For over 65 years, Ashcraft & Gerel has prided itself on providing the best possible counsel to our clients. Now, in the expanding field of whistleblower/qui tam law, our dedicated team is raising the bar. Thequi tam team is here, ready, and willing to help you understand your case and develop it into the best it can possibly be before presenting it to the Department of Justice for possible intervention.
However, the government, for a number of reasons, cannot intervene in and pursue every whistleblower case. Ashcraft & Gerel’s whistleblower attorneys are uniquely qualified to litigate non-intervened cases.
We know and appreciate how much you’ve put on the line to ensure that justice is served. Our goal is not only to seek justice for the taxpayers and federal government, but also to ensure the well-being of our clients. Because of this, we’ll put just as much—and more—down, working closely with you during each stage of this process.
Have You Witnessed Pharmaceutical or Medical Device Fraud?
Pharmaceutical companies have millions, and sometimes billions, of dollars at stake in the development and marketing of new drugs. Patients’ best interests can often be lost in the drive for profit. Ashcraft & Gerel’s pharmaceutical lawyers are deeply familiar with the industry and the regulations surrounding common areas of fraud.
We are committed to protecting those who want to protect consumers by revealing instances of off-label marketing, kickbacks, scientific study fraud, or other instances of pharmaceutical and medical device fraud within the organisations they work for.
Off-Label Marketing
While doctors may prescribe drugs for any use in the exercise of their professional judgment, drug companies may not legally promote the use of a drug for purposes that are not approved by the FDA. Many of the recent large settlements between the Department of Justice and pharmaceutical companies like Glaxo SmithKline, Pfizer, Eli Lilly, Abbott, and Amgen resolved allegations of off-label marketing.
Some examples of pharmaceutical drugs that were marketed for off-label use by their manufacturers include Zofran, Risperdal, and others.
Kickbacks
It is a violation of the federal Anti-Kickback Statute for drug companies to offer to pay or pay doctors and other medical professionals money or other items of value (like free medical equipment or travel to luxury resorts, for example) to prescribe certain drugs or perform certain procedures. Similarly, doctors are prohibited by the federal Stark Law from referring cases to hospitals or other institutional providers in which they have a financial interest. The government has settled dozens of cases resolving allegations that pharmaceutical companies paid kickbacks in exchange for prescriptions over the past decade.
Scientific Safety Fraud
In recent years, drug companies have been investigated for deliberately altering, covering up, or fabricating the results of a clinical drug trial in order to gain FDA approval for a drug or to hide drug risks that might affect sales.
Good Manufacturing Practices
Federal law sets standards called Good Manufacturing Practices (GMP) that drug manufacturers are required to follow to ensure the safety of drugs. Violations of these GMPs can result in serious harm to patients, as is clear from recent news coverage of the meningitis outbreak caused by alleged failures to follow GMPs at the New England Compounding Center.
Have You Witnessed Healthcare Fraud?
Healthcare fraud is in the news virtually every day, with cases ranging from billing for procedures that are not medically necessary to billing for services not rendered, also known as “upcoding” services to a higher level in order to increase revenues. This type of fraud costs the government and, by extension, U.S. taxpayers about $60 billion a year.
Ashcraft & Gerel’s healthcare fraud lawyers have significant expertise in the area of healthcare fraud, including:
- Billing for Unnecessary Medical Services: Doctors and other medical professionals may perform procedures that are medically unnecessary to increase their income and profits. These cases have serious consequences for patients and for government health benefit programs, like Medicare and Medicaid.
- Upcoding: Medicare and Medicaid reimburse providers based upon CPT (for physician practices) and DRG (for hospitals) codes that are assigned by the American Medical Association to different procedures and office visits. Providers commit fraud when they “upcode” a procedure, office visit, or hospital stay to a higher level CPT code to increase their reimbursement. Billing Medicare or Medicaid for services not provided violates the FCA as well.
- Kickbacks: It is a violation of the federal Anti-Kickback Statute (AKS) for hospitals, nursing homes, or other providers to offer to pay or pay doctors and other medical professionals money or other items of value (such as free office space or staff) in exchange for the referral of patients. Similarly, doctors are prohibited by the federal Stark Law from referring patients to hospitals or other institutional providers in which they have a financial interest.
Have You Witnessed Government Contractor Fraud?
There has been a rapid growth in government contracting over the last few decades, as successive administrations have chosen to outsource many government functions. With this growth has come increased opportunity for contracting fraud, where contractors mismanage government money or power or fraudulently provide services or products. Government contract fraud hurts taxpayers and the government.
Ashcraft & Gerel’s government contractor fraud lawyers have successfully investigated, negotiated, and tried numerous government contracting fraud cases, including:
- Best Price Violations: Many government agencies buy goods and services through GSA Schedules, which cover everything from computers to hospital supplies. GSA regulations require sellers to give the federal government the “best price” available to their commercial customers. Failure to do so can result in liability for hundreds of millions of dollars under the False Claims Act. Ashcraft & Gerel has extensive experience in this area of practice, including a $128 million settlement in the Network Appliance, Inc. best price case.
- Trade Agreement Act Fraud: Contractors who sell to the government usually must ensure that the goods are produced in countries that have trade agreements with the United States, a requirement that excludes products from China, which does not have an agreement with the U.S. Ashcraft & Gerel also has substantial expertise in Trade Agreement Act cases.
- Billing Fraud: Billing fraud can take many forms, ranging from billing the government at inflated rates to billing for work never performed. The most common type of fraud involves switching costs from firm fixed-price contracts to cost-plus contracts to cut a contractor’s losses.
- Davis-Bacon Act Violations: This 1931 Act requires all federal contractors to pay construction workers prevailing wages. Violations of the Davis-Bacon Act also violate the False Claims Act (FCA), because the government pays the contractor the full prevailing wage under the contract. Ashcraft & Gerel attorneys frequently counsel their many union clients about DBA violations.
Have You Witnessed SEC Fraud?
In 2010, the Securities and Exchange Commission (SEC) introduced a whistleblower program targeting violations of federal securities law that may defraud investors. Though similar to the False Claims Act (FCA) whistleblower program, the SEC program has some important differences.
When a SEC fraud lawyer files a claim under the False Claims Act, the damages are limited to the money the government has lost as a result of the fraud. If a company is found liable for violating securities law, the company may have to disgorge profits related to its fraud or repay investors for losses incurred because of the fraud.
For an SEC whistleblower to receive a share of a settlement or judgment in an SEC case, the amount recovered by the SEC must exceed $1 million.
SEC violations include:
- Mail or Wire Fraud: Using the U.S. postal service, the telephone system, or the internet to commit or conspire to commit fraud is a federal offense.
- Material Misrepresentations in Stock or Debt Offering: When publicly traded companies withhold significant financial information from the public, investors may believe that a company’s stock is worth more; companies may withhold financial information that would cause the company’s stock price to decrease.
- Failure to Disclose Material Risks in Conduct of Business: Financial advisers and publicly traded companies are required to tell the public of all of the potential risks and liabilities of a course of action so that stockholders can make an informed decision whether to invest. By failing to do so, companies can artificially inflate the value of their stock; when these risks are revealed, investors can incur substantial losses for which the company may be held liable.
- Nursing Home Abuse: Nursing homes are required to provide patients with quality care and an environment that is comfortable and welcoming. When they fail to do so, they are violating 42 CFR § 483.10, and the FCA may come into play for services billed for but not provided.
Retaliation
We understand that many people hesitate to report fraud for fear of losing their jobs and livelihoods, and we recognize how much courage is necessary to take a stand and do the right thing.
We can offer you some reassurance—it is illegal for an employer to harass, demote, withhold wages, fire, or retaliate in any way against an employee who has chosen to speak to company superiors or outside legal counsel about suspected fraud (31 U.S.C. §3730(h)). Our goal is not only to seek justice for the taxpayers and government, but to ensure the well-being of our clients. Before you report fraud within your company, you should make sure that you do so in a way that is fully protected. Consulting a whistleblower attorney beforehand can help boost your confidence and arm you with knowledge of your rights.
If you have information regarding fraud, Ashcraft & Gerel’squi tam and whistleblower attorneys can answer your questions and help you understand your rights. We are happy to meet with you at one of ouroffice locations in Washington D.C., Silver Spring, Baltimore, Landover, Rockville, Fairfax, and Manassas.
