AbbVie: The TriCor Sales Pitch and the Humira Patent Fight

AbbVie fraud and antitrust cases include a $25 million TriCor settlement over alleged kickbacks and off-label promotion, and a dismissed private antitrust challenge to Humira’s patents and market-entry agreements. The TriCor complaint reaches inside the sales operation: what representatives were trained to say, what they allegedly left out of their notes, and which doctors received payments. The Humira case turns on patent rights and the terms competitors accepted to enter the market.

The TriCor whistleblower case, one of the pharmaceutical fraud cases built from inside a sales force, began with a former Abbott sales representative. Abbott Laboratories and AbbVie agreed to resolve it in a civil False Claims Act settlement the Department of Justice announced on October 26, 2018. The allegations concerned the promotion of a lipid-regulating drug and payments intended to influence prescriptions. Abbott split into Abbott and AbbVie in 2013, with AbbVie taking over its proprietary pharmaceutical business.

What Is Considered Off-Label Promotion?

Off-label promotion means marketing a drug for uses the FDA has not approved. In the TriCor settlement, the government alleged off-label promotion for reducing cardiovascular events and cardiac risk, combining TriCor with statins, and using it as a first-line treatment for diabetic patients. The Justice Department said those promoted uses lacked FDA approval and federal healthcare coverage.

TriCor’s approved role was treating lipid disorders alongside diet. The alleged sales campaign reached further, into claims about preventing cardiac problems and treating diabetic patients. For a medical-affairs or sales employee, that difference lives in the product information, the studies circulated to physicians and the messages used during a doctor’s visit.

The settlement also covered alleged physician kickbacks between 2006 and 2008. According to the government, sales representatives supplied gift baskets, gift cards and other items to induce prescriptions. The government said Abbott also paid for consulting and speaking engagements in which one purpose of the payment was to induce or reward TriCor prescribing.

Both parts concerned influence over the prescription: the clinical message delivered to the doctor and the benefit offered to the person deciding what to prescribe. Taxpayers paid through the government health care programs that the alleged campaign reached.

The TriCor Sales Campaign Inside the Doctor’s Office

The whistleblower alleged that Abbott supplied the sales message while controlling how much of it survived in the written account of a visit. The complaint’s account of the call notes is unusually specific:

The alleged instruction put a hole in the record exactly where the disputed promotion would have appeared. Someone reviewing the notes could see that a sales call happened while missing the part of the conversation the complaint challenged.

The complaint also alleged that Abbott trained representatives and supplied scripts encouraging doctors to prescribe TriCor with statins, but omitted the combination’s risks from those materials. It said a study involving TriCor and the statin Pravachol appeared in the product insert to show combination-therapy dangers, yet Abbott gave neither the representatives nor physicians copies of that study.

Those allegations identify a concrete comparison for an insider: the information in the product insert against the information put into the sales force’s hands. A training script can show how the company wanted the conversation to go. Instructions about call notes can show how it wanted that conversation recorded.

When the Study and the Sales Message Diverged

The complaint alleged that Abbott coached representatives to downplay the FIELD Study’s lack of a significant reduction in coronary heart disease mortality. It said the study appeared in the product insert and went to doctors, but the sales force received instructions on minimizing the disappointing outcome.

The whistleblower also alleged that Abbott told representatives to answer doctors’ concerns about TriCor’s outcomes with the VA-HIT study, which did not involve TriCor. According to the complaint, the resulting efficacy claims lacked support in the data and contradicted the product insert.

That is a different problem from simply leaving a study undistributed. In the alleged FIELD strategy, doctors received the study and then heard a message designed to discount its result. In the alleged VA-HIT strategy, results from a study of another treatment answered questions about TriCor. The underlying study and the company’s instructions for discussing it belong together.

How Do Pharmaceutical Kickbacks Work?

The alleged TriCor kickbacks worked by putting money or benefits in the hands of doctors selected for their prescribing. The complaint described a targeted speaker receiving $500 or more, plus dinner at an expensive restaurant. The speaker could supply an audience of staff, friends and practitioners whose specialties had nothing to do with coronary care or cholesterol and triglyceride management.

That audience matters. The allegation described a paid event whose attendees could include people outside the clinical subject supposedly being discussed. The invitation, the fee and the room’s actual occupants tell more about the event than the label on an expense report.

The complaint also described payments to doctors serving as preceptors for sales representatives:

The alleged selection criterion was already high prescribing. The alleged purpose was more prescribing. Those are the decisions a sales employee may recognize behind a consulting or educational payment.

Where the Sales Message Met the Prescription

For the TriCor allegations, the disputed connection ran from the company’s promotion and physician payments to prescriptions billed to government programs. Sales materials, doctor targeting and payment records show different parts of that connection. Our work with pharmaceutical whistleblowers starts with what their role lets them explain about those decisions.

Abbott challenged that connection in its filed response to the complaint. The company argued that the challenged uses fell within approved or medically accepted uses, and that the complaint failed to connect its conduct sufficiently to doctors’ prescriptions, pharmacy reimbursement requests and false government claims.

For an insider, the practical point is the link between the field message and the paid prescription. A medical-affairs employee may understand what a study showed and how the sales force presented it. A sales employee may understand why a doctor received an invitation or payment. We examine how that knowledge fits the prescribing and reimbursement evidence.

Abbott’s earlier Depakote matter shows the same alleged pattern: a sales force promoting a drug for uses outside its approved label. In an agreed statement of facts filed in the Depakote criminal case, Abbott admitted maintaining a nursing-home sales force targeting agitation and aggression in elderly dementia patients. In TriCor, the disputed pitch concerned lipid treatment, statin combinations and cardiac-risk claims.

The TriCor Settlement and Whistleblower Reward

The TriCor settlement allocated $23.2 million to the federal government and $1.8 million to state Medicaid programs. The Justice Department announced a $6.5 million share of the recovery for the former sales representative who brought the qui tam case.

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

Public Citizen’s 2010 study of pharmaceutical penalties found that whistleblower cases accounted for 67% of total payouts in federal pharmaceutical settlements from 2001 through 2010. The TriCor sales representative’s account fits a much larger pattern: insiders explaining what happened behind the prescription.

AbbVie Humira Patent Count and Antitrust Dismissal

The Humira antitrust case was a challenge by private health plans to AbbVie’s patent portfolio and agreements with potential competitors. The challenge was dismissed, as the Seventh Circuit’s opinion explains.

Humira is adalimumab, a biologic used for conditions including rheumatoid arthritis and Crohn’s disease. The plans paid for their beneficiaries’ treatment and alleged that AbbVie’s patent thicket kept competing biosimilars off the market.

The court said the basic U.S. Humira patent expired at the end of 2016, but AbbVie had obtained 132 additional patents covering details such as manufacturing or administering the medicine. The last of those patents would expire in 2034. The original patent expired. The barriers facing competitors did not disappear with it.

The House Committee on Oversight and Reform’s May 2021 report counted a broader group: at least 257 Humira-related patents owned or applied for, with the last set to expire in 2037.

The plans argued that the number of potentially applicable patents deterred competitors from launching. The court rejected their attempt to make the portfolio’s size itself the basis of an antitrust claim.

Humira’s European and U.S. Entry Dates

The purchasers also alleged that AbbVie traded earlier European competition for later U.S. competition. According to the court, the patent settlements allowed U.S. entry during 2023, with different dates for different competitors, while the European agreements used an October 2018 entry date.

The purchasers treated the European opportunity as something AbbVie gave competitors in return for waiting in the United States. The court rejected that reasoning, distinguishing earnings AbbVie gave up from a payment to a rival to stay out. For a market-access employee, the terms linking territories and entry dates were the business decisions at the heart of this dispute.

You Know How the Prescription Was Won

If you know how the sales message, doctor payments and prescribing targets fit together, talk with our whistleblower experts about building your strongest pharmaceutical whistleblower case. We work beside you to build the pharmaceutical fraud case and bring in pharmaceutical whistleblower lawyers who understand promotion, kickbacks and government reimbursement. Your knowledge of how the company sold the drug belongs at the center of that work.