Garden State Cardiovascular To Pay $3.6 Million For Settlement In False Claims Act!

Garden State Cardiovascular Specialists P.C. (Garden State), a cardiology practice which owns and operates several facilities in New Jersey under the name NJ MedCare/NJ Heart, has agreed to pay more than $3.6 million to resolve allegations that its facilities falsely billed federal health care programs for tests that were not medically necessary, announced today by U.S. Attorney Paul J. Fishman for the District of New Jersey.

The settlement announced today resolves allegations that Garden State and its principals, Jasjit Walia M.D. and Preet Randhawa M.D., submitted claims to Medicare for various cardiology diagnostic tests and procedures, including stress tests, cardiac catheterizations and external counterpulsation, which were not medically necessary.

The allegations resolved by today’s settlement were raised in a lawsuit filed under the qui tam, or whistleblower provisions of the False Claims Act.  The act allows private citizens with knowledge of fraud to bring civil actions on behalf of the government and to share in any recovery.  The whistleblower, Cheryl Mazurek, will receive more than $648,000 as part of today’s settlement.

The settlement is the culmination of an investigation conducted by special agents of the U.S. Department of Health and Human Services Office of Inspector General, under the direction of Special Agent in Charge Scott J. Lampert.                           

Actos Causing Heart Attacks and Bladder Cancer!

The Actos class action lawsuit investigation does not dispute the claims by Takeda Pharmaceuticals that Actos can help treat type-2 diabetes. Actos lawyers and Actos bladder cancer attorneys are investigating claims that long-term treatment with Actos may cause cancerous tumors in the bladder as a side effect of using Actos.

A 10-year study showed that diabetics who took Actos (pioglitazone) for more than a year had not just a slightly elevated risk of cancerous bladder tumors, but, increased their risk of bladder cancer by 40%. Recently a lawsuit was filed by an Actos user who only used the type 2 diabetes treatment for four months before developing bladder tumors and being diagnosed with bladder cancer.

Actos Heart Attacks, Heart Failure

Clinical trials and studies show a link between Actos and congestive heart failure. This risk of Actos heart failure is so significant that the medication now carries a black-box warning, as mandated by the FDA in 2007. The warning states that Actos may cause or exacerbate congestive heart failure in some patients. Patients taking Actos should be monitored “carefully” for signs and symptoms of heart failure, including excessive, rapid weight gain, dyspnea, and/or edema.
One Actos heart failure study published in August 2010 in the American Heart Association journal found that patients taking Actos and Avandia were 4% more likely to experience heart attacks, heart failure, and die. Both medications belong to a class of drugs known as thiazolidinediones, which are designed to lower blood sugar levels by making tissues more sensitive to insulin. Thiazolidinediones have also been known to cause heart problems.
After the study concluded, researchers found that 602 patients who took Avandia and 599 patients who took Actos suffered either a heart attack, heart failure, or both, or died. There were 217 deaths in each group.

ConAgra Grocery To Settle Salmonella Contamination in Peanut Butter Suit

ConAgra Grocery Products LLC, a subsidiary of ConAgra Foods Inc., today agreed to plead guilty and pay $11.2 million in connection with the shipment of contaminated peanut butter linked to a 2006 through 2007 nationwide outbreak of salmonellosis, or salmonella poisoning, the Department of Justice announced today.  ConAgra Grocery Products LLC is based in Omaha, Nebraska, with a manufacturing facility in Sylvester, Georgia.

Acting Associate Attorney General Stuart F. Delery, Principal Deputy Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division and U.S. Attorney Michael J. Moore of the Middle District of Georgia announced the filing of a criminal information against ConAgra Grocery Products alleging a misdemeanor violation of the federal Food, Drug and Cosmetic Act.  The company signed a plea agreement admitting that it introduced Peter Pan and private label peanut butter contaminated with salmonella into interstate commerce during the 2006 through 2007 outbreak.  The plea agreement provides that ConAgra Grocery Products will pay a criminal fine of $8 million and forfeit assets of $3.2 million.  The criminal fine is the largest ever paid in a food safety case.
“As parents, we can make sure that our kids look both ways before they cross the street and wear a helmet when they ride their bikes,” said Acting Associate Attorney General Delery.  “But we have to rely on the companies that make their food to make sure it is safe.  That’s why the Department of Justice is dedicated to using all the tools we have to ensure the processors and handlers of our food live up to their legal obligations to keep the public’s safety in mind.”
“The safety of the nation’s food supply is a top concern, and every company, large and small, must take appropriate measures to ensure that their products don’t make customers sick,” said Principal Deputy Assistant Attorney General Mizer.  “No company can let down its guard when it comes to these kinds of microbiological contaminants.  Salmonellosis is a serious condition, and a food like peanut butter can deliver it straight to children and other vulnerable populations.”
In February 2007, the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) announced that an ongoing outbreak of salmonellosis cases in the United States could be traced to Peter Pan and private label peanut butter produced and shipped from the company’s Sylvester peanut butter plant.  The company voluntarily terminated production at the plant on Feb. 14, 2007, and recalled all peanut butter manufactured there since January 2004.  The CDC eventually identified more than 700 cases of salmonellosis linked to the outbreak with illness onset dates beginning in August 2006.  The CDC estimated that thousands of additional related cases went unreported.  The CDC did not identify any deaths related to the outbreak.
The criminal information, filed in the Middle District of Georgia, specifically alleges that on or about Dec. 7, 2006, the company shipped from Georgia to Texas peanut butter that was adulterated, in that it contained salmonella and had been prepared under conditions whereby it may have become contaminated with salmonella.  The company admitted in the plea agreement that samples obtained after the recall showed that peanut butter made at the Sylvester plant on nine different dates between Aug. 4, 2006, and Jan. 29, 2007, was contaminated with salmonella.  Environmental testing conducted after the recall identified the same strain of salmonella in at least nine locations throughout the Sylvester plant.
“We, as consumers, take for granted that the food we feed our families is safe,” said U.S. Attorney Moore.  “We count on the companies who prepare and package the things we eat to be just as concerned with the product we put in our mouths as they are with the profit they put in their pockets.  The proposed criminal fine and sentence in this case should sound the alarm to food companies across the country – we are watching, and we are expecting you to hold yourselves to a standard reflective of the trust that your consumers have placed in you.  No more excuses.  A lot of people got very sick because of the conduct in this case and we are committed to doing all we can to make sure that does not happen again.”
As part of the plea agreement, the company admitted that it had previously been aware of some risk of salmonella contamination in peanut butter.  On two dates in October 2004, routine testing at the Sylvester plant revealed what later was confirmed to be salmonella in samples of finished peanut butter.  Company employees attempting to locate the cause of the contamination identified several potential contributing factors, including an old peanut roaster that was not uniformly heating raw peanuts, a storm-damaged sugar silo, and a leaky roof that allowed moisture into the plant and airflow that could allow potential contaminants to move around the plant.  As stated in the plea agreement, while efforts to address some of these issues had occurred or were underway, the company did not fully correct these conditions until after the 2006 through 2007 outbreak.  In public statements after the 2007 recall, company officials hypothesized that moisture entered the production process and enabled the growth of salmonella present in the raw peanuts or peanut dust.
The company also admitted in the plea agreement that between October 2004 and February 2007, employees charged with analyzing finished product tests at the Sylvester plant failed to detect salmonella in the peanut butter, and that the company was unaware some of the employees did not know how to properly interpret the results of the tests.
“U.S. consumers expect and deserve the highest standards of food safety and integrity,” said Acting Commissioner Dr. Stephen Ostroff of the FDA.  “Today’s plea agreement reflects the FDA’s commitment to ensuring the safety of the nation’s food supply and demonstrates that those who risk the health of Americans will be held accountable.”
Following the outbreak and shutdown, the company made significant upgrades to the Sylvester plant to address conditions the company identified after the 2004 incident as potential factors that could contribute to salmonella contamination.  The company also instituted new and enhanced safety protocols and procedures regarding manufacturing, testing and sanitation, which it affirmed in the plea agreement it would continue to follow.
This information is according to the Dept. of Justice report!

PharMerica Corporation has agreed to pay the United States $31.5 million

PharMerica Corporation has agreed to pay the United States $31.5 million to resolve a lawsuit alleging that they violated the Controlled Substances Act by dispensing Schedule II controlled drugs without a valid prescription and violated the False Claims Act by submitting false claims to Medicare for these improperly dispensed drugs, the Justice Department announced today. 

“Pharmacies put patients at risk when they dispense Schedule II narcotics, which have the highest potential for abuse of any prescription drug, without a valid prescription from a physician,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer of the Department of Justice’s Civil Division.  “Today’s settlement demonstrates our commitment to the fight against the misuse of controlled substances.”

The government’s complaint also alleged that PharMerica violated the False Claims Act by knowingly causing the submission of false claims to Medicare Part D for improperly dispensed Schedule II drugs.  The False Claims Act imposes treble damages and penalties for the knowing submission of false claims for federal funds.  PharMerica has agreed to pay $23.5 million to resolve its alleged False Claims Act violations.

“Today’s significant settlement represents a single but critical significant step toward promoting integrity in the administration of public health programs,” said U.S. Attorney James L. Santelle of the Eastern District of Wisconsin.  “This civil litigation and its meaningful resolution demonstrates that our fight against health care fraud is helping to protect all Americans, including the elderly, people with disabilities and other who may be vulnerable to mistreatment and abuse.”

The False Claims Act claims resolved by today’s settlement were originally brought by Jennifer Denk, a pharmacist formerly employed by PharMerica, under the whistleblower provisions of the act, which authorize private parties to sue on behalf of the United States and to receive a portion of any recovery.  The act permits the United States to intervene and take over the lawsuit, as it did in this case with respect to some of Ms. Denk’s allegations.  Ms. Denk will receive $4.3 million as her share of the settlement.

“DEA registrants are responsible to handle controlled substances in compliance with the Controlled Substances Act,” said Special Agent in Charge Dennis Wichern of the Drug Enforcement Administration (DEA) Chicago Field Division.  “Failure to do so increases the potential for diversion and jeopardizes the public health and safety”.

“The DEA is committed to investigating organizations that are not in compliance with the Controlled Substances Act,” said Special Agent in Charge Michael J. Ferguson of the DEA New England Field Division.  “Our obligation is to ensure public safety and public health and we are committed to working with our law enforcement and regulatory partners nationwide to ensure that these rules and regulations are followed.”

“The legal requirement that narcotics like oxycodone be prescribed by a physician is a crucial patient protection, which is especially important to safeguard the health of the vulnerable elderly and disabled patients in long term care facilities,” said Special Agent in Charge Lamont Pugh of the U.S. Department of Health and Human Services-Office of Inspector General (HHS-OIG).  “Our agency is dedicated to protecting the taxpayer-funded Medicare and Medicaid programs as well as the millions of beneficiaries who rely on those programs for their health and well-being.”

As part of the settlement announced today, the settling defendant has also agreed to enter into a corporate integrity agreement with the HHS-OIG, which obligates PharMerica to undertake substantial internal compliance reforms and to submit federal health care program claims for an independent review for the next five years. 

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 the Attorney General and the Secretary of Health and Human Services.  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 $24 billion through False Claims Act cases, with more than $15.3 billion of that amount recovered in cases involving fraud against federal health care programs.

How Safe Are Your Prescriptions?

Three California men and a Minnesota company were charged in an indictment today in the Southern District of Ohio for their roles in a massive prescription drug diversion scheme. 

The indictment alleges that David Jess Miller, 50, of Santa Ana, California; Artur Stepanyan, 38, and Mihran Stepanyan, 29, both of Encino, California, and Minnesota Independent Cooperative Inc. (MIC) engaged in a conspiracy to sell prescription drugs from illegal, unlicensed sources to wholesalers and pharmacies throughout the United States.  The 12-count indictment charges the defendants with conspiracy to commit mail and wire fraud, multiple counts of mail fraud, and conspiracy to distribute prescription drugs without a license and to make false statements.   
 
Principal Deputy Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division, U.S. Attorney Carter M. Stewart of the Southern District of Ohio, Director George M. Karavetsos of the U.S. Food and Drug Administration (FDA)’s Office of Criminal Investigations and Assistant Inspector in Charge Christopher White of the U.S. Postal Inspection Service (USPIS) announced the charges. 

According to the indictment, from 2007 through April 2014, David Miller and his company, MIC, of Eagan, Minnesota, purchased prescription drugs from a network of illegal and unlicensed sources in New York, Florida and California.  Artur Stepanyan and Mihran Stepanyan, worked together to sell drugs from illegal sources to Miller and MIC.  Artur and Mihran Stepanyan, using a variety of company names, including Panda Capital Group, Red Rock Capital Group, Trans Atlantic Capital Group and GC National Wholesale, were Miller’s largest source of illegal drugs.  During the course of the conspiracy, Miller and MIC paid the Stepanyans approximately $160 million for these prescription drugs. 

“American consumers should be able to rely on the prescription drug supply chain,” said Principal Deputy Assistant Attorney General Mizer.  “Prescription drug diversion schemes like the one charged in this indictment undermine that supply chain and increase the risk that counterfeit, adulterated, misbranded, sub-potent or expired drugs will be sold to patients and consumers.” 

To hide the true, illegal sources of their prescription drugs, David Miller and MIC falsified so-called drug pedigree documents.  Pedigrees are documents required by law that show the source of drugs.  For most of the conspiracy, the fraudulent pedigrees falsely listed B&Y Wholesale, a company located in Puerto Rico and co-owned by co-conspirator Yusef Yassin Gomez (Yassin) as the source of the drugs.  The pedigree documents also falsely stated that Yassin’s company was an authorized distributor of the drugs.  On Feb. 19, 2014, Yassin pleaded guilty in U.S. District Court for the Southern District of Ohio to conspiracy to engage in the wholesale distribution of prescription drugs without a wholesale license.  In connection with his guilty plea, Yassin admitted the he agreed to allow Miller and MIC to use his company’s name on pedigree documents to hide the true drug sources.  In exchange, Miller and MIC paid Yassin a commission on all of the drug sales. 

 “Once a prescription drug is diverted outside of the regulated distribution channels, it becomes difficult, if not impossible, for regulators, law enforcement and end-users to know whether the prescription drug package actually contains the correct drug or the correct dose,” said U.S. Attorney Stewart.  “We will aggressively prosecute individuals and companies that ignore the law and sell illegally diverted prescription drugs to pharmacies, and ultimately, to American consumers.
“We are committed to protecting the integrity of the pharmaceutical supply chain, especially as criminals go to more extreme measures to subvert it,” said FDA’s Office of Criminal Investigations Director Karavetsos. “We will continue to pursue these criminals and work to bring them to justice.”
“The Postal Inspection Service is proud to partner with the FDA Office of Criminal Investigations to bring to bear our mail fraud expertise to help the fight against drug diversion,” said USPIS Assistant Inspector in Charge White.

Throughout the course of the conspiracy charged in the indictment, using these fraudulent pedigree documents, Miller and MIC sold approximately $393 million worth of prescription drugs to wholesalers and retail pharmacies throughout the United States, including to multiple customers in the Southern District of Ohio. 

In addition to Yassin, two of Miller’s other illegal drug suppliers, Peter Kats and Joseph Dallal, previously pleaded guilty to conspiracy to commit mail and wire fraud for their sales of illegally-diverted prescription drugs to Miller and MIC. 

This matter is being investigated by the FDA and USPIS.  Assistant U.S. Attorneys Anne L. Porter and Christy Muncy of the Southern District of Ohio and Trial Attorney John W. Burke of the Civil Division’s Consumer Protection Branch are prosecuting this case.

David Miller, Artur Stepanyan, and Mihran Stepanyan were charged amongst 30 other individuals in the Northern District of California in a separate indictment on charges including federal Racketeer Influenced and Corrupt Organizations (RICO) Act; conspiracy to commit identity theft; conspiracy to commit access device fraud; conspiracy to commit mail, wire, and bank fraud; money laundering conspiracy; and conspiracy to distribute prescription drugs without a wholesale license.

This information is according to the Department Of Justice website.

The charges in the indictment are merely allegations, and do not constitute proof of guilt.  Every defendant is presumed to be innocent unless and until proven guilty.

Davita To Pay $495 Million

DaVita HealthCare Partners said Monday it will pay up to $495 million to settle a whistle-blower lawsuit accusing the Denver company of defrauding the federal Medicare program of millions of dollars.

The company, which said it does not admit any wrongdoing, has now settled its third whistle-blower lawsuit since 2012, with payouts totaling nearly $1 billion.

The civil suit, filed in Atlanta in 2011, revolves around a claim by Dr. Alon J. Vainer and nurse Daniel D. Barbir, who both worked for DaVita. They noticed that DaVita was throwing out good medicine that it then billed Medicare and Medicaid for, according to the lawsuit.

Vainer and Barbir, who could be paid up to $135 million as part of the settlement, said in court filings that they questioned DaVita about the waste and claimed the company submitted fraudulent claims for reimbursement between 2003 and 2010.

Lin Wood, the Atlanta-based attorney for the plaintiffs, and co-counsel Marlan B. Wilbanks did not return requests for comment on Monday.

DaVita Kidney Care CEO Javier Rodriguez said in a statement: "Our 67,000 teammates across 11 countries look forward to putting this behind us. We can now renew our focus on collaborating with regulators to avoid situations like this going forward."

The case began as a sealed lawsuit filed with the federal government in 2007. But, after two years of investigating, the government decided not to join the lawsuit, according to The New York Times.
Vainer and Barbir filed the case again under the False Claims Act in civil court in 2011.

The lawsuit cited DaVita's inefficient use and costly waste of the drugs Zemplar, or vitamin D, and Venofer, an iron supplement. If a patient, for example, needed 25 milligrams of Venofer, the physician would use that much and toss the rest of the 100 mg vial. Medicare would be billed for the 100 mg.

In other instances, if a patient needed 8 mg of Zemplar, DaVita doctors were instructed to a use a 10 mg vial, instead of four 2 mg vials.

According to the lawsuit, the National Centers for Disease Control and Prevention recommended against allowing multiple uses of the same vial in 2001, based on infection outbreaks caused by the re-entry of another drug, Epogen. But a year later, CDC changed its policy and allowed re-entry of single-use vials Epogen, Zemplar and Venofer if procedures were followed.

DaVita did not do this but "should have," according to the lawsuit, "but they (DaVita) intentionally did not do so in order to purposefully create and maximize their waste and receive significantly higher reimbursements and revenue for Venofer and Zemplar usage."

False Claims Act cases have the strongest whistle-blower protection in the U.S., according to the National Whistleblowers Center. Violators face huge penalties of $5,000 to $10,000 for each false claim. The whistle-blower could get between 15 to 30 percent of the settlement funds.

Because of its False Claims status, a DaVita loss during a jury trial could mean it must pay thousands of dollars per claim, which could be millions because it would count every instance a patient was given a dose of the drugs. DaVita announced the settlement in an April 15 Securities and Exchange Commission filing.

As part of the settlement, DaVita will pay the government $450 million, plus reserve an additional $45 million to cover fees. The government would then work with Vainer's and Barbir's lawyers to compensate the former DaVita employees.

"Although we believe strongly in the merits of our case, we decided it was in our stakeholders' best interests to resolve it," DaVita's chief legal officer Kim Rivera said in a statement Monday. "The potential mandatory penalties for being found in the wrong in even a small percentage of instances were simply too large."

Since the case was filed, DaVita has settled on two other lawsuits brought on by whistle-blowers. In 2012, DaVita agreed to pay $55 million to the federal government and others over fraud claims that it medically overused and double-billed the government for Epogen, an anemia drug. The suit was filed by Ivey Woodard, a former employee of Epogen-maker Amgen, in 2002.

In October, the company paid $389 million to settle criminal and civil investigations into whether DaVita offered kickbacks to kidney doctors for patient referrals. David Barbetta, a DaVita senior financial analyst, filed the suit in 2009. The company in January paid an additional $22 million to settle related claims by five states, including Colorado.

Black and Decker to Pay $1.575 Million For Faulty Lawn Mower

The Department of Justice and the Consumer Product Safety Commission (CPSC) jointly announced today that Black & Decker Inc. has agreed to pay a $1.575 million penalty to settle allegations that it knowingly violated the reporting requirements of the Consumer Product Safety Act (CPSA) with respect to cordless electric lawnmowers that started spontaneously and that continued to operate after consumers released the lawnmower handles and removed the safety keys.  Black & Decker has also agreed to establish and maintain a compliance program with internal recordkeeping and monitoring systems to keep track of information about product safety hazards.  The settlement agreement is awaiting judicial approval.

Black & Decker has previously paid four civil penalties relating to Black & Decker’s untimely reporting of defects and risks presented by other Black & Decker products. 

“Not for the first time, Black & Decker held back critical information from the public about the safety of one of its products,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division.  “The Department of Justice will continue to protect the public against companies that put profits over safety.”

“Black & Decker’s persistent inability to follow these vital product safety reporting laws calls into question their commitment to the safety of their customers,” said Chairman Elliot F. Kaye of the CPSC.  “They have a lot of work to do to earn back the public’s trust.  Companies are required to report potential product hazards and risks to CPSC on a timely basis.  That means within 24 hours, not months or years as in Black & Decker’s case.”

The complaint relates to cordless lawnmowers manufactured and sold by Black & Decker from 1995 to 2006.  According to the complaint, in as early as November 1998, Black & Decker started receiving reports that its cordless electric lawnmowers continued to run even after a user released the lawnmower’s handle and removed the safety key, referred to as a continuous-run defect.  A second defect involved lawnmowers that unexpectedly started even though the handle was released and the safety key removed, referred to as a spontaneous ignition defect. 

The United States alleged that between 1998 and 2009, Black & Decker received more than 100 complaints regarding the continuous-run or spontaneous ignition defects.  Dozens of these complaints specifically reported that the lawnmower continued to run or exhibited spontaneous ignition after the lawnmower’s handle was released and the safety key was removed.  The United States further alleged that, after consulting an outside expert, the company knew in 2004 that the lawnmowers could continue to run even if a user released the handle and removed the safety key.  Despite knowledge of all of this information, Black & Decker failed to report to the CPSC until early 2009, even though federal law requires “immediate reporting.”

The complaint further notes that at least two consumers informed Black & Decker that the lawnmower’s blades started unexpectedly while the consumer cleaned them, resulting in injury.  The complaint states that in one case, the lawnmower continued to run, with the handle released and without the safety key, for several hours while the consumer sought treatment in a hospital emergency room for injury to the consumer’s hand, and after fire department personnel arrived and removed the blade.

In addition to the civil penalty, Black & Decker agreed to be bound by a consent decree of permanent injunction that prohibits the company from committing future violations of the CPSA.  The consent decree requires that Black & Decker continue to implement and maintain a robust compliance program that ensures timely, truthful, complete and accurate reporting to the CPSC as required by law.  In addition Black & Decker is subject to liquidated damages for each day the company is not in compliance with the consent decree.