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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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  3. All these sites putting up all the crap they do making Brent Look like A Monster like he's not a good person . First off th fight actually started not because of Brent but because of one of his friends then when the fight popped off his friend ran like a coward which left Brent to fend for himself .It IS NOT a crime to defend yourself 3 of them and 1 of him . just so happened he was a better fighter. I'm Brent s wife so I know him personally and up close . He's a very caring kind loving man . He's not abusive in any way . He is a loving father and really shouldn't be where he is not for self defense . Now because of one of his stupid friends trying to show off and turning out to be nothing but a coward and leaving Brent to be jumped by 3 men not only is Brent suffering but Me his wife , his kids abd step kidshis mom and brother his family is left to live without him abd suffering in more ways then one . that man was and still is my smile ....he's the one real thing I've ever had in my life .....f@#@ You Lafayette court system . Learn to do your jobs right he maybe should have gotten that year for misdemeanor battery but that s it . not one person can stand to me and tell me if u we're in a fight facing 3 men and u just by yourself u wouldn't fight back that you wouldn't do everything u could to walk away to ur family ur kids That's what Brent is guilty of trying to defend himself against 3 men he wanted to go home tohisfamily worse then they did he just happened to be a better fighter and he got the best of th others . what would you do ? Stand there lay there and be stomped and beaten or would u give it everything u got and fight back ? I'd of done the same only I'm so smallid of probably shot or stabbed or picked up something to use as a weapon . if it was me or them I'd do everything I could to make sure I was going to live that I would make it hone to see my kids and husband . I Love You Brent Anthony Forever & Always .....Soul 1 baby

  4. Good points, although this man did have a dog in the legal fight as that it was his mother on trial ... and he a dependent. As for parking spaces, handicap spots for pregnant women sure makes sense to me ... er, I mean pregnant men or women. (Please, I meant to include pregnant men the first time, not Room 101 again, please not Room 101 again. I love BB)

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