Overview: The Pomona Valley Hospital Medical Center is being accused of using Medtronic Infuse Bone Graft and Stryker’s OP-1 Putty in experimental procedures without patients’ knowledge or consent. Stryker and Medtronic are also facing claims of off-label promotion, an issue that already has Medtronic in the midst of many lawsuits over Infuse.
- The California Health Department is investigating a local hospital over allegations that doctors used Medtronic Infuse and Stryker’s OP-Putty in an experimental/off-label manner without patients’ consent
- Stryker and Medtronic have been accused of off-label promotion
- Medtronic is already facing a number of off-label marketing lawsuits over Infuse; the company has been investigated over reports that they paid doctors to hide side effects such as cancer and male sterility
Product: Medtronic Infuse Bone Graft
Manufacturer: Medtronic, Inc.
Side Effects & Complications
- Difficulty breathing, swallowing
- Uncontrolled bone growth
- Nerve injury
- Male sterility
- Retrograde ejaculation
Accusations of Off-Label Promotion, Involuntary Experimentation
The California Health Department began investigating the Pomona Valley hospital after a lawsuit alleged that Medtronic Infuse and a Stryker bone growth product were used experimentally without telling patients. The initial lawsuit was filed by April Cabana, who had back surgery after being injured in car accident four years ago. Originally, the suit only accused Medtronic and Stryker of off-label promotion. Now, the allegations also state that Cabana was an unknowing participant in a secret research project.
Cabana’s first surgical procedure involved a combination Stryker’s OP-1 Putty and Calstrux bone-filler, a combination that has never been approved by the U.S. Food and Drug Administration (FDA), according to Mass Device. She says that this combination caused excessive bone growth in the lower back, causing nerve injury and debilitating pain; these complications reportedly led to a second surgery. During her second procedure, the unwanted bone tissue was removed and Medtronic Infuse Bone Graft was used on the remaining bone. According to Cabana, the surgeon never informed her that he was using it off-label by performing the surgery through the back of her body, nor was she told about the experimental nature of her first surgery.
Hospital Denies Allegations
Pomona Valley Hospital Medical Center told Mass Device that “Pomona Valley Hospital Medical Center strongly disputes both the allegations of the complaint and the assertions made by the plaintiff’s counsel in the media,” Company spokesperson Katherine Roche said “We believe that the allegations are unfounded and have released a statement to the media that have inquired.”
Medtronic Infuse is an artificial bone graft product that uses a synthetic protein known as rhBMP-2. The FDA approved the device in 2002 for the use in lumbar spine in procedures performed through the front of the body. Doctors are allowed to use medical devices in unapproved manners, but it is illegal for companies to promote it. Medtronic is facing several lawsuits alleging that it engaged in off-label promotion of Infuse.
Medtronic drew more skepticism over Infuse last summer, when the Spine Journal published an article suggesting that the company paid doctors to hide side effects such as male sterility and cancer.