A product liability lawsuit has been filed against Synthes Inc. on behalf of the families of two elderly women who died during clinical trials for a bone cement that was being tested for spinal surgery. Plaintiffs in the suit claim that the product, Norian Bone Cement XR, was only approved for use in the arm at the time the test was performed, making the trial illegal.
What’s the Problem?
The Bone Cement Lawsuit was filed in Contra Costa County California Superior Court by the decedents of two women who were in their 80s who allegedly lost their lives on the operating table after being injected in the spine with Norian Bone Cement XR. According to the complaint, use of cement in the spinal column had not been approved by the U.S. Food & Drug Administration, making its application in this capacity illegal or “off-label”.
This is not the first time Synthes has come under fire for the misuse of Norian Bone Cement XR. In 2011, the company and its Norian division pleaded guilty to federal charges that between 2002 and 2004 they conspired to conduct unauthorized clinical trials using the cement for spinal surgery.
Synthes used Norian Bone Cement XR despite FDA warnings declaring such use to be unapproved and highly dangerous. According to the indictment, research had indicated that the bone cement could cause toxic reactions in the bloodstream which could lead to blood clots. Subsequent animal studies determined that blood clots could became lodged in the lungs, causing a life-threatening pulmonary embolism. Unfortunately, Synthes and Norian disregarded this information and performed unauthorized clinical trials on humans.
Bone Cement Implantation Syndrome (BCIS)
In addition to causing blood clots and pulmonary embolism, bone cement products have been linked to a potentially fatal toxic reaction called bone cement implantation syndrome. BCIS has been found to occur during hip replacement surgeries where the surgeon used bone cement to hold the implant in place. A recent study led by the U.K.’s National Institute of Health chief medical officer Liam Donaldson found at least 62 cases of bone cement implantation syndrome which occurred between 2005 and 2012. Of these:
- 41 patients died
- 14 had a heart attack
- 7 suffered a “peri-arrest period”, where their condition became dangerously unstable
In 55 of the 63 patients, bone cement implantation syndrome occurred within three minutes of the product being applied.
- Pulmonary hypertension
- Increased central venous pressure
- Pulmonary edema
- Cardiac dysrhythmia/arrhythmias
- Cardiogenic shock
- Cardiac arrest
- Sudden death
- Fat/marrow emboli