Medtronic Nets DOJ Subpoena for Off-Label Promotion

Medtronic was served with a US Department of Justice (DOJ) subpoena as part of an investigation into the off-label promotion, that is to say, encouraging a modality of use unapproved by the [US] Food and Drug Administration (FDA) of its bone graft product.

Bill Hawkins, chairman and chief executive officer of Medtronic, revealed the subpoena during a conference call, but did not provide details about the DOJ request. "For years, Medtronic has had strict guidelines in place on appropriate promotion of products according to labeled indications," Mr. Hawkins held. "We are complying appropriately with the DOJ's request."

The product, Infuse Bone Graft, contains recombinant human bone morphogenic protein (rhBMP-2) that provides an alternative to bone grafts. This protein, the purpose of which is to stimulate bone growth, occurs naturally in very small amounts in all humans. Infuse is FDA approved for use in degenerative disc disease, acute tibial fractures, sinus augmentation, and localized alveolar ridge augmentation.

Although US law forbids medical companies the promotion of their products for unapproved uses, doctors are free to use medicines and medical devices for off-label uses, if they think it serves the interests of the patient.

In July 2008, the FDA issued a safety alert to warn the medical community of the 38 reports it had received within the past four years of complications following the off-label use of Infuse to repair the cervical spine. Among the complications listed were swollen necks, difficulty swallowing, breathing, and speaking. Some patients required emergency medical treatment. The FDA had approved the use of Infuse Bone Graft for the lower lumbar area of the spine. Infuse Bone Graft is implanted between the vertebrae in a titanium cage containing a collagen sponge soaked in the recombinant human bone morphogenic protein. Some surgeons, however, had been directly injecting the protein or implanting the material without the cage.

Industry analysts conclude that Medtronic does not have much to worry about, however, sales of Infuse fell after the July 2008 FDA safety alert. Metronic's spinal therapy segment of the business generates over one-fifth of its total revenue; accordingly, the company has lowered its revenue forecast for the fiscal year.

Medtronic (Minneapolis, Minnesota, USA), a Fortune 500 company, is a global leader in medical technologies that develops and manufactures a wide range of products and therapies. Its key business sectors are: cardiac rhythm disease management, neurmodulation therapies, spinal disorders, diabetes management, cardiovascular products, surgical technologies and operating room equipment; and physiologic control devices. Medtronic employs 38,000 people worldwide, and the company generated US$13.5 billion in revenues year ending April 2008.

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