In Lake Worth, Florida, Jennifer English underwent lumbar spinal surgery with Medtronic, Inc.’s Infuse Bone Graft. After the surgery, English developed uncontainable bone growth in her spine that, in turn, began to compress her nerves and cause severe and ongoing pain. Even though the FDA had not approved the device for English’s surgery, the company marketed its product to her for the spinal surgery.
Medtronic Markets Product for Unapproved Uses
In a press release, English asserted that Medtronic did not accurately represent the pitfalls and benefits of their product and marketed the device improperly for uses not approved by the FDA. According to English’s attorney, when the device is used for certain surgeries, it can cause bones to grow out of control, leading to chronic pain. Patients must then undergo revision surgeries to correct the damage and remove the extra bone growth.
Since the lumbar surgery, English has endured two more surgeries, one of which was an emergency procedure, to rid her of the unwanted bone growth. She reports continuous pain from which she gets no relief, making everyday activities difficult. English cannot stand or sit for long periods without experiencing terrible pain.
Medtronic, the country’s largest manufacturer of medical devices, created and marketed the Infuse Bone Graft to aid bone growth during bone graft surgeries. This bioengineered material is implanted during routine spinal fusion operations, a surgery in which affected bones in the spine are joined together to decrease back pain. Over 100,000 patients across the nation receive an Infuse Bone Graft device during spinal fusion surgeries every year.
The FDA approved the Infuse Bone Graft in 2002 only for anterior (front) approach lumbar fusion. The device was not approved for other fusion lumbar surgeries or for cervical (neck) spinal fusions. Despite the FDA’s position, Medtronic marketed the defective medical device for risky, experimental surgeries in both the lumbar and cervical spine areas.
Improper Marketing Prevents Informed Decisions
When a patient receives a device for off-label use, the doctor must make sure the patient is fully informed of the benefits, risks and side effects so he or she can make an informed decision. The doctor cannot implant a device into a patient without their full, expressed consent. Medtronic’s marketing of the device was highly questionable, even resulting in a Justice Department investigation.
The company paid researchers to conduct studies that only promoted the product, rather than providing unbiased analysis. None of the studies reported side effects with the device, although there is a certain level of risk for every medical device. This unethical marketing made it impossible for English to make an informed decision about using the Medtronic device. She will continue to suffer the consequences for the rest of her life.
If you or someone you love was fitted with a medical device that caused unwanted side effects, contact our office. The time to file a claim is limited, so act quickly. You may entitled to money for past and future medical bills, lost wages and pain and suffering.