Because the medical device market is extremely competitive, medical device manufacturers face significant pressure to maximize sales and profits. Some medical device manufacturers engage in deceptive sales practices and other fraudulent activity to beat the competition. Given the fact that government insurers (e.g. Medicaid and Medicare) cover a significant portion of medical device costs, such unlawful activity is a violation of the False Claims Act. If you have knowledge of medical device fraud, an experienced whistleblower attorney can help you obtain a significant financial reward.
At Newman & Shapiro, our practice is dedicated to providing powerful representation to whistleblowers throughout the nation. Well-versed in the False Claims Act and the applicable regulations promulgated by the Food and Drug Administration (FDA) concerning medical devices, our whistleblower attorneys have a proven history of helping clients recover significant financial rewards. When you partner with us, we will explain all your rights, thoroughly assess the validity of your claim, and help you obtain the reward you have earned.
What is medical device fraud?
While there are many forms of medical device fraud, common violations of the False Claims Act include:
- Off-label marketing — This involves marketing or advertising medical devices for purposes other than those for which the device has been approved by the Food and Drug Administration (FDA). Although doctors can prescribe medical devices for additional uses, manufacturers that violate device marketing regulations by promoting uses for off-label purposes can be held liable in a qui tam lawsuit.
- Defective medical devices — Medical device manufacturers that knowingly provide defective devices to patients covered under Medicaid or Medicare may cause physicians and hospitals to submit false claims for payment. Manufacturers that fail to disclose medical device defects to the FDA or that continue selling such devices after the defect has been discovered are in violation of the false claims act.
- Kickbacks/referrals — It is unlawful to accept, offer, or solicit kickbacks to encourage care providers to prescribe medical devices to patients, or to make improper payments for referrals of Medicare and Medicaid patients. These violations of the federal Anti-kickback Statute and the Stark Law may involve paying improper fees to physicians and offering rebates for future business.
- Unnecessary Billing — Often referred to as upcoding, this occurs when manufacturers encourage doctors to use an inappropriate treatment protocol or billing code for the procedures involving its device.
In addition, medical device fraud may involve the following unlawful activities:
- Violating good practices in the design and manufacture of medical devices
- Failing to report adverse events associated with medical devices
- Marketing defective medical devices, despite knowledge or reasonable cause to believe that the device is defective
- Billing Medicaid/Medicare/Tricare for medical devices that are not medically necessary for a patient and/or which are not covered by government insurance
- Billing for medical devices which are not provided, or for more expensive medical devices than devices provided to patients
Because these schemes are complicated and difficult to detect, it takes brave whistleblowers to come forward and report information about medical device fraud. Under the qui tam provisions of the False Claim Act, individuals can file a civil lawsuit to hold the responsible party accountable. If a favorable settlement or jury verdict is reached, manufacturers face civil penalties for each offense plus treble damages (three times the value of the government’s loss) and whistleblowers may be awarded up to 15 to 30 percent of the money recovered.
Contact Our Medical Device Fraud Whistleblower Attorneys
Medical device fraud not only costs the government millions of dollars in false claims, but such unlawful conduct also jeopardizes patient safety. Given the federal government’s limited ability to uncover this type of fraudulent activity, whistleblowers play a crucial role in combating medical device fraud. At Newman & Shapiro, we believe that manufacturers must be held accountable for defrauding the government.
If you have knowledge of medical device fraud, our legal team will work to protect your rights and help bring a qui tam lawsuit under the False Claims Act. We understand that you may fear retaliation from your employer for reporting this form of healthcare fraud; however, you should know that the False Claims Act protects you against employment retaliation. If your employer takes an adverse employment action against you (e.g. firing, demotion, reassignment, harassment), you may have a legal basis for a civil lawsuit to recover damages such as back pay, attorneys’ fees, and costs.
Although going up against powerful corporations that engage in medical device fraud is daunting, we will leverage our knowledge and skills to level the playing field and help you recover the reward you have earned. Our whistleblower attorneys have a well-earned reputation for providing our clients with informed representation and efficient service and for always putting their best interests first. Please contact our office today to set up a consultation.