Doctors Face Medtronic Infuse Bone Graft Lawsuit

Minneapolis, MNTwo former employees of Medtronic Inc.'s spinal products division have alleged that over 100 physicians and physician groups received kickbacks to promote Medtronic's Infuse Bone Graft. The former employees made their claims in a federal whistleblower lawsuit last year, however the lawsuit was only recently made public.

According to the lawsuit, the Infuse Bone Graft was illegally marketed for uses that were not approved by regulators. Infuse has now been linked to life-threatening complications when it is used for not approved purposes. Complications include swelling of the neck and throat tissue, which compresses the airways. This can cause difficulty swallowing and breathing and can require tracheotomies and additional surgeries to repair. So far, the FDA has received reports of 38 adverse events over a four year period, however those numbers are likely low as not all adverse events are reported.

It is illegal for Medtronic to promote the off-label use of Infuse Bone Graft, but it is not illegal for doctors to use the product for off-label purposes. However, it is illegal for doctors to promote or market the use of the product if they were paid by Medtronic to do so or if they have financial ties to the company.

According to the lawsuit, "…a manufacturer still may not legitimately promote off label uses through physician studies when the investigating physician is not truly independent or impartial, nor if the physician is in fact an agent of the manufacturer based on significant financial relationships." The suit goes on to note, "Under the anti-kickback laws, companies may not offer or pay any remuneration, in cash or kind, to induce physicians or others to order or recommend drugs or devices which may be paid for by a federal healthcare program such as Medicare or Medicaid."

The lawsuit alleges that doctors were involved in improper off-label promotion of products, withholding adverse data and publishing favorable off-label data authored by physicians who received compensation from Medtronic. Finally, the lawsuit claims that the doctors involved were paid false "consulting fees" in 2006, despite not ever performing actual consulting services for the company. At least one physician allegedly received over $375,000 a year for such consulting fees, while others received upwards of $200,000 a year.

Infuse was responsible for $815 million of Medtronic's $13.5 billion in revenues in 2007. The company has faced other lawsuits that alleged it paid kickbacks, however those suits were either settled out of court or were dismissed. So far, Medtronic has not admitted any wrongdoing and has asserted that its doctors are fully compliant with the law.

Patients who received Infuse Bone Graft are now left to wonder if it was used for off-label purposes in their surgery and if they may suffer the same adverse reactions as those reported by the FDA. Although the FDA's warning is related to neck surgeries, it is possible that patients may have suffered negative reactions when Infuse Bone Graft was used under other off-label circumstances. Those who suffered adverse reactions may not have realized that their problems were related to the use of Medtronic's Infuse Bone Graft.

If you or someone you love suffered a serious reaction after the use of Medtronic's Infuse Bone Graft, contact a lawyer to discuss your legal options.