Big Pharma Whistleblower Attorney
It seems as if any time that “big” is involved in the world of business, the chances for fraud and wrongdoing grow. Our largest drug developers and manufacturers, otherwise known as “Big Pharma,” have seen their share of settlements and whistleblowers—perhaps even more than their share. During the combined years of 2014 and 2015, pharmaceutical companies paid out $1.2 billion in settlements and judgments involving cases of fraud brought under the False Claims Act (FCA).
There is no question that our lives have been improved by advances in drugs, starting with anesthesia and antibiotics and continuing right up to today’s high survival rates for some diseases that were formerly considered death sentences. But never forget that the main purpose of a drug company is to make a profit—as you would expect in a capitalist country. Normally, this works to everyone’s good. But when those in charge concern themselves with profits at any price, with little regard for ethics, malfeasance and fraud cannot be far behind. In these cases, the whistleblower provides a needed check on such behaviors.
Which Companies Make Up Big Pharma?
When we talk about Big Pharma, what do we mean? It means we are referring to the largest drug companies. Here is the 2015 ranking by revenue, in billions of US dollars, of the top 10 pharmaceutical and biotech companies worldwide:
- Johnson and Johnson (USA)
- Novartis (Switzerland)
- Pfizer (USA)
- Roche Holding (Switzerland)
- Merck & Co. (USA)
- Sanofi (France)
- GlaxoSmithKline (UK)
- AstraZeneca (UK)
- Abbott Laboratories (USA)
- Amgen (USA).
Trillions of dollars and hundreds of thousands of employees are controlled by these ten companies alone. If you have taken at least one prescription drug in the past 30 days, as nearly half of U.S. citizens have, then there’s a fair chance that the drug or drugs you took (or take) have a link to one of these 10 corporations. Your drug may have been developed by one of them, or manufactured by one of them.
Fraudulent Actions by Drug Providers That Break Federal Laws
The most frequent violations of federal laws encountered by whistleblowers usually involve money or payments. A whistleblower is most likely to encounter some form of kickbacks or pricing fraud.
- Off-label marketing. Sometimes doctors are permitted to prescribe drugs for off-label usage, meaning other than the usage approved by the FDA. However, Medicare, Medicaid, and TRICARE do not pay for drugs that are prescribed for off-label usage, and doctors are not supposed to conceal the actual reason for the prescription in an effort to obtain government healthcare payments for them. What sometimes happens is that the drug companies will use illegal kickbacks (essentially bribes) to push for their drugs to be prescribed for off-label usage.
- Illegal kickbacks. Providing any type of financial incentives to doctors or hospitals to convince them to prescribe specific drugs is against the law. Incentives can take the form of cash bonuses, free meals, free entertainment, free vacations, phony drug trials, out-of-the-ordinary payments for serving on boards, unrestricted grants, paying for a doctor’s conference fees and expenses, and free samples that are sold, not given, to patients.
- Best price fraud. Sometimes pharmaceutical companies sell to Medicaid at a price that is more than their actual “best price” because of discounts and rebates; this is a fraudulent practice. If a company wants to sell drugs to the Medicaid program, it is required to charge Medicaid the lowest price, as based on other sales the company makes.
- Overcharges in the 340B drug pricing program. This situation is related to best price fraud. The 340B drug pricing program demands that drug manufacturers provide significant discounts to those providers, such as hospitals, that serve a substantial number of patients who are poor, uninsured, or otherwise disadvantaged.
- Fraud resulting from pharmaceutical benefits managers (PBMs). Originally created to help insurance providers manage prescription drug plans and claims, PBMs can sometimes be involved in fraud such as kickbacks, illegal rebates, and illegal discount arrangements. Other fraudulent actions include hiding the failure to meet contracts by switching medications and canceling prescriptions. A famous whistleblower case involving the PBM Medco Health Solutions resulted in a settlement of $155 million.
Some other types of fraud that can sometimes occur in the pharmaceutical industry are:
- The sale of adulterated (contaminated) drugs
- Not reporting manufacturing problems, such as contamination, in the production of the drugs
- Not reporting a drug’s side effects to the FDA, especially serious side effects such as birth defects or suicidal behavior
- Falsifying data for drug trials that is then given to the FDA
- Other less common violations, such as selling drugs without the appropriate licenses, or exporting drugs inappropriately.
Meeting with a qualified whistleblower attorney can increase your chances of winning.
Pharmaceutical Companies and False Claims Act Settlements
Pharmaceutical company FCA cases made up 25 percent of all FCA cases from 2000 to 2010, according to one study. In 2015 alone, these significant pharmaceutical FCA settlements came about:
- Daiichi Sankyo Inc. settled for $39 million, amid allegations that they engaged in kickbacks to Medicaid physicians.
- Allegations were brought that AstraZeneca LP and Cephalon Inc. paid out less in rebates than they should have as part of the Medicaid Drug Rebate Program. The tally: AstraZenica paid the U.S. $26.7 million, and Cephalon paid $4.3 million, plus the companies together paid $23 million to certain state Medicaid programs.
- PharMerica Corporation, the second largest pharmacy in the U.S. for nursing homes, settled for $9.25 million over alleged kickbacks involving Abbott Laboratories’ drug Depakote.
In 2016, the following cases were settled:
- Pfizer settled for $784 million because of allegations it overcharged Medicaid for Protonix, a heartburn medication. A Louisiana doctor blew the whistle and was awarded $59 million.
- Genentech Inc. and OSI Pharmaceuticals LLC together settled for $67 million amid FCA allegations over misleading statements concerning the effectiveness of Tarceva, a drug used to treat non-small cell lung cancer.
Making a Difference
If you think you have the facts needed to bring a whistleblower case, our experienced whistleblower attorneys can review your case and help you file the appropriate disclosure statement.
For a free, confidential evaluation of your case, call today at 1-803-454-1200 or, if you prefer, you can fill out our online contact form.