Published By: Maxwell S. Kennerly, Esquire

false claims act

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Can you guess the best-selling class of drugs? It may be that a fifth of Americans suffer gastroesophageal reflux disease at least once a week, over 30% have hypertension, and over a third of U.S. adults have high LDL cholesterol, but the best-selling class of drugs isn’t proton-pump inhibitors for reflux, or angiotensin II receptor antagonists for blood pressure, or statins. It’s anti-psychotics.

The best-selling drug in America is Abilify, the prescribing information for which says it is only approved for:

  • Use as an add-on treatment to an antidepressant for adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy
  • Treatment of manic or mixed episodes associated with Bipolar I Disorder in adults and in pediatric patients 10 to 17 years of age
  • Treatment of Schizophrenia in adults and in adolescents 13 to 17 years of age
  • Treatment of irritability associated with Autistic Disorder in pediatric patients 6 to 17 years of age

It’s commonplace for people to refer to themselves or others as “depressed” or “bipolar,” but that’s a far cry from a diagnosis. The NIH has a handy page with the statistics on mental illness. At the most generous estimate, 5-8% of the adult population can be diagnosed with Major Depressive Disorder, and Abilify isn’t even indicated for them — it’s indicated only for those who haven’t responded to typical antidepressants, which is half or less. Bipolar Disorder affects 2.6% of the popular, but Bipolar I, the more severe version defined by a week or more of mania or mania so severe it requires hospitalization, is only a small fraction of that. Schizophrenia affects 1% of the population. Finally, depending on your definition, between 0.8% and 1.2% of children have autism.

Adding all of those up gets us to 5% or so of the population that could even qualify for Abilify, less than a quarter of the people with GERD, hypertension, or high cholesterol. So who is taking all of this Abilify, and why? As the Wall Street Journal reported last week, “Federal health officials have launched a probe into the use of antipsychotic drugs on children in the Medicaid system, amid concern that the medications are being prescribed too often to treat behavioral problems in the very young.” The quote Mark Duggan, a health-policy expert at the University of Pennsylvania’s Wharton School, saying that more than 70% of the cost of the five leading antipsychotics was paid for by Medicaid and other government programs.

While the public school system in many urban areas is in collapse — a problem we feel quite acutely here in Philadelphia — and there’s still no interest in putting tax dollars into early childhood education or after-school problems, and even the upper-middle-class can’t afford childcare so both parents can work, it seems Medicaid has $3.6 billion to spend on antipsychotic medications like Abilify, Zyprexa, Geodon, and Seroquel. (That’s just as of 2008 — the number is likely double or higher now given how rapidly prescriptions have grown.)

So what happened? Maybe it has something to do with this: 
Continue Reading Taxpayers Spend Billions Giving Children Antipsychotic Medications

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If you suspect your employer has violated securities, tax, or government contract laws, you can contact our firm for a free, confidential, no-obligation consultation using this form.  

Corporate Counsel reported yesterday:

The new federal whistleblower law is proving a hot item for many plaintiff law firms. Attorneys say that tipsters with visions

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Over at the Delaware Corporate and Commercial Litigation Blog, Francis Pileggi highlights one of the many quirks of practice in Delaware:

Professor Bainbridge discusses an article here from The Wall Street Journal that quotes a Delaware Superior Court judge in connection with a dress code for those who appear in his court. Most Delaware

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The False Claim Act envisions a broad definition under 31 U.S.C. § 3729(b) for when a defendant “knowingly” makes a false or fraudulent claim to the federal government:

(b) Knowing and Knowingly Defined.— For purposes of this section, the terms “knowing” and “knowingly” mean that a person, with respect to information—

(1) has actual knowledge

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Via the WSJ Law Blog, Amy Kolz at The American Lawyer has a new article about the False Claims Act:

"[FCA cases] are a big gamble," says Piacentile’s counsel, former Boies, Schiller & Flexner partner David Stone of Stone & Magnanini, who cites cost-benefit analyses and good relationships with prosecutors as essential to his

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The New Colossus:

Not like the brazen giant of Greek fame,
With conquering limbs astride from land to land;
Here at our sea-washed, sunset gates shall stand
A mighty woman with a torch, whose flame
Is the imprisoned lightning, and her name
Mother of Exiles. From her beacon-hand
Glows world-wide welcome; her mild eyes

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As The Recorder reported,

Four states and dozens of California cities and water districts have joined a qui tam lawsuit, unveiled this week, seeking millions of dollars in damages against a company for allegedly supplying customers with substandard PVC pipe.

The suit, brought against J-M Manufacturing Co. and its former parent company, Formosa Plastics

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Another interesting statutory construction case arising from allegations scientists at Cornell University Medical College and Thomas Jefferson University "misrepresented the findings of their DNA research when they applied for National Institute of Health research grants and did not correct the misrepresentations on subsequent progress reports and renewal applications." Problem is, the grants in question were…