Infuse Bone Graft Lawsuit

Medtronic, the company that manufactures the INFUSE bone graft, has come under scrutiny by physicians, the FDA and even the federal government in recent years. Some patients have chosen to file an INFUSE bone graft lawsuit, claiming Medtronic failed to provide proper warning about the risks associated with their medical product. The number of lawsuits continues to grow, even as Medtronic begins negotiating settlements with plaintiffs who have cases already pending in courts nationwide.

About INFUSE bone grafts

The INFUSE bone graft is a product originally approved by the FDA in 2002 for use in some lower spine surgeries. The INFUSE features a manufactured version of a protein produced by the human body, human bone morphogenetic protein or rhBMP-2. The product is designed to promote the body’s own bone growth, eliminating the need for bone harvesting from the patient or a donor.

Based on claims of safety and effectiveness made by Medtronic, the FDA began expanding approval of INFUSE for other specific uses. In 2004, the agency approved its use for injuries of the tibia and in 2007, the product was approved for use in specific dental procedures.

INFUSE lawsuit allegations

Reports of adverse effects associated with the INFUSE bone graft began as early as 2004, shortly after the device was placed on the market. Now, studies are emerging to investigate whether or not the medical product may be linked to serious complications. Concerns about the product’s safety have prompted the FDA to revise warnings for INFUSE. and the federal government to launch an inquiry into Medtronic’s research and marketing of their product.

Some injured INFUSE patients are filing lawsuits against Medtronic that include the following allegations:

• Complications associated with the INFUSE were known, or should have been known, by Medtronic
• Medtronic manufactured a defective product and marketed it as safe
• Medtronic knowingly and willfully concealed dangers associated with their product
• Medtronic overstated the benefits of the INFUSE bone graft
• Medtronic failed to provide proper warning to the medical community or general public about risks associated with the INFUSE
• Medtronic failed to issue a recall of the INFUSE after adverse reports suggested the product was defective

INFUSE complications

INFUSE bone grafts were only approved by the FDA for a single procedure, anterior lumbar interbody fusion surgery, or ALIF, a procedure performed on an area of the lower back. However, some physicians claim Medtronic also marketed their product for numerous off-label uses in spine surgery, including surgeries of the upper (cervical) spine area. This practice allegedly expanded sales to approximately $900 million in 2011, with off-label use for INFUSE making up as much as 85 percent of those sales.

The prevalence of off-label use was a contributor to the rising number of complications associated with Infuse bone grafts, according to lawsuit allegations.

In 2008, the FDA issued a warning to the medical community about using INFUSE for other types of surgery, particularly those of the cervical spine. The agency reminded surgeons and other healthcare providers that the product had not been “demonstrated” in cervical spine surgeries.

In the advisory statement, the FDA specifically recommended, “practitioners either use approved alternative treatments or consider enrolling as investigators in approved clinical studies,” when determining the best approach to cervical spine injuries.

Injuries linked to INFUSE

Injuries have been linked to the INFUSE bone graft include:

• Bone loss and tissue degeneration
• Sterility in men
• Infection
• Complications of the urinary tract
• Inflammation and nerve injuries
• Unwanted bone growth along spine
• Increased risk of some types of cancer
• Death

About Medtronic

Medtronic was founded in 1949 and, according to the company website, is now the largest medical technology company in the world. In addition to the INFUSE bone graft, the company manufactures devices for treatment of diabetes, cardiovascular diseases, neurological disorders and musculoskeletal conditions.

As federal lawmakers and the FDA have looked into Medtronic’s practices concerning the INFUSE, questions have arisen as to the ethical behavior of the company.

In 2011, a study by Dr. Eugene J. Carragee and colleagues was published in The Spine Journal. The study linked the INFUSE bone graft to potentially serious complications. In addition, researchers discovered Medtronic may have secretly funded studies supporting the safety and effectiveness of the INFUSE, raising questions about the objectivity and accuracy of those studies.

Carragee and his team also found that Medtronic had paid head researchers of those studies $1-$23 million annually.

In response to this information, the U.S. Congress launched an investigation into the research and marketing practices of Medtronic. In October 2012, members of Congress verified that Medtronic had indeed paid researchers more than $200 million as consultants for their company. At the close of the Senate investigation, Sen. Max Baucus (D-Montana) stated, “Patients are at serious risk when companies distort the facts the way Medtronic has.”

Eligibility for a Medtronic lawsuit

Patients who have been injured by the INFUSE bone graft may have grounds for legal action against Medtronic. Currently, more than 950 plaintiffs have filed an INFUSE bone graft lawsuit, alleging serious injuries and insufficient warning by the company about potential risks associated with the device. Hundreds more potential lawsuits may be waiting in the wings.

Many of the claims relate to the fact that INFUSE was used off-label, allegedly based on safety claims made by Medtronic to surgeons. Although physicians are allowed to use products off-label as they see fit, companies are not legally allowed to market their product for those off-label purposes.

Individuals who allege that their injuries were the result of INFUSE bone grafts have sued for punitive damages, as well as compensatory damages to reimburse them for medical bills, lost wages and non-economic losses.

INFUSE verdicts and settlements

To date, only one Medtronic lawsuit has made it to trial. In a summary judgment, the plaintiff dropped Medtronic as a defendant and continued to pursue her complaint against other medical companies. Medtronic has also announced plans to spend around $22 million to settle approximately 950 lawsuits currently pending in courts across the country.

It is estimated that at least 3,800 additional complaints have been filed or will be filed against the medical device manufacturer in the future. Those cases could potentially cost Medtronic another $120 to $140 million in additional settlement costs. The company has said it will take a special charge to cover those costs against results of its fourth fiscal quarter that recently ended.

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