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PROVING CAUSATION IN THE FAILURE TO
DIAGNOSE BREAST CANCER CASE Two
million women in the U.S. are diagnosed with breast cancer
every year. Of that number, forty-six thousand women will die.
Nearly half the women diagnosed are under 50 years old.
Most of
the time, breast cancer is detected by mammogram.
Mammograms are x-rays that can see things that might be
too small for a woman to feel.
About 1/3 of mammograms are misread and each year tens
of thousands of women lose their lives due to negligent
readings. Insurance
company statistics show that breast cancer cases represent the
greatest liability pay out of all negligence cases.[1]
So why are breast cancer cases so hard to win?
It’s hard enough to prove medical negligence in
Florida. First,
you have to obtain an affidavit from a doctor.
Good luck finding one that will sign it.
Then, we are forced to go through a harassing Presuit
Procedure that serves no purpose but to inform the defense of
how strong or weak a case we have, and help them build their
defense early on the huge battle called causation.
Therefore,
a medical malpractice case should not be valued on negligence
or damage alone, since one must consider causation as equally
important. What
exactly does causation mean?
Simply stated: “did whatever negligence we are saying
the doctor caused make some kind of difference in the
outcome?” In
breast cancer cases, this causation can be extremely
difficult. The
key is to convince a jury that even though the defendant
doctor did not cause the cancer, he did fail to diagnose or
treat it properly. CAUSE OF ACTION Failure
to properly read a mammogram is the most common type of breast
cancer litigation. The
defense is often that the mammogram was normal so no further
study was required. The
problem is that even though mammograms are the “gold
standard” of breast examinations, they are far from
infallible. Mammograms
can find most invasive breast cancer, but they miss some. If
100 women under age 50 with invasive breast cancer have
a mammogram for the first time, the cancer will show up on the
mammogram in about 70 of these women. The other 30 women with
breast cancer will have normal mammograms. Thus, mammograms
can miss cancer, and having a normal mammogram does not rule
out the possibility of having breast cancer.[2]
The proportion of cancers missed by mammograms is
mostly influenced by the age of the woman. Mammograms miss
about the same proportion of cancers among women of similar
age regardless of family history.[3] Nearly
all breast cancer arises in the milk ducts of the breast. (DCIS)[4]
When cancer cells grow and spread outside these ducts the
cancer is considered to be invasive. DCIS lesions contain
cells that appear to be cancer but not all such lesions behave
as cancer, i.e. they will not spread outside the ducts and
invade surrounding tissue nor will they be life-threatening.
Doctors cannot tell which DCIS lesions will become
invasive cancer and which will not. CLASSIC DEFENSES IN THE BREAST CANCER CASE 1.
“THE CANCER WAS TOO FAR ADVANCED” DEFENSE: The
most prominent defense is “so what”.
Even if we had diagnosed the cancer timely the outcome
would still be the same.
The patient would have had a lumpectomy, mastectomy or
died anyway. And
besides, you cannot prove otherwise.
If she would have needed the same radiation, chemo,
surgery and loss of work, then there is no causation.
The defense is generally supported by the junk science
of doubling time. DOUBLING TIME ARGUMENT-Tumor size and staging. The defense uses a model that generally discards
prognostic information and assumes that tumor’s growth rate
is stable. Counter
argument: This assumption usually discounts blood supply,
hormones, and microscopic and macroscopic tumor size and lymph
node involvement. There
are a number of articles that destroy this argument,
especially the American Cancer Society that published an
article stating that doubling time is essentially a “flawed
concept”. Sometimes,
the doubling time calculations used by defense lead to absurd
figures, suggesting that the cancer was present before the
patient was even born. In
such a situation consider utilizing a Frye test
challenge to disqualify the testimony.
Under the Frye standard, the expert testimony
must be deduced from a scientific principle or discovery
sufficiently established to have gained general acceptance in
the particular field in which it belongs.
Holy Cross Hospital v. Marrone, 816, So.2d 1113
(4DCA 2002). LEAD TIME BIAS THEOREY The lead-time bias theory is based upon the theory
that the patient was going to die from cancer sooner or later
and that the defendant should not be criticized for his
actions. Counter argument: Cure rates based upon early diagnosis.
There are standard prognosis charts given the staging
of cancer to determine statistical prognosis.
The charts take into consideration tumor size (T),
Lymph Node Involvement (N), and the absence or presence of
metastasis. a.
TUMOR
b. LYMPH NODES
c.
METASTASIS MX:
Metastasis cannot be assessed. MO:
No distant metastasis to other organs. M1:
Distant
metastasis to other organs. VI.
Stage Grouping for Breast Cancer[5]
(T) (N)
(M)
Stage
0
Tis
N0
M0
LCIS
and DCIS Carcinoma in Situ Stage
I
T1
N0
M0
Primary
tumor is 2 cm. or less and no lymph nodes Stage
IIA
T0
N1
M0 Primary
tumor is between 2 and 5 cm.s
and no lymph node or is less than 2 cms and has spread
to lymph nodes ________________________________________________________________ Stage
IIB
T2
N0
M0
Tumor
is between 2 and 5 cm with
positive lymph nodes or the tumor is larger than 5 cm but no
lymph nodes. _________________________________________________________________ Stage IIIA
T0
N2
M0
T1
N2
M0
T2
N2
M0
T3
N1N2
M0 Tumor size is greater than 5 cm. and/or has spread to
lymph nodes that adhere to one or another or the surrounding
tissue. Stage
IIIB
T4
N*
M0
T*
N3
M0 The
cancer has spread to skin, chest wall or internal mammary
lymph nodes beneath the breast. _________________________________________________________________ Stage
IV
T*
N* M1 The
cancer has spread to distant sites, i.e. lungs, brain and or
bone. *Any node or any tumor size. PROGNOSIS by STAGE Percentage chance for survival five years from
diagnosis
Stage
Five Years
In Situ
100%
Stage I
98%
Stage IIA
88%
Stage IIB
76%
Stage IIIA
56%
Stage IIIB
49%
Stage IV
16% Educate the Expert In order for the expert oncologist to obtain an
opinion that will survive cross-examination and directed
verdict, you must provide him with ample ammunition.
Obtain all medical records that note or do not note
any kind complaints or findings of breast lumps.
Provide her all mammograms (preferably originals) and
operative notes and pathology reports.
The expert may also rely on other factors such as
menopausal status, cell type, tumor aggressiveness, hormone
receptivity, reaction to chemo, tumor biology and blood
supply in reaching her opinion. Relevant Case Law: In order to obtain wrongful death damages one has to
prove that “but for” the negligence the plaintiff would
have more likely than not survived.
Tappan v. Florida Medical Center, Inc., 488
So.2d 630 (1986). If one cannot prove the “but for” test, the Plaintiff may
still have a cause of action under the survivor statute.
Future damages based on increased risk of cancer
recurrence and decreased chance of survival is not
recoverable if expert witness testifies that patient is more
likely than not to remain cancer free.
Merced v. Akhtar, 811 So.2d 702 (5DCA 2002). Gooding v. University Hospital,
445 So. 2d 1015 (1984) essentially holds that if the
plaintiff did not have a chance of survival of at least 50%
at the time of the doctor’s negligence will not have a
cause of action for malpractice. Therefore, if the patient
had less than 50% chance of survival at the time of
negligence, and as a result of the negligence now has a
lesser percentage, that patient can sue for loss of chance.
In order to prevail on this theory, the plaintiff
must still prove by the greater weight of the evidence that
the defendant’s conduct operated to decrease her chance
for a more favorable outcome. Mamographers
have a duty to do more. They
should advise their patients of the mammogram limitations and
for additional follow up. [1] Physician Insurer Ass’n of Am. National Study on Breast Cancer Claims, in 5(5) PRACTICE AND LIABILITY CONSUTANTS LOSS PREVENTION LETTER (1990). [2] Kerlikowske KM, Grady DG,
Barclay J, Sickles EA, Ernster V. Effect of age, breast
density, and family history on the sensitivity of first
screening mammography? JAMA 1996;276:33-38. Kerlikowske K,
Barclay J. Outcomes of modern screening mammography.
Mongraph Natl Cancer Inst 1997;22:105-111. Kerlikowske K,
Carney P, Geller B, Mandelson MT, Taplin S, Malvin K,
Ernster V, Urban N, Cutter G, Rosenberg R, Ballard-Barbash
R. Performance of screening mammography among women with
and without a first-degree relative with breast cancer.
Ann Intern Med 2000;133:855-863. [3] Kerlikowske
K, Grady D, Barclay J, Sickles EA, Ernster V. Effect of
age, breast density, and family history on the sensitivity
of first screening mammography. JAMA 1996;276:33-38. [4]. [5] American Joint Commission on Cancer |
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