Florida Resident Charges Infuse Caused Uncontrolled Bone Growth
September 19, 2011
Wendy Fleishman of the national plaintiffs’ law firm Lieff Cabraser Heimann & Bernstein, LLP, announced that Jennifer English of Lake Worth, Florida, filed a personal injury lawsuit against Medtronic, Inc. In August 2007, English, a physical therapist, was implanted with Medtronic’s Infuse Bone Graft (“Infuse”) during a posterior-approach lumbar spine surgery, a type of surgery for which the Food and Drug Administration has not approved Infuse. English charges that Infuse caused her to develop ectopic, or uncontrolled, bone growth in her spine, compressing nerves and leading to chronic and ongoing severe pain.
“The complaint alleges that Medtronic fraudulently misrepresented the risks and benefits of Infuse and improperly promoted and marketed Infuse for non-FDA approved uses,” stated attorney Fleishman. “When Infuse is implanted in off-label surgeries, medical research shows that it can cause uncontrolled bone growth into or around the spinal cord, often leading to intractable pain and difficult and dangerous revision surgeries to remove unwanted bone.”
English has been forced to undergo two revision surgeries so far to remove the excessive bone growth, including an emergency surgery. She suffers continuous pain in her back and legs from ordinary everyday activities, such as sitting or standing for extended periods of time.
“I trusted Medtronic with my life,” stated English. “It is disappointing to find out Medtronic is not looking out for the best interests of the patient, but for own its financial interests.”
The complaint, entitled English v. Medtronic, Inc., Case No. 9:11-cv-81054, was filed late Friday, September 17, 2011, in the U.S. District Court for the Southern District of Florida.
About the Infuse Bone Graft and Side Effects
Infuse is a bioengineered material (rhBMP-2) that spurs bone growth. It is often used in spinal fusion operations, a procedure in which spinal vertebrae are fused together to reduce back pain. Infuse is manufactured by Medtronic, the nation’s largest maker of medical devices. Each year over 100,000 U.S. patients undergoing spinal fusion surgery receive Infuse.
In 2002, the FDA approved Infuse for only one specific type of spine surgery – anterior approach lumbar fusion. Infuse was not approved by FDA for (and still is not approved for) use in either lateral or posterior approach lumbar fusion surgeries.
Infuse has never been approved by FDA for use in the cervical spine (the portion of the spine that runs from the shoulders to the head). However, many patients have received Infuse in risky off-label uses in either the lumbar or cervical spine.
When any drug or medical device, such as Infuse, is used by a physician in an off-label use, the patient must be informed of this off-label or experimental use. The risks of the off-label use must be fully disclosed prior to the surgery, so the patient may make an informed decision as to whether or not he or she wishes to receive the Infuse bone graft.
On June 28, 2011, The Spine Journal, a medical journal, criticized research by Medtronic-funded physicians encouraging the widespread off-label use of Infuse as “biased and corrupted research.” The articles in The Spine Journal charge that the prior studies in support of Infuse were authored by researchers with significant financial ties to Medtronic, and that this prior research vastly understated or failed to disclose Infuse’s side effects and risks.
Legal Resources for Injured Infuse Patients
Lieff Cabraser represents patients across America who have been seriously injured by faulty medical devices and products, and the families of loved ones who died from dangerous or defective drugs and devices. Learn more about Infuse bone problem side effects.
About Lieff Cabraser
Lieff Cabraser Heimann & Bernstein, LLP, is a sixty-plus attorney law firm founded in 1972 with offices in San Francisco, New York and Nashville. Described by The American Lawyer as “one of the nation’s premier plaintiffs’ firms,” Lieff Cabraser enjoys a national reputation for professional integrity and the successful prosecution of our clients’ claims.
In the 2010 edition of its annual list of the top plaintiffs’ law firms, The National Law Journal again selected Lieff Cabraser. Lieff Cabraser is one of only two plaintiffs’ law firms in the United States to receive this honor for the last ten years.
Infuse is a registered trademark of Medtronic, Inc. The uses of this trademark is for product identification and informational purposes only. Lieff Cabraser is in no way affiliated with Medtronic.
Wendy R. Fleishman
Lieff Cabraser Heimann & Bernstein, LLP