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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. I just wanted to point out that Congressman Jim Sensenbrenner, Senator Feinstein, former Senate majority leader Bill Frist, and former attorney general John Ashcroft are responsible for this rubbish. We need to keep a eye on these corrupt, arrogant, and incompetent fools.

  2. Well I guess our politicians have decided to give these idiot federal prosecutors unlimited power. Now if I guy bounces a fifty-dollar check, the U.S. attorney can intentionally wait for twenty-five years or so and have the check swabbed for DNA and file charges. These power hungry federal prosecutors now have unlimited power to mess with people. we can thank Wisconsin's Jim Sensenbrenner and Diane Feinstein, John Achcroft and Bill Frist for this one. Way to go, idiots.

  3. I wonder if the USSR had electronic voting machines that changed the ballot after it was cast? Oh well, at least we have a free media serving as vicious watchdog and exposing all of the rot in the system! (Insert rimshot)

  4. Jose, you are assuming those in power do not wish to be totalitarian. My experience has convinced me otherwise. Constitutionalists are nearly as rare as hens teeth among the powerbrokers "managing" us for The Glorious State. Oh, and your point is dead on, el correcta mundo. Keep the Founders’ (1791 & 1851) vision alive, my friend, even if most all others, and especially the ruling junta, chase only power and money (i.e. mammon)

  5. Hypocrisy in high places, absolute immunity handed out like Halloween treats (it is the stuff of which tyranny is made) and the belief that government agents are above the constitutions and cannot be held responsible for mere citizen is killing, perhaps has killed, The Republic. And yet those same power drunk statists just reel on down the hallway toward bureaucratic fascism.

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