MEDTRONIC INFUSE OFF-LABEL USE LAWSUIT

“Off-label” use of Medtronic Inc.’s Infuse bone graft product in cervical spine surgeries, as well as lateral approach or posterior approach spinal procedures, has been linked to serious, and even life threatening side-effects. Some of these Medtronic Infuse injuries include ectopic or uncontrolled bone growth at or near the site of the surgery; ongoing or chronic radiating pain in the legs or arms; male sterility, retrograde ejaculation, or other uro-genital injuries; nerve injuries causing severe and chronic pain; and even cancer. In cervical spine surgeries, which is an off-label use of Infuse, some patients experience acute severe neck swelling several days after surgery resulting in death or permanent injury. Medtronic has been accused in lawsuits of aggressively promoting unapproved uses of Infuse, and it has also been alleged that research sponsored by the device maker downplayed many serious Infuse bone graft side effects.


Our lawyers are investigating these allegations, and would like to hear from anyone who suffered a serious Infuse bone graft complication. If you sustained a serious injury after undergoing an off-label Medtronic Infuse surgery, you could be eligible for compensation for your medical bills, lost wages, and pain and suffering. If you or a loved one were injured due to a procedure where this product was used inappropriately, it is vital you contact Holland Law Firm, LLC as soon as possible to protect your legal rights.



INJURIES LINKED TO OFF-LABLE USE OF INFUSE BONE GRAFT INCLUDE:
  • Acute severe swelling of the neck several days after surgery, resulting in death or permanent injury;
  • Cancer – may types including stomach, thyroid, breast, skin (melanoma), ovarian, lung, leukemia, prostate, laryngeal, lymphoma, pancreatic;
  • Difficulty swallowing;
  • Difficulty breathing
  • Difficulty speaking
  • Ectopic or uncontrolled bone growth at or near the site of the surgery (a study found that 75% of Infuse patients experienced ectopic bone growth)
  • Nerve injuries causing severe and chronic pain;
  • Ongoing or chronic radiating pain in the legs or arms (i.e., neuritis, radiculopathy, or radiculitis);
  • Male sterility (Independent researchers at Stanford University found evidence that Infuse was linked to a complication that causes sterility in men)
  • Retrograde ejaculation, or other uro-genital injuries in male patients.

In 2008, the FDA warned Infuse bone graft and similar products had caused serious problems when they were used off-label in cervical spine surgeries. At the time, the agency said that it had received dozens of reports of side effects linked to off-label Infuse procedures, mainly swelling of neck and throat tissue, which resulted in compression of the airway and other structures in the neck. Patients reported difficulty swallowing, breathing and speaking. Several required emergency treatment, including tracheotomies and the insertion of feeding tubes, as well as second surgeries.

In November 2008, Medtronic disclosed that the U.S. Department of Justice (DOJ) was investigating the off-label use of a Medtronic's Infuse bone graft. According to a report from The Wall Street Journal, at least 280 reports of side effects involving Infuse had been made to the FDA when the investigation was announced. About three-quarters of those reports involved off-label use. While doctors are permitted to use approved medical devices in any way they see fit, it is illegal for manufacturers to market products based on such uses.

MEDTRONIC INFUSE OFF-LABLE USE COMPLICATIONS:

Medtronic Infuse, which contains rhBMP-2 (recombinant human Bone Morphogenetic Protein-2, a protein that stimulates bone growth), was approved by the U.S. Food & Drug Administration (FDA) for use in a type of spine surgery called anterior approach lumbar fusion. This is the ONLY type of spine surgery for which Infuse is approved, though the FDA did later grant clearance for its use in two types of dental surgeries. Despite its limited approval, it has become clear that Infuse bone graft is frequently used off-label in other spine procedures, especially cervical (neck) spine surgery, as well as in lateral approach (through the side of the body) or posterior approach (through the back of the body) spinal procedures. Unfortunately, it has also become apparent that such off-label use puts patients at risk for serious, and even life-threatening, injuries.

If you or someone you know sustained an injury due to off-label use of the Medtronic Infuse bone graft, you have valuable legal rights. To learn how Holland Law Firm, LLC can help you, please fill out our online form, or call 1-877-255-3352 to discuss your case.

Medtronic Infuse Off-Label Use Lawsuit News

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Have you or someone you love been injured due to Medtronic Infuse Off-Label product? This means that the Medtronic Infuse Bone Growth product was used “off label” or in a neck surgery or a back surgery using posterior entry.
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Order denying motion to dismiss

by gmacweb on
Wednesday, October 23, 2013 3:06 PM

Medtronic recently moved to dismiss the complaint filed by a plaintiff in Arizona federal court.  One of the major points of contention was whether plaintiff’s state law claims were preempted under federal law because the state law claims could impose standards of conduct that differ from those set by the FDA.  The court rejected this argument finding that the claims stemming from the doctor’s off label use which could be traced back to Medtronic’s off-label promotion were not preempted. Additionally, the court denied the motion to dismiss as to various claims including fraud, failure to warn, design defect, and misrepresentation, and plaintiff was allowed to re-plead her breach of warranty allegations to conform to the law.

View Entire Ruling


Spine Journal 2013 Article – Black, white or grey

by gmacweb on
Wednesday, October 23, 2013 3:04 PM

This article reviews the findings of four different studies.   It is a good primer on the spectrum of research on BMP and the controversy surrounding the different conclusions.  The article recognizes that the “BMP issue” is of undeniable importance and that it is the privilege and responsibility of every provider affected to examine the facts and reach their own conclusions while upholding the highest standards.

View Entire Article


Spine Journal 2013 Article – Clinical sequelae after rhBMP-2 use in a minimally invasive transforaminal lumbar interbody fusion

by gmacweb on
Wednesday, October 23, 2013 3:02 PM
Results: Of the 573 patients, 10 (1.7%) underwent 15 additional procedures based on recalcitrant radiculopathy and CT evidence of neuroforaminal bone growth, vertebral body osteolysis, and/or cage migration. Thirty-nine patients (6.8%) underwent reoperation for clinically symptomatic pseudarthrosis. Bone overgrowth was associated with nerve impingement and radiculopathy in all 10 patients.  Osteolysis and cage migration occurred in 2 (20%) of these same 10 patients. Average total costs were calculated per procedure ($19,224), and the costs for reoperation equaled $14,785 per encounter for neuroforaminal bone growth and $20,267 for pseudarthrosis.

Conclusions: Symptomatic ectopic bone formation, vertebral osteolysis, and pseudarthrosis are recognized complications with the use of rhBMP-2 in MIS-TLIFs. Potential causes include improper dosage and a closed space that prevents the egress of the postoperative BMP-2 fluid collection.

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Spine Journal 2013 Article – Moving forward after YODA

by gmacweb on
Wednesday, October 23, 2013 3:01 PM

This article is a follow-up to the June 2011, Spine Journal article entitled ‘‘A critical review of rhBMP-2 trials in spinal surgery: emerging safety concerns and lessons learned’’ (see below).  It examines the disconnect between company sponsored studies and real world outcomes.  Amongst other conclusions, the article states that it is about putting patient safety ahead of personal financial profit, professional pride/ego, and surgical convenience.

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Spine Journal 2013 Article – When money talks

by gmacweb on
Wednesday, October 23, 2013 2:59 PM

This article explores the problematic relationships between physicians and researchers on one hand and drug and device companies on the other hand, and the effects on academic and scientific research and publications.  Patient welfare and scientific integrity are too important to allow bias to affect the research reports in journal articles, the prescribing habits of physicians, the content of lectures, the decisions of professional associations’ guideline committees, and the choices made by formularies for drugs and devices. The better part of wisdom is to select individuals for these assignments who are free of entanglements.

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Senate: Medtronic shaped articles promoting InFuse

by gmacweb on
Wednesday, October 31, 2012 1:45 PM
(AP)–October 25, 2012 WASHINGTON (AP) — Medical device maker Medtronic Inc. helped write and edit medical journal articles attributed to outside physicians, which downplayed the risks of the company's best-selling bone graft, according to a report by Senate investigators. The Senate Finance Committee said Thursday that the world's largest device maker did not disclose its role in shaping 13 key studies of InFuse, which helped turn the bone graft into an $800-million a year product. The studies, funded by Medtronic, failed to mention serious risks of InFuse including male sterility, infection and increased back and leg pain. Senate investigators also reported that Medtronic paid the study authors $210 million in consulting fees for unrelated work over 15 years. "Medtronic's actions violate the trust patients have in their medical care," said Sen. Max Baucus, D-Mont, in a statement. "Medical journal articles should convey an accurate picture of the risks and benefits of drugs and medical devices, but patients...

MEDTRONIC MOTION FOR SUMMARY JUDGMENT DENIED

by gmacweb on
Monday, August 27, 2012 2:20 PM
On August 20, 2012, Plaintiffs were given an important victory in the fight against Medtronic when a Los Angeles Superior Court Judge denied the drug company’s motion to dismiss a Southern California woman’s complaint arising out of the use of an INFUSE Bone Graft during surgery.  Medtronic argued that the case was preempted by the Medical Device Act, meaning that the plaintiff could not file a lawsuit against device companies when its products were approved by the FDA because the approval supercedes state law claims challenging safety, efficacy, or labeling.

As background, the plaintiff claimed an INFUSE Bone Graft that was used off-label  in her back surgery not only failed to cure her pain, but exacerbated her back condition and caused debilitating and permanent injuries.  She alleged that Medtronic illegally promoted the INFUSE Bone Graft for a number of off label procedures and that it was only approved for a limited surgical procedure. 

The Court stated that “plaintiff’s claim is not based...

Letter from Department of Health and Human Services

by gmacweb on
Wednesday, June 13, 2012 2:19 PM

The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has completed its review of your premarket approval application (PMA) for the Infuse Bone Graft. This device is indicated as an alternative to autogenous bone graft for sinus augmentations, and for localized alveolar ridge augmentations for defects associated with extraction sockets. We are pleased to inform you that the PMA is approved. You may begin commercial distribution of the device in accordance with the conditions described below and in the "Conditions of Approval" (enclosed).

Click here to download the full letter


Senate letter - Senatrs Kohl, Grassley, Bluenthal Letter to Medtronic December 2011

by gmacweb on
Wednesday, June 13, 2012 12:28 PM

As Chairman of the Senate Special Committee on Aging, Ranking Member of the Senate Judiciary Committee, and a member of the Senate Helth. Education, Labor and Pensions Committee, we take seriously our responsibility to protect the interests of our nation's health care consumers.  We are writing today to request information on how your company handles recalls, and post-marketing surveillance of your products, two important tools for ensuring that only safe and effective medical devices remain in the marketplace.

View the entire letter


MEDTRONIC INFUSE CONCERNS PROMPT QUESTIONS FROM SENATORS

by gmacweb on
Wednesday, June 13, 2012 11:30 AM
December 2011



Medtronic Inc. is taking more heat over its controversial Infuse bone graft product.  Now, three U.S. Senators are asking questions about Infuse, and want to know if research for the bone growth protein downplayed serious side effects, including cancer, associated with it. Infuse is a recombinant human Bone Morphogenetic Protein (rhBMP-2) that is widely used in spinal fusion surgery. However, it has only been approved by the U.S. Food & Drug Administration (FDA) for use in anterior-approach lumbar fusion. The FDA issued a safety alert for rhBMP products in 2008, after their off-label use in cervical spine (neck) surgeries had been associated with serious, and sometimes life-threatening complication. In their letter, Senators Charles Grassley, R-Iowa, Herb Kohl, D-Wis., and Richard Blumenthal, D-Conn. inquire about Medtronic's tracking of safety information for devices once they have been released to the market. But the Senators also ask specifically about side effects linked...