Medtronic Infuse Bone Graft Lawsuit
Medtronic has marketed its Infuse bone graft for uses not approved by the Food and Drug Administration and many patients have suffered complications and economic losses as a result. Edelman, Krasin & Jaye represent clients in New York who’ve been harmed by defective and illegally marketed products. The Infuse bone graft, mostly used in spinal fusion therapy, has been the topic of dozens of lawsuits across the country, as patients seek legal recourse for purported deceptive marketing practices that put patients at needless risk for serious injuries.
Bone grafts: what they are and how they work
Bone grafts are bone substitutes or replacements. They may be created from a patient’s existing bone, synthetic products or animal bone. Medtronic Infuse bone graft is surgically placed where new bone growth is needed. It attracts the body’s own bone-building cells to the site and over time, new bone is expected to form. Infuse bone grafts are used in spinal fusion surgery, traumatic tibial fractures and two dental procedures, sinus augmentation and localized alveolar ridge augmentation.
Medtronic’s Infuse bone graft has been highly successful commercially. It accounted for 44 percent of the total U.S. bone graft market in fiscal year 2011, totaling $800 million in sales. From April 2012 to April 2013, $528 million worth of the product was sold.
The Infuse bone graft contains two parts: a protein that is found in everyone’s body, plus a carrier for delivery. The protein ingredient is rhBMP-2 (recombinant human bone morphogenetic protein-2), a genetically engineered version of a protein that the body produces in small amounts to regulate bone growth and healing.
The natural carrier is a sponge manufactured from cow collagen – a protein that helps promote bone strength and elasticity. It releases the protein over time and provides a framework for new bone to grow into. Eventually it is absorbed by the body and replaced by bone.
The Infuse bone graft was FDA approved in 2002, as the demand for synthetic bone grafts grew. With Medtronic’s product, the risks of bone harvesting from the patient’s own body were eliminated completely. Since Infuse is a synthetic bone morphogenetic protein (rhBMP-2), patients also avoided the risk of disease and infection from donated bone – either from animals or other people.
But these benefits come at a cost. It’s expensive ($2,500-$5,000 more per surgery) and its use also carries serious and possibly life-threatening risks.
Infuse bone graft surgery complications
Reported side effects and complications of Medtronic Infuse bone graft include:
- Bone and nerve injuries
- Male sterility
- Urinary problems
- Increased risk of cancer
- Male sterility
- Retrograde ejaculation (semen reversing and entering the bladder)
- Increased cancer risk
- Osteolysis, or bone loss and tissue degeneration
- Persistent pain, usually in the back or legs
- Radiculitis, a type of spinal nerve pain
- Ectopic bone formation (unwanted bone growth along the spinal canal)
- Bone spurs
- Wound complications
Medtronic accused of paying for slanted research to aid sales
In a 2011 edition of The Spine Journal, a group of spine specialists publicly repudiated the research of other experts who previously supported the widespread use of the Medtronic Infuse bone graft. The articles charge that researchers with financial ties to Medtronic wrote articles that were misleading, biased, overstated Infuse benefits and vastly understated its risks by claiming there were none.
In one article, experts said reports in thirteen medical journals played down Infuse bone graft risks and slanted them to favor their performance over an autogenous bone graft, the material traditionally used in a fusion. Those experts estimated that the incidence of adverse events in connection with Infuse’s use actually ranged from 10 to 50 percent, depending on how it was used.
Those complications include male sterility, infection, bone loss and unwanted bone growth. In 2008, the FDA warned the public that it received reports of life-threatening injuries associated with the use of Infuse in the cervical portion of the spine, a use that was not approved by the agency. The FDA has only cleared Infuse for one particular type of spinal surgery – anterior approach lumbar fusion.
The median amount of money received by researchers involved in Infuse bone graft studies ranged from $12 million to $16 million, with most of that going to a few individuals, The Spine Journal estimated.
After this scathing critique, Medtronic spent $2.5 million for a neutral review of medical literature concerning their Infuse bone graft. The resulting studies, published in 2013 in the Annals of Internal Medicine, carry a mixed message that needs to be carefully explained so patients “can make informed choices about the type of surgery they would prefer,” the researchers wrote. While Infuse is less invasive than a bone graft, which can require a separate surgery, the rise in cancer rates and other potential risk are worrisome, they said.
“I remain concerned that products like these are approved with too little study before they reach the market and too little afterward,” Harlan Krumholz, the Yale University professor who was in charge of the project, said in a telephone interview with Bloomberg. “There is a tremendous amount of uncertainty about the benefit it provides and how safe it is.”
Medtronic Infuse bone graft litigation
About a million people throughout the nation have used the Medtronic Infuse bone graft. Increasing numbers have filed legal actions against Medtronic because of alleged complications, deceptive marketing and unethical practices.
Legal actions against Medtronic include:
- Five plaintiffs filed an Infuse bone graft lawsuit in California Superior Court, claiming they received the device as an unapproved use and have since suffered serious complications due to bone overgrowth, neuropathy and other side effects.
- Claimants in a Missouri state court action sued a physician and Medtronic, arguing that the Infuse product was used in an off-label procedure that lead to severe complications.
- A Texas resident is suing Medtronic due to injuries and economic losses suffered as a result of complications from spinal fusion surgery. She seeks $2 million in damages.
In 2012, Medtronic paid $85 million to settle a shareholder lawsuit accusing it of making misleading statements concerning Infuse.The settlement resolves claims that it failed to reveal that as much as 85.2 percent of Infuse sales depended on “off-label” uses, where doctors sometimes paid by Medtronic would prescribe the product for applications not approved by the FDA.
File an Infuse bone graft lawsuit in New York
If you or a loved one has suffered injuries or complications stemming from the Infuse bone graft, contact a personal injury lawyer at Edelman, Krasin & Jaye for a free legal consultation. From initial case review through investigation, settlement negotiations through trial, each step of the process is championed with our singular purpose in practice – our CLIENT’S success is OUR success! Call us toll free at 800-469-7429 to speak with a product liability lawyer to get the legal process started today.
- Elixir Industry, The Importance of Collagen for Bone and Joint Health, http://www.elixirindustry.com/Collagen-Production.htm
- Medtronic, Questions and Answers – Infuse Bone Graft and LT Cage Device, http://www.medtronic.com/patients/lumbar-degenerative-disc-disease/surgery/questions-and-answers/index.htm
- Bloomberg News Service, Medtronic’s Infuse No Better Than Bone Graft With Risk, http://www.bloomberg.com/news/2013-06-17/medtronic-s-infuse-benefits-equal-bone-graft-with-risk.html
- New York Times, Spine Experts Repudiate Medtronic Studies, http://www.nytimes.com/2011/06/29/business/29spine.html?pagewanted=all&_r=0
- Reuters News Service, UPDATE 1-Medtronic to pay $85 mill to settle Infuse lawsuit, http://www.reuters.com/article/2012/03/30/medtronic-settlement-idUSL2E8EUCG820120330