You may be entitled to compensation!
INFUSE® BONE GRAFT FDA APPROVED USES
At the time of writing this, the INFUSE bone graft product is approved by the FDA for use in anterior spinal fusion of the lumbar spine, and for repair of open tibial shaft fractures. In addition, the device is approved for two minor dental procedures.
Off-label use of INFUSE is part of the issues some patients are experiencing with this product. As with many drugs and devices, off-label use of the INFUSE bone graft is allowed if doctors believe it will be of benefit to their patients.
Some examples of "off-label" uses of this product include performing spinal fusion surgeries with the INFUSE product, using techniques not approved by the FDA. Another example is use in the cervical (neck) spine area.
We are on the watch for a potential INFUSE recall and will provide free current information if you contact us.
INFUSE: GENETICALLY ENGINEERED BONE MORPHOGENIC PROTEIN POTENTIALLY LINKED TO SEVERE SIDE EFFECTS
The Medtronic Infuse Bone Graft is a product that helps stimulate bone growth after lower spine surgery. This device has been linked to many adverse event reports, and even death. Many of the people who are implanted with this device suffer from over-growth of bone in the area of the implantation.
The company is now facing Infuse Bone Graft Lawsuits from individuals who were severely injured, died, or were left permanently disabled due to side effects of the INFUSE device.
We are interested in hearing from you if you suffered an injury related to any potentially defective medical device or medication. Please call us for help at 1-888-446-8087 or fill out any of the forms on this website. Even if you live outside of the USA we would like to hear from you.
Serious Injuries and Severe Complications are connected to Medtronic's INFUSE Bone Graft product, especially when the product has been used in off-label surgeries.
The INFUSE Bone Graft Product - What is it?
the INFUSE bone graft product is used to encourage bone growth and is located inside a small compartment or cage-like device that is surgically implanted in the spine (and other areas at times). INFUSE, manufactured by Medtronic, Inc., consists of this "LT-Cage Device", which is a small and hollow metal cylinder that is filled with a genetically engineered material that stimulates bone growth in the body.
FDA and INFUSE - Timeline:
In 2002 the FDA approved INFUSE for use in an anterior approach in the lumbar spine during fusion procedures to treat degenerative disc disease. At this time, the INFUSE device was not approved by the FDA for use in any other parts of the spine such as the cervical and neck areas.
In 2004 the FDA made a secondary approval of the INFUSE product for treatment of various types of tibia fractures in the lower leg.
In 2008 the FDA put out a Safety Communication warning of life-threatening complications connected to the use of the INFUSE product in cervical spine areas. The FDA recommended that INFUSE only be used by physicians for FDA-approved uses.
In June 2011, The Spine Journal publishes an important article on INFUSE. Also in June, 2011 the United States Senate sent a letter to Medtronic, Inc. stating concern about reports in the press that state that physicians who conducted safety trials concerning INFUSE may have not reported complications possibly due to their financial ties with Medtronic.
In April, 2012, Medtronic is to pay $85 million in a lawsuit by shareholders that alleges that Medtronic witheld important information and made statements that mislead various parties about the INFUSE product.
A significant problem in the use of INFUSE, is "off-label" use of the product by physicians for uses not approved by the FDA. When any drug or medical device such as INFUSE is used by a doctor in an "off-label" use, the surgeon must fully disclose to the patient the risks of the off-label use prior to the surgery. This is so that patients and their families can make an informed decision as to whether or not they wish to proceed with the surgical use of the product in an "off-label" manner.
Technical Description of the Device
The Medtronic Infuse Bone Graft is a medical device that is meant to be surgically implanted after lower back spine surgery (lumbar spine). The device works by stimulating bone growth in the area of implantation. The device is intended as an alternative to traditional bone grafts. Traditional bone grafts involve painful bone harvesting from other parts of the body.
The INFUSE device consists of two parts, including a sponge-type substance that is soaked in a biological fluid. The biological fluid is a type of synthetic liquid bone morphogenetic protein (BMP). This device is implanted between vertebrae, among other uses, and the BMP is supposed to stimulate bone to grow. The sponge is then supposed to be dissolved and absorbed into the body.
Some Alleged Potential Side Effects Include, But Are Not Limited To:
- Some patients have allegedly died from the use of INFUSE.
- Angioedema (swelling of the neck and - or throat, which can cause fatal suffocation)
- Nerve Damage
- Respiratory Depression, or difficulty breathing
- Compression of the Airway (leading to difficulty breathing, speaking, and swallowing)
- Male sterility or Male infertility, urogenital injuries, or retrograde ejaculation
- Chronic pain such as in the arms or legs, sometimes severe and life-altering
- Paralysis or Loss of Range of Movement
- Uncontrolled Bone Growth (at or near the site of surgery)
Contact us immediately if you or a loved one have suffered an injury from a bond graft, even if you do not know which type of bone graft you received. Please do not delay as failure to act quickly can cause you to lose your legal rights forever if your statute of limitations period expires. Your statute of limitations period is particular to your potential claim and requires individual examination to know.
Call us today at 1-888-446-8087 and we will mail you free information as well as provide an initial intake evaluation. We have lawyers ready to speak with you.
Medtronic INFUSE Bone Graft Failure Facts
The Medtronic INFUSE Bone Graft is a device that is primarily used by physicians to help fuse vertebrae in the lower spine in order to treat degenerative disc disease. It also has other uses, some of which are not approved by the FDA.
The FDA primarily approved the INFUSE Bone Graft for use in the lumbar spine - the lower back. However, physicians have used the device in off-label use in the cervical spine and neck, a use that has allegedly caused serious complications.
Some potential repesentative injuries from the device include, but are not limited to, difficulty breathing; difficulty speaking; difficulty swallowing; ectopic or uncontrolled bone growth; chronic pain, often in the legs or arms; retrograde ejaculaton and - or other related injuries; nerve injuries; sterility in males; cancer; permanent injury or death; acute and severe swelling; paralysis; neck injuries.
The FDA issued a warning in July, 2008, where the FDA stated that the safety and effectiveness of the device in the cervical spine is not demonstrated and is not approved by the FDA.
Mass Tort vs. Class Action: What is the Difference between the two?
You may find this website because you put "class action" into your search engine, along with a drug name, such as "INFUSE Class Action".
You might think "class actions" are the way most cases are handled by law firms dealing with prescription drugs that harm people. Many consumers think this is how defective medical devices and drugs are dealt with in the courts. However, actually this is not precisely accurate. Most pharmaceutical drug claims are handled as "mass torts."
You probably did not put "mass tort" into the search engine as the term "mass tort" is a far less well known legal term in the public generally. It is more commonly a term used by lawyers. Therefore, we make sure to help you find us by discussing class actions frequently and explain the difference between class actions and mass torts here.
The term "mass tort" is simply not used frequently by consumers.
A class action is a type of legal proceeding where a lawsuit is filed on behalf of a group of people who share a set of circumstances, harms, injuries, sufferings, or potential damages. Class actions are designed to help promote "judicial economy" and decrease pressure on courts when large numbers of people suffer a harm in the same manner.
For example, class actions are sometimes used in the context of when a bank or large corporation charges fees that are determined unfair to a large number of clients. In those instances, one harmed person may stand as the single claim that determines the outcome for the entire class of claimants. Often the recovery is not good for the class of harmed individuals as a whole.
Typically a class action has several criteria that must be met. The individuals in the class must be notified of the claim and given a chance to "opt in" or "opt out" of the class, or find lawyers of their own. Prior to the actual class action lawsuit, a motion is filed in court that certifies a particular plaintiff as the acting party on behalf of the larger group or class of plaintiffs.
One of the factors looked at is whether the individual recoveries for each plaintiff are too low to warrant each plaintiff hiring their own attorney; when this is present a class action may be certified as the best way to proceed. For example, this is often the case when dealing with small bank fees.
The representative plaintiff also shows that he or she is typical in that his or her experience with the company or product is typical of the experiences of the other similarly situated plaintiffs, and that this type of class action lawsuit is the most efficient for holding the defendants accountable. The evidence against the defendants must be typical and represented in a similar manner by all the harmed individuals, and finally, a showing that individual lawsuits against the defendant would never be prudent nor efficient in time and money is part of the process of determining that a class action is the best way to proceed. It is easy to see that the often massive and very different injuries sustained by people who take prescription drugs do not fit this mold for "class actions."
Simply, class actions are usually in cases of very uniform injuries shared by a multitude of people: bank fees charged unfairly and in the same manner to many people, for example.
Mass Tort Lawsuits
Mass torts are different from class actions despite the fact that they are related in the sense that both share a large group of people who have suffered harms.
Mass tort claims, like class actions, try to reduce the number of court claims in the legal system and promote judicial economy and efficiency. However, they cover a much broader range of subjects typically than class actions and they are handled differently.
Perhaps the simplest way to understand the difference is mass torts still involve each plaintiff having their own individual claim.
There is no "representative plaintiff" (as that term is used in the class action context) in mass tort claims. The mass tort plaintiffs are each receiving their own legal process and individual remedy tailored to their particular circumstances.
Mass tort claims are the most common way that consumers are provided legal remedies when they are injured on a large scale by defective drugs or defective products. While drugs and defective medical devices, for example, injure large groups of people, the injuries are often very different among each plaintiff. All cases in drug defect claims rarely fit neatly into a single class of individuals who share the exact same type of injury.
Mass tort litigation allows one attorney or a group of attorneys to represent several injured parties in individual cases. The attorneys often share information to help each other and their clients proceed against the defendants in a more powerful manner as a result of the cooperation of the plaintiffs' attorneys. Attorneys all over the country, and in fact sometimes internationally, pool resources, research, information, time, financial resources, and their intellectual energy and ideas to make sure that all of the plaintiffs hopefully obtain some measure of justice.
Mass tort claims are often complicated with detailed litigation and numerous plaintiffs and defendants. Sometimes experts are used just to determine the proper way to award damages to the various parties.
The Mulligan Law Firm and DrugRxRecall are actively evaluating potential Medtronic INFUSE Bone Graft claims for injuries such as spine injuries and related medical side effects.
If you or a loved one received an INFUSE Bone Graft and suffered any injury, the lawyers of The Mulligan Law Firm would like to talk with you.
Please contact us today at 888 446 8087. We have intake staff ready to answer your questions and mail you a free information packet and questionnaire.
We can evaluate claims originating in all 50 United States. We also can help American citizens living abroad.
Act quickly as failure to investigate your legal rights and delay may cause you to lose your potential claim if it is barred by the statute of limitations that applies to your potential claim.
For more information on DrugRxRecall.com, including our terms and conditions of use of this site, please visit our parent site www.drugrxrecall.com.
Medtronic INFUSE Additional Legal Information
We are now actively evaluating potential INFUSE claims. Medtronic INFUSE is a genetically engineered bone morphogenic protein used (amongst other potential uses) in spinal fusion surgical procedures to help fuse vertebrae.
The FDA approved this product only for use in specific circumstances and in specific ways. For example, FDA approved single-level lumbar fusions with very specific guidelines (an anterior, abdominal, approach for surgical placement). However, the product has allegedly been used by surgeons in an off-label manner, including posterior approaches, placement in the cervical spine, etc.
Please check FDA information releases for exact and up-to-date information on FDA approved uses of this product.
INFUSE allegedly causes overgrowth of bone that has been connected to increased pain, neuropathy, decresed range of motion, and other issues.
Placement in the cervical spine can potentially cause terrible and tragic life-threatening, and life-altering, side effects such as dyshagia, dyspnea, paralysis or loss of range of motion, and swelling.
The Side-Effects of INFUSE Morphogenic Protein
Some of the side effects potentially linked to INFUSE Morphogenic Protein, include but are not limited to:
• Difficulty Breathing
• Difficulty Speaking
• Difficulty Swallowing
• Nerve Injuries
• Ectopic Or Uncontrolled Bone Growth
• Retrograde Ejaculation
• Urogenital Injuries
• Chronic Pain, (Leg Or Arm Most Common)
• Neck Injuries
• Severe Swelling
If you or a loved one have received INFUSE or are unsure what kind of bone graft you received, but you have experienced injury, please contact us immediately for a free consultation.
Procedures Used To Implant INFUSE Devices May Include:
- Cervical Fusion
- Posterior Approach
- Anterior Appoach
- Lateral Approach
- Dental Implant
If you or a loved one has been injured after surgical implantation of an INFUSE Bone Graft, please contact us immediately for a free consultation. We would like to speak with you regardless of where you live.
Who We Are
The Mulligan Law Firm, a national law firm located in Dallas, Texas, provides legal information and resources for injured individuals and their families. The firm has successfully resolved over $600,000,000 in claims for its clients. Formed in 1995, it has been helping people for almost 15 years, with the strength and experience to represent plaintiffs in all 50 states.
The Mulligan Law Firm with www.DrugRxRecall.com is currently investigating injury claims involving the Medtronic INFUSE Bone Graft.
If you or a loved one has been injured after surgical implantation of a Medtronic INFUSE Bone Graft, it is important that you consult with a legal professional immediately. The Mulligan Firm's lawyers are standing by to help you.
You may be entitled to compensation for your injuries. We take all cases on a contingency-fee basis, which means you do not pay for our services unless you receive an award or compensation. Do not delay, as your rights and compensation may be lost forever if you wait, as the statute of limitations period governing your potential claim may pass.
We have Medtronic INFUSE Bone Graft Attorneys standing by ready to speak with your about your potential claim related to Medtronic INFUSE Bone Graft Failures.
For more information on DrugRxRecall.com including our terms and conditions of use of this related site, please visit our parent site www.drugrxrecall.com and click on the User Agreement at the bottom of the home page.
Medtronic devices on this webpage may not have been the subject of an FDA recall as of the time of the writing of this article. Please check the FDA website for up to date information on potential recalls of any medical device. FDA is constantly issuing safety warnings and recalls and information can change at any time. The term "recall" is used in this website to help injured consumers locate us as they often believe their device should be, or is, the subject of a formal recall.
Our lawyers and attorneys (Abogado de Ley) evaluate potential claims or lawsuits from cities throughout the United States, including, but not limited to Northern California, Bay Area cities such as: Alameda, Albany, American Canyon, Antioch, Atherton, Belmont, Belvedere, Benicia, Berkeley, Brentwood, Brisbane, Burlingame, Calistoga, Campbell, Clayton, Cloverdale, Colma, Concord, Corte Madera, Cotati, Cupertino, Daly City, Danville, Dixon, Dublin, East Palo Alto, El Cerrito, Emeryville, Fairfax, Fairfield, Foster City, Fremont, Gilroy, Half Moon Bay, Hayward, Healdsburg, Hercules, Hillsborough, Lafayette, Larkspur, Livermore, Los Altos, Los Altos Hills, Los Gatos, Martinez, Menlo Park, Mill Valley, Millbrae, Milpitas, Monte Sereno, Moraga, Morgan Hill, Mountain View, Napa, Newark, Novato, Oakland, Oakley, Orinda, Pacifica, Palo Alto, Petaluma, Piedmont, Pinole, Pittsburg, Pleasant Hill, Pleasanton, Portola Valley, Redwood City, Richmond, Rio Vista, Rohnert Park, Ross, San Anselmo, San Bruno, San Carlos, San Francisco, San Jose, San Leandro, San Mateo, San Pablo, San Rafael, San Ramon, Santa Clara, Santa Rosa, Saratoga, Sausalito, Sebastopol, Sonoma, South San Francisco, St. Helena, Suisun City, Sunnyvale, Tiburon, Union City, Vacaville, Vallejo, Walnut Creek, Windsor, Woodside, Yountville.