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COA clears way for negligence complaint against medical device company

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A lawsuit filed against medical device manufacturer Medtronic following the death of a man who had one of the company’s medical devices implanted can continue, the Indiana Court of Appeals ruled Friday. It held the Medical Device Amendments to the Federal Food, Drug and Cosmetics Act does not preempt a family’s negligence claim.

Dr. Lawrence Klein implanted a Medtronic defibrillator and a Medtronic Transvene Model 6936 right ventricular lead in David Malander in 1997. The lead was a Class III medical device subject to premarket Food and Drug Administration approval. Malander’s lead experienced several short V-V intervals, in which the defibrillator senses electrical activity not related to the heart. A surgery was performed to replace the defibrillator, but the lead was left in place in December 2006. Malander died several weeks later after an incident of ventricular tachycardia on Dec. 31, 2006. Testing revealed 361 short V-V intervals of his defibrillator Dec. 14-31, 2006.

During the surgery, Klein called Medtronic’s technical services department to ask questions.

Malander’s relatives sued the doctor and Medtronic, alleging negligence, when Medtronic did not recommend that the lead be removed or capped off during the December surgery. Medtronic argued the claim was preempted by the MDA of the Food, Drug and Cosmetics Act. The preemption clause from the amendments has only been interpreted once by Indiana courts, but that case was distinguishable from the instant one. Turning to jurisdictions outside of Indiana, the appellate court affirmed the denial of summary judgment for Medtronic.

“The Malanders’ claim concerns the allegedly negligent interaction between the physician and Medtronic’s technicians. Their claim does not concern the design, manufacture, or labeling of the lead,” Judge Michael Barnes wrote. “Rather, the Malanders’ challenge involves negligence of Medtronic’s technicians in giving David’s physician allegedly faulty advice regarding the performance of one specific lead. As such, we conclude that the Malanders’ claim is not preempted by the MDA, and the trial court properly denied Medtronic’s motion for summary judgment on this issue.”

The judges also found there to be genuine issue of fact as to whether the company owed a duty to David Malander, so denial of summary judgment was proper in Medtronic, Inc., v. Lori A. Malander, Individually and as Personal Representative of the Estate of David M. Malander, Sr., Deceased and Kathleen Malander, 49A02-1211-CT-925.
 

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  1. My husband financed a car through Wells Fargo In dec 2007 and in Jan 2012 they took him to court to garnish his wages through a company called autovest llc . Do u think the statue of limitations apply from the day last payment was received or from what should have been the completion of the loan

  2. Andrew, you are a whistleblower against an ideologically corrupt system that is also an old boys network ... Including old gals .... You are a huge threat to them. Thieves, liars, miscreants they understand, identify with, coddle. But whistleblowers must go to the stake. Burn well my friend, burn brightly, tyger.

  3. VSB dismissed the reciprocal discipline based on what Indiana did to me. Here we have an attorney actually breaking ethical rules, dishonest behavior, and only getting a reprimand. I advocated that this supreme court stop discriminating against me and others based on disability, and I am SUSPENDED 180 days. Time to take out the checkbook and stop the arrogant cheating to hurt me and retaliate against my good faith efforts to stop the discrimination of this Court. www.andrewstraw.org www.andrewstraw.net

  4. http://www.andrewstraw.org http://www.andrewstraw.net If another state believes by "Clear and convincing evidence" standard that Indiana's discipline was not valid and dismissed it, it is time for Curtis Hill to advise his clients to get out the checkbook. Discrimination time is over.

  5. Congrats Andrew, your street cred just shot up. As for me ... I am now an administrative law judge in Kansas, commissioned by the Governor to enforce due process rights against overreaching government agents. That after being banished for life from the Indiana bar for attempting to do the same as a mere whistleblowing bar applicant. The myth of one lowly peasant with the constitution does not play well in the Hoosier state. As for what our experiences have in common, I have good reason to believe that the same ADA Coordinator who took you out was working my file since 2007, when the former chief justice hired the same, likely to "take out the politically incorrect trash" like me. My own dealings with that powerful bureaucrat and some rather astounding actions .. actions that would make most state courts blush ... actions blessed in full by the Ind.S.Ct ... here: https://www.scribd.com/doc/299040839/2016Petitionforcert-to-SCOTUS

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