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Law Firm Files First Minimed Lawsuit in Federal
Court
Thousands of diabetic patients who use MiniMed
Paradigm insulin pumps may be at risk of serious,
potentially fatal injuries. The first lawsuit was
filed in Federal Court on behalf of six patients who
claim to have suffered injuries after using a
defective pump.
Houston, TX February 1, 2010 -- Houssiere, Durant
& Houssiere, LLP filed the first lawsuits against
Medtronic, Inc., Medtronic MiniMed, Inc. and
Medtronic Puerto Rico Operations Company, Nov. 30,
2009, on behalf of six patients who claim they have
suffered severe injuries as a result of using a
defective MiniMed insulin pump. With an estimated
60,000 defective insulin pumps on the market,
thousands of patients may be at risk.
Medtronic Paradigm Quick-set Infusion Sets
“MiniMed lawsuits are product liability lawsuits
where the product itself is on trial,” said Charles
R. Houssiere III of Houssiere, Durant & Houssiere,
LLP. “Trusting customers of Medtronic may have
sustained injuries and damages because of their
body’s possible reaction to the lack of insulin or
the excessive insulin infused through the Quickset
infusion device.”
MiniMed Insulin Pumps are designed to provide to
Diabetic patients the correct amount of insulin
their bodies need to survive. However, a potential
defect in some of the Quick-set® Infusion sets that
are used in conjunction with the MiniMed Paradigm
insulin pumps may deliver an incorrect dose of
insulin to Diabetic patients, which may result in
severe injuries and death.
“As trial lawyers, we represent the injured and
their families. We hope to inform victims of product
defects of what they can do to be compensated for
injuries caused by those products,” said Houssiere.
“We intend to learn what Medtronic knew and when
they knew it in regard to any possible defect in the
insulin pump system.”
Medtronic, Inc. issued a Class I recall of their
Quick-Set® Insulin Infusion sets, July 10, 2009. The
company estimated that roughly 60,000 out of 3
million infusion sets could be affected. The recall
explained a manufacturing defect of the tubing used
in the Quick-Set® Infusion sets, referred to as “Lot
8,” which may prevent the pumps from properly
venting air. The defect could potentially cause
patients to receive too little or too much insulin,
which could ultimately result in injury and death.
“We believe it is our responsibility, as trial
lawyers representing people and families, to bring
possible defects to the public,” says Houssiere. “We
need to do as much as we can to inform the public if
we learn there is something wrong with this device.”
He says potential injuries can include confusion,
fainting, dizziness, difficulty speaking, sweating,
seizures, coma and death.
This is the first lawsuit to be filed against
MiniMed, Inc. regarding the insulin pumps. The
multi-plaintiff lawsuit (case number 4:09-cv-03854)
was filed with the United States District Court,
Southern District of Texas, Houston Division Nov.
30, 2009.
For more information call
206-279-8057
According
to a report by the FDA in May 2008, insulin pump problems among teens
could lead to a risk of death or serious injury. Issues could be caused
by a product defect which results in a malfunction or by medical
malpractice as a result of a providers failure to properly instruct the
child and family on the proper use and care of the pump.
STATUS OF INSULIN PUMP LITIGATION: Potential medical malpractice
lawsuits are being evaluated and reviewed
OVERVIEW: An FDA analysis of data involving adverse events over a ten
year period found over 1,500 injuries and 13 insulin pump deaths
associated with the use of the medical devices among children between 12
and 21 with Type 1 diabetes. Many of these problems could have been
prevented if the parents and teens had been properly educated about how
to use the insulin pumps and care for the medical devices.
THEORY: Medical Malpractice
Physicians and healthcare providers have a duty to make certain that a
child is properly educated on the use and maintenance of an insulin pump
before prescribing the medical device.
An evaluation of a teens ability to properly follow the regimen should
be completed before an insulin pump is considered. Both parents and
teens should be properly educated about the risks associated with use of
an insulin pump and the proper care which must be taken to avoid the
risk of potentially fatal injuries.
To determine if an injury or death associated with the use of an insulin
pump by a teenage may give rise to an insulin pump lawsuit, consult with
a medical malpractice lawyer to review the circumstances surrounding the
treatment and injury.
The insulin pump is a medical device used for the
administration of
insulin in the treatment of
diabetes mellitus, also known as continuous
subcutaneous insulin infusion therapy. The device
includes:
- the pump itself (including controls, processing
module, and batteries)
- a disposable reservoir for insulin (inside the
pump)
- a disposable
infusion set, including a
cannula for subcutaneous insertion (under the
skin) and a tubing system to interface the insulin
reservoir to the cannula.
An insulin pump is an alternative to multiple daily
injections of insulin by
insulin syringe or an
insulin pen and allows for
intensive insulin therapy when used in conjunction
with
blood glucose monitoring and carb counting.

To use an insulin pump, the reservoir must first be
filled with insulin. Some pumps use prefilled cartridges
that are replaced when empty. Most, however, are filled
with the insulin prescribed for the user (usually
Apidra,
Humalog, or
Novolog). Setting up includes:
- Opening a new (sterile) empty pump reservoir;
- Withdrawing the plunger;
- Inserting the needle into a vial of insulin;
- Injecting the air from the reservoir into the
vial to prevent a vacuum forming in the vial as
insulin is withdrawn;
- Drawing insulin into the reservoir with the
plunger, and then removing the needle;
- Squirting out any air bubbles from the
reservoir, and then removing the plunger;
- Attaching the reservoir to the infusion set
tubing;
- Installing the assembly into the pump and
priming the tubing (pushing insulin and any air
bubbles through the tubing). This is done with the
pump disconnected from the body to prevent
accidental insulin delivery;
- Attaching to the infusion site (and priming the
cannula if a new set has been inserted).
An insulin pump allows the replacement of slow-acting
insulin for basal needs with a continuous infusion of
rapid-acting insulin. The insulin pump delivers a
single type of fast-acting insulin in two ways:
- a
bolus dose that is pumped to cover food eaten or
to correct a high
blood glucose level.
- a
basal dose that is pumped continuously at an
adjustable
basal rate to deliver insulin needed between
meals and at night.
Bolus
shape
An insulin pump user has the ability to influence the
profile of the rapid-acting insulin by shaping the
bolus. While each user must experiment with bolus shapes
to determine what is best for any given food, they can
improve control of
blood sugar by adapting the bolus shape to their
needs.
A standard bolus is an infusion of insulin
pumped completely at the onset of the bolus. It is most
similar to an injection. By pumping with a "spike"
shape, the expected action is the fastest possible bolus
for that type of insulin. The standard bolus is most
appropriate when eating high carb low protein low fat
meals because it will return blood sugar to normal
levels quickly.
A standard bolus is an infusion of insulin pumped
completely at the onset of the bolus. It is most similar
to an injection. By pumping with a "spike" shape, the
expected action is the fastest possible bolus for that
type of insulin. The standard bolus is most appropriate
when eating high carb low protein low fat meals because
it will return blood sugar to normal levels quickly.
An extended bolus is a slow infusion of insulin
spread out over time. By pumping with a "square wave"
shape, the bolus avoids a high initial dose of insulin
that may enter the blood and cause low blood sugar
before digestion can facilitate sugar entering the
blood. The extended bolus also extends the action of
insulin well beyond that of the insulin alone. The
extended bolus is appropriate when covering high fat
high protein meals such as steak, which will be raising
blood sugar for many hours past the onset of the bolus.
The extended bolus is also useful for those with slow
digestion (such as with gastroparesis or
Coeliac disease).
A combination bolus is the combination of a
standard bolus spike with an extended bolus square wave.
This shape provides a large dose of insulin up front,
and then also extends the tail of the insulin action.
The combination bolus is appropriate for high carb high
fat meals such as pizza, pasta with heavy cream sauce,
and chocolate cake.
A super bolus is a method of increasing the
spike of the standard bolus. Since the action of the
bolus insulin in the blood stream will extend for
several hours, the basal insulin could be stopped or
reduced during this time. This facilitates the
"borrowing" of the basal insulin and including it into
the bolus spike to deliver the same total insulin with
faster action than can be achieved with spike and basal
rate together. The super bolus is useful for certain
foods (like sugary breakfast cereals) which cause a
large post-prandial peak of blood sugar. It attacks the
blood sugar peak with the fastest delivery of insulin
that can be practically achieved by pumping.
Bolus
timing
Since the pump user is responsible to manually start
a bolus, this provides an opportunity for the user to
pre-bolus to improve upon the insulin pump's capability
to prevent post-prandial hyperglycemia. A pre-bolus is
simply a bolus of insulin given before it is actually
needed to cover carbohydrates eaten.
There are two situations where a pre-bolus is
helpful:
- A pre-bolus of insulin will mitigate a spike in
blood sugar that results from eating high glycemic
foods. Infused insulin analogs such as
NovoLog and
Apidra typically begin to impact blood sugar
levels 15 or 20 minutes after infusion. As a result,
easily digested sugars often hit the bloodstream
much faster than infused insulin intended to cover
them, and the blood sugar level spikes upward as a
result. If the bolus were to be infused 20 minutes
before eating, then the pre-bolused insulin will be
hitting the bloodstream simultaneously with the
digested sugars to control the magnitude of the
spike.
- A pre-bolus of insulin can also combine a meal
bolus and a correction bolus when the blood sugar is
above the target range before a meal. The timing of
the bolus is a controllable variable to bring down
the blood sugar level before eating again causes it
to increase.
Similarly, a low blood sugar level or a low glycemic
food might be best treated with a bolus after a
meal is begun. The blood sugar level, the type of food
eaten, and a person's individual response to food and
insulin have an impact on the ideal time to bolus with
the pump.
Basal rate patterns
The pattern for delivering basal insulin throughout
the day can also be customized with a pattern to suit
the pump user.
- A reduction of basal at night to prevent low
blood sugar in infants and toddlers.
- An increase of basal at night to counteract high
blood sugar levels due to growth hormone in
teenagers.
- A pre-dawn increase to prevent high blood sugar
due to the
dawn effect in adults and teens.
- In a proactive plan before regularly scheduled
exercise times such as morning gym for elementary
school children or after school basketball practice
for high school children.
Basal rate determination
Basal insulin requirements will vary between
individuals and periods of the day. The basal rate for a
particular time period is determined by fasting while
periodically evaluating the blood sugar level. Neither
food nor bolus insulin must be taken for 4 hours prior
to or during the evaluation period. If the blood sugar
level changes dramatically during evaluation, then the
basal rate can be adjusted to increase or decrease
insulin delivery to keep the blood sugar level
approximately steady.
For instance, to determine an individual's morning
basal requirement, they must skip breakfast. On waking,
they would test their blood glucose level periodically
until lunch. Changes in blood glucose level are
compensated with adjustments in the morning basal rate.
The process is repeated over several days, varying the
fasting period, until a 24-hour basal profile has been
built up which keeps fasting blood sugar levels
relatively steady. Once the basal rate is matched to the
fasting basal insulin need, the pump user will then gain
the flexibility to skip or postpone meals such as
sleeping late on the weekends or working overtime on a
weekday.
Many factors can change insulin requirements and
require an adjustment to the basal rate:
- continued beta cell death following diagnosis of
type 1 diabetes (honeymoon period)
- growth spurts particularly during
puberty
- weight gain or loss
- any drug treatment that affects insulin
sensitivity (e.g.
corticosteroids)
- eating, sleeping, or exercise routine changes
- whenever the control over hyperglycemia is
degrading
- and according to the seasons.
A pump user should be educated by their diabetes care
professional about basal rate determination before
beginning pump therapy.
Temporary basal rates
Since the basal insulin is provided as a rapid-acting
insulin, the basal insulin can be immediately increased
or decreased as needed with a temporary basal rate.
Examples when this is helpful include:
- During a long car drive, when more insulin is
needed due to inactivity.
- During and after spontaneous exercise or sports
activities, when the body needs less insulin.
- During illness or stress, when basal demand
increases due to insulin resistance.
- When blood
ketones are present, when additional insulin is
needed.
- During
menses, when additional basal insulin is needed.
Advantages
of pumping insulin
- Pumpers report better quality of life (QOL)
compared to using other devices for administering
insulin.The improvement in QOL is being reported not
only in type 1 but also in insulin requiring type 2
diabetes subjects on Pumps.[1]
- The use of rapid-acting insulin for basal needs
offers relative freedom from a structured meal and
exercise regimen previously needed to control blood
sugar with slow-acting insulin. The alternative
basal insulins, such as the
long lasting insulins injected once a day, often
release their insulin at a very unpredictable rate.
- Many pumpers feel that bolusing insulin from a
pump is more convenient and discreet than injection.
- Insulin pumps make it possible to deliver more
precise amounts of insulin than can be injected
using a syringe. This supports tighter control over
blood sugar and
Hemoglobin A1c levels, reducing the chance of
long-term complications associated with
diabetes. This is predicted to result in a long term
cost savings relative to multiple daily injections.[2]
- Many modern "smart" pumps have a "bolus wizard"
that calculates how much bolus insulin you need
taking into account your expected carbohydrate
intake, blood sugar level, and still-active insulin.
- Painful neuropathy is a troublesome complication
of diabetes resistant to usual treatment.There are
reports of alleviation or even total disappearance
of resistant neuropathic pain with the use of
Insulin Pumps.[3]
- Recent studies of use of Insulin pumps in Type 2
diabetes have shown profound improvements in
HbA1c,sexual performance and neuropathic pain.[4]
Disadvantages
of pumping insulin
- Insulin pumps, cartridges, and infusion sets are
far more expensive than syringes used for insulin
injection.
- Since the insulin pump needs to be worn most of
the time, pump users need
strategies to participate in activities that may
damage the pump, such as rough sports and activities
in the water. Some users may find that wearing the
pump all the time (together with the infusion set
tubing) is uncomfortable or unwieldy.
- An episode of
diabetic ketoacidosis may occur if the pump user
does not receive sufficient fast acting insulin for
many hours. This can happen if the pump battery is
discharged, if the insulin reservoir runs empty, the
tubing becomes loose and insulin leaks rather than
being injected, or if the cannula becomes bent or
kinked in the body, preventing delivery. Therefore
pump users typically monitor their blood sugars more
frequently to evaluate the effectiveness of insulin
delivery.
- Possibility of insulin pump malfunctioning, and
having to resort back to multiple daily injections
until a replacement becomes available.
Acceptability
Use of insulin pumps is increasing throughout the
world because of:
- easy delivery of multiple insulin injections for
those using
intensive insulin therapy.
- accurate delivery of very small boluses, helpful
for infants.
- growing support among doctors and insurance
companies due to the benefits contributing to
reducing the incidence of
long-term complications.
- improvements in
blood glucose monitoring. New meters require
smaller drops of blood, and the corresponding lancet
poke in the fingers is smaller and less painful.
These meters also support
alternate site testing for the most routine
tests for practically painless testing. This
compensates for the need for pump users to test
blood sugar more frequently.
- support groups demonstrating techniques for
adapting insulin pump use to sports, exercise, and
water sports. Expert help is becoming common in user
groups and books. The pump can be effectively
combined with partial basal insulin from the pump
and partial basal insulin from a long-acting insulin
such as
Lantus and
Levemir. This is becoming known as the
untethered regimen.
Recent developments
Antique
Insulin MachineNew insulin
pumps are becoming "smart" as new
features are added to their design.
These simplify the tasks involved in
delivering an insulin bolus.
- insulin on board: Based
on the time and quantity of the last
bolus, the pump software keeps track
of the insulin remaining in the
bloodstream and displays it on the
screen. This supports the process of
performing a new bolus before the
effects of the last bolus are
complete and, thereby, helps prevent
the user from overcompensating for
high blood sugar with unnecessary
correction boluses.
- bolus calculators: Pump
software helps by calculating the
dose for the next insulin bolus. The
user enters the grams of
carbohydrates to be consumed, and
the bolus "wizard" calculates the
units of insulin needed. It adjusts
for the most recent blood glucose
level and the insulin on board, and
then suggests the best insulin dose
to the user to approve and deliver.
- custom alarms: The pump
can monitor for activities during
specific times of day and alarm the
user if an expected activity did not
occur. Examples include a missed
lunch bolus, a missed blood glucose
test, a new blood glucose test 15
minutes after a low blood glucose
test, etc. The alarms are customized
for each user.
- touch bolus: For persons
with visual impairments, this button
on the pump can be used to bolus for
insulin without using the display.
This works with a system of beeps to
confirm the bolus parameters to the
pump user. This feature is described
as 'touch', 'audio', or 'easy' bolus
depending on brand. The feature was
first introduced in the mid- to late
1990s.[citation
needed]
- interface to personal
computers: Since the late 1990s,
most pumps can interface with
personal computers for managing and
documenting pump programming and/or
to upload data from the pump. This
simplifies record keeping and can be
interfaced with
diabetes management software.
-
integration with blood glucose
meters: Blood glucose data can
be manually entered into the pump to
support the bolus wizard for
calculation of the next insulin
bolus. Some pumps support an
interface between the insulin pump
and a blood glucose meter.
- The
Medtronic Diabetes
Minimed Paradigm series of
insulin pumps allow for
radio frequency (RF)
communication. This enables the
pump to receive data from a
Lifescan (in the US) or Bayer
(in other countries) blood
glucose meter. The RF link also
supports a
continuous blood glucose sensor
known as the Paradigm REAL-Time
Continuous Glucose Monitor that
wirelessly provides an
interstitial glucose value every
5 minutes on the pump screen.
The Medtronic REAL-Time System
is the first to link a
continuous monitor with an
insulin pump system.
- The DANA Diabecare IISG
insulin pump has blood glucose
meter in it. After blood glucose
check with the integrated
glucometer, the user can use
bolus wizard and deliver a
required bolus.
- The Insulet Omnipod
has a separate remote that
features a built-in meter that
uses Freestyle test strips.
- full featured remote:
Insulet's OmniPod has a separate
electronic display and controls.
This remote features a built-in
meter that uses Freestyle test
strips. The Animas OneTouch Ping
pump has a meter remote included
based on the Lifescan OneTouch
UltraSmart meter that can be used as
a glucose meter and a pump remote
control.
- simple remote: The
Medtronic pumps offer an optional RF
remote control that allows the user
to deliver a discrete bolus or stop
insulin delivery when the pump is
concealed or inaccessible. This
feature was introduced in 1999.
- tubeless pod: The OmniPod
pump is attached directly to the
skin by its infusion set,
eliminating the tube from the pump.
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