Humana, Inc. filed a lawsuit against Minnesota-based Medtronic on May 30 for allegedly marketing the Infuse bone-graft product for uses that the U.S. Food and Drug Administration did not approve and that it made misrepresentations to insurers to cover those uses. This device has sparked products liability charges in numerous forums.
Infuse constituted $471 million in sales for the 2014 fiscal year, according to Medtronic’s earnings report. It is utilized to assist with the healing of bones after surgery.
In this complaint filed in federal court, Humana said that Medtronic paid physicians hundreds of millions of dollars to promote this product’s safety and effectiveness for various spinal surgeries, although the FDA limited its use to lower-back procedures. It alleged that it relied upon Medtronic’s misrepresentations on the efficacy and necessity of this product through fraudulent studies and peer-reviewed publications.
Medtronic characterized Humana’s claims as baseless and that it listed health risks related to Infuse on its label since sales began in this country in 2002. Medtronic also said that it does not compensate doctors for the use or endorsement of its products.
The FDA warned surgeons not to use this product in cervical-spine procedures in July 2008 after learning that dozens of patients suffered complications. According to studies, Infuse posed an increased risk of cancer and infections and male sterility.
A U.S. Senate Committee claimed in 2012 that Medtronic officials paid over $200 million in consulting fees and royalties to physicians who marketed the product to colleagues in speeches or articles. Senate investigators also contend that the company’s officials ghost-drafted sections of medical papers endorsing this product.
In April, Medtronic settled 950 lawsuits over Infuse by agreeing to pay $22 million and said that it was taking a charge of up to $140 million to cover litigation costs. In late May, it agreed to pay $9.9 million to settle federal government claims that it paid kickbacks to doctors to implant its defibrillators, pacemakers and other heart-rhythm devices.
Product liability and deceptive trade practices can result in the payment of large sums of money. Representation can assist with protecting rights and addressing the complex legal and technical aspects of this type of litigation.
Source: Bloomberg, “Medtronic sued by Humana for fraud over bone-graft device,” Jef Feeley, June 2, 2014