Transcript Healthcare Litigation

Healthcare Litigation: An
Interprofessional Approach to
Reducing Medical Errors.
My Experience
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Two murder cases
One manslaughter case
Two product liability cases
One animal abuse case
One workman’s compensation case
A life care plan with extensive medication list
Several malpractice cases involving
– Pharmacists
– Doctors
– Nurse Practitioners
Learning Objectives
1. Recognize the costs, both human and financial,
of medical errors
2. Define liability and malpractice
3. Identify problems in the delivery of healthcare
especially the transition of care from one
environment to another
4. Describe methods to decrease medical errors
by improving interprofessional communication
and medical records
5. Identify at least two classes of medication that
may cause harm and result in healthcare
litigation even if they are used within the
established guidelines.
Introduction
• Pharmacists are an integral part of the medical home
model and can help avert costly medication-related
problems by working collaboratively with other
healthcare providers.
• The New England Healthcare Institute estimates that
annual medication-related problems in the U.S. cause:
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156 million physician visits
23 million emergency department visits
11 million hospitalizations in the US.
Annual cost of medication-related morbidity and mortality is
$290 billion; more than the amount spent on the
medications themselves.
– Annual cost of medication-related problems in Maine exceeds
$1.7 billion.
Liability
• Criminal- imposed under criminal laws
and by means of criminal prosecution
• Civil- relating to private rights and to
judicial proceedings in connection with
them
• Product- liability imposed on a
manufacturer or seller for a defective
and unreasonably dangerous product
Malpractice
• Negligence, misconduct, lack of
ordinary skill, or a breach of duty in the
performance of a professional service
(as in medicine) resulting in injury or
loss
Negligence vs Intentional Act
• Negligence- the failure to exercise that degree of
care which a person of ordinary prudence (practical
wisdom; caution) would exercise under the same
circumstances.
• Example- a broken nose in a car accident vs a punch
• In a negligence case the plaintiff must prove four
elements
Duty
• Requirement to behave in a certain manner
for the benefit of another
– Duty to fill a patient’s prescription correctly
– Duty to counsel patients and perform a drug
regimen review
Breach of the Duty
• A duty can be breached in one of two ways
– Nonfeasance- duty is not performed
– Malfeasance- activity is performed, but it is
incomplete or incorrectly done
– Expert witness will draw on their own experience,
laws and regulations, codes of ethics, and other
such items to determine if the pharmacist
performed their required duties adequately.
Harm
• A patient must prove they were injured
or harmed.
– Many states require a physical injury in
order to make a claim for emotional
injuries.
– Difficult to separate the symptoms
associated with the negligent act from the
patient’s underlying pre-existing conditions.
Proximate Cause
• The injury the patient suffered must have
been caused by the breach of duty not some
other cause or underlying condition
– Very important in cases where it is not clear if the
patient actually took the drug in question, or that
the symptoms could be caused by some other
factor
– Superceding or interceding cause- another event
unrelated to the negligent act causes harm or
injury
Examples of Pharmacy Negligence
• Dispensing a medication that is different than the dug
ordered by the prescriber.
• Correct medication is dispensed in an incorrect dose.
• Dispensing the proper medication with a label
containing improper use instructions.
• Inadequate or erroneous warnings.
• Dispensing a drug that is contraindicated with one or
more of the current medications the patient is taking
with no physician order approving the simultaneous
use of both substances.
Case #1
• A 19 year old Africa American with a
history of Sickle Cell Disease presented
to the emergency room complaining of
chest and bilateral arm pain at 1:45am
• Vital signs
– Within normal limits except an oxygen
saturation of 93% (normal 95-100%)
Case #1
• Oxygen therapy via nasal cannula
• Medications
– Diphenhydramine 25mg IV x 2 @ 2:50am and 4:10am
– Vicodin (5mg hydrocodone/500mg acetaminophen) 2 tablets
by mouth @ 2:40am
– Morphine Sulfate 5mg IV @ 2:52am, 10mg IV @ 3:00am,
3:10am, 3:20am, 3:30am, 3:45am, 3:55am, 4:05am (75mg
over 73 minutes)
– Ketorolac 30mg IV @ 3:32am
– Levaquin 500mg by mouth @ 5:25am
Case #1
• Patient was awakened from sleep and reexamined at
5:30am
• His lungs were clear and he had an oxygen
saturation of 99%
• He was discharged from the hospital at 5:30am
• He was found unresponsive at home by his girlfriend
at 5pm
• Emergency Medical Technicians arrived at 5:17pm
and were unable to obtain a blood pressure, pulse
was 54 with sinus bradycardia, respiratory rate was
4, oxygen saturation was 48%
• Patient was intubated and transported to the hospital
where resuscitative efforts were unsuccessful
• Patient was pronounced dead at 6pm
Case #1
• An autopsy was performed the next day and
death was deemed natural secondary to
vascular occlusion as a consequence of
Sickle Cell Disease (multiple pulmonary
emboli)
• Toxicology- Morphine blood levels were
sufficient enough to produce anesthesia and
potentially toxic
Case #1
Additional information
• Pain index initially 9 out of 10 by 3:45am the
pain index is 3 out of 10 the patient is given
the 3:45am injection and two more injections
• They were initially unable to find a vein for the
IV so an IV team was paged and they gave
the two tablets of Vicodin
• Patient had a history of respiratory
depression after opiate administration
Case #1
• How did the morphine contribute to the
patient’s death?
• How could this death have been
prevented?
Case #2
• A 78 year old Caucasian female admitted to
the hospital (8/27) with a fractured hip two
days after a fall (8/25)
• History of hypertension, hyperlipidemia,
depression, dementia, hypothyroidism,
glaucoma, and a previous ischemic stroke
two years ago.
• Medications- Synthroid, metoprolol, Lexapro,
Namenda, Enablex, Simvastatin, Xalatan,
Darvocet, Plavix
• Plavix was discontinued on 8/27 two days
before the surgery on 8/29
Case #2
• Lovenox was prescribed to prevent
deep vein thrombosis
• Patient was transferred to a skilled
nursing facility for rehabilitation on 9/2
• Lovenox was discontinued on 9/20
• Patient suffered a second ischemic
stroke on 9/30
Case #2
Transition of care
• Primary care physician
• Admitting Emergency Room physician
• Orthopedic surgeon
• Cardiologist who cleared the patient for
surgery
• Physician at the skilled nursing facility
• Nurse practitioner at the skilled nursing
facility
• Consulting pharmacist at the skilled nursing
facility
Case #2
• What could have prevented the second
stroke?
• Who is liable?
• How could the transition of care be
improved?
Case #3
• A 48 year old Caucasian man who works as a
marine propeller technician presents with
diminished kidney function.
• A renal biopsy confirms a diagnosis of Antineutrophil Cytoplasmic AutoantibodyAssociated (ANCA) Glomerulonephritis
• The patient had an influenza vaccine
administered by a pharmacist six months prior
to the impaired kidney function.
Case #3
• Should the pharmacist be held liable for
not adequately explaining the potential
adverse effects of the vaccine?
Case #3
• There are no manufacturer reported kidney
adverse effects after immunization of influenza
vaccines
• A literature search found two cases of kidney
related toxicity after an influenza vaccine.
• One of the cases occurred four days after the
vaccination and the diminished kidney function
resolved itself after supportive care.
Case #3
• The patient presented with various
symptoms including ear pain, GI pain, and
flu-like symptoms (sinusitis and a cough) a
few months prior to the vaccination.
• Should the primary care physician be held
liable for not diagnosing the ANCA
glomerulonephritis?
Case #4
• A 60 year old female with a history of diabetes
(insulin dependent), hypertension, chronic
obstructive pulmonary disease, chronic back pain
and possible muscular dystrophy was found dead at
her home.
• Other significant historical notes- patient had a
recent colonoscopy to remove polyps and an
artificial heart valve replacement
Case #4
• Autopsy findings- obesity, systemic arteriosclerosis,
cerebral vascular disease, cardiomegaly, advanced
peripheral vascular disease, fatty liver, degenerative
joint disease of the spine, possible kidney failure
and poorly controlled diabetes, and toxic levels of
fentanyl
• Cause of death- cardiomegaly and poorly controlled
diabetes
– Contributory factor- fentanyl intoxication
– Classified as an accident due to drug intoxication
Case #4
• Current medications- Advair diskus, alprazolam,
aspirin (81mg), bupropion, fenofibrate, fentanyl (50
mcg/hr), furosemide, gabapentin, Lantus,
melocicam, metoprolol, Nexium, nitroglycerin pump,
Novolog, oxycodone, paroxetine, Pro-Air, Vytorin,
Warfarin
• The attorney filed a wrongful death complaint
against the manufacturer of fentanyl patches
claiming the product was defective.
Case #4
• The patch removed from the deceased was
discarded.
• At autopsy, the fentanyl patch was removed from
the sacral region of the lower back
• Black Box Warnings for fentanyl patches and
possible contributing factors
– Associated risk of fatal overdose by respiratory
depression
– Only use the 50, 75, and 100 mcg/h dosages in patients
who are already on and are tolerant of opioid therapy
• 60mg of morphine/day, 30mg/oxycodone/day or 8mg
hyrdomorphone/day for a week or longer
– Peak fentanyl levels occur between 20 and 72 hours of
treatment
Case #4
Patient Information (Facts and Comparisons)
• Avoid exposing the fentanyl application site to direct
external heat sources, such as heating pads,
electric blankets, heat or tanning lamps, sunbathing,
saunas, hot tubs, and heated water beds.
• Potential for temperature-dependent increase in
fentanyl release from the patch that could result in
an overdose. Therefore, if patients develop a high
fever or increased temperature due to exertion
while wearing the patch, they should contact their
health care provider.
Case #4
Warnings/Precautions (Facts and Comparisons)
• Administer fentanyl with caution to patients with
preexisting medical conditions predisposing them to
hypoventilation.
• Insufficient information exists to make
recommendations regarding the use of fentanyl in
patients with renal or hepatic function impairment. If
the drug is used in these patients, use it with
caution because of the hepatic metabolism and
renal excretion of fentanyl.
• Do not use soaps, oils, lotions, alcohol, or any other
agents on the application site that might irritate the
skin or alter its characteristics.
Other Cases Involving
Pharmacists
• A 75 year old post-leukemia patient with multiple
complications including chronic pain
– Pharmacist dispensed immediate release oxycodone
on two separate occasions instead of sustained release
– The patient called the pharmacy after the first mistake
and the pharmacist told the technician to tell the client
they are from a different manufacturer.
– What should have been done differently to prevent this
error?
Other Cases Involving
Pharmacists
• A 51 year old woman with an amoxicillin
prescription for an infection.
– Pharmacist dispenses Seroquel 400mg
– The Seroquel prescription vial with a label for another
patient was in a bag with the correct amoxicillin receipt.
– What changes in the workflow would you implement to
avoid these types of mistakes?
Interactive Case
• A 17 year old with mental status changes
resulting from three concussions in a short
time period overdoses after the administration
of two fentanyl patches stolen from a
pharmacy and excessive amounts of alcohol.
• Is the pharmacist liable for this wrongful
death?
Interactive Case
• A 43 year old female has been treated for soft tissue
injury over the span of four years as the result of a
motor vehicle accident.
• Current pain medications
– Fentanyl patch 100mcg every 3 days
– Opana Extended Release 60mg twice a day
– Opana Immediate Release 10mg 4 to 6 tablets every 4 to 6
hours quantity 672 tablets/month
• Does the pharmacist have a legal obligation to
assess the efficacy of her pain medication therapy
and make recommendations to the prescribing
physician?
Interactive Case
• Two dosage increases were noted in
her medical record
– Opana IR 10mg #120 was increased
to #240
– Opana IR 10mg #240 was increased
to #672
Lessons Learned
• Most mistakes are avoidable and many occur
during transition of care or when healthcare
professionals are overwhelmed taking care of too
many patients.
• Advocate for electronic medical records.
• Pharmacist verified orders in an institutional facility
may catch mistakes.
• Document errors and use the data to implement
solutions.
• When you make a mistake try not to make excuses.
Offer a sincere apology and let the patient know
how you will change your policies and procedures
to avoid similar mistakes in the future.
Professional Advice
• Reach out to other healthcare professionals to
optimize patient care
• Purchase individual malpractice insurance
• Read and understand the laws, rules and
regulations governing your profession
– Contact your professional board or inspector if you have
any questions, concerns or you need interpretation of a
legal problem.
– If you have to appear before your professional board,
bring legal counsel
Evaluating Patients with
Chronic Pain versus the Small
Percentage of Patients who
Divert Pain Medications
The Maine Predicament of
Prescription Drug Overdose:
Myths and Realities
Kenneth McCall, PharmD1,Christina Holt, MD, MSc2,;
Chunhao Tu, PhD1; Todd Michaelis, MD2; Emily Bourret, PharmD
Candidate1 , Jonathan Balk, PharmD Candidate1
1. College of Pharmacy, University of New England, Portland, ME
2. Maine Medical Center, Department of Family Medicine, Portland, ME
Methods
• Design: Retrospective data analysis of
the Maine Prescription Monitoring
Program (PMP) from fiscal years 2005 –
2010 linked to Medical Examiner Cases
of all Prescription Drug deaths.
Study Population
• Maine PMP (2005-2010):
• 1,024,649 unique patients with 11,542,850
controlled substance prescriptions.
• Rx Drug Overdose Deaths:
• 1,007 decedents with 31,736 controlled
substance prescriptions.
Maine Overdose Rate increase
among highest in nation
Non-heroin opiate admissions by state per
100,000 population aged 12 and older: 19982008
Source: Center for Behavioral Health Statistics and Quality, Substance Abuse and Mental Health Services Admini
Treatment Episode Data Set (TEDS), Data received through 8.31.09.
Treatment Admissions for
Substance Abuse
9000
8000
7000
6000
Alcohol
5000
Marijuana
4000
Heroin
Cocaine
3000
Opiates
2000
1000
0
2003
2006
2009
2012
Number of Deaths caused by Pharmaceutical
and Illicit Drugs, 1997-2009 †
†Sorg MH. Drug-induced Deaths in Maine 1997-2008, with Estimates for 2009. Available at
http://www.maine.gov/dhhs/samhs/osa/pubs/data/2011/DrugInducedDeathsReport%2097-08%20Final%202[1].pdf
National and Maine Federal
Prosecutions
Source: Chief Judge John A. Woodcock, Jr. US District Court.
Prescription Drug Abuse Summit, October 2011, Camden, Maine.
Proportion of ME Cases with any
record in PMP from 2005 -2010
100%
80%
76
55
52
48
50
36
112
102
116
129
131
2006
2007
2008
2009
2010
60%
Percent of
decedents with
PMP records
40%
100
20%
0%
2005
Year of death
ME Cases in PMP
ME cases not in PMP
“If someone dies of a Prescription Overdose,
they must have been suicidal”
men
525
86
women
261
82
No PMP records
247
54 16
29
539
With PMP records
0
100
200
Accident
300
Suicide
24
114
400
500
600
Other Manner of death
37
700
800
• In 2006, 1.77 million prescriptions were
authorized by 4,703 in-state prescribers
(377 prescriptions per prescriber). In
2010, 5,808 in-state prescribers
authorized 2.39 million prescriptions (411
prescriptions per prescriber). In-state
prescribers accounted for an additional
614,213 prescriptions in five years; a
34.6% increase.
11th Annual Interprofessional
Spring Symposium
The Science of Pain & the Art of
Healing
Thursday April 4, 2013
Alfond Forum, Biddeford Campus
Case Study
• In 2001, at age 13, Paula’s life changed
. dramatically. During an athletic event,
she twisted her ankle and was left with
unremitting pain.
• Her injury was initially diagnosed as a
sprain and was treated with elevation
and a tensor bandage
• X-rays revealed nothing broken; her
ankle was wrapped and she was given
a pair of crutches.
Case Study
• Another x-ray and a bone scan showed no
. fractures but the pediatrician still
recommended that her leg (right leg, from
knee to toes) be put into a walking cast.
• Six weeks later the cast was removed yet
the pain escalated. Paula now used a
wheelchair and crutches to aid her
mobility.
• Fascia, a layer of fibrous tissue around
her leg muscles, was painfully twisted.
Case Study
• The pediatrician next sent Paula to an
. orthopedic surgeon who put her ankle into
an anterior ankle cast and referred her to
a rheumatologist who ruled out arthritis.
• Paula’s pain worsened and she was seen
by a series of practitioners who were
stymied by her condition.
• According to Paula and her mother Judy,
doctors saw her pain as a symptom, not
as an aspect of a diagnosable disease.
Case Study
• By this juncture Paula also experienced
. allodynia
• She obtained some relief of the severe
and constant foot pain she was
experiencing through the use of orthotics.
• Her deteriorating pain condition and the
side effects of medications increasingly
compromised Paula’s daily activities and
quality of life.
Case Study
• A physical therapist suspected Paula
. might have Reflex Sympathetic Dystrophy
(RSD).
• A pain specialist formally diagnosed her
with Complex Regional Pain Syndrome
(CRPS), a chronic systemic disease
characterized by severe pain, swelling,
and changes in the skin and vascualture.
Case Study
Medication List
.nabilone
amitriptyline
memantine
venlafaxine
hydromorphone
granisetron
psyllium
gabapentin
ketamine
pregabalin
clonidine
diclofenac
docusate calcium
acarbose