FindLaw KnowledgeBasePublished: 2012-05-08
Patients trust their doctors when making medical decisions. Doctors, in turn, trust medical literature to guide them in their recommendations to patients. But what happens when trusted medical literature is tainted?
Congress is investigating Medtronic, one of the nation’s most prominent medical device companies, based on media reports that the company may have used financially motivated physicians to produce overly positive reviews and recommendations within medical literature for one of their products. The investigation focuses on a treatment commonly used in spinal surgery that can cause medical complications. Although complications are common with many treatments, reports allege Medtronic and clinical trial doctors intentionally downplayed the severity and frequency of the risks connected to the use of Medtronic Infuse Bone Growth.
The device in question is a biological agent made up of two parts, a protein and a carrier. The agent is injected during spinal surgery and these parts work together at the site of implantation to generate bone growth. The treatment is used in place of grafting bone harvested from other parts of the body. It was approved by the FDA in 2002 specifically for use in lumbar spinal repair surgeries. However, due to off-label use, the product has been used on other parts of the spine and has sometimes been used to supplement traditional harvesting methods.
Congressional Hearing for the Probe into Medtronic’s PMA Testing
The Senate Finance Committee called Medtronic to produce documents connected to Infuse, the controversial bone growth product. The Committee is raising concerns after recent media investigations state medical researchers may have falsified results of the product, intentionally downplaying risks associated with the product including potentially fatal swelling of the neck and throat, cancer risks, radiating pain down arms and legs and sterility in men.
Media researchers speculate the falsified reports may be connected to financial incentives. Many doctors running clinical trials on the product were on Medtronic’s payroll, fifteen of whom received at least $62 million in payments for unrelated work. In a letter to Medtronic, the Committee noted discrepancies between Medtronic funded research and findings from doctors who were not affiliated with the company.
Independent physicians that are not receiving funding from Medtronic found otherwise, though. They noted the presence of “neurological impairment” in some patients that experienced ectopic bone growth. Another unaffiliated surgeon notes two of his patients had to undergo additional surgery to remove the unintended growths because they “painfully impinged on nerve roots.”
Unfortunately, a concern regarding unreported complications is not the only issue with Infuse. Rampant off-label use in other surgical procedures has also been an issue and can lead to an increased rate of associated risks. One report states up to 85 percent of Infuse use is off-label.
Promotion of Off-Label Use
Off-label use is any use of the drug not specifically approved by the FDA. This particular drug was approved for use only in spinal surgery conducted within the lower back or lumbar spine.
Industry critics note the trajectory of Infuse was not uncommon. First excitement grows over a new and innovative treatment, FDA approval is granted and the doctors begin to promote other uses for the drug. This same pattern was followed with Infuse.
The FDA has received over 250 reports of side effects connected to the medical device and almost 75 percent of those reports involve off-label use. One popular off-label use of the drug involves the cervical spine, which is found in the upper back of the patient. Many complications have resulted from this use, including a potential connection to the deaths of several patients.
There are a number of injuries that experts believe may be connected to the use of Infuse. Men treated with the product were found more likely to develop a certain form of sterility compared to those who received a bone graft instead. In addition to potentially fatal swelling of the neck and ectopic bone growth, other patients have complained of radiating leg or arm pain following their surgery. Professionals also call for more research regarding a potential connection to use of the drug and increased cancer rates.
Doctors and medical device suppliers owe a duty of care to their patients. Manufacturers of the product have a duty to test the drugs, accurately report findings and warn patients of potential side effects. With Infuse, it is alleged that the findings were not accurately reported and risks tied to the product’s use were withheld. If true, Medtronic will likely be liable for resulting injuries.
If you or a loved one were injured as the result of Medtronic Infuse Bone Growth or another medical device, it is important to contact an experienced Medtronic Infuse Bone Growth attorney to ensure all your legal rights and remedies are protected.