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.