MESSAGE
| DATE | 2017-06-10 |
| FROM | Ruben Safir
|
| SUBJECT | Subject: [Hangout - NYLXS] Abbott Scam
|
One should NEVER access an Abbott product.... EVER.
Abbott Pharmacuetics is giving kickback to healthcare insurance
companies to mandate that Pharmacies must use their lifestyle diabetic
testing supplies. This is thanks to Obama care.
To make it worst, Abbott Labs is one of the slimest healthcare companies
that ever existed. They have made it impossible to use any competing
products and then, in addition to giving a kickbase for each billed
strips, they then profit by selling the strips to Pharmacies for more
than they can be purchased for. So when the pharmacy distributes
diabetic supplies, they pay Abbott labs about $5.00 a prescription.
Diabetic supplies by law must be covered by healthcare insurance, and so
the costs for insulin and supplies has skyrocketed to absurd costs. So
this is the backdoor attempt to monopolize the market and undo the
governments intention when they mandated diabetic drug coverage for all
healthcare plans.
So, as a result, the grey market goods entered to fill in the gap, and
this has caused by Roche and Abbott to peruse healthcare providers.
http://www.frierlevitt.com/articles/pharmacylaw/pharmacy-audit-alert-cvs-caremark-takes-aggressive-position-pharmacies-purchases-unauthorized-drug-distributors/
PHARMACY AUDIT ALERT: CVS Caremark Takes Aggressive Position Against
Pharmacies for Purchases from “Unauthorized” Drug Distributors
By Harini Bupathi, Esq., Alexandra M. Pearsall, Esq., and Jason M.
McLaren, Esq., Pharm.D.
In a recent but aggressive trend, CVS Caremark (Caremark) has begun to
audit and subject pharmacies across the nation to recoupment for
purchases from allegedly “unauthorized distributors.”
Specifically, Caremark has taken the position against pharmacies that
“only wholesalers for diabetic supplies that are Authorized Distributors
by that manufacturer can be considered for credit.” Caremark appears to
rely upon a circulation that they issued in June 2016 titled “Audit
Tips: Foreign Sourced Diabetic Test Strips” that allegedly would have
required pharmacies to purchase only from wholesalers listed as an
“authorized distributor” on pharmaceutical manufacturers’ websites. In
taking this position, Caremark has disregarded pharmacies’ otherwise
valid purchases from properly licensed wholesalers and has instead,
maintained that pharmacies have insufficient inventories to support the
quantities of drugs billed despite providing Caremark proper invoices
and proof of payment. Caremark’s actions have caused pharmacies to be
exposed to large recoupment amounts and potentially, a risk of termination.
If your pharmacy has been subjected to an audit and/or subsequent
recoupment from Caremark for alleged purchases from an “unauthorized”
wholesaler, contact Frier Levitt today to speak to an attorney and
understand the pharmacy’s rights, claims, and defenses in this issue.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Express Scripts Leverages Limitations on Pharmacy Practice to Terminate
Network Pharmacies
By Jason M. McLaren, Esq., Pharm.D.
Express Scripts (ESRX), in the face of increasing pressure from Wall
Street and analysts because of their potential to lose Anthem as its
largest single customer, has created multiple tactics, to terminate
network independent pharmacies, in an effort to drive prescription
volume to their own mail order and Specialty Pharmacies. Listening to
ESRX’s earning calls show that analysts are asking about the potential
enormous drop in prescription volume if ESRX loses Anthem. Thus,
independent pharmacies should take note.
An example of one such tactic being employed by ESRX utilizes the
limitations of pharmacy practice itself. In July 2016, ESRX made a minor
amendment to an innocuous section of its Provider Manual regarding
Formulary Overview and the effects of this modification are starting
affect otherwise compliant network pharmacies which are now receiving
termination notices for conduct not entirely within their control.
The July 2016 amendment modified the following phrase: “Network
Provider’s pharmacists should make their best effort to dispense the
Formulary drug and/or product” to “Network Provider’s pharmacists must
make their best effort to dispense the Formulary drug and/or product”.
With this modification and starting sometime in August 2016, ESRX
started sending network pharmacies notices to cease and desist
dispensing high volumes of non-formulary products and demand network
pharmacies to adopt and report its measures that network pharmacies will
take ensure the network pharmacy is using its “best efforts” to
effectuate compliance with this term.
In response, network pharmacies complied with ESRX’s request and set
forth varied operating procedures to satisfy ESRX’s request. Now,
however, ESRX is terminating those very same network pharmacies due to
their proposed measures purported ineffectiveness, many of which
involved contacting the prescriber to inform the prescriber that generic
alternatives are available and documenting the encounter. As many
pharmacists know, and indeed this author agrees, the pharmacist’s scope
of practice, outside some collaborative practice arrangement, is limited
to advising and counseling a prescriber on the clinical aspects of the
prescriber’s selected drug regimen for a given patient and the measures
taken by network pharmacies were as far as the practice of pharmacy in a
retail setting allows. Ultimately it is the prescriber’s decision
whether to move forward with a particular drug regimen, albeit off
formulary.
ESRX has taken notice of this regulatory limitation on a pharmacist’s
scope of practice and has begun using it to its own advantage to
terminate independent network pharmacies whose only choices are to fill
and dispense the prescriber’s selected drug regimen, which in most
instances ESRX ultimately approves through its prior authorization
process, and possibly face termination or reject the patient which
contractually they are prohibited from doing. Either option is
potentially detrimental to network pharmacies.
The exact reason behind ESRX’s new found tactic are unknown. However, it
is speculated that two possible reasons for ESRX’s conduct are likely.
First, this author believes ESRX’s actions are aimed at disrupting a
manufacture’s supply chain in order to obtain better negotiating power
in a rebate dispute. Second, this author believes ESRX’s conduct is
aimed at curtailing the use of manufacturer’s co-payment coupons that
aid patient’s in bringing down co-payments imposed by pharmacy benefit
managers (PBM), like ESRX, for necessary treatment. Regardless of ESRX’s
motivations behind this conduct, network pharmacies are forced into an
impossible position with negative implications to its business.
It is essential pharmacies take action and protect their rights. Frier
Levitt has successfully defended and reversed ESRX’s termination of
several network pharmacies who have been affected by ESRX’s conduct and
is committed to defending independent pharmacies against aggressive PBM
tactics and the network terminations resulting therefrom. If you or your
pharmacy have received a notice to cease and desist or have received a
notice of termination by ESRX, it is important that you act swiftly to
ensure that your legal rights are protected. Contact Frier Levitt today
to speak with an attorney.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
PHARMACY ALERT: Roche Begins Issuing Demand Letters Seeking Repayment
for Test Strips Claims
By Steven L. Bennet, Esq., Todd Mizeski, Esq., and Jonathan E. Levitt, Esq.
Pharmacies have begun receiving demand letters from Roche Diagnostics
Corp. and Roche Diabetes Care, Inc. (“Roche”) for repayment of money as
it relates to claims for vials/boxes of Roche Accu-Chek blood-glucose
test strips. Roche states that, based on data gathered from rebate
claims submitted by insurers, pharmacies received reimbursement for test
strips intended for retail sale while actually dispensing discounted
products, including test strips that are marked as Durable Medical
Equipment (“DME”) or not-for-retail sale. According to Roche, this
constitutes fraud due to the pharmacy allegedly falsely submitting the
retail product NDC and thereby obtaining reimbursements for retail
product when what is actually being sold is one of Roche’s discounted
products. If the pharmacy fails to repay Roche, these actions could end
in Roche litigating claims against the pharmacy.
If you or your pharmacy have received a demand letter or have been sued
in the Roche litigation, it is important that you act swiftly to ensure
that your legal rights are protected. Contact Frier Levitt today to
speak with an attorney.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
http://www.jdsupra.com/legalnews/abbott-secures-preliminary-injunction-60086/
On November 6, 2015, Abbott Laboratories and its diabetes care units
secured a preliminary injunction against multiple pharmacies,
distributors and associated individuals engaged in the sale of gray
market Abbott FreeStyle diabetes test strips designed for sale
internationally to U.S. consumers.
In the trade-infringement action brought under the Lanham Act in the
United States District Court for the Eastern District of New York,
Abbott prevailed in proving that the likely confusion caused by
differences in its international and domestic test strips, as well as
the interference with quality-control prerogatives, warranted enjoining
the further domestic sales of the international strips. ***Although the
domestic and international test strips were identical in design, ***
testimony and exhibits introduced as evidence established eight key
differences in packaging and instructional inserts that the court
concluded were capable of confusing the American public.
First, the U.S. packaging contained National Drug Codes which pharmacies
used for reimbursement from purchasers’ insurance companies. Insurers,
in turn, submitted claims for contractually agreed-upon rebates, an
arrangement that resulted in a higher domestic list price.
Second, the instructional inserts for the U.S. strips directed users to
three test sites on their bodies, while the international versions
listed the same three, plus four other sites. These differences were
driven by FDA’s limitation of the number of sites based on its
determination of insufficient accuracy of results from the four
additional sites.
Third, were the language differences in packaging and instructional
inserts, with some overseas versions destined for certain markets not
including the English language.
Fourth were various symbols with no accompanying explanatory text which
were not destined for U.S. markets, because FDA does not approve of the
use of symbols for consumer labeling.
Fifth, measurements for international products were listed as millimoles
per liter and in Celsius, while U.S. products were listed in
FDA-directed U.S. units of milligrams per deciliter and Fahrenheit.
Sixth, the written warnings “Do no reuse” and “For in vitro diagnostic
use” were omitted from the international products.
Seventh, although FreeStyle strips were approved for use internationally
in any meter with FreeStyle technology, domestic products, as stated on
U.S. packaging, were approved only for specific meters.
Eighth, domestic packaging prominently states a toll-free telephone
number for users’ questions, while the international product listed a
foreign telephone number. Importantly, Abbott’s U.S. call centers were
manned by operators trained only in the domestic product. Consumer calls
were also logged, categorized, tracked and analyzed for trends and,
where necessary, for recalls directed to the country or region to which
affected strips were directed.
As is customary with other drug and medical device manufacturers,
Abbott’s ongoing security efforts involved making “buys” from
distributors and wholesalers. Beginning in 2013, Abbott began detecting
international strips in its purchases, and the number spiked in late
2014-early 2015. By then it had already notified FDA’s Office of
Criminal Investigation, which had been already investigating one or more
of the diverters detected by Abbott.
In the final analysis, the Court found that the differences between
international and domestic products were material and likely to confuse
consumers, and rejected the diverters’ assertion that they openly
disclosed the international aspect of the products to their purchasers.
In addition, the Court found that these differences interfered with
Abbott’s quality control processes and potentially impeded controlled
recall efforts, thereby making it likely for Abbott to succeed on the
merits of its Lanham Act claim. Moreover, the Court found that Abbott
risked losing good will and suffering reputational harm when a domestic
user received international strips. The Court also rejected the
defendants’ assertion that Abbott delayed in bringing the lawsuit,
noting that it had been pursuing non-judicial actions to cease the
infringement, such as cease-and-desist letters before resorting to
judicial intervention. Finally, the Court found that the balance of
hardships and the public consequences of allowing product to continue to
be sold warranted the preliminary injunction.
The circumstances of this case underscore the damage that gray market
can cause to consumers and manufacturers of drugs and medical devices.
The International Trademark Association has notes estimates of billions
of dollars in revenue per year lost to gray market diversion in the
United States and worldwide, along with the potential for negative
consumer experiences that damage the goodwill and reputation of a brand.
The Abbott Court’s analysis lays out nicely the issues surrounding
consumer protection, product integrity, quality control impediments,
service and warranties, and recall notifications. *** Gray market
diversion causes financial harm by impacting rebate agreements and
undercutting the prices of, and sales by, authorized domestic
distributors through the sale of goods at lower price points. ***
The only way to fend off gray marketers is to shore up the supply chain,
monitor the movement of product, ensure quality control procedures are
in place, and notify the authorities when product integrity is
potentially compromised through the sales of gray market goods.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Replace the word Rebate with Kickbacks.
http://www.healthcarelawinsights.com/2015/11/court-strips-importation-and-sale-of-gray-market-glucose-test-strips-in-u-s/
Court strips importation and sale of ‘gray market’ glucose test strips
in U.S.
By Nick de la Torre on November 10, 2015
POSTED IN INTELLECTUAL PROPERTY, LITIGATION, PHARMACEUTICALS AND PBMS
Abbott Labs recently obtained a preliminary injunction prohibiting
numerous pharmacies, wholesalers, and other distributors from importing
or otherwise using in the U.S. Abbott’s FreeStyle® blood glucose test
strips that are intended for sale internationally. Chief Judge Amon of
the Eastern District of New York found that Abbott is likely to succeed
on the merits of its Lanham Act claim that consumers will likely be
confused by the sale of “gray market” FreeStyle test strips in the U.S.
According to Abbott’s complaint, millions of diabetics use Abbott’s
FreeStyle® branded test strips on a daily basis to monitor their blood
glucose levels and help control their diabetes. Due to the differences
between U.S. and international insurance, reimbursement, and rebate
practices, Abbott sells FreeStyle test strips outside the United States
at markedly lower list prices.
***Unlike the diverted international test strips, the domestic FreeStyle
test strips are eligible for reimbursement from insurers. Thus, by
selling the international test strips in the U.S., Abbott alleges, the
defendants are able to pass the unapproved test strips off to
unsuspecting U.S. consumers thereby capitalizing on the pricing
differences and receiving undeserved reimbursement payments from
insurers. Abbott, in turn, pays rebates to insurers for those undeserved
reimbursement payments – resulting in the wrongful payout of millions of
dollars in rebates.***
In its complaint to halt these unauthorized sales, Abbott asserts
several claims including trademark infringement, fraud, racketeering,
and unfair competition. While functionally the same as FreeStyle test
strips packaged and cleared for sale in the U.S., strips intended for
international sale are not packaged and labeled to meet the requirements
of the Food and Drug Administration (“FDA”). Included among the
packaging differences are:
Unlike diverted international test strips, packaging of FreeStyle test
strips intended for retail sale in the U.S. bears a specific National
Drug Code (“NDC”) number, which is required for reimbursement;
As a result of FDA clearance the instructional inserts for U.S.
FreeStyle test strips and international FreeStyle test strips provide
conflicting instructions as to where on the body a blood sample can be
taken to perform a blood glucose test;
Unlike diverted international test strips, every box of U.S. FreeStyle
test strips provides a U.S. toll-free customer care phone number;
U.S. FreeStyle test strips are accompanied by instructions written in
English and Spanish;
The handling and use instructions for diverted international FreeStyle
test strips utilize units of measurement that are not used in the U.S.
instructions;
The range of temperatures in which FreeStyle test strips can be stored
are stated in Fahrenheit on U.S. packaging and Centigrade on diverted
international packaging;
Packaging for diverted international FreeStyle test strips contain
symbols that are unfamiliar to U.S. consumers and are prohibited by the
FDA for use on in-home consumer-use packaging; and
The outer package label of U.S. FreeStyle test strips provides several
FDA-required written warnings and instructions, which are not present on
the outer package label of international FreeStyle test strips.
In issuing the preliminary injunction, Chief Judge Amon focused her
analysis on Abbott’s Lanham Act trademark infringement claim. The court
concluded that Abbott is likely to succeed on the merits of its claim
given the likelihood of confusion that may result to unsuspecting U.S.
consumers who are purchasing diverted international FreeStyle test
strips. Though often subtle, the court found the differences in
packaging and labeling to be material, noting that U.S. consumers are
likely to find it relevant that their test strips’ packaging contains,
for instance, unexplained and unfamiliar symbols, atypical warnings,
international units of measurement, different languages, and a lack of a
toll-free number.
The court further concluded that such confusion to consumers will likely
result in irreparable harm to Abbott in the form of damage to Abbott’s
goodwill and reputation that cannot be quantified or recovered. On this
point Judge Amon noted that the differences in packaging and labeling
are precisely the type likely to frustrate consumers resulting in damage
to Abbott’s goodwill and reputation. Moreover, the court noted that
Abbott’s trademark protects not only its reputation, but its ability to
control that reputation through quality-control procedures. The domestic
sales of international test strips interfere with Abbott’s ability to
effectuate its quality-control procedures.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Abbott has also had enormous quality control issues and really shouldn't
be allowed in the business as all
http://www.wolfandpravato.com/abbott-freestyle-test-strip-lawsuit-attorney/
If you’ve been a user of Abbott FreeStyle ® Blood Glucose Test Strip in
the United States, contact our attorneys by calling (800) 428-3476 today!
The attorneys at Wolf & Pravato are the FIRST legal team to file a
lawsuit based on this recall!
Abbott Diabetes Care and the United States Food and Drug Administration
(FDA) announced a voluntary recall of the FreeStyle ® Blood Glucose Test
Strips. The faulty strips may produce erroneously low blood glucose
results when used with a FreeStyle ® blood glucose meter built into the
OmniPod Insulin Management System.
This is a CLASS 1 RECALL! According to the FDA, Class 1 Recall is “a
situation in which there is a reasonable probability that the use of or
exposure to a violative product will cause serious adverse health
consequences or death.”
Lawsuit Filed Against Abbott Laboratories, Inc. et al.
FreeStyle ® Blood Glucose Test Strip lawsuit has been filed against
Abbott Laboratories Inc., Abbott Diabetes Care Inc. and Abbott Ireland
Diabetes Care, because of the company’s disregard for their customers’
well-being. Instead of staying loyal to the people they serve, Abbott
Laboratories, Inc. decided to ignore the medical device safety rules –
rules that were put in place to protect the consumers from serious
medical complications or even death.
The lawsuit filed by the attorneys from Wolf & Pravato is the very first
lawsuit in United States filed in response to the Class I Recall of
defective FreeStyle ® Blood Glucose and FreeStyle® Lite Blood Glucose
Test Strips that – may cause inaccurately low readings when used with
either of the following products:
FreeStyle ® Flash Blood Glucose Meter
FreeStyle ® Blood Glucose Meter
Insulet OmniPod ® Insulin Management System.
Contact an Abbott FreeStyle Test Strip Lawsuit Attorney Today!
If you, your family member or a loved one have been adversely affected
by this recall, please contact an attorney to discuss your options right
away! To speak with an attorney from the legal team spearheading the
pursuit of claims against Abbot Laboratories, Inc. et al, contact the
Law Offices of Wolf & Pravato immediately! Please, call us at (800)
428-3476 or fill out the form at the bottom of this page to schedule
your free consultation with one of our attorneys who will evaluate your
case and advise you of the best course of action and the options
available to you.
Urgent Class 1 Recall of Abbott FreeStyle ® Blood Glucose Test Strips
Explained
This urgent Class 1 Recall has been issued by three separate legal
entities: Abbott Laboratories Inc., Abbott Diabetes Care Inc., and
Abbott Ireland Diabetes Care.
The object of this recall was a line of defective products used by
people with diabetes in order to self-monitor their blood glucose levels
– an activity required for a diabetic in order to function properly and
quite literately a matter of life and death. The products in questions
are strips for blood glucose levels testing, more specifically the
Freestyle ® Blood Glucose Test Strips and FreeStyle ® Lite Blood Glucose
Test Strips.
The cause of the recall is the possibly erroneous low blood sugar
reading produced by the test strips in question when used together with
particular glucose measuring devices and insulin management systems.
Those devices include the FreeStyle ® Blood Glucose Meter, the FreeStyle
® Flash Blood Glucose Meter, as well as the Insulet OmniPod ® Insulin
Management System.
The faulty readings produced by the FreeStyle ® Testing Strips may make
a person think their glucose level in their bloodstream is are lower
than it is in reality. Such misinformation can have a very serious
medical consequences and may even result in the person’s death.
Far-Reaching Consequences of the Urgent Recall of FreeStyle Glucose
Level Testing Strips
According to the estimate by American Diabetes Association there are
25.8 Million people in United States with diagnosed and diagnosed
diabetes. This number includes both adults and children who are
dependent on devices such as the FreeStyle ® Test Strips to monitor
their blood-sugar levels in order to manage their disease and lead at
least semi-normal lives. They trust that the readings they get from
medical devices, sold by huge pharmaceutical companies, are accurate.
When such a corporation fails to abide by safety rules and manufactures,
then distributes defective products, they put the lives of all these
people – adults and children alike – in grave danger. Such situation
affects the lives of thousands of people in United States and Worldwide.
This is why the legal team at Wolf & Pravato decided to act quickly and
file a lawsuit against the negligent corporations. We are here to
protect the interests of those people who put their trust in Abbott
Laboratories and were let down. We are advising all those affected to
file a law suit as soon as possible. Our attorneys are just a call away
and are ready to help and guide you through this process and ensure that
you receive a fair compensation for your pain, and suffering, as well as
any other expenses, such as medical bills or the opportunity cost of
lost wages if the faulty test strips made it impossible for you to work
during the recovery process. Once again, we can be reached at (800)
428-3476 or by filling out the contact information form located below.
The voluntary recall has been announced in November of 2013 by three
corporations: Abbott Laboratories, Abbott Diabetes Care and Abbott
Ireland Diabetes Care. Since then, the recall has been modified and
expanded into an Urgent Product Recall, which has been distributed to
consumers – see links below:
>> FDA Recall, November 18, 2013
>> Abbott Diabetes Care Press Releases & Notifications
>> Abbott Diabetes Care Product Recall, February 19, 2014
>> Abbott Diabetes Care FreeStyle Blood Glucose Monitoring System Recall
While Abbott Diabetes Care promised to replace the faulty strips at no
cost to the consumers, there have been instances reported of victims who
were not fully reimbursed for the recalled test strips. As of now, the
company is providing only 400 testing strips without replacing all of
the strips purchased by some of their customers. Unfortunately, those
who elected to buy the strips in bulk are now left with big amounts of
unusable testing strips. To date, there has been no action taken by the
company to reimburse customers for the thousands of strips that were
used in the past and provided inacurrate results.
Unfortunately, for many the damage done by the use of the defective
product goes much further than the financial loss of buying a useless
product. A lot of Abbott’s customers have suffered major health problems
caused by the improper glucose level readings provided by the FreeStyle®
Test Strips. The legal team at Wolf & Pravato believes that Abbott
should be held liable for any case of wrongful death, as well as any
instances of pain and suffering, medical expenses, and lost wages caused
by their product that failed to provide accurate people that put their
lives on the line by trusting that the FreeStyle® Test Strips provide
accurate results.
As of now, a class action lawsuit or any individual lawsuits against the
liable corporations is the only avenue for many of the victims to
receive a fair compensation for their losses. As the first law firm in
United States to initiate a lawsuit in this case, the attorneys at Wolf
and Pravato are ready to fight for the rights of the consumers who have
suffered as a result of the negligence of these companies. If you are
such a person or if it was your family member or a loved one who
suffered do to the inaccurate results provided by the FreeStyle® Test
Strips, please do not wait – call our trial lawyers today at (800)
428-3476 or fill out the Free Consultation Form below to schedule your
free consultation during which you will meet with an injury attorney
from the Law Office of Wolf & Pravato to discuss your case and evaluate
your options to select the best course of action for you and your
family. Do not hesitate, call or email us today!
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Abbott Laboratories recalls glucose test strips
The Chicago-based company pulls back 359 million because the strips may
give diabetics false low readings. So far, 22 such cases have been reported.
December 22, 2010|By Andrew Zajac, Washington Bureau


Email



Share


Reporting from Washington — Abbott Laboratories announced a recall
Wednesday of as many as 359 million glucose test strips used to monitor
diabetics' blood sugar because the strips may give false low readings.
The strips may not absorb enough blood quickly enough to give a proper
reading, which can lead users to try to raise sugar levels
unnecessarily, or to fail to treat elevated glucose levels, the company
said in a statement.
The chemically treated paper strips were manufactured at an Abbott
facility in the United Kingdom between January and May 2010, according
to company spokesman Scott Davies.
The defect came to light via routine in-house testing, Davies said.
Abbott, based in north Chicago, reported 22 cases of "false low"
readings to the Food and Drug Administration and volunteered to conduct
the recall, FDA spokeswoman Erica Jefferson said in an e-mail.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
https://www.justice.gov/opa/pr/abbott-laboratories-pays-us-5475-million-settle-claims-company-paid-kickbacks-physicians
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JUSTICE NEWS
Department of Justice
Office of Public Affairs
FOR IMMEDIATE RELEASE
Friday, December 27, 2013
Abbott Laboratories Pays U.S. $5.475 Million to Settle Claims That
Company Paid Kickbacks to Physicians
Abbott Laboratories has agreed to pay the United States $5.475 million
to resolve allegations that it violated the False Claims Act by paying
kickbacks to induce doctors to implant the company’s carotid, biliary
and peripheral vascular products, the Justice Department announced
today. Abbott is a global pharmaceuticals and health care products
company based in Abbott Park, Ill.
“Patients have a right to treatment decisions that are based on their
own medical needs, not the personal financial interests of their health
care providers,” said Assistant Attorney General Stuart F. Delery of the
Civil Division of the Department of Justice. “Kickbacks undermine the
ability of health care providers to objectively evaluate and treat their
patients, and will continue to be a primary focus of the Department’s
health care enforcement efforts.”
The settlement resolves allegations that Abbott knowingly paid prominent
physicians for teaching assignments, speaking engagements and
conferences with the expectation that these physicians would arrange for
the hospitals with which they were affiliated to purchase Abbott’s
carotid, biliary and peripheral vascular products. As a result, the
United States alleged Abbott violated the Anti-Kickback Act and caused
the submission of false claims to Medicare for the procedures in which
these Abbott products were used.
“Physicians should make decisions regarding medical devices based on
what is in the best interest of patients without being induced by
payments from manufacturers competing for their business,” said U.S.
Attorney Bill Killian of the Eastern District of Tennessee.
“Offering financial inducements can distort health care
decision-making,” said Special Agent in Charge Derrick L. Jackson of the
U.S. Department of Health and Human Services, Office of Inspector
General in Atlanta. “OIG and our law enforcement partners vigilantly
protect government health programs from such alleged abuses.”
Carotid and peripheral vascular products are used to treat circulatory
disorders by increasing blood flow to the head and various parts of the
body, respectively. Biliary products are used to treat obstructions
that occur in the bile ducts.
The settlement resolves allegations originally brought in a lawsuit
filed by Steven Peters and Douglas Gray, former Abbott employees, under
the qui tam provision of the False Claims Act , which allows
whistleblowers to file suit on behalf of the United States for false
claims and share in any recovery As part of today’s resolution, Peters
and Gray will receive a total payment of more than $1 million.
This settlement illustrates the government’s emphasis on combating
health care fraud and marks another achievement for the Health Care
Fraud Prevention and Enforcement Action Team (HEAT) initiative, which
was announced in May 2009 by Attorney General Eric Holder and Health and
Human Services Secretary Kathleen Sebelius. The partnership between the
two departments has focused efforts to reduce and prevent Medicare and
Medicaid financial fraud through enhanced cooperation. One of the most
powerful tools in this effort is the False Claims Act. Since January
2009, the Justice Department has recovered a total of more than $17
billion through False Claims Act cases, with more than $12.2 billion of
that amount recovered in cases involving fraud against federal health
care programs.
This settlement was the result of an investigation by the Justice
Department’s Civil Division, the U.S. Attorney’s Offices for the Eastern
District of Tennessee and the Northern District of California and the
Office of Inspector General at the U.S. Department of Health and Human
Services.
The lawsuit is captioned United States ex rel. Peters et al. v. Abbott
Laboratories, Inc., Civil Action No. 3:09-CV-430 (E.D. Tenn.). The
claims settled by this agreement are allegations only, and there has
been no determination of liability.
Component(s):
Civil Division
Press Release Number:
13-1367
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
http://www.chicagotribune.com/business/ct-abbott-wrongful-death-lawsuit-0310-biz-20150309-story.html
University of Chicago law student died after using diabetic test strips
that were recalled days after her death, according to a lawsuit filed in
Cook County Circuit Court against Chicago-area companies Abbott
Laboratories and Walgreen.
Abbie Harper, 23, in her second year of law school, had been diagnosed
with Type 1 diabetes as a teenager, according to her family, which filed
the suit in late 2014 but chose to speak out publicly Monday.
ADVERTISING

Harper used Abbott's FreeStyle-brand test strips and a blood glucose
meter in conjunction with an OmniPod insulin pump made by
Massachusetts-based Insulet, also a defendant, according to the suit.
The suit stated that the products gave Harper falsely low glucose
readouts for about two days. As a result, she didn't take enough insulin
and she died Nov. 14, 2013, according to the suit.
Four days later, on Nov. 18, Abbott recalled its FreeStyle test strips
because they were found to provide "erroneously low blood glucose
results," in some cases, according to the suit.
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"We ... believe the evidence will show that the manufacturing error was
the tip of the iceberg and that compatibility problems among the devices
existed for quite some time before Abbie's death," said Corboy &
Demetrio attorney Ken Lumb, who is representing the Harpers.
A Chicago Walgreens store filled Harper's prescription for FreeStyle
brand test strips. Walgreen declined to comment on the pending litigation.
"Our sympathies are with the Harper family," Abbott said in a statement.
"We have been committed to supporting people with diabetes for 20 years
and the safety and quality of our products is our top priority."
The young woman's father, Ken Harper, said he hopes the lawsuit brings
awareness to the products that "failed Abbie."
"Abbie trusted and relied upon her diabetic test strips and glucose
monitor," Ken Harper said. "They were her lifeline."
ehirst-at-tribpub.com
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So many immigrant groups have swept through our town
that Brooklyn, like Atlantis, reaches mythological
proportions in the mind of the world - RI Safir 1998
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DRM is THEFT - We are the STAKEHOLDERS - RI Safir 2002
http://www.nylxs.com - Leadership Development in Free Software
http://www2.mrbrklyn.com/resources - Unpublished Archive
http://www.coinhangout.com - coins!
http://www.brooklyn-living.com
Being so tracked is for FARM ANIMALS and and extermination camps,
but incompatible with living as a free human being. -RI Safir 2013
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