Boehringer Ingelheim Pays $95M To Settle Off-Label, Kickback Claims In Civil Suit

by Tara Arick on October 27, 2012 · 0 comments

in Product Liability

- From LexisNexis® Mealey’s™ Daily Legal News.

BALTIMORE – Boehringer Ingelheim Pharmaceuticals Inc. will pay $95 million to the federal government to resolve civil allegations that it marketed three drugs for off-label uses, promoted high doses of two drugs and paid kickbacks to health care professionals, according to a settlement agreement filed Oct. 25 in Maryland federal court (United States of America, ex rel. Robert Heiden v. Boehringer Ingelheim, et al., No. 1:05-484, D. Md.).

The federal government will get $78.4 million plus interest and state Medicaid programs will get $16.5 million plus interest.

The settlement stems from a 2005 False Claims Act, 31 U.S.C.S. § 3729-3733, lawsuit filed by Robert Heiden against Boehringer and Abbott Laboratories.  Heiden will be paid his statutory share of $17 million plus interest out of the federal recovery. 

Boehringer will pay Heiden’s attorney fees and costs under a separate agreement.  The fees and costs were not specified.

Off-Label Promotion

According to the settlement agreement filed in the U.S. District Court for the District of Maryland, Boehringer marketed Aggrenox, Combivent and Micardis for off-label uses.  Aggrenox is approved to treat secondary strokes.

Combivent is approved to treat continued symptoms of bronchospasm in patients with chronic obstructive pulmonary disease (COPD) who are already using a bronchodilator.  Micardis is approved to treat hypertension.

Heiden alleged that Boehringer marketed Aggrenox for a variety of uses, including certain cardiovascular events such as myocardial infarction and peripheral vascular disease, both of which are off-label uses not covered by federally funded health care programs.

Heiden alleged that Boehringer marketed Combivent as a primary or first-line treatment of COPD, an off-label use not covered by federal health care programs.

High-Dose Promotion

Micardis was marketed for treatment of early diabetic kidney disease, another off-label use not covered by federal health care programs, Heiden alleged.

Heiden also alleged that Boehringer knowingly promoted the sale and use of Combivent and Atrovent at doses that exceeded those covered by federal health care programs.  Atrovent is another COPD drug.

Boehringer also made unsubstantiated claims about the efficacy of Aggrenox, Heiden alleged, including claiming that the drug was superior to Plavix, a competing clot-preventing drug.

All of Boehringer’s actions resulted in false claims being filed with federally funded health care programs, such as Medicare and Medicaid, Heiden alleged.


Finally, Heiden alleged that Boehringer paid kickbacks to health care professionals in return for them prescribing Aggrenox, Atrovent, Combivent and Micardis.

Boehringer does not admit liability, according to the settlement agreement.

On Oct. 22, the federal government told the court it elected to intervene in the allegations against Boehringer but declined to intervene in the allegations against Abbott Laboratories that are made in the same lawsuit.  The court unsealed Heiden’s fourth amended complaint, which was filed in November 2010, along with the government notice and settlement, but left the rest of the docket sealed.

Corporate Integrity Agreement

In addition to the settlement agreement, Boehringer entered into a five-year corporate integrity agreement with the U.S. Office of Inspector General.  That agreement requires implementation of a compliance program, the hiring of ethics compliance officers and restrictions on the use of marketing materials and the sponsorship of medical education programs.The federal government is represented by Assistant U.S. Attorneys Thomas F. Corcoran and Roann Nichols of the U.S. Attorney’s Office in Baltimore; Joyce R. Branda, Dan Anderson and Brian McCabe of the U.S. Justice Department in Washington, D.C.; Gregory E. Demske of the Office of Inspector General in Washington; Paul J. Hutter of the U.S. Defense Department in Washington; and Shirley R. Patterson and David Cope of the U.S. Office of Personnel Management in Washington.

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