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As attorneys who are providing free case evaluations to individuals injured by the off-label use of the Medtronic infuse product, we wanted to advise that state law claims accusing Medtronic of improperly promoting the off-label use of its bone graft device were not preempted according to Arizona Federal Judge G. Murray Snow of the United States District Court for the District of Arizona.

On March 2, 2009, Christina Ramirez underwent a lumbar fusion procedure to alleviate her back pain during which her surgeon used Medtronic’s infuse, a bioengineered liquid bone graft substance that is a class 3 medical device under the Food, Drug and Cosmetic Act.  After surgery, Ms. Ramirez began experiencing severe pain and it was discovered that she had developed uncontrolled bone growth in the area where the surgeon had implanted the infuse device.  Ramirez sued Medtronic in March 2013 asserting claims of fraudulent misrepresentation/fraud in the inducement, failure to warn, defective design, misrepresentation, negligence and breach of express warranty.  All state law claims were based on the surgeon’s off-label use of the device, which allegedly resulted from Medtronic’s active promotion of that use.

Medtronic moved to dismiss the complaint in its entirety asserting that the complaints were federally pre-empted under Section 360(k) of the Medical Device Act which prohibits states from imposing any requirement which is different from or in addition to any requirement which relates to the safety or effectiveness of a Class 3 pre-market approved medical device intended for human use.

Judge Snow reviewed in detail infuse’s safety and effectiveness only for the uses Medtronic specified in its pre-market approval application, and held that the regulations were based on that review.  However, because the requirements are not use-specific, a claim arising solely from the off-label use of the device could face pre-emption.  “The MDA does not seek to control how physicians use regulated devices; indeed, off-label use is expressly permitted as an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.”  Judge Snow followed stating that “when a plaintiff is injured because her doctor used a FDA-approved device for an unapproved use, and she brings state law claims against the manufacturer claiming that it should have provided additional warnings or designed the product differently in light of its unapproved use, the plaintiff is asking the manufacturer to do something ‘different from or in addition to’ federal law.”

The crux of Ramirez’s claim is that she was injured due to an off-label use of infuse that resulted in Medtronic’s practice of promoting such uses.  Judge Snow concluded that Ms. Ramirez’s allegations regarding Medtronic’s off-label promotion allowed the majority of her claims to escape pre-emption.  “When the device is not being used in the manner of the FDA pre-approved and the manufacturer is actually promoting such use, there is no law or policy basis on which to preempt the application of state law designed to provide that protection.”  Judge Snow further explained that “it is true that federal requirements are still applicable to the device, including requirements that Medtronic not alter the design or label of the device without FDA consent.  But when Medtronic allegedly violated federal law by engaging in off-label promotion that damaged that plaintiff and thereby misbranded the Infuse device, it departed the realm of federal regulation and returned to the area of traditional state law remedies.”

Judge Snow not only found that claims not preempted, Judge Snow found that under Fed. R. Civ. P. 9, Ms. Ramirez had sufficiently alleged why statements made by Medtronic representatives were false or misleading and how Medtronic assured the medical community that off-label use of Infuse was safe and effective despite Medtronic’s knowledge of the true effects of off-label use. Furthermore, Ms. Ramirez alleged that her surgeon was paid a consultant fee by Medtronic and therefore was a recipient of the alleged off-label promotion.  The judge similarly ruled that failure to warn and misrepresentation claims survive any pre-emption challenge because those claims exist independent of any federal enactment.  Likewise, the design defect claim was not pre-empted because Ms. Ramirez alleged that Medtronic actually promoted the use of Infuse outside of the prescribed federal approval process.

All this being said, Judge Snow did dismiss the negligence claims as impliedly pre-empted pursuant to Buckman because that claim was based wholly on violations of the FCA and MDA.  The claims were not parallel to any such violation.

Finally, the judge dismissed the breach of express warranty claims in which Ms. Ramirez alleged Medtronic of using articles, advertisements, and the like to promote off-label usage of the Infuse device.  Although the claims survives pre-emption, it fails under Arizona law because Ms. Ramirez failed to allege that Medtronic targeted her specifically with any guarantees.

If you have been injured by a Medtronic Infuse device, please contact us as soon as possible for a free case evaluation.

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NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.

FREE CASE EVALUATION: 1-800-632-1404

As attorneys that are offering free case evaluations to persons injured by the Medtronic Infuse device, we wanted to advise that Magistrate Judge Paul Papak of the District of Oregon has found that a majority of claims brought by plaintiffs have survived a preemption analysis.

On March 11, 2013, Richard D. Alton sued Medtronic and Medtronic Safamor Danek USA, Inc. alleging he suffered complications following an April 2, 2010 implantation of Medtronic’s Infuse device in his spine.  He also asserted claims of fraud, strict products liability (failure to warn, defective design, misrepresentation), negligence, and breach of express warranty.

The Infuse device is a Class 3 medical device under the medical device amendments of the 1976 Food, Drug and Cosmetic Act.  It contains a bone morphogenetic protein used in connection with a collagen scaffold and a tapered metallic spinal fusion cage.  At the time that Medtronic obtained FDA approval for Infuse, it began to aggressively promote off-label uses of the device including that protein in posterior lumbar interbody fusion procedures (PLIF).  PlaintiffAltonunderwent PLIF surgery in which the protein component of the Infuse device was implanted in his lumbar spine without the interbody cage. Altonalleged his surgeon was unaware of the risks associated with such an application of the protein component of the device due to Medtronic’s suppression of information regarding such risks.  Mr. Alton claimed he developed uncontrolled exuberant bone growth in his lumbar spine necessitating further surgery and significant pain.

Magistrate Judge Papak was charged with ruling on Medtronic’s Motion to Dismiss under the preemption doctrine holding that a medical device manufacturer cannot be held to a higher standard of care and imposed to different or additional requirements other than those approved by the FDA.  Magistrate Judge Papak noted that state law claims arising out of the use of Class 3 medical devices approved by the FDA may be impliedly preempted or expressly preempted.  The Judge found, however, that “parallel state law claims escape expressed preemption as those claims are either based on conduct that violates the FDCA and is independently actionable under state law or based on conduct that contravenes state law duties of such generality as not to present any risks of interferences with the Federal Medical Device Regulatory scheme.”

In the claims for fraud and misrepresentation, Mr. Alton alleged that Medtronic intentionally misrepresented material health and safety risk information to the public, to Mr. Alton and to his physicians in the course of affirmatively marketing off-label applications of the Infuse device.  Judge Papak found that these claims were not preempted because they were “based on conduct that contravenes state law duties of such generality as not to present any risk of interference with the Federal Medical-Device Regulatory scheme.”  Judge Papak also addressed failure to warn claims.  The Magistrate Judge concluded that such a claim was parallel because the off-label application that resulted in Mr. Alton’s injury was an intended use.  Accordingly, Mr. Alton’s allegations described conduct in contravention of Medtronic’s duty to provide adequate directions to an intended use of its product labeling.

Nevertheless, Judge Papak found that failure to warn claims were preempted under Section 360(K)(a) to the extent that recognition of the claim would constitute imposition of any warning requirement in addition to or different from the adequate directions for use that would be mandated under the FDCA for PLIF surgery involving bone protein component alone.  Judge Papak found that the negligence claim was parallel because it did not seek to impose any state law requirements different from or in addition to those requirements imposed by the FDA.  Nothing that pleading suggested that the theory of Medtronic’s’ breach of its duties of harms would implicate any state law requirement.

Unfortunately, defective design claims were preempted because those constitute imposition of requirements of the design on the device in addition to those mandated by the FDA through PMA approval.

If you or someone you know has been injured as a result of the Infuse device, please contact us as soon as possible for a free case evaluation.

CALL: 1-800-632-1404

EMAIL: clicking here

FILL OUT THIS FORM FOR A FREE CONSULTATION AND CASE EVALUATION:

NOTE: Our team of attorneys will review potential cases for all fifty states, including Alabama Alaska Arizona Arkansas California Colorado Connecticut Delaware Florida Georgia Hawaii Idaho Illinois Indiana Iowa Kansas Kentucky Louisiana Maine Maryland Massachusetts Michigan Minnesota Mississippi Missouri Montana Nebraska Nevada New Hampshire New Jersey New Mexico New York North Carolina North Dakota Ohio Oklahoma Oregon Pennsylvania Rhode Island South Carolina South Dakota Tennessee Texas Utah Vermont Virginia Washington West Virginia Wisconsin and Wyoming.