Herring announces $13.5 million multistate consumer settlement with BIPI

Attorney General Mark R. Herring announced that Virginia has joined 49 other states and the District of Columbia in a $13.5 million settlement with Boehringer Ingelheim Pharmaceuticals Inc. regarding its off-label marketing and misleading representations made in the promotion of four prescription drugs: Micardis®, Aggrenox®, Atrovent®, and Combivent®.

Virginia will receive approximately $277,000 of the settlement.

“We will not tolerate deceptive or untrue marketing of any products in Virginia, especially when it involves prescription drugs that affect Virginians’ health,” said Attorney General Mark Herring. “Under this settlement, Boehringer Ingelheim will be required to provide unbiased and clinically relevant information to doctors, so Virginians can have confidence that the drugs they’re being prescribed are the ones they need and the ones that will work.”

The Complaint, filed today in Richmond Circuit Court, alleges that BIPI violated state consumer protection laws by making misrepresentations about these four prescription drugs and by representing that the prescription drugs had approval, characteristics, uses, benefits, or qualities that they did not have.

Specifically, the Complaint alleges that BIPI:

1. Misrepresented that its antiplatelet drug, Aggrenox®, was effective for many conditions “below the neck,” such as heart attacks and congestive heart failure, and that it was superior to Plavix® without evidence to substantiate that claim;
2. Misrepresented that Micardis® protected patients from early morning strokes and heart attacks and treated metabolic syndrome;
3. Misrepresented that Combivent® could be used as a first-line treatment for bronchospasms associated with chronic obstructive pulmonary disease (“COPD”); and
4. Falsely stated that Atrovent® and Combivent® could be used at doses that exceeded the maximum dosage recommendation in the product labeling and that they were essential for treatment of COPD.

The Consent Judgment requires BIPI to ensure that its marketing and promotional practices do not unlawfully promote these prescription drug products.  Specifically, BIPI will:

• Limit product sampling of the four drugs to health care providers whose clinical practice is consistent with the product labeling;
• Refrain from offering financial incentives for sales that may indicate off-label use of any of the four drugs;
• Ensure clinically relevant information is provided in an unbiased manner that is distinct from promotional materials; and
• Provide that requests for off-label information regarding any of the four drugs are referred to BIPI’s Medical Division.
• The settlement, which is in the form of a Consent Judgment, has been filed with the Circuit Court for the City of Richmond for approval.

All 50 states and the District of Columbia are participating in the settlement.

This matter is being handled by Attorney General Herring’s Consumer Protection Section. In 2016, Attorney General Herring announced the completion of a reorganization of the OAG Consumer Protection Section to more efficiently and effectively enforce Virginia’s consumer protection laws, provide exceptional customer service in resolving complaints and disputes, and provide robust consumer education to keep Virginians from being victimized by fraud, scams, or illegal or abusive business practices. During Attorney General Herring’s administration the OAG Consumer Protection Section has recovered more than $234 million in relief for consumers and payments from violators.

If you have any consumer-related inquiries, the Office of the Attorney General’s Consumer Protection Hotline telephone counselors are available to assist you with your consumer questions.  Please call the Consumer Protection Hotline at 1-800-552-9963 if calling from Virginia, or 804-786-2042 if calling from the Richmond area. You can also subscribe to the Consumer Protection Quarterly Newsletter here.