What Counts as Pharmaceutical or Device Fraud?

• Off-label promotion: marketing a drug or device for a use, dose or patient population the FDA has not approved, causing Medicare and Medicaid to pay for prescriptions that are not covered.
• Kickbacks to prescribers: speaker programs with no audience, consulting agreements with no work, free staff, lavish meals and travel, and grants tied to prescribing volume.
• Kickbacks to pharmacies, distributors and group purchasing organizations to favor a product.
• Copay assistance routed through charities to keep patients on an expensive drug while Medicare pays the rest.
• Price reporting fraud: misreporting average manufacturer price or best price under the Medicaid Drug Rebate Program, or inflating average wholesale price.
• 340B program fraud: overcharging covered entities such as safety-net hospitals and clinics for drugs that must be sold at the discounted 340B ceiling price.
• Manufacturing and quality fraud: selling product made in violation of current good manufacturing practice, concealing contamination or failed testing, or shipping devices that failed inspection.
• Clinical trial fraud: falsifying data submitted to the FDA to win approval.
• Device fraud: promoting an unapproved device, paying surgeons for implants, and concealing adverse events the company was required to report.

How a False Claims Act Case Works

The False Claims Act lets a private person, called a relator, file a lawsuit in the government’s name against anyone who knowingly submits a false claim for federal money or knowingly avoids an obligation to pay the government. The complaint is filed under seal in federal court and served on the Department of Justice, not on the defendant. The government investigates while the seal is in place, which usually takes a year or more, and then decides whether to take over the case. If the government joins, the relator generally receives 15 to 25 percent of what is recovered. If the government declines and the relator goes forward alone, the share is 25 to 30 percent. A defendant that loses pays three times the government’s damages plus a civil penalty for each false claim, which the government adjusts for inflation each year and which now runs from more than $14,000 to more than $28,000 per claim. The person who files first with the information controls the case; a later relator with the same facts is barred.

Who Brings These Cases?

Sales representatives and district managers, medical science liaisons, marketing and brand managers, contracting and pricing staff, government-pricing analysts, regulatory and quality employees, clinical trial staff, and physicians who were offered or paid kickbacks. Competitors and consultants with first-hand knowledge have also brought successful cases.

What Our Firm Does

• Evaluate whether the conduct caused false claims to federal programs, which is the element these cases turn on.
• Prepare the complaint and the disclosure statement to the Department of Justice in the detail the government expects from a pharmaceutical case.
• File under seal and work with the government’s investigators.
• Coordinate the federal case with state false claims acts where state Medicaid money is involved.
• Protect you from retaliation and pursue your share of the recovery.

Before You Report

• Do not confront the people involved or announce what you intend to do.
• Do not use a work computer, work phone or work email to contact a lawyer.
• Do not take documents you do not already have a right to see. Ask us first what you may keep.
• Write down what you know: who, what, when and how you know it.
• Do not wait. The first person to report is in the strongest position, and a later report with the same information may receive nothing.

Frequently Asked Questions

The company has a compliance program. Does that matter?

No. A compliance program does not excuse false claims, and companies with elaborate programs have paid the largest settlements. What matters is what the company actually did and what it knew.

I signed a confidentiality agreement. Can I still report?

Yes. A confidentiality agreement cannot lawfully bar you from reporting fraud to the government or filing a False Claims Act case. Do not take documents beyond what you are already entitled to have; ask us first.

Does off-label prescribing by a doctor violate the law?

No. Doctors may prescribe off label. The violation is the manufacturer promoting the off-label use and causing federal programs to pay for prescriptions that are not covered.

How long do I have?

Six years from the violation, or three years from when the government knew or should have known, but no more than ten years. The first person to file controls the case, so delay has a cost.

What does it cost?

The first conversation is free and confidential. If we take your matter, the fee terms are put in writing before any work begins.

Talk to Us Before You Report

Email msiddons@siddonslaw.com from a personal account with a general description of what you know. Do not send documents. We will reply and tell you what to do next. Attorney Michael A. Siddons represents whistleblowers in Pennsylvania, New Jersey, New York, Maryland and Washington, D.C.