IN THE UNITED STATES DISTRICT COURT

FOR THE MIDDLE DISTRICT OF TENNESEE

NASHVILLE DIVISION
11
GURSHEEL S. DHll..LON
(Relator)
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8-11
0098
On behalf of the United States of America,
and all Health Related plans that
purchased Lidoderm and any cash payers,
Civil Case No .._____ _
FILED UNDER SEAL
vs
JURY TRIAL p: ff J tf)
DEMANDED u H t\,, ;_, 1J

ENDO PHARMACEUTICALS
QUI TAM COMPLAINT
REALTOR, Gursheel S. Dhillon, M.D. prose, brings this qui tam action in t
the United States Government, all health related plans in the fifty United States that purchased
the product Lidoderm, and all cash paying consumers in the fifty states that constitute the United
States of America.
SUMMARY INTRODUCTION
1. This is an action by qui tam Relator on behalf of the United States of America, all health
related plans and any cash paying customers to recover penalties and damages arising
from false and misleading statements made by Endo Pharmaceuticals regarding product
use of Lidoderm, for use other than Post Herpetic Neuralgia ("PHN"), in an effort to
obtain federal and state monies pursuant to Medicare, Medicaid, and other private health
benefits plans. Relator obtained knowledge, as a private health care provider, directly
observed such misstatements made by Endo Pharmaceuticals Representatives, their guest
speakers and a corporate culture of making claims that gave rise to an over prescription
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of this medication. These representatives also discouraged use of other medications that
were approved for "certain" conditions, and a scared physician into prescribing Lidoderm
for other uses other than Post Herpetic Neuralgia. The Representatives described training
seminars where speakers routinely described other than approved uses for a large portion
of their presentations. The Representatives also detailed physicians that due to increasing
regulatory oversight of "Scheduled Medications for pain" their product provided
equivalent therapy after third day of use. The Relator would also state that the
corporation knew and had knowledge that the number of prescriptions was far and above
the number of cases of Post Herpetic Neuralgia (PHN), and routinely rewarded its
representatives with trips and gifts, and encouraged dinner meetings with company
provided speakers, that encouraged use of Lidoderm for uses such as Carpal Tunnel
Syndrome, arthritic knee pain, back and neck pain.
2. Relator would also show that in response to subpoenas by the Office of Inspector General
(OIG), the company began an internal investigation to "evaluate the companies risk of
promotion for 'off-label use' of Lidoderm, and met with representatives of the law frrm
of Arnold and Porter in Pennsylvania, and fired employees that testified truthfully,
confiscated computers, and other literature, all business cards and other materials such as
clinical studies which Relator would state was to hide and impede investigations, and
have not resulted in any actions by the government. Although the company states it has
"responded to the subpoenas", and states it is co-operating with the governments
investigations. Relator would state that action to fire employees because of the
statements they made is a contradiction to the company's actions and he is afraid that the
company seeks to delay investigations to delay statues for time limits to seek recovery of
funds due or destroy evidence or eliminate witnesses, under the false pretense of
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downsizing or other causes, which bears close temporal proximity to their
testimony.
PARTIES
3. Relator Gursheel Dhillon is a citizen of the State of Tennessee.
4. Defendant, Endo Pharmaceuticals is a foreign corporation and has been registered to do
business in the State of Tennessee. The State records show Endo Phannaceutical's to be
active and registered to do business since 09/23/1997 (Control ID 000338056). Its
principal office is at Chad's Forth Pennsylvania. It routinely conducts business in
Tennessee and accepts correspondence at several addresses .
.IURIDSTICTION AND VENUE
5. This action arises under the False Claims Act, 31 U.S.C. 33729 et seq.
This court maintains subject matter jurisdiction over the action pursuant to 31 U.S.C.
3372 (a) (False Claims Act) and 28 U.S.C. 133l(Federal Question).
6. Venue is proper in this court pursuant to 31 U.S.C. 37372(a) because Endo
Pharmaceuticals("EP"), (i) conducts business in this district and did at all times relevant
to this complaint and as averred below, (iii) committed acts proscribed by 28
U.S.C.3729, such acts giving rise to this action-within this district.
7. Before filing this complaint the Relator did serve a copy of the complaint upon the
United States Department of Justice, Office of the United States Attorney with the name
of a witness and other information contained herein pursuant to the requirements of 31
u.s.c. 3730(b)(2).
8. Relator has to the best of his ability complied with all other conditions precedent to
bringing this action.
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9. Relator is the original source of, and has direct and independent knowledge of all
publicly disclosed information on which any allegations here might deemed be based,
and has voluntarily provided such information to the U. S. Government
contemporaneously with filing this action.
10. Only the following evidence was reviewed and available on the internet by Relator
prior to the filing of this complaint.
Anonymous
PostS: nta.
Affairs Activity Report 1/11
it .. funny we haven't heard squat out of the government affairs folks since they
fcheated us out of our money @ the 2010 NSM when old man Holvek and the PRRMA Pres
did their dog and pony show over a little wine, cheese and crackers. How stupid those of us:
bought into they're lies were and a TOTAL WASTE OF OUR MONEY. What did we get out
:of it???? Endo using our $$$ along with the company bank account to pay homage to:
Obamacare. We were sold a false bill of goods that night and I'm starting this thread In
ihopes to ask all of you who read my thread to spread the word NOT to fall into this trap
.again next month when we're all in Vegas sipping on more wine, etc., etc. Never again will I
contribute to PAC with this pharma company or any other. Look how well PAC has saved the
'so,OOO+ reps who Pharmaceutical Rep magazine reported lost their jobs in 2010. Did you
(see government affairs keeping us updated on how we were fighting Obamacare last spring?,
Hell no, cause Endo rolled over and took it up the rear side from Obama and his rulers.
Please, please do not waste your money on Endo PAC again this year. Take what you spent
on that BS in 2010 and go gambling instead cause it's no worse than throwing your money
,away to a so called organization that does not have our best interest at heart. I call total BS:
on .Encjo spread the word. before the NSM!!! Th(3F1kS ...... .
Risks related to our business
We may incur significant liability if it is determined that we are promoting or have in the past promoted the "off-
label" use of drugs.
Companies may not promote drugs for "off-label" uses-that is, uses that are not described in the product's labeling
and that differ from those approved by the FDA. Under what is known as the ''practice of medicine," physicians and
other healthcare practitioners may prescribe drug products for off-label or unapproved uses, and such uses are
common across some medical specialties. Although the FDA does not regulate a physician's choice of medications
or treatments, the Federal Food, Dn1g and Cosmetic Act ("FFDCA") and FDA regulations significantly restrict
permissible communications on the subject of off-label uses of drug products by pharmaceutical companies. The
FDA, the Office of Inspector General of the Department of Health and Human Services ("OIG"), and the
Department of Justice ("DOJ") actively enforce laws and regulations that prohibit the promotion of off-label uses. A
company that is found to have improperly promoted off-label uses may be subject to significant liability, including
civil fines, criminal fines and penalties, civil damages and exclusion from federal funded healthcare programs such
as Medicare and Medicaid. Conduct giving rise to such liability could also form the basis for private civil litigation
by third-party payors or other persons allegedly harmed by such conduct.
Notwithstanding the regulatory restrictions on off-label promotion, the FDA's regulations and judicial caselaw allow
companies to engage in some forms of truthful, non-misleading, and non-promotional speech concerning their
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products. The Company has endeavored to establish programs in order to
instruct employees on complying with the relevant advertJsmg .legal re_qmrements. th.e
FDA, OIG or the DOJ may take the position that the Company IS not m comphance w1th such reqUirements, and, 1f
such non-compliance is proven, we may be subject to significant liability, including administrative, civil and
criminal penalties and fines. In addition, management's attention could be diverted from our business operations and
our reputation could be damaged.
In January 2007, we received a subpoena issued by the OIG. The subpoena requests documents relating to
Lidoderm (lidocaine patch 5%) focused primarily on the sale, marketing and promotion of Lidoderm"'. We are
cooperating with the government. At this time, we cannot predict or determine the of government's
investigation or reasonably estimate the amount or range of amounts of fines or penalt1es that m1ght result from a
settlement or an adverse outcome. However, should the government choose to initiate action against us, we could
face substantial penalties, which could have a material adverse effect on our business, financial condition, results of
operations and cash flows.
We may incur liability if our continuing medical or health education programs and/or product promotions are
determined, or are perceived, to be inconsistent with regulatory guidelines.
The FDA regulations and the Anti-Kickback Statutes provide guidelines with respect to the type and scope of
appropriate product promotion and continuing medical and health education activities. Although we endeavor to
follow these regulations, should it be determined that we have not appropriately followed the guidelines, the
government may initiate an action against us which may result in significant liability, including administrative, civil
and criminal sanctions. Such penalties could have a material adverse effect on our business, financial condition,
results of operations and cash flows. In addition, management's attention could be diverted and our reputation could
be damaged. '
Our reporting and payment obligations under the Medicaid rebate program and other governmental pricing
programs are complex and may involve subjective decisions. Any failure to comply with those obligations could
subject us to penalties and sanctions.
We are subject to various federal and state laws pertaining to healthcare fraud and abuse, including prohibitions on
the offer of payment or acceptance of kickbacks or other remuneration in return for the purchase-of our products.
Sanctions for violating these laws include criminal penalties and civil sanctions and possible exclusion from the
Medicare, Medicaid, and other government healthcare programs. There can be no assurance that our practices will
not be challenged under these laws in the future or that such a challenge would not have a material adverse effect on
our business or results of operations.
We also are subject to federal and state laws prohibiting the presentation (or the causing to be presented) of claims
for payment (by Medicare, Medicaid, or other third-party payers) that are determined to be false, fraudulent, or for
an item or service that was not provided as claimed. These false claims statutes include the Federal Civil False
Claims Act and the Federal Criminal False Claims
Act, the former of which permits private persons to bring suit in the name of the government alleging false or
fraudulent claims presented to or paid by the government (or other violations of the statutes) and to share in any
amounts paid by the entity to the government in fines or settlement. Such suits, known as qui tam actions, have
increased significantly in the healthcare industry in recent years. These actions against healthcare companies may
result in payment of fines or exclusion from the Medicare, Medicaid, and/or other government healthcare programs.
We and other pharmaceutical companies are defendants in a number of lawsuits filed by local and state government
entities, alleging generally that we and numerous other pharmaceutical companies reported false pricing information
in connection with certain drugs that are reimbursable under Medicaid. We intend to defend these lawsuits
vigorously. Depending on developments in the litigation however, as with all litigation, there is a possibility that we
will suffer adverse decisions or verdicts of substantial amounts, or that we will enter into monetary settlements in
one or more of these actions as we recently did with a number of New York counties. See "Legal proceedings" in
Note 12 of our unaudited interim condensed consolidated financial statements incorporated by reference in this
offering memorandum and the section entitled "Business-Legal proceedings" included in this offering
memorandum. Any unfavorable outcomes as a result of such litigation could have a material adverse effect on our
business, financial condition, results of operations cash flows.
Government regulations regarding reporting and payment obligations are complex and we are continually evaluating
the methods we use to calculate and report the amounts owed with respect to Medicaid and other government
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_,:1
pricing programs. Our calculations are s u j e ~ t to review and .chall:nge by. various government agencies and
authorities and it is possible that any such review could result either m matenal changes to the method used for
calculating the amounts owed to the pertinent government agency (or agencies), or to the amounts themselves. In
addition, because our processes for these calculations and our judgments supporting these calculations involve, and
will continue to involve, subjective decisions, these calculations are subject to the risk of errors. As noted above, any
governmental agency that commences an action, if successful, could impose, based on a claim of violation of fraud
and false claims laws or otherwise, civil and/or criminal sanctions, including fines, penalties and possible exclusion
from federal healthcare programs (including Medicaid and Medicare). Some of the applicable laws impose liability
even in the absence of specific intent to defraud. Furthermore, should there be ambiguity with regard to how to
properly calculate and report payments-and even in the absence of such ambiguity-a governmental authority may
take a position contrary to a position we have taken, and may impose civil and/or criminal sanctions. Any such
penalties or sanctions could have a material adverse effect on our business, financial position, results of operations
and cash flows, and could cause the market value of our common stock to decline.
New and proposed federal and state laws and regulatory initiatives relating to various initiatives in healthcare
reform (such as improving privacy and the security of patient information and combating healthcare fraud)
could require us to expend substantial sums to appropriately respond to and comply with this broad variety of
legislation (such as acquiring and implementing new information systems for privacy and security protection),
which could negatively impact our business, results of operations, financial condition and cash flows.
Recent legislation and several regulatory initiatives at the state and federal levels address patient privacy concerns.
New federal legislation extensively regulates the use and disclosure of individually identifiable health-related
information and the security and standardization of electronically maintained or transmitted health-related
information. We do not yet know the total financial or other impact of these regulations on us. Continuing
compliance with these regulations will likely require us to spend substantial sums, including, but not limited to,
purchasing new computer systems, which could negatively impact financial results. Additionally, if we fail to
comply with the privacy laws and regulations, we could suffer civil penalties of up to $I ,500,000 per calendar year
for violations of an identical standard and criminal penalties of up to $250,000 and I 0 years in prison for offenses
committed with the intent to sell, transfer, or use individually identifiable health information for commercial
advantage, personal gain or malicious harm. In addition. healthcare providers will continue to remain subject to any
state laws that are more restrictive than the federal privacy regulations. These privacy laws vary by state and could
impose additional penalties.
The provisions of HIPAA criminalize situations that previously were handled exclusively civilly through
repayments of overpayments, offsets and fines by creating new federal healthcare fraud crimes. Further, as with the
federal laws, general state criminal laws may be used to prosecute healthcare fraud and abuse. We believe that our
business arrangements and practices comply with existing healthcare fraud law. However, a violation could subject
us to penalties, fines and/or possible exclusion from Medicare or Medicaid. Such sanctions could significantly
reduce our financial results.
Future healthcare legislation or other changes in the administration of or interpretation of existing legislation
regarding governmental healthcare programs could have an adverse effect on our business and the results of our
operations.
Read more: http://www.fags.org/sec-filings/JOII19/ENDO-PHARMACEUTICALS-HOLDINGS-INC 8-
K/dex99l.htm#ixzz1Ck2CRX9V
8th Annual Pharmaceutical Compliance Congress - The Center for ...
He has more than fifteen years of experience in investigations and compliance in the ... U.S. Department of
Health and Human Services (OIG) in Washington, DC .... David P. Holveck, President and Chief Executive
Officer, Endo Pharmaceuticals ... 11: 10 Key Insights and Lessons Learned Operating Under a Corporate ...
www.cbinet.com/show_conference.cfrn?confCode=PCIIOOl&f... -Similar
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11. It is believed by Relator that Sevrin Anderson, of Williamson County may have
additional information and a letter which are highly supportive of these allegations.
FACTUAL ALLEGATIONS
1. ENDO PHARMACEUTICALS ("EP") is the manufacturer and seller of Lidoderm
patches that have been approved by the FDA for the treatment of neuropathic pain,
associated with residual pain due to Herpes Zoster outbreaks which causes severe pain,
known as Post Herpetic Neuralgia (PHN).
2. The Number of Lidoderm prescriptions far exceeds the number of PHN patients who may
use other methods of pain control or other treatment options. The number of Lidoderm
prescriptions that were prescribed far exceeds the number of patients with PHN in the
United States, estimated at 500,000 yearly.
3. Lidoderm contributes to approximately two thirds of the company's revenue.
4. The sales goals set by EP for their pharmaceutical representatives was far above the
actual and potential number of PHN cases and this was widely known throughout the
company and was routinely discussed by management and sales personnel. It is also
widely known that there are many alternative methods for the treatment of PHN and no
single treatment ever gets 100 percent of the patients since many alternative therapies are
available.
5. EP managers and regional managers met quarterly with their pharmaceutical sales force
and knew the methods that were being utilized to sell Lidoderm patches.
6. EP sales personnel were encouraged to criticize PHN alternative treatment options, and
used scare tactics regarding increased regulatory oversight of narcotic medication to
encourage Lidoderm use for almost any conceivable disease associated with pain.
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7. EP sales representatives that met or exceeded their goals which were grossly out of
proportion of the number of actual and potential PHN cases were rewarded and their
future goals were increased.
8. EP sales people who did not meet their Lidoderm set goals were not given bonuses.
9. As a result of these deceptive trade practices, and false claims EP was unjustly enriched
by obtaining proceeds of sales from Medicare, Medicaid, other health benefit providers
and private payers throughout the United States through prescription reimbursement
payments when the patches did not alleviate or help patients with pain not occasioned by
PHN.
I 0. EP sales people were instructed that the patches had to be applied consistently for three
days and either patient or physician error was responsible if the patient did not obtain any
relief. Because EP engaged program speakers in training and inspiring their sales
personnel to advocate the use of Lidoderm for conditions other than PHN, the persuasive
corporate culture of deception and marketing for "Off Label Use" was rampant and
palpable throughout the organization.
11. Relator has been informed that "Off Label Use" was a persuasive culture at EP and
encouraged by EP and its management, particularly and specifically at numerous training
sessions EP held and required its sales people to attend.
12. EP had knowledge that the number of Lidoderm prescriptions was ''way out" of
proportion to the number of actual and potential PHN patients and by the companies own
account the product Lidoderm was only used for PHN in ten percent of the prescriptions
filled for the product.
13. The Relator is a physician in Tennessee and learned of such information first hand.
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.,i !; ---
14. It is believed that EP has engaged in an internal method of possibly eliminating
evidences, and denying access to witnesses and failing to completely comply with the
OIG summons issued to it.
15. The United Sates and no other entity has to date filed any charges, has not filed any
lawsuits in an attempt to recover such funds or fines in this matter and is asked to join
Relator in the complaint as set forth.
WHEREFORE RELATOR, Gursheel S. Dhillon, M.D., on behalf of himself, the United States
Government, and all state governments, all health benefit payers, and cash paying and any or
other privately or municipally insured payers that purchased or used Lidoderm prays;
(I) That this Court enter a judgment against Defendant Endo Pharmaceuticals for three times
the amount of damages experienced by the United States Government, all health
prescription benefits providers, and cash payers that purchased Lidoderm for other uses
other than PHN as a result of Defendants violations ofthe False Claims Act;
(2) That this Court enters a judgment against defendant for a civil penalty of $10,000 for
each of Defendants False Claim Act violations;
(3) That Relator Gursheel S. Dhillon recovers all costs of this action, with interest including
the cost to the United States Government for its actions related to this action;
(4) That in the event Relator Gursheel S. Dhillon retains attorney Relator be awarded all
reasonable attorney fees in bringing this action;
(5) That in the event the United States Government or other plaintiffs included proceeds with
this action Relator Gursheel S. Dhillon be awarded an amount of twenty five percent of
the proceeds in the action;
(6) That in the event the United States or any other plaintiff proceeds with this action,
Relator Gursheel S. Dhillon be awarded an amount of at least 25% but not more than
30% of the proceeds of the action;
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(7) That Relator, Gursheel S. Dhillon be awarded prejudgment interest;
(8) That a trial by jury be held in all issues so triable;
(9) That Relator. Gursheel S. Dhillon, or any of the aforementioned parties or the United
States Government, or other Health Benefit Providers or purchasers of Lidoderm using
other payment methods may be allowed further amendments of the complaint as
necessary to perfect such claim;
(10) That Relator, Gursheel Dhillon and the United States of America receive all relief
to which either or both may be entitled at law or equity.
ursheel S. Dhillon, M.D.
Prose
Estill Springs, TN 37330
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1;.
CERTIFICATE OF SERVICE
I, Gursheel S. Dhillon, M.D., certify that a true and exact copy of this complaint was filed
with the United State Department of Justice, in Nashville, Tennessee at the U. S. Federal District
Court House.
A copy of this complaint has been filed with the Clerk of the United States District Court
for the Middle District of Tennessee, Nashville Division to be held for sixty (60) days to allow
the United States Government through the office of the United States Attorney to proceed with
Relator.
ursheel S. Dhillon, M.D.
Prose
112 Plainview Drive
Estill Springs, TN 37330
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