Skip to main content

Pharmaceutical Fraud

Nolan Auerbach & White provides experienced pharmaceutical fraud attorneys for healthcare whistleblowers with knowledge of pharmaceutical kickbacks, pharmaceutical fraud, and pharmaceutical pricing fraud schemes under the qui tam provisions of the federal False Claims Act. Our pharmaceutical fraud lawyers have helped numerous clients receive multi-million dollar Relator share awards. This area of the Nolan Auerbach & White site provides information for pharmaceutical fraud whistleblowers.

The purpose of the qui tam provisions of the False Claims Act is to encourage private individuals who are aware of pharmaceutical off-label marketing fraud, pharmaceutical kickbacks, pharmaceutical pricing fraud, and other fraudulent activities being perpetrated against the government to bring such information forward. Nolan Auerbach pharmaceutical fraud attorneys have broad experience in preparing, investigating, and prosecuting False Claims Act cases involving, inter alia, drug company kickbacks, pharmaceutical pricing schemes, false average sales price cases, and off-label whistleblower cases.

In increasing numbers, pharmaceutical fraud whistleblowers have come out of the woodwork to expose pharmaceutical fraud. Several hundred pharmaceutical fraud cases covering more than 500 drugs are now under investigation by the U.S. Department of Justice under the False Claims Act. Settlement of the first 16 pharmaceutical fraud cases (including kickbacks, Medicaid rebate fraud, and best price violations) brought by whistleblowers has returned over $10 billion to the U.S. On the radar screen in addition to pricing schemes, off-label marketing fraud and pharmaceutical kickbacks, are NDA fraud, GMP fraud, clinical trial fraud, average sales price fraud, Medicaid rebate fraud, and a variety of other fraudulent schemes exposed by pharmaceutical fraud whistleblowers.

Kickbacks

Federal law prohibits pharmaceutical kickback fraud because it is thought to color the judgment of the physician, i.e. the physician will prescribe a prescription drug based not on what is best for the patient, but based upon what prescription drug product most increases the physician’s bottom line. This is bad for the patient and bad for Medicare, Medicaid and other Government healthcare programs. Other examples of kickbacks are as follows:

  • Offering Pharmaceutical Kickbacks to Physicians in the Form of Phony Drug Studies
    Some pharmaceutical companies have provided remuneration for post-marketing clinical studies as a means to induce physicians to prescribe their products. The “research” performed has no legitimate value, and is merely a pretext for payments for referrals.
  • “Phony Speaker fees” paid for by Honoraria
    Some pharmaceutical companies have used “honorarium” fees or “speaker” fees for physician marketing. Approved by management, they are ostensibly compensation to physicians for agreeing to speak at a true educational event.
  • Phony Grants
    Approved by management, pharmaceutical sales representatives have been allowed by certain companies to give “grants” to physicians, physician groups and other healthcare providers, ostensibly for an educational program or research program.
  • Phony Investigator Meetings
    In some pharmaceutical companies, investigator meetings are ostensibly called for physicians to talk about potential non-indicated uses of drugs. Sales representatives are allowed and instructed to spend lavishly on all physicians, both the speakers and invitees. It has been typical for investigator meetings to last only two hours, yet pharmaceutical companies paid for the physicians’ airfare, hotel, golf, spa treatments, etc. at luxury hotels around the country.
  • Advisory Board and other Meetings
    These meetings are typically for the ostensible purpose of getting input/feedback from physicians on drug performance, how they treat disease states, etc. During Advisory Board meetings, honoraria, lavish entertainment and expenses for physicians are paid for by the pharmaceutical companies.

Read more about Kickbacks

Off-label Marketing

Nolan Auerbach pharmaceutical fraud lawyers have extensive experience in this area of the law, but we are very selective. We believe that an off-label marketing case is worth pursuing only if there is some type of efficacy issue and/or patient harm resulting from the illegal off-label promotion. Our pharmaceutical fraud lawyers have been very successful with this approach. For more information on off-label marketing, click here.

Read more about Off-Label Marketing

Clinical Trial Fraud

Clinical trials sponsored by pharmaceutical companies (“pharma”) may not always produce the same results as those conducted by the government and other public entities. For example, in an analysis published in the American Journal of Psychiatry, it was found that in every publicly available trial funded by pharma that compared five new antipsychotic drugs against each other, the results of 9 out of 10 studies concluded that the best drug was the one manufactured by the pharmaceutical company sponsoring the study. The article suggests that such divergent results can be the result of biases in trial design and even in interpreting the study outcome. Experts say that this situation is even more prevalent in trials that measure symptomatic relief as opposed to whether or not a disease was actually cured, as such trials lend themselves to less stringent interpretation. Nolan Auerbach pharmaceutical fraud attorneys represent whistleblowers in qui tam cases involving drugs that were approved by the FDA based upon fraudulent manipulation of clinical trial data – clinical trial fraud.

 

GMP Fraud

GMP fraud is a practice that also frustrates the scientific process and jeopardizes the integrity of the drug product. “GMP” fraud is the acronym for the Current Good Manufacturing Practice Guidelines.

The GMP regulations stem from Congressional concern over the danger that impure and otherwise adulterated drugs might escape detection under a system predicated only on seizure of drugs shown to be in fact adulterated. That is, Congress desired to require manufacturers to abide by laws that, if complied with during the manufacturing stage, would theoretically prevent pharmaceuticals from contamination, bioavailability, or potency defects, for example. The GMPs require manufacturers to have adequately equipped manufacturing facilities, adequately trained personnel, stringent control over the manufacturing process appropriate laboratory controls, complete and accurate records, reports, appropriate finished product examination, and so on. Certain violations of the Good Manufacturing Practice Regulations may be the basis for a False Claims Act lawsuit.

Read more about GMP Fraud

Complete our Pharmaceutical Questionnaire for a quick response. We understand and we care.

  • CGMP Violations – describes violations of the Current Good Manufacturing Practices promulgated by the FDA.
  • Best Price Fraud – a quick trigger questionnaire to determine if Best Price Fraud has occurred.
  • CME Fraud – describes the use of Continuing Medical Education by pharmaceutical companies as a means to improperly influence and induce physicians to prescribe their products.
  • Unapproved Drugs – describes the Drug Efficacy Study Implementation Program.

REAL PEOPLE making real change Meet Some of our Heroes

Kathleen Hawkins

Dignity Health
$37 million

Kathleen Hawkins, RN MSN, had been employed by Defendant, Catholic Healthcare West (CHW) for approximately 6 years when she decided she had had enough of trying to change the hospital system from within.

CHW, a California not-for-profit corporation that operated hospitals in California, Arizona, and Nevada, was at the time the eighth largest hospital system in the nation and the largest not-for-profit hospital provider in California.

READ MORE

Joe Strom

Johnson & Johnson
$184 Million

Joe Strom contacted us in 2005. We were very grateful that he did. We immediately formed an all-star legal team and a process to stop a very harmful pharmaceutical marketing strategy. It was this process we set into motion that ultimately returned hundreds of millions of dollars to the U.S. Treasury, and a portion of that, very well-deserved, into Joe’s bank account.

Joe told us a very troubling story about the off-label promotion of a pharmaceutical drug for patients who already suffered from chronic heart failure.

READ MORE

Bruce A. Moilan Sr.

$27 Million

Bruce Moilan was a seasoned hospital systems expert by the time he contacted our Firm. At the time he decided to file his qui tam lawsuit, he was employed by South Texas Health System as a System Director for Materials Management. In this position, he oversaw $24 million in annual purchases of supplies and equipment and helped determine budget, reduction and cost analysis throughout the contract bidding and negotiations process. His job was to insure proper implementation for purchasing, receiving and management of inventory, for McAllen Hospitals, L.P.

READ MORE

Description
Description
Description

“I collaborated with Nolan, Auerbach and White on a broad variety of cases where whistleblowers stepped forward to disclose tactics employed by large companies to influence physicians' medical decision-making in patient care. They provide ample resources to not only optimize their client cases, but in doing so consistently leverage best medical evidence to further patient safety and resource utilization.”

— Fred Polsky M.D., Former Medical Director, CMS Zone 7 Integrity Contractor

Any Questions?

Am I potential whistleblower that matches up well with our firm?

We only want to represent amazing people.

How much will I make?

We cannot guarantee anything, but we will deliver on this promise: we will give you feedback and a prognosis within 48 hours of your submission of all details to us. We are the first healthcare fraud qui tam law firm, and have been doing only healthcare fraud whistleblower lawsuits for decades-so you can expect as accurate a picture as is possible.

Are my communications with you confidential?

They are 100% confidential. If we do not take your case, your information becomes inaccessible. We have no interest in it. Besides, it is protected by the attorney-client privilege under our lawyer regulations, and we would lose our license if we were to disclose one iota of information about you or your potential case.

    Contact Us

    Contact Us

    The more detailed the response, the more likely it is that we will be able to evaluate and determine if your potential False Claims Act case falls within our case requirements. IF IT DOES, WE WILL RESPOND TO YOU WITHIN 24 HOURS. (Names of potential defendants are not necessary at this point, should you feel more comfortable omitting them.) By law, all communications to us are 100% confidential.

    No. of Employees at the Company?
    Please read the following statement and then click "Send Form":

    Any response to your e-mail will be solely to communicate about our possible representation of you under the qui tam provisions of the False Claims Act. All e-mails submitted to us, whether we take your case or not, are 100% confidential. If we do not respond to your e-mail, then you have communicated information which we cannot address because it appears to fall outside of the False Claims Act or our case requirements.

    Back to top