States settle with drugmaker on ‘below the neck’ marketing claim
The attorneys general of all 50 states and the District of Columbia recently settled with German drugmaker Boehringer Ingelheim Pharmaceuticals (BIPI) over allegedly false and misleading off-label marketing claims involving four prescription drugs. Most notably, BIPI touted one drug, Aggrenox, as effective for a variety of conditions “below the neck” such as congestive heart failure and heart attacks.
BIPI also misled Aggrenox users on the comparative effectiveness of the drug. The company said the blood thinner was better than Plavix but had no evidence substantiating that claim.
Regarding another drug, a hypertension drug called Micardis, BIPI allegedly misled patients about its ability to prevent early morning strokes and heart attacks.
BIPI is said to have misrepresented its two drugs Combivent and Atrovent as effective in treating chronic obstructive pulmonary disease (COPD).
The settlement did not require BIPI to admit any wrongdoing. However, the company will be required to pay a total of $13.5 million to the states and Washington, D.C. In addition, BIPI will be required to make certain its marketing does not unlawfully promote or misrepresent the effectiveness of the four drugs. It will also have to change its promotional practices by limiting the number of samples it provides to clinicians whose practice is related to the products’ labeling.
BIPI settled with the federal government over essentially the same conduct in 2012.
“The period during which the alleged conduct occurred ended in 2008, and most allegations are now more than a decade old,” said a spokesperson for BIPI.
Doctors can legally prescribe drugs to treat diseases other than the ones listed on the product labels. However, the U.S. Food and Drug Administration prohibits marketing drugs for off-label uses, because such uses are typically not proven by rigorous scientific and clinical studies. Nevertheless, some pharmaceutical manufacturers continue to promote drugs for off-label use.
Off-label promotions change the decisions doctors make in their patients’ interest. It is a dangerous practice that needs to be stopped.
If you were given a drug for an off-label purpose and it harmed you, it’s important to find out if the drug was marketed illegally. We urge you to contact an attorney familiar with defective drug claims and have your situation evaluated.