DUSA Pharmaceuticals: The Instructions Behind the Levulan Claims

In the DUSA Levulan settlement, DUSA Pharmaceuticals agreed to pay $20.75 million to resolve allegations that it promoted an unsupported drug administration process and caused physicians to submit false government claims. The allegation reached into the instructions a manufacturer gave doctors about using Levulan Kerastick. Patients received the treatment, and taxpayers faced the bill for a process the government said lacked sufficient clinical support.

DUSA is a Massachusetts-based subsidiary of Sun Pharmaceutical Industries. The government alleged that DUSA knowingly promoted a process that contradicted instructions approved by the Food and Drug Administration and lacked sufficient clinical evidence, causing claims to Medicare and the Federal Employee Health Benefit Program. This pharmaceutical fraud case puts the manufacturer’s message and the physician’s claim in the same story.

Levulan Instructions and the Clinical Evidence

Levulan Kerastick is a prescription topical solution approved for minimally to moderately thick actinic keratoses, precancerous skin lesions, of the face or scalp. Its approved instructions described two stages: apply the solution to the target lesions, then, after an incubation period of 14 to 18 hours, illuminate them with blue light.

The government alleged that by January 2014, senior management at DUSA and Sun Pharmaceutical Industries knew that short incubation periods of one to three hours produced clearance rates significantly lower than those achieved in clinical trials using the 14 to 18-hour incubation. Between January 2014 and December 2016, DUSA allegedly encouraged physicians to use the shorter periods anyway, through paid physician speaker programs, paid peer-to-peer discussions, its sales force, and incomplete or misleading answers to prescribing doctors’ questions. The government also alleged that DUSA failed to tell physicians about the lower clearance rates and, in some instances, falsely stated that the rates were the same. The U.S. Attorney’s statement said patients endured repeated, less effective treatments to try to clear their lesions.

That is where product knowledge becomes valuable. A person familiar with the clinical work may recognize a difference between what a study examined and what a sales message says it supports. A person familiar with the promotion may know how that message reached a practice.

Are Pharmaceutical Companies Liable for False Claims?

Yes. DUSA agreed to settle False Claims Act allegations that its promotion caused physicians to submit false claims. As part of the settlement, DUSA and its parent, Sun Pharmaceutical Industries, agreed to a corporate integrity agreement with the Office of Inspector General of the Department of Health and Human Services, which puts procedures and reviews in place to avoid and promptly detect similar conduct. The government pursued the manufacturer over the message that led to the doctors’ bills.

The company can control the product message while a physician’s practice handles the claim. The case therefore has to connect decisions made in different places: the instruction promoted by the manufacturer, its use by the physician and the request for government payment.

Medicare and the Federal Employee Health Benefit Program were the health care payers named in the DUSA allegations. That puts public money behind the dispute over the instructions. The government’s account connects what the manufacturer encouraged to what physicians billed, so the sales side of the business belongs in the same inquiry as reimbursement.

What Is Considered Off-Label Promotion?

Off-label promotion concerns a manufacturer’s promotion of a drug for use beyond its FDA-approved labeling. In DUSA’s case, the disputed use involved the administration process. The government tied that process to insufficient clinical support and false claims for payment.

A separate allegation against Abbott Laboratories shows what that gap can look like inside a sales organization. In the TriCor case, a whistleblower described the difference between the product insert and the instructions given to representatives:

The TriCor whistleblower also alleged that representatives used a study that did not involve TriCor to answer doctors’ concerns about the drug’s outcomes. The complaint also alleged that Abbott withheld from representatives and physicians another study involving TriCor and a statin, even though the product insert used it to show the dangers of combination therapy. The contrast was in which evidence reached the sales conversation: a study that did not involve TriCor allegedly supplied reassurance, while a study involving the product stayed out of the discussion.

The same complaint alleged that Abbott required representatives to make notes after meetings with doctors, but told them to leave off-label discussions out. That detail matters to someone who remembers the conversation: the account written afterward may omit the very message at issue. The allegation points to a gap between what a company asks representatives to say and what it asks them to record.

What Evidence Is Needed to Prove Fraud?

An administration-based case turns on the connection between the company’s instruction, its clinical support and the treatment billed to the government. Our experts assess that connection with you. Someone inside sales, medical affairs or a physician’s practice may see a different part of that connection. For pharmaceutical whistleblowers, knowledge of the message behind a treatment can bring something the bill alone does not show.

Training materials and the studies behind them answer different questions from treatment and billing records. One shows what the manufacturer encouraged. Another shows what the clinical work supported. The practice’s records can connect the message to what happened with a patient and what the payer was asked to cover.

The 2018 Managed Care article Indication-Specific Drug Pricing–Simple in Theory, Complex in Reality describes a problem for payers trying to identify why a drug was used: the indication may appear in an electronic medical record without being captured at the point of sale. For an inquiry into Levulan promotion, that distinction is useful: the clinical information and the payment information may sit in different records.

How Much Money Do Pharmaceutical Whistleblowers Get for Exposing Fraud?

A whistleblower case under the False Claims Act can pay 15% to 30% of what the government recovers.

A former DUSA sales representative brought the qui tam case. The Justice Department’s announcement identified an approximately $3.5 million whistleblower reward.

The government announced the resolution on August 24, 2020.

You Know the Instruction Behind the Claim

If you know how a drug maker’s sales message differed from its approved instructions or clinical evidence, speak with our whistleblower experts. We build your strongest case with you and bring in pharmaceutical whistleblower lawyers who understand healthcare fraud, drug promotion and government reimbursement. We stay beside you as the case moves from what you saw inside the business to the pursuit of a recovery.