Dangerous Drugs & Medical Devices

Cardiac Ablation

U.S. Department of  Justice Investigates Manufacturers

The U.S. Department of Justice is investigating whether manufacturers of surgical devices that have been used to treat heart arrhythmias by cardiac ablation have violated federal law. All devices used to treat medical conditions require the approval of the U.S. Food and Drug Administration (FDA) before they can be sold and used in medical treatment. If the FDA approves a device, the approval is for specific medical purposes. In the case of a surgical instrument, FDA approval is often limited to surgery on particular parts of the body, such as the eye or knee.

Devices that use an electrical current to destroy tissue have been used by surgeons for decades as a kind of electrical scalpel to cut through tissue. However, the devices in question have not been approved by the FDA for use in surgeries to treat heart arrhythmias by cardiac ablation. When a device or drug is used for a purpose that the FDA has not approved, it is called an “off label” use. FDA regulations require manufacturers to include a written “label” with drugs or medical devices that includes a description of the FDA approved purposes. Doctors are not bound by FDA regulations and can prescribe drugs or use devices for unapproved, or off-label, purposes.

However, it is illegal for manufacturers to encourage doctors to use products for uses that the FDA has not approved. Because the sale of drugs or devices for off label purposes can result in large profits for manufacturers, some manufacturers break the law. Manufacturers sometimes advertise their products for off label uses or have salespeople promote their products to doctors at their offices for unapproved purposes. For example, in January 2009 Eli Lilly, one of the largest pharmaceutical companies in the world, paid $1.415 billion and pleaded guilty to a criminal misdemeanor charge for promoting one of its drugs for off label uses. The  Department of Justice is currently investigating whether manufacturers were illegally encouraging doctors to use their devices for the unapproved use of treating cardiac arrhythmias.

If you or a loved one has had a surgical procedure performed to treat a heart arrhythmia, you may have a legal claim.

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