Posts Tagged ‘Department of Justice’

Risperdal drug maker faces $1B in lawsuits, yet mother charged for refusing use on child

Tuesday, August 16th, 2011

NaturalNews – August 16, 2011

by Monica G. Young

Click image to visit CCHRInt's Psychiatric Drug Side Effects Search Engine

What irony. Detroit mother, Maryanne Godboldo, was just charged with child neglect for refusing to obey a Child Protective Services order to give her daughter Risperdal, a powerful psychoactive drug. Meanwhile federal and multiple state prosecutors are suing Johnson & Johnson for deceptively marketing the drug – including mismarketing its use on children – and hiding dangerous adverse effects. J&J now faces a potential $1 billion in damages.

Having earlier observed the drug’s dreadful effects on her child, Maryanne was correctly pursuing holistic treatment for the child instead when the legal battle began. The jury’s ruling, now handed down against the mother, is not only a travesty of justice, but a reflection of psychopharma’s vast propaganda machine. (http://www.naturalnews.com/033295_p…)

Fortunately not everyone is fooled. The US Department of Justice (DOJ) has been investigating J&J for years in regards Risperdal – its sales practices, pay-offs to doctors to promote the drug, and failures to disclose harmful effects. The pharma giant has now tentatively agreed to settle a misdemeanor criminal charge, however the DOJ and US attorney’s office are pursuing additional criminal actions.

The government plans to join civil lawsuits filed by company whistleblowers, aiming to recover millions of dollars paid for prescriptions via government health programs like Medicare and Medicaid.

Already multimillions in fines have been levied against J&J for this powerful antipsychotic which is widely prescribed not only for schizophrenia but mood and anxiety disorders, dementia and other unapproved uses.

In June, a South Carolina judge demanded the company pay $327 million to the state for deceptively marketing Risperdal and concealing its dangers. The judge called J&J’s practices “detestable.” Last October, a Louisiana jury ordered the company to ante up $257.7 million for misleading claims about the drug’s safety.

Recently, Massachusetts Attorney General joined the fight, filing a lawsuit against J&J for illegal marketing and failing to disclose “an increased risk of death” connected with the drug.

In Texas the Attorney General Office has joined forces with whistleblowers, with a jury trial scheduled for this fall. This lawsuit alleges that Janssen, J&J’s pharmaceutical division, intentionally marketed Risperdal for use on children even though it was only approved for adult schizophrenia. The suit also involves a company scheme to boost prescriptions by paying hundreds of thousands of dollars to “experts” to evaluate and recommend the drug state-wide and nationally. Awarded damages are anticipated to be much larger than in South Carolina or Louisiana. Texas has paid more than $500 million for the drug since it was first brought to the market.

Attorneys general in about 40 other states have shown interest in suing the company.

Users speak out – beware of this drug!

(Note from CCHRInt –search Risperdal or antipsychotic drug side effects in CCHR’s Psychiatric Drug Database here http://www.cchrint.org/psychdrugdangers/drug_warnings.php – simply type in Risperdal  in the Red Search box or choose it from the drop down menu)

Risperdal’s documented “side effects” include huge weight gain, diabetes, lethargy, muscular tics, breast development in males, and many more.

Below are just a few sample statements made online by individuals from their experience with this so-called “medication” (the root word of medicate means “to heal”):

“Basically I lost the drive for everything. Total shut down to my outgoing personality. Massive weight gain.”

“Tardive dyskinesia [involuntary movement disorder], diabetes, gained 100 pounds in the first year, was a zombie… I was put on this nightmare drug when I was six. I was forced to take it against my will, and it ruined my life… This is a horrible, HORRIBLE drug, and should be banned.”

“Apathy, not talking, just staring, sleeping constantly, tongue movements, loss of sexual function. This is a very BAD DRUG…a mental straight jacket. DO NOT put children on this drug!!! It’s poison.”

“I gained weight, became very tired, and of course that just led them to put me on antidepressant medications…. I have been on it since fifth grade and hardly knew what was happening to me.”

“My son has gained over 100 pounds… He was an excellent student, received a doctorate and now cannot even remember what he studied. He sleeps all day and cannot work a job. His quality of life is nil. His mouth twitches and he has no control over it… It is like taking a dose of legalized poison every day. This is a LIFE WASTED AND RUINED, a brilliant mind destroyed and tortured. As a mother, it rips out my heart every day.”

Yet per Johnson & Johnson annual reports, global Risperdal sales from 1994-2010 totaled nearly $29 billion.

http://www.naturalnews.com/033336_Risperdal_child_neglect.html

Sources for this article include:

http://www.google.com/hostednews/ap…

http://www.thefix.com/content/jj-su…

http://www.reuters.com/article/2011…

http://www.kxan.com/dpp/news/invest…

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How Seroquel, a Risky Antipsychotic, Became a “General Purpose” Mental Health Drug

Friday, May 27th, 2011

BNET
By Jim Edwards
May 27, 2011

In 2008, the FDA declared that powerful antipsychotics such as AstraZeneca (AZN)’s Seroquel were being over-prescribed and started a monitoring initiative to curb their use. It hasn’t worked, judging by an analysis of the FDA’s adverse event database by the Institute for Safe Medication Practices.

Seroquel is only approved for schizophrenia, mania and bipolar disorders. It’s a powerful drug that has serious side effects if taken for a long time: It’s associated with weight gain and diabetes, among other problems.

Yet the ISMP found that 47 percent of all adverse events linked to Seroquel since 2004 occurred when the drug was being used for unapproved or “off-label” purposes, such as depression. 21 percent of adverse events are linked to off-label use of Seroquel in depression — a condition for which there are plenty of other available drugs — and 26 percent of events occur with other off-label uses:

The ISMP said:

the adverse event data show quetiapine [Seroquel] has become a general purpose psychiatric drug with most reported injuries occurring outside its core indication for treatment of the most severe mental disorders, schizophrenia and psychosis.

In the off label category more than half the cases were for sleep disorders and insomnia. The next largest group was anxiety, and the remainder was divided among many other medical uses including autism, panic attack, headache, restlessness, nervousness, dementia and agitation.

The report is yet another in a series of publications from a variety of sources that suggest some psychiatric doctors are abusing their patients with Seroquel. In addition to the FDA’s 2008 declaration, consider:

Injuries from Seroquel’s side effects can be severe and permanent. In addition to diabetes they include suicidal/self-injurious behavior, and neurological movement disorders such as tardive dyskinesia, dystonia and parkinsonism.

AstraZeneca’s role in promoting Seroquel for off-label uses is well documented. The company has paid $1.5 billion in legal costs and settlements for its mismarketing of the drug ($520 million to the Department of Justice; another $743 million in legal costs in unresolved cases through March 2011; and $198 million in civil settlements.)

So doctors have no excuse. The FDA — which has almost no jurisdiction over physicians — and the courts have performed their roles. It’s time for the medical profession to take responsibility for the damage it is causing and cut down on its dispensing of Seroquel.

Read article here:  http://www.bnet.com/blog/drug-business/how-seroquel-a-risky-antipsychotic-became-a-8220general-purpose-8221-mental-health-drug/8545

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AstraZeneca paying $68.5M to settle off-label marketing charges for anti-psychotic Seroquel

Thursday, March 10th, 2011

ABCNews.com

by Matthew Perrone AP Health Wire, March 10,  2011

Thursday's deal is the second multimillion-dollar Seroquel settlement brought by government prosecutors in the past two years. Last April AstraZeneca agreed to pay $520 million to settle similar allegations brought by the federal Department of Justice.

AstraZeneca will pay $68.5 million as part of a multistate settlement over allegations that the drug developer promoted its blockbuster psychiatric drug Seroquel for insomnia, Alzheimer’s and other unapproved uses.

The New Jersey Attorney General’s Office announced the agreement Thursday, describing it as the largest multistate pharmaceutical settlement of its kind. New Jersey will receive $1.85 million from the deal with 36 other states and the District of Columbia as party to the settlement.

The states alleged that salespeople for AstraZeneca promoted its anti-psychotic Seroquel for off-label, or unapproved uses, and did not disclose side effects of the pill, which include weight gain and muscle spasms.

“Consumers rightfully expect pharmaceutical companies to engage in responsible marketing efforts that are consistent with approved purposes,” said Thomas Calcagni, acting director of New Jersey’s division of consumer affairs.

Seroquel is approved to treat schizophrenia, bipolar disorder and depression, though the majority prescriptions are for off-label uses like insomnia. The drug, approved in 1997, is AstraZeneca’s second-best-selling product, with U.S. sales of $5.3 billion last year. But that success has been marred by frequent allegations that the company illegally marketed the drug and downplayed its risks.

Seroquel’s side effects, including blood sugar increases, weight gain and uncontrollable muscle spasms, have resulted in thousands of lawsuits from patients. The drugmaker had settled nearly 25,000 personal injury lawsuits related to Seroquel at the end of 2010, with 3,950 remaining.

Pharmaceutical companies are prohibited from marketing drugs for unapproved uses, though doctors are free to prescribe them as they choose.

London-based AstraZeneca denied any wrongdoing.

“While we deny the allegations, AstraZeneca believes it is important to bring these matters to a close and move forward with our business of providing medicines to patients,” said company spokesman Tony Jewell, in a statement.

Thursday’s deal is the second multimillion-dollar Seroquel settlement brought by government prosecutors in the past two years. Last April AstraZeneca agreed to pay $520 million to settle similar allegations brought by the federal Department of Justice.

The new settlement stemmed from a separate three-year investigation led by the Attorney General of New Jersey. As part of the agreement AstraZeneca must publish any gifts or payments to physicians on a public website. The company also agreed to make sure that payment incentives to sales representatives do not encourage off-label promotion.

Allegations of off-label drug marketing have become increasingly common in the past decade, with the drug industry eclipsing all others as the source of fraud-related settlements with the federal government. Approximately 80 percent of the $3.1 billion in penalties collected last fiscal year by the government came from the health care sector, including drugmakers, insurers and hospitals, according to Taxpayers Against Fraud.

http://abcnews.go.com/Business/wireStory?id=13105486

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Is J&J Cooking Its Books? Suit Alleges Double-Counting at the Pharma Giant

Wednesday, March 2nd, 2011

BNET – March 1, 2011

by Jim Edwards

A whistleblower lawsuit filed against Johnson & Johnson (JNJ) didn’t get much attention in the media because the unproven accusations within it — paying kickbacks to nursing home pharmacy Omnicare (OCR) — sounded familiar. But the details in the complaint are worth exploring because they go further than the usual allegations of paying for no-work contracts to boost pharmacy distribution of their drugs.

Plaintiff Scott Bartz, a former sales compensation manager at J&J, alleges that the company is cooking its books in two ways, both of which could lead to prison time for senior managers if his allegations are true:

  • The company is overstating its revenues by counting the discounts it pays to drug repackagers under the “cost of goods sold” line on its income statement. COGS are supposed to reflect manufacturing and shipping costs, not price discounts and rebates.
  • The company is double-counting sales of the injectable antipsychotic Risperdal Consta as the drug passes through wholesalers and retailers. The double-counting is part of a “channel-stuffing” scheme in which the company falsely inflates its sales by counting shipments to wholesalers as if they were actual sales at the retail level.

J&J has yet to respond to the suit, which was unsealed in December and didn’t surface in regulatory filings until last week. The company will be comforted by the fact that the Department of Justice has so far declined to intervene. That doesn’t necessarily mean the DOJ believes the case is without merit; the DOJ chooses its cases based on a range of criteria, including policy priorities and available resources. Nonetheless, the accusations should be taken with a pinch of salt until J&J responds.

The last time channel stuffing reared its ugly head in the drug industry was when Bristol-Myers Squibb (BMS) settled fraudulent accounting charges with the SEC for $150 million. In that case, BMS’ former president and CFO were indicted for fraud and conspiracy, but the charges were dropped last year in favor of a pair of deferred-prosecution agreements and $400,000 in fines.

Bartz worked for J&J from 1999 to 2007 and had responsibility for analyzing J&J’s financial and sales data from companies such as IMS Health, a market research company whose information is used as an industry benchmark. In 2004 and 2005, Bartz noted an alleged discrepancy between the amount of Risperdal Consta J&J sold to three wholesalers and the amount that pharmacies actually sold to patients:

  • J&J’s Risperdal Consta sales to wholesalers McKesson, Cardinal and AmeriSource Bergen
  • 2004: $130 million reported; $75 million actually sold
  • 2005: $285 million reported; $145 million actually sold

Bartz investigated, and found further alleged discrepancies. Alkermes, the company that makes Risperdal for J&J, reported worldwide sales to J&J’s Janssen unit worth $1 billion in 2005, Bartz alleges. But Janssen’s net sales of that drug in the same year were only recorded as $664 million; and sales from outlets and other distributors were $390 million, Bartz claims. J&J concealed its channel-stuffing scheme by counting the same sales twice, Bartz claims (click to enlarge):

The discrepancy between the sales J&J racked up with its wholesalers and actual sales at retail and pharmacy level did not go unnoticed, Bartz claims. An IMS Health executive said that there seemed to be “very little sellout” of some Risperdal Consta shipments that J&J had sent to McKesson:

Bartz alleges channel stuffing was widespread at J&J:

Plaintiff has also discovered that the practice of channel stuffing was used in all or most of the J&J products as a means to increase profit margins of distributors such as McKesson, Cardinal and AmeriSource Bergen.

For investors, the most serious allegation Bartz has to make is furnished with the least detail. He claims that J&J inflated sales of the Alzheimer’s drug Razadyne through a number of different schemes, including removing sales from the company’s books only to reinsert them once the books were closed at year’s end, and pretending that discounts J&J offers to repackagers on the drug are manufacturing costs:

That scheme would allow J&J to pretend it is making more money on the drug than it actually is, albeit at smaller margins. Oddly, the net effect of such a scheme on J&J’s bottom line would be a wash, but it would give outside observers the impression that the market for Razadyne is bigger than it actually is.

Bartz claims he was harassed and demoted after he complained to management that he believed the company’s accounting was false. He claims he had a stress-induced heart attack before he was finally terminated in 2007.

http://www.bnet.com/blog/drug-business/is-j-j-cooking-its-books-suit-alleges-double-counting-at-the-pharma-giant/7552

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Federal Judge & DOJ back lawsuit accusing Johnson & Johnson of illegal kickback scheme to push antipsychotic drugs on elderly

Tuesday, March 1st, 2011

AboutLawsuits.com

March 1, 2011

A federal judge has refused to toss out a whistleblower lawsuit backed by the Department of Justice (DOJ), which accuses Johnson & Johnson of involvement in an illegal kickback scheme to push their antipsychotic drugs on elderly nursing home residents that did not need them.

Johnson & Johnson sought to have claims brought by the DOJ, a number of whistleblowers and states dismissed, saying that what the plaintiffs are calling illegal kickbacks were completely legal rebates. However, U.S. District Judge Richard Stearns found that plaintiffs had sufficient evidence to go forward with the complaint.

Judge Stearns did remove several plaintiffs from the case, including the states of Nevada, Texas and Illinois, but allowed Kentucky, Indiana and Virginia to stay part of the lawsuit. Whistleblower David Kammerer was also removed from the lawsuit.

The DOJ filed a civil False Claims Act compliant against J&J on January 15, 2010, saying that the company paid millions to Omnicare, Inc. as kickbacks for selling Risperdal to nursing home patients.

In 2009, Omnicare settled charges brought against it by the government for allegedly paying kickbacks to nursing homes to prescribe the drug. At that time, the Justice department investigators indicated that the illegal nursing home drug kickbacks were hidden as data fees, education fees and as payments to attend Omnicare meetings.

According to the DOJ complaint against Johnson & Johnson, the drug maker paid $50 million to Omnicare between 1999 and 2004 to get it to prescribe Risperdal to elderly patients with dementia, and then hid those kickbacks as payments for services that Omnicare never actually provided. Omnicare then enacted intervention programs such as the “Risperdal Initiative” to persuade physicians to prescribe the drug to elderly dementia patients.

Omnicare, the largest pharmaceutical supplier for nursing homes in the U.S., has pharmacists on staff who review patients’ records and then makes recommendations to the patients’ physicians. Those recommendations are followed about 80% of the time, the DOJ said.

The claims were originally made by Omnicare pharmacist Bernard Lisitza in 2003, and the DOJ chose to intervene on Lisitza’s behalf.

Whistleblowers who report a false claim against the government may be entitled to receive a portion of any money that the government recovers from the offenders under the qui tam provision of the False Claims Act. In return, the whistleblower must be the first to bring the case to the government’s attention, and must not publicize the claim until the DOJ decides to prosecute the claim.

Risperdal (risperidone) is manufactured by Janssen, a division of Ortho-McNeil-Janssen, which is a subsidiary of Johnson & Johnson. Risperdal is approved by FDA for the treatment of schizophrenia, bipolar disorder and autism, but it is commonly used among elderly with dementia and sometimes as a form of chemical restraint in nursing homes.

Risperdal is not approved for treatment of dementia, and patient advocates have been pushing nursing homes to reduce the use of the drug among elderly due to the health risk and a lack of actual health benefits. According to a recent report from the United Kingdom, side effects of Risperdal and other similar antipsychotics, like Seroquel, Zyprexa and Abilify, could be linked to as many as 1,800 deaths and 1,620 strokes per year in elderly patients with dementia.

http://www.aboutlawsuits.com/risperdal-omnicare-lawsuit-proceeds-16571/

To see more international drug regulatory warnings and studies on Risperdal and other antipsychotic drugs, visit CCHR’s Psychiatric Drug Side Effects Database here: http://www.cchrint.org/psychdrugdangers/drug_warnings.php

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$1,000 a Pop: How Forest Labs Bribed Doctors to Prescribe Antidepressants to Kids

Thursday, September 16th, 2010

BNET

By Jim Edwards | September 15, 2010

Forest Labs (FRX) appears to have initially underestimated how much it needed to pay the feds to go away: In 2009, the company said it had set aside $170 million in case it needed to settle a Department of Justice investigation of the kickbacks it paid in its marketing of Celexa and Lexapro, two antidepressants. Today, the company paid $313 million to wrap up the probes.

Forest’s management is used to lavish spending, however, as the whistleblower complaints behind the settlement allege.

The meat of Forest’s wrongdoing is that the company promoted Celexa for children even though the FDA had specifically rejected the drug for kids, and even though European data showed it was not useful in youths. The company did something similar with Lexapro — one pharmaceutical sales rep recommended crushing up Lexapro into apple sauce in order to make it more palatable to children.

Forest overcame resistance to the pediatric use of its antidepressants by bribing doctors with cash and gifts, the lawsuits alleged. Among the goodies Forest handed out were:

  • Tickets to St. Louis Cardinals games.
  • A $1,000 certificate to Alain Ducasse, one of the best (and most expensive) restaurants in New York, according to this suit.
  • A trip to see a George Carlin concert. (They’re antidepressants and he’s funny, geddit?).
  • $1,000 in cash to attend dinner at the Doral Park Country Club in Miami.
  • A trip to the Great Escape amusement park in New York.
  • Tickets to The Nutcracker at the Paper Mill Playhouse in Millburn, N.J., according to this suit.

The settlement, in which Forest pleads guilty to the accusations against it, also implies that one unnamed Forest executive lied to Congress in September 2004 — which is in itself a crime.

Read the rest of the article here: http://www.bnet.com/blog/drug-business/1000-a-pop-how-forest-labs-bribed-doctors-to-prescribe-antidepressants-to-kids/5753

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GSK & AstraZeneca face corruption investigation—hospitality lavished on those who prescribe drugs could constitute bribery

Monday, August 16th, 2010

Market Watch
By London Bureau
August 14, 2010

U.K. pharmaceutical firms GlaxoSmithKline PLC (GSK 38.15, +0.01, +0.03%) and AstraZeneca PLC (AZN 51.88, +0.49, +0.95%) are facing a corruption investigation in the U.S. over claims that the hospitality lavished on those who prescribe their treatments could constitute bribery, The Independent newspaper in London reported Saturday, without citing sources.

The newspaper said the two firms are among those facing the investigation being carried out by the Department of Justice and Securities and Exchange Commission.

The investigation is thought to center around allegations that drug companies might have contravened the Foreign Corrupt Practices Act, which limits their ability to spend on such things as hospitality, charitable donations and other non-business activities, the newspaper said.

Read entire article here:  http://www.marketwatch.com/story/gsk-astrazeneca-facing-us-probe-report-2010-08-14

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BNET: ‘The Dog Ate AstraZeneca’s Homework! Evidence on Misleading Drug Ad Disappears From Company’s Files’

Wednesday, July 7th, 2010

BNET
By Jim Edwards
July 7, 2010

AstraZeneca (AZN) says it has lost a crucial internal document that would explain how an ad for its antipsychotic Seroquel misleadingly claimed there was “no weight gain” with the drug and described its “favorable weight profile.” But the company admits it kept the six-year-old envelope that once allegedly contained the ad’s approval certificate, according to a ruling by the U.K.’s Prescription Medicines Code of Practice Authority.

The drug industry watchdog also alleges AZ’s Seroquel management team “pressured and manipulated” executives around them in order to make sure negative data on Seroquel was buried. The PMCPA ruled that AZ had breached its code of practice, which requires companies to operate in “a professional, ethical and transparent” manner.

If there’s a lesson here for managers, it’s this: Simply winning the legal war isn’t good enough. Consumers — and your own employees, as the Seroquel case shows — expect companies to go above and beyond. (AZ has mostly won the litigation filed against it which alleges the company failed to warn patients that Seroquel causes weight gain and diabetes. It settled with the Department of Justice for $520 million.)

Many of the allegations in the PMCPA case are familiar, but what’s new is the source: One of the complainants was an unnamed male former AZ executive, employed at the company from 1992 to 2001, who from 1995 to 2000 was responsible for the medical aspects of the U.K. launch and subsequent marketing of Seroquel.*

In terms of the ad, the BBC reported in January that AZ had published a misleading ad in the British Journal of Psychiatry in April 2004. The PMCPA asked AZ to produce all the documentation behind the ad. Here’s its characterization of AZ’s response:

… for a product that had been marketed for more than 12 years in the UK, the company did not believe that it could reasonably investigate and respond to such a broad request in relation to specific clauses of the code.

The Code requires companies keep relevant documents for three years, AZ argued, and the ad itself was at least five years old, thus, “AstraZeneca had been unable to produce the certificate approving the advertisement from its archive.” But:

The Appeal Board noted from the AstraZeneca representatives at the appeal that although the job bag for the advertisement at issue still existed, it did not contain the relevant certificate.

How unfortunate!

More seriously, the PMCPA appeared to take seriously the ex-employee’s allegation that AZ buried or manipulated data on Seroquel long after the company became aware of weight-gain effects on its patients. The executive alleged that in 1997 he was told by a colleague…

Read entire article here:  http://industry.bnet.com/pharma/10008835/the-dog-ate-astrazenecas-homework-evidence-on-misleading-drug-ad-dissappears-from-companys-files/

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