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Pharma Fraud

This archive displays posts tagged as relevant to pharmaceutical fraud. You may also be interested in our pages:

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December 8, 2021

Pharmacist Riad “Ray” Zahr and two pharmacies he owned and operated, Plymouth Towne Care Pharmacy Inc. and Shaska Pharmacy LLC will pay $1 million to resolve a lawsuit initiated by a whistleblower alleging that the pharmacies submitted false claims for Evzio, a naloxone hydrochloride product used for the rapid reversal of an opioid overdose.  The government alleged that the claims included false and misleading prior authorization requests, including forged physician authorizations.  In addition, defendants dispensed Evzio without collecting or attempting to collect co-payments. DOJ; USAO MA

December 7, 2021

Vyera Pharmaceuticals, LLC and its parent company Phoenixus AG will pay up to $40 million and have agreed to make its drug Daraprim available to any potential generic competitor at list price to resolve claims of anticompetitive conduct.  The federal government and state governments alleged that Vyera principals Martin Shkreli and Kevin Mulleady enacted a plan to acquire life-saving toxoplasmosis drug, Daraprim, and dramatically raise its list price by 400% while engaging in conduct to prevent generic competition and protect their monopolistic pricing.  The resolution also bars Mulleady from working in the pharmaceutical industry for seven years; claims against Shkreli are continuing.  FTC; CA; NY; NC; VA

December 6, 2021

Pharmacy benefit manager Centene Corp. will pay $27.6 million to the State of Kansas to resolve allegations that it failed to satisfy its obligation to represent the state’s best interests in negotiations with companies that supply drugs to the state Medicaid program, failed to accurately report discounts it received from CVS-Caremark on certain retail pharmacy claims, and artificially inflated dispensing-fee amounts reported to state regulators.  The state alleged that Centene used an opaque reporting system that made it difficult for the state to determine the nature and appropriateness of certain pharmacy transactions.  As part of the settlement, Centene also agreed to change certain business practices to ensure greater transparency.  KS

Recent Settlements Show Kickbacks are Always a DOJ Enforcement Priority

Posted  11/15/21
Person Handing Hundred Dollar Bill to Another Person
The Department of Justice regularly highlights the areas of fraudulent conduct it intends to target as enforcement priorities.  These identified enforcement priorities tend to cover burgeoning areas of fraud or particular misbehavior especially ripe or prevalent because of the particular times we live in.  As might be expected, DOJ's current listing of priorities includes fraud related to the pandemic, opioids, the

November 9, 2021

Kaléo, Inc., a pharmaceutical manufacturer in Virginia, has agreed to pay $12.7 million to resolve a whistleblower’s allegations that it violated the Anti-Kickback Statute and False Claims Act in claims submitted to Medicare, TRICARE, and the Federal Employees Health Benefits Program.  Between 2017 and 2020, kaléo allegedly provided kickbacks to physicians and their staff to induce and reward them for prescribing Evzio, a higher-priced version of a drug used to reverse opioid overdoses and which often requires prior authorization.  Kaléo also allegedly directed pharmacies to submit false prior authorizations and dispense Evzio without collecting required co-pays.  USAO MA

October 1, 2021

Pharmaceutical manufacturers Taro Pharmaceuticals USA, Inc., Sandoz Inc. and Apotex Corporation have agreed to pay a total of $447.2 million to resolve alleged violations of the False Claims Act and Anti-Kickback Statute arising from unlawful compensation received through arrangements on price, supply and allocation of customers with other pharmaceutical manufacturers of various generic drugs.  In connection with the FCA settlements, Taro will pay $213.2 million, Sandoz will pay $185 million, and Apotex will pay $49 million.  The civil settlements are in addition to previous deferred prosecution agreements resolving related criminal charges, pursuant to which Taro paid a criminal penalty of $205.6 million, Sandoz paid a criminal penalty of $195 million, and Apotex paid a criminal penalty of $24.1 million.  DOJ

Court says that fraudsters who violate rules they later claim are unclear may not violate the False Claims Act

Posted  08/19/21
Red and yellow pills scattered on hundred dollar bills
Last week, the Seventh Circuit Court of Appeals, the federal appellate court for Illinois, Indiana, and Wisconsin decided U.S. ex rel. Yarberry v. Supervalu, an important decision that may lead more unscrupulous government contractors to help themselves to public funds to which they are not entitled.  Unless the Supreme Court or Congress steps in to correct the Seventh Circuit’s errors, the government may have...

August 9, 2021

The owners of North Carolina compounding pharmacy Wellcare Compouding, David Tsui and Lois Tsui, paid $1.1 million to resolve allegations that they violated the False Claims Act by submitting false claims for payment to the TRICARE program in 2014 and 2015.  The government alleged that Wellcare made improper payments to physicians and “marketers” in violation of the Anti-Kickback Statute and encouraged medically unnecessary prescriptions consisting of high-margin ingredients in order to maximize the pharmacy’s reimbursement. David Tsui had been convicted of healthcare fraud in 2009 and was excluded from participation in federal healthcare programs; the government alleged that his involvement and ownership was intentionally concealed.  USAO MD NC

July 21, 2021

For their part in creating and fueling the opioid epidemic, three of the nation’s largest drug distributors—McKesson Corporation, Cardinal Health Inc., and AmerisourceBergen Drug Corporation—as well as one of the nation’s largest drug manufacturers, Johnson & Johnson, have agreed to pay $26 billion over the next 18 years to resolve claims from nearly 4,000 lawsuits, including multiple state and local governments.  In addition to the monetary settlement, the companies have signed onto a 10-year injunctive relief agreement that will require them to implement certain data-driven oversight measures and not fund or lobby to promote opioids, among other things.  CA AG; FL AG; MI AG; NY AG; PA AG

FDA’s Approval of Alzheimer’s Drug Highlights Need for Whistleblowers

Posted  07/9/21
By Edward Baker
stamping saying fda approved
The Food and Drug Administration (FDA) is supposed to protect American consumers from unscrupulous private actors—charlatans, snake-oil salesmen, and the like—seeking to profit by selling unproven medical “cures,” treatments, and devices to the public.  Emerging during the era of the robber barons as part of Theodore Roosevelt’s efforts to “civilize capitalism,” the FDA has prevented untold harm to...
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