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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. From back in the day before secularism got a stranglehold on Hoosier jurists comes this great excerpt via Indiana federal court judge Allan Sharp, dedicated to those many Indiana government attorneys (with whom I have dealt) who count the law as a mere tool, an optional tool that is not to be used when political correctness compels a more acceptable result than merely following the path that the law directs: ALLEN SHARP, District Judge. I. In a scene following a visit by Henry VIII to the home of Sir Thomas More, playwriter Robert Bolt puts the following words into the mouths of his characters: Margaret: Father, that man's bad. MORE: There is no law against that. ROPER: There is! God's law! MORE: Then God can arrest him. ROPER: Sophistication upon sophistication! MORE: No, sheer simplicity. The law, Roper, the law. I know what's legal not what's right. And I'll stick to what's legal. ROPER: Then you set man's law above God's! MORE: No, far below; but let me draw your attention to a fact I'm not God. The currents and eddies of right and wrong, which you find such plain sailing, I can't navigate. I'm no voyager. But in the thickets of law, oh, there I'm a forester. I doubt if there's a man alive who could follow me there, thank God... ALICE: (Exasperated, pointing after Rich) While you talk, he's gone! MORE: And go he should, if he was the Devil himself, until he broke the law! ROPER: So now you'd give the Devil benefit of law! MORE: Yes. What would you do? Cut a great road through the law to get after the Devil? ROPER: I'd cut down every law in England to do that! MORE: (Roused and excited) Oh? (Advances on Roper) And when the last law was down, and the Devil turned round on you where would you hide, Roper, the laws being flat? (He leaves *1257 him) This country's planted thick with laws from coast to coast man's laws, not God's and if you cut them down and you're just the man to do it d'you really think you would stand upright in the winds that would blow then? (Quietly) Yes, I'd give the Devil benefit of law, for my own safety's sake. ROPER: I have long suspected this; this is the golden calf; the law's your god. MORE: (Wearily) Oh, Roper, you're a fool, God's my god... (Rather bitterly) But I find him rather too (Very bitterly) subtle... I don't know where he is nor what he wants. ROPER: My God wants service, to the end and unremitting; nothing else! MORE: (Dryly) Are you sure that's God! He sounds like Moloch. But indeed it may be God And whoever hunts for me, Roper, God or Devil, will find me hiding in the thickets of the law! And I'll hide my daughter with me! Not hoist her up the mainmast of your seagoing principles! They put about too nimbly! (Exit More. They all look after him). Pgs. 65-67, A MAN FOR ALL SEASONS A Play in Two Acts, Robert Bolt, Random House, New York, 1960. Linley E. Pearson, Atty. Gen. of Indiana, Indianapolis, for defendants. Childs v. Duckworth, 509 F. Supp. 1254, 1256 (N.D. Ind. 1981) aff'd, 705 F.2d 915 (7th Cir. 1983)

  2. "Meanwhile small- and mid-size firms are getting squeezed and likely will not survive unless they become a boutique firm." I've been a business attorney in small, and now mid-size firm for over 30 years, and for over 30 years legal consultants have been preaching this exact same mantra of impending doom for small and mid-sized firms -- verbatim. This claim apparently helps them gin up merger opportunities from smaller firms who become convinced that they need to become larger overnight. The claim that large corporations are interested in cost-saving and efficiency has likewise been preached for decades, and is likewise bunk. If large corporations had any real interest in saving money they wouldn't use large law firms whose rates are substantially higher than those of high-quality mid-sized firms.

  3. The family is the foundation of all human government. That is the Grand Design. Modern governments throw off this Design and make bureaucratic war against the family, as does Hollywood and cultural elitists such as third wave feminists. Since WWII we have been on a ship of fools that way, with both the elite and government and their social engineering hacks relentlessly attacking the very foundation of social order. And their success? See it in the streets of Fergusson, on the food stamp doles (mostly broken families)and in the above article. Reject the Grand Design for true social function, enter the Glorious State to manage social dysfunction. Our Brave New World will be a prison camp, and we will welcome it as the only way to manage given the anarchy without it.

  4. When I hear 'Juvenile Lawyer' I think of an attorney helping a high school aged kid through the court system for a poor decision; like smashing mailboxes. Thank you for opening up my eyes to the bigger picture of the need for juvenile attorneys. It made me sad, but also fascinated, when it was explained, in the sixth paragraph, that parents making poor decisions (such as drug abuse) can cause situations where children need legal representation and aid from a lawyer.

  5. Some in the Hoosier legal elite consider this prayer recommended by the AG seditious, not to mention the Saint who pledged loyalty to God over King and went to the axe for so doing: "Thomas More, counselor of law and statesman of integrity, merry martyr and most human of saints: Pray that, for the glory of God and in the pursuit of His justice, I may be trustworthy with confidences, keen in study, accurate in analysis, correct in conclusion, able in argument, loyal to clients, honest with all, courteous to adversaries, ever attentive to conscience. Sit with me at my desk and listen with me to my clients' tales. Read with me in my library and stand always beside me so that today I shall not, to win a point, lose my soul. Pray that my family may find in me what yours found in you: friendship and courage, cheerfulness and charity, diligence in duties, counsel in adversity, patience in pain—their good servant, and God's first. Amen."

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