We all think we know what a bribe looks like, but do we? Most corporations are too sophisticated to get caught handing over brown paper bags of cash.
So how do pharmaceutical companies bribe doctors? In many ways, some of which may even seem legitimate at first: educational grants, speaking fees, all-expenses-paid retreats, preceptorships, gifts, and undisclosed discounts — all may be kickbacks if the intent is to induce a purchase.
In United States ex rel. Bennett v. Abiomed (Civil Action 13-cv-12277 IT), our client alleged Abiomed overspent on lavish meals for doctors to influence device choice. Abiomed agreed to pay $3.1 million to the federal government.
Read the articleIn United States v. Amgen et al. (Civil Action No. 06-10972-WGY), our client alleged Amgen overfilled vials of Aranesp and used the overfill as a “liquid kickback” for a decade. That case settled, with others, for a total of $780 million.
Read the articleIn United States, et al. Collins v. Pfizer Inc. (Civil Action No. 04-11780-DPW), the DOJ settled our client’s allegations of a nationwide kickback scheme for Lipitor, Norvasc and Viagra — a record criminal fine of $1.3 billion and a $1 billion civil settlement.
Read the articleIn United States ex rel. Relators v. Aegerion Pharmaceuticals, Inc. (Civil Action 13-11785 IT), we represented three whistleblowers who alleged Aegerion marketed Juxtapid off label. The DOJ and SEC jointly settled: a $28.8 million civil penalty, $7 million criminal fine and $4.1 million to the SEC — believed to be the first joint DOJ/SEC settlement ever.
Read the articleWe then teamed with Berman Tabacco to pursue declined claims against Aegerion executives, resulting in an additional $6.5 million settlement.
Read the articleIn United States v. Elan Corporation, PLC, et al. (Civil Action 04-11594 RWZ), the Irish manufacturer of Zonegran paid $214 million to settle allegations of off-label marketing for weight loss and mood stabilization; Elan pled guilty and paid a $97 million criminal fine.
Read the articleTo put it simply, a doctor can prescribe a drug for its “off label” effects but a pharmaceutical company can’t market a drug for its off label effects.
To allow pharmaceutical companies to market off label would make the “label” meaningless and breach the False Claims Act. For some companies the temptation is too great.
Along with flat-out bribery, this has got to be the most obvious of all false claims scenarios.
Healthcare providers bill under CPT codes; “upcoding” means assigning a code that artificially increases the rate of pay. Billing government healthcare programs for services never rendered, or not medically necessary, is also fraudulent.
In United States ex rel. Ruckh v. CMC II, et al. (Civil Action 11-1303 SDM), our client, a Registered Nurse, saw a chain of skilled nursing facilities billing codes disconnected from the care actually provided. We took the case to trial; the jury awarded $345 million, reduced on appeal to $250 million.
Read the articleIn United States ex rel. Relators v. Aegerion Pharmaceuticals, Inc. (Civil Action 13-11785 IT), the government alleged Aegerion used a PAP to “eliminate price sensitivity” to its flagship product — arguably the first such settlement, followed by Lundbeck ($52 million), Jazz ($57 million), Pfizer ($23 million) and United Therapeutics ($210 million).
Read the articleOver the last few years, certain PAPs have become a means by which pharmaceutical companies simply subsidize their own drugs.
Used as intended, PAPs make prescription drug copays affordable for Medicare patients. But a study found that for every $1 donated to a copay charity, a pharmaceutical company can reap a $21 benefit — and “captive” PAPs can funnel money to a single drug.
Medical providers are not permitted to bill the government for medically unnecessary services or procedures performed solely for the provider’s profit.
The most basic requirement for reimbursement eligibility under Medicare and Medicaid is that the service must be reasonable and medically necessary. Fraud in this area often includes unnecessary services, kickbacks for referrals, and manipulated stay/readmission dates.
In United States ex rel. Ruckh v. CMC II, et al. (Civil Action 11-1303 SDM), the jury awarded a landmark verdict of $345 million, of which $250 million was upheld on appeal.
Read the articleIn our case United States ex rel. Relators v. Aegerion Pharmaceuticals, Inc. (Civil Action 13-11785 IT), the DOJ and SEC jointly settled: a $28.8 million civil penalty, $7 million criminal fine and $4.1 million to the SEC — believed to be the first joint DOJ/SEC settlement ever.
Read the articleAt one time there was no reward for an insider to shed light on SEC violations. That has changed.
Under the Dodd-Frank Wall Street Reform and Consumer Protection Act, the SEC pays awards — up to 30% of monetary sanctions collected — to eligible whistleblowers whose information leads to an enforcement action yielding at least $1 million, and prohibits employer retaliation.
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