Boehringer Ingelheim: The Uses, Doses and Claims Behind the Sales Pitch

In the Boehringer Ingelheim whistleblower settlement, the company agreed to pay $95 million to resolve allegations of improper drug promotion and kickbacks that caused false government health care claims. The drugs were Aggrenox, Atrovent, Combivent and Micardis. The government alleged that taxpayers paid for prescriptions the programs should not have covered.

The Department of Justice announced the civil settlement on October 25, 2012. A former sales representative for the Connecticut-based manufacturer brought the False Claims Act case. The pharmaceutical fraud case reached from the manufacturer’s sales pitch to the public money spent on prescriptions.

What the Settlement Covered

The settlement allocated $78,455,048 to the federal government and $16,544,952 to state Medicaid programs.

Boehringer also agreed to enter a Corporate Integrity Agreement overseen by the Department of Health and Human Services’ Office of Inspector General. It called for procedures and reviews to prevent and promptly detect similar conduct. Its stated focus included making the company’s relationships with physicians more transparent and holding board members and corporate executives accountable.

Promoting a drug for a different disease, promoting a higher dose, overstating its advantage over another product and paying someone to prescribe it each leave a different trail inside a manufacturer.

What Is Considered Off-Label Promotion?

Off-label promotion means marketing a drug for a use outside its FDA-approved labeling. In the Boehringer Ingelheim off-label promotion case, the government connected the promoted uses to prescriptions that federal health care programs did not cover.

That connection matters because the manufacturer and the healthcare provider occupy different places in the transaction. The manufacturer promotes the product. A physician or pharmacy submits the claim. The False Claims Act allegation connects the promotion to the resulting government bill.

Medicaid’s medically accepted uses include FDA-approved uses and uses supported by specified drug reference works. The Boehringer allegations turned on what the drugs were promoted to treat, not just which brand appeared on the prescription.

Aggrenox and the Claim of Superiority to Plavix

Aggrenox carried allegations about both the conditions it was promoted to treat and the evidence behind its sales pitch. The Justice Department described its approved use as preventing secondary strokes, meaning another stroke after an earlier one.

The government alleged that Boehringer instead promoted Aggrenox for certain other cardiovascular events, including myocardial infarction and peripheral vascular disease. Those were the uses it identified as outside medically accepted indications and federal program coverage.

Separately, the government alleged that Boehringer knowingly made unsubstantiated efficacy claims, including that Aggrenox was superior to Plavix. That allegation concerns the comparison a prescriber was being asked to believe. A claim about which drug works better can influence the choice between products, while a claim about another condition can expand the patients for whom the product is prescribed.

Combivent and Its Place in Treatment

Combivent’s alleged promotion changed where the drug belonged in treatment. The Justice Department described its FDA-approved use as treating continuing bronchospasm symptoms in patients with chronic obstructive pulmonary disease who were already taking a bronchodilator.

The government alleged that Boehringer promoted Combivent for use before another bronchodilator. The disease could remain the same while the sequence changed.

Atrovent and Combivent Doses Beyond Coverage

Atrovent’s specific promotion allegation concerned dose. The government alleged that Boehringer knowingly promoted its sale and use at doses above those covered by federal health care programs, alongside the same allegation about Combivent.

For an insider, the dose is a concrete part of the pitch that can be compared with the prescription and the program’s coverage.

Micardis and Early Diabetic Kidney Disease

Micardis was approved to treat hypertension. The government alleged that Boehringer promoted it for early diabetic kidney disease, a use it identified as neither medically accepted nor covered by federal health care programs.

The Separate Boehringer Ingelheim Kickback Allegation

The Boehringer Ingelheim kickback allegation concerned payments to healthcare professionals to induce prescriptions for all four products.

Payments intended to buy prescriptions raise a different question from the accuracy of a clinical claim. The promotion allegations concerned what Boehringer said about a drug. The kickback allegation concerned what it paid people to do.

The alleged bargain gave the prescriber a financial reason to choose the company’s drugs, while public programs paid the bill.

What a Sales Representative Can See

A former Boehringer sales representative brought the qui tam case behind this settlement. The role puts the company’s promotional message at the center of the account: what a product was presented as doing, which prescribers heard it and what use the company wanted them to adopt.

For this kind of case, our work connects the insider’s account to the particular product, promoted use or dose, supporting clinical claims and resulting government payments. Someone familiar with the sales message may recognize the disputed promise before someone reviewing claims sees why the prescription was written.

Public Citizen’s Health Research Group found in its 2010 study of pharmaceutical settlements that whistleblower cases accounted for 67% of federal settlement payouts from 2001 through 2010.

The study described why employees matter:

A Different Boehringer Case Turned on Reported Prices

The separate average wholesale price case involving Roxane Laboratories shows another way a manufacturer’s commercial decisions can affect public payments. In December 2010, the Justice Department announced a $280 million settlement involving Roxane and Boehringer Ingelheim over alleged inflated reported prices for nine generic drugs and marketing of the reimbursement spread.

The alleged selling point there was the gap between what providers paid for the drugs and what government programs reimbursed. The promotion case turned on clinical uses, doses, efficacy statements and prescribing payments. Product-promotion records explain one. Reported prices and acquisition costs explain the other.

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. In this case, the Justice Department announced a Boehringer Ingelheim whistleblower award of more than $17 million for the former sales representative who brought the case.

You Know the Pitch That Reached Prescribers

If you know how a drug’s uses, doses or claimed advantages were sold inside the business, speak to one of our whistleblower experts about that pitch. We put your product knowledge to work building your strongest pharmaceutical whistleblower case and bring in pharmaceutical fraud whistleblower lawyers who understand promotion and prescribing incentives. We stay with you through the case.