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Are You Aware of Medical Equipment Fraud?
Nolan Auerbach & White provides experienced Medical Device Fraud Whistleblower Lawyers for private individuals with knowledge of medical equipment fraud under the qui tam provisions of the federal False Claims Act (FCA).
Medical Equipment Fraud and Medical Device Fraud are sometimes engaged in by manufacturers, distributors, and others, from failure to report adverse events, off-label marketing, fraud on the FDA, to providing financial inducements or kickbacks.
Contact our Whistleblower Medical Equipment Fraud Lawyers to get started on a free and confidential review of your important case. Our healthcare fraud law firm has extensive experience handling whistleblower fraud cases including FDA Off-Label Marketing of Medical Devices and more. Our durable medical equipment fraud attorneys have played a part in the recovery of over $64 billion collected and returned to taxpayers since the False Claims Act (FCA) was amended in 1986.
Call our Qui Tam attorneys at 800-372-8304
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Rewards for Medical Equipment Fraud Whistleblowers
The qui tam provisions of the FCA are designed to encourage private individuals who are aware of medical device fraud and other fraudulent activities being perpetrated against Government Healthcare Programs (such as Medicare and Medicaid), to bring such information forward.
The law provides incentives for medical equipment fraud whistleblowers to collect a percentage of recoveries from qui tam lawsuits. Whistleblower rewards for Medical Device Fraud vary from 15-30 percent of the amount collected.
Nolan Auerbach medical device fraud attorneys have broad experience in preparing, investigating, and prosecuting FCA cases involving noncompliance with reporting requirements by medical device manufacturers, false data in 510(k), and Premarket Approval filings, post-approval modification of medical devices, kickbacks, off-label marketing whistleblower cases and more.
Whistleblower Confidentiality and Protection
If you are aware of medical device fraud or other FCA violations, the law protects you as a whistleblower. We invite you to submit an overview of your case to our team of medical equipment fraud lawyers to begin this important service and duty. Your communications with our experienced medical device fraud attorneys are confidential. Contact us online or call us at 800.372.8304 to get started.
LEARN MORE: Whistleblower Protection
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The Federal Food, Drug, and Cosmetic Act (FD&C)
The Medical Device Amendments of 1976 amended the Federal Food, Drug, and Cosmetic Act (FD&C Act) and established a comprehensive system for the regulation of medical devices intended for human use.
The FD&C Act directs the U.S. Food and Drug Administration (FDA) to classify and reclassify devices into one of three regulatory control categories:
- Class I (general controls)
- Class II (special controls)
- Class III (premarket approval)
These classifications depend upon the degree of regulation necessary to provide reasonable assurance of their safety and effectiveness.
U.S. Ownership of Medical Devices
One-third of the market share for medical devices is owned by Medtronic Inc., General Electric Company (GE), and St. Jude Medical Inc. Cardiac rhythm management devices (defibrillators, pacemakers, etc.) are the largest source of revenue for both Medtronic and St. Jude, whereas GE focuses on the manufacturing of diagnostic imaging technologies like CT and MRI machines.
When measured in terms of therapeutic area, spending is highest in the following three markets:
- Spinal
- Cardiovascular
- Neuromodulation
Common Types of Medical Device Fraud
Medical Equipment Fraud and Medical Device Fraud take place throughout the country. Our medical device fraud law firm can help when you’re ready to consider bringing a case as a whistleblower.
Some of the most common fraud schemes we encounter in our work as whistleblower medical fraud lawyers include:
- Failure To Report Adverse Events – Noncompliance with reporting requirements by a Medical Device Manufacturer may be a violation of the False Claims Act.
- Medical Equipment Kickbacks – This can present a Stark Statute violation, particularly when doctors have unreported equity positions in the device manufacturing companies.
- False 510(k) Notices to Avoid Class III Premarket Approval Process – Companies might fraudulently obtain FDA approval for their products by mischaracterizing their medical devices as Class II devices in order to obtain FDA approval through the lenient 510(k) approval process.
- Modified Medical Devices – Device fraud may exist when manufacturing equipment and devices deviate from the product’s Premarket Approval (PMA) or that are made in violation of Good Manufacturing Practices (GMP).
- Physician-Owned Entities (PODs) – Problematic relationships that can violate the anti-kickback statute or Stark Act if, for example, physicians prescribing or using medical equipment do so as paid “consultants, ” purportedly to help in the designing, testing, or developing of new products. These schemes sometimes expand to include hospitals and hospital systems.
- Unapproved Medical Devices & Uses – Equipment manufacturers may not promote and distribute medical devices in interstate commerce with the intent that those devices be used for unapproved purposes.
The best way to determine the viability of bringing a fraud qui tam case and learning the process is by completing our case evaluation form. Our medical device fraud attorneys typically respond the same day.
We’ll Support You: Medical Device Fraud Lawsuits
Our Medical Equipment Fraud Law Firm is familiar with the various ways in which manufacturers and other Medical Devices and Medical Equipment health care providers have cut corners and engaged in fraud. We are fully focused on healthcare fraud, and otherwise qualified to represent you in whistleblower medical device fraud cases.
We suggest that whistleblowers take the following steps in preparation for contacting your attorney:
- Gather available documentation – Be careful not to violate any company policies or procedures in this process. Be sure you are entitled to view, download or photocopy all materials and documentation.
- List all relevant documents – Even if you cannot access the documents, create a list of those relevant to the case that are not in your possession.
- Describe the fraud in a written memo – The process of reducing the situation to writing, ideally with the facts fresh in your mind, will allow you to recall more and fill in blanks over time. This will help your future recall of the events and assist your lawyers in the preparation of your case. The goal is to make communications about your situation as comprehensive as possible.
LEARN MORE: Preparing for a Medical Equipment Fraud Case
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Other Fraud Cases We Handle for Whistleblowers
Our experienced Medical Device Fraud Lawyers are available to discuss and research your potential case in-depth. As Healthcare Fraud is The Whistleblower Firm’s only practice area, we encourage private individuals to become courageous whistleblowers and address all types of Healthcare Fraud, to include:
Does your case have merit? Submit your facts confidentially to our experienced Medical Device Fraud Law Firm today for a free case evaluation.
CONTACT THE WHISTLEBLOWER FIRM
Join the many whistleblower heroes we have represented. We understand the pressure of becoming aware of significant fraud, with so much on the line both professionally and personally. We’re here to help you take the next courageous step in doing the right thing and pursuing justice.
You are protected by law from retaliation and FCA whistleblowers can receive a percentage of the funds recovered from fraudulent activity.
Get started by filling out our online form, or call our team of experienced medical device fraud attorneys today at 800.372.8304.
Frequently Asked Questions About Medical Equipment Whistleblower Cases
✅ Do Whistleblowers Get a Reward for Exposing Medical Device Fraud?
Yes, eligible whistleblowers may receive between 15-30 percent of the amount collected in medical equipment fraud cases. To learn more about eligibility, begin a free evaluation of your important case.
✅ What Is Medical Device Fraud? Medical Device Fraud and Medical Equipment Fraud typically result in violations of the False Claims Act. Some common schemes include noncompliance with reporting requirements, kickbacks, promotion of unapproved and ineffective medical device uses, continuing to market devices that deviate from their 510(k) or Premarket Approval (PMA) submissions. To learn more, click here to contact our team of Medical Device Fraud Attorneys.