVoice Magazine

11. See McVay v. Rich, 874 F.2d 641 (Kan. Sup Ct. 1994); see also K.S.A. 65–442(b).

27. Id.

12. See Cunningham v. Herbert J. Thomas Memorial Hosp.

Ass’n, 737 S.E.2d 270 (Sup Ct. of Appeals W. Virg. 2012).

13. See Paulino v. QHG of Springdale, Inc., 386 S.W.3d 462 (Ark. Sup. Ct. 2012).

28. Id. at 658-63.

29. 876 N.E.2d 697 (Ill. App. 2007).

30. Id. at 702-03.

31. Id.

14. See Hall v. Jennie Edmundson Memorial Hosp., 812 N.W.2d 681 (Iowa 2012).

32. Id. at 705, 726.

33. Bell v. Sharp Cabrillo Hosp., 212 Cal.App.3d 1034 (Cal.

15. See Lake Cumberland Regional Hospital, LLC v. Adams, 536 S.W.3d 683 (Sup. Ct. Ky. 2017).

(Sup. Ct. Maine 1999).

34. 212 Cal.App.3d at. 1039-40.

35. Id.

17. See St. Luke’s Episcopal Hosp., v. Comfort & Kingsley AGBOR, 952 S.W.2d 503 (Sup. Ct. Tex. 1997).

Privileging:

36. 99 Wis.2d 708 (Wis. 1981).

37. Id.

18. Utah Code Annotated, § 78B-3-425. and

App. 1989); see also Rule by Rule v. Lutheran Hospitals & Homes Soc. of America, 835 F.2d 1250 (8th Cir. 1987).

16. See Gafner v. Down East Community Hosp., 735 A.2d 969

19. “Credentialing

26. Id. at 656-58.

38. “Ongoing Professional Practice Evaluation (OPPE) – Implementing

a

Understanding the Requirements”, The Joint Commission,

process”, The Joint Commission (March 12, 2012),

(Aug.

https://www.jointcommission.org/resources/news-

standards/standard-faqs/critical-access-hospital/

and-multimedia/blogs/ambulatory-buzz/2012/03/

medical-staff-ms/000001500/.

guest-blogger-virginia-mccollum-credentialing-and-

39. Id.

privilegingimplementing-a-process/

40. Id.

20. Id.

17,

2020)

https://www.jointcommission.org/

41. “Focused Professional Practice Evaluation (FPPE)

21. Id.

–

22. Engelhardt v. St. John Health System, 2012 WL 1367543

Commission,

(Mich. App. Apr. 19, 2012).

Understanding

The

(Aug.

Requirements”, 17,

2020)

The

Joint

https://www.

jointcommission.org/standards/standard-faqs/critical-

23. Taylor v. Singing River Hosp. System, 704 So.2d 75 (Sup Ct. Miss. 1997).

access-hospital/medical-staff-ms/000001485/.

42. Id.

24. Id. at 79-80.

43. Id.

25. 587 S.W.3d 647 (Mo. banc 2019).

44. Id.

Amy Collignon Gunn Amy Collignon Gunn is an attorney at The Simon Law Firm, P.C., located in St. Louis, MO. Ms. Gunn can be reached at (314) 241-2929 or agunn@simonlawpc.com.

Elizabeth S. Lenivy Elizabeth S. Lenivy is an attorney at the same firm. Ms. Lenivy can be reached at (314) 241-2929 or elenivy@simonlawpc.com.

21

AIEGVoice Magazine

The People Have th Litigating A Lack of Informed Consent Case

22

AIEGVoice Magazine

he Right to Know Andrew D. Nebenzahl

O

n July 4, 1776, upon the birth of the United States, the authors of the Declaration of Independence declared: “We hold these truths self-evident that all [people] are endowed … with certain unalienable rights,

that among these are Life, Liberty and the pursuit of Happiness.” It was not, however, until the twentieth century that our right to liberty encompassed the obligation of a physician to obtain consent from a patient before conducting an invasive procedure. Today, while the informed consent doctrine is recognized throughout the country, its application differs by jurisdiction.

Background of the Informed Consent Doctrine The obligation to obtain consent from a patient was first expressed in the United States in Pratt v. Davis, 118 Ill.App. 161, 166 (Ill.App. Ct. 1905), where the court recognized that ”under a free government at least, the free citizen’s first and great­est right, which underlies all others—the right to the in­violability of his person, in other words, his right to him­self—is the subject of universal acquiescence, and this right necessarily forbids a physician or surgeon, however skillful or eminent, who has been asked to examine, diagnose, ad­vise and prescribe (which are at least necessary first steps in treatment and care), to violate without permission the bodily integrity of his patient by a major or capital opera­tion, placing him under anesthetics for that purpose, and operating on him without his consent or knowledge.”

Similarly, around the same time, the court held in Mohr v. Williams, 95 Minn. 261, 268 (1905) that “[t]he patient must be the final arbiter as to whether he shall take his chances with the operation or take his chances of living without it. Such is the natural right of the individual, which the law recognizes as a legal right.”1

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AIEGVoice Magazine

Eight years later, citing Pratt and Mohr, Justice Benjamin

number of American jurisdictions, but more largely on

Cardozo gave further prominence to this principle, writing:

a different rationale. The majority of courts dealing

“Every human being of adult years and sound mind has a

with the problem have made the duty depend on

right to determine what shall be done with his own body;

whether it was the custom of physicians practicing in

and a surgeon who performs an operation without his

the community to make the particular disclosure to

patient’s consent, commits an assault, for which he is liable

the patient. If so, the physician may be held liable for

in damages. Schloendorff v. Society of New York Hospitals,

an unreasonable and injurious failure to divulge, but

211 N.Y. 125, 129-130, 105 N.E. 92 (1914). As such, the

there can be no recovery unless the omission forsakes a

concept of patient consent became firmly established in

practice prevalent in the profession. We agree that the

American law. However, it was not until 1957 when the

physician’s noncompliance with a professional custom to

California Supreme Court decided in Salgo v. Leland Stanford

reveal, like any other departure from prevailing medical

Jr. Univ. Bd. of Trustees, 154 Cal. App. 2d 560, 317 P.2d 170,

practice, may give rise to liability to the patient. We do

181 (1957), that the concept of “informed consent” and its

not agree that the patient’s cause of action is dependent

intended requirements was defined: “A physician violates

upon the existence and nonperformance of a relevant

his duty to his patient and subjects himself to liability if he

professional tradition.”

withholds any facts which are necessary to form the basis of an intelligent consent by the patient to the proposed

Notably, the court did not simply give the plaintiff a blank

treatment. Likewise, the physician may not minimize the

check to rely on his/her subjective view of what disclosure is

known dangers of a procedure or operation in order to

necessary. Instead, Canterbury established the requirement

induce his patient’s consent.””

of an objective finding “when a reasonable person, in what the physician knows or should know to be the patient’s

Fifteen years later, in the landmark case of Canterbury

position, would be likely to attach significance to the risk

V. Spence, 464 F. 2d.772 (D.C. Cir 1972) the doors were

or cluster of risks in deciding whether or not to forego the

effectively blown open on the scope of the physician’s

proposed therapy.”

obligation to provide informed consent: a case which spanned over two years from argument to decision. In a

Finally, for better or worse, Canterbury’s greatest legacy is

prolific opinion, the court recognized:

that it sparked accelerated attention by legislatures and

“True consent to what happens to one’s self is the informed

appellate courts throughout the country to address the

exercise of a choice, and that entails an opportunity to

different requirements for proof of a physician’s duty to

evaluate knowledgeably the options available and the risks

disclose alternatives to the recommended treatment of a

attendant upon each. The average patient has little or no

patient. The result of this attention is that, while the concept

understanding of the medical arts, and ordinarily has only

of informed consent is a rule in every jurisdiction and, indeed,

his physician to whom he can look for enlightenment with

a widely accepted ethical and regulatory requirement for

which to reach an intelligent decision. From these almost

the delivery of health care, the need for and the scope of

axiomatic considerations springs the need, and in turn

disclosure differ significantly across the country. As such,

the requirement, of a reasonable divulgence by physician

the nature of a cause of action, and the proof required of

to patient to make such a decision possible. … To enable

plaintiffs to attach liability under the informed consent

the patient to chart his course understandably, some

doctrine varies from state to state.

familiarity with the therapeutic alternatives and their hazards becomes essential.

A Tale Of Two Standards – Patient Based Or Physician Based

Duty to disclose has gained recognition in a large

Full disclosure of both the nature of the proposed

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AIEGVoice Magazine

treatment, its accompanying risks and all alternative

knows or should know is his patient’s position, would

methods to what is being advised is the cornerstone of

attach to the disclosed risk or risks in deciding whether

the informed consent doctrine. However, the way states

to submit or not to submit to surgery or treatment. …

have crafted a physician’s obligations – and the evidence

The materiality determination is one that lay persons

necessary to prove a breach of that obligation – differ

are qualified to make without the aid of an expert.”

substantially and generally fall into two camps. These are

Canterbury, supra at 784–85.

commonly referred to as “patient based” or “physician based.” While the latter standard requires analysis of

In short, to prevail in patient-based states the jury must

whether a reasonable doctor in the same position would

be convinced that not only would this plaintiff have made

have informed the patient about certain risks, considering

another choice if full disclosure of risks and alternatives

their significance and likelihood, the former looks to

been provided, but a reasonable person would have done

whether a reasonable patient would have undergone the

so as well.

treatment if the risks were revealed with viable medical alternatives.

Contrary to Canterbury, nearly half of the other states in the country follow the physician-based standard of

The patient-based standard is the Canterbury standard and

informed consent.3 While this standard also requires

is used by almost half of the states in the country.2 Under

disclosure, the focus for the jury is on what a reasonably

this approach, physicians must disclose to the patient

prudent physician in the same field would do under

information that a reasonable person in the patient’s

similar circumstances.4 The states that fall under this

shoes would want to know before undergoing a particular

category all seem to indicate that in order to determine

type of medical treatment. Appropriate information

whether informed consent was given, or how much

should include the nature of the patient’s condition, the

information is needed to satisfy the informed consent

nature and probability of risks involved, the benefits to

obligation, the focus is on what is reasonable within the

be reasonably expected, the inability of the physician to

medical community and what other physicians would

predict results (if that is the situation), the irreversibility

do under the same or similar circumstances. Thus, the

of the procedure (if that be the case), the likely result of

primary distinction among the two approaches is that

no treatment, and the available alternatives, including

in order to prove a breach of the informed consent

their risks and benefits. The obligation to give adequate

doctrine in physician-based states, the plaintiff must

information does not require the disclosure of all risks

introduce expert testimony to establish the materiality

of a proposed therapy, or of information the physician

component where in patient-based jurisdiction it is

reasonably believes the patient already has, such as

not required.5

the risk of infection, which is inherent in any invasive procedure.

And Then There are the Hybrids Two states, Minnesota and New Mexico, follow a hybrid

While expert testimony is necessary to establish the

approach that favors shared medical decision-making.

risks of and alternatives to a prescribed treatment plan,

Physicians are given limited discretion, and patients are

in patient-based states, materiality is paramount and the

given the right to choose their desired course of treatment

extent to which a physician must share that information

based on detailed information. In Minnesota, physicians

with a patient depends upon what information the

have the typical duty to disclose information that other

physician should reasonably recognize is material to the

physicians would disclose under similar circumstances.

plaintiff’s decision. “Materiality may be said to be the

However, when a patient exhibits curiosity about other

significance a reasonable person, in what the physician

less serious risks, those risks must also be disclosed.5

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AIEGVoice Magazine

In New Mexico, the legal standard respects the patient and

Careful attention must be given to when and by whom

what he or she needs to know to make a decision, but also

the patient was asked to sign the consent form. The

gives the physician the flexibility to decide what should

consent may be defective if the information which was

be discussed with the patient. This standard is neither

required to be disclosed (e.g. risks and alternatives)

subjective to the physician nor the patient but objective

was not given by a physician; if the patient was

as to both.

medicated at the time (s)he signed it; if the patient

6

was in the immediate vicinity of the operating room

Negligence v. Informed Consent

and had already been prepped and importantly, if the

Except in states where negligence is an element of an

patient signed the consent form in blank before being

informed consent claim,

distinguishing a cognizable

informed of any risks. Additionally, consent forms

informed consent claim from a straight up negligence

may be attacked on the basis that the terms were

claim can be challenging. Courts generally will be

nonspecific or that the patient did not understand the

careful to preclude conflation of the two claims. See

meaning of the technical terms used. It is essential

Roukounakis v. Messer, 63 Mass. App. Ct. 482 (2005),

that these questions must be explored in every case

where a radiologist failed to properly read the plaintiff’s

as the defense will wave the consent form in front

mammogram which then led to the failure to perform

of the jury and thoroughly interrogate your client

an ultrasound which would have detected the plaintiff’s

at trial. The following is a typical cross examination

cancer. The trial court judge refused to instruct the jury

regarding the execution of the applicable consent form.

7

on informed consent and ruled instead that the informed consent claim could not be separated from the negligence

Q

Now, up until this point, your testimony has been

claim. The Appeals Court upheld the trial court noting

that when you were presented with consents for treatment

“[t]he crux of the plaintiff’s claim was [the physician’s]

and for anesthesia, you always read before you signed the

failure to properly diagnose and to recognize the need

document. Is that correct?

for further tests. That failure gives rise to a claim for

A Correct.

negligence but not to a claim on principles of informed consent.” Roukounakis, 63 Mass. App. Ct. at 487. Stated

Q

I’m now showing you the consent for anesthesia

another way: whether the physician has “[become] aware

relative to the TEE cardioversion on November 6th of 2013.

of a condition by diagnosing it” will dictate whether the

That is your signature?

duty to disclose is in play. Without diagnosis, there can

A Yes.

be no duty to disclose. Bays v. St. Luke’s Hosp., 63 Wash.

App. 867, 881 (1992).

Q

Okay. And you’ll agree with me that the document

includes, relative to the risks of anesthesia, these risks may

Overcoming The Consent Form

be as severe as adverse drug reaction, brain damage, or

In one respect, informed consent is much like the

death. Additional risks may include such things as injury to

concept of agreement in contract law; it is a meeting

teeth and dental work, damage to vocal cords, respiratory

of the minds with both parties talking about the same

problems, minor pain and discomfort, damage to veins, or

subject matter. It is customary almost everywhere for

arteries, or hags. Is that correct?

medical facilities to require consent forms prior to

A Correct.

invasive treatment. The circumstances of the execution of these forms, and the language contained therein are

Q

as varied as wildflowers.

2013 at 11:06 a.m.?

A Correct.

26

th

And you executed the document on November 6 ,

AIEGVoice Magazine

Q

This is the patient to consent to procedure for the

It may appear that this colloquy was devastating to the

TEE cardioversion. Is it not?

Plaintiff. It was not, however, because of the specific events

A Yes.

which surrounded the execution of the forms which had been described on direct overcame the language of the

Q

Okay. And you executed that document at 12:15 on th

form. For instance, in this case, the Plaintiff did not know,

November 6 .

nor was he informed that his health condition going into

A Yes.

the procedure made him particularly susceptible to the injury he ultimately sustained. In short, it is up to the jury to

Q

Okay. And the document indicates that the risks

discussed including —included the risks of TEE cardioversion.

determine, after hearing all the evidence, if actual informed consent was given by the Plaintiff-patient.8

Did I read that correctly?

A

Yes.

Practical Suggestions Generally speaking, both the law and good medical

Q

Okay. And also discussed some of the general

practice take the same approach in determining what a

complications above that. Right? I can read them, just to be

physician must disclose to a patient. In addition to the

clear. I understand the risks and benefits I can reasonably

statutory or common law rules of each jurisdiction, there

expect from this procedure and surgery compared to those

are numerous other sources of rules which define the

that I can expect from other approaches. Did I read that

nature and extent of disclosure required of physicians.

correctly?

Examples include hospital protocols, Medicare or

A Yes.

Medicaid regulations, standards established by The Joint Commission (formerly “JACOH”) as well as ethical

Q

And then below that, I understand the risks and

standards of the American Medical Association. 9 Though

the possibility of major complications of this procedure/

the provisions contained in these sources, will not

surgery. I understand that among the risks of the procedures

necessarily have the force of law in every jurisdiction,

are drug reactions, bleeding, infection, complications from

they are persuasive evidence to a jury.

receiving blood, or blood components. I also understand

that with every procedure of surgery there is a possibility of

A Stealth Approach to the Defendant’s Deposition

unexpected complications. Did I read that correctly?

Informed consent is often overlooked as a cause of action

A Yes.

by both Plaintiffs and the Defense. Plaintiff lawyers should appreciate the instinctual appeal of informed consent to

Q

And at the bottom it reads, I have had an opportunity

jurors and take advantage of any apparent lack of focus

to ask about the risks and benefits of this procedure surgery

by the defense. When an informed consent claim is in a

and of all the alternatives. All my questions have been

case, it is often viewed as a fall back to the malpractice

answered to my satisfaction and I consent to this

claim. However, in the right case the informed consent

procedure surgery. Did I read that correctly?

can be everything. Medical negligence is frequently hard

A Yes.

to decipher, particularly when the medicine is complex.

In such cases, experts put their own spin on the standard

Q

And you executed that document again on 12:15

of care to the point of hopeless confusion. Conversely,

on November 6th?

the desire for individual autonomy easily resonates with

A Yes.

Jurors. They want autonomy over their treatment. They want to know what their options are, what the risks and

I have no further questions, Your Honor.

benefits are for each option and most importantly to decide 27

AIEGVoice Magazine

for themselves which treatment (including no treatment) to

Once the treatment options are established during the

choose. It is not difficult for a juror to identify with the effect

deposition, counsel should take considerable time exploring

of not getting the whole story about something as important

other areas such as the patient’s history, what the test

as one’s health care, as many have had a similar experience

results mean, what is written in the chart – anything except

in life and resent it.

what the doctor told the plaintiff. Save that testimony to later in the deposition. In all likelihood, the physician will

The foundation for this is the defendant physician’s

testify that he has little to no memory of his discussions

deposition. It is critically important for the defendant

with your client. It is conventional wisdom among defense

physician to admit/list out all the ways the plaintiff’s

lawyers that this is an effective strategy in a malpractice

condition could be treated. Having developed a thorough

case. The testimony is frequently accompanied by custom

understanding of all the treatment options from the medical

and practice testimony. However, it is not as effective in

literature and their experts, the lawyer should not reveal

an informed consent case because the doctor would be

such knowledge in the manner of the way the questions

leaving it to the Plaintiff as the only reliable historian of

are posed. Physicians are apt to want to show how smart

their conversations. The doctor will be more than happy

they are and how lawyers are simply ignorant. This is a

to discuss his diagnosis and treatment and this should be

tactical advantage for Plaintiff’s counsel. The goal is to get

exploited. If there is a disconnect between the treatment

the defendant to list as many ways to treat, or not treat the

alternatives, the treatment which was provided and what

condition as possible. This should be worked into the early

the doctor told the patient, you will have a powerful

part of the deposition during the time you are questioning

weapon at trial.

the defendant about his education and professional career.

Getting this testimony early and moving on to other issues,

Conclusion

rather than discussing the facts of your case, can often

A substantial body of literature corroborates a considerable

disguise its importance.

gap between the goal and the practice of providing informed consent to patients undergoing medical treatment. Physicians

Simple questions such as “what are some of the ways

receive little training regarding the practice of informed

condition 'x' can be treated” are helpful. If the defendant

consent, are pressed for time and by competing demands,

physician missed any treatment options counsel is aware

and often misinterpret the requirements and legal standards.

of a non-confrontational follow up question such as “is

Patients often have meager comprehension of the risks and

treatment 'y' a method of treatment for condition 'x'?” Once,

alternatives of offered surgical or medical treatments, and

you have a nice list of several options, go back over them

their decisions are driven more by trust in their doctor or by

and count them out so the number is on the transcript. For

deference to authority than by the information provided. This

example, “we’ve gone over five different ways one can treat

reality, and its underlying rationalizations notwithstanding,

condition 'x' right”; followed by “they are 1…., 2…., 3…. Did

the patient’s right to know is being ignored. It is hard to

I miss any”; and then “is that everything?” In short, a little

argue with the proposition that the informed consent

looping can go a long way.

doctrine really places no additional burden on the health care provider beyond what has always been required as part

If the defendant physician will not admit to any alternative

of the delivery of complete, competent care and compliance

modes of treatment, lock in his testimony that there is only

with ethical norms. Notwithstanding, particularly in those

one way. It is not credible to a jury that there is only one

physician-based states where the requirements of proof are

way to treat a condition – at the very least, no treatment is

more demanding, enforcement of the rules often falls short

always a treatment option.

of its theoretical ideal.

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AIEGVoice Magazine

1. Although Mohr was the first of the two to come to

have gone ahead with the operation had the doctor

the lower courts, the final opinion in that case came

fulfilled his duty to disclose the nature of the procedure.”

down after the first lower court ruling in Pratt, which it

Id.

cites extensively. Thus, the chronologically earlier case

7. For example, Texas states that “the only theory on

(Mohr) cites a previous lower court opinion in a “later”

which recovery may be obtained is that of negligence

case (Pratt) as precedent.

in failing to disclose the risks or hazards that could have

2. Patient based jurisdictions include Alaska, California, Washington

D.C.,

Hawaii,

Louisiana,

influenced a reasonable person in making a decision to

Maryland,

give or withhold consent.” TEX. CIV. PRAC. & REM.

Massachusetts, Mississippi, New Jersey, North Dakota,

CODE ANN. § 74.101.

Iowa, Ohio, Oklahoma, Oregon, Pennsylvania, Rhode

8. However, in Florida, Idaho and Utah, the execution of a

Island, South Dakota, Texas, Utah, Washington, West

written consent form creates a presumption of validity

Virginia, and Wisconsin.

absent fraud, bad faith or the like.

3. Physician based states include Alabama, Arizona,

9. According to the AMA: “Informed consent to medical

Arkansas, Colorado, Connecticut, Delaware, Florida,

treatment is fundamental in both ethics and law.

Georgia, Idaho, Illinois, Indiana, Kansas, Kentucky,

Patients have the right to receive information and ask

Maine, Michigan, Missouri, Montana, Nebraska, Nevada,

questions about recommended treatments so that

New Hampshire, New York, North Carolina, South

they can make well-considered decisions about care.

Carolina, Tennessee, Vermont, Virginia, Wisconsin, and

Successful communication in the patient-physician

Wyoming.

relationship fosters trust and supports shared decision

4. Additionally. Florida, Idaho, Maine, Nevada, and North

making. The process of informed consent occurs when

Carolina, add more to the general standard, indicating

communication between a patient and physician

that a signed consent form creates a rebuttable

results in the patient’s authorization or agreement to

presumption that consent was given. Iowa, Ohio, and

undergo a specific medical intervention. In seeking

Utah state laws also establish that a signed consent

a patient’s informed consent … physicians should:

form creates a presumption that informed consent was

Assess the patient’s ability to understand relevant

given and acknowledged.

medical information and the implications of treatment

5. Kinikin v. Heupel, 305 N.W.2d 589, 595 (Minn. 1981See

alternatives and to make an independent, voluntary

also:MINN. STAT. § 144.651 (2018). “Patients and

decision. Present relevant information accurately and

residents shall be given by their physicians complete

sensitively, in keeping with the patient’s preferences

and current information concerning their diagnosis,

for receiving medical information. The physician should

treatment, alternatives, risks, and prognosis as required

include information about: The diagnosis (when known),

by the physician’s legal duty to disclose.”

The nature and purpose of recommended interventions,

6. See Gerety v. Demers, 589 P.2d 180, 191 (N.M. 1978).

The burdens, risks, and expected benefits of all options,

The Court reasoned “[i]nformed consent is not a key

including forgoing treatment.” AMA Principles of Medical

issue.” Id. “There need be no proof that the patient may

Ethics: I, II, V, VIII.

Andrew D. Nebenzahl Andrew D. Nebenzahl is the founder of The Nebenzahl Law Group, located in Sharon, MA. Mr. Nebenzahl can be reached at (781) 784-2000 or anebenzahl@neblawgroup.com.

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The Electronic Medical Record: More Than What Is Produced Sara M. Davis

T

he medical record in medical malpractice lawsuits is typically one of the most, if not the most, important evidence in a case. Since the transition from handwritten medical charts to

electronic medical records, the amount of data that can be obtained from the record has exponentially increased. There tends to be confusion surrounding the discovery of the data within the electronic medical records by both attorneys and the courts. In most cases, simply getting a copy of the electronic medical record will leave important information undiscovered. Defendants typically fight the production of this discoverable data. In this article I will attempt to explain the electronic medical record in more detail, pointing out what information is available, and how to obtain it.

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AIEGVoice Magazine

The medical record is evidence of the official documentation

What information a doctor had or was accessible to her

of care. In the last 15 years, there was a push for medical

at the time of the alleged negligence can be critical. Take

records to transition to an electronic format. In 2011,

for instance in a misdiagnosis case, the more information

physicians', clinics', and hospitals' initial resistance subsided

available to the physician, the narrower his differential

when the government offered financial incentives: physicians

diagnoses ought to be. How can a physician argue there was

received $67,250 and hospitals received a minimum of $1.2

low suspicion for atrial fibrillation if he is or should have been

million as a base payment for implementing an electronic

aware of the results of a stress test? If you only get the EMR

medical record system (EMR). Only a handful of hospitals

and not the EHR you may wrongly believe the physician’s

serving the Medicare- and Medicaid-eligible population did

testimony that he did not know about the client’s prior tests

not receive funding from the Federal Government .

with another physician. The EHR may show the test results

1

from all treaters in the system. But the records produced by To qualify for the government payment, the medical provider

the doctor are often only the physician’s EMR.

had to implement a “certified” electronic medical record system. In order to be listed as an “approved vendor” by

EMR's look very different on paper or in pdf format than

the government, EMR vendors had to go through testing

they do on a medical provider’s screen. The format that the

and evaluation as well as attest to ability to meet program

providers see is often referred to as the “native format.” It is

requirements. To qualify, EMR vendors had to have

also nearly impossible to determine if the print/pdf version

transaction level auditing — known as an audit trail. Once

produced in discovery is complete. One reason for this is

a vendor met the requirements it would be included on the

that under HIPPA the provider must disclose the “designated

Office of National Coordinator’s website under a list of EMR

set” upon request by a patient.3 Defendants will also argue

products meeting requirements to qualify for the financial

that by defining a designated set, HIPAA has limited the

incentives . Products had to recertify in 2015. Physicians

forms which a patient may receive from a medical record and

and hospitals, not willing to risk not receiving the financial

that HIPAA has ordered providers to disclose the “minimum

incentives, largely used vendors on this “approved list.”

necessary."4 Defendants rely on the Department of Health

2

and Human Services' interpretation to support its position

The Electronic Health Record

that records not defined as part of the designated set are

Non-electronic medical records are now the rare exception.

privileged.5 The argument may be effective in response to

To ensure that we get all the electronically stored information

a patient request for records, but it will not succeed in the

available, we need to understand the various components

context of discovery. HIPAA carves out an exception for

and capabilities of the electronic medical record.

disclosure in judicial proceedings where liberal discovery rules apply. It may often take motion practice for a court

The term electronic medical record (EMR) and electronic

to rule that the records must be produced. If your client

health record (EHR) may sound like two terms for the same

comes to you with records in hand you still must request the

data but that they are two different systems. The electronic

complete EHR in discovery.

medical record is the localized medical record or the electronic version of a patient’s chart. The electronic health

It is not unusual to have a situation where you have several

record is broader. It encompasses various providers that are

different versions of records from a single provider: the client

part of one digital body. Records and data from a physician’s

brings you records she obtained, your office requests the

practice included in the electronic health record of hospital

records from the provider through a HIPAA authorization,

systems is becoming more common as large health systems

and the provider, once named as a defendant, produces

continue to buy up private practices. Both EHR and EMR

records in discovery. No single format of the reproduced

contain relevant information.

electronic medical record contains all the information.6 32

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"EMR's look very different on paper or in pdf format than they do on a medical provider’s screen. The format that the providers see is often referred to as the 'native format.'"

These situations highlight how difficult it is to ensure you

of the “designated record set” to argue that only the

have obtained a complete set of the electronic medical

designated record set must be produced. The “designated

record.

record set” being the definition within HIPPA. However, for the same reason this argument is unsuccessful when seeking

The Audit Trail

other parts of the medical record in discovery, it should be

To qualify as a “certified electronic medical record” the record

similarly unsuccessful with requests for audit trails. Courts

must contain an audit trail. The audit trail must maintain data

routinely require production of audit trails.9

including, among other things, who accessed the electronic information and what was done during that access period.7

A thoughtful explanation of why audit trails should be

The audit trail is required to include any modifications made

produced can be found in Gilbert v. Highland Hospital. In

to the patient’s medical record, what was changed, what it

Gilbert the Plaintiff sought production of the audit trail

was changed to, and what it was changed from. The audit

because there was an issue as to whether a physician ever

trail saves the “metadata”: the unseen, embedded, “data

reviewed the Plaintiff’s medical records prior to her discharge

about the data” that tracks every keystroke to a computer.

from the emergency department. The Court explained:

The audit trail must be maintained for a minimum of six years.8

The Defendant argues that the audit trail is not “material and necessary” because it would not demonstrate all of

The states administer the EHR certification criteria set

the efforts of the Emergency Department Attending

forth by the federal government. The program requires self-

Physician, only those efforts that bore a relation on

reporting of non-compliance to the Inspector General as

accessing the decedent’s electronic records. While it is

well as audits. If a hospital or provider received government

true that the audit trail will not account for the Attending

funds and does not maintain an audit trail it can result in a

Physician’s actions, which did not relate to accessing

very substantial financial loss. If a defendant makes the claim

and viewing the decedent's electronic records, the audit

that it did or does not maintain audit trails, the next step is

trail will account for the Attending Physician’s accessing

to determine if that entity received the government funds

and viewing the decedent’s electronic records, a topic the

for establishing its EMR. Once confirmed that the defendant

Plaintiff may wish to explore further during a deposition

did receive the funds (the majority of providers and systems

or on cross-examination. The Fourth Department has

did), remind the defendant of its self-reporting requirements

held that if, “there is any possibility that the information

for failing to maintain an audit trail. The audit trail typically

is sought in good faith for possible use as evidence-in-

follows.

chief or in rebuttal or for cross-examination,” it should be considered evidence material and necessary (Matter

The audit trail will not be produced in response to a request

of Schneier’s Estate, 74 A.D.2d 22, 28, 426 N.Y.S.2d 624

for the medical record. It will require a separate request.

[4th Dept.1980]).

Defendants will claim that the audit trail is not part of the patient’s record. They will often site the statutory definition 33

The Defendant argues that the Plaintiff’s request for AIEGVoice Magazine

the audit trail is a “fishing expedition.” To the contrary,

Another popular defense argument to resist production of

the Plaintiff has not offered “a litany of theoretical

an audit trail is to suggest the request is nothing more than a

questions

speculations

fishing expedition because there is no evidence the defendant

calculated to justify a fishing expedition” (Minister, Elders

improperly altered the medical record. But a Plaintiff’s right

& Deacons of the Reformed Protestant Dutch Church of

to production of the audit trail is independent of such a

City of New York v. 198 Broadway, Inc., 59 N.Y.2d 170,

finding, and thus claims of alterations to the medical record

175, 464 N.Y.S.2d 406, 451 N.E.2d 164 [1983]). Rather,

are not relevant to the analysis.10 The defendant received

the Plaintiff requested the decedent’s audit trail, a

government funds to purchase the system — taxpayer

document *559 the Plaintiff knows must exist because

money was used for the system — the very system whose

it is mandated by Federal and New York law, for the

data the defendant now seeks to hide from the taxpayer. A

specific reason of quantifying the level of involvement

quick reminder of this reality is also often persuasive.

followed

by

hypothetical

of the Emergency Department Attending Physician with the decedent’s care while she was in the Emergency

When the audit trail is produced it can be very difficult to

Department.

interpret. A sanitized copy of an audit trail appears below.

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AIEGVoice Magazine

For this page of the audit trail, it documents when the

are going to need to give me a minute.” The clinical format

patient’s primary care physician reviewed this patient’s

is interactive with drop down menus, etc. It is intended

hospital admission records, what portion of the record

to provide information easily and quickly to providers. It

was accessed, and what action was taken. It notes that

may include picture archives, voice messages, diagnostic

the provider modified the problem list six times. It does

images, electronic communication between providers.11

not indicate what was modified — or whether there were

That is not what is produced when it is printed or saved

additions and/or deletions. This document was identified

to a pdf.

by the defense as an “Access Log.” This was produced by a large hospital system. The access log is just one component

Where you feel that you have not received the complete

of the audit trail. A helpful way to think of an audit trail is

record, where the accuracy of the record is an issue, or

that it is not a separate document. It is a query and report of

when it is important to know what the doctor knew and

the metadata. So in this example the query was when Dr. X

what information he had available to him at the exact time

accessed the records.

of treatment — an inspection of the medical records is often necessary. This request will often be met with significant

Some systems (Cerner) omit changes that were made to

opposition.

the record when the audit trail is printed. You can see that changes were made in the native format (on a screen) but

The first line of defense to the notice of inspection will be the

when printed or downloaded to a pdf the changes made

blanket claim that all the records have been produced and

are not captured. This is one of the scenarios where an

the inspection is unnecessary and burdensome. What will

inspection of the system is necessary.

be absent from this argument is an affidavit of completeness from any hospital employee. The reason for this is that the

Inspect the System

defendant knows that there is information only available in

We have all found ourselves in a situation where we do not

the electronic medical record when it is viewed in its clinical

believe that we have received all the medical records from a

format (native format).

provider/system. Perhaps we received an itemized Medicare lien listing dates of service for which we do not have records.

If a court seems inclined to agree with the defendant, ask

Or we find ourselves in the situation set forth in Donato v.

for an affidavit of completeness from the compliance officer

Nutovits, infra, where you get several different versions of

or request his/her deposition. The compliance officer

the same chart. Or maybe you have an audit trail that you

knows that if he signs the affidavit, he will be attesting to

know is not capturing all the available information. At this

its record system not meeting the minimum requirements

point you may want to consider hiring an expert in electronic

to be considered certified for the funding program. The

medical records. The EMR is a database, it is not a document.

compliance officer will not risk losing hundreds of millions

The experts understand the functioning of the database.

in government funds over a production request. He will not

They can pinpoint the missing data. Experts can also provide

jeopardize falling out of compliance.

you with the exact language to use in production requests and inspection notices. It is not in this format when it is

The next argument is typically that it is burdensome

printed or saved to a pdf: the very formats medical records

without a showing that the record is incomplete. However,

are produced in.

an inspection is no more burdensome than a deposition.

The cost and time are minimal. The courts must consider

How often have we been in a deposition and when we ask a

the proportionality of a discovery request. An inexpensive

doctor to look at a medical record and hand her the record,

inspection to ensure complete discovery of the official

she responds, “This isn’t what it looks like on my screen. You

document of care. It is certainly proportional.

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WORDS OF ADVICE from the author

"If a court seems inclined to agree with the defendant, ask for an affidavit of completeness from the compliance officer or request his/her deposition.

The compliance officer knows that if he signs the affidavit, he will be attesting to its record system not meeting the minimum requirements to be considered certified for the funding program. The compliance officer will not risk losing hundreds of millions in government funds over a production request."

The Defendant may also argue it does not have someone to

contract you/your expert can glean what EMR components

facilitate the inspection. In response, request the individual

the provider/health system has purchased and will then

that facilitates audits administered by the state’s department

know what information there is to obtain.

of public health to ensure the providers’ compliance. These audits occur regularly as part of the certification process.

An inspection will typically require a court order. It is recommended the order include the following language12:

Another argument that the defendant may advance is “We cannot allow an inspection because the intellectual

IT IS HEREBY ORDERED:

property is owned by the vendor and the vendor does not

The electronic health record, audit and compliance system

allow inspection/production pursuant to the contract.” This

inspection is to take place on a date agreed by the parties

argument is popular among users of the Epic record system.

at [FACILITY].

Request the contract between the health system/hospital and Epic. The defendant has made it relevant. You will find

IT IS FURTHER ORDERED:

that it is rarely in these contracts and if it is it can be cured

A. The term “meta-data” means information embedded in a

by a protective order. If you are able to get a copy of the

native file that is not ordinarily viewable or printable from

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AIEGVoice Magazine

the application that generated, edited, or modified such native file; and information generated automatically by the operation of a computer or other information technology

Health Record Incentive Program; 5. The dates in which they met compliance with Adopt, Implement or Upgrade, Meaningful Use 1 and 2;

system when a native file is created, modified, transmitted,

6. For each EHR system, auditing and compliance module,

deleted or otherwise manipulated by a user of such system.

identify the ONC Certified Health Production number;

Meta-data is a subset of electronically stored information

7. All user, administrative, implementation guides and

(ESI).

manuals for the Electronic Health Record system, system modules, auditing, and compliance systems;

B. The term “native file(s)” means ESI in the electronic

8. The retention policies, procedures, and schedules in

formation of the application, in which such ESI is normally

effect regarding the complete EHR in effect during

created, viewed and/or modified. Native Files are a subset

Plaintiff’s stat at [hospital];

of ESI.

9. Besides medical data that is part of the complete medical

C. The term “electronic health record” refers to electronic

record produced per request of the Plaintiff, identify

information systems and/or computerized devices containing

the metadata that exists in all EHRs or computer-based

electronic records of patient data captured in any care

medical devices from [date] to [date]. This specifically

delivery setting within [hospital] and is often referred to as

includes, but is not limited to: computer-based

an electronic medical record. Records include, but are not

medication orders, orders for therapy, instrumentation

limited to: patient demographics, histories and physicals,

and interventions, and physiological data such as

progress notes, clinician orders, lab tests, diagnostic

blood pressure, pulse, temperature, etc. automatically

imagines, graphical data such as EKG tracings, physiological

measured or otherwise obtained; and,

data such as blood pressure, pulse, respiratory rate and

10. Whether any changes and/or upgrades that have

temperature, automated decision support-generated alerts

occurred in [hospital’s] EHR since Plaintiff’s treatment

and reminders, and any other data.

that could affect or change the clinical data or metadata as reproduced in response to these requests in any way.

D. The term “database” means a data structure that stores organized information. Most databases contain multiple

At the time of the inspection, the Plaintiff and the Plaintiff’s

tables, which may each include several different fields. For

expert shall be entitled to:

example, an electronic health record database may include

11. Access to all EHR systems, databases, auditing and

tables for patients, diagnosis, access, and compliance

compliance systems using the highest level credentials

records. Each of these tables would have different fields

for login;

that are relevant to the information stored in the table.

12. Access to all systems and data to view and capture the date, time, and author from [date] to the present day;

Fourteen days prior the inspection, Defendant shall provide:

13. All dictation audit trails;

1. Identity of the person most knowledgeable for the HER

14. All types of actions to including amendments, additions,

software/auditing and compliance system;

copy, print, sign, create, and delete with the original

2. Any EHR vendor software/auditing and compliance system changes, within the last 10 years;

documentation unobscured to the EHR from [date] to the present day;

3. The software name(s) and version(s) of the EHR system, system modules, auditing, and compliance system(s) in use during the time of the patient’s care to date;

15. All specific portions of the chart accessed from [date] to the present day; 16. Terminal/device identification and physical location of

4. Whether any government funds received by for each practitioner and entity for participation in the Electronic 37

all accesses from [date] to the present date; 17. Time event stamp and display time stamp; AIEGVoice Magazine

18. Any and all hyperlinked documents (scanned or PDF) in

1. In 2011, the Department of Health and Human Services

the medical record;

(DHHS) Centers for Medicare and Medicaid Services

19. Clinical data used in monitoring and providing medical

(CMS) established the Medicare and Medicaid EHR

care to the patient; and

Incentive Program. The Funding came from the 2009 as

20. A court reporter and/or videographer to record said

part of the Health Information Technology for Economic

inspection.

and Clinical Health (HITECH) Act. 2. https://www.healthit.gov/faq/where-can-i-find-list-ehr-

IT IS FURTHER ORDERED:

products-have-been-certified-or-certified-ehrs

21. Screenshots of the auditing portion of the program will be allowed;

3. 45 C.F.R. ยง 164.501 4. Summary of the HIPPA Privacy Rule; Compliancy

22. Defendants will make available the EHR system,

Assistance, published by the Department of Health

databases, system modules, auditing and compliance

and Human Services, pg. 12,

systems to the Plaintiff and her experts as to not restrict

www.hhs.gov/sites/default/files/ocr/privacy/hipaa/

any view of data during a site inspection for four hours;

understanding/summary/privacysummary.pdf

23. Defendants will assist by navigating the systems and answering questions as to the system capabilities and

available at htttps://

5. Id. at pg. 10.

6. See Donato v. Nutovits, 2016 WL 9738291 (N.Y. Sup. Ct.

navigate of the system;

2016) for an example of this situation.

24. Defendants will not answer questions as to the contents of the medical records;

7. 45 C.F.R. ยง 170.210(b); 45 C.F.R. ยง 164.312(b) 8. 45 C.F.R. ยง 164.316

25. Plaintiffs will direct defendants when to screen capture certain sections of the systems and those screenshots will be produced within seven days of the site inspection, and 26. If Defendants cannot navigate to the requested location of the system, Defendants shall engage support from the software manufacturer.

9.

I was unable to find a single appellate decision where failure to produce an audit trail was upheld. CA, IL, NY, KA, PA, KY, MO, CO, VI all have enforced the production of audit trails and have excellent language in the opinions that can be useful in motion practice around the issue of audit trails.

10. Gilbert v. Highland Hospital, 52 Misc. 3d 555, 31 N.Y.S.3d Witness testimony is often unreliable or insufficient to

397 (Sup 2016).

recreate the details of care. As EMR records become more

11. Fundamental of the Legal Health Record and Designated

sophisticated in retaining and organizing data we can expect

Record Set; November 5, 2020, https://library. Ahima.

the fight over metadata to become more contested. The

org/doc?oid+104008#.X6Rhq2hKiUK

medical record is evidence of the care provided to the patient.

12. This language is pulled directly from the website for

In situations where we cannot reconcile the medical records

Garrett Discovery. A vendor we use regularly for EMR

with the outcome, we need to investigate the actual care

investigations. It can be found at garret discovery.com/

that was administered. The truth may lie in the metadata.

resourcelibrary

Sara M. Davis Sara M. Davis is a partner at Cogan & Power, located in Chicago, IL. Ms. Davis can be reached at (312) 4772500 or sdavis@coganpower.com.

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Liability for

Hemorrhages Bruce R. Pfaff

Editorial assistance from Sarah Fraser and Meghan Mays

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"Yeah, we all need someone we can bleed on Yeah but if you want it, well you can bleed on me."

Keith Richards/Mick Jagger Hemorrhage - “a copious or heavy discharge of blood from blood vessels or organs.”

Knives and bullets wound. Surgeons cut. When a blood vessel or organ gets in the way, there is bleeding. If there is enough uncompensated bleeding, organs do not get enough oxygen and they are damaged. When this happens to someone in a medical care setting, there can be liability and compensation. This paper will discuss the biology of uncontrolled bleeding; contexts in which it can give rise to liability; and misleading defenses for us to defeat.

Biology of Uncontrolled Bleeding Each of us is walking around with a certain amount of circulating blood volume. An average size American female has about 4.5 liters of blood in her body; an average male perhaps 5 liters.

The formula for calculating blood volume of an average adult person is 70 mL per kg of body weight. Because blood volume decreases in a nonlinear manner with increasing weight, the same calculation cannot be used for the non-average adult. For the morbidly obese, the formula uses a lesser number per kg and it varies based on the degree of obesity.

During a surgery, if an average female loses 1.5 liters of blood, she has lost one third of her blood volume. If the loss is not replaced promptly and with appropriate fluids, her blood pressure will drop, her heart rate will increase, and her end tidal CO2 will drop. These changes in the patient’s vital signs indicate decreased cardiac output and diminished perfusion of oxygenated blood to organs. The extent of damage to the patient’s 40

AIEGVoice Magazine

organs will be affected by pressure, volume, and duration.

provider will often administer fluid therapy such as lactated

The longer a patient has low blood volume and low blood

ringers. This increases the volume of fluid in the vessels

pressure, the more likely organ damage is to occur. If the

and can help reduce some of the harm from the bleeding.

patient regularly takes medication for hypertension, her

It temporizes. It also dilutes the proportion of protein cells

heart rate will usually not increase much, if at all, with acute

and red blood cells in the vessels. It takes some time for

bleeding.

the dilutional effect to occur, but when hemoglobin and hematocrit drop in the OR, it is usually because of the non-

Measurements of hemoglobin and hematocrit are sometimes

blood fluid therapy.

used to assess bleeding. The results of those measurements

Giving fluid alone is not a cure for substantial acute blood

can be quite misleading in a patient who is bleeding acutely.

loss. Blood products should be given as well, packed red

Preoperatively, there will be H&H values taken and charted

blood cells first. The goal is to improve the clinical picture

by the surgeon or anesthesia provider. In a bleeding event,

fast. Fluids like lactated ringers are usually always on hand

rechecking of H&H is often done. Doctors are often reassured

in the OR, whereas the blood is stored elsewhere, requiring

when the H&H (which covary) does not drop substantially.

time to be cross matched and delivered.2 Anticipating a

Their reassurance is false and dangerous.

patient’s transfusion needs, should significant bleeding occur in the perioperative period, is an important step in the

A hemoglobin test measures the amount of hemoglobin in

pre-operative planning for the entire OR team.

your blood. Hemoglobin is a protein in your red blood cells that carries oxygen to your body’s organs and tissues and

Uncompensated Bleeding Lawsuits

transports carbon dioxide from your organs and tissues

In recent cases our office has prosecuted, the surgeons

back to your lungs. Normal results for adults vary, but in

claimed “occult bleeding” occurred and it was acceptable

general for men are 13.8 to 17.2 grams per deciliter (g/dL).

for him (in each case) not to notice. “Occult bleeding” is

A hematocrit test measures the proportion of red blood cells

simply bleeding that the doctor does not see.3 It is not a

in your blood. Red blood cells carry oxygen throughout your

special sneaky kind of bleeding; it occurs in the presence of

body. https://www.mayoclinic.org/

a physician who is ignorant of the bleeding, which is often inexcusable. When you think of it, how funny is it for the

Both tests measure proportions of either protein cells or

profession to develop a fancy name to describe bleeding the

red blood cells per unit of blood sampled. If a patient has

doctor missed seeing?

a pre-op hemoglobin of 14 and loses 2 liters of blood in an hour with no replacement, the hemoglobin will not change.

Dr. Kindred did a laparoscopic hysterectomy on a 36-year-

If no fluids are given, the proportion of cells in the blood will

old woman who bled to death on the OR table. She had

be the same. This phenomenon is not obvious to lay people

significant internal bleeding for longer than 45 minutes

and sometimes not to attending doctors. This explains the

before the assembled team of doctors decided an exploratory

medical truth that people can bleed to death with normal

surgery was needed. By then, her fate was sealed. Until

hemoglobin levels. Nevertheless, some doctors will see a

the exploratory began, Dr. Kindred did not think there was

hemoglobin value that only dropped from 14 to 11.5 and

bleeding. All the monitoring data said that she was bleeding,

incorrectly conclude that acute bleeding is not likely. That

but Dr. Kindred was unpersuaded by the anesthesia staff

would be wrong.

who, very late in the game, suggested that an exploratory

1

laparotomy was needed. Consequently, a wife and mother of In the presence of adverse clinical signs like low blood

three died in the OR. Dr. Kindred did not look behind where

pressure, high pulse and low end tidal CO2, the anesthesia

he was operating with the scope when it became apparent

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things were amiss. Had he done so he would have

anesthesiologist received a hemoglobin result of 11.5

seen free blood.

(pre-op was 14). That also made her think bleeding was less likely — but it should not have because she

In another case, Dr. Rossi did not see bleeding that

whiffed on the medicine. Ten minutes later, another

he also called occult when he was performing a

blood draw was done: the reported hemoglobin was

laparoscopic Roux en Y gastric bypass on a 58-year-

4.9. Finally, they ordered blood and waited another

old woman. Like Dr. Kindred, Dr. Rossi caused the

six minutes to call in a general surgeon to explore the

bleeding. When he first noticed the bleeding, he

belly.

said 500 cc of blood was “oozing” and later he detected another 700 cc of oozing blood. He said

How much blood had the patient lost? The surgeon

the bleeding was occult and had been ongoing for

said, “liters and liters.” This lovely patient died on

an hour of more before he first saw it. He and his

the table. The surgeon could not see the bleeding

expert felt that his causing the bleeding and not

because he was operating on the hip and the bleeding

seeing it for more than an hour is acceptable. That’s

was in the retroperitoneum. In this case, the surgeon

not all right. There were 1.5 liters of bleeding, at

legitimately could not see the bleeding. Even though

least in the case when the usual Roux en Y involves

there are reported cases of retroperitoneal bleeding

approximately 50-100 ml of blood loss.

in hip replacement surgeries, he said the precautions he takes make that virtually impossible. But it

The anesthesia team was slow to respond. When

happened and his patient died. Both the surgeon and

the CRNA learned of the blood loss, she waited

the anesthesia team should have been aware that

18 minutes to order blood from the blood bank. It

there can be retroperitoneal or abdominal bleeding

was delivered 15 minutes later and given another

during this type of procedure and properly treated

5 minutes later. Rather than give 2 or 3 units of

their patient, but they did not.

blood, they gave one unit in the OR. The patient remained hypotensive for more than two hours

Lastly, in another case, an infant was on bypass

and sustained brain damage due to the poorly

during surgery to repair aortic stenosis. There was a

compensated bleeding during surgery. Fault lies

significant drop in the cerebral oxygenation during the

both with the surgeon and the anesthesia team.

time she was on bypass. There was also a decrease in hematocrit. In response to the drop in hematocrit,

Dr. Manning did an anterior approach left total hip

the perfusionists wanted to administer packed red

replacement on a healthy 62-year-old woman. This

blood cells. At that moment, they discovered that the

procedure utilizes a small operative field and there

PRBC were not in the OR refrigerator as they should

is not usually more than 200-400 ml of blood loss.

have been. The cells were in the blood bank. It took

An hour into the surgery with the patient crashing,

an additional 35 minutes for the cells to arrive. The

the CRNA finally paged the anesthesiologist to

delay in administering the PRBC proximately caused

come. She came, she saw, and she whiffed. Her

our client’s brain injury.

immediate thought was “this looks like hypovolemic shock due to bleeding.” She told the surgeon this

The hospital’s nursing staff failed to make sure the

and asked about the bleeding. He said words to

blood, which had been typed and cross matched

the effect, “nothing more than normal.” This led the

three days earlier, was delivered to the blood bank

anesthesiologist to think hemorrhage was less likely.

before the case began. The perfusionists failed to

Then 45 minutes after she arrived in the OR, the

make certain the blood was available in the OR before

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the case began. One of the perfusionists noted on their form

severed blood vessel (query—if blood is flowing out of the

checklist that blood was “available” in the OR when in fact

vessel, how does gas flow in to the vessel?), passed through

it was not. The indefensible care led to an early, substantial

the venous system and lodged in the right side of the heart

settlement.

for an hour.

Misleading Defenses

CO2 embolism is exceptionally rare and is mostly reported in

Some published standards in the field of transfusion

cases where the Veress needle that injects the CO2 into the

medicine recommend against giving transfusions of packed

abdomen hits a blood vessel and directly injects the CO2.5

red blood cells unless the patient’s hemoglobin is below a

Uniformly, the patient crashes within a few minutes. If the

certain number; for instance, 7-9. Those standards are

embolism is appropriately diagnosed, the patients do fine.

thrown at plaintiff’s experts who argue that the blood loss

Nevertheless, in the almost-impossible-to-defend hemorrhage

warranted prompt blood replacement. There are at least two

case, consider the potential of this misleading defense.

4

good answers to this half true cross examination: • Many patients have died due to bleeding with normal hemoglobin levels.

1. An attending anesthesiologist at Northwestern Memorial Hospital had such trouble remembering the medicine

• The standards generally do not govern patients who are actively bleeding.

on this topic that he took a break in his deposition and googled hemoglobin, hematocrit, and acute blood loss before discussing the topic further. DeCaria, 5/16/19,

What should a doctor do when someone’s arm is blown off

pp. 60-65.

and he is gushing blood—take a blood test and wait to see if

2. I recommend this substantial article by Dr. Teo Dagi,

the Hgb gets below seven before transfusing? Of course not,

The Management of Postoperative Bleeding, Surg Clin

the patient would already be dead. Doctors need to order

N Am 85 (2005) 1191–1213. It is also applicable to

blood based on the clinical condition of their patient.

intraoperative bleeding.

3. Bresci, G., Occult and obscure gastrointestinal bleeding:

There are always defense experts willing to spin the “alien

Causes and diagnostic approach in 2009, World J

virus from Mars” theories of causation rather than to

Gastrointest Endosc. 2009 Oct 15; 1(1): 3–6.

acknowledge that the patient’s death or brain injury is due

4. Retter, A., Guidelines on the management of anaemia

to undercompensated bleeding. A local favorite in Illinois,

and red cell transfusion in adult critically ill patients

who has testified in more than 200 trials for the defense but

British Journal of Haematology, 2013, 160, 445–464;

never for the plaintiff, will always try something. We recently

Qaseem, A., Treatment of Anemia in Patients with Heart

heard him say that a CO2 embolism occurred causing heart

Disease: A Clinical Practice Guideline From the American

block, preventing blood from going to the brain to cause the

College of Physicians, Ann Intern Med. 2013;159:770-

brain injury Dr. Rossi’s surgery, infra, caused. He posited that

779, among others.

the CO2 injected in the abdomen during the laparoscopic procedure somehow entered the blood stream through a

5. Brull, S., Vascular air embolism: A silent hazard to patient safety, Journal of Critical Care 42 (2017) 255–263.

Bruce R. Pfaff Bruce R. Pfaff is a partner at Pfaff, Gill & Ports Ltd., located in Chicago, IL. Mr. Pfaff can be reached at (312) 828-9666 or bpfaff@pgptrials.com.

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SEA CHANGE: Winning a Spinal Epidural Abscess Case Bruce L. Braley

Introduction Undiagnosed and untreated/improperly treated spinal epidural abscesses (SEA) can cause catastrophic injuries to patients, including paraplegia, quadriplegia and death.

Patients who survive can face a lifetime of expensive medical and lifecare needs. Because of the growing incidence of SEA over the past three decades, knowing how to recognize and evaluate SEA cases can literally be a life-and-death decision for your client.

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What is a Spinal Epidural Abscess?

presentation.”3 Only about 10 percent of patients with SEA

A spinal epidural abscess is an area of infection located within

present with the classic triad, and less than 66 percent have

the epidural space. “SEA can be catastrophic in no time. The

fever.4 The classic triad is present “in only a few patients and

progression of neurologic deterioration to severe spinal cord

delayed diagnosis is common.”5

dysfunction can occur in a matter of just a few hours, making diagnosis and treatment imperative.”1

What are the Four Stages of SEA? Stage I is characterized by spinal pain; Stage II is characterized

Doctors and nurses need to have a high index of suspicion

by nerve root pain; Stage III involves loss of motor, sensory,

when it comes to diagnosing and treating SEA: “Spinal

and sphincter function, and stage IV is paralysis.6

epidural abscess is difficult to diagnose if clinical suspicion is not high. When left untreated, spinal epidural abscess can

What Diagnostic Imaging is Required?

cause significant morbidity and mortality. Thus any clinical

Magnetic Resonance Imaging (MRI) is typically required to

concern for this diagnosis requires prompt evaluation and

rule out SEA, and is usually diagnostic.7,8

treatment.” (emphasis added)1

Importance of Neurologic Assessments Risk Factors

If SEA is suspected but has not been confirmed, it is critical

Diabetes mellitus is the most common risk factor for

to have regular neurologic assessments by nurses: “Initial

SEA. Other risk factors include immunosuppression from

care for a neurologically asymptomatic patient with a spinal

alcoholism, cirrhosis, end-stage renal disease, and HIV, IV

abscess includes antibiotic therapy, frequent neurologic

drug abuse, acupuncture, paraspinal and epidural injections,

examinations, and serial MRIs to monitor progression of

lumbar puncture, CNS surgery and bacteremia. When

infection.9 When medical management is chosen over

these risk factors are present in a patient who may have

surgical intervention, “frequent reassessment of neurologic

SEA on a differential diagnosis, clinical suspicion should be

function is imperative, because deficits may develop

heightened.

quickly and become permanent. Any evidence of spinal

2

cord compression requires emergent surgery, with better

Potential Defendants

outcomes linked to earlier decompression. By 24 to 36 hours,

Potential defendants in SEA cases include specialists in

neurologic deficits may be permanent.”10 Neurologic deficits

family medicine, internal medicine, pediatrics, emergency

include loss of strength, paraplegia or quadriplegia, sensory

medicine, neuroradiology, infectious diseases, neurologic

loss, loss of sphincter tone, and radicular symptoms.11

surgery, critical care medicine, hospitalists, physician assistants, nurse practitioners, nurses and hospitals.

Failure to Properly Treat SEA Once SEA is diagnosed, the choice of treatment can have

Theories of Liability

enormous implications for whether the patient lives, dies, or

Most SEA cases can be divided into two basic types: failure

becomes catastrophically disabled. The most critical initial

to diagnose SEA or failure to treat/properly treat SEA. Failure

decision is whether to treat the patient solely with medical

to treat cases frequently focus on decisions to use medical

management (administration of antibiotics only) or whether

management vs. surgical management of a known SEA.

to combine surgical intervention with aggressive medical management.

Failure to Diagnose SEA

What is the “Classic Triad” of a SEA? Historically, the classic

Standard of Care

triad consists of fever, back pain and neurologic deficit. It is

“Emergent surgical spine consultation is the standard of care

important to know that “the classic triad … is not a common

for all patients with radiographic findings epidural abscess

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"Once SEA is diagnosed, the choice of treatment can have enormous implications for whether the patient lives, dies, or becomes catastrophically disabled" and abnormal neurological examinations due to mass effect

monitoring of the neurologic examination.”13

from an epidural abscess. These patients usually require an emergent surgical evaluation to decompress the spinal cord

Physicians who consider a non-surgical treatment plan

and nerve roots.

for medical management (antibiotic therapy alone) of SEA do so at significant risk: “Physicians rarely use antibiotics

“Overall, the treatment of spinal epidural abscess focuses on

alone because some patients will suffer neurologic deficit

the elimination of the [pus] and eradication of the [infection].

progression despite antibiotics. Complications can ensue

This is accomplished through aspiration, surgical drainage,

abruptly and unpredictably, without warning. The resultant

and antibiotic therapy. The assistance of interventional

paresis or paralysis may not be reversible even if surgery is

radiology or spine surgery (orthopedics or neurosurgery) will

performed urgently.”14 “The decision to pursue non-operative

be required in the management of many if not all of these

management should only be made with direct neurosurgical

patients.

consultation for risk factor assessment ….”15 Factors related to failure of medical (non-surgical) management include:

“Empiric antibiotic regimens should include vancomycin (30-

age > 65, diabetes, MRSA, neurologic compromise, and

60 mg/kg) plus a third or fourth-generation cephalosporin

circumferential SEA.16

(2 g cefotaxime Q6H, 2 g ceftriaxone Q12H, 2 g ceftazidime Q8H, or 2 g cefepime Q8H) until speciation and sensitivities

Nursing Liability

of the infecting organism result for more targeted antibiotic

Conduct of nurses involved in patient care should never

therapy. Typically patients will require a prolonged course of

be overlooked when evaluating SEA cases. Nurses have

antibiotics (4 to 6 weeks) to treat this infection.”12

independent duties to make nursing diagnoses, carry out a plan of care, monitor vital signs, comply with standing and

Translation: The “gold standard” for treatment of SEA

specific orders, notify doctors of significant changes in the

includes emergency decompressive laminectomy with

patient’s condition, and invoke the chain of command when

debridement combined with long-term antibiotic treatment.

a patient is not getting the care she needs. Nurses have

Broad-spectrum antibiotics should be given before surgery.

significant responsibilities that can cause or contribute to

Once culture results are back, antibiotics should be modified

catastrophic injuries and deaths due to SEA.

and continued for a minimum of 4-6 weeks. “Consensus opinion advocates for surgical drainage of epidural abscesses

“Delayed treatment of a [SEA] may result in … flaccid

in addition to antimicrobial therapy. Patients diagnosed with

paraplegia with sensory loss at the level of the abscess.” ***

[SEA] should be evaluated immediately by a neurosurgeon,

Nursing Assessment: 2. Perform Neurologic assessment,

and input should be sought from infectious disease

including cranial nerve evaluation, motor and cognitive

specialists. In the absence of neurologic deficit, conservative

status. *** Nursing Diagnoses: Risk for Injury related to

management may be cautiously considered, with close

neurologic deficits. *** Evaluation: Expected Outcomes –

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No injury related to neurologic deficits.”17

Medicine, Concepts and Clinical Practice (7th ed. 2017), p. 1396.

6. Krishnamohan P, Berger JR. Spinal epidural abscess. Curr

Prognosis When patients are promptly and accurately diagnosed and treated for SEA, their prognosis is very good — up to two-

Infect Dis Rep. 2014 Nov;16(11):436.

7. Tintinalli’s

Emergency

Medicine

(8th

ed.

2010)

thirds will have significant recovery. When patients are not

Nontraumatic Musculoskeletal Disorders - Neck and

promptly diagnosed and treated, they face catastrophic

Thoracolumbar Pain, pp. 877-881.

injuries with life-changing and life-long complications … or death.18 Mortality can be as high as 59 percent in SEA cases with persistent bacteremia or septic shock.

8. Spinal Epidural Abscess, Clinical Key – First Consult (Rev. Jan. 31, 2012).

9. Spinal Epidural Abscess, Clinical Key First Consult (Rev.

19

Jan. 31, 2012), p. 1.

10. Tirrell, Sandra, M.D., Handa, Sajeev, Spinal Infections,

Conclusion When evaluating a potential SEA case, it is important to have a basic understanding of what causes spinal epidural abscesses, what risk factors make a patient more susceptible

Clinical Key (Oct. 30, 2017), p. 516.

11. Tirrell, Sandra, M.D., Handa, Sajeev, Spinal Infections, Clinical Key (Oct. 30, 2017), p. 517.

to an SEA, when SEA should be included on a differential

12. Ameer, Muhammad A., Knorr, Thomas L., Mesfin, Fassil

diagnosis, why a high index of suspicion is important, what

B., “Spinal Epidural Abscess,” StatPearls, p. 2-3 (January

diagnostic imaging should be considered, how SEA can and

2020)

should be diagnosed, and proper treatment considerations, including surgical decompression and antibiotic therapy.

I hope this article helps you help patients who have experienced life-changing injuries due to medical errors in diagnosing and treating SEA.

13. Tirrell, Sandra, M.D., Handa, Sajeev, Spinal Infections, Clinical Key (Oct. 30, 2017), p. 518-19.

14. Akhondi, Hossein, Baker, Mari B., “Epidural Abscess,” StatPearls, p. 4 (July 6, 2020) 15. Singleton, Jennifer M., Heffner, Matthew, Spinal Cord Compression, StatPearls (May 15, 2020), p. 5.

1. Akhondi, Hossein, Baker, Mari B., “Epidural Abscess,” StatPearls, p. 1 (July 6, 2020)

16. Singleton, Jennifer M., Heffner, Matthew, Spinal Cord Compression, StatPearls (May 15, 2020)

2. Ameer, Muhammad A., Knorr, Thomas L., Mesfin, Fassil B., “Spinal Epidural Abscess,” StatPearls, p. 1 (January 2020)

17. Lippincott Manual of Nursing Practice (9th ed. 2010), p.

527.

18. Hauser, Stephen L., Ropper, Allen H., Ch. 377 “Diseases

3. Scalera, Nikole, MD, Ferri, MD, FACP, Misulis,Karl MD,

of the Spinal Cord,” Harrison’s Principles of Internal

PhD, Norden, Andrew, MD. Spinal Epidural Abscess.

Medicine (18th ed. 2012), p. 3370. [Note: Dr. Anthony

First Consult. Jan. 31, 2012.

Fauci, Director of the National Institute of Allergy and

4. Managing Nontraumatic Acute Back Pain, Edlow, Annals of Emergency Medicine, 66(2):151 (2015).

Infectious Diseases at NIH, is a principal editor of this edition of Harrison’s]

5. Chapter 104 –Spinal Cord Disorders, Rosen’s Emergency

19. Spinal Epidural Abscess, Clinical Key First Consult (Rev. Jan. 31, 2012), p. 1.

Bruce L. Braley Bruce L. Braley is a partner at Leventhal Puga Braley, P.C., located in Denver, CO. Mr. Braley can be reached at (303) 759-9945 or bbraley@leventhal-law.com.

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&

settlements verdicts /COLLISION AVOIDANCE TECHNOLOGY

lane departure warning and lane keeping assist systems, to alert the driver when the vehicle is drifting out of its lane and keep the vehicle in its lane of travel. McDaniel

Lack of Blind Spot Assist – Chevrolet Trax

v. Weikert/General Motors. AIEG members Jaime Jackson

General Motors settled a case involving lack of blind spot

and Benjamin Vanasse represented the plaintiff. Plaintiff

assist on a 2016 Chevrolet Trax. The vehicle was changing

Expert: Anne Stodola (accident reconstruction). Defense

lanes from the right lane to the left lane when it struck

experts were not disclosed prior to settlement.

a motorcycle that was lawfully passing in the left lane.

Plaintiffs alleged the 2016 Chevrolet Trax was defective

/OCCUPANT RESTRAINT

because it lacked a blind spot assist system to identify and alert the driver when a vehicle is in their blind spot or

Failure to Equip Rear Airbags/Failure to Deploy –

travelling alongside the vehicle. General Motors offered

Chevrolet Malibu

blind spot detection safety systems on the 2017 Trax,

General Motors settled a case involving a failure to equip

but not the 2016. Extensive testing was done utilizing a

with rear airbags claim in a 2005 Chevrolet Malibu. On

2017 Trax equipped with blind spot assist to confirm the

March 31, 2018, Defendant Conners was driving the subject

motorcycle was detected and driver alerted each time.

vehicle in Granite City, Illinois and Plaintiff Harvey Moore

Kyer v. General Motors. AIEG members Lee Javins and Jaime

was an occupant in the rear passenger side of the vehicle.

Jackson represented the plaintiffs. Plaintiff Experts: Mehdi

Defendant Conners failed to keep a careful lookout, drove

Ahmadian (testing). Defense experts were not disclosed

while distracted, failed to maintain his lane of travel and

prior to settlement.

allowed the subject vehicle to leave the roadway. The vehicle then skidded on the grass adjacent to the roadway and struck

Lack of Lane Keeping Safety System – GMC Canyon

a tree near the rear passenger door where plaintiff Moore

General Motors settled a case involving lack of a lane

was seated. The subject vehicle was not equipped with rear

keeping safety system on a 2016 GMC Canyon. The

airbags or the rear airbags failed to deploy. Moore v. General

vehicle drifted over the center line into the opposite lane

Motors. AIEG member Chad Lucas, along with nonmember

of travel striking plaintiff’s 2004 Chevrolet Silverado

Andrew Mundwiller, represented the plaintiff. Plaintiff

1500 pickup truck in a head on collision. Plaintiffs alleged

Experts: Paul Lewis (biomechanics), William Davenport and

the vehicle that crossed the center-line was defective

Catherine Doty (life care plan). Defense Experts: Elizabeth

because it lacked a lane keeping system, consisting of

Raphael (biomechanics).

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/TIRE

/GENERAL

Tread Separation/Tire Mismatch – Hyundai Sonata/

Spontaneous Non-Collision Fire – Honda CR-V

Firestone Tire

Honda agreed to settle a spontaneous non-collision fire case

BJ’s Auto Sales and Bridgestone Americas Tire

involving a 2014 Honda CR-V. On November 26, 2014 Meike

Operations settled a tread separation, tire mismatch

Foster drove the subject vehicle a short distance from the

case involving a 2009 Hyundai Sonata and Firestone

parking area of the Meridian Valley Country Club up the

P215/65R17 Model FR710 tire. Decedent, Princeton

main driveway when the vehicle spontaneously ignited. Ms.

Moorer, purchased the vehicle from BJ's Auto on

Foster attempted to escape the burning car, but because

October 11, 2018. He returned the vehicle to BJ's as

the fire spread so quickly, she died of smoke inhalation and

a result of a shaking of the vehicle at highway speed.

thermal burns before she could escape. Plaintiffs claimed

At that time Defendant BJ's modified the tires on the

that rodent nesting material that was trapped near hot

subject vehicle and should have known that the tires

exhaust elements by plastic and metal shielding beneath the

on the vehicle were mismatched and of different sizes

engine compartment was the cause of the spontaneous fire.

and that the treads on the rear tires were worn more

Honda produced documents relating to several similar fires

than the tires on the front of the vehicle. On November

where such debris was found by Honda during inspections.

7, 2018, Plaintiff, was traveling south on Interstate 85

Foster v. Honda. AIEG members Peter O’Neil and Thomas

heading toward his place of employment when the left

Breen represented the plaintiff. Plaintiff Experts: Mark Arndt

rear tread separated from the main body of the tire

(design/fire cause and origin), Grzegorz Buckowski (rodent

causing the subject vehicle to go out of control and

behavior). Defense Experts: Larry Brown (fire cause and

go off the interstate, When the vehicle left the paved

origin), Robert Scheibe (engineering design and fire cause),

surface of the road and onto the shoulder it went into a

George Kenagy (rodent behavior).

ditch and rolled up an embankment causing the death of Mr. Moorer. Connie Martin v. BJ’s Auto Sales/Bridgestone

Distracted Driving/Failure to Keep Proper Lookout for

Americas Tire Operations (BATO). AIEG members Greg

Pedestrian

Allen and LaBarron Boone represented the plaintiff.

Defendant Jackson agreed to settle a distracted driving

Plaintiff Experts: Bryant Buchner (handling and stability/

case that involved the serious injury of a pedestrian. On

accident reconstruction), Troy Cottles (tire design).

November 27, 2016, defendant was operating her 2008

Defense experts were not disclosed prior to settlement.

Volkswagen Jetta in Independence, Missouri. At the same

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&

settlements verdicts time, Plaintiff Christopher Smith was crossing the road. The

the defendant, Henry Marine Service, Inc. was moored

vehicle operated by defendant struck the plaintiff. As a direct

and/or docked at Barry Steam Plant in Bucks, Alabama. On

and proximate result plaintiff was severely injured, including

that same date, Daniel Lee Smith, as he was attempting to

but not limited to brain injury damage. Christopher Smith v.

board the said tug boat fell, struck his head and drowned.

Jackson. AIEG members Chad Lucas and Nick Brand, along

At the time of the incident, the only means of ingress to or

with nonmember Peter Goss, represented the plaintiff.

egress from the Jamie H was to an unreasonably dangerous

Plaintiff Experts: Paul Atchley (distracted driving/visual

platform at which, by design, created a large gap between

attention), Roger Huckfeldt (life care plan), Robert Johnson

the tug boat and platform, requiring crew members to jump

(economist). Defense Experts: Robert Margolis (neurologist),

back and forth to board and/or disembark from the tug

Kuba Glazek (brain and cognitive sciences).

boat. Pugh v. Henry Marine Services, Inc./Alabama Power.

AIEG member David Cain represented the plaintiff. Plaintiff

Lack of Interlock Machine Guarding/Improper Lock Out Tag

Experts: Captain Mitchell Stoller (OSHA regulations/

Out – Six Roll Helix Delumper, Outlet Transition and Slide

dock hazards). Defense Experts: Alabama Power: Captain

Gate

Christopher Karentz (senior marine consultant); Henry

Brabender

Technologies/Davis-Standard,

LLC/Thompson

Marine: Captain David Seruton (master mariner), Jon Ver

Industrial Services settled a lack of interlock machine

Halen (human factors/anthropometrics), Staci Turner

guarding, improper lock out tag out case involving a 2015

(forensic pathologist).

Six Roll Helix Delumper, Outlet Transition and Slide Gate.

Plaintiff was injured while unclogging a delumper and outlet

Defective Hip Implant/Failure to Warn – Biomet MoM

transition used in the manufacture of duct tape. Nemley v.

M2a-Magnum Hip Implant System

Brabender. AIEG member Hugh McAngus represented the

A Missouri jury returned a plaintiff verdict in a defective

plaintiff. Plaintiff Experts: Michael Klein (machine design and

hip implant, specifically negligent design, involving a

performance/machine components). Defense Experts: Tim

Biomet MoM M2a-Magnum hip implant system. Plaintiff

Jur (machine design and performance/machine components).

Mary Bayes underwent a surgical procedure to implant the M2a-Magnum Hip Implant System in plaintiff’s right

Negligence/Premises Liability/Failure to Provide Egress/

hip on January 14, 2008 by Dr. Daniel Martin and on April

Ingress/Platform Gap – Tug Boat and Platform

28, 2008 at St. John’s Mercy Medical Center in St. Louis,

Henry Marine Service, Inc. and Alabama Power settled a

Missouri. She did not know nor have any reason to know

negligence case involving a tugboat and platform. On October

her hip implants were defective or causing her an injury until

7, 2017 the Jamie H, a tug boat owned and/or operated by

September 24, 2010, when MRI and CT Scan first showed

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injuries that could have potentially been caused by a metal-

the vehicle. As he struggled to maintain control, Mr. Jones

on-metal reaction. Thereafter, she began receiving treatment

repeatedly attempted to apply the brakes but he quickly

for the injuries to her hips. On March 28, 2011, she underwent

realized they had failed. Although his body was nearly

a complex surgery known as a revision surgery to remove the

engulfed in flames, Mr. Jones managed to steer the truck to

failed M2a-Magnum Hip Implant System from plaintiff’s left

the right and into a guardrail to slow it down to a stop. All

hip. As a direct and proximate result of the failure, plaintiff

three plaintiffs managed to escape the burning truck, but

experienced 11 hip dislocations resulting in multiple revision

were seriously injured in the incident. Mr. Jones sustained

surgeries – six left and one right. Bayes v. Biomet. AIEG member

severe burns over his legs, arms, hands, neck, and face, and

James O’Leary was one of several attorneys who represented

Ms. Geesling and Ms. Jones were also injured. Jones v. FCA/

the plaintiff. Plaintiff Experts: Mari Truman (biomedical/

Chrysler. AIEG members Jim Gilbert, Devin Daines and

biomechanics), George Kantor (general causation), Francis

Craig McClellan, along with non-member Conor Hulburt,

Gannon (orthopedics/pathology/immunology), Daniel Martin,

represented the plaintiffs. Plaintiff Experts: Joe Roming (fire

Jr., Paul Lux and Ryan Nunley (treating physicians). Defense

cause and origin), Jay Zembower (maintenance/service), Dr.

Experts: Steven Kurtz (biomedical engineer), Thomas Fleeter

Kevin Foster (burn injuries), D.J. Gaughan (psychologist),

(orthopedics), Thomas Bauer (pathology).

Ruth Rimmer (life care planner), Lisa Clapp (life care planner/vocational), Dr. Larry Stokes (economist), Dr. Mark

Drive Shaft Failure – Dodge Ram 2500 Pickup Truck

Campbell (orthopedic injuries). Defense Experts: AAM:

A case involving the drive shaft failure leading to fire in a 2007

John Glennon (maintenance), Marc Zupan (metallurgy),

Dodge Ram 2500 Pickup Truck resolved. William Jones, Jr. was

Michelle Albers (life care planner), Dwight Duncan

driving the subject vehicle traveling eastbound on Interstate

(economist), Nancy Fraser Michalski (price of medical care),

10 in Arizona with Gabriele Geesling and Jennifer Jones as

John Beck (psychologist); WJK: Chris Harte (standard of

passengers. While traveling at highway speeds, the truck

care), Robert Basile (failure analysis & prevention), Thomas

experienced a catastrophic failure of its driveshafts, u-joints,

Kulaga (spoliation of evidence of Zembower), Mikal

transfer case, transmission, brake lines, fuel system, floorpan

Balmforth (metallurgy); FCA: Joseph Sesniak (fire cause and

and/or other underbody components and began to violently

origin), James Smith (design), Joseph Arruda (maintenance),

shake to the point where Mr. Jones could barely maintain

Jeff Colwell (cause and origin), Robert Benson (design and

control. Believing he had experienced a tire blowout, Mr. Jones

metallurgy), Michael Kirk (FMEA/design), Jack Ridenour

attempted to maneuver the truck to the shoulder to assess the

(service/maintenance/design), Michelle Vogler (weld issues),

problem. As he attempted to do so, however, there was a loud

Paul Frantz (maintenance instructions/warnings).

pop noise, and fire suddenly burst through a large hole into

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2 0

A Banner Year for e

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2 0

eDiscovery Case Law Jeff Dreiling

I

n a year where an unprecedented global pandemic affects every aspect of life, you might expect less eDiscovery case law coming down. Quite the opposite has proven true.

According to eDiscovery case law research site, eDiscovery Assistant (eDA), 2020 has been a banner year. As of mid-November, eDA has published over 2,100 decisions for 2020. This is roughly 15 percent of all eDiscovery case law in existence.

On a Macro-level, the data shows us some interesting trends in the issues being addressed in these rulings: 1. The number one issue is spoliation.

2. The second leading issue is proportionality.

The trend line shows that proportionality will overtake all other issues sometime in 2021. As we’ve discussed in this space over the last few years, defending against discovery proportionality claims is nothing new to requesting parties.

What is new is that Judges are beginning to treat proportionality as the twoway street that it is. If we complain against blanket claims of proportionality with no evidence or facts, then we must also be prepared to target our requests and have realistic expectations.

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In granting the defendant’s request for cost shifting, Let’s take a look at some recent ruling examples.

Judge Mitchell explains, “the ESI/TAR process became disproportionate to the needs of the case” after previously

Lawson v. Spirit Aerosystems, Inc.

warning the plaintiff that their inability to focus ESI requests

No. 18-1100-EFM-ADM (D. Kan. October 29, 2020)

would result in the court shifting costs. The plaintiff was ultimately forced to pay the entire bill incurred, from the

This case, which is in front of Magistrate Judge Angel D.

vendor who performed the TAR process as well as the legal

Mitchell in D. Kan., is a cautionary tale to requesting parties

fees of defense counsel.

everywhere.

This is a rare occurrence and not shared to scare you In April 2019, the Judge established a search protocol due to

from demanding discovery that you are entitled to. Instead,

the party’s inability to gain consensus during the meet and

let it serve as a cautionary tale about the importance of a

confer process. The protocol called for both parties to work

cohesive eDiscovery strategy early in a case. By conducting a

together on search terms to try and achieve an 85 percent

deposition or two, most requests can become much more

responsiveness rate for targeted data.

targeted and effective.

As a sample, the defendant harvested data from 10 custodians

Oppenheimer v. Episcopal Communicators, Inc.

and applied the agreed upon list of search terms to the

No. 1:19-cv-00282-MR (W.D. N.C. August 14, 2020)

data. The resulting 468,595 documents that hit on one of the search terms were then sampled and manually reviewed

Not all proportionality claims went against the producing party.

by the producing party. The sample of 384 documents were determined to have only a 7.80 percent responsive rate. Of

This case demonstrates a more common occurrence.

those, many were technically responsive to the search terms

The requesting party found the initial production to

but irrelevant to the claims and defense in this lawsuit.

be insufficient. This was made clear in a letter sent to the producing party outlining the specific issues

The defendants agreed to redo the data culling and sample

with the first production. Additionally, the parties held

review using a search term list of the plaintiffs' choosing.

another meet and confer to attempt to resolve the production

The new keyword list yielded 322,000 documents. Again,

issue.

a random sampling was selected and reviewed returning a similarly low responsive rate, this time hitting 5 percent.

The producing party contended that the requests were “vague, ambiguous, irrelevant to any claim or defense,

In August, the parties began discussing the possibility

overbroad, not proportionate to the needs of the case and

of using technology assisted review (TAR) on the set of

overly burdensome.” Sound familiar?

322,000 documents. Even though the defendants had shown that only 5 percent of these documents were

After four months of failed efforts, the requesting party

responsive, the plaintiff still pursued the defense counsel’s

filed a motion to compel production. The motion was

use of TAR and asked that it be applied to all 322,000

granted because the producing party offered little evidence

documents. The defendant ultimately did have a vendor

to support its claim that the production requests were

perform TAR and the results were that only 3.3 percent of

disproportionate, privileged or protected. The producing

the documents were deemed responsive.

party never gave specific reasons or evidence to support their boilerplate claim of proportionality.

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These first two examples show how important cooperation

it was entitled to excise such information on the grounds

is when trying to identify proportional eDiscovery

of relevance. The entire document in question was ordered

parameters. We can’t control the attitudes or actions

produced with a designation of Attorney’s Eyes Only.

of opposing counsel, but we can predict them. At this point, defending a claim of proportionality should be

Rodriguez-Ruiz v. Microsoft Operations

expected when drafting each request for ESI production.

No. 18-1806 (PG) (Puerto Rico, D. P.R. March 5, 2020)

Corker v. Costco Wholesale

Mobile device and social media data were upheld as relevant

No. C19-0290RSL (W.D. Washington, Seattle. April 27,

sources of data in all types of lawsuits and for both plaintiffs

2020)

and defendants.

The right to receive and review documents in their native

Specifically, in Rodriguez-Ruiz v. Microsoft Operations, the

format when necessary is an important one for receiving

defendant sought the plaintiff’s cell phone data and,

parties. That right was upheld in Corker v. Costco Wholesale.

specifically, Facebook posts. The plaintiff objected to the request stating that the posts were not related to the

At issue in Corker, the producing party declined to produce a

wrongful termination at question and amounted to an

relevant Excel spreadsheet in its native format. They argued

invasion of privacy, stating his income tax returns and

that it would produce irrelevant and “commercially-sensitive

medical records should be enough.

information” to litigation advisories who were industry competitors. The producing party had first produced

The defendants filed a motion to compel the production

“summary documents” in lieu of the actual spreadsheet.

of the plaintiff’s Facebook profile. The court found that the

When the requesting party demanded the actual document,

plaintiff’s Facebook history was relevant to the case and that

they were given a 2,269-page PDF that was heavily redacted

“posted or published content in a social networking site,

and missing the usable metadata that accompanies native

such as a Facebook profile, is devoid of a right to privacy.”

files.

Seek the Expert Advice You Need The Corker court ruled in favor of the requesting party,

If you are in an eDiscovery dispute and are at an impasse like

rejected the PDF production and ordered the producing

many of the cases described in this article, send me a

party to produce the relevant spreadsheet in native

message or give me a call. Our role as consultants is to help

format. The court also ruled that although in theory a

you solve eDiscovery, so you can take advantage of less mess

relevancy redaction to protect commercially sensitive

and surprises, more efficiencies, and higher case values. We

information is a useful remedy in certain situations, in this

will help ensure you never get to a point where you must pay

case, the producing party had failed to demonstrate why

any, let alone all, of the cost of the production you receive.

Jeff Dreiling Jeff Dreiling is the Co-Founder of Complete Legal, a regional eDiscovery firm with heavyweight resources and integrity. Complete Legal’s team of experts serves a wide variety of clients, from solo attorneys to large corporate firms, helping them get the information they need to succeed. Jeff’s 17 years in the legal support industry include a multitude of experiences consulting, speaking, and writing on eDiscovery and ESI for hundreds of clients. Rediscover eDiscovery at completelegalkc.com.

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November 19, 2020

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