Medtronic Faces Medical Injury Lawsuit Over Off-Label Use of Infuse
Medtronic Inc. is facing a lawsuit over the death of a California woman after a surgery during which the company's Infuse bone growth medical product was inserted into the neck. The lawsuit is the first for the company stemming from allegations that Medtronic indulges in promotion of off-label use of its bone growth product, a liquid protein sealed in a casing and inserted between the vertebrae.
The lawsuit is unusual in that it doesn't blame the doctor for the complications that resulted after 74-year-old Shirley Nesbit underwent the surgery to insert the bestselling bone growth protein in her neck. The FDA had recently warned doctors against use of the product in the neck, because of the possibility of respiratory difficulties. Nesbit underwent the surgery in August, a few weeks after the FDA's warning. She developed serious respiratory problems because of the pressure on her neck and throat. Attempts to insert a breathing tube lost precious minutes for Nesbit, and she slipped into a coma, dying 9 days later.
Her family alleges in the lawsuit that Medtronic's representative who was present during the surgery, pressured the doctor to use Infuse in her neck, although the FDA approves it for use only in the lower back, and for certain dental applications. Doctors are not prohibited from using any medical product for applications that are not approved by the FDA, but companies are not allowed to push for off label use of the product, which is what Medtronic is accused of doing. Both Medtronic and the surgeon in question, deny any pressure to use Infuse. The company, no stranger to medical injury lawsuits because of its earlier problems with its defective Medtronic defibrillator devices, claims that representatives are sometimes present at procedures for support and advice to the surgeon. Making things worse for Medtronic are two whistleblower lawsuits by former employees that charge the company with paying doctors to use Infuse in ways not approved by the FDA.
Medtronic Encouraging Unapproved Use of Infuse
There have been several complaints about off-label use of Infuse, and patients have suffered obstruction of the airways leading to breathing problems after insertion. Lack of oxygen can cause brain damage in a patient. Patients often need tracheotomies to relieve pressure on their airways, and require respiratory and feeding support.
Infuse Medical Device Lawsuits
Medtronic is facing a Department of Justice probe into allegations of promotion of off-label use. However, for patients who have been injured because of such unapproved use, there is a way to obtain justice – through a defective medical device or product lawsuit against the company with the help of a medical injury lawyer. If you or a loved one has been injured by an off-label use of Infuse - meaning use of the product anywhere, except on the lower back or in oral treatments – then you may be entitled to compensation for your suffering. Contact the experienced medical injury lawyers at Arnold & Itkin LLP for a free evaluation of your case.
