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Medtronic Infuse Bone Graft Lawsuit

Last Updated: December 1, 2022

Since the late 2000s, the medical device company Medtronic plc has been hit with 1000s of lawsuits from people who claim the company’s Infuse Bone Graft system caused serious injury. The plaintiffs claim that Infuse Bone Graft, a synthetic protein treatment used to repair diseased or damaged bones, caused severe side effects, serious injury, and even death in some cases. As a result, Medtronic agreed to pay millions of dollars to settle a large number of lawsuits from various claimants, including individual plaintiffs, Medtronic shareholders, several states, and the U.S Department of Justice. In total, Medtronic said they put aside $300 million to settle claims for the Infuse Bone Graft lawsuits.

The underlying allegation of the Medtronic bone graft lawsuits is that the company’s product, Infuse Bone Graft, was used “off label”, meaning it was unapproved for use in that particular type of procedure by the FDA, and this unregulated product caused injury to many bone graft patients. Medtronic disputes this interpretation of FDA regulation, claiming there is scope within the rules to use off-label products. Furthermore, there were accusations that Medtronic manipulated studies on the safety of Infuse Bone Graft.

What is Medtronic Infuse Bone Graft?

Bone grafting is a type of surgical treatment to repair damaged or diseased bones. The treatment often requires the harvesting of bone from the hip to repair bones elsewhere, often in the spine. However, in 2002 Medtronic, an Irish-American medical devices company, launched a new type of system, Infuse Bone Graft (often shortened to Infuse). Infuse uses special protein (Bone Morphogenetic Protein-2, rhBMP-2) and a sponge-like substance made from collagen to act as “scaffolding” for the remodeling and natural formation of new bone. It has been used in various types of bone surgeries over the last 20 years (over 1 million surgeries, according to Medtronic), but it is most noted for its use in complicated surgeries on the spine. Medtronic calls Infuse “revolutionary,” but there are serious concerns over patient outcomes. In 2022, a statement on the company’s website admits there can be serious complications with its product, listing several dangerous side effects and risks of Infuse Bone Graft.

Medtronic Infuse Bone Graft Lawsuit

Medtronic Infuse Bone Graft Lawsuit Updates & News

  • December 1, 2022 - An update from Medtronic website: Brief Summary of Indicatons, Contradictions & Warnings for the following Infuse Bone Graft products:
    Infuse Bone Graft/LT-Cage™ Lumbar Tapered Fusion Device
    Infuse Bone Graft/Inter Fix™ Threaded Fusion Device
    Infuse Bone Graft/Inter Fix™ RP Threaded Fusion Device
    Infuse Bone Graft/Perimeter™ Interbody Fusion Device
    Infuse Bone Graft/Clydesdale™ Spinal System
    Infuse Bone Graft/Divergence-L™ Anterior/Oblique Lumbar Fusion System
    Infuse Bone Graft/Pivox™ Oblique Lateral Spinal System
  • November 22, 2022 - INFUSE Bone Graft - Important Medical Information update by the FDA.

Over 10,000 people filed Infuse Bone Graft lawsuits against Medtronic from the late 2000s onwards. The company faced multiple allegations, ranging from cases filed from former Infuse patients who suffered injuries after the bone graft procedure to lawsuits from stockholders who took issue with Medtronic’s business practices. The key aspect of the Medtronic bone graft lawsuits centered around the term “off label.” Normally, off-label refers to a drug that has been approved by the FDA for one type of treatment but has been used in another. In this case, it refers to the off-label use of the specialized procedure and equipment used for Infuse Bone Graft for spine surgeries. In a sense, Medtronic was accused of going rogue, persuading doctors, some of whom had undisclosed financial relationships with Medtronic, to perform these off-label procedures. In short, Medtronic faced multiple allegations of improper use of Infuse Bone Graft. As a result, the company paid out millions in compensation. In 2017, the company tried to draw a line in the sand, setting aside $300 million to resolve pending and future Infuse improper use lawsuits. 

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Infuse Bone Graft Complications

There can be serious complications with any surgery. On its website, Medtronic admits that Infuse is certainly not exempt from that. It lists “infection, pain or discomfort, bone fracture, damage to nearby tissue, foreign body (allergic) reaction, incisional complications, non-union, side effects from anesthesia or the surgical approach, and death (among others),” as some of the possible complications of Infuse Bone Graft.

Reasons for Infuse Bone Grafting

Bone graft surgery is a procedure where bone is taken from one part of the body and used to repair the bones in another. Bone grafts can be used throughout the body, for example in bone-based dental procedures, when repairing broken leg and hip bones, and in complicated procedures involving the neck and spine. Essentially, bone grafts are a type of bone transplant. While it’s not ideal to take bone from one part of the body to use in another (it’s often harvested from the hip), sometimes it is deemed necessary, the best option among less sound ones. Medtronic’s Infuse Bone Graft aimed to solve this less-ideal situation by eliminating the need for harvesting natural bone, with the company claiming its Infuse system encouraged natural bone growth through its “revolutionary” Infuse system. However, some of the allegations against Medtronic, including those backed up by a Senate report, claimed that the company manipulated studies of Infuse, deliberately coerced patients into opting for Infuse ahead of alternatives, and covered up information regarding Infuse complications.

Medtronic Infuse Bone Graft Side Effects

Medtronic claims that Infuse has been used in over 1 million bone graft surgeries worldwide. But there are many reported side effects of Infuse Bone Graft, some of which are listed by claimants in the Medtronic lawsuits as being willfully covered up by the company. This was uncovered in an email exchange, which showed a Medtronic employee recommending against publishing a complete list of Medtronic side effects possibly linked to Infuse in a Journal of Bone and Joint Surgery article. Below we list some of the reported Infuse Bone Graft side effects:

Infuse Bone Graft Common Side Effects

  • Infection
  • Inflammation
  • Pain in back and legs
  • Unwanted bone growth (Ectopic bone formation)
  • Implant displacement
  • Sterility, infertility, and retrograde ejaculation (male patients)
  • Bone tissue degeneration (osteolysis)
  • Radiating nerve pain (radiculitis)
  • Cancer

Infuse Bone Graft Dangerous Side Effects

  • Fatalities
  • Cancer
  • Pain and paralysis
  • Severe allergic reaction
  • Sterility in males
  • Breathing difficulties and swelling of airways
  • Abnormal and uncontrollable bone growth
  • Bone loss
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Infuse Bone Graft Recall

Due to the concerns of the dangers of Infuse Bone Graft, there may have been an expectation of an FDA recall for Infuse. However, there isn’t a current Infuse recall issued by the FDA or on a voluntary basis by Medtronic. There was a limited Infuse Bone Graft recall issued in May 2013 by Medtronic due to the possible contamination of the collagen sponges (used in Infuse procedures) with elevated endotoxin levels. This particular Infuse recall was terminated a year later in May 2014.

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Infuse Bone Graft FDA Warning

The FDA has issued Infuse Bone Graft warnings and revised guidance at several points since the procedure started being used in 2002. For instance, there was an initial FDA warning about Infuse stating that “women of childbearing potential should be advised not to become pregnant for one year following the treatment.” This is but one example of several guidelines set out by the FDA around Infuse. New Infuse Bone Graft warnings came in July 2008, when the FDA pointed out risks of off-label use of Infuse for certain procedures on the spine. Infuse, the FDA stated, had not been approved for that specific type of procedure, hence the use of the term off-label.

Infuse Bone Graft FDA Approval

To be clear, Infuse Bone Graft is approved by the FDA, gaining that approval in 2002 when launched. However, one of the key allegations in the Infuse Bone Graft lawsuits, as well as the Senate inquiry, was that Medtronic had – directly and indirectly – pushed doctors to perform procedures where explicit approval was not given by the FDA. This is one of the cornerstones of the allegations against Medtronic. It maintained the initial FDA Infuse Bone Graft approval offered broad enough scope to take in those off-label procedures. Those injured by Infuse Bone Graft disagreed, and the hundreds of millions of dollars paid in Infuse injury settlement payments by Medtronic would suggest they were correct.

Infuse U.S. Senate Investigation and Results

Back in 2011, the actions of Medtronic caught the eye of the U.S. Senate. It duly launched an investigation into reports that Medtronic had improper financial ties with doctors and other medical professionals who received royalties and other benefits for using Infuse Bone Graft off label. The results of the Infuse Senate Investigation, led by Senator Max Baucus and Senator Chuck Grassley, were published around a year later. It found that Medtronic had “manipulated studies” and improper “close financial ties with researchers.” The key points of the Infuse investigation were:

  • Medtronic was involved in drafting and editing articles on Infuse’s use and safety, sometimes in collaboration with authors who were finically incentivized by the company.
  • Medtronic employees recommended against publishing the full extent of dangers and side effects of Infuse.
  • Medtronic inserted language into – supposedly independent – studies to suggest that Infuse was a better technique than alternatives by stressing the dangers of the latter.
  • Medtronic paid over $210 million to researchers over a 15-year period, many of whom had financial ties to the company.

Senator Baucus summed it up by saying that “Medtronic’s actions violate the trust patients have in their medical care.” We should make clear that the Senate did not take any action against Medtronic, but it’s clear from the report that the Senate thoroughly disapproved of Medtronic’s activities.

The History of Medtronic Infuse Bone Graft Lawsuit

Infuse Bone Graft has been on the market since 2002, although development and testing of the system started years earlier. Not long after it launched, the FDA began receiving reports of complications and serious side effects presented in those who had the Infuse procedure. These included infections, abnormal bone growth, and even cancer. While the FDA issued new warnings for Infuse procedures, this also had the knock-on effect of new scrutiny on Medtronic’s actions, including how peer-reviewed studies of Infuse Bone Graft may have been manipulated, how the dangers of Infuse may have been downplayed, and how doctors may have been incentivized financially by Medtronic to carry out the off-label Infuse Bone Graft surgeries.

Towards the end of the 2000s, hundreds, then thousands, of Infuse Bone Graft injury lawsuits were filed against Medtronic. Initially, Medtronic tried to tackle these on a case-by-case basis, including settling out of court for undisclosed fees. Soon after, attorney generals representing several states also filed suits against Medtronic. By the mid to late-2010s, the number of lawsuits reached around 10,000. Medtronic decided the best course of action was to settle the cases, paying compensation to thousands of claimants and putting around $300 million aside to settle pending and future cases.

Medtronic Infuse Bone Graft Lawsuit Settlement Amounts

Due to the weight of evidence in the Infuse Bone Graft lawsuits, Medtronic was forced to settle with various groups of claimants over the years. This included a payment of $22 million to settle with a group of claimants (represented by around 950 individual lawsuits), settlements of $85 million (2012) and $43 million (2018) to Medtronic stockholders, and $12.5 million to five states who claimed that Medtronic had deceptively and fraudulently marketed Infuse. In addition, Medtronic set aside $300 million to settle other lawsuits (around 6,000 cases were pending at the time).

Infuse Bone Graft Lawsuit Payouts

As mentioned above, there were some hefty settlement amounts paid by Medtronic to settle some of the Infuse Bone Graft lawsuits. But what does this mean for individual Infuse Bone Graft payout awards? The amount each person receives would depend on individual circumstances, including level of injury caused by Infuse, medical bills, pain and suffering, as well as other factors like loss of earnings and mental anguish.

Infuse Bone Graft Lawsuit Awards

As mentioned, there have been several payout awards for claimants in Infuse Bone Graft lawsuits. In total, it has been estimated that Medtronic paid out around $460 million as a direct result of the Infuse legal cases.

Is The Medtronic Infuse Bone Graft a Class Action Lawsuit or a Mass Tort?

The Medtronic Infuse Bone Graft lawsuits were not consolidated into a class-action lawsuit, which is usually reserved for mass consumer litigations, with claimants having almost identical grievances against a company or individual. As the allegations against Medtronic were more complex, with claimants citing different types of injuries, some of the lawsuits were initially consolidated into a mass tort. This means that the cases are combined for efficiency in front of the courts, but it ensures that claimants will be treated as individuals when it comes to payouts and settlements.

Medtronic Infuse Bone Graft Lawyers

If you have been injured by an Infuse Bone Graft procedure, you may be eligible to pursue financial compensation with the help of an Infuse Bone Graft injury lawyer. As we laid out earlier, Medtronic has already been forced to pay out millions of dollars to settle some of the cases. The company also set aside money – around $300 million – to settle other cases, including some future cases. If you believe you have a case against Medtronic, there are specialist Infuse Bone Graft injury law firms that might be able to help you secure compensation and justice.

Medtronic Infuse Bone Graft Device Lawsuit FAQs

What is Infuse Bone Graft made of? 

The key element of Infuse Bone Graft is rhBMP-2, a manufactured protein that is a replica of human bone proteins and acts to regenerate the bone. The Infuse Bone Graft procedure also involves a collagen sponge that acts to scaffold the target area for bone growth and repair.

Is infuse still on the market?

Yes. Despite the success of various lawsuits against Medtronic and a Senate investigation, Infuse is still being used for surgical procedures today. 

Is Medtronic being sued?

Medtronic has been sued by 1000s of people, governmental departments, and individual states. The company has already paid out millions in settlements.

What are the side effects of Medtronic Infuse bone grafts?

Many side effects of Infuse Bone Graft have been listed, both by patients and by Medtronic. Some of the more serious reported Infuse side effects include cancer, paralysis, and death.  

Is there a recall on Medtronic Infuse bone grafts device?

No. The last recall of Infuse Bone Graft was in 2013. But this was for an issue unrelated to the Medtronic bone graft lawsuits.

 Are there Infuse Bone Graft lawsuits against Medtronic?

Over 10,000 bone graft injury compensation lawsuits have been filed against Medtronic, many of which the company was forced to settle.

Who is eligible for compensation in an Infuse bone graft lawsuit?

People who have been injured as a direct result of the Infuse Bone Graft procedure may be eligible to join a lawsuit against Medtronic. Speak to an Infuse Bone Graft lawyer to get more information on your eligibility.

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© Copyright Jazz Media Ltd. 2021. All rights reserved

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We are here to help you and loved ones advocate for justice. Feel free to send us any questions you might have, either about an injury or the process for pursuing justice so we can help you exercise your rights.

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