What do you need to know if you’re a whistleblower in a pharmaceutical case? Get the details you need about pharmaceutical whistleblower lawyers.
Pharmaceutical whistleblower lawyers work on cases involving drug fraud against the government. These cases fall under the qui tam provision of the False Claims Act (FCA). This law allows a person to sue companies on behalf of the government. The exact process depends on the specific type of drug fraud. The following categories cover the most common types of fraud:
- Off label drug promotion
- Medicaid rebates
- Adulterated drugs
Off Label Drug Promotion
Off label drug promotion is the most common type of drug fraud. It occurs when a company receives FDA approval to use a drug for one use but promotes it for another use. Assume for this example that the FDA approves drug XYZ for the treatment of diabetes. The drug company then contacts doctors to promote its benefits for treating depression. It may even say the drug has FDA approval without saying that it’s only approved for treating diabetes.
Your evidence needs to show the company intentionally promoted off label drug use for this case to qualify as fraud. The key requirement is specific evidence showing this intent. This evidence includes documents of training sessions that explain how to promote drugs for off label uses. Another example of strong evidence for drug fraud would be letters to doctors with marketing information on off label uses.
Recognizing Kickback Schemes
Kickbacks are the second most common form of drug fraud. This type of fraud occurs when a drug company pays a healthcare worker to promote their drugs. These workers may include doctors, nurses, hospitals, pharmacies, and nursing homes.
It’s generally illegal for drug companies to offer financial incentives to their customers. These activities are rarely as obvious as handing over a bag full of cash. For example, drug makers can provide healthcare workers with marketing materials. These materials could include inexpensive items such as pens and coffee mugs. Such items don’t constitute drug fraud by themselves. However, companies often cross the line by offering more costly items.
Another example is when a drug company hires a doctor to provide consulting services. It can be difficult to show that this case is a kickback since the doctor is providing a service.
Drug companies go to extreme lengths to hide kickback schemes. You could be eligible for a reward if you attended a discussion of these schemes. The minutes from such a meeting can be useful for showing kickbacks. This is especially true if the speakers at the meeting were executives. Inside information on how these schemes are taking place can also be strong evidence of kickbacks.
Medicaid Rebate Fraud
Medicaid rebate fraud involves drug companies underpaying Medicaid rebates to the government. Drug companies must belong to the Medicaid Rebate program to provide drugs for Medicaid patients. This program prohibits companies from charging Medicaid more than they charge other customers. Drug companies must submit a report to Medicaid every quarter showing the highest price they charged for each drug. They must then pay Medicaid a rebate if Medicaid paid a healthcare provider more than the company charged other customers for that drug.
The specific schemes for committing Medicaid rebate fraud are highly varied. You might be eligible for a reward if someone at a drug company lied about drug prices. You generally need to show that someone lied about a drug’s average manufacturer price (AMP) or average wholesale price (AWP). Drug companies use these figures to calculate the rebate they owe to Medicaid.
The use of adulterated drugs is a less common form of drug fraud. However, its frequency is increasing as process controls for drug manufacturing becomes stricter. The FDA must approve a drug’s manufacturing processes, including quality control procedures. A drug company may commit drug fraud when it materially deviates from its approved processes.
The key criterion for this type of fraud is whether these changes have the potential to affect the drug. Small errors aren’t enough to file a lawsuit by themselves. However, a large number of such errors may justify a lawsuit. Your evidence must show these errors call the drug’s performance or safety into question.
Assume for this example that a company tells the FDA that it will use a sterile lab for a particular process. The company then decides not to use a sterile lab because it’s too expensive. The FDA could consider the drugs made without the sterile lab to be non-conforming. This scenario could thus qualify as drug fraud.
Pharmaceutical fraud is complex and often hard to prove. Find out more about how pharmaceutical whistleblower lawyers can help by contacting the Bothwell Law Group.