Court to hear whistleblower's case alleging Celgene's aggressive push of Thalidomide 

the modern drug-regulation system traces back to a once-popular morning-sickness pill whose linkage to babies born with flipper-like limbs in the 1960s led the U.S. to tighten oversight for approving medications.

That makes it all the more amazing that Celgene Corp. has built itself into a biotech powerhouse, rebranding the drug thalidomide using a slightly different name: Thalomid. Recently unsealed documents in a lawsuit by a company saleswoman-turned-whistleblower allege that its success is due to an aggressive campaign to encourage doctors to prescribe it and successor drugs to treat maladies beyond those the FDA authorized.

After some studies suggested thalidomide could treat blood cancer but long before it was authorized for it, Celgene created a thriving market by hiring doctors to tout uses beyond what the product was approved for and ghostwriters to promote the drug in medical journals, according to the suit. Though doctors have broad latitude in prescribing drugs, even for uses that aren't approved, drugmakers can't push "off-label" uses. Manufacturers including Pfizer and Johnson & Johnson have paid billions of dollars to settle such claims.

U.S. appeals court declines to reconsider Bank of America ruling

A U.S. appeals court refused on Monday to reconsider its decision to overturn a $1.27 billion penalty against Bank of America Corp and a jury verdict finding it liable for mortgage fraud leading up to the 2008 financial crisis.

The 2nd U.S. Circuit Court of Appeals in New York rejected a petition by Manhattan U.S. Attorney Preet Bharara's office to have a three-judge panel rehear the case and give the government at least an opportunity to seek a new trial.

Bharara's office had argued that the ruling in May "overlooked a wealth of evidence" establishing the fraud perpetrated through a mortgage program called "Hustle" run by Countrywide Financial Corp, which Bank of America acquired in 2008. read more »

Multinationals, Distributors, and the FCPA

When doing business overseas, you’ll want to stay on the right side of the Foreign Corruption Practices Act. Just ask LATAM Airlines. The Chilean company is paying $22 million in fines for allegedly bribing Argentinian officials. While LATAM’s violation appears to be overt, companies can violate the FCPA in subtler ways.

Two US agencies enforce the FCPA: the Department of Justice and the Securities and Exchange Commission. FCPA violations include, but are not limited to, kickbacks, bribes, or any other perks given to foreign government officials for purposes of favorably influencing them on behalf of one’s enterprise.

And if a multinational exporter is relying on a distribution partnership, FCPA compliance can get a whole lot dicier. 

5th Circ. Won't Order $6M Ponzi Clawback From Golf Channel

The Fifth Circuit on Tuesday declined to overturn a lower court’s finding that refused to allow a clawback of $5.9 million paid to the Golf Channel Inc. from now-convicted Ponzi schemer Robert Allen Stanford's businesses, after receiving guidance from the Supreme Court of Texas.

The court-appointed receiver for Stanford International Bank Ltd. sought to recoup the funds Stanford paid to the Golf Channel in exchange for a range of advertising services aimed at recruiting additional investors into Stanford’s multibillion-dollar Ponzi scheme. read more »

A.G. Schneiderman Announces $13.4 Million Settlement With NYC Hospital For Illegally Charging Medicaid

NY Downtown Hospital Paid Illegal Kickbacks For Referrals To Unlicensed Drug And Alcohol Treatment Program, Billed Medicaid For Unnecessary Services

Agreement Will Return $13.4 Million To Medicaid And Medicare Program

NEW YORK— Attorney General Eric T. Schneiderman today announced that his office secured a $13.4 million settlement with New York Downtown Hospital to resolve a Medicaid fraud case involving illegal payments the hospital received on claims for unlicensed inpatient drug and alcohol treatment services and rendered to patients who were unlawfully referred there. The settlement also resolves charges that NY Downtown Hospital conspired with a for-profit out-of-state vendor of purported administrative services to submit false claims to Medicaid. Under the terms of the settlement, more than $12,600,000 will be returned to the Medicaid program, and $800,000 to the federal Medicare program. read more »