Friday, January 30, 2015

TSA Defrauds All Travelers

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The United States Supreme Court has spoken.  Former TSA employee Robert J. MacLean was illegally fired from federal service.  MacLean blew the whistle in 2003 on a bad management decision to cancel air marshal flights post 9/11, leaving the flying public at risk of terrorist attacks.  The decision affirmed federal employees are protected from whistleblower retaliation.
 
This case sends a clear and resounding message.  Federal employees must obey the oath they swear to for federal service.  They shall report fraud, waste, abuse, mismanagement and dangers to public health and safety.  And the federal government, the largest employer in the world shall not fire whistleblowers for doing their job, nor parse legislative statutory wording to cover-up management wrongdoing.
 
 
At last a lesson in ethical conduct in the workplace from the highest court of the land.  A lesson every employer and employee must remember.
 
For employers-Don’t fire an employee for reporting wrongdoing.
 
For employees-When facing a Goliath that attempts to gut laws that protect employees, don’t give up because sometimes good people win.

Monday, January 26, 2015

$30 Miillion in Medicare Fraud Commited by Nation's Best Care in Miami

 

 

The owner and operator of a Miami home health care agency was sentenced today to 106 months in prison for his participation in a $30 million Medicare fraud scheme.

Assistant Attorney General Leslie R. Caldwell of the Justice Department’s Criminal Division, U.S. Attorney Wifredo A. Ferrer of the Southern District of Florida, Special Agent in Charge George L. Piro of the FBI’s Miami Field Office and Special Agent in Charge Derrick Jackson of the U.S. Department of Health and Human Services-Office of Inspector General’s (HHS-OIG) Miami Regional Office made the announcement.

Ramon Regueira, 66, of Miami, pleaded guilty to one count of conspiracy to commit health care fraud on Nov. 13, 2014.  In addition to the prison sentence, U.S. District Judge Cecilia M. Altonaga of the Southern District of Florida ordered Regueira to pay $21 million in restitution, both jointly and severally with his co-conspirator. 

According to his plea agreement, Regueira was an owner of Nation’s Best Care Home Health Corp. (Nation’s Best), a Miami home health care agency that purported to provide home health and therapy services to Medicare beneficiaries.  Regueira admitted that he and his co-conspirators operated Nation’s Best for the purpose of billing the Medicare program for, among other things, expensive physical therapy and home health care services that were not medically necessary or not provided.

Specifically, Regueira admitted that he and his co-conspirators paid kickbacks and bribes to patient recruiters who provided patients to Nation’s Best, as well as prescriptions, plans of care (POCs) and certifications for medically unnecessary therapy and home health services.  Regueira and his co-conspirators then used these prescriptions, POCs and medical certifications to fraudulently bill the Medicare program for unnecessary home health care services.

From January 2007 through January 2011, Nation’s Best submitted approximately $30 million in claims for home health services that were not medically necessary or not provided, and Medicare paid approximately $21 million for these fraudulent claims. 

Since its inception in March 2007, the Medicare Fraud Strike Force, now operating in nine cities across the country, has charged nearly 2,100 defendants who have collectively billed the Medicare program for more than $6.5 billion.  In addition, the HHS Centers for Medicare & Medicaid Services, working in conjunction with the HHS-OIG, are taking steps to increase accountability and decrease the presence of fraudulent providers.   

Sunday, January 25, 2015

Botox and Children Not A Good Combination. Allergan to Pay More Than $600 Million

A federal court jury in Vermont returned a $6.5 million in favor of the parents of a 6-year-old boy with cerebral palsy who suffered seizures after receiving off-label Botox treatment for his mild muscle spasticity. The jury determined that the defendant, Allergan Inc., negligently promoted the off-label use of Botox to treat muscle spasticity in children at unsafe high doses and failed to sufficiently provide the little boy’s parents and his health care providers with information about the drug’s known risks and dangers, such as seizures, side effects and harmful immune responses.

The jury did find, however, that Allergan had not violated the Vermont Consumer Fraud Act by deceptively promoting Botox for its off-label use in children with muscle spasticity. The jury awarded the Drakes $2.5 million in compensatory damages and $4 million in punitive damages. The trial strategy for the plaintiffs was to put the CEO of Allergan and the company’s ethics on trial in this case.

The parents filed suit in 2013 against the pharmaceutical company after their son, who had mild spasticity in his legs, began having seizure-like episodes requiring hospitalization after a Vermont doctor injected him with Botox. The Drakes said: Prior to his Botox injections, J.D. could walk, feed himself, brush his teeth and speak. He had no history of seizures.

Dr. Scott Benjamin injected almost 7 u/kg of Botox into the boy’s calves in April 2010. Two days after the injections, the child’s complained of pain and his walking became more and more unstable. The doctor injected him again in May with almost twice as much Botox. The next day, the boy began vomiting and had trouble breathing and speaking, in addition to having seizure-like symptoms. He was rushed to the emergency room and diagnosed with an allergic reaction to Botox.

Since then, the boy has continued to have seizures and has developed a chronic, life-threatening immune response. The maximum safe dose for Botox, which has never been approved by the U.S. Food and Drug Administration to treat pediatric spasticity, is 8 u/kg. The denied to approve the drug for that indication because Allergan couldn’t show it was effective at safe doses.

Allergan has continued to promote the off-label use of Botox to treat children. The majority of Botox sales are for off-label indications. It was alleged in the complaint:

The made clear to Allergan in 2009 that it was free to warn physicians about the maximum safe dose for children, but to date Allergan has failed to make that information public. Instead of warning, Allergan continues to sponsor ‘medical education’ activities and dosing schedules that encourage physicians to use unsafe doses higher than 8 u/kg.

Allergan pled guilty to off-label promotion of, among other indications, pediatric spasticity, and agreed to pay $600 million in civil and criminal penalties to the United States government in 2010. Allergan never disclosed information about side effects or seizures in warnings, promotional or marketing materials. Instead, it had a corporate plan to illegally promote the off-label use of Botox by physicians. In addition to promoting Botox at doctors’ conferences, Allergan established and funded two organizations for the express purpose of promoting off-label use of Botox. Allergan has publicly stated that Botox is a miracle drug and has often compared it to penicillin. Side effects are rarely mentioned and consistently understated.

Wednesday, January 21, 2015

Honda Motor Co Fined $70 Million for Under Reporting Injuries



 American Honda Motor Co. Inc. has agreed to pay $70 million in fines to resolve allegations made by US federal regulators that during a near 10-year period, from 2003 to 2014, the auto maker failed to report 1729 deaths and injuries related to possible safety defects in its vehicles. According to the National Highway Traffic Safety Administration (NHTSA), Honda will pay two $35 million civil penalties, effectively resolving its alleged lapses in early-warning reporting.

The early-warning reporting requirements are part of the Transportation Recall Enhancement, Accountability and Documentation (TREAD) Act, which requires car manufacturers to submit reports to the NHTSA every quarter to alert the agency of deaths or injuries arising from possible safety defects. The NHTSA states that Honda failed to provide early-warning reports to the agency to alert it about safety-related issues. The fines also address Honda's alleged failure to report some warranty claims and customer satisfaction-related claims during that time, according to the agency.

Honda faced a barrage of class actions related to defective Takata air bags late in 2014, after which the NHTSA issued a special order directing Honda to explain its failure to fully report deaths and injuries related to possible auto safety defects, as required under the TREAD act.

According to the early-warning reports filed with the NHTSA, the 1,729 unreported injuries and deaths that Honda allegedly failed to report constituted more than double the number of incidents the automaker reported to the NHTSA during the past 11 years.

According to Honda, the under-reporting of those death and injury notices was due to “errors related to data entry, computer coding, regulatory interpretation, and other errors in warranty and property damage claims reporting.” Therefore, under the terms of the settlement, Honda has also agreed to conduct third-party audits of its reporting, train its staff in fulfilling TREAD Act requirements and devise compliance procedures, the NHTSA said.

Monday, January 19, 2015

Syngenta To Be Penalized Again?

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The Judicial Panel on Multidistrict has agreed to consolidate in Kansas multiple class actions and lawsuits filed by corn farmers, grain exporters and others who accuse Syngenta Corp. of “tainting” the U.S. corn supply with genetically modified seed before China gave import approval. The JPML centralized about 177 suits over Syngenta’s decision to commercialize corn seeds with a genetically modified trait, known as “MIR162,” that gives the plants increased resistance to certain insects. The U.S. Department of Agriculture authorized the introduction of the trait in April 2010, by which time the U.S. Environmental Protection Agency (EPA) and the U.S. Food & Drug Administration (FDA) had already approved the trait, though the Chinese government has not yet approved it.

The panel said it chose the “readily accessible” district of Kansas largely because it could then be assigned to U.S. District Judge John W. Lungstrum, whom it said was “well-versed in the nuances of complex, multidistrict litigation.”

Syngenta commercialized the trait for the 2011 growing season under the brand name “Viptera.” Syngenta misled farmers into believing that approval from China was imminent, but the trait remains unapproved. Syngenta’s early release of Viptera corn cost the U.S. corn market somewhere between $1 billion and $3 billion due to the rejection and resulting seizures of U.S. containers and cargo ships transporting U.S. corn to China

Syngenta offered farmers a “side-by-side program,” which encouraged them to plant Viptera corn adjacent to other corn seed. But in so doing, the farmers risked co-mingling the GMO corn with the non-GMO corn, thereby making it likely that Chinese regulatory officials would reject U.S. shipments of corn. The U.S. Department of Agriculture determined that China purchased approximately 5 million tons of U.S. corn in 2012/13, making China the third-largest export market for U.S. corn. Since November 2013, however, Chinese imports for U.S. corn have decreased by an estimated 85 percent.

Tuesday, January 13, 2015

$97 Million In Medicare Fraud Again This Time In Houston TX

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The two physician owners of a Houston-area mental health clinic were sentenced to 148 months and 120 months respectively for their roles in a $97 million Medicare fraud scheme. A group home owner who sent residents to the clinic in exchange for kickbacks was also sentenced to 54 months in prison for her role.

Physicians Mansour Sanjar, 81, and Cyrus Sajadi, 67, the owners of Spectrum Care P.A., a community mental health clinic, were each convicted following a jury trial on March 12, 2014, of conspiracy to commit health care fraud and conspiracy to pay and receive kickbacks, as well as related counts of health care fraud and paying illegal kickbacks.  Chandra Nunn, 36, a group home owner, was convicted of conspiracy to commit health care fraud and conspiracy to pay and receive kickbacks, as well as related counts of receiving illegal kickbacks.  In addition to the prison sentences, U.S. District Judge Vanessa D. Gilmore of the Southern District of Texas ordered Sanjar and Sajadi to pay $8,058,612.39 in restitution, and Nunn to pay $1,885,667.41 in restitution.  Co-defendants Adam Main, Shokoufeh Hakimi, Sharonda Holmes and Shawn Manney were also convicted and are scheduled to be sentenced on Jan. 20, 2015.

According to evidence presented at trial, Sanjar and Sajadi invented scheme to defraud Medicare beginning in 2006 and continuing until their arrest in December 2011.  Sanjar and Sajadi owned Spectrum, which purportedly provided partial hospitalization program (PHP) services.  A PHP is a form of intensive outpatient treatment for severe mental illness.  The Medicare beneficiaries for whom Spectrum billed Medicare for PHP services did not qualify for or need PHP services.

Evidence showed that Sanjar and Sajadi signed admission documents and progress notes certifying that patients qualified for PHP services, when in fact, the patients did not qualify for or need PHP services.  Sanjar and Sajadi also billed Medicare for PHP services when the beneficiaries were actually watching movies, coloring and playing games, which are not activities covered by Medicare.

Other evidence also showed that Sanjar and Sajadi paid kickbacks to group care home operators and patient recruiters, including Nunn, Holmes and Manney, in exchange for delivering ineligible Medicare beneficiaries to Spectrum.  In some cases, the patients received a portion of those kickbacks.

 

Wednesday, January 7, 2015

Antibiotics That Are Causing Peripheral Neuropathy!

Quinolones are a key element of physicians’ antibiotic arsenal, but a growing number of lawsuits allege that drug makers downplayed a serious risk associated with these drugs: nerve damage known as peripheral neuropathy.

It was hoped that quinolone antibiotics’ artificial nature would help them avoid some of the problems seen in other antibiotics like antibiotic resistance. While quinolone antibiotics have not proven full proof against antibiotic resistance, they have proven to be a particularly effective group of drugs and have joined the ranks of important antibiotics. This includes drugs like Avelox, Cipro, and Levaquin. However, concerns have arisen that some patients may experience a particularly serious side effect from quinolone antibiotics: peripheral neuropathy.

Peripheral neuropathy is Latin for “damage to the outer nerves,” referring to the main process of the disease. In Peripheral neuropathy, nerves of extremities like hands and feet start to malfunction, and sometimes die, causing peripheral neuropathy symptoms.

Peripheral neuropathy symptoms include pain and numbness in the extremities. Often, one of the first peripheral neuropathy symptoms is a tingling in the effected area, similar to the feeling of a limb “falling asleep.”

Many patients taking quinolone antibiotics who went on to suffer from peripheral neuropathy suffer from cases classified as severe. And many cases of peripheral neuropathy may be permanent, since nerves do not regenerate as readily as some other tissues within the body.

New quinolone antibiotic lawsuits have begun to allege that drug companies bear a responsibility for peripheral neuropathy. These lawsuits allege that drug makers have been aware of this risk—or reasonably should have been aware due to their legal obligations to monitor reports of new post-market complications.

Allegedly, research dating back to 1992 has demonstrated a link between quinolone antibiotics and peripheral neuropathy. Research studies have continued to mount suggesting that peripheral neuropathy can be a side effect of quinolone antibiotics, to the point that in 2013, the FDA mandated changes to the labeling of Avelox, Cipro, Levaquin, and several other common fluoroquinolones advising patients of this possible risk.

Additionally, peripheral neuropathy lawsuits may allege that drug makers were not only aware of these risks, but that deliberately downplayed these risks, continuing to aggressively market their drugs in spite of the alleged anger of peripheral neuropathy. Peripheral neuropathy lawsuits generally seek to recoup the cost of medical care, lost wages due to hospital time or disability, legal fees, and other cost allegedly caused by quinolone antibiotics.

Saturday, January 3, 2015

Fiskars Agrees to $2.6 million Civil Penalty!



The Department of Justice has announced that Gerber Legendary Blades, a division of Fiskars Brands Inc., of Madison, Wisconsin, has agreed to pay a civil penalty of $2.6 million to settle allegations that it knowingly failed to immediately report to the U.S. Consumer Product Safety Commission (CPSC) a safety hazard associated with Fiskars’ Gator Combo Axe.  Fiskars 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.
“Fiskars received numerous reports from consumers who were harmed by this product,” said Acting Assistant Attorney General Joyce R. Branda for the Justice Department’s Civil Division.  “The company had an obligation to immediately report to the CPSC and it failed to do so.  We will take action against those who fail to abide by the law so that our partners at the CPSC can protect consumers from injuries.”
The Axe was a combination product that had a knife embedded in its handle that was supposed to be secured by two small magnets.  In a complaint filed on behalf of the CPSC in U.S. District Court for the District of Oregon, the United States alleged that Fiskars became aware that the knife in the Axe handle could and did dislodge from the Axe’s handle when the Axe was in use, causing serious injuries to consumers.  Fiskars imported approximately 103,000 Axes from Taiwan through its Gerber Legendary Blades division in Portland, and distributed those Axes to retail sporting good chains and stores throughout the United States.
“CPSC’s job is to protect consumers,” said Chairman Elliot F. Kaye. “The sooner a firm informs CPSC about incidents or injuries with defective products, the quicker we can act to protect the American public. Failure to report in a timely basis is not only illegal, it can endanger consumer safety. We will not tolerate such irresponsible and dangerous behavior.”
Under the Consumer Product Safety Act (CPSA), manufacturers, distributors and retailers are required to report product hazards to the CPSC.  A knowing violation of the CPSA subjects a firm to civil penalties.  The United States alleged that beginning as early as 2005 and continuing over the next several years, Fiskars received consumer complaints and warranty claims indicating that the knife fell out of the Axe handle while the Axe was being used to chop, pound or hammer.  In several instances, the knife dislodged from the handle during use and caused injuries including lacerations requiring stitches, permanent nerve damage and surgery to repair severed tendons.
“In this case, Fiskar’s failure to report to the CPSC not only put consumers at risk, it contributed to people being injured as a result of the unsafe product design,” said U.S. Attorney S. Amanda Marshall for the District of Oregon.  “The settlement not only addresses the product safety issue, but also holds the company accountable and sends a message to others that these violations will be taken seriously.”
In March 2011, Gerber and the CPSC announced a voluntary recall of the Axe.  At that time, consumers were advised to remove the knife from the axe handle and contact Gerber to receive a free handle cap for holding the knife in the axe handle during transport and storage, instructions and a warning label.  Information on the recall can be found on the CSPC website.
The matter is being handled by Trial Attorney Roger Gural of the Civil Division’s Consumer Protection Branch, Assistant U.S. Attorney Neil J. Evans for the District of Oregon and Harriet Kerwin of the CPSC Office of the General Counsel.
In agreeing to settle this matter, Fiskars has not admitted that it knowingly violated the CPSA.

Is This The American Way? Fraud-Fraud-and More Fraud!

 
What does Fraud look like? Inside gated communities where guards demand photo ID even from Santa, CEOs’ Christmas plums are super-sugared with record-breaking corporate profits.

These are people somehow not derided as moochers, even though their million-dollar pay packages are propped up by tax breaks.
The parable of Charles Dickens’ A Christmas Carol springs to mind as Wall Street banks and law firms hand out six- and seven-figure year-end bonuses while Wal-Mart and fast food workers protest wages so low that their holiday meals are food pantry dregs. It is CEOs, not the working poor, who deserve public scorn for their dependence on government handouts.

The Institute for Policy Studies issued a report last month that details the mooching of the nation’s top corporations and CEOs. It’s called “Fleecing Uncle Sam.” The findings are pretty galling.
Of America’s 100 top-paid CEOs, 29 worked schemes that enabled them to collect more in compensation than their corporations paid in income taxes. The average pay for these 29: $32 million. For one year. And corporations mangle tax the code to deduct that too.
Though their corporations reported combined pre-tax profits of $24 billion, they wrangled $238 million in tax refunds out of the federal government. That’s refunds — the government gave money to highly profitable corporations.

That’s an effective tax rate of negative one percent.
That means middle-class taxpayers helped cover the cost of million-dollar pay packages for CEOs. Middle class taxpayers, whose median family income is $51,324 and whose federal income taxes are withdrawn directly from their checks before they see a cent of pay, support CEOs who pull down $32 million a year.

Their corporations pay nothing for essential government services that middle class taxpayers provide. That includes patent protection, the Commerce Department’s sanctions against foreign trade rule violations and federal court dispute resolution.
Some corporations haven’t developed schemes enabling them to tax the federal government. Instead, they pay, but not at that 35 percent rate they’re always whining about. Between 2008 and 2012, the average large corporation, according to Fleecing Uncle Sam, paid just 19.4 percent. Individuals earning $50,000 a year pay 25 percent. Clearly, corporations are not paying a fair share at 19 percent.

There’s this wacky theory that if governments excuse corporations from paying their share, then they’ll expand and create jobs. It’s wacky because it’s fiction. Highly profitable corporations aren’t expanding and creating jobs; they’re buying back their own stock.

A study by University of Massachusetts professor William Lazonick, president of the Academic-Industry Research Network, showed that between 2003 and 2012, S&P 500 corporations used 54 percent of their earnings – $2.4 trillion – to buy their own stock.

And this is the AMERICAN Way??