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Medtronic Lawsuit Plaintiffs Earn Relief from Special Appeals Court

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Annapolis, MDThe plaintiffs in a Medtronic lawsuit may have faced stormy seas when a trial court dismissed various claims against the manufacturer of the Medtronic Infuse bone graft. However, when a Special Appeals Court reviewed the case within the framework of the Medical Device Amendments Act of 1976 (MDA) and the various nuances of the framework that governs whether or not state obligations are preempted by federal oversight, the plaintiffs found some relief.

Judging from the details of the Medtronic bone graft lawsuit, the relief imposed by the Court of Special Appeals of Maryland is about the only “relief” that plaintiff Steven McCormick could look forward to.

But first, a brief synopsis of the Medtronic Infuse bone graft system that was approved by the US Food and Drug Administration (FDA) in 2002. Infuse is characterized by the application of a synthetic, genetically engineered protein that stimulates bone growth. One can imagine, given the robust nature of bone once growth is stimulated, that strict parameters are required in order to ensure against overgrowth or bone stimulation in the wrong place - potentially posing dire consequences to the patient.

To that end, the FDA approval of Infuse was based on a strict set of criteria: among them, access to the spine was required from the front (anterior) rather than the back (posterior). Also, the specific use of a recommended cage in order to direct the bone growth along a specific pathway.

However, that didn’t appear to happen for plaintiff Steven McCormick, who underwent spinal fusion surgery to relieve chronic back pain. According to court documents, the surgeon is alleged to have used a Medtronic cage that had not been approved by the FDA. What’s more, the surgeon approached the patient’s spine from the back (posterior) rather than the front (anterior), and is alleged to have used an excessive amount of the Infuse protein.

In other words, the surgery became a Medtronic off-label situation.

McCormick is reported to have become permanently disabled as of 2008, and required revision surgery in the fall of 2010 in order to address Medtronic complications described as “bony overgrowth.” Surgeons had also found when McCormick was examined the previous spring that the cervical disc space where the Medtronic Infuse bone graft had been implanted had narrowed.

The Medtronic Guy was in the operating room…

McCormick and his wife jointly sued Medtronic and various other parties. Amongst the allegations was the alleged promotion of Medtronic for off-label use. While a doctor or surgeon has the legal, moral and medical authority to use a product for indications not approved by the FDA (off label), a manufacturer cannot be seen as promoting a medical device for uses beyond those sanctioned by the regulator.

According to the Medtronic lawsuit brought by the McCormicks, a Medtronic sales rep was present in the operating theater when the surgeon performed the procedure.

Claims were brought against Medtronic, and a Medtronic subsidiary, for negligence, strict products liability, breach of warranty, fraud and violations of the Consumer Protection Act. The attending surgeon, Dr. Michael K. Rosner, was cited for alleged failure to obtain informed consent. Medtronic sales rep Vincent Profitt, who was allegedly present when the surgery occurred, was also named in the lawsuit.

The trial court dismissed the charges against Medtronic, concluding that federal law preempts the claims for breach of any express warranties that Medtronic may have made in voluntary communications with the public or members of the medical professions outside of the context of the FDA-mandated and FDA-approved labeling for the device.

However, the Special Appeals Court took a different view: “The conduct on which the plaintiff’s claim is premised must violate [The United States Federal Food, Drug, and Cosmetic Act, FDCA] if the claim is to escape express preemption, but the conduct must also be the type of conduct that would traditionally give rise to liability under state law even if the FDCA had never been enacted.”

In other words, the preemption of state law claims is limited to when a manufacturer has duly complied with federal law, not when the manufacturer has been seen or is alleged to have violated federal law in some fashion.

About a year following his revision surgery, plaintiff McCormick learned about the presence of two nodules in his lungs that require monitoring to ensure they are not cancerous. Medtronic Infuse bone graft has been linked to cancer.

The case is Steven L. McCormick, et ux. v. Medtronic, Inc., et al.,. Case No. 670, in the Court of Special Appeals of Maryland.

READ ABOUT MEDTRONIC INFUSE BONE GRAFT LAWSUITS

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READER COMMENTS

Posted by

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I to have had very little luck finding a attorney to help with my Medtronic lawsuit. I've had 5 surgeries Two revisions It's a shame that lawyers don't want to help the weak and defenseless it sees it's all about the money. I say we file our own class action lawsuit put up a message board and get as many victims as we can and file I to am in MD. And the damage has permanently changed my life with losses and more losses. Anyone interested contact me at

Posted by

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My surgery was a L5S1 in 2010 in Minneapolis, MN. It was performed for chronic lower back pain and degenerative bone disease. Procedure was to relive and correct the problem and future ones. After one year of waiting for the product to fuse, it did not take. Return to surgeon, still under his care, the surgeon wanted to go back into his spine and remove the small screws and replace with larger ones. Not knowing if it would work, the surgeon says. That implant, "cow bone" I have in my lower back has been recalled. For 6 years now, my pain has escalated. I'm totally disable and my medical condition has deteiorated with other new medical problems. I can't find an attorney that will take my case due it being against Medtronic. I did have an attornoey out of Louisana and after 2 1/2 years they sent an offer of $10,000.00 and to never persue Medtronic ever again. I refused the settlement and they stated to me that there was a statue of time and that time had past. He needed to take the settlement, "consider it has free money", they stated. I've been calling and talking to varies attorney offices but no one is willing to take my case when Medtronic is mentioned. Someone please help me and point me in the right direction. Thank you

Posted by

on
I had infused surgery in 2005 , with problems since, and lung surgery removed nodels from my lungs. And now I need surgery again. They want to give people peanuts . I guess my life mean nothing to that company.

Posted by

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now 3 years and nothing, get no replies and at this point in time most likely living in my car bad heart and all in this heat, have my sister as poa and if they ever respond she will find me as she helps the homeless. # of these in my back going thru my back, never told they were doing this and never hear from law firm. Even a little info from them may have let me buy a house I want for less than 200 a month. I take pain meds all day long, now knees gone due to how I walk with a cane and again never any replies and any info I get are lies. Something just not right with the way this lawsuit is going or not going, may be time to go after law firm for all they did not do for me and let them pay big time.....what choice do we have as I cannot work and out priced where I live...the law firm that cares, even tried for a loan against settlement as I was told settled Feb1, 2016 and wanted a grand for Christmas, all I got was a yelling at by firm for the papers loan company sent, all should be looked into as something not right being in the dark for all this time, I hung with many lawyer friends, had to use law firms and did a workers comp case myself so know a bit of the law and know this is not right on how it is handled, prayers for all suffering like me and for a big settlement as we deserve all we can get!

Posted by

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I'm also going thru lower level paralyses. Im a 3 level APLIF L2-L5 with 8 screws 2 7/8" long posteriorly, 3 shorter wide screws anteriorly with 2 posterior rods 3 allograft and bmp. I let the firm that was handling my case go a couple months ago. Last week I also received a 6800.00 offer in which the law firm also hired another firm I was never told of plus a mediator to figure what insurance got paid back.. this all to come out of the lousy 6800.00 with a stipulation I could never tell anyone about having bmp damage or Medtronic could could take up to 25 ? of the settlement for a fine for each occurrence your caught talking about it along with anytime in the future they could take action against me for it. I'm suppose to have 5 more levels done but when I called to schedule it I was told my surgeon can't operate at this time. Nobody will touch a bmp fusion patient in need a revision. My foot was ordered amputated from this. I've gotten my orders for my camber chair that'll run 3500.00 plus a ramp needed and accessories for the house. For 6800.00 I'm darn glad I fired them months ago. I shouldn't have even gotten an offer. Big Pharma.. keep your money I'm keeping my freedom of speech. After bmp it's all I've got left to defend myself and others from your product. I'd like to see a study done on stray voltage and the effects it's had on patients with bmp in legs or without a spine. I've done my reading.. I hope the rest will do the same and save yourselves the misery. I consider this product population control not a medical break thru. To anyone that did take this horrible offer of 6800.00 lousy bucks.. I understand they made it entirely impossible to go back to work and support ourselves the way we planned and if your hungry the money is needed. Just remember to keep your mouth shut or the company will take you to court according to my papers or you may not even receive your settlement if you speak of it prior to the money being in your hand. Best wishes to all the patients. Find a support group or start one cuz our life is worth living still, no matter how much pain.. we all have to be strong for our families. I know mine gets pretty down watching me struggle. Keep your smiles no matter what people:)

Posted by

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I had emergency spine surgery after being paralyzed by a myelogram. During this surgery 4 large kits of Infuse were placed in my spine during open posterior surgery which this product was not approved for. I had no idea what was being done to me because after I became paralyzed I was sedated until they got me into the operating room. My wife was with me and they shoved papers in front of her and she signed them. When I woke up I had at least four spinal fusions with instrumentation. These were located in the lumbar and thoracic spine. Since then I have experienced nerve damage, bone growth in the spinal canal, and chronic pain. I was examined by a neurosurgeon and was told there was nothing that could be done because my spine was a wreck and anything they attempted might either paralyze me from the waist down or even possibly kill me. I filed a lawsuit about three years ago and recently received a settlement offer of $6800.00.
You haven't been embarrassed until you have crapped all over yourself in Wal-Mart because the nerves to your anal sphincter have been damaged and losing your ability to have sex because you have nerve damage to those nerves as well makes for some marital problems that aren't easily resolved either. Plus the nerves in my right leg are continuing to degrade and I am losing my ability to even walk with crutches. I have no health insurance only the VA which is mostly useless for anything above a cold and sniffles. I have fought for years undergoing many hours of exercise therapy and doing everything I could to keep walking but the battle is nearly over now and there is a big wheel chair sitting in my living room and it won't be much longer before I'm stuck in it for the rest of my days. I certainly never thought this would be my end and I am most certainly disappointed in a legal system that allows attorneys to make millions while the people who were injured get crumbs. By the way the wheel chair cost more than they offered me to settle but fortunately I got it before I lost my health insurance.

Posted by

on
Good Read!

Kuzmich Law

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