Warner-Lambert: When the Medical Liaison Was the Sales Force

The Warner-Lambert Neurontin whistleblower case produced an $83.6 million federal civil settlement over alleged off-label promotion that drove improper Medicaid prescriptions. The alleged sales operation for the drug, also known as gabapentin, reached doctors through medical liaisons, paid consulting and company-controlled education. For an insider, the revealing question was who controlled the message behind the scientific title, the lecture and the published article.

A former medical liaison brought the False Claims Act qui tam case. Parke-Davis was Warner-Lambert’s division, and Pfizer acquired Warner-Lambert in June 2000. The Department of Justice announced the resolution on May 13, 2004. This pharmaceutical fraud case put the work of selling a drug beside the work of making that sales pitch look like independent medical judgment.

Medical Liaisons With a Sales Assignment

The whistleblower alleged that Parke-Davis employed its medical liaisons exclusively in sales and promotion while presenting them as research personnel. He alleged that they received instructions to exaggerate safety and efficacy claims and misrepresent their scientific credentials.

The Food and Drug Administration originally approved Neurontin in December 1993 for supplemental treatment of epileptic seizures alongside another drug. According to the Justice Department, Warner-Lambert promoted it for bipolar disorder, pain disorders, migraine, attention deficit disorder and other unapproved uses, as well as for use on its own in epilepsy.

The government’s account described sales representatives initiating one-on-one pitches about those uses without a prior inquiry from the doctor. Medical liaisons supplied another route into the same conversation, presenting themselves as scientific experts in particular diseases.

Paid Consulting and Company-Controlled Education

Warner-Lambert allegedly paid doctors to receive the pitch as well as paying people to deliver it. The Justice Department described consulting meetings at expensive dinners and conferences where physicians received fees but provided little or no significant consulting. Trips included Florida, Hawaii and the Atlanta Olympics.

The company also used teleconferences. Sales representatives recruited doctors to dial in and hear a physician or company employee discuss an off-label use.

The alleged control extended across purportedly independent medical education: topics, speakers, content and participants. The Justice Department said Warner-Lambert misled the medical community about both the content and the lack of independence. When one speaker proposed unfavorable remarks, the company planted people in the audience to ask questions highlighting the drug’s benefits. Even the questions could be part of the promotion.

Preceptorships brought the representative into the examination room. Warner-Lambert allegedly paid physicians to let a sales representative accompany them while they saw patients, with the representative offering treatment advice biased toward Neurontin. The payment bought access at the moment a doctor was deciding how to treat someone.

The Efficacy Claim Against the Study Result

The alleged Neurontin off-label marketing included efficacy claims that contradicted the evidence. The Justice Department said the company promoted Neurontin as the sole treatment for epileptic seizures after the Food and Drug Administration had rejected that use. It also described promotion for bipolar disorder despite a study in which a placebo worked as well or better.

That changes the significance of a training deck or medical presentation. An insider may know both the result the company received and the claim it instructed staff to make. The difference connects the scientific work to the sales decision.

The 2012 literature review Corporate Crime in the Pharmaceutical Industry Is Common, Serious and Repetitive, from the Nordic Cochrane Centre, describes another part of that system. Its Neurontin discussion reports that the company tracked high-volume prescribers and rewarded them with speaker, consulting or study-recruitment roles. It also describes ghostwritten articles:

The review’s point reaches beyond a misleading conversation. An article carrying a physician’s name could lend apparent independence to the same message the company wanted its representatives to deliver.

Why Warner-Lambert Avoided New Approvals

According to the Justice Department, Warner-Lambert decided against seeking approval for new uses because it feared helping generic competitors compete with a planned successor drug. Neurontin was expected to lose patent protection. The company wanted its successor approved for epilepsy and other uses, without first giving those additional uses to the product that generics would compete against.

A manufacturer sells a drug with a particular approved label, dosage form and route, under the patents and exclusivities attached to that product. Decisions about which use to develop therefore affect both the present drug and the next product’s competition.

The approval history later changed. The court’s account of subsequent FDA dealings records that Pfizer sought a broad neuropathic-pain indication and withdrew that application. In May 2002, the Food and Drug Administration approved the narrower use of Neurontin for post-herpetic neuralgia in adults, pain associated with shingles. Approval concerned a specific use, while the marketing strategy sought a much wider market.

What the Later Kaiser Case Exposed

A separate case brought by Kaiser produced court findings about the Neurontin paper trail. In its August 31, 2011 amended findings, the federal court in Massachusetts found that Pfizer showcased favorable information while suppressing negative clinical-trial evidence.

The court traced the promotion through healthcare advertising and medical-communications agencies. A joint publications committee developed messages about off-label uses for journal articles and medical education while unfavorable evidence was delayed or suppressed.

The court also found that Parke-Davis sponsored a medical education event in 1997 where doctors were told to use up to 4800 mg a day for bipolar disorder. The approved maximum was 1800 mg a day, and the court found that the higher-dose pitch was an intentional misrepresentation.

One internal document made the selection rule unusually plain. The court quoted a cover letter to a bipolar marketing assessment:

The condition for publication was a favorable result. The court credited an expert’s comparison of study protocols, research reports, internal emails and published articles, which exposed differences between what had been planned, what had been done and what doctors could read. A doctor relying on the published literature could not see the negative reports kept out of it.

The medical-liaison training supplied another comparison. The court recounted testimony that a recorded presentation described the FDA’s rules. Once the camera was off, the trainers told the liaisons to dismiss what had just been said and concentrate on selling. The same training meeting included an instruction about the importance of avoiding a paper trail. Compliance was for the camera. Selling was the job.

How Neurontin Promotion Reached Medicaid

Medicaid coverage for outpatient drugs turned on an approved use or support in recognized drug reference works, called compendia. That made the evidence behind a prescribing claim important to payment as well as treatment.

The government’s payment allegation connected false statements and inducements to prescriptions Medicaid should not have paid. The Justice Department said doctors wrote prescriptions for Medicaid patients that were ineligible for reimbursement because the company had obtained them through false claims to physicians and kickbacks, including consulting fees and trips.

Taxpayers funded the prescriptions, while patients depended on doctors whose judgment the company had allegedly distorted. The connection runs from the message or payment to the prescribing decision and then to reimbursement by government health care programs. Our work with an insider is to connect those parts of the same transaction.

Federal purchasing also showed how far the product had spread. The Department of Veterans Affairs reported that its total Neurontin purchases rose from $287,000 in 1994 to $43.2 million in 2002, attributing part of that growth to Parke-Davis’s marketing.

What Evidence Is Needed to Prove Fraud?

In a case like Neurontin, the useful evidence connects what the company knew, what it told doctors, what it paid for and the prescriptions government programs funded. A medical-affairs employee may know the study findings. A sales employee may know the instructions delivered in training. Someone working on publications or education may know who actually controlled a supposedly independent message.

The original whistleblower alleged that liaisons were instructed to coach doctors on concealing the off-label nature of prescriptions when reimbursement questions arose. He also alleged document shredding, falsification and instructions to market without leaving a paper trail. These allegations explain why the case concerned concealment as well as the claims made about the drug.

The later Kaiser findings show the value of comparing records across functions: the research protocol against the article, the negative result against the publication plan, and the recorded training against the instruction employees actually received. The paid meetings and education programs add another comparison, between the work described and the work performed. Those are connections we examine with you when assessing the conduct you saw.

A separate whistleblower complaint against Bayer alleged a similar use of apparently independent literature in promoting Trasylol:

That complaint alleged that Bayer ghostwrote or influenced the studies while hiding its relationship with the authors. The parallel is the apparent independence of the evidence handed to the doctor. The person who knows how an article or education program was commissioned may see the company’s role where the recipient cannot.

Neurontin Settlement and Whistleblower Reward

The federal civil amount in the Neurontin settlement addressed the federal share of Medicaid losses. Warner-Lambert separately agreed to pay $68.4 million for state Medicaid losses and $38 million for consumer harm and a remediation program.

Pfizer also undertook a compliance program addressing training and supervision of marketing and sales staff, with detection and correction of future off-label marketing. Those obligations reached the same work the case had exposed: how the sales message was taught, delivered and monitored.

How Much Money Do Pharmaceutical Whistleblowers Get for Exposing Fraud?

The Justice Department announced that the former medical liaison would receive approximately $24.64 million from the civil recovery. A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

You Know What the Scientific Message Left Out

If you know how a study result became a sales claim, or who controlled an independent-looking education program, speak with our whistleblower experts. We build your strongest pharmaceutical whistleblower case with you, bring in pharmaceutical whistleblower lawyers who understand promotion and government reimbursement, and stay beside you through the whole journey.