McEldrew Young Purtell Merritt Whistleblower Lawsuit Against INSYS Results in $225 Million Settlement of Allegations Involving Opioid Sales and Marketing Abuses

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INSYS Agrees to Global Resolution of Claims Arising from Separate DOJ Criminal and Civil Investigations

The Department of Justice announced that INSYS Therapeutics, Inc. (“INSYS”) has agreed to pay $225 million to resolve allegations that it paid kickbacks and engaged in other illegal marketing tactics to promote sales of its fentanyl spray, Subsys. According to the terms of the settlement, INSYS will pay a criminal fine of $2 million and forfeit $28 million. The pharmaceutical manufacturer will also pay $195 million to settle civil claims based on allegations in five different qui tam lawsuits filed by separate relators.

McEldrew Young Purtell Merritt represents one of the five relators, a former INSYS sales representative who became concerned as the drug manufacturer continually pushed the boundaries of its marketing tactics to boost sales of its powerful opioid painkiller. In 2016, McEldrew Young Purtell Merritt filed a complaint under seal on behalf the relator in the United States District Court for the Central District of California. The complaint included allegations that INSYS promoted Subsys for various off-label, or unapproved, uses including musculoskeletal pain, fibromyalgia, neck pain, and back pain, despite the fact that the FDA only approved the drug for the management of breakthrough cancer pain.

Allegations of Improper Dosing Instructions and Meddling with Insurance Authorizations

INSYS management allegedly directed its sales representatives to encourage physicians to prescribe Subsys for continuous use, rather than only as needed, and to start new patients at twice the starting dose permitted by the FDA-approved label. Sales representatives were also allegedly instructed to complete prior authorization forms on behalf of the patient or physician. They also provided physicians with an appeal letter template that would be filled out if patients could not obtain prior authorization from their insurer.

The TIRF REMS Access Program

INSYS allegedly employed other less subtle tactics to remove certain “obstacles” purposely set in place to control distribution of the dangerous class of fentanyl-based painkillers, such as Subsys. For example, the FDA requires that physicians and pharmacists enroll in a program known as the TIRF REMS (Transmucosal Immediate Release Fentanyl – Risk Evaluation and Mitigation Strategy) Access Program. The program was designed to reduce the risks of misuse, abuse, addiction, overdose and serious complications due to medication errors with the use of TIRF medicines. Prescribers and pharmacists must study educational materials and pass an online knowledge assessment exam is order to obtain certification.

In an effort to increase the number of prescribers in the TIRF REMS Access Program, INSYS sales representatives allegedly provided physicians with cheat sheets that contained all the correct answers to the knowledge assessment exam. The practice of distributing the test answers was allegedly considered commonplace among sales representatives. Physicians who allegedly received the cheat sheets could easily circumvent the educational requirement of the program which was intended to ensure that they had sufficient information to make informed risk-benefit decisions prior to starting a patient on a TIRF drug.

Allegations of Sham Speaker Programs and Other Physician Incentives

Much like a number of other pharmaceutical manufacturers, INSYS utilized “speaker programs,” which were purportedly intended to be educational programs through which physicians were paid to present medical information to their colleagues at lunch and dinner events. It was alleged that these events were, in reality, sham programs whose only purpose was to pay doctors and pharmacists to convince their peers to prescribe Subsys for various off-label uses.

According to allegations in the case, many of the speaking events were held at inappropriate locations, such as noisy restaurants and strip clubs, and were nothing more than a pretense to provide attendees with free food, alcohol, and monetary compensation. The alleged payment of bribes and kickbacks to attending prescribers was designed as a way to increase the number of Subsys prescriptions written, as well as the dosage of those prescriptions. Many physician-speakers allegedly received compensation without ever having provided any educational content whatsoever at these events.

Another form of illegal kickbacks allegedly involved the use of gift cards. INSYS management allegedly encouraged sales representatives to provide gift cards to physicians as an incentive to continue prescribing Subsys. Sales representatives allegedly employed covert techniques to conceal the details of the transactions involving the purchase of the gift cards. Under one such scheme, an INSYS sales representative would allegedly purchase gift cards at a local food establishment and persuade the store owner to create fraudulent receipts for the value of the purchase price of the gift cards. The doctored receipts would falsely reflect the purchase of coffee and other small food items which could permissibly be given to a physician’s office. The sales representative would allegedly submit the fraudulent receipts for reimbursement by INSYS and then directly give the gift cards as a form of illegal and untraceable kickbacks to the physicians who prescribed Subsys.

The Rochester Connection

As the manufacturer of Subsys, INSYS was only the first link in the chain of bad actors who allegedly put profit ahead of preventable harm to thousands of vulnerable patients. Rochester Drug Cooperative (“RDC”), the sixth largest distributor of pharmaceutical products in the country, was charged as a corporate entity with conspiring to distribute drugs, conspiracy to defraud the United States, and failing to file suspicious order reports.

Last month, the CEO of RDC signed a Deferred Prosecution Agreement (“DPA”) in connection with the pending charges against the company. Under the DPA and a related consent decree, RDC agreed to: 1) accept responsibility for its conduct by making admissions and stipulating to the accuracy of an extensive statement of facts; 2) pay a $20 million penalty; 3) reform and enhance its Controlled Substances Act compliance program; and 4) submit to supervision by an independent monitor. If RDC remains compliant with the DPA, the government will defer prosecution and seek to dismiss the charges after five years.

The recent charges against RDC stem from a two-year investigation by the Drug Enforcement Administration (“DEA”) after RDC violated the terms of a prior civil settlement. The disclosure of the prior investigation and resulting civil settlement came to light after RDC’s former CEO, Laurence Doud III, filed a lawsuit against the company last year. In the suit against RDC, Doud claims he was fired so that RDC could shift responsibility to him for the recent DEA criminal investigation.

Mr. Doud and RDC’s former chief compliance officer were both recently charged with conspiring to distribute drugs and defrauding the government. The indictments mark the first time that federal criminal charges have been brought against company executives for conspiring to illegally distribute opioids

Linden Care Specialty Pharmacy

In his lawsuit against RDC, Mr. Doud also alleged that two members of RDC’s executive team defamed him by asserting that he and BelHealth Investment Partners had an improper financial relationship. BelHealth Investment Partners is a private equity firm that acquired Linden Care LLC (“Linden Care”), a company that ran a now-defunct specialty pharmacy based in Woodbury, New York.

The recent investigation by the DEA was based, in part, on the inaccurate reporting, or lack of reporting, of pharmaceutical sales between RDC and Linden Care. Prior to going out of business, it is believed that Linden Care was one of the largest, if not the largest, distributors of Subsys in the nation.

McEldrew Young Purtell Merritt’s initial investigation of the allegations against INSYS identified the critical role that Linden Care played as the leading dispenser of Subsys throughout the country. The complaint filed by McEldrew Young Purtell Merritt on behalf of its client was the only one to name Linden Care as a defendant in the INSYS qui tam lawsuit. Although the case against INSYS has settled, McEldrew Young Purtell Merritt’s suit against Linden Care and Belhealth Partners is currently pending before the United States District Court for the Central District of California.

The False Claims Act

The INSYS case demonstrates the importance of whistleblowers in identifying and reporting fraud. Fraud against the government takes many forms, and employees and contractors are often in the best position to detect and report such conduct. The government simply doesn’t have the resources to identify and prosecute every instance of fraud. Consequently, many unscrupulous actors continue to defraud the government, and American taxpayers, for years without detection or prosecution.

The False Claims Act provides a monetary incentive to whistleblowers who provide original information. If the government makes a monetary recovery based on the information provided, a whistleblower can receive between 15 and 30 percent of the recovery. The False Claims Act also contains provisions that protect a whistleblower from retaliation by an employer.

If you have information about fraud against the government, the experienced attorneys at McEldrew Young Purtell Merritt can assist with all aspects of the process, from investigating your claim, filing a complaint, and successful recovery of a reward.

Southern District of New York Federal Court Greenlights McEldrew Young Purtell Merritt’s False Claim Act Case Against Teva Pharmaceuticals for Trial Involving Allegations of Nationwide Kickback Scheme

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Chief U.S. District Judge Colleen McMahon ruled on February 27th that a False Claims Act suit brought by two former employees of Teva Pharmaceuticals USA, Inc. will proceed to a trial on the merits.  In a detailed seventy-page opinion, the Court rejected numerous arguments asserted by Teva Pharmaceuticals USA, Inc. and two of its subsidiaries (“Teva”) in its motion for summary judgment.  The ruling preserves all of the relators’ claims asserted against Teva under the federal False Claims Act.

Electronic Health Records: A Prognosis for Missteps and Potential Fraud

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Misread pap smear lawsuits

The Wall Street Journal recently reported that the Department of Veterans Affairs is in discussions with Apple to provide portable electronic health records (“EHRs”) to military veterans. The plan reportedly calls for Apple to develop specialized software tools that would allow veterans and their families to access their EHRs through Apple’s Health Records EHR data viewer. The proposed plan is intended to simplify and streamline health data access for patients visiting VA healthcare sites.

Retina Institute Settles with Government for $6.65 Million Over Allegations of False Claims Act Violations

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On October 2, 2019, Retina Institute of California Medical Group (RIC), along with its former CEO and several physicians, agreed to pay $6.65 million to resolve allegations of False Claims Act violations. RIC is a medical partnership of ophthalmologists with multiple locations in California. The medical group was alleged to have defrauded government health care programs by billing for unnecessary exams, improperly waiving Medicare copayments, and other regulatory violations. Eric Young, managing partner of McEldrew Young Purtell Merritt’s whistleblower practice, worked on the case with attorneys from the law firm of Berger Montague.

The case, United States ex rel. Smith and Rogers v. Chang, No. 13-CV-3772-DMG (C.D. Cal.), was filed in May 2013. The complaint was unsealed in July 2016 after the government elected not to intervene in the case. The two Relators were both former employees of RIC who provided substantial documentation to support allegations in the complaint. Bobette Smith was the CEO of the practice group from June 2012 to January 2013, and Susan Rogers worked as the manager of the billing department over the same six month period. The allegations in the complaint were based on information discovered by the Relators during the course of their employment, as well as their personal observations and investigation into what they believed to be fraud against the federal government and the State of California.

Routine Waiver of Medicare Deductibles and Copayments Can Result in False Claims Act Violations

Medical service providers are required to collect copayments and deductibles from all Medicare beneficiaries, except in specific cases of financial hardship. Any incentive that generates improper referrals, particularly where a medical service provider offers free or discounted items or services to Medicare beneficiaries, or promotes overutilization of medical services can constitute the submission of false claims to the federal government. Thus, a service provider that routinely waives cost-sharing amounts for Medicare beneficiaries, but bills Medicare for the full allowable amount, can be face substantial penalties under the False Claims Act.

The Office of Inspector General for the Department of Health and Human Services set forth detailed guidance on this issue back in 1994:

“Routine waiver of deductibles and copayments by charge-based providers, practitioners or suppliers is unlawful because it results in (1) false claims, (2) violations of the anti-kickback statute, and (3) excessive utilization of items and services paid for by Medicare.

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A provider, practitioner or supplier who routinely waives Medicare copayments or deductibles is misstating its actual charge. For example, if a supplier claims that its charge for a piece of equipment is $100, but routinely waives the copayment, the actual charge is $80. Medicare should be paying 80 percent of $80 (or $64), rather than 80 percent of $100 (or $80). As a result of the supplier’s misrepresentation, the Medicare program is paying $16 more than it should for this item.

In certain cases, a provider, practitioner or supplier who routinely waives Medicare copayments or deductibles also could be held liable under the Medicare and Medicaid anti-kickback statute . . . When providers, practitioners or suppliers forgive financial obligations for reasons other than genuine financial hardship of the particular patient, they may be unlawfully inducing that patient to purchase items or services from them.

One important exception to the prohibition against waiving copayments and deductibles is that providers, practitioners or suppliers may forgive the copayment in consideration of a particular patient’s financial hardship. This hardship exception, however, must not be used routinely; it should be used occasionally to address the special financial needs of a particular patient. Except in such special cases, a good faith effort to collect deductibles and copayments must be made. Otherwise, claims submitted to Medicare may violate the statutes discussed above and other provisions of the law.”

Retina Institute’s Alleged Systematic Waiver of Medicare Copayments and Deductibles

According the allegations in the complaint, the defendants attempted to induce referrals by routinely waiving Medicare copayments and deductibles for patients without properly investigating or documenting their financial status. In order to disguise the practice, the defendants sometimes allegedly had patients complete a financial hardship form; however, most deductible and copayment waivers were allegedly granted without the completed form. On those limited occasions when the form was used, patients often signed the forms, allegedly without providing any information regarding their financial status.

A ophthalmologist who maintained a general practice near one of RIC’s locations allegedly told an RIC ophthalmologist he expected that copays for Medicare patients to be waived, and that he would not refer patients if copays were not waived. The Relators had records which identified the patients who were referred to RIC by this particular ophthalmologist. The documents showed the receipts for those patients amounted to only 80% of the Medicare allowable amount. Without consideration of financial hardship or any documents to verify such designations, the copayments for these patients were allegedly waived as a matter of course.

Relators independently investigated several patients whose records indicated a financial hardship waiver. They discovered that some of those patients lived in expensive homes, including one residence valued in the millions of dollars.

The Relators each separately explained to Dr. Tom Chang, one of RIC’s physician/owners, that the policy and practice of routinely waiving Medicare copays and deductibles did not comply with Medicare regulations. Dr. Chang allegedly responded, on more than one occasion, that he would prefer to continue using the financial hardship waivers to ensure that RCI did not lose any referrals or patients. Dr. Chang allegedly said he would simply pay the fines if Medicare ever learned about the practice. In light of his former position as a Medicare compliance officer for the Department of Ophthalmology at the University of Southern California School of Medicine, Dr. Chang’s alleged comments and lack of concern are quite noteworthy.

Relator Smith made several attempts to advise RIC’s partners about changing the manner in which financial hardship cases were handled. She even made a presentation to the RIC senior management team and Executive Committee warning of the potential adverse consequences of continuing with the current practice. During the presentation, Dr. Chang allegedly repeated that he would pay the fines if Medicare ever discovered the way in which RCI handled the waivers.

The History and Purpose of the Anti-Kickback Statute

The Anti-Kickback Statute, 42 U.S.C. § 1320a-7b(b) (“AKS”), prohibits any person or entity from offering, making, soliciting, or accepting remuneration, in cash or in kind, directly or indirectly, to induce or reward any person for purchasing, ordering, or recommending or arranging for the purchasing or ordering of federally-funded medical goods or services. The statute was enacted in 1972 to address concerns that remuneration provided to those who influence health care decisions would result in services that were medically unnecessary, of poor quality, or harmful to a vulnerable patient population. Congress therefore passed the AKS to prohibit the payment of kickbacks in any form. The statute was amended in 1977, and again in 1987, to ensure that kickbacks could not be disguised as legitimate transactions to circumvent the law.

Retina Institute’s Alleged Violations of the Anti-Kickback Statute

A physician who refers a patient for medical services to an entity in which the physician has a financial interest violates the AKS unless the referral falls within the “safe harbor” regulations.

The physician defendants named in the complaint had financial ownership interests in an ambulatory surgery center known as the San Gabriel Surgery Center. Those physician defendants, as well as other RIC physicians, routinely referred RIC patients in need of surgery to the San Gabriel Surgery Center.  Such referrals would only be covered by the safe harbor regulations if the physician’s investment interest was fully disclosed to the patient.

According to the allegations in the complaint, RIC physicians did not advise their patients that RIC principals had an investment interest in the San Gabriel Surgery Center.  Patients were allegedly given a brochure instead that stated, “The ownership for San Gabriel Ambulatory Surgery Center may be obtained by contacting the center at (626) 300 – [XXXX].”

In order to ascertain whether accurate information was disseminated, Relator Smith asked the scheduling agent at RIC to call the phone number on the brochure to learn who owned the surgery center. The scheduling agent allegedly reported to Relator Smith that the individuals who responded to the call could not provide any information about the ownership of the center nor could they find anyone who could answer the question.

The Government Relies on the Assistance of Whistleblowers

This case illustrates the important role that whistleblowers play in identifying and reporting fraud.  Due to the enormity of claims processed under government-funded health care programs, it is impossible for every instance of fraud to be detected.  Employees are often in the best position to observe fraud and gather evidence to corroborate their observations. The government depends on such individuals to come forward and report what they reasonably believe to be fraud.

The False Claims Act permits a private individual to sue on behalf of the United States and share in any recovery. The government may intervene in the action, in which case a Relator may receive a reward of 15 percent to 25 percent of any monetary recovery.  In cases such as this one, where the government declines to intervene, the whistleblower may pursue the action on their own and can receive a reward of 25 percent to 30 percent of any monetary recovery.

If you have evidence of fraud being committed against the government by an employer, business competitor or contractor, call the experienced whistleblower attorneys McEldrew Young Purtell Merritt at (215) 367-5151 for a free, no-obligation consultation.

Record Breaking Settlement of Declined False Claims Act Lawsuit

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Personal Injury Lawyers Philadelphia PA

DaVita Healthcare Partners agreed to pay up to $495 million to settle a False Claims Act lawsuit brought by two whistleblowers, a doctor and a nurse, that worked at DaVita. It is the largest settlement ever in a case where the Department of Justice chose to decline intervention. The company has now agreed to pay nearly $1 billion to settle allegations of Medicare and Medicaid fraud since 2012.

DaVita provides dialysis services to patients with chronic kidney failure and end stage renal disease.  The lawsuit concerned allegations that DaVita wasted medicine in vials and billed Medicare for it. The CDC since 2002 has allowed the reuse of single-use vials in the drugs at issue if proper procedures are followed. The company billed Medicare for the unused portions of the drugs which it discarded.

What is a declined case? The government, after conducting an investigation on the merits of the litigation, generally intervenes and takes over prosecution of the civil claims in around 20 percent of cases brought under the False Claims Act. The rest of the whistleblowers receive a declination letter from the Department of Justice which informs the relator (as a whistleblower under the FCA is known) that they may continue the lawsuit on the government’s behalf (this is what is meant by qui tam, which you may often see in this context).

There have only been five years in the history of the False Claims Act where non-intervened cases reached settlements or judgments exceeding $100 million. Looking at the statistics since 1987, none of the annual totals of these cases exceeded $200 million.

In the past, relatively few non-intervened cases reached a successful settlement or judgment. Some whistleblowers evaluate the situation and decide that they are not interested in prosecuting it themselves if the government isn’t interested in vindicating the fraud against them. However, the success ratio may be improving as more law firms have decided to take these cases and run with them against the large corporations that they challenge.

When False Claims Act cases like these settle, the whistleblowers who file them typically get between 15 and 30 percent of the settlement. The law mandates these percentages, but there are few situations where the amount paid could be less than the minimum award. However, the Department of Justice, on behalf of the U.S. Government, investigated the relator’s claims and declined to intervene in it. In a declined case, the mandated percentage by the law is between 25 and 30 percent.

If you have additional questions about how these lawsuits worker, or have evidence of misconduct by a company which you wish to report, contact one of our Philadelphia FCA attorneys.

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LOUISIANA SETTLES FALSE CLAIMS ACT CLAIM WITH OPTOMETRIST’S OFFICE

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On November 18, 2013, the Department of Justice announced a settlement with Sabine Optical, an optometry office located in Baton Rouge, Louisiana, based on allegations of Medicaid fraud.  According to the details of the case, Sabine Optical (“Sabine”) which does business as The Vision Center, engaged in a pattern of billing behavior designed to garner illegal U.S. and Louisiana Medicaid payments.

The qui tam lawsuit, filed under the False Claims Act, was brought by whistleblower and former Sabine employee William Y. Guess.  Mr. Guess claims that Sabine employed a number of traditional fraud schemes, commonly seen in False Claims Act cases.  Mr. Guess alleges that the tactics ran the gamut, from billing Medicaid for procedures that were never performed to falsification of Medicaid patients’ prior authorization forms.  Mr. Guess also contends that Sabine routinely billed Medicaid using another provider’s Medicaid number.

The case was filed under both the Federal False Claims Act and its Louisiana counterpart, demonstrating once again the value of individual states’ false claims laws.  Pursuant to the settlement, Sabine will pay $1.2 million in damages, $819,960.00 to the U.S. and $380,040.00 to Louisiana.  For his efforts, Mr. Guess will receive twenty percent of the total recovery.

Young Law Group is a nationwide leader in whistleblower representation and has successfully represented numerous clients in some of the nation’s largest qui tam cases for over a decade.  For a free confidential consultation, please call Eric L. Young, Esquire at (800) 590-4116 or complete the online form here.

TEVA Agrees to Pay $54 Million to Settle McEldrew Young False Claims Act Qui Tam Whistleblower Lawsuit

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Attorney Eric. L. Young announced today that Teva Pharmaceuticals USA, Inc., Teva Neuroscience, Inc., and Teva Sales and Marketing, Inc. (hereinafter collectively referred to as “TEVA”) have settled allegations in a qui tam complaint filed by McEldrew Young, Attorneys-at-Law, and co-counsel, Shepherd, Finkelman, Miller & Shah, LLP (“SFMS”), on behalf of two relators, Charles Arnstein and Hossam Senousy, both of whom previously worked as sales representatives for TEVA.

The allegations in the qui tam complaint focused on a scheme to induce physicians to write prescriptions for the drugs Copaxone and Azilect by paying them as “speakers” or “consultants,” when, in reality, many of the programs at issue were sham events. As a result of TEVA’s allegedly illegal payments, the physicians prescribed Copaxone, which treats relapsing-remitting multiple sclerosis, and Azilect, which treats symptoms of Parkinson’s disease, and influenced other prescribers to do the same.

According to the complaint, physicians who participated in the alleged sham speaker programs wrote prescriptions for the two drugs that were filled at pharmacies across the country.  After filling and dispensing the prescriptions, the pharmacies then submitted claims for reimbursement to various government-funded health care programs.  The pharmacies’ claims resulted in payments by the government for prescriptions that were allegedly induced through fraud, i.e., TEVA’s alleged illegal payments to physicians who wrote the prescriptions.  Since TEVA’s actions allegedly caused the submission of false claims to the government via the dispensing pharmacies, those actions constituted violations of the False Claims Act (“FCA”), 31 U.S.C. §§ 3729-3733.

The complaint also alleged violations of the Anti-Kickback Statute (“AKS”), 42 U.S.C. § 1320a -7b, which, among other things, criminalizes “knowingly or willingly” offering or paying a person “remuneration,” in the form of  kickbacks, bribes, or rebates, to “induce” that person to “recommend” the purchase of a drug covered by a “Federal health care program.” 42 U.S.C. § 1320a-7b(b)(2).  Simply stated, the AKS prohibits a pharmaceutical manufacturer from offering, directly or indirectly, any remuneration to induce a physician to prescribe, or a Medicare patient to purchase, that manufacturer’s drugs.

The AKS was amended in 2010 to explicitly state that “a claim that includes items and services resulting from a violation of [the AKS] constitutes a false or fraudulent claim for purposes of [the FCA].”  42 U.S.C. § 1320a-7b(g). Thus, a claim submitted to a government-funded health care program for a prescription drug in violation of the AKS also constitutes a violation of the FCA.  The 2010 amendments also reduced the standard for “intent” under the AKS, such that “a person need not have actual knowledge of [the AKS] or specific intent to commit a violation of [the AKS].”  42 U.S.C. § 1320a-7b(h).

Background

McEldrew Young and SFMS filed the original qui tam complaint on behalf of the relators in May 2013.  The complaint alleged that, beginning in 2003, TEVA provided bogus honoraria or speaking fees to physicians for participation in numerous sham speaker programs in connection with the drugs Azilect and Copaxone.

On November 18, 2014, the United States, along with the various state and municipal governments that were also named as plaintiffs in the complaint, notified the Court of their decision to decline intervention in the case.  On March 12, 2015, the Court issued an Order unsealing the complaint while confirming that the various governments had declined to intervene in the action.

Despite the governments’ decision against intervention, McEldrew Young and SFMS were not deterred in prosecuting the case on behalf of their clients, as well as the federal, state and municipal governments that suffered damages as a result of TEVA’s allegedly illegal practices. “Although we were faced with an adversary of disproportionate size and considerably greater resources, we remained steadfast and aggressively prosecuted the case based on our belief in our clients and the correctness of our position,” said Eric Young, managing partner of McEldrew Young’s whistleblower practice. McEldrew Young and SFMS were assisted during litigation by co-counsel David J. Caputo and Joseph Trautwein of Youman & Caputo, LLC, and Heidi A. Wendel of Heidi Wendel Law.

Summary Judgment Motion

On February 27, 2019, Chief U.S. District Judge Colleen McMahon issued a Memorandum Decision and Order denying TEVA’s motion for summary judgment in its entirety.  In a detailed, seventy-page opinion, Judge McMahon rejected numerous arguments asserted by TEVA and ruled that all allegations of TEVA’s FCA violations would proceed to trial on the merits, which was scheduled to start on August 19, 2019.

In dismissing TEVA’s assertion that the AKS required evidence of a quid pro quo arrangement, the Court found that the relators’ complaint raised a genuine issue of material fact as to whether TEVA had violated the AKS.  The Court also ruled that there was a genuine issue of material fact regarding the efficacy of TEVA’s compliance program.  Although TEVA’s written compliance polices had “all of the right language,” the Court noted that the existence of those policies had no bearing on whether TEVA actually adhered to them.

Settlement of Complaint Allegations

“This settlement helps ensure that when a physician chooses a prescription drug for his or her patient, that choice will be motivated solely by the best interests of the patient and not tainted by any improper financial considerations,” said Eric Young.  Mr. Young added, “We were inspired by the level of our clients’ commitment to hold TEVA accountable for its alleged misconduct.  Today’s result is also a victory for American taxpayers who are the ultimate victims when unscrupulous individuals and companies defraud the government, oftentimes with impunity.”

As the managing partner of McEldrew Young’s whistleblower practice, Eric Young has a distinguished track record of success.  Mr. Young has recovered more than $2 billion dollars for the government on behalf of his whistleblower clients. McEldrew Young represents whistleblowers from across the country and abroad.  Many whistleblower cases are brought under the False Claims Act, which allows a private individual, known as a relator, to file a lawsuit on behalf of the United States government against an individual or company that has perpetrated a fraud against the government.  If a relator successfully recovers funds on behalf of the government, he or she may receive a reward of up to twenty-five percent (25%) of the civil monetary recovery if the government intervenes, and up to thirty percent (30%) if the government declines to intervene, such as in this case.

Case citation: United States ex rel. Arnstein and Senousy v. Teva Pharmaceuticals USA, Inc., No. 1:13-cv-03702-CM-OTW (S.D.N.Y.)

United States Joins Whistleblower Lawsuit Against Novartis Pharmaceuticals

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Philadelphia, Pa, April 26, 2013 PRWeb, Young Law Group (www.young-lawgroup.com; e-mail: eyoung@young-lawgroup.com)

The United States Department of Justice has announced that it is intervening in a qui tam whistleblower suit under the False Claims Act accusing Novartis Pharmaceuticals Corporation of fraudulently billing Medicare, Medicaid, TRICARE, and other federal and state-funded healthcare programs by Novartis’ Cardiovascular Diseases Division through a wide array of kickback schemes involving drugs including Lotrel, Valturna, and Starlix.

U.S. Attorney Preet Bharara announced the intervention in court documents that were unsealed in the United States District Court for the Southern District of New York on April 26, 2013.

“Novartis’ pervasive business practices to fraudulently market numerous drugs including Lotrel, Valturna, Starlix, Tekturna, Diovan, and Exforge, cost taxpayers hundreds of millions of dollars” said Eric L. Young, Esquire, Young Law Group, who, with James E. Miller, Esquire, of Shepherd, Finkelman, Miller, and Shah, LLP, and John Minnino, Esquire, of Minnino Law Offices, is representing the whistleblower, former Novartis sales representative, Oswald Bilotta.

“Novartis’ payment of kickbacks to increase market share is yet another example of abuse in the pharmaceutical industry that contributes to skyrocketing medical costs,” said James E. Miller, Esquire, of Shepherd, Finkelman, Miller, and Shah, LLP.

The whistleblower complaint alleges that Novartis committed massive taxpayer fraud by marketing drugs Lotrel, Valturna, Starlix, Tekturna, Diovan and Exforge through a widespread “pay to play” scheme whereby the company paid off doctors who prescribed its drugs.  As detailed in the government’s intervention Complaint, Novartis’ Cardiovascular Division engaged in a number of schemes whereby the company paid kickbacks to doctors to ensure increased prescriptions at the federal government’s expense.

None of this is new for Novartis. In September 2010, the company announced that it would pay approximately $422 million in criminal and civil fines and penalties to resolve claims that it had paid kickbacks to prescribers of Trileptal, Diovan, Zelnorm, Sandostatin, Tekturna, and Exforge, in addition to claims that the company had promoted some of these drugs for unapproved uses. Nonetheless, Novartis continued paying kickbacks and promoting drugs for unapproved uses, the complaint alleges.

After retaining SFMS, Minnino, and YLG, the whistleblower filed a qui tam lawsuit in federal district court in Manhattan on January 5, 2011. The qui tam case was kept under seal, meaning that it was not known to the public, while the government investigated the allegations.  “Thanks to courageous people like Mr. Bilotta, perpetrators of fraud are being held to account for fraudulent sales and promotional activities that artificially increases the burden on taxpayers . . . we are confident based upon the evidence presented by Mr. Bilotta and the results of the ensuing government investigation that Novartis will be held to account for its wrongs”, said Mr. Young, a veteran qui tam litigator.

Case citation: U.S. ex rel. Oswald Bilotta v. Novartis Pharmaceuticals, Corp., S.D.N.Y. 11-CV-00071-PGG.

Young Law Group, specializes in representing whistleblowers (“relators”) throughout the United States and internationally in qui tam lawsuits brought under the False Claims Act. The False Claims Act allows private individuals to sue companies that are defrauding the federal government and to recover funds on the government’s behalf. Whistleblowers may be entitled to 15 percent to 30 percent of the civil recoveries that result from the qui tam lawsuit.

SFMS represents clients, including business entities, consumers, individual and institutional investors, fiduciaries, state and other governmental entities, and whistleblowers, in complex litigation and other matters with offices in California, Connecticut, Florida, New Jersey, New York, Pennsylvania and Wisconsin.

John Mininno, Esq. has offices in Collingswood, N.J. with practice areas including False Claims Act litigation.

Contact: Young Law Group
123 South Broad Street
Philadelphia, Pennsylvania, 19109
Phone 215-367-5151
www.young-lawgroup.com
Eric Young, Young Law Group, 215-367-5151, eyoung@young-lawgroup.com
 
 

WHISTLEBLOWER SUES FOR ALLEGED FRAUD AGAINST POSTAL SERVICE

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Recently revealed court documents allege that Virginia-based Northrop Grumman (“Northrop”) defrauded the United States Postal Service (“USPS”) out of millions of dollars.  The allegations could spell trouble for Northrop, a defense and aerospace powerhouse, which regularly contracts with the United States government.

The Complaint, filed under the False Claims Act, alleges that Northrop and sub-contractor Motor Drives & Controls, Inc. profited illegally pursuant to a 2007 contract with the USPS to deliver one-hundred Flats Sequencing System machines (“FSS”).  The FSS machines were designed to sort mail to reflect delivery sequences, a process that is currently performed by manual labor.  The USPS hoped to save approximately $600 million a year, by using the machines.

The whistleblower behind the claim is Maryland resident and former Northrop employee Beau Michaud.  Mr. Michaud worked on the FSS project from January 2007 to February 2011 and claims his internal complaints were met with resistance.  According to Mr. Michaud the contract mandated that Northrop issue efficiency reports certifying compliance with performance standards as a prerequisite to installment payments from the USPS.  Mr. Michaud alleges that Northrop made material misrepresentations to USPS regarding the FSS machine’s efficiency, reliability and speed.  Moreover, the Complaint contends that the company deliberately concealed documents to hide the fact that the FSS machines were not meeting the standards of the contract.  Of course if these allegations are true, these actions constituted false claims for payment against the government.

The lawsuit is seeking over $179 Million in damages.  For its part, Northrop vigorously denies all liability.

Young Law Group is a nationwide leader in whistleblower representation and has successfully represented numerous clients in some of the nation’s largest qui tam cases for over a decade.  For a free confidential consultation, please call Eric L. Young, Esquire at (800) 590-4116 or complete the online form here.

CAREMARK LLC SETTLES FALSE CLAIMS ACT CASE FOR $4.25 MILLION

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Yesterday the U.S. Department of Justice (“DOJ”) announced an agreement with Caremark, LLC to settle allegations filed that it defrauded the federal government and five states.  Caremark, LLC is a pharmacy benefit management company (“PBM”), operated by CVS Caremark, Corp. a company which is no stranger to the False Claims Act.  PBMs are third-party administrators, whose primary role is the payment and process of prescription drug claims on behalf of healthcare plans.

The allegations surfaced in a lawsuit filed by former Caremark employee, Janaki Ramadoss, pursuant to the qui tam provisions of the False Claims Act.  The details of the case allege that Caremark knowingly disregarded its obligations to reimburse Medicaid for the costs of prescription drugs received by Medicaid beneficiaries, which should have been covered under the beneficiaries’ private healthcare plans administered by Caremark.  Medicaid, commonly referred to as the payer of last resort, is not responsible for health care and prescription costs which are simultaneously covered by a private health care plan.  Individuals with overlapping coverage from Medicaid and a private plan are classified as “dual eligible.”  In addition to paying for the care and prescriptions of a “dual eligible” beneficiary, private insurers are required to reimburse claims erroneously paid by Medicare.  Assistant Attorney General for the Justice Department’s Civil Division, Stuart F. Delery, noted that, “it is vitally important that cash-strapped Medicaid programs receive reimbursement for costs they incur that should have been paid for by other insurers.”  By failing to do so, Caremark caused false claims for payment to be submitted to Medicaid.

In addition to the federal government, Arkansas, California, Delaware, Louisiana, and Massachusetts joined the case and will receive proceeds from the settlement.  The federal government will receive approximately $2.3 million, while the five states share $1.94 million.

The case is captioned United States ex rel. Ramadoss v. CVS Caremark Inc., SA-12-CA-929WRF (W.D. Texas).

Young Law Group is a nationwide leader in whistleblower representation and has successfully represented numerous clients in some of the nation’s largest qui tam cases for over a decade.  For a free confidential consultation, please call Eric L. Young, Esquire at (800) 590-4116 or complete the online form.

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