Off-Label Marketing of rhBMP and the InFuse Bone Graft
In mid-November 2008, Medtronic disclosed that the Department of Justice (“DOJ”), is investigating the off-label use of a Medtronic implant. The off-label use investigation is believed to center around the InFuse Bone Graft being used in cervical spine (neck) surgeries. The active ingredient in the InFuse Bone Graft is rhBMP, which is a protein that may be causing various potentially lethal side effects to patients within hours or days of surgery, including swelling of neck and throat tissue that can result in suffocation. Use of the InFuse Bone Graft and/or rhBMP in the cervical spine surgeries is clearly off-label. According to a report in the WSJ, the FDA has received 280 reports of side effects involving the InFuse and about three-quarters of those reports involved off-label use of the InFuse Bone Graft.
In July 2008, the FDA put out a warning that reiterated that the FDA has approved the use of two rhBMPs for what the FDA refers to as “well-defined medical conditions in limited patient population[.]” The approved uses include:
- rhBMP-2 (contained in the Medtronic InFuse Bone Graft), which the FDA gave premarket approval to for fusion of the lumbar spine in skeletally mature patients with degenerative disc disease at one level from L2-S1 and for healing of acute, open tibial shaft fractures stabilized with an IM nail and treated within 14 days of the initial injury. rhBMP-2 is also approved for certain oral and maxillofacial issues.
- rhBMP-2 (referred to as OP-1 and contained in OP-1 Implant and OP-1 Putty), which the FDA gave humanitarian device exemption approval as an alternative to autograft in recalcitrant long bone nonunions where use of autograft is unfeasible and alternative treatments have failed. The FDA has also approved rh-BMP-7 as an alternative to autograft in compromised patients requiring revision posterolateral (intertransverse) lumbar spinal fusion for patients whom autologous bone and bone marrow harvest are not feasible or are not expected to promote fusion.
The government typically investigates claims of off-label use involving medical devices and pharmaceutical drugs because the government, through insurance programs like Medicare and Medicaid, purchases such health care products. Off-label use of the InFuse Bone Graft would likely not be covered by Medicare and any claims submitted for reimbursement to Medicaid or Medicare might require a representation that the device was used for its intended purpose and not for any off-label purpose. Because the InFuse Bone Graft is not approved for cervical spine surgery, use for that purpose would be considered off-label.
The federal government has recovered billions of dollars from drug companies in recent years over charges that their products were promoted for sues beyond those approved by the Food and Drug Administration. Such claims are frequently brought through whistleblowers, who bring the fraud to the attention of DOJ.
Seek Legal Help Today
If you or a loved one underwent spine graft surgery in the neck area and suffered an allergy like reaction, contact us today for a confidential free case evaluation to determine whether rhBMP or the InFuse Bone Graft was used in your surgery. You may have claims against the surgeon, Medtronic and/or Wyeth for the off-label use of rhBMP and the InFuse Bone Graft. Contact us today.